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Minimally Invasive Bariatric Surgery, Second Edition
Minimally Invasive Bariatric Surgery, Second Edition
Brethauer
Philip R. Schauer
Bruce D. Schirmer
editors
Minimally
Invasive Bariatric
Surgery
Second Edition
123
Minimally Invasive Bariatric
Surgery
wwwwwwww
Minimally Invasive Bariatric
Surgery
Second Edition
Editors
Stacy A. Brethauer, MD
Assistant Professor of Surgery
Cleveland Clinic Lerner College of Medicine
Bariatric and Metabolic Institute
Cleveland Clinic
Cleveland, OH, USA
Philip R. Schauer, MD
Professor of Surgery
Cleveland Clinic Lerner College of Medicine
Director, Bariatric and Metabolic Institute
Cleveland Clinic
Cleveland, OH, USA
Bruce D. Schirmer, MD
Stephen H. Watts Professor of Surgery
Department of Surgery Health Sciences Center
University of Virginia Health System
Charlottesville, VA, USA
Editors
Stacy A. Brethauer, MD Philip R. Schauer, MD
Assistant Professor of Surgery Professor of Surgery
Cleveland Clinic Lerner College of Medicine Cleveland Clinic Lerner College of Medicine
Bariatric and Metabolic Institute Director, Bariatric and Metabolic Institute
Cleveland Clinic Cleveland Clinic
Cleveland, OH, USA Cleveland, OH, USA
Bruce D. Schirmer, MD
Stephen H. Watts Professor of Surgery
Department of Surgery
Health Sciences Center
University of Virginia Health System
Charlottesville, VA, USA
To my wife, Pam, and our great kids, Katie, Anna, and Jacob for their
continued support and encouragement. Also, to my patients who give me the
privilege of helping them on their journey to a healthier life.
SAB
It is truly amazing how rapidly the field of bariatric surgery has changed over the last two
decades. As we proudly present our second edition of this text, it is clear that much has changed
in our field even since the first edition was published. The obesity and diabetes epidemic that
is upon us has spurred a sense of urgency among bariatric surgeons to provide safe and effec-
tive treatment to as many patients as possible and to educate our referring physicians about the
benefits of these metabolic procedures. There is still much work to be done to provide even
better access to patients and to ensure high quality care at a national level, but there are few, if
any, disciplines in surgery that have come so far in such a short time as bariatric surgery. The
morbidity and mortality rates after laparoscopic bariatric surgery are now equivalent to many
other commonly performed elective operations such as hysterectomy, hip replacement, and
cholecystectomy. That is a remarkable accomplishment that reflects the impact of laparoscopic
techniques, advanced training programs, and an emphasis on quality patient care that have
been the hallmarks of bariatric surgery since the 1990s.
This new edition highlights many of the advances in our field over the last 7 years with
regard to the multidisciplinary management of the obese patients and surgical outcomes.
Updated chapters on the medical and perioperative management of these patients provide
state-of-the-art management pathways to guide practicing bariatric physicians and surgeons.
Quality improvement, value-based care, and outcome reporting have entered the lexicon of
every practicing surgeon now, and we have also added an important chapter on patient safety
and quality improvement for the bariatric surgery program.
A major shift that has occurred in bariatric surgery over the last decade has been the accep-
tance of sleeve gastrectomy as a primary bariatric procedure. As sleeve gastrectomy surpasses
gastric bypass in the United States as the most commonly performed procedure, there is still
much debate about the long-term role of this relative newcomer to our field. This updated text
incorporates current updates on techniques, outcomes, and management of complications after
sleeve gastrectomy to address the successes and challenges of this operation. New investigative
techniques and procedures, both surgical and endoscopic, comprise a small proportion of clini-
cal activity currently, but are discussed in this update as these concepts may hold promise for
less-invasive and more widely accepted interventions in the future.
This second edition provides surgical technique chapters written by leaders in the field
accompanied by updated illustrations and videos to inform the resident or fellow preparing for
the next day’s case. Outcome chapters for each procedure reflect the current state of the evi-
dence and the text also provides practical management strategies for complications that occur
after each procedure accompanied by figures and images that illustrate these clinical
challenges.
As the emphasis on weight loss after these operations has been overtaken by the discussion
regarding metabolic benefits, we have added new chapters and authors to provide clear
vii
viii Preface
ix
x Contents
Sean J. Barnett
Cincinatti Children’s Hospital Medical Center, Pediatric and General Thoracic Surgery,
Cincinatti, OH, USA
xiii
xiv Contributors
Bipan Chand
Department of Surgery, Stritch School of Medicine, Loyola University Chicago, Chicago, IL,
USA
George M. Eid
Allegheny Health Network, Pittsburgh, PA, USA
Giselle G. Hamad
Department of Surgery, University Pittsburgh Medical Center, Pittsburgh, PA, USA
Dennis Hurwitz
UPMC Magee Women’s Hospital—Plastic Surgery, University of Pittsburgh, Pittsburgh, PA, USA
Thomas H. Inge
Department of Pediatric and General Thoracic Surgery, Cincinatti Children’s Hospital Medical
Center, Cincinatti, OH, USA
Karina A. McArthur
Kaiser Permanente Mid Atlantic, Holy Cross Hospital, Pittsburgh, PA, USA
Kathleen M. McCauley
Goodman Allen & Filetti, PLLC, Glen Allen, VA, USA
Contributors xvii
Marc P. Michalsky
Nationwide Children’s Hospital, Columbus, OH, USA
Cyrus Moon, MD
Minimally Invasive Bariatric Surgery, Fresno Heart and Surgical Hospital, Fresno, CA, USA
Pornthep Prathanvanich
Department of Surgery, Stritch School of Medicine, Loyola University Chicago, Chicago,
IL, USA
Krzysztof J. Wikiel
Department of Surgery, Magee-Women’s Hospital of UPMC, Pittsburgh, PA, USA
One could only wonder what aliens who visited Earth briefly Of the high-income nations, there were divergent trends for
40 years ago and returned today would think of the changes both men and women with greater rises in obesity prevalence in
seen in the dominant intelligent life form inhabiting the Australasia and North America compared with Western Europe
planet. Large numbers of humans have become quite bloated, and high-income areas of Asia. Women had greater increases in
sluggish, and many have difficulty getting around. This obesity prevalence than men in sub-Saharan Africa and Latin
would appear the most obvious change in the human condi- America and the Caribbean. Men had greater a increase in
tion during that period. What has happened? What has gone prevalence throughout Europe and the high-income regions of
wrong? What will things be like should our visitors return in the Asia-Pacific region [1]. “If the rates of weight gain
another 40 years? (in Australia) observed in the first 5 years of this decade are
The obesity-diabetes epidemic has rolled out progres- maintained, our findings suggest that normal-weight adults will
sively and inexorably since the 1970s, and little has been constitute less than a third of the population by 2025, and the
done globally to prevent it. The causes are poorly under- obesity prevalence will have increased by 65 %” [2].
stood, and any attempts to change the trends appear piece- With increasing levels of obesity, we see an exponential
meal, tokenistic, and ineffective. Regions of the developing rise in class III obesity (BMI > 40 kg/m2). In the USA between
world that appeared to be protected with their economic and 2000 and 2005, the prevalence of obesity increased by 24 %,
lifestyle characteristics are surpassing all expectations, and class III obesity by 50 %, and BMI >50 kg/m2 by 75 %, two
even those in rural areas of developing countries are running and three times faster, respectively [3]. Similar trends are
head first into the diabesity epidemic. reported in Australia [4]. The resultant exponential increase
in class III obesity and super obesity is an expected trend as
Obesity a Global Issue: The global age-standardized preva-
the mean BMI for a community steadily increases. There is
lence of obesity nearly doubled from 6.4 % in 1980 to 12.0 %
also an important gender trend with increasing levels of
in 2008. Half of this rise occurred in the 20 years between
obesity with women more likely to have the more severe
1980 and 2000 and half occurred in the 8 years between 2000
forms of obesity Table 1. Scattered reports of a leveling off of
and 2008 [1]. The magnitude of rise has varied with region,
obesity prevalence in small subsections of the community,
country, and gender; however, stabilization of the obesity
for example, in adolescent and young adult women, should be
prevalence is rare, and of great concern, the rise has acceler-
treated cautiously as levels are still high, and we need to reflect
ated globally over the last decade. In 1980, half of the 572
about the weight trajectories of their mothers and grand-
million adults with a BMI >25 kg/m2 lived in just five coun-
mothers who at an equivalent age were generally more petite.
tries headed by China 72 million and the USA 70 million. In
For years we have watched as the US CDC state by state
2008, countries with the most overweight people were China
obesity levels have risen year by year and reassured our-
(241 million) and the USA (158 million). The largest abso-
selves that either our state was not the worst or, better still,
lute rise in obesity (BMI >30 kg/m2) occurred in the USA
we lived outside the USA and were immune to the catastro-
(56 million) and China (42 million), followed by Brazil
phe within. But alas, we can now watch similar changes in
(20 million) and Mexico (18 million). The region with the
the Canadian provinces and UK counties, and thanks to the
highest global prevalence of obesity includes small islands in
International Association for the Study of Obesity (IASO),
the Western Pacific such as Nauru, Samoa, Tonga, and the
we have a global atlas of the emerging trends. Sadly no
Cook Islands where obesity rates exceed 50 % and for some
global area is or will remain immune.
subgroups 70 % [1].
TABLE 1. Estimates of the proportion of the US adult population with a BMI > 40 kg/m2
1960 (%) 1980 (%) 2000 (%) 2010 (%)
Women (USA) 1.4 2.8 6.1 7.4
Men (USA) 0.4 0.8 2.9 4.3
Adapted from the IASO website [5]
Ethnic Differences Risk: Ethnic-Based China indicates a major public health problem that has
occurred in parallel with the massive changes in development
Action Points and gross domestic product [8].
A recent review of diabetes prevalence in the rural areas
Diabetes as a Global Issue: While it can be often assumed of low- and middle-income countries revealed a quadrupling
that the emerging epidemic of type 2 diabetes parallels the of prevalence over the last 25 years. Diabetes prevalence
obesity epidemic, there are a range of other important con- increased over time, from 1.8 % in 1985–1989, 5.0 % in
siderations that influence the global and regional incidence, 1990–1994, 5.2 % in 1995–1999, 6.4 % in 2000–2004, to
prevalence, and total burden of type 2 diabetes. 8.6 % for 2005–2010 [9]. However, this is only part of the
The International Diabetes Federation “World Diabetes story as it is estimated that between 2010 and 2013, the num-
Atlas” updated in 2012 provides an excellent overview of the ber of adults with diabetes will increase by 69 % in devel-
global situation, and there are very important regional con- oping countries, while the expected increase in developed
siderations. Globally it is estimated that 371 million live with countries is 20 % [10]. The diabetes burden in developing
diabetes, an overall adult prevalence is 8.3 %, and half of countries is also troubling as the increase in diabetes preva-
these cases are undiagnosed: lence is dominated by the 40–59 age group, a time of produc-
• Countries with the highest prevalence of diabetes are in tivity and employment, rather than being driven by aging as
two regions the Western Pacific Island nations and in the is the case developed countries (Fig. 1) [10].
Middle East. Examples of the highest prevalence rates in Factors influencing the number of people with diabetes
adults include Federation of Micronesia (37 %), Nauru also vary considerable between developed and developing
(31 %), and Marshall Islands (27 %) in the Western Pacific countries. If the incidence of diabetes exceeds mortality, then
and Kuwait (24 %), Saudi Arabia (23 %), and Qatar the prevalence rises. The absolute number of people with
(23 %) in the Middle East. diabetes will be influenced by a range of factors, and the
• Countries with the highest absolute numbers in descend- relative contributions of these factors vary considerably
ing order are China (92 million), India (63 million), the (Fig. 2). An increased prevalence of diabetes is not simply
USA (24 million), and Brazil (14 million). And the region related to an increase incidence. In the period between 1999
with the highest numbers is the Western Pacific with 132 and 2004 in Taiwan, the prevalence of diabetes increased
million. 38 % and 24 % in men and women, respectively, but during
• Sub-Saharan Africa is the region with the highest level of the same period, incidence dropped 4 % and 13 %, respec-
undiagnosed diabetes (80 %). tively. An increased incidence in younger adults and a
reduced incidence in the elderly increased prevalence sub-
It is the Asian area that now contributes to more than 60 % stantially [11].
of the world’s population with diabetes where some of the Diabetes incident and prevalence data from Ontario
most dramatic increases in diabetes prevalence have occurred Canada between 1995 and 2005 provides another example of
over recent decades. All Asian countries have seen major rises the interactions that lead to prevalence. During this period,
as the rapid socioeconomic growth and industrialization inter- the age- and sex-adjusted prevalence of diabetes in the prov-
act with populations that have a strong genetic and ethnic risk ince increased 69 %, from 5.2 % in 1995 to 8.8 % in 2005.
of diabetes. Asians develop diabetes at a lower threshold of The rate of increase in prevalence was greater in a younger
environmental and anthropometric risk (BMI and waist cir- population and the mortality of those with diabetes fell by
cumference) [6]. Another striking characteristic of diabetes in 25 %. Thus, the increased prevalence in diabetes is attributed
the Asian region is the striking narrowing of the urban–rural to both an increased incidence and improved survival [12].
divide in diabetes prevalence. While urbanization and industri- The prevalence of diabetes in the USA is also greatly
alization were thought to drive increased risk of diabetes, it is influenced by an increased survival of those with diabetes.
now clear that the rural areas are following very closely During the period 1997 to 2004, the National Health
behind. In the Shanghai region of China, urban diabetes preva- Interview Survey found that age-adjusted excessive death
lence rose from 11.5 to 14.1 % between 2002–2003 and 2009, rates for those with diabetes (compared with those without
while the rural diabetes prevalence rose from 6.1 to 9.8 % dur- diabetes) declined by 60 %, from 5.8 additional deaths/1000
ing the same period [7]. The rapid rise in diabetes numbers in to 2.3 additional deaths/1000, for cardiovascular disease, and
1. The Global Burden of Obesity and Diabetes 3
100
80
60
40
20
0
2010 2013 2010 2013 2010 2013
Increasing
Increasing numbers Improved survival of
numbers of
of people at risk people with
people with DM
diabetes
for all-cause age-adjusted mortality a decline of 44 % from It becomes clear that while increasing levels of obesity
10.8 to 6.1 deaths/1000. The declines were similar in both play a major role in the increasing global population with
men and women [13]. Similar declines in mortality have diabetes, there are other major contributing determinants.
been reported in other developed countries including Canada, The contrast in these determinants in developing compared
Norway, and Finland. These encouraging findings have been with developed nations is presented in Table 2.
attributed to a range of advances including systematic Causes Are Complex: The global biological determinants
improvements in the quality and organization of care, for the obesity-diabetes epidemic appear complex and poorly
improved models of chronic disease management, and the understood. They extend well beyond the global marketing
active promotion of self-care behaviors. More intensive of Westernized energy dense foods and the obligatory reduc-
pharmacotherapy targeting optimal levels of blood pressure tion in human movement that a developed society delivers.
[14] and cholesterol [15] has been shown to reduce morbid- The interaction with the environment is far more complex,
ity and mortality, while the targets for glucose control remain and a large number of additional conditions also appear to
more controversial [16]. There have also been reductions in contribute to the evolving catastrophe. This complexity may
smoking, limb amputations, and visual loss associated with partly explain the impotence of current preventative measures.
retinopathy. Early life and metabolic programming appear to be very
4 J.B. Dixon
TABLE 2. The differing determinants of the increasing population In those with diabetes, overweight and obesity appears
with diabetes in developing compared with developed countries to be associated with lower age-adjusted mortality.
Developed Developing A series of recent population assessments raise a very rel-
Population growth + ++ evant issue with respect to diabetes, BMI, and mortality.
Population aging + +++ All are different populations, but there are consistent find-
Increasing high-risk ethnicities ++ − ings and all would raise substantive questions about the
Increased incidence + ++ value of weight loss in the overweight and class I obese
Falling mortality ++ −
BMI ranges.
Data from 5 pooled analyses of 5 large US longitudinal
important factors contributing to obesity and may include cohort studies were examined for incident diabetes in men
genetics, maternal age, assertive mating, childhood infec- and women over the age of 40 years and subsequent cardio-
tions, the pattern of established gut microbiota, and epigen- vascular and all-cause mortality. After adjusting for demo-
etic programming changes to the ovum, the fetus, and the graphics and established cardiovascular risk factors, those
infant during the early years of life [17, 18]. The most impor- who were overweight and obese had a reduced all-cause and
tant 4 years that influence a person’s weight throughout the cardiovascular mortality [21].
life cycle may well occur before the 3rd birthday. Early life Similar and very confronting data has been reported from
programming sets an organism up for the environment that Taiwan where a national diabetes registry is active [22].
the organism is likely to encounter for living. To be pro- Almost 90,000 diabetic patients were recruited after 1995
grammed for a lean nutritional environment and being born and the national death registry examined at the end of 2006
into the “land of plenty” is aberrant representing a clear when 30 % had died. The adjusted analysis found that
programming-environmental mismatch. One only has to increasing body mass index was associated with progressive
look at the obesity and metabolic plight of indigenous popu- reduction in all-cause mortality. The effect was statistically
lations globally when confronted with Western living condi- significant for all causes of mortality other than cancer
tions. It may not surprise that people of European origin fare deaths. Those with a BMI >30 (which is uncommon in
best in “a land of plenty” and indeed may be the global Taiwan) had the lowest mortality. This is one example of the
exceptions in their resistance to developing diabetes and obesity survival paradox.
other metabolic disturbance associated with obesity. A third study in Scotland examined BMI at the time of
Other environmental conditions are also likely to contrib- diabetes diagnosis in over 100,000 patients and mortality.
ute to the obesity emidemic: sleep time over the decades has There were 9,631 deaths between 2001 and 2007. BMI at the
been reduced and is partly replaced with screen time; tem- time of diagnosis was associated in a U-shaped mortality
perature-controlled environments reduce our energy expen- with the lowest index mortality in the overweight group.
diture in both heating and cooling our bodies; endocrine The authors question if weight loss interventions reduce
disrupters are widely dispersed within our environment and mortality [23].
some contribute to weight gain; antibiotics and other factors Black and Caucasian men followed by the USA VA
have been designed to grow our food supply rapidly and effi- medical centers also demonstrate an inverse relationship
ciently may also change or gut microbiome to encourage between BMI and diabetes mortality. The obese men, even
weight gain; and iatrogenic contributions to weight gain those with a BMI > 35, have a lower mortality than normal-
through medications to treat mental illness, epilepsy, chronic weight men [24].
autoimmune and inflammatory disease, and diabetes [17]. These data add important contributions to the metabolic
surgery—type 2 diabetes debate and raise issues about
intentional weight loss in those not in the BMI > 35 category.
Obesity and Its Influence on Diabetes This emerging data, combined with the issues with the large
Sibutramine SCOUT study [25] and the premature cessation
The risk of developing type 2 diabetes at any given BMI is of the Look Ahead study for lack of hard end-point efficacy,
strongly related to ethnicity, and the World Health all raise questions about any value in intentional weight loss
Organization and the International Diabetes Federation rec- in the overweight and class I obese BMI range in those with
ommend modified action points for interventions based on diabetes. It is becoming clear that bariatric-metabolic sur-
ethnicity (Table 3). gery will need to provide hard all-cause mortality, cardiovas-
Obesity also has additional influences on the number of cular mortality, and suicide outcomes [26] data before it
people with diabetes for reasons beyond increased incidence. could be a broadly acceptable therapy for overweight and
Obesity is leading to an onset of type 2 diabetes in younger class I obese individual with diabetes. The same pattern has
age groups. There is a negative relationship between BMI emerged for the approval of pharmacotherapy for weight loss
and the age of onset of type 2 diabetes [19, 20], and this is and diabetes although it is easier to stop drug therapy than
clearly associated with a longer period living with diabetes. reverse bariatric procedures.
Life expectancy for diabetes diagnosed at 30 years is quite In summary, diabetes and obesity prevalence continues to
different to that of 70 years. rise, especially in the young and in developing countries.
1. The Global Burden of Obesity and Diabetes 5
TABLE 3. The classification of weight category by BMI (d) There is insufficient data to know how many in our com-
BMI (kg/m ) 2 munities have the more severe forms of obesity.
Classification Principal cutoff points Cutoff points for Asians The answer is C.
Normal range 18.5–24.9 18.5–22.9
23.0–24.9 Question 2
Pre-obese 25.0–29.9 25.0–27.4
27.5–29.9 The increasing prevalence of diabetes in developed countries
Obese class I 30.0–34.9 30.0–32.4
32.5–34.9
such as the USA is related to:
Obese class II 35.0–39.9 35.0–37.4 (a) Increased aging
37.5–39.9 (b) Increased overweight and obesity rates
Obese class III ≥40.0 ≥40.0 (c) Increased survival of those with diabetes
For Asian populations, classifications remain the same as the international (d) Increased proportion within the population with a high
classification, but public health action points for interventions are set at 23, ethnic risk
27.5, 32.5, and 37.5 [27] (e) All of the above
We address eligibility and prioritization for bariatric surgery within the
colored zones above
The answer is E.
Source: Adapted from WHO 2004 [28]
Question 3
Increasing obesity and its associated increase in incident
diabetes do not explain all the increase in diabetes preva- Which of the following is true about diabetes prevalence in
lence, and the determinants of prevalence vary considerably developing countries?
in developing countries when compared with developed. The (a) Diabetes rates are much lower than in developed
morbidity and mortality associated with diabetes has countries.
decreased substantially in developed countries where the (b) Diabetes rates are only rising in urban regions.
major increase in diabetes is likely to occur in those over 60 (c) The expected increase in diabetes will have its greatest
years. In contrast in developing countries, the obesity- impact in the working years of middle age rather than
diabetes epidemic burden will impact those of working age. the elderly.
Longitudinal epidemiological data indicates that overweight (d) The expected increase in diabetes will have its greatest
and obesity may be associated with improved survival in impact in elderly.
those with diabetes and that the benefits of intentional weight (e) Diabetes is not a major health issue in developing
loss are unclear. countries as it is in the developed.
The burden of obesity and diabetes remains high globally, The answer is C.
and national and regional obesity-diabetes prevention and
management strategies are essential.
Acknowledgment: I would like to thank Professor References
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2
Pathophysiology of Obesity Comorbidity:
The Effects of Chronically Increased
Intra-abdominal Pressure
Harvey J. Sugerman
Severe obesity is associated with multiple comorbidities that bypass (GBP) surgery (Fig. 1) [9]. The cause(s) of these
reduce the life expectancy and markedly impair the quality phenomena remained unexplained until women with stress
of life. Morbidly obese patients can suffer from central overflow urinary incontinence, in whom resolution of the
(android) obesity or peripheral (gynoid) obesity or a combi- problem occurred within months following GBP surgery,
nation of the two. Gynoid obesity is associated with degen- underwent measurement of urinary bladder pressures
erative joint disease and venous stasis in the lower extremities. (UBPs) in the gynecologic urodynamic laboratory before
Android obesity is associated with the highest risk of mortal- and 1 year following obesity surgery [10]. These women
ity related to problems due to the metabolic syndrome or were noted to have extremely high UBPs that normalized
syndrome X, as well as increased intra-abdominal pressure following surgically induced weight loss. Their pressures
(IAP). The metabolic syndrome is associated with insulin were as high as, or even higher than, UBPs noted in criti-
resistance, hyperglycemia, and type 2 diabetes mellitus cally ill patients with an acute abdominal compartment syn-
(DM), which in turn are associated with nonalcoholic liver drome where treatment is urgent surgical decompression
disease (NALD), polycystic ovary syndrome, and systemic [11–13]. It was hypothesized that severely obese patients
hypertension [1–7]. Increased IAP is probably responsible in with central obesity have a chronic abdominal compartment
part or totally for obesity hypoventilation, venous stasis dis- syndrome with high UBPs, as an estimate of an increased
ease, pseudotumor cerebri, gastroesophageal reflux disease IAP, and this would be related to a number of obesity comor-
(GERD), stress urinary incontinence, and systemic hyperten- bidity problems [14].
sion. Central obesity is also associated with increased neck
circumference and sleep apnea. Other comorbidities are not
specifically associated with either the metabolic syndrome or Animal Studies
an increased IAP, such as degenerative joint or disc disease.
A previous clinical study of patients with obesity Several studies were performed to evaluate the effects of
hypoventilation syndrome noted extremely high cardiac acutely elevated IAP in a porcine model, using either an infu-
filling (pulmonary artery and pulmonary capillary wedge) sion of iso-osmotic polyethylene glycol normally used for
pressures, as high as or higher than in patients with conges- bowel cleansing (Go-Lytely®), on the cardiovascular, pulmo-
tive heart failure (CHF), but most of these patients were not nary, and central nervous systems. Polyethylene glycol was
in heart failure. It was initially hypothesized that this could chosen, as it is not osmotically active nor absorbed into the
have been secondary to hypoxemic pulmonary artery vaso- central circulation in significant amounts to cause significant
constriction; however, the pressures remained elevated changes in intravascular volume. UBPs correlated well
immediately following gastric surgery for obesity despite (r = 0.98, p < 0.0001) with directly measured IAP in this
postoperative mechanical ventilation and correction of both model. Acutely elevated IAP produced a significant increase
hypoxemia and hypercarbia. This pressure returned to nor- in the pulmonary wedge pressure (Fig. 2) and hemodynamic
mal within 6 to 9 months after surgically induced weight changes characterized by decreased cardiac output, increased
loss [8]. High lumbar cerebrospinal fluid (CSF) pressures filling pressures, and increased systemic vascular resistance.
were noted in obese women with pseudotumor cerebri (also Pulmonary effects were hypoxia, hypercarbia, increased
known as idiopathic intracranial hypertension). Resolution inspiratory pressure, and elevated pleural pressure [15]. These
of headache and marked decreases in CSF pressures were changes were consistent with the pulmonary pathology
noted when restudied 34 ± 8 months following gastric characteristic of obesity hypoventilation syndrome.
FIG. 1. Elevated cerebrospinal fluid (CSF) pressure prior to, and sig- FIG. 3. Progressive increase in directly measured intracranial pres-
nificant (p < 0.001) decrease 34 ± 8 months following, gastric sur- sure with increasing intra-abdominal pressure associated with the
gery for severe obesity associated with pseudotumor cerebri intra-abdominal instillation of iso-osmotic polyethylene glycol in
(Sugerman et al. [9], with permission). an acute porcine model and prevention of this increase in animals
that had undergone a median sternotomy and pleuropericardiotomy
(Bloomfield et al. [16], with permission).
Although an increased WHR is a recognized measure- 2. Animal studies have shown that pseudotumor cerebri is a
ment of central obesity and metabolic complications, we result of:
found a poor correlation between the WHR and UBPs in (a) An increased thoracic pressure
women but a good correlation in men. This is probably the (b) An increased intra-abdominal pressure
result of the diluting effect of peripheral obesity, commonly (c) An increased intracranial pressure
present in women, on the estimate of central obesity. The (d) All of the above
greater problem of central obesity in men was reinforced by
3. Increased intra-abdominal pressure is associated with:
the finding of a greater SAD and UBP in men compared to
(a) Urinary incontinence
women despite an equal BMI [14]. Unlike the WHR, the
(b) Pseudotumor cerebri
SAD provided good positive correlations with UBP in both
(c) Venous stasis disease
men and women, corroborating the computed tomography
(d) Obesity hypoventilation
(CT) scan data reported by Kvist et al. [46, 47] that the SAD
(e) All of the above
is a better reflection of central obesity than the WHR.
In the study of UBP in patients following GBP surgery, 4. Roux-en-Y gastric bypass for severe obesity is associated
significant weight loss was associated with a marked reduc- with:
tion in both pressure-related and non-pressure-related (a) A significant decrease in body weight
comorbidity, except for incisional hernias and the need for (b) A significant decrease in spinal fluid pressure
cholecystectomy. Several studies have documented improve- (c) A significant improvement in arterial blood gases
ment following surgically induced weight loss in conditions (d) All of the above
presumed to be caused by an abnormally high IAP, such as
urinary incontinence [10, 32–35], respiratory insufficiency
Answers
including sleep apnea and hypoventilation [8, 22–30], GERD
[31, 48, 49], pseudotumor cerebri [9, 24, 41, 42], hyperten- 1. (b)
sion [45], and cardiac dysfunction [8, 45]. The increased intra-abdominal pressure is secondary to
These possible pathophysiologic consequences of an an increased fat mass within the abdomen (i.e., central
increased IAP (hypertension, peripheral edema, proteinuria, obesity). This is best measured by either the waist cir-
increased CSF pressures, increased cardiac filling pressures, cumference or the sagittal abdominal diameter. Large
and increased hepatic venous pressures) suggest that the lower abdominal obesity produces a large hip circumfer-
chronic abdominal compartment syndrome could be respon- ence; this reduces the waist:hip ratio, and therefore makes
sible for toxemia of pregnancy. This hypothesis is supported this ratio misleadingly low.
by the increased association of preeclampsia in primiparas
2. (d)
(where the abdomen has never been stretched before), twin
The increased intra-abdominal pressure pushes the dia-
pregnancies, morbid obesity where an increased IAP is pre-
phragm cephalad and increases intrathoracic pressure.
dictable, and its correction with parturition. Furthermore,
This decreases venous return from the brain, which leads
there is no clinical animal model of preeclampsia, presum-
to vascular engorgement and an increased intracranial
ably because animals carry their fetuses in the prone posi-
pressure and severe headaches. It is called pseudotumor
tion. The hypothesis is that an increased IAP compresses and
cerebri because there is no mass within the brain. It is also
reduces blood flow in the abdominal venous system which
called “idiopathic intracranial hypertension.”
leads to fetal/placental ischemia, systemic hypertension, pro-
teinuria, hepatic ischemia, platelet consumption in the spleen 3. (e)
and liver, pulmonary insufficiency, and intracranial hyper- All of these obesity-related comorbidities are a result of
tension [50]. The placental/fetal ischemia is thought to cause an increased intra-abdominal pressure and all improve
an increased release of sFlt-1, endoglin, placental growth significantly after surgically induced weight loss.
factor and a decreased VEGF.
4. (e)
Surgically induced weight loss is associated with signifi-
cant weight loss, decreased spinal fluid pressure and relief
Review Questions and Answers of severe headache associated with pseudotumor cerebri,
improved respiratory function with a decreased PaCO2
Questions and increased PaO2, and healing of venous stasis ulcers.
1. Increased intra-arterial pressure is related primarily
to the:
(a) Hip circumference References
(b) Waist circumference
(c) Waist:hip ratio 1. Eckel RH, Grundy SM, Zimmet PZ. The metabolic syndrome.
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12 H.J. Sugerman
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Detection, Evaluation, and Treatment of High Blood Cholesterol in gastric surgery for treating respiratory insufficiency of obesity. Am
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Cholesterol Education Program (NCEP) Expert Panel on Detection, 23. Sugerman HJ, Kellum Jr JM, Reines HD. Greater risk of incisional
Evaluation, and Treatment of High Blood Cholesterol in Adults hernia with morbidly obese than steroid-dependent patients and low
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weight loss significantly improves nonalcoholic fatty liver disease tric bypass in morbidly obese patients with severe venous stasis
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3
Medical Management of Obesity
Bartolome Burguera and Joan Tur
Scientific Evidence Supporting treats less than 1 % of the eligible morbid obese population,
and that already implies waiting lists averaging more than 1
the Potential Efficacy of Medical year. Should all the obese patients with the current indica-
Treatment of Obesity tions ask for surgery, we simply would not have either the
economical and infrastructure resources or the health profes-
It is generally believed in the scientific community that medi- sionals necessary to operate on 3–5 % of the Western popula-
cal (nonsurgical) treatments alone have not been effective in tion. Therefore, it is important to count with effective
achieving a significant long-term weight loss in obese adults. comprehensive interdisciplinary medical therapies alterna-
The situation is even less optimistic in regard to patients with tive (and complementary) to bariatric surgery.
obesity class II (moderate) and III (morbid obesity). However, Setting unrealistic goals concerning the weight loss is fre-
very few studies have specifically examined the effects of quently associated with weight management failure. Recent
nonsurgical treatment in these morbidly obese patients, so studies have shown the short efficacy of lifestyle interven-
conclusions about nonsurgical therapy in this population are tions for the treatment of severe obesity and related comor-
based on inference. In studies of class I (minimal) and class II bidities [22, 23].
obesity, medical therapy can achieve about 10 % body weight
loss in 10–40 % of patients depending on study design, use of
medications, and duration of the intervention. Duration of the Dietary Modifications
weight loss response increases with duration of treatment and
with use of medications and behavior modification. The macronutrient composition of different weight loss diets
Some studies have demonstrated the beneficial effect that is a topic of great interest, and several clinical trials have
dietary plans, behavior therapy programs, and physical activ- attempted to compare their effectiveness [24–34] (Table 1).
ity have in helping to lose weight and to improve the comor- Most studies have indicated that hypocaloric diets, low in
bidities associated to obesity [19, 20]. Also, some clinical calories from carbohydrates, help patients to achieve a
trials have shown the beneficial effect that drugs such as greater weight loss in the short term than low-fat diets [24–
sibutramine and orlistat have had in reducing weight and 29]. In line with these observations, a Cochrane review con-
improving the glycemic and lipid profiles in obese patients. firmed that low-carbohydrate diets are associated with a
The subjects participating in these clinical trials also received greater weight loss than others [35]. Below are presented
dietary advice. Their BMI was between 30 and 35 kg/m2 and some of latest evidence and recommendations available [36].
the average duration of these studies was only 1 year [20, 21].
It is very important to set realistic expectations before
starting medical treatments of obesity. Both physician and Changes in Total Calorie Intake
the patient should be aware that a weight loss of 5–15 %
reduces obesity-related health risks significantly. There are a The Balanced Hypocaloric Diet
substantial number of patients who respond to weight loss
Evidence:
interventions with important changes in their lifestyle, which
translates in long-term weight loss. Identifying the patients A caloric restriction between 500 and 1,000 kcal daily
who will respond to nonsurgical interventions would be very induces weight loss ranging between 0.5 and 1.0 kg/
important to maximize resources and avoid unnecessary week, equivalent to a weight loss of 8 % for an average
surgeries. We need to keep in mind that bariatric surgery period of 6 months (evidence level 1+).
TABLE 1. Some common diets • Long term (12 months or more): a low saturated fat diet
Average weight can help patients to achieve a further decrease in the con-
Type Description loss, kg (95 % CI) centration of low-density cholesterol (LDL-Cl) than a
Mediterranean Fruits, nuts, red wine, fiber, whole −4.4 kg (−5,9 to low-carbohydrate diet (evidence level 2+).
diet grains, fish, and vegetable fat −2,9 kg) • Low-carb diets cause more adverse effects than low-fat
(extra virgin olive oil) diets (evidence level 2++).
Weight watchers Moderate energy deficit −2.8 kg (−5.9 to • Low-carb diets can increase long-time mortality if the fat
Portion control −0.7 kg) contained is, mostly, from animal origin.
LEARN Moderate energy deficit (lifestyle, −2.6 kg (−3.8 to
exercise, attitude, intensive −1.3 kg) Recommendations:
lifestyle, relationships, nutrition)
modification • The reduction in the proportion of carbohydrates, with an
Ornish Vegetarian based −2.2 kg (−3.6 to
increase in fats, is not helpful to enhance the effects of
Fat restricted (<10 % of total −0.8 kg) diet on weight loss (grade A recommendation).
calories) • In an obese patient, a low-fat diet is useful to control the
Zone Low carbohydrate −1.6 kg (−2.8 to levels of LDL cholesterol, whereas a low-carb diet allows
Carbohydrate/protein/fat 40/30/30 −0.4 kg) to achieve better triglyceride and HDL cholesterol control
Atkins Very low carbohydrate −4.7 kg (−6.3 to (grade B recommendation).
Minimal fat restriction −3.1 kg) • Low-carb diets may not contain a high proportion of ani-
mal fats (grade D recommendation).
the amount of glucose available to metabolize or store case, both weight loss and maintenance of weight loss
after ingestion of food containing carbohydrates [38]. (evidence level 1−).
• This benefit is greater when those meal replacements are
Evidence:
used in the context of structured treatments that include
• In the treatment of obesity, dietary modifications in GI or physical activity, education, and food behavior modifica-
GL have no persistent effect on weight loss (evidence tion (evidence level 3).
level 1+). • There have not been clinically significant adverse effects
• There are not enough data to establish evidence on the associated with the use of meal replacements in the con-
role of low-GI diets or low GL on maintenance of weight text of low-calorie diets (evidence level 3).
loss after a low-calorie diet.
Recommendations:
Recommendations:
• In obese or overweight adults, replacing some meals for
• As a specific strategy for the dietary management of obe- meal replacements (in the context of low-calorie diets)
sity, the decrease in GL and GI, can’t be recommended can be useful for weight loss and its maintenance (grade
(grade A recommendation). D recommendation).
• A high-protein diet can induce greater weight loss in the • In the short term (less than 3 months), very-low-calorie
short term (less than 6 months) than a conventional diet, diets (VLCD) (400–800 kcal/day) result in a greater
rich in carbohydrates (evidence level 2+). weight loss than low-calorie diets (>800 to <1,200 kcal/
• A high-protein diet does not induce greater weight loss in day) (evidence level 1+).
the long term (over 12 months) than conventional diet, • In the long term (over 1 year), these diets do not result in
rich in carbohydrates (evidence level 1+). a greater weight loss than low-calorie diets (evidence
• There are insufficient data to establish the effectiveness of level 1+).
high-protein diets in the maintenance of weight loss after • The use of a VLCD before bariatric surgery, in patients
an initial phase of weight loss with other diets. with hepatic steatosis and increased surgical risk, can
• A high-protein diet helps to preserve lean mass, better reduce surgical risk (evidence level 1+).
than a diet rich in carbohydrates (evidence level 2+). • At the moment, there are no data available to establish
• A high-protein diet can increase (in the long term) the risk whether VLCD with commercial products help patients to
of total mortality and cardiovascular mortality, mainly reach an adequate protein intake.
when the protein is of animal origin (evidence level 2+). • The VLCD presents a higher risk of adverse effects than
the low-calorie diet (evidence level 1−).
Recommendations: • The evidence available does not support that the VLCD
• In the treatment of obesity, it is not recommended to are associated with a greater lean mass loss in relation to
induce changes in the proportion of dietary protein (grade fat mass loss, compared to less restrictive calorie diets.
A recommendation). Recommendations:
• To ensure the maintenance or the increase of the lean
mass during a low-calorie diet, it is effective to increase • The VLCD can be used in the treatment of obese patients,
the protein content of the diet above 1.05 g/kg (grade B following a specific clinical indication and a close medi-
recommendation). cal monitoring (grade D recommendation).
• When a high protein is prescribed, the intake of animal • The VLCD can’t be used in patients who don’t meet
protein in the diet should be limited, to prevent an the guidelines, requirements, and criteria (grade A
increased risk of mortality in the very long term (grade C recommendation).
recommendation). • Under medical supervision, and considering the possible
adverse effects that can be observed, the use of VLCD can
be justified in the preoperative bariatric surgery in patients
Meal Replacement Diets with hepatic steatosis and increased surgical risk (grade B
recommendation).
Evidence:
• Using VLCD with commercial products could be justified
• The use of commercial meal replacements for one or in the immediate postoperative of bariatric surgery to help
more meals a day may facilitate the monitoring of a the patient reach an adequate protein intake (grade D
hypocaloric diet more effectively, promoting, in this recommendation).
18 B. Burguera and J. Tur
Mediterranean Diet (MedDiet) good results for weight loss and its maintenance [56, 57].
However, subsequent recommendations of the American
Evidence: College of Sports Medicine indicate that physical activity in
• Studies point to a possible role of MedDiet in the preven- itself has a limited effect on weight loss [58].
tion of overweight and obesity, although there are incon- Since the publication in 1999 of the report “A one year
sistent results (evidence level 2−). follow-up to Physical Activity and Health: A report of the
• The available evidence suggests that greater adherence to Surgeon General” [59] in the USA, a large amount of
the MedDiet could prevent the increase of the abdominal evidence-based knowledge has been accumulated on the
circumference (evidence level 2+). benefits of physical activity in overweight and obese indi-
viduals, although not so much in the morbidly obese.
Recommendations: In order to update the scientific knowledge, an Experts
• Increased adherence to the MedDiet could prevent over- Committee reviewed new research and classified the degree
weight and obesity and prevent the increase of the abdom- of evidence of the benefits of physical activity on health. The
inal circumference (grade C recommendation). results of this review were published in the report Physical
Activity Advisory Committee Report, 2008 [60]. These
Benefits of the Mediterranean Diet: guidelines suggest that the health benefits of physical activ-
Most prospective studies researching the association between ity include the prevention of disease and the reduction of
dietary quality and risk of obesity found that an overall multiple risk factors associated with many diseases and
dietary pattern based on the traditional Mediterranean diet chronic conditions, becoming part of the treatment recom-
was inversely associated with the risk of obesity or weight mendations of some of these, as in the case of obesity.
gain [39–42]. The inverse association between the MedDiet
and adiposity indices has also been reported in some studies Benefits of Physical Activity
[43–47]. Some clinical trials have added support for this
association [48–50]. The benefits of physical activity include reduced risk of pre-
Nutrigenetic studies [51–53] have analyzed the biological mature death of any cause, CVD, T2DM, some cancers
and statistical interactions between the Mediterranean diet (breast cancer and colon cancer), depression, prevention of
and its components and variations in key genes in lipid weight gain, weight loss (in combination with caloric restric-
metabolism, inflammation, adipocytokines, obesity, diabe- tion), and improvement of physical fitness and musculoskel-
tes, and cardiovascular disease (APOA1, APOA2, ABCA1, etal fitness [61, 62]. Inactivity and low cardiorespiratory
LIPC, COX-2, FTO, TCF7L2, PRKAG3, PRKAA2, fitness are as important as overweight and obesity as mortal-
ADIPOQ, CD36, NR1H3, etc.). There have been many sta- ity predictors [63].
tistically significant interactions in which greater adherence In elderly people there is strong evidence supporting the
to the MedDiet, or some of its typical foods, is able to reverse improvement of cognitive function in people who are
the adverse effects that have risk allelic variants in these physically active and moderate evidence in regard to overall
genes on their specific phenotypes, being able to modulate improvement in well-being [64] and functional health, reduc-
the adverse effects of certain genetic variants, dyslipidemia, tion of abdominal obesity, reduced risk of developing hip frac-
hyperglycemia, and/or obesity. ture, risk reduction of lung cancer, and weight loss maintenance.
This evidence suggests that the typical MedDiet pattern, In a recent systematic review and meta-analysis, Hobbs et al.
based on whole foods, minimally processed, which includes [65] found that interventions in adults aged 55–70 years led to
fruits, nuts (walnuts), vegetables, legumes, whole grains, red long-term improvements in physical fitness at 12 months;
wine, fiber, fish, vegetable protein, and vegetable fat (from however, maintenance beyond this is unclear. Interventions
extra virgin olive oil), has qualitative elements that promote which involved individually tailoring with personalized activ-
weight loss and glycemic control and enhances the manage- ity goals or provision of information about local physical
ment of the metabolic syndrome [54]. It has recently been dem- activity opportunities in the community may be more effective
onstrated a further reduction in the incidence of cardiovascular in this population [65], and the benefits associated with regular
events in people at high risk who consumed a Mediterranean exercise and physical activity contribute to a more healthy,
diet supplemented with extra virgin olive oil or nuts [55]. independent lifestyle, greatly improving the functional capac-
ity and quality of life in this population [66].
2. In order to obtain significant benefits of physical activity in In summary, the available evidence suggests that physi-
adults, its duration should be at least 2.5 h/week (150 min) cally active people live longer than sedentary people and do
of moderate-intensity activity or 75 min of vigorous activ- so with a greater quality of life by improving their rest,
ity or a combination of both (category: “active”). reducing the risk of cardiovascular disease, type 2 diabetes,
3. To obtain additional benefits, adults should increase their hypertension, dyslipidemia, and colon cancer. In relation to
aerobic activity to 300 min of moderate activity, or 150 of obesity, physical activity appears to help weight loss
vigorous activity, or a combination of both (considered as (although not induce weight loss by itself) and, in a dose suf-
“highly active”) [60, 67]. ficient, help in the maintenance of weight loss [57, 72–74].
The guidelines also recommend that adults should get
involved in physical activity, increasing gradually its dura- Behavioral Therapy
tion, frequency, and intensity, with the aim of minimizing the
risk of injury. Behavioral therapy is a key tool to help overweight and obese
As for the type of exercise recommended, muscle- patients make long-term changes in their behavior by modi-
strengthening activities involve all muscle groups 2 or more fying and monitoring their food intake, increasing their
days a week. The elderly at risk of falling should also prac- physical activity, and controlling cues and environmental
tice exercises to maintain and/or improve their balance. stimuli that trigger overeating [56, 57, 75–78].
There appears to be a linear relation between physical Different eligibility criteria, target population, and inclu-
activity and health status, such that a further increase in sion criteria (T2DM and BMI) have been used in the most
physical activity and fitness will lead to additional improve- important clinical trials (Table 2). Two of the most cited
ments in health status. In addition to the recommendations studies involving behavioral therapy in the context of a life-
from the guidelines, different studies provided data underly- style modification targeted diabetic and/or nondiabetic per-
ing the importance of avoiding a sedentary lifestyle as a key sons with elevated fasting and post-load plasma glucose
tool in health promotion [68, 69]. These recommendations concentrations: the Diabetes Prevention Program (DPP) [79]
are mainly addressed to obese people who are fairly inactive, and the Action for Health in Diabetes (Look AHEAD) [80–
encouraging them to reach gradually higher levels of physi- 82]. DPP participants (overweight, sedentary, and nondia-
cal activity in order to obtain the maximum benefit from its betic persons with elevated fasting and post-load plasma
protective effects. glucose concentrations) were randomly assigned to a metfor-
Some studies have focused attention on the sedentary pro- min group, a lifestyle modification group, and a placebo
file of patients, in order to observe the benefit that certain group. The research team hypothesized that modifying these
dose of physical activity (in intensity and duration) would risk factors with a lifestyle intervention program or the
produce greater benefit in terms of weight loss and cardio- administration of metformin would prevent or delay the
vascular function. These studies concluded that the duration development of diabetes. This program was based on 16
of exercise (150 min) is more important than the intensity individual education sessions during the first 24 weeks and
(moderate vs. vigorous), but these studies did not include bimonthly the rest of the period. A low-fat, hypocaloric diet
patients with BMI > 40 kg/m2 [70]. was prescribed (1,200–2,000 kcal/day depending on the
The rise of new technologies on the development and degree of overweight), composed of conventional foods, and
marketing of instruments to measure the amount of physical 150 min/week of physical activity (generally brisk walking),
activity (pedometers, accelerometers) will undoubtedly help with a goal of losing 7 % of their initial body weight.
to better determine the amount of physical activity needed to In the Look AHEAD study, more than 5,100 overweight
optimize the dose–response results on physical activity- participants with DM2 were randomized to a Diabetes
based interventions [71]. Support and Education group (DSE) or an Intensive Lifestyle
There are few randomized controlled clinical trials eval- Intervention (ILI) with a weight loss goal of 7 % of their
uating the impact of physical activity in a lifestyle interven- baseline weight and an increase of the time spent in physical
tion in morbidly obese patients. Goodpaster et al. [22] activity to an average of 175 min a week. In the first 6
conducted a trial designed specifically to evaluate the months, the patients attended to three group sessions and
effects of an intensive lifestyle intervention on weight loss, one individual visit. They used two meal replacement prod-
abdominal fat, hepatic steatosis, and other cardiovascular ucts a day, with a 1,200–1,800 kcal/day caloric intake goal.
risk factors in people with obesity (degrees II and III, BMI Between months 7–12, patients had a single and a group
>35 and >40 kg/m2, respectively) without T2DM. They session per month, using one meal replacement product
concluded that, among patients with severe obesity, a life- every day. From years 2–4, participants attended a single
style intervention involving diet combined with initial or visit to the hospital and received a telephone call or an
delayed initiation of physical activity resulted in clinically e-mail every month, with regular group sessions to help
significant weight loss and favorable changes in cardiomet- maintain a 7 % initial weight loss and/or neutralize possible
abolic risk factors. weight regain.
20 B. Burguera and J. Tur
TABLE 2. Eligibility criteria, population targeted, and inclusion criteria (T2DM and BMI) in the clinical trials Look AHEAD, DPP, LOSS,
and TRAMOMTANA
Ages eligible for study Ethnically diverse population Inclusion criteria: T2DM Inclusion criteria: BMI
Look AHEAD 45–74 Yes Yes 25 or higher (27 or higher if on insulin)
DPP 25 at least Yes No (ADA 1997 criteria) 24 or higher (22 or higher in Asians)
Impaired glucose tolerance
(WHO 1985 criteria)
LOSS 20–60 Yes No 40 or higher
TRAMOMTANA 18–65 No No 40 or higher
These two examples illustrate the wide range of approaches morbidly obese patients undergoing either laparoscopic gas-
(Table 3) in regard to the number and configuration of indi- tric bypass surgery or a comprehensive lifestyle intervention
vidual visits, group sessions, dietary changes, exercise pro- program. Lifestyle intervention was associated with more
grams as well as patterns in weight loss and weight loss favorable dietary 1-year changes than gastric bypass surgery
maintenance through these changes in lifestyle. The literature in morbidly obese patients, as measured by intake of vegeta-
suggests that the current weight loss programs usually achieve bles, whole grains, dietary fiber, and saturated fat.
a reduction of 7–10 % of the initial body weight [75, 83] after A Spanish randomized clinical trial, performed in
6–9 months of intervention, and the combination of diet, Mallorca (multidisciplinary treatment of morbid obesity—
physical activity, and behavioral changes can obtain even bet- TRAMOMTANA) [89, 90], was designed to examine the
ter results if anti-obesity agents are added to the therapy [84]. effects of an Intensive Lifestyle Intervention (ILI) on the
One of the biggest challenges is to maintain this weight therapy of morbid obesity in comparison with a conventional
loss over the medium- and long-term periods [77]. It is obesity therapy group (COT) and with a third group consist-
important to make these changes durable enough to allow a ing of patients already included in the bariatric surgery wait-
significant improvement in their comorbidities, quality of ing list (SOG). The ILI group received behavioral therapy
life [85, 86], and body composition [87]. and nutritional/physical activity counseling. These morbidly
One of the few clinical trials focused on the treatment of obese patients attended weekly group meetings from weeks
morbid obesity was the Louisiana Obese Subjects Study 1 through to 12 and biweekly from weeks 13 to 52. Meetings
(LOSS Study) [23] (Table 4). The main objective of the study included 10–12 subjects, lasted 90 min, and were led by a
was to test whether, with brief training, primary care physi- registered nurse, who mastered in nutrition. The group ses-
cians could effectively implement weight loss for individuals sions were focused on the qualitative aspects of the dietary
with a BMI of 40–60 kg/m2. In this 2-year randomized, con- habits, such as the distribution of energy intake, frequency of
trolled, clinical trial, the recommendations for patients in the consumption, and food choices. The research team provided
Intensive Medical Intervention (IMI) group included a information on the benefits of the Mediterranean diet and
900 kcal liquid diet for 12 weeks or less, group behavioral encouraged the patients to follow this diet. There were no
counseling, structured diet, and choice of pharmacotherapy restrictions in calorie intake. A sport medicine physician pre-
(sibutramine hydrochloride, orlistat, or diethylpropion scribed daily home-based exercise (led by a physiotherapist),
hydrochloride) during months 3–7 and continued use of with gradual progression toward a goal of 175 min of
medications and maintenance strategies for months 8–24. moderate-intensity physical activity per week. Patients could
Ryan et al. [23] obtained data indicating that severely receive treatment with weight loss medicines, such as orlistat
obese patients randomized to an intensive weight loss pro- or antidepressants at the endocrinologist discretion. Forty
gram in primary care lost a significant amount of weight, percent of the patients included in this group received treat-
compared to those receiving usual care (21 % of patients lost ment with sibutramine for a period of 1–2 months until it was
10 % or more of the initial weight). The authors reported a withdrawn from the market in January of 2010.
weight loss of 5 % or higher in 31 % of the analyzed patients The COT group received the standard medical treat-
and a 10 % weight loss in 21 % of cases, with a significant ment available for these patients (one visit with the endo-
improvement in many metabolic parameters. These results crinologist every 6 months). Patients who received ILI
suggest that, with minimal training, primary care profession- achieved a significant weight loss compared with COT
als could treat, successfully, a high percentage of morbidly group (Fig. 1). The weight loss effect was already obtained
obese patients. However, retention (retention rate in IMI after 6 months of ILI intervention. These results seriously
group = 51 %) and weight loss maintenance were two key question the efficacy of the COT approach to morbid obe-
points to improve, according with the researchers. sity. Furthermore, they underscore the use of ILI programs
In a 1-year non-randomized controlled trial, Johnson to effectively treat morbidly obese patients which might
et al. [88] compared changes in the dietary patterns of help to reduce the number of candidate patients for
ABLE
T 3. Comparison of different lifestyle interventions: (1) Look AHEAD vs. DPP
Frequency of sessions/visits Format Weight loss goal Physical activity goal Special features Weight loss drugs Meal replacements
Look AHEAD phase Weekly Three groups, one Lose 7 % of Exercise #175 min/ Treatment toolbox No Two meal replacement products,
3. Medical Management of Obesity
1.1 (months 1–6) individual initial weight week by month 6 one portion-controlled snack,
and a self-selected meal each
day
Look AHEAD phase Three per month Two groups, one Increase minutes per One meal replacement per day
1.2 (months 7–12) individual week of activity; and two meals of self-
10,000 steps/day selected foods are allowed
Look AHEAD phase Two per month One on site, one by mail Continued weight goal Advanced treatment One meal replacement per day
2 (months 13–48) or telephone loss or weight toolbox orlistat
Additional: refresher maintenance
groups are offered
three times a year
Look AHEAD phase Two per year On site. Additional phone Additional support
3 (month 49+) calls and/or e-mail through newsletters,
contacts. Participants phone, or e-mail
may also join refresher contact
groups
Diabetes Prevention 16 in 24 weeks + 4 Individual and group Lose 7 % of 150 min/week Toolbox: adherence No Structured meal plans and meal
Program (DPP), supervised phisic physical sessions initial weight strategies, local and replacement products were
initial structured activity. Supervised national network of provided as an option for
core curriculum sessions training, feedback, participants
(months 1–6) and clinical support
Diabetes Prevention Face to face at least once Motivational campaigns
Program (DPP), every 2 months and by Small incentives
maintenance phone at least once (T-shirts, magnets,
program (months between visits weight graphs.
7–12) newsletters
21
22
ABLE
T 4. Comparison of different lifestyle interventions: (2) LOSS vs. TRAMOMTANA
Frequency of sessions/
visits Format Weight loss goal Physical activity goal Special features Weight loss drugs Meal replacements
LOSS phase 1 No No Lose 10 % of Exercise 150 min/ Flexibility Low-calorie liquid diet
(12 weeks or initial weight week (900 kcal/day), 5 shakes per
less) day
LOSS phase 2 4 weekly, then every 2 Group sessions + individual Individualized treatment Sibutramine Two daily meal replacements
(months 3–7) weeks monthly physician visit strategies
Monthly physician visit Orlistat
LOSS phase 3 Monthly Group sessions $100 gift card rewarded Diethylpropion One daily meal replacement,
(months 8–24) attendance at month 24 low-calorie liquid diet in
4- to 12-week episodes
TRAMOMTANA Weekly Four group sessions + 1 Lose 10 % of Exercise 150 min/ Social toolbox Sibutramine until No
phase 1 individual visit with initial weight week by month 12 Rockport test withdrawal (40 %
(months 1–3) specialist every 3 patients during
Healthy cooking show
months 1–2 months)
Small incentives (umbrellas,
magnets)
TRAMOMTANA Two per month Two group sessions + 1 Social toolbox No
phase 2 individual visit with Rockport test
(months 4–24) specialist every 3
Workshop: eat slowly and chew
months
B. Burguera and J. Tur
3. Medical Management of Obesity 23
0,00 Conventional
Obesity Therapy
-20,00
-40,00
0 3 6 9 12
Month
Error bars: 95% confidence interval
bariatric surgery, at a lower cost (evaluating medical visits, Overview of Current Obesity
surgery, sessions, and meds).
Non-pharmacological strategies for weight reduction have Medications
reported 10 % losses that have been difficult to maintain [91].
Changes in dietary behavior, the stimulation of physical activ- Lifestyle measures are the cornerstone of prevention and
ity, and emotional support continue to be the mainstays for the treatment of obesity. However, there is general agreement in
management of obesity in adults, children, and adolescents. the scientific community that the use of anti-obesity drugs
Sustained caloric restriction (to 1,500 kcal/day for women should also be considered (after careful considerations of
and 1,800 for men), regardless of dietary macronutrient com- the pros and cons), in patients who did not have an optimal
position or regimen [19], has fairly similar effects on weight response to lifestyle interventions. Weight loss medications
loss, ranging from 3 to 5 kg over 2 years [20]. The addition could also be considered in some cases as “jump-start”
of physical exercise facilitates weight loss by increasing intervention, acting as coadjutant therapy to lifestyle inter-
energy expenditure and increasing basal metabolic rate ventions. In many circumstances adding medications to
through an increase in muscle mass. behavioral interventions helps to accomplish the recom-
Unfortunately, lifestyle interventions alone rarely result mended 10 % weight loss and also reinforces adherence to
in long-term weight loss and the majority of dieters return to these lifestyle/behavioral interventions.
baseline weight within 3–5 years. This even holds true for FDA guidance for the approval of new weight loss thera-
participants in weight loss trials who are offered education pies intended for long-term use recommends a 5 % placebo-
and intensive support to help prevent weight regain [21, 22]. corrected weight reduction that should be maintained for at
The improvements described in morbidly obese patients least 12 months after treatment initiation. Small, sustained
using behavioral therapy as an element of an intensive life- reductions in weight can significantly improve CVR factors,
style intervention could benefit a huge number of people: particularly glycemia and BP, in overweight and obese indi-
those who will undergo bariatric surgery and those who are viduals. The target adult population for drug therapy is set at
not interested in surgery and just need to lose 5–10 % of the BMI > 30 (or a BMI >27 plus a comorbidity such as HTA or
bodyweight. These interventions must be provided by multi- T2DM). This opens up a potentially huge market for the
disciplinary, academic, or clinical groups and can be pro- development of new weight loss drugs. Despite the great
vided at the hospital or primary care setting, to groups of strides in the understanding of the mechanisms involved in
10–15 patients with an optimal duration of 20–26 weeks and the hypothalamic regulation of appetite and energy balance,
a follow-up period of monitoring and maintenance (also we still have a very limited armamentarium of drugs useful
20–26 weeks) [57]. for the treatment of obesity.
24 B. Burguera and J. Tur
Given the previous history of several obesity medications used in combination with fenfluramine (“phen-fen”).
that have been removed from the market due to significant Unfortunately, dexfenfluramine, a related drug, was found to
side effects (HTA, depression, cardiac valvular abnormali- cause valvular heart abnormalities and primary pulmonary
ties) and the current obesity-related health crisis, the need to hypertension and was removed from the market in 1997 [94].
identify safe and efficacious weight loss drugs is more than Data on adverse events in weight loss trials that used sym-
evident. Unfortunately, the medications currently available pathomimetic amines are limited but include increases in HR
for obesity therapy are limited in number and efficacy and BP, dry mouth, nervousness, insomnia, and constipation.
(Table 5). Phentermine is contraindicated in patients with CAD, con-
gestive heart failure (CHF), stroke, and uncontrolled
HTA. There are no long-term data suggesting that treatment
Sympathomimetic Amines with this agent reduces CVD. Given the fact that phenter-
mine is just approved for short-term use, this medication has
The oldest weight loss drugs still approved by the US FDA very limited use in the management of obesity, as a chronic
as weight loss adjuncts are sympathomimetic (amphetamine- disease. However, as previously mentioned, it could be a
like drugs) such as methamphetamine, phentermine, and helpful tool to use as a jump start to get patients motivated to
diethylpropion. These medications act centrally as adrener- participate in a lifestyle intervention program and start mak-
gic stimulants, reducing appetite and increasing energy ing small improvements in their daily habits, which could
expenditure through generalized sympathetic activation. translate in long-term weight loss.
Diethylpropion (Tenuate®)
Phentermine (Adipex®)
Diethylpropion is another amphetamine-like analogue, with
Phentermine (a central norepinephrine-releasing drug) is an fewer stimulant side effects, which has been approved by the
approved anti-obesity agent, indicated as an adjunct to US FDA for treatment of obesity since 1959. Diethylpropion
appropriate nutrition and physical exercise for short-term (up is used as part of a short-term plan, along with a low-calorie
to 12 weeks) treatment of obesity. In the 1970s, phentermine diet, for weight reduction. Although most studies evaluating
hydrochloride was developed, with doses ranging from 8 to the efficacy of diethylpropion for weight loss were short
37.5 mg [92]. term (less than 20 weeks), obese patients treated with dieth-
Phentermine remains as the most widely prescribed ylpropion lost an average of 3.0 kg of additional weight com-
weight loss drug in the USA. The phentermine hydrochlo- pared to placebo [95].
ride salt easily dissociates in the GI tract, resulting in imme- A report evaluated the efficacy of diethylpropion 50 mg
diate release of the phentermine drug causing a significant BID or placebo for 6 months. After this period, all partici-
appetite suppressant effect. Phentermine is classified by the pants received diethylpropion in an open-label extension for
FDA as a Schedule IV drug. It carries a risk for addiction an additional 6 months [96]. The study included 69 obese
and/or habituation, though its abuse potential is considered healthy adults who received a hypocaloric diet. After the ini-
very low [93]. Short-term use of phentermine was associated tial 6 months, the diethylpropion group lost an average of
with a mean weight loss of about 3 kg more than with pla- 9.8 % of initial body weight vs. 3.2 % in the placebo group
cebo. No long-term (>1 year) randomized controlled trials of (Fig. 2). From baseline to month 12, the mean weight loss
phentermine have been reported. Phentermine was widely produced by diethylpropion was 10.6 %. Participants in the
3. Medical Management of Obesity 25
Open Phase
0
Diethylpropion
Placebo
-2
-4
Change in Body Weight (Kg)
-6
-8
-10
-12
placebo group who were switched to diethylpropion after 6 The XENDOS study (XENical in the prevention of
months lost an average of 7.0 % of their initial body weight. Diabetes in Obese Subjects) assessed the effect of the treat-
No differences in BP, pulse rate, EKG, and psychiatric evalu- ment with orlistat in 3,300 obese patients with impaired glu-
ation were observed. As with phentermine, common side cose tolerance [21], a 4-year, prospective, randomized,
effects of diethylpropion included insomnia, dry mouth, diz- double-blind, placebo-controlled study; it demonstrated that
ziness, headache, mild increases in BP, and palpitations. orlistat (plus lifestyle modification) significantly reduced the
Very few studies have evaluated the long-term use of incidence of T2DM and improved weight loss, when com-
diethylpropion. pared with placebo plus lifestyle changes. Mean weight loss
after 4 years was significantly greater with orlistat (5.8 vs.
3.0 kg with placebo). The 3.0 kg weight loss achieved by the
Orlistat (Xenical®) placebo plus lifestyle changes group over 4 years was com-
Orlistat is currently the only medication approved by the parable with that in the intensive lifestyle intervention arms
European Medicine Agency (EMEA) for the treatment of of the DPS (3.5 kg) and DPP (3.5 kg). XENDOS was the first
obesity [97]. Xenical acts by inhibiting the intestinal lipase, study to show that a weight loss agent such as orlistat in
which translates into a reduction up to 30 % of ingested fat combination with lifestyle changes was more powerful than
absorption. The recommended dosage is 1 capsule TID with lifestyle changes alone helping patients to obtain long-term
meals. It has a dose-dependent effect: 120 mg decreases up weight loss and improvements in their CVR factors. After 4
to 30 % fat intake, whereas a dose of 60 mg decreases up to years’ treatment, the cumulative incidence of diabetes was
25 %. In 2007, GlaxoSmithKline, under license from Roche, 9.0 % with placebo and 6.2 % with orlistat, corresponding to
launched a low dose of orlistat (Alli®) which is not a neces- a risk reduction of 37.3 %. A meta-analysis of studies with
sary prescription. orlistat [98] showed a drop of average weight of 2,39 kg.
26 B. Burguera and J. Tur
Other benefits of orlistat include a reduction of LDL choles- frequently observed after sibutramine therapy was discontin-
terol more than expected by the drop in body weight. ued. In the year 2010 both the EMA and FDA requested mar-
Fat-soluble vitamin supplements should be taken 2 h ket withdrawal of sibutramine after reviewing data from the
before or after taking orlistat. The most common adverse Sibutramine Cardiovascular Outcomes Trial (SCOUT)
effects included flatulence with discharge and fecal urgency, [104]. SCOUT was part of a post market requirement to look
which occurred especially after high-fat dietary indiscre- at cardiovascular safety of sibutramine after the European
tions, and were responsible for a significant rate of drug dis- approval of the drug. It is important to emphasize that in this
continuation. Serious, but very uncommon (only 12 cases), study patients participated for over 55 years with high CVR
adverse effects have been reported such as liver damage, and that, in the vast majority of cases, they did not corre-
which were thought to be cases of individual hypersensitiv- spond with the type of patients for which this drug was origi-
ity. Liver function should be monitored while doing Xenical nally approved for. After 6 years of treatment, the individuals
therapy. who took sibutramine showed an increased risk of serious
A study [99] warned of a possible link between reported heart events, including nonfatal heart attack, nonfatal stroke,
cases of acute renal damage in orlistat users (incidence of and death of 11.4 %, compared to 10.0 % in a placebo con-
2 %). The authors hypothesized that the nonabsorbed dietary trol group.
fat binds enteric calcium and reduces their ability to bind and The results of the SCOUT were not surprising, if we take
sequestrate oxalate in the intestine that leads to excessive into account that most of the patients included in the SCOUT
absorption of free oxalate with the consequent deposit in the did not meet criteria for treatment with sibutramine. The
renal parenchyma. odds were against sibutramine, because CVR is embedded in
Xenical continues to be a useful therapy which could help its mechanism of action and the study sample consisted of
obese patients to modified their dietary habits and lose older obese patients, deliberately selected for high CVR, and
weight. exposed to sibutramine for 5 years (five times the maximum
licensed duration of treatment) [105]. A large number of
investigators and Scientific Societies felt that the SCOUT
Sibutramine (Meridia®, Reductil®) study was flawed as it only covered high-risk patients and
Sibutramine was approved on November 1997 for weight did not consider obese patients who did not have
loss and maintenance of weight loss in obese people, as well cardiovascular complications or similar contraindications,
as in certain overweight people with other risks for especially considering that those were the patients who could
CAD. Sibutramine induces weight loss by selectively inhib- really benefit from this medication.
iting the neuronal reuptake of serotonin and norepinephrine
within the hypothalamus. To a smaller degree, it also inhibits
the reuptake of dopamine. Treatment with sibutramine Recently Approved Drugs
resulted in an increase in satiety and a reduction in appetite for the Treatment of Obesity
[100, 101].
In a meta-analysis of randomized placebo-controlled tri-
Lorcaserin (Belviq®)
als of at least 1 year in duration (10 studies with 2,623
patients), sibutramine reduced body weight 4.3 kg more than Lorcaserin is a new agonist of the 5-hydroxytryptamine
placebo [102]. There was also a greater reduction in BMI in (5-HT, or serotonin) receptor 5-HT2C. It binds selectively to
the sibutramine group and a 4 cm decrease in waist circum- the central 5-HT2C receptors, with poor affinity for 5-HT2A
ference with sibutramine therapy. and 5-HT2B, respectively. Nonselective serotonergic agents,
Sibutramine also prevented weight regain when adminis- including fenfluramine and dexfenfluramine, were with-
tered after a dietary intervention. In the Sibutramine Trial of drawn from the market in 1997, after they were reported to
Obesity Reduction and Maintenance (STORM) study [103], be associated with valvular heart abnormalities [106]. Due to
605 obese patients were treated with sibutramine (10 mg its selective agonist effect on 5-HT2C receptors, lorcaserin
QD) and followed a low-energy diet for 6 months. Patients theoretically should not have similar cardiac adverse effects
achieving >5 % weight loss after 6 months (n = 467) were as fenfluramine.
randomly allocated to continue sibutramine (10 mg QD upti- Lorcaserin was approved by the FDA in June 2012, and it
trated to 20 mg QD if weight regain occurred, or placebo for marked the end of a long era without any new drugs to treat
18 months. The sibutramine group had less weight regain obesity. The indication for lorcaserin is an addition to a
than the placebo group. In a subgroup of patients in STORM reduced-calorie diet and exercise for patients who are obese
study, computed tomography showed a preferential reduc- or overweight with at least one medical comorbidity, such as
tion in visceral fat. T2DM, HTA, high cholesterol, or OSA. The mechanism by
Sibutramine therapy was associated with an increase in which lorcaserin results in weight loss appears to be by
BP and heart rate in some patients. As expected with any reducing appetite, which in turn reduces total energy intake.
therapy for a chronic disease, significant weight regain was Three important phase 3 randomized clinical trials have eval-
3. Medical Management of Obesity 27
uated the efficacy of lorcaserin helping obese patients to lose lorcaserin QD vs. 1.5 % with placebo. Also 37.5 % of patients
weight [107]. treated with lorcaserin 10 mg twice daily achieved at least
The BLOOM (Behavioral Modification and Lorcaserin 5 % weight loss, more than double the 16.1 % of patients
for Overweight and Obesity Management) was a 104-week, taking a placebo. Additionally, 16.3 % of lorcaserin 10 mg
clinical trial to assess the safety and efficacy of lorcaserin in BID patients achieved at least 10 % weight loss compared to
obese patients. The primary outcome measure at year 1 was 4.4 % of patients taking a placebo. HgA1C decreased by
the proportion of patients achieving >5 % weight loss from 0.9 % with lorcaserin BID, 1.0 % with lorcaserin QD, and
baseline. At year 2 the primary outcome measure was the 0.4 % with placebo. Symptomatic hypoglycemia occurred in
proportion of patients maintaining >5 % weight loss at week 7.4 % of patients on lorcaserin BID, 10.5 % on lorcaserin
104. In this study 3,182 obese adults (BMI >36 kg/m2) were QD, and 6.3 % on placebo.
randomly assigned to lorcaserin (10 mg) or placebo BID for Lorcaserin produced side effects in human clinical trials,
1 year, followed by a 1-year extension period. All subjects but at rates not significantly different than placebo and
participated in a behavioral modification program which mostly with mild and transient severity. The most common
included dietary and physical activity counseling. Obese side effect was headache, experienced by about 18 % of drug
patients treated with lorcaserin lost 3.6 kg more than controls arm participants compared to 11 % of placebo participants.
at the end of the first year. Approximately 50 % of partici- Other reported side effects and their rates for lorcaserin and
pants remained in the trial during year 2. Additionally, the placebo patients, respectively, were as follows: upper respi-
weight reduction was maintained in more patients who con- ratory tract infection (14.8 % vs. 11.9 %), nasopharyngitis
tinued to receive lorcaserin during the second year (68 %) (13.4 % vs. 12.0 %), sinusitis (7.2 % vs. 8.2 %), and nausea
than in patients who received a placebo (50.3 %) [108]. (7.5 % vs. 5.4 %). Lorcaserin has been associated with per-
A second phase 3 Lorcaserin clinical trial was the ceptual disturbances, and because lorcaserin has the poten-
BLOSSOM (Behavioral Modification and Lorcaserin Second tial to bind 5-HT2A receptors, it has been evaluated and
Study for Obesity Management) [109]. In this 52-week clini- found to have low abuse potential. Adverse events of
cal trial, 4,008 patients were treated with lorcaserin 10 mg depression, anxiety and suicidal ideation were infrequent
QD or BID compared to placebo. The study was designed to and were reported at a similar rate in each treatment group.
assess the efficacy and safety of a dose range of lorcaserin In agreement with the FDA, Arena conducted regular echo-
when administered in conjunction with a nutritional and cardiograms of the phase III participants. At the 3-, 6-, and
physical exercise program to promote weight loss, in obese 12-month intervals, the echocardiograms of participants of
patients and at-risk overweight patients. The primary out- the BLOOM trial did not show any significant increase in
come measure was again the proportion of patients achieving valvulopathy over baseline.
>5 % weight loss from baseline to week 52. Significantly Thus, lorcaserin is a new therapeutic tool to treat obesity
more patients treated with lorcaserin 10 mg BID and QD lost and is a well-needed addition to an area where therapeutic
at least 5 % of baseline body weight (47.2 % and 40.2 %, agents are sparse. Lorcaserin has also been shown to improve
respectively) as compared with placebo (25.0 %). Weight loss glycemic control and it has modestly beneficial effects on
of at least 10 % was achieved by 22.6 and 17.4 % of patients lipids and BP as well. This data justifies the proposed indica-
receiving lorcaserin 10 mg BID and QD, respectively, and tions for the use of lorcaserin as an adjunct to diet and physi-
9.7 % of patients in the placebo group. Thus, the weight cal activity for weight management, including weight loss
losses seen with lorcaserin were slightly greater than that seen and maintenance of weight loss in obese patients and over-
in the orlistat studies, which provided 2–3 kg of placebo-sub- weight patients with at least 1 weight-related comorbidity.
tracted weight loss. Headache, nausea, and dizziness were the
most common lorcaserin-related adverse events. Phentermine and Topiramate Controlled
A third lorcaserin trial BLOOM-DM (Behavioral
Modification and lorcaserin for Overweight and Obesity
Release (Qsymia®)
Management in Diabetes Mellitus) [110] was carried out in The scientific literature and clinical experience tell us that
604 T2DM obese and overweight patients. The BLOOM- anti-obesity drugs that specifically target just one area within
DM’s purpose was to assess the weight loss effect of lorcase- the brain may have a limited effect inducing weight loss in
rin during and at the end of 1 year of treatment in patients obese patients; consequently the idea of targeting more than
treated with metformin, sulfonylurea (SFU), or either agent one circuit in the regulatory pathways of energy balance has
in combination with other oral hypoglycemic agents. Patients become a popular and potentially efficient strategy to treat
were randomized to lorcaserin 10 mg BID (n = 256), lorcase- patients with obesity.
rin 10 mg dosed QD (n = 95), or placebo (n = 253). Lorcaserin The FDA recently approved a combination of low doses
10 mg BID met the three primary efficacy endpoints by pro- of controlled-release (CR) phentermine and the anticonvul-
ducing statistically significant weight loss compared to pla- sant agent topiramate (in one capsule) for adults with a BMI
cebo. At week 52, the data showed that weight loss was ≥30 kg/m2 or with a BMI ≥27 kg/m2 and at least one weight-
4.5 % of total body weight with lorcaserin BID and 5 % with related comorbidity such as HTA, T2DM, and dyslipidemia
28 B. Burguera and J. Tur
(July 2012). Several trials had evaluated the efficacy of this The most common adverse events were dry mouth (2, 13,
combination inducing weight loss in obese patients and 21 %) in the groups assigned to placebo, phentermine-
[111–115]. topiramate CR 7.5/46 mg, and phentermine-topiramate CR
In the CONQUER clinical trial [111], 2,487 overweight 15/92 mg, respectively, paraesthesia (2 %, 14 %, and 21 %,
and obese patients with HTA, high cholesterol or T2DM par- respectively) and constipation (6 %, 15 %, and 17 %, respec-
ticipated. Patients received a combination of phentermine- tively) none of these events caused study discontinuation in
topiramate CR (7.5/46 or 15/92 mg) compared with placebo more than 1 % of patients [116]. There was a dose-related
over 56 weeks [49]. At 56 weeks, change in body weight was increase in the incidence of psychiatric (e.g., depression,
−1.4, −8.1, and −10.2 kg in the patients assigned to placebo, anxiety) and cognitive (e.g., disturbance in attention) adverse
phentermine-topiramate 7.5/46 mg, and phentermine- events in the active treatment group. Although BP improved
topiramate CR 15/92 mg, respectively. 21 % of the patients slightly with active therapy, there was an increase in heart
achieved at least 5 % weight loss with placebo, 62 % with rate (0.6–1.6 beats/min) compared with placebo.
phentermine-topiramate CR 7.5/46 mg, and 70 % with The FDA does not recommend the use of this drug com-
phentermine-topiramate CR 15/92 mg; for ≥10 % weight bination in patients with recent stroke, unstable heart dis-
loss, the corresponding numbers were 7, 37, and 48 %. ease, HTA or CAD, glaucoma, hyperthyroidism or in patients
In an extension of the CONQUER (the SEQUEL study) who have taken monoamine oxidase inhibitors within 14
[112], investigators addressed the longer-term efficacy and days. Women of child-bearing age should have a pregnancy
safety of lifestyle intervention and two doses of phentermine- test before starting this therapy and monthly thereafter.
topiramate CR for an additional 52 weeks (total treatment Because topiramate can produce renal stones, this combina-
duration of 108 weeks) in overweight and obese subjects tion preparation should be used cautiously in patients with a
with cardiometabolic disease. Overall, 84 % of subjects history of kidney stones.
completed the study, with similar completion rates between A recommendation for the use of phentermine-topira-
treatment groups. At week 108, phentermine and topiramate mate CR was recently presented [115]. This algorithm
CR was associated with significant, sustained weight loss titrates the dose starting with a phase-in dose of phenter-
compared with placebo. Mean percentage changes from mine-topiramate CR 3.75/23 mg QD for 2 weeks. The dose
baseline in body weight were −1.8, −9.3, and −10.5 % for then is increased to a half dose of 7.5/46 mg QD for 12
placebo, 7.5/46, and 15/92, respectively. Phentermine- weeks. Patients are evaluated at that point for weight loss,
topiramate CR improved cardiovascular and metabolic vari- and “responders” (patients with weight loss >3 %) are main-
ables and decreased rates of incident T2DM in comparison tained on that dose. “Nonresponders” (those with weight
with placebo. Phentermine-topiramate CR was well toler- loss <3 %) are either discontinued or receive increased
ated over 108 weeks. Of note, phentermine-topiramate CR doses. Those receiving increased doses are stepped up to an
was less effective causing weight loss in the second year of intermediate dose of 11.25/69 mg QD for 2 weeks, then the
use, although most individuals were able to maintain the treatment is increased to a final full dose of 15/92 mg QD
weight they lost achieved in year 1. for 12 weeks. At the end of the full-dose period, responders
In a third clinical trial (EQUIP) [113], 1,267 morbidly with weight loss of 5 % or more are maintained on their
obese patients (BMI >35 kg/m2) were included into three doses. If an individual does not lose 5 % of body weight
arms: placebo, phentermine-topiramate CR 3.75/23 mg, and after 12 weeks on the highest dose, phentermine-topiramate
phentermine-topiramate CR 15/92 mg with a total treatment CR should be discontinued gradually, as abrupt withdrawal
duration of 56 weeks. Both doses of phentermine-topiramate of topiramate could cause seizures.
CR yielded significantly greater 1-year weight loss compared Phentermine-topiramate CR may be considered for
with placebo, with a greater proportion of patients losing more obese postmenopausal women and men without CVD, par-
than 5, 10, or 15 % of baseline body weight. Patients treated ticularly those who do not tolerate orlistat or lorcaserin
with phentermine-topiramate CR 15/92 and 3.75/23 lost [116]. The possibility of adding this combination therapy
10.9 % and 5.1 % of body weight, respectively, when analyzed to orlistat should also be considered. Clinicians who pre-
as ITT-LOCF, compared with 1.6 % weight loss on placebo scribe and pharmacists who dispense the drug must be
and 14.4 and 6.7 % weight loss in completers-only analyses enrolled in a Risk Evaluation and Mitigation Strategy,
compared with 2.1 % weight loss with placebo. Of importance which includes a medication guide, a patient brochure, and
was that weight loss induced by phentermine-topiramate CR a formal training program for prescribers, detailing safety
was accompanied by improvements in several cardiovascular information [114].
and metabolic risk factors, such as waist circumference, sys- In Europe, the combination of phentermine-topiramate
tolic BP, and total cholesterol/HDL cholesterol ratio in both CR has not been approved yet. The EMA’s Committee for
doses. As previously shown Phentermine-topiramate CR Medicinal Products for Human Use first rejected the product
15/92 treatment was also associated with significant improve- in October of 2012. In February of 2013 the EMA refused
ments in diastolic BP, fasting glucose, LDL cholesterol, HDL again to grant approval for this drug combination in the
cholesterol, and total cholesterol. European Union.
3. Medical Management of Obesity 29
TABLE 6. Effect of GLP-1 analogues on body weight compared to other T2DM therapies
Drug Mechanism of action/effect Daily dosage Average weight change (kg)
Liraglutide (Victoza) GLP-1 receptor agonist. Decreases appetite 1.8 mg (3 mg) −4.8 to −7.2 kg (dose dependent; 20 weeks)
Exenatide (Byetta) GLP-1 receptor agonist. Decreases appetite 5–10 μg −2.8 to −4.4 kg (dose dependent, 30–82
weeks)
Exenatide ER (Bydureon) GLP-1 receptor agonist. Decreases appetite 0.8–2 mg −2.8 to −4.0 kg (dose dependent, 15–30
weeks)
Metformin (Glucophage) Increases FA oxidation Decreases glucose absorption 2,000 mg 1–2 kg
DpP-4 inhibitors (sitagliptin) Increase incretin (GLP-1 and GIP) levels VBFa Weight neutral
(Vildagliptin, Saxagliptin, Linagliptin, Alogliptin)
Alpha-glucosidase (acarbose, miglitol) Inhibit the breakdown and inhibitors 25, 50, 100 mg Weight neutral
Absorption of carbohydrates in the GI tract
Sulfonylurea Stimulate insulin secretion VBFa + 1 to +5 kg
Non-sulfonylurea (meglitinides) Stimulate insulin secretion 0.5–1–2 mg +0.7 to +2.4 kg
Secretagogues
Thiazolidinediones Enhancing of muscle/adipose tissue insulin sensitivity 15–30–45 mg + 1 to +5 kg
Insulin Glucose uptake. Decreases appetite by inhibiting VBFa + 1 to +5 kg
NPY/AgRP-secreting neurons
a
Varies by formulation (VBF)
Incretins as Potential Anti-obesity for the treatment of T2DM in the USA, EU, Japan, and other
countries worldwide under the brand name Victoza® (Novo
Drugs: GLP-1 Analogues Nordisk) (1.2 or 1.8 mg QD) [123, 124]. Because GLP-1
decreases appetite and causes a dose-dependent weight loss
Glucagon-like peptide 1 (GLP-1) is an incretin hormone in obese individuals [125], it could be an attractive treatment
secreted from the L-cells in the lower gut in response to meal option for both T2DM and obesity. To explore the mecha-
ingestion, which stimulates endogenous insulin secretion in nism behind the observed weight loss with liraglutide, the
a glucose-dependent manner. GLP-1 reduces appetite in lean effect of this drug on various body weight-related parameters
and normal-weight individuals, as well as in obese individu- known to be affected by native GLP-1 has been investigated.
als [117], and it has been shown to reduce body weight in Results from various trials have shown that liraglutide 1.8 mg
overweight individuals with T2DM [118, 119] (Table 6). The seems to exert a mild suppression of hunger ratings and
underlying mechanism mediating the weight reducing effects increase postprandial fullness, as indicated by appetite rating
of GLP-1 is most likely a combination of effects on the gas- endpoints [126].
trointestinal tract and the central nervous system. GLP-1 also More than 50 clinical trials with liraglutide have been com-
decreases blood glucagon levels and has been shown to pro- pleted (with doses up to 3.0 mg). Out of 10,000 subjects
mote B-cell growth and proliferation in animal models [120]. included, more than 7,000 subjects were exposed to liraglutide.
The combination of these mechanisms makes GLP-1 A total of 986 obese subjects without T2DM (<9 % of all sub-
receptor stimulation, an interesting target to investigate for jects) have been included to date in the obesity clinical devel-
obesity therapy. However, a major drawback with endoge- opment program for liraglutide. The first of three confirmatory
nous GLP-1 with regard to administration as medical treat- phase 3 trials within the liraglutide obesity development
ment is the short elimination half-life of <1.5 min after IV program (NN8022-1923, o SCALE-Maintenance) was recently
administration, due to rapid degradation by dipeptidyl pepti- completed. Reporting is ongoing. The trial was a 56-week ran-
dase (DPP-4) present on the capillary endothelium [121]. domized, double-blind, placebo-controlled trial investigating
Hence, GLP-1 treatment has limited clinical value, and alter- treatment of liraglutide 3.0 mg vs. placebo as an adjunct to diet
native therapeutic strategies have already been developed. A and exercise in overweight/obese subjects with comorbidities
successful approach that has been employed to prolong the who had already lost at least 5 % of their body weight during a
in vivo half-life of GLP-1 is to protect the peptide from 4- to 12-week run-in period on a low-calorie diet. The mean
cleavage by DPP-4 by exchanging amino acids at the second weight loss for subjects in the run-in period was approximately
and third N-terminal positions of the peptide; cleavage by 6 kg. From a body weight of approximately 100 kg at random-
this enzyme is reduced [122]. ization, treatment with liraglutide for 56 weeks provided an
additional estimated mean weight loss of 5.7 kg, compared to
weight neutrality or maintenance in the placebo group
Liraglutide (Victoza®)
(+0.16 kg vs. baseline). Treatment with liraglutide maintained
Liraglutide is a long-acting GLP-1 analogue, with a 97 % and in some instances further improved beneficial effects on
structural homology to human GLP-1 and recently approved markers of glycemic control and CVR.
30 B. Burguera and J. Tur
An important study including obese patient (BMI reported adverse effects of exenatide were nausea and vomit-
30–40 kg/m2) without T2DM was conducted by Astrup et al. ing, which occurred in 40–60 % and ≤10 % of patients,
[125]. This placebo-controlled 20-week clinical trial included respectively. Antibodies against exenatide were detected in
564 obese individuals. They used one of four liraglutide 40–60 % of patients treated with the drug [128–130]. The
doses (1.2, 1.8, 2.4, or 3.0 mg) compared to placebo- clinical relevance of these antibodies cannot be known with
administered QD s.c. or to orlistat (120 mg) p.o. TID. Weight certainty, but in the majority of patients, their presence does
change analyzed by intention to treat was the primary end- not seem to impair the efficacy of exenatide. Several addi-
point. An 84-week open-label extension followed. Patients tional GLP-1 agonists, including lixisenatide, albiglutide,
on liraglutide lost significantly more weight than did those and taspoglutide, are in various stages of clinical trials and
on placebo or orlistat. Mean weight loss with liraglutide 1.2– have been modified to increase their half-lives.
3.0 mg was 4.8, 5.5, 6.3 g, and 7.2 kg compared with 2.8 kg
with placebo and 4.1 kg with orlistat [127].
Exenatide Long-Acting Release (Bydureon®)
Treatment with liraglutide was generally well tolerated,
with high completion rates in groups (75 % in liraglutide The long-acting formulation exenatide LAR was developed
group, 70 % in placebo group). Serious adverse events were to maintain a constant plasma level of the drug with once-
relatively uncommon, but were more frequent in liraglutide- weekly (QW) administration. Exenatide is incorporated into
treated subjects (4.2 %) compared to placebo (2.4 %). There a matrix of poly(d,l-lactide-co-glycolide) (PLG), which pre-
were no events of pancreatitis or medullary thyroid cancer, viously has been used as a biomaterial in sutures and in
and no treatment-related increases in blood calcitonin levels. extended release preparations. Once injected subcutaneously
The most commonly reported adverse events were from the the compound breaks down over time and allows a controlled
gastrointestinal system, with nausea reported by 47 % of sub- rate of drug delivery resulting in the longer duration of
jects in the liraglutide group compared to 17 % in the placebo exenatide release [131]. Once released, exenatide is elimi-
groups and vomiting by 17 % vs. 2 %, respectively. It will be nated via the kidneys. Exenatide LAR exhibits a median
important to see the results from the studies currently con- half-life of 2 weeks and reaches steady-state plasma concen-
ducted evaluating the efficacy and safety of liraglutide for the trations in approximately 6–10 weeks. Absorption is similar
treatment of obesity and its impact on CVD disease. when given subcutaneously in the abdomen, thigh, or upper
arm. When exenatide LAR 2 mg was given once weekly by
injection, the concentration reached 50 pg/mL by end of
Exenatide (Synthetic Exendin-4) (Byetta®) week 2. This level has been associated with reduced fasting
Exenatide, an exendin-based GLP-1 receptor agonist, is a and postprandial plasma glucose in previous studies using
synthetic 39-amino acid peptide which was discovered in a continuous infusion of exenatide. Exenatide LAR was
search for biologically active peptides in venom from the approved for marketing in the USA in 2011 and in Europe in
Gila monster (Heloderma suspectum). It is currently avail- 2013.
able in the USA and EU (Eli Lilly). This reptilian protein A small randomized, placebo-controlled, double-blinded
shares 53 % amino acid homology to human GLP-1 [128] phase 2 study compared exenatide LAR (0.8 or 2 mg) admin-
and is resistant to DPP4-mediated degradation. istered subcutaneously QW [132] in patients with T2DM
Exenatide 5 or 10 μg administered twice daily s.c. was during 15 weeks. From baseline to week 15, exenatide LAR
associated with a dose-dependent mean weight loss of up to reduced mean HbA1c by −1.4 % (0.8 mg) and −1.7 % (2 mg)
2.8 kg at 30 weeks, which increased to 4.4 kg at week 82 in an compared to +0.4 % with placebo. In the exenatide LAR
open-label trial extension [127, 129, 130]. Weight reductions 2 mg treatment arm, body weight reductions of 3.8 kg were
were greatest in persons with the highest baseline BMI and in seen, while no change was noted in either the 0.8 mg exena-
those taking metformin, with lesser reductions occurring in tide LAR and placebo arms. All results were clinically sig-
those patients taking an SU or a combination of metformin nificant. No participants receiving exenatide withdrew from
and SU. the study; adverse events reported included mild to moderate
At a dose of 10 μg BID, exenatide reduced HbA1c con- nausea, gastroenteritis, and hypoglycemia.
centrations by 0.8–1.5 % [128–130]. In particular, exenatide Several clinical trials including the DURATION Program
lowered postprandial glucose levels after breakfast and din- (Diabetes therapy Utilization: Researching changes in
ner to a much greater degree than after lunch. A pooled anal- HbA1c, weight and other factors Though Intervention with
ysis of three trials of adjunctive treatment with exenatide 5 or exenatide ONce weekly) have evaluated the efficacy of
10 μg BID showed a mean decrease in SBP and DBP of 2.6 exenatide LAR, compared to placebo and other antidiabetic
and 1.9 mmHg, respectively, at week 104, suggesting sus- drugs to improve body weight and metabolic parameters
tained improvement in BP. Changes in lipid parameters at 82 [133–136].
weeks included decreased triglyceride (−38.6 mg/dL), LDLC The clinical trial DURATION-1 studied the effect of
(−1.6 mg/dL), and apolipoprotein B (−1.1 mg/dL) levels and exenatide QW in a head to head comparison against BID
an increase in HDL-C (+4.6 mg/dL). The most frequently exenatide, over 30 weeks, in 295 patients with T2DM.
3. Medical Management of Obesity 31
Treatment with exenatide LAR resulted in significantly The number of patients who discontinued treatment because
greater improvements in HgA1C compared to exenatide BID of adverse effects was 5 % (exenatide group) vs. 1 % (insulin
(HgA1C changed from baseline, −1.9 % ± 0.08 vs. glargine group). More patients discontinued exenatide QW
1.5 % ± .0.08). The weight loss did not differ between the two than insulin glargine due to nausea and inject reactions.
groups by 30 weeks (−3.7 kg for QW vs. −3.6 kg for BID), The DURATION-4 study [136] assessed the relative effi-
and about 75 % of the patients lost weight. Both treatments cacy of exenatide LAR head to head with metformin (2.5 g
were associated with reduction in triglycerides and blood QD), pioglitazone (45 mg QD), or sitagliptin (100 mg QD).
pressure. As previously seen, nausea was predominantly After 26 weeks of treatment, exenatide LAR produced an
mild and transient and occurred less frequently with exena- average weight loss of 2 kg, which was statistically signifi-
tide LAR. The size of the needle required for subcutaneous cantly greater than the average 0.8 kg that patients lost with
injection of exenatide LAR is bigger than that required for sitagliptin and the average 1.5 kg patients gained with Actos.
administration of exenatide (23 gauge [0.64 mm] vs. 29–32 Patients receiving metformin experienced an average weight
gauge [0.24–0.34 mm]). Injection site reactions, such as ery- loss of 2 kg. Patients randomized to exenatide LAR experi-
thema, nodules, or pruritus, are more common with exena- enced a reduction in HgA1C of 1.5 % from baseline, which
tide LAR and have been reported in 10–15 % of patients was significantly greater than the reduction of 1.2 % for sita-
[133]. By contrast, injection site reactions have been found gliptin in drug-naive subjects with T2DM. The most fre-
in less than 2 % of patients treated with exenatide. The quently reported adverse events among exenatide LAR users
DURATION-1 study illustrates that exenatide QW is more were nausea (11.3 %) and diarrhea (10.9 %) [136].
effective in reducing HbA1c and fasting plasma glucose than A recent article by Visboll et al. [137] presented a system-
BID, while the reduction in weight did not differ. atic review with meta-analyses of all randomized controlled
Most patients with T2DM often begin pharmacotherapy trials of adult participants with a BMI of 25 or higher, with
with metformin but eventually need additional treatment. In or without T2DM, and who received exenatide BID, exena-
DURATION-2, exenatide QW (2 mg) was compared with tide QW, or liraglutide QD at clinically relevant doses for at
pioglitazone (45 mg) and sitagliptin (100 mg) to assess the least 20 weeks. They showed that GLP-1R agonist groups
potential differences between these antidiabetic drugs as achieved a greater weight loss than control groups (weighted
add-on therapy to metformin during a period of 26 weeks. In mean difference −2.9 kg). They recorded weight loss in the
this study exenatide LAR produced superior HbA1c reduc- GLP-1R agonist groups for patients without T2DM (−3.2 kg)
tion (1.5 %) and weight loss (2.3 kg) compared to results as well as patients with T2DM (−2.8 kg). In the overall anal-
obtained with sitagliptin (−0.9 % HgA1C, −1.5 kg weight ysis, GLP-1R agonists had beneficial effects on systolic and
loss) or pioglitazone (−1.2 % HgA1C, +2.8 kg weight gain) diastolic BP, plasma concentrations of cholesterol, and gly-
in a head to head study of patients with T2DM not achieving cemic control. GLP-1R agonists were associated with nau-
adequate glycemic control (starting HgA1C of 8.5 %) on sea, diarrhea, and vomiting, but not with hypoglycemia.
metformin therapy [134]. The reduction in SBP was signifi-
cantly greater with exenatide (−4 mmHg) compared with
sitagliptin, but not pioglitazone. About 24 and 10 % regis- Anti-obesity Medications in the Late
tered nausea with exenatide and sitagliptin, while diarrhea Phase of Development
was observed in 18 % and 10 %, respectively. Fewer patients
withdrew from treatment with sitagliptin (13 %) than with Naltrexone-Bupropion Extended Release
exenatide (21 %) or pioglitazone (21 %). No major hypogly-
(Tentatively Named Contrave)
cemia occurred in any group.
In the open-label DURATION-3 trial [135], exenatide This combination of naltrexone-bupropion extended release
QW (2 mg) was compared with insulin glargine QD. (SR) is not yet approved for marketing in the USA. Naltrexone
Exenatide QW treatment resulted in greater HbA1c reduc- is an opioid receptor antagonist that is approved for the treat-
tion (−1.5 %) after 26 weeks than insulin glargine (−1.3 %). ment of alcohol and opioid dependence [138]. Bupropion is
Insulin glargine produced greater reduction in fasting glu- a dopamine and norepinephrine reuptake inhibitor that was
cose than did exenatide, while significantly greater reduc- first approved for the treatment of depression [139] and later
tions in postprandial glucose excursions were obtained with for smoking cessation [140].
exenatide LAR. The safety and efficacy of this combination were studied
Mean weight changes were −2.6 kg in the exenatide group by the Contrave Obesity Research (COR) program which
and +1.4 kg in the insulin glargine-treated patients. Mean consists of four randomized, double-blind, placebo-
heart rate at week 26 was raised compared with baseline in controlled, phase III clinical studies of 56-week duration
the exenatide but not in the insulin glargine group. No other (COR-I [141], COR-II [142], COR-BMOD (COR-Behavior
CVR factors including lipid concentrations differed between MODification) [143], and COR-Diabetes), assessing the effi-
the groups. Risk of hypoglycemia was reduced with exena- cacy, safety, and tolerability of naltrexone SR-bupropion SR
tide. One patient taking exenatide developed pancreatitis. combination therapy in obese patients with or without T2DM.
32 B. Burguera and J. Tur
In COR-I trial 1,742 obese patients were randomly during the first weeks of the study. There were two serious
assigned in a 1:1:1 ratio to a fixed oral (p.o.) of naltrexone- cases of cholecystitis (followed by successful surgery) in
bupropion 32/360 mg SR (8 + 90 mg in each tablet, two tab- patients on naltrexone-bupropion SR who had achieved
lets taken BID), naltrexone-bupropion 16/360 mg SR weight loss >15 kg.
(4 + 90 mg in each tablet, two tablets taken BID), or match- In the COR-Diabetes trial, 505 overweight or obese
ing placebo for 56 weeks [141]. Weight loss was significantly T2DM patients with a mean HbA1c = 8.0 % and on several
greater in the combination treatment groups compared with oral hypoglycemic drugs were randomized in a 2:1 ratio to
placebo. In the study population that completed 56 weeks of either naltrexone-bupropion 32/360 mg SR or placebo [145].
treatment, weight loss was −8.1 %, −6.7 %, and −1.8 % in More patients on combination treatment lost >5 % of their
the naltrexone-bupropion 32/360 SR, naltrexone-bupropion initial weight compared with the placebo group (44.5 % vs.
16/360 SR, and placebo groups, respectively. Waist circum- 18.9 %, respectively). Furthermore, reductions in mean
ference, TG, CRP, and HOMA-IR were significantly reduced, HbA1c values were greater in the naltrexone-bupropion SR
and HDL-C levels were significantly increased in the combi- group compared with placebo (−0.6 % vs. −0.1 %, respec-
nation treatment groups compared with placebo. COR-I tively), leading to a higher proportion of T2DM patients
investigators also reported greater improvements in the qual- achieving HbA1c target levels of <7 % in the combination
ity of life, eating behavior, and food craving in participants treatment group compared with placebo (44 % vs. 26 %,
on naltrexone-bupropion SR compared with placebo. respectively).
The percentage of participants achieving weight loss of Diabetic patients on naltrexone-bupropion SR showed
≥10 % in the COR-II trial was also significantly higher in the significantly greater improvements in various cardiometa-
naltrexone-bupropion 32/360 mg SR group compared with bolic risk factors compared with placebo (waist circumfer-
the placebo group (32.9 % vs. 5.7 %, respectively) as was the ence, −5 vs. 2.9 cm; TG, −11.2 % vs. −0.8 %; HDL-C, −3 %
proportion of those achieving weight loss of ≥15 % (15.7% vs. −0.3 %). Mean reductions in LDL-C, fasting glucose,
vs. 2.4 % in the naltrexone-bupropion 32/360 mg SR group insulin, HOMA IR, and CRP levels were also greater in the
vs. placebo. The most frequently reported side effects were combination group compared with placebo, although they
nausea, constipation, and headache. did not reach significance. As previously shown the most fre-
In the COR-BMOD trial, 793 obese patients were ran- quently reported adverse events were nausea, vomiting, con-
domly assigned in a 3:1 ratio to a fixed p.o. dose of naltrexone- stipation, and dizziness. Discontinuation usually occurred
bupropion 32/360 mg SR or placebo. All participants were due to nausea.
on an energy-reduced diet and attended group behavioral Even though the mechanisms by which the naltrexone-
modification sessions. At week 56 a significantly greater bupropion induces weight loss are not entirely understood,
weight loss was observed in the naltrexone-bupropion SR this combination deserves further evaluation because it can
group compared with placebo (−11.5 % vs. −7.3 %, respec- be an important new tool in the therapy of obesity. The com-
tively). Participants in both groups attended a similar number bination of bupropion and naltrexone was favorably reviewed
of BMOD sessions; the more sessions attended, the higher by an FDA Advisory Panel in 2012. The FDA has required a
the percentage of weight reduction. The data showed that pre-marketing study of the combination drug with assess-
reductions in mean SBP and DBP were greater in the pla- ment of cardiovascular outcomes. There will be an interim
cebo group compared with the combination treatment group. analysis of the trial and the FDA may allow the marketing of
Pulse rate was slightly increased in patients treated with the combination as Contrave as early as 2014, provided the
naltrexone-bupropion SR, whereas it remained unchanged in cardiovascular outcomes are acceptable [146].
the placebo group. This finding suggests that naltrexone-
bupropion SR may attenuate the favorable effects of weight
loss on BP. The smaller reduction in BP (as well as the small
Cetilistat
increase in pulse) in the naltrexone-bupropion SR group is Cetilistat (Norgine, Amsterdam, the Netherlands) is a lipase
consistent with the pharmacological properties of bupropion inhibitor and, while similar to the currently FDA-approved
[144]. As previously shown, quality of life, as assessed by Roche’s anti-obesity drug orlistat, may have a more tolerable
the IWQOL-Lite total score and subscales, was improved side-effect profile due to a different molecular structure.
significantly more in the naltrexone-bupropion SR group To determine the efficacy, safety, and tolerability of cetili-
compared with placebo. stat in obese patients, a phase II, multicenter [147], random-
Significantly more participants in the combination treat- ized, placebo-controlled, parallel group study was developed.
ment group reported adverse events compared with placebo The 442 enrolled patients were advised a hypocaloric diet for
(nausea, 34.1 % vs. 10.5 %; constipation, 24.1 % vs. 14 %; a 2-week run-in period before they were randomized to
dizziness, 14.6 % vs. 4.5 %; dry mouth, 8 % vs. 3 %; tremor, either placebo or one of three different doses of cetilistat
5.8 % vs. 1 %; upper abdominal pain, 5.5 % vs. 1.5 %; and (60 mg TID, 120 mg TID, and 240 mg TID) for 12 weeks.
tinnitus, 5.3 % vs. 0.5 %, respectively) [143]. These adverse Treatment with cetilistat reduced mean body weight to simi-
events were mostly mild to moderate in severity and occurred lar extents at all doses, which were statistically significant
3. Medical Management of Obesity 33
compared with placebo (60 mg TID 3.3 kg, 120 mg TID obesity. Both physician and the patient should know that a
3.5 kg, 240 mg TID 4.1 kg). Total serum and LDL choles- weight loss of 5–10 % reduces obesity-related health risks
terol levels were likewise significantly reduced by 3–11 % at significantly.
all doses of cetilistat. Cetilistat was well tolerated. The fre- There are emerging data in the literature suggesting the
quency of withdrawal owing to treatment-emergent adverse possible effectiveness of medical, intensive, and interdisci-
events was similar between cetilistat-treated groups (5.3– plinary weight loss programs in subjects with morbid obe-
7.6 %) and placebo (7.6 %). sity. Behavioral therapy especially in the context of group
The incidence of GI adverse events was increased in the therapy can be effective helping an important number of
cetilistat-treated groups compared to placebo. However, obese and morbidly obese patients to lose weight and to keep
those GI adverse events, such as flatus with discharge and it off. The use of medications should be seriously considered
oily spotting, only occurred in 1.8–2.8 % of subjects in the as adjuvant therapy early in the course of the therapy. The
cetilistat-treated groups. Cetilistat produced a clinically and current armamentarium to combat the obesity epidemic is
statistically significant weight loss in obese patients in this very limited, and what is more worrisome, the list of new
short-term 12-week study. This was accompanied by signifi- medications to treat this condition is also slim.
cant improvements in other obesity-related parameters. Unfortunately the history of significant side effects of
Kopelman et al. [148] carried out a clinical trial to deter- some of these medications, and the fact that many health-
mine the efficacy and safety of cetilistat and orlistat relative care legislators still feel that obesity is not a disease, has
to placebo in obese patients with T2DM, on metformin. limited the effort of many governments to develop effec-
Patients were randomized to placebo, cetilistat (40, 80, or tive obesity prevention as well as obesity therapeutic pro-
120 mg TID), or orlistat 120 mg TID, for 12 weeks. Similar grams. Also both socialized medicine and private insurance
reductions in body weight were observed in patients receiv- have put very limited effort in financing behavioral or
ing cetilistat 80 or 120 mg TID or 120 mg TID orlistat (3.85, pharmacological obesity therapies. These circumstances
4.32, 3.78 kg, respectively); and these reductions were sig- have also impacted in the general interest of pharmaceuti-
nificant vs. placebo. Statistically significant reductions in cal companies to develop new weight loss medications,
glycosylated hemoglobin were also noted. Discontinuation which usually suffer exaggerated scrutiny by health regu-
in the orlistat group was significantly worse than in the latory agencies. In consequence, a large part of the drug
120 mg cetilistat and placebo groups and was entirely due to development efforts have been switched to identify new
gastrointestinal AEs. T2DM treatments which interestingly cause weight loss as
Since successful management of obesity is likely to a side effect.
require long-term compliance with prescribed medication, It is important to keep in mind that in addition to phenter-
cetilistat may have benefits over currently marketed anti- mine, diethylpropion, and orlistat, we have two new drugs,
obesity drugs such as orlistat, with respect to better tolera- lorcaserin and the combination of phentermine and topira-
tion. Takeda submitted a New Drug Application (NDA) to mate, approved for the treatment of the obesity, which could
the Ministry of Health for cetilistat for the treatment of obe- be useful tools to help treat our obese patients. Interesting
sity with complications, based on data obtained from three new anti-obesity drugs are in the pipeline and hopefully
phase III clinical trials in Japan in October of 2012. The three some will reach the market in the near future. Meanwhile we
studies included a 52-week placebo-controlled study that should also take advance of the new GLP-1 analogues, which
evaluated the efficacy and safety of cetilistat and 24- and in some circumstances can be helpful to treat obese patients
52-week open-label safety studies that were conducted on with T2DM.
obese patients with T2DM and dyslipidemia. New studies combining these medications and the ones to
come in the context of lifestyle interventions will hopefully
help to develop successful weight loss programs which bring
Conclusions some optimism to the field of obesity in the near future.
CORRECT ANSWER (A): A −5 to −15% weight loss (c) Topiramate is an antiepileptic drug with a weight loss
reduces obesity-related health risks significantly. There side effect.
are a substantial number of patients who respond to (d) Lorcaserin, in addition to a reduced-calorie diet and
weight loss interventions with important changes in their exercise, could be a potential useful drug to treat
lifestyle, which translates in long-term weight loss. obesity.
(e) All of the above.
2. Which of the following sentences would be false when
we speak of the benefits of physical activity? CORRECT ANSWER (E).
(a) Reduced risk of premature death of any cause.
5. Which of the following sentences is correct?
(b) Reduced risk of diabetes mellitus.
(a) Bydureon is an exenatide long-acting release without
(c) Weight loss (without caloric restriction).
weight loss effect.
(d) In elderly people there is strong evidence supporting
(b) Naltrexone is a dopamine reuptake inhibitor with
the improvement of cognitive function in people who
weight loss effect.
are physically active.
(c) Topiramate in combination with bupropion extended
CORRECT ANSWER (A): The benefits of physical release is effective in causing weight loss.
activity include reduced risk of premature death of any (d) Bupropion is an effective smoking cessation tool.
cause, cerebrovascular disease, diabetes mellitus, some (e) Cetilistat has central as well as gastrointestinal weight
cancers (breast cancer and colon cancer), depression, pre- loss mechanism.
vention of weight gain, weight loss (in combination with
CORRECT ANSWER (D). Bupropion is a dopamine and
caloric restriction), improvement of physical fitness, and
norepinephrine reuptake inhibitor that was first approved
musculoskeletal fitness. Inactivity and low cardiorespira-
for the treatment of depression [139] and later for smok-
tory fitness are as important as overweight and obesity as
ing cessation [140].
mortality predictors.
In elderly people there is strong evidence supporting
the improvement of cognitive function in people who are References
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4
History of Bariatric and Metabolic Surgery
Adrian G. Dan and Rebecca Lynch
interferes with fat absorption and results in weight loss. This such surgical intervention for obesity continued to grow, and
finding led them to proceed with the first documented human in 1963, Payne and colleagues of the University of Southern
jejuno-intestinal bypass performed in 1954 at the Mount California reported the results of 10 patients undergoing var-
Sinai Hospital in Minneapolis, Minnesota. The interest in ious types of intestinal bypass operations including jejunoil-
eal (JIB) and jejunocolic shunts with end-to-side anastamoses
(see Fig. 1) [4]. This represented the very first publication of
TABLE 1. Major events in bariatric and metabolic surgery a case series of patients undergoing gastrointestinal surgery,
Timeline of major events in the history of bariatric and metabolic surgery specifically with the intent of treating morbid obesity.
Multiple other variations on the jejunoileal and jejuno-
1952 First gastrointestinal operation to reduce weight by Henrikson in
Sweden colic bypass followed. Each attempted to alleviate the com-
1954 First gastrointestinal bypass procedure by Kremen and Linner in plications of the preceding operations and determine the
Minnesota optimal amount of bowel to bypass. Dr. William Scott and
1963 First series of bariatric surgery patients reported by Payne colleagues at the Vanderbilt University Medical Center
1967 Mason and Ito devise the loop gastric bypass attempted an end-to-end anastomosis instead of an end-to-
1977 Griffen publishes results of modification to a Roux-en-Y gastric side anastomosis and varied the length of bypassed bowel
bypass showing improved weight loss in patients with more exten-
1978 Scopinaro introduces the biliopancreatic diversion sive bypass procedures, but worsened side effects [5].
1980 Vertical banded gastroplasty The JIB became the most commonly utilized procedure
1983 American Society of Bariatric Surgery (ASBS) founded in Iowa for weight loss in the 1960s and 1970s. Although weight loss
City was commonly achieved and appealing, these procedures did
1985 First adjustable gastric bypass reported not come without complications. As the popularity of the
1988 Biliopancreatic diversion with duodenal switch devised by Hess procedure increased, series of patients were studied, and the
1991 NIH consensus conference held on bariatric surgery undesirable side effects became more evident. Malabsorption
1992 First minimally invasive bariatric procedure (nonadjustable band) not only caused weight loss but also led to multiple nutri-
1993 First laparoscopic Roux-en-Y gastric bypass performed by tional deficiencies [6] and anaerobic bacterial overgrowth in
Wittgrove
the long blind loop of the small bowel [7]. This led to abdom-
1995 International Federation of Societies for Obesity (IFSO) founded
inal distention and absorption of bacterial products into the
in Stockholm
bloodstream resulting in distal manifestations. Patients often
1998 First laparoscopic BPD with DS performed by Gagner
presented with a broad spectrum of complications including
2005 ASBS accredits first bariatric Center of Excellence
severe diarrhea, protein malnutrition, vitamin deficiencies,
2007 Diabetes Summit held in Rome, Italy
electrolyte imbalance, perianal irritation, polyarthralgias,
2013 AMA recognizes obesity as a disease
calcium oxalate stones, nephropathy, and severe liver
FIG. 1. Jejunoileal (left) and jejunocolic (right) bypass (by permission from AJS).
4. History of Bariatric and Metabolic Surgery 41
Due to the significant complications encountered with FIG. 4 Panel of gastroplasties (Getch), with permission.
malabsorptive procedures, numerous attempts were also
made during the 1970s and 1980s to find a successful, purely
restrictive procedure to decrease the stomach reservoir and
limit caloric intake without interfering with small intestine
anatomy. Printen and Mason introduced a horizontal gastro-
plasty involving a single staple line along the superior por-
tion of the stomach starting from the lesser curvature [23]
(Fig. 4). This formed a small gastric pouch connected to the
remainder of the stomach through a channel at the end of the
staple line along the greater curvature. Since the stomach
reservoir was still able to dilate, adequate weight loss was
not achieved, and other attempts with different stapling con-
figurations followed. Gomez added a double-staple tech-
nique with mesh reinforcement that often failed due to mesh
erosion and obstruction [24]. Pace also attempted to partition
the stomach with a horizontal staple, but placed the channel
between the upper and lower pouch in the center of the
stomach [25]. Nonetheless, this allowed upper pouch dila-
FIG. 5 Vertical banded gastroplasty (Getch), with permission.
tion due to the thinner nature of the stomach wall near the
greater curvature, and such procedures did not lead to lasting
weight loss. Surgeons hypothesized that the fixed, thicker was then placed around this window to secure the narrow,
lesser curvature may be less likely to dilate. Long and Collins tubularized stomach reservoir. The VBG eventually was
applied this theory by reorienting the staple line adjacent to abandoned in favor of other operations such as the Roux-
the greater curvature by the angle of His obliquely toward en-Y gastric bypass and adjustable gastric banding. Its draw-
the lesser curvature [26]. Despite this reorientation and backs included stenosis of the pouch outlet due to excessive
efforts to stabilize the stoma with permanent suture, these scarring and reaction to the foreign material, mesh erosion,
procedures had limited success [27]. and subsequent breakdown of the vertical staple line leading
The gastroplasty variations ultimately led to the vertical to loss of the intended restriction [29, 30].
banded gastroplasty (VBG) (Fig. 5) performed by Mason in Wilkinson and Peloso placed the first gastric band in
1980 which involved vertically partitioning the stomach at 1978 in New Mexico. This consisted of a 2 cm-wide piece of
the angle of His through a window created near to the lesser polypropylene mesh placed around the superior portion of
curvature at the base of the pouch [28]. Polypropylene mesh the fundus, restricting the channel for food passage [31].
4. History of Bariatric and Metabolic Surgery 43
Many other materials were then used for restriction includ- Japan, to observe the creation of a Japanese obesity society
ing: Dacron used by Molina and Oria in Texas, silicone and as the problem had become more conspicuous in that coun-
Marlex mesh used by Näslund in Sweden, and a long 10.5 cm try. Dr. Mason felt that if Japan had a need for an obesity
polypropylene clip with steel used by Bashour and Hill in the society, then surely one should be created in the United
United States [32]. Although these methods were intended to States. Thus, he converted his 7th annual postgraduate course
be less invasive, several complications arose. Specifically, in bariatric surgery to the first meeting of what would become
band migration, band erosion, and severe vomiting became the ASBS. Dr. Mason became the first president of the soci-
significant early problems requiring interventions ranging ety, and the first meeting hosted approximately 60 physicians
from endoscopy with dilation to reoperation and revision. and scientists in Iowa City, IA.
Late complications involved pouch dilation similar to that At that time, the overwhelming consensus within the surgi-
encountered with the earlier gastroplasties. On reoperation, cal establishment remained that obesity was a result of glut-
surgeons found that many bands caused significant scarring, tony and overindulgence. Prejudice existed not only within
and the stoma size could not easily be altered after the first medicine against patients suffering from obesity but also
operation. Since the various gastroplasties attempted to this within academic departments and societies against surgeons
point incorporated staple lines and permanent alterations in who held interest in weight loss surgery. Bariatric research
gastric anatomy, surgeons across the world attempted to studies were often not accepted at national meetings, unless
devise less invasive and potentially adjustable gastric restric- they pointed out the potential complications and shortcomings
tive options. of the current bariatric procedures. The ASBS meeting served
Silicone became the mainstay material for banding in as a setting where such research could be presented and cri-
1983 given findings that it caused less tissue reaction and tiqued without such bias. The society grew dramatically and
scarring [33]. Szinicz and Schnapka of Austria made novel advocated not only for research related to obesity surgery but
modifications to the idea of banding and experimented with also in other areas of the field such as access to care and estab-
adjustable silicone bands in rabbits. Each band contained an lishment of quality standards. Dr. Mason’s early efforts
inner balloon linked to a subcutaneous port allowing the bal- entailed forming a database first of his patients and those of his
loon to be inflated or deflated with saline [34]. close circle of friends. Eventually, the database grew to include
In 1985, Hallberg and Forsell of Sweden created an adjust- patients of other members of the society. Over time, several
able band to be utilized in humans, ultimately known as the standardized databases were formed, including the Bariatric
Swedish Adjustable Gastric Band (SAGB) (Ethicon Endo- Ongoing Longitudinal Database (BOLD). Surgeons taking
Surgery, Inc., Cincinnati, OH) [35]. During this same time, part in the ASBS Center of Excellence program were required
Kuzmak of the United States was developing an adjustable to enter their patients into this database, providing a wealth of
gastric band made from inflatable silastic silicone which data for future bariatric research.
became the American Band or Lap-Band (Allergan Inc, Irvine, Armed with scientific evidence that bariatric surgery
CA)[36]. In 1986, Kuzmak reported the first case of an adjust- leads not only to weight loss but also extensive metabolic
able gastric band placement. These adjustable bands reduced changes and resolution of numerous other metabolic comor-
the trouble of finding the perfect stomal size, since the aper- bidities, the society voted to reflect this important aspect in
ture could now be adjusted through saline injections into a 2007 and ratified the name change to the American Society
subcutaneous port. This feature made the purely restrictive for Metabolic and Bariatric Surgery (ASMBS). This concept
banding operations much more tolerable by reducing emesis was brought to the forefront and strongly endorsed by doc-
and pressure erosions when band pressures were properly tors Buchwald and Pories whose vision is credited with
adjusted. Similar weight loss rates were seen early on when bringing about the dialogue to begin consideration of the
compared with the vertical banded gastroplasty [36, 37]. name change. Through its evolution, the ASMBS became a
force, championing significant endeavors in the areas of
access to care, patient advocacy, research, data collection,
The American Society for Metabolic and public relations among many others. In 2013, the
and Bariatric Surgery ASMBS celebrated its 30-year anniversary and stands as one
of the most respected and accomplished surgical societies in
The creation of the American Society for Bariatric Surgery the world.
(ASBS) in 1983 had a major impact upon the development of
the subspecialty. It provided a venue for the exchange of
ideas and encouraged the application of scientific rigors to The International Federation
research methods. of Societies for Obesity (IFSO)
In the late 1970s, Dr. Edward Mason, regarded as the
father of bariatric and metabolic surgery, began hosting a In addition to the ASMBS, numerous societies across the
yearly postgraduate course on obesity and obesity surgery. In world have sprung up to organize, support, and represent
1983, Dr. Mason was invited as an honorary guest in Tokyo, bariatric and metabolic surgeons and their patients. Societies
44 A.G. Dan and R. Lynch
devices. In addition, other experimental modalities aimed at published a consensus statement on “gastrointestinal surgery
achieving weight loss without the risk of surgery include for severe obesity,” which to this day influences the guide-
endoluminal gastric partitioning, the gastric balloon, endo- lines for indication for surgery [56]. In 2004, Dr. Henry
scopically placed gastric sleeves, and neurostimulation. Buchwald again hosted a consensus conference and pub-
lished a report updating the 1991 recommendations [57].
In an effort to further promote program standardization,
A New Golden Era the ASBS developed the Center of Excellence designation in
2004 and then combined efforts with the American College of
The turn of the century ushered a new beginning for the sub- Surgeons starting in June of 2012. The first COE program
specialty. The increased prevalence of obesity along with the was credentialed by the ASBS in 2005. Participation in such
laparoscopic surgical advancements caused a dramatic rise programs required surgeons to submit data on their patients to
in the number of procedures performed. With this increase the BOLD database. The abundance of data led to subsequent
came new hurdles and political issues that needed to be publications showing the remarkable safety and efficacy of
addressed on behalf of bariatric patients and professionals. bariatric surgery when performed at accredited centers [58].
Efforts were undertaken on the part of the surgical societies Despite the evidence supporting the benefits of bariatric
to improve access to care and promote the public awareness surgery, the increase in demand led some insurance compa-
of the efficacy and safety of surgical weight loss options. nies to continue to limit the coverage of such procedures due
In 2001, the catastrophic events which occurred in to the economic pressure resulting from their costs. On
New York City on September 11 did not pass without a pro- February 21, 2006, the Center for Medicare and Medicaid
found impact upon bariatric surgeons. This incident caused services (CMS) announced coverage of bariatric surgery for
numerous insurance companies to close their medical mal- its beneficiaries nationwide. This gave millions of patients
practice business sections leaving many surgeons without suffering from obesity an opportunity to seek surgical weight
coverage. In addition, the number of claims resulting from loss after failing medical therapy. This decision also
surgeons with inadequate training in complex minimally prompted many private insurance carriers to consider the
invasive procedures erupted, leading to apprehension to inclusion of surgery as a core benefit in their health-care
cover by malpractice insurance carriers. According to Dr. plans. Initially approved procedures for Medicare and
Kenneth Jones, who presided over the ASBS at the time, that Medicaid beneficiaries included the LRYGB and the
combination was a “perfect storm” which produced a “near LAGB. After several years of extensive lobbying by the
disaster for our subspecialty.” The integration of bariatric members of the bariatric community, the LSG was added to
surgery in the advanced laparoscopic fellowship training was the list of approved procedures. The lack of universal inclu-
instrumental as bariatric procedures became the “bread and sion of bariatric benefits in every health-care plan remains a
butter” of advanced minimally invasive surgery. Appropriately disappointment for many bariatric professionals and patients.
trained surgeons began setting up comprehensive bariatric
programs throughout the country and delivered quality of
care which turned the tide and furthered the results of these The Scientific Advances
new operations from the dubious problem-ridden procedures
of the early days. The development and refinement of bariatric procedures
Aspects of bariatric care began enjoying positive portray- have been accompanied by the investigation of the metabolic
als and representation in the press. However, this was tar- effects of such operations. With the first reported bariatric
nished to some degree by surgeons who attempted advanced procedure, Henrikson’s patient noted a generalized improve-
laparoscopic procedures after minimal proctoring instead of ment in her overall health despite a failure in weight loss. As
formal training. The development of bariatric-focused surgi- early as the 1950s, surgeons observed health-related benefits
cal fellowship programs overseen by the Minimally Invasive associated with procedures which unintentionally induced
Surgery Fellowship Council provided a formal match for can- weight loss. Patients undergoing subtotal gastrectomy with
didates and bariatric fellowship training programs. This reconstruction for other indications were noted to sustain an
enabled surgeons to appropriately learn and develop the improvement in the control of diabetes as an unexpected side
advanced skills necessary to complete such procedures safely. effect [59].
Several consensus conferences also served as a means to Surgeons also witnessed a wealth of anecdotal evidence
educate practitioners and to standardize bariatric and of the resolution of numerous obesity-related conditions and
metabolic surgery. The first consensus conference on the role the metabolic syndrome. While such observations were com-
of bariatric surgery to treat obesity was chaired by Dr. Henry monplace, obesity-related research to illuminate the impact
Buchwald in 1978. The guidelines were based upon a small conferred by metabolic surgery upon the resolutions of such
body of literature that was available at that time, and it finally diseases was scarce. In 1980, O’Leary and colleagues pub-
discouraged the use of the JIB. Throughout the next decade, lished the first account of JIB positively affecting diabetes
the use of surgery for weight loss became more frequent with and hyperlipidemia [60]. In 1995, Pories and colleagues also
the advent of the RYGB and the VBG. In 1991, the NIH published a noteworthy article underlining the effectiveness
46 A.G. Dan and R. Lynch
and durability of the RYGB to treat adult-onset diabetes mel- The increased application of weight loss surgery ignited
litus [61]. A follow-up article from the same group showed a an interest in research of gastrointestinal physiologic and hor-
decrease in the progression of diabetes and decreased mor- monal mechanisms. The term “metabolic surgery” has been
tality in patients undergoing RYGB versus a nonoperative coined to reflect the utility of surgery for the treatment of type
cohort [62]. The impact of the LRYGB on diabetes mellitus 2 diabetes and other medical conditions strongly associated
was further exposed in a landmark article by Schauer’s group with obesity. The groundbreaking discoveries of gastrointes-
published in 2003 [63]. The provoked impact upon insulin tinal hormones mediating metabolic responses quickly con-
resistance was studied and shown to be mediated by mecha- firmed that the impact of gastrointestinal surgery reached far
nisms which were independent of the actual sustained weight beyond that of restriction and malabsorption. The association
loss. Numerous authors also reported significant rates of of decreased levels of ghrelin, a hunger hormone, with gastric
resolution of hypertension, obstructive sleep apnea, hyper- bypass was one such landmark discovery by Cummings in
lipidemia, and GERD among other conditions strongly 2002 [79]. In addition, authors such as Rubino and colleagues
linked to obesity [64–67]. further elucidated the relationship between diabetes and gas-
In 2004, Buchwald and colleagues published a large trointestinal bypass [80]. To this day, these mechanisms are
meta-analysis of the literature evaluating present-day bariat- not fully known, and both scientists and surgeons persist in
ric surgery [68]. They reviewed 2,738 citations in the English their quest to better understand the underlying physiology.
language from 1990 to 2003. This was a landmark piece of
literature which evaluated excess weight loss for the various
contemporary procedures as well as the resolution rate of A Look to the Future
obesity-related comorbidities including diabetes mellitus,
hyperlipidemia, hypertension, and obstructive sleep apnea. At its annual meeting in June of 2013, the American Medical
Other landmark publications included articles from the Association recognized obesity as a disease. It is noteworthy
Swedish Obese Subject (SOS) study, led by Dr. Lars that those individuals who have done so much to advance the
Sjostrom, which evaluated the impact of surgery upon the field of bariatric and metabolic surgery are often the ones
health of morbidly obese individuals when compared to stan- who point out that the best understanding and treatment of
dard medical therapies over several decades. This included obesity are yet to come. There is much work left to be done
studying the impact on diabetes, cardiovascular risk factors, in order to augment what has already been accomplished.
lifestyle, and long-term mortality [69, 70]. This includes elucidating physiologic mechanisms that still
The impact of consistent weight loss upon physical, remain an enigma, improving access to care for patients who
social, and economic comorbidities was also studied and would benefit from surgery, advancing surgical techniques
reported upon in publications too numerous to mention. The and technology, and promoting the training of our future bar-
evidence of enhanced health and quality of life enjoyed by iatric and metabolic surgeons.
obese patients who underwent weight loss surgery became
abundant and clear. Some of the most compelling evidence
came about from well-structured randomized controlled
studies, solidifying the role of surgery in the treatment of the References
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5
Developing a Successful Bariatric Surgery
Program
Andrew S. Wu and Daniel M. Herron
Credentialing of bariatric surgeons is the process through unacceptable terminology. For example, the term “severely
which individual hospitals determine that a surgeon is overweight” is equivalent to the expression “morbidly
appropriately qualified to safely perform bariatric proce- obese” but is viewed as being less offensive to the bariatric
dures. The credentialing process will necessarily be slightly patient [7].
different at every hospital. At present, there is no nationally Office staff will need to understand the basics of bariatric
recognized board providing certification in bariatric surgery. surgery including the indications and contraindications to
However, since the American Board of Surgery (ABS) surgery, the various types of surgery, and the need for a truly
does include bariatric surgery within its curriculum, most multidisciplinary approach involving a team of physicians
hospitals include certification by the ABS or equivalent and consultants. Office staff are to be familiar with specific
organization as part of the bariatric surgery credentialing bariatric terminology such as “Roux-en-Y bypass” and
requirements. Detailed recommendations regarding the cre- “sleeve gastrectomy” and should be taught to calculate a
dentialing and recredentialing processes are provided by the patient’s BMI. There are many resources available that the
American College of Surgeons (ACS) as part of the newly office staff has access to that are written for the layperson
developed Metabolic and Bariatric Surgery Accreditation which provide an overview of bariatric surgery [8]. Not only
and Quality Improvement Program (MBSAQIP) jointly will this aid in the answering of questions that patients will
administered with the ASMBS. Any hospital seeking initially have, but this will provide an underlying framework
accreditation in this national quality improvement program for a screening tool to differentiate patients who indeed are
must adhere to the program, facility, and surgeon standards candidates for surgery from those who are not. This will
outlined in the program. make the office encounter more efficient for the physician
A new bariatric program in the United States should and staff when scheduling patients who are truly candidates
develop with the goal of becoming nationally accredited by for bariatric surgery discussion.
MBSAQIP. Such accreditation serves several functions. In
addition to serving as a rigorous quality improvement (QI)
program, the accreditation, or participation in a similar out- Patient Education Materials
comes reporting program, is required by many private and
public payors. With the exponential growth of informational technology via
Until 2012, Bariatric Surgery Center certification included the television, public ads, and the Internet, patient access to
rigid volume requirements for both the hospital and the indi- information regarding bariatric surgery is abundant. A wide
vidual surgeons. In such a model, surgical volume was used range of initial patient knowledge is seen: some patients will
as a surrogate measure of quality. The MBSAQIP program have already researched all there is to know about bariatric
has been revised to use outcomes measures to directly assess surgery and some will have none. It is important to provide
program quality, has decrease emphasis on volume as a com- all the necessary educational tools and information written
ponent of a quality composite score, and has decreased the and accessible to the patient for the initial visit, as a tremen-
volume requirements to be consistent with current evidence dous amount of preoperative education is necessary. Most
and avoid problems with access to care. bariatric centers now provide an initial informational session
which is held monthly during the evening and free to the
public for anyone wishing to learn about bariatric surgery.
Facilities: Outpatient Office This is of significant importance as this is the most uniform
and concise way for patients to start their bariatric journey
Establishing a bariatric surgery program requires substantial and learn about the essentials of the bariatric program.
infrastructure in the outpatient setting. The patient’s desire Diligent work and coordination between the surgeon, bariat-
for bariatric surgery begins with the initial visit in the sur- ric team, and the marketing and public relations manager of
gery outpatient office, and thus adequate office staff training the hospital or practice is necessary in order to provide
and patient education are all important for the initial patient awareness of an existing free informational session.
encounter. At the initial encounter in the office, packets of informa-
tion should be available to give to each patient which has all
of the necessary information of the bariatric experience. With
Office Staff Training the increased use of the Internet, practices should establish a
website detailing everything that is in the packet for patients
Office personnel need to be educated regarding the unique so that patients have permanent and public access to this on
physical and psychological issues pertaining to the bariatric the Internet while at the same time saving distribution costs.
patient. Often times, the initial encounter is that of a phone Care should be given to making an accurate and educational
call in which a prospective patient inquires about bariatric website as many websites for bariatric surgery may have mis-
surgery. The office staff should engage the new patients in a leading information. If done correctly, it may be a powerful
professional manner and be sensitive to the use of socially tool and invaluable educational resource for the patient [9].
5. Developing a Successful Bariatric Surgery Program 51
Information Systems
Because of the multidisciplinary team of physicians and pro-
viders for each individual bariatric patient, there is an exten-
sive amount of paperwork and preoperative and postoperative
visits that require documentation. Most patients will have at
the minimum, four physician encounters not including the
bariatric surgeon. Patients will likely have preoperative visits
with their internist, cardiologist, psychologist, and nutrition-
ist. Additional consults include gastroenterologists, endocri-
nologists, and pulmonologists. Each will have a documented
patient encounter, and hence an organized and streamlined FIG. 2. An appropriate and accurate weight scale is necessary to
medical record is absolutely necessary. In addition, the post- have in the office.
operative visit and follow-ups for years after the surgery will
accrue even more patient encounters requiring documenta- Benefits of the EMR include higher-quality charting, faster
tion. Achieving this with the traditional paper-based medical charting procedures, less risk of data loss, and decreased
record system is feasible, but patient information will be medicolegal risk from inadequate charting [7].
more difficult to manage and organize. With the increased For the bariatric patients, charting their weight loss or
use of electronic medical records (EMRs), employing such a gain needs to be documented at every visit. In addition,
system significantly aids in organizing and accessing a single patients who have had a gastric band placed and has routine
database which has all of the necessary patient information. follow-ups with band filling readjustments need to have the
52 A.S. Wu and D.M. Herron
Psychologist/Psychiatrist
Office Personnel
The mental and emotional aspects of obesity, weight loss,
The team approach begins in the office. The office may and weight loss surgery are an important consideration in the
require 2 receptionists: one to check the patient in and care of bariatric patients. Most weight loss programs in the
another to confirm that their insurance covers bariatric sur- United States require that a patient undergo a mental health
ger. The insurance specialist is critical in assessing insur- evaluation prior to undergoing surgery. In fact, many insur-
ance coverage for the surgical procedure. This person should ance companies require such psychological evaluation prior
receive his or her own office as taking charge of the insur- to granting precertification for a bariatric procedure.
ance needs and requirements is a full-time job [10]. Surgeons want to treat the whole person in order to increase
the likelihood of a positive outcome for their patients. While
20–60 % of bariatric patients have a psychiatric disorder
Nurse Coordinator and Bariatric Nurse noted preoperatively, some psychiatric disorders are diag-
nosed postoperatively [18]. In addition, while some psychi-
A nurse coordinator is essential, and they may function to atric conditions are improved with weight loss, others are
partake in patient care in both the clinical outpatient setting made worse or become apparent with weight loss.
and the inpatient setting. First and foremost, they must ben- The psychological evaluation in the preoperative setting
efit from education regarding the proper use of bariatric is the first step to ensure that the patient does not have any
equipment, lifting techniques, and tailored dietary needs for psychological needs that must be addressed. It is also a
these patients. The ASMBS has developed a certification means for educating and introducing a patient to the expecta-
program for Clinical Bariatric Nurse Specialists. In addition, tions of their journey ahead as they proceed with surgery.
the ASMBS, the AORN, and the Betsy Lehman Center for Adequate time and attention should be provided for preop-
Patient Safety and Medical Error Reduction publish bariatric erative assessment of and support for psychological disor-
surgical nursing guidelines to address nursing education, ders. Patients referred for bariatric surgery are more likely
practices, and certification goals, in an effort to improve than the overall population to have psychopathology such as
patient care [15]. somatization, social phobia, obsessive compulsive disorder,
5. Developing a Successful Bariatric Surgery Program 55
substance abuse/dependency, binge-eating disorder, post- The anesthesiologist must be fully cognizant of this in their
traumatic stress disorder, generalized anxiety disorder, and preoperative anesthetic risk assessment and intraoperative
depression [19]. In addition, a higher rate of suicide after management. Issues of specific concern include the airway
bariatric surgery has been documented when compared to exam and potential for difficult intravenous access.
the general population [20]. While none of these is a contra- Anesthesiologists realize that a morbidly obese patient can
indication to surgery, these disorders should be controlled potentially present a difficult airway and be cognizant of
prior to undergoing surgical weight loss in an effort to reduce intubation difficulties. Insertion of a central line and/or an
recidivism and produce greater sustained and successful arterial line may be additional components necessary for safe
weight loss. While many patients will only require a single intraoperative patient monitoring.
preoperative visit with a mental health professional, other Many of the bariatric procedures may involve the place-
patients may benefit substantially from continued short-term ment of a bougie, a nasogastric tube, an anvil for a circular
or long-term psychotherapy. Of note, the bulk of evidence stapler anastomosis, or an intraoperative upper endoscopy at
shows no relationship between preexisting axis I psychiatric some point during the operation. Thus, the surgeon must
diagnosis or axis II personality disorder and total weight always be in direct communication with the anesthesiologist
loss. It is not certain which psychosocial factors predict suc- to ensure that instrumentation of the oropharynx, esophagus,
cess following bariatric surgery, yet many programs exclude and down into the stomach be done smoothly and safely.
patients who are illicit drug and/or alcohol abusers and have Surgical staplers are often used when creating a gastric
active uncontrolled psychosis, severe mental retardation, or pouch in a Roux-en-Y gastric bypass or when performing a
lack of knowledge about the surgery [21]. sleeve gastrectomy. It is important that any unnecessary
intraluminal objects whether it is an NG tube, bougie, or
temperature probe all be removed before firing the surgical
Medical Consultants stapler. The anesthesiologist must also be aware of the car-
diovascular impact that persistent instrumentation of the oro-
Because a majority of patients getting bariatric surgery have pharynx with these devices may cause.
comorbidities, it is important to have patients evaluated pre-
operatively regarding their medical diseases. A separate
chapter in this book details the patient selection and preop- House Staff/Physician Assistants
erative assessment requirements.
As part of the entire bariatric surgery team, medical con- Many hospitals especially those with academic affiliations or
sultants become extremely important not only in the preop- academic centers have a team of resident physicians, fellows,
erative workup stage but in the inpatient hospital stage of and physician assistants who treat and oversee the inpatient
their operation and most importantly adequate postoperative care of the bariatric patient. In many ways, these providers
follow-up for the long term. Immediately after surgery, are those who have constant interaction with the patient and
patients are most fragile to fluctuations in their hemodynam- have easy access to examine and evaluate them should these
ics whether it is their blood pressure or their glucose control. patients have any questions or should they have any medical
Many patients have hypertension and are on multiple antihy- or surgical emergency. They are the direct liaison between
pertensive medications. Many are brittle diabetics with an the patient and the surgeon who is most likely occupied else-
exact insulin regimen whom may experience drastic changes where in clinic or in the operating room. The surgeon must
to their glucose levels in the perioperative setting. Some have recognize the importance of such a team because this may
sleep apnea and require careful monitoring of their pulmo- provide a means for a more efficient mode of patient care
nary status. It is not uncommon to incorporate the medical should an emergency necessitate a professional medical
care in the perioperative and postoperative setting with cardi- evaluation.
ologists, internists, pulmonologists, and endocrinologists to In-house physician assistants, nurse practitioners, or
ensure that patients in the immediate postoperative setting house staff should perform a postoperative checkup on the
are stable. Days after that the patient is discharged, they need patient several hours after surgery which includes a physi-
to have frequent follow-up with these medical consultants to cal exam and careful evaluation of all acute postoperative
ensure continuity of care of their health. needs and orders. Although the complications of bariatric
surgery are rare, when they do happen, they may be devas-
tating with a high mortality rate especially when encoun-
Anesthesiologist tering postoperative patients with an acute anastomotic
leak, bowel obstruction, or pulmonary embolus. The in-
Most of the bariatric patients undergoing surgery have a house providers must critically understand the presenta-
significant number of comorbidities including complex pul- tions of these particular life-threatening complications so
monary issues including sleep apnea, patients on CPAP or as to adequately and expediently care and treat them
BIPAP, and patients with cardiovascular comorbidities. should they happen.
56 A.S. Wu and D.M. Herron
Lifetime Follow-Up, Support Groups, to their nutritional needs and weight fluctuations. This same
concept applies to the psychologist/psychiatrist. Most hos-
and Education pitals specializing in weight loss surgery will have dedi-
cated seminars and support groups to help further promote
Weight loss surgery is a lifetime commitment to healthy eat- and continue the commitment to healthy living for bariatric
ing habits and exercise. Bariatric surgery is only one of many patients.
components to achieve this. The National Institutes of Health
(NIH) guidelines indicate that lifelong medical surveillance
after surgical therapy is a necessity and that patients who opt Support Group Meetings
for surgical intervention should be followed by a multidisci-
plinary team [13]. This is especially true of patients who Postoperative support groups are an important aspect of a
undergo gastric banding, because they may need frequent bariatric program and may improve postoperative results and
adjustments and advice regarding choice of foods. Data has limit relapse. Two nonrandomized studies have shown that
shown that inadequate adherence to follow-up care has been patients attending support groups achieve greater weight loss
recognized as contributory to the development of complica- than those who do not [24, 25].
tions after bariatric surgery. The consequences of missing Support groups can be an effective approach to the educa-
appointments can lead to the late diagnosis of complications, tion of patients prior to surgery and to maintain strong lines
los of a support network, and lack of reinforcement to follow of communication after the operations. In well-run groups,
the medical regimen [22]. patients can learn from each other, not only about the surgery
but also about how to adjust to changed personal relation-
ships, how to maintain their weight, how to employ new
Lifetime Follow-Up exercise regimens into their lives, how to cook, how to apply
for jobs, and how to deal with other personal concerns.
The follow-up of patients who have had bariatric surgery Comparisons of weight loss and appearance lead to far more
includes assessments for complications, nutritional deficien- realistic expectations. By sharing experiences amongst peo-
cies, psychological adjustments, medical management, and ple who have undergone similar journeys after bariatric sur-
weight gain. Many of the surgical and medical assessments gery will shed light into living a healthier lifestyle and will
require seeing the bariatric surgeon and the medical physi- mentally keep them motivated for continued success.
cians on a timely basis. The models and infrastructure for support groups vary per
For the first year follow-up, adherence with postoperative institution. A common approach is to have the principal
appointments has been shown to be associated with improved nurse coordinator of the practice also serve as the lead person
patient outcomes. One study published in 2008 identified in the support group because the patients know and trust this
five significant predictor variables that affect patient adher- person. In some places, surgeons will play a role in the
ence to postoperative appointments after bariatric surgery. groups on an occasional basis so as to further promote a life-
The predictors that indicated more likely adherence were long journey for continued healthy leaving. After introduc-
increasing patient age, being single, and being employed. tions, a 1-h session may include a 15- to 20-min instructional
The predictors that indicated less likely adherence were self- talk on various pertinent subjects as plastic surgery, prepar-
payment for appointments and a greater BMI [23]. The long- ing meals, choosing clothes, and interpersonal relationships,
term follow-up visits are generally scheduled for every 6 with ample time for both questioning and shared discussions
months for several years and then, by most groups, on an of individual experiences. In some clinics, the support groups
annual basis with the understanding that the patients can also serve as postoperative follow-up visit opportunities.
secure an immediate appointment upon request. In these vis- Some centers and programs employ the use of a personalized
its, the following information should be recorded: weight, journal that each patient creates and keeps. This journal
BMI, a review of each comorbidity that was present prior to tracks the progress of each individuals’ personal experience
surgery, documentation of new concerns, a list of current and records their weight and BMI on a quarterly basis as well
medications, a list of medical problems including admissions as personal pictures of patients to serve as a visual reference
since the last visit, and laboratory studies including a hemo- in seeing their change over time.
globin, hematocrit, vitamin B12 level, and Hb1AC if the
patient was a diabetic or demonstrated glucose impairment
prior to surgery. Additional studies are ordered as indicated Educational Seminars and Social
by additional symptoms or signs. Programs
Seeing a nutritionist should be done more often such as
every 3 months or every 6 months in order to ensure that the Educational seminars are slightly different from support
patient has maintained their weight and continue to eat a groups. Support groups serve as the foundation for meeting
healthy diet. Certainly this can be tailored with every patient with similar patients to share and further discuss their bariatric
5. Developing a Successful Bariatric Surgery Program 57
experience. Educational seminars are those that provide addi- incorporates their bariatric program. A professional market-
tional and more in-depth knowledge about particular topics ing and website designer is well worth the time and expense
related to obesity and the bariatric experience. in creating this website because it will be a tool easily and
The most important seminar is the preoperative informa- most often accessed by the bariatric patient.
tional session that patients attend which introduces them to The benefits of using the Internet are that the Internet
bariatric surgery. This is a free seminar, usually one hour reaches many patients at one time, and travel to appointments
long, meant to educate the patient who is not familiar with is not an obstacle. It provides many pictures and videos to
bariatric surgery and who simply wants to know what it help patients understand surgery at their own individual pace.
entails. It is often a seminar given by members of the bariat- The downside to the Internet is that it does require a computer-
ric team including a bariatric nurse, dietitian, and a surgeon. savvy audience and it is less personal than a face-to-face dis-
Topics include defining obesity, methods for weight loss cussion with a physician or nutritionist. We encourage the use
without surgery, nutritional needs and changes, indications of the Internet and personal website as an adjunct to the
and contraindications of surgery for weight loss, expecta- patients’ bariatric experience, not a replacement.
tions and inpatient experience of surgery, the various types of A relatively new arena within the world of informational
bariatric operations that are done with pictures and descrip- technology is the incorporation of the Internet as the central
tions of their differences and similarities, and the postopera- part of the patient’s bariatric and weight loss experience after
tive experience after surgery [26]. It is at the discretion of the surgery. Websites may be designed to give each patient a per-
bariatric program to either have patients whom are interested sonal login that has charting of their own progress. There
in bariatric surgery either attend this informational seminar may also be links for online nurses and nutritionists that may
before seeing the surgeon in clinic or to attend it after a first offer feedback and counseling. A study in 2003 by Tate
encounter with the surgeon provider. Some institutions pre- looked at the effects of Internet behavioral counseling on
fer having patients attend the seminar first because it will weight loss in adults and showed that patients who under-
give patients the necessary information needed for the went a dedicated electronic counseling treatment program
patients prior to individually coming to the first encounter requiring patients to log on weekly and submit weekly
with the surgeon so they have an idea of what they want or weights, food log, and exercise log had significantly
expect from surgery. In addition, this may serve to filter out increased weight loss and lower BMIs than patients without
patients who decide not to proceed with surgery, thus improv- electronic counseling [27].
ing on the efficiency of the surgeon’s outpatient practice and The web-based technology for Internet communication
not losing time seeing patients who effectively are not candi- and education on diet and exercise has been expanding rap-
dates or have no desire to proceed with bariatric surgery. idly over the past 5–10 years. This has a dramatic impact on
There are also postoperative educational seminars and how people communicate, learn, and share information. For
social programs that often are provided by the hospital or a bariatric practice, incorporating a personalized website
from community groups coordinated through the hospital should absolutely be a necessity.
which may cover other pertinent topics related to their bar-
iatric surgery. These topics may be a more in-depth look at
trends in diabetes, what is new in bariatric surgery, nutrition
for the bariatric patient, or exercise techniques for the bariat- Costs of Developing a Bariatric Practice
ric patient as an example. Social programs may interest
groups from within the bariatric community that serve as a Malpractice Insurance
meeting place for patients with similar interests such as
cooking classes for the bariatric patient or a morning walk- It is mandatory to ensure that appropriate malpractice cover-
ing exercise group for interested patients. age is in place prior to performing any bariatric procedures.
While some insurance carriers may consider bariatric sur-
gery to be included within general surgery coverage, many
Electronic Resources others require a separate policy or rider specifically covering
metabolic and bariatric surgery. Since these policies may
With the integration of the Internet into daily living, it is not cost significantly more than general surgery coverage alone,
surprising that many patients are turning to the Internet for this expense should be carefully evaluated early in the pro-
information. Many patients use the internet to initiate their cess of establishing a new metabolic/bariatric program.
search about learning about bariatric surgery and finding a A decade ago, it was estimated that a typical busy bariat-
surgeon. Patients will use the Internet to first learn about ric surgeon was sued for malpractice one to two times per
weight loss techniques, healthy eating habits, and exercise year [28]. Since morbidity and mortality rates have dropped
regimens without having to do surgery. Bariatric practices significantly since then, it is expected that malpractice
should keep up with informational technology and dedicate expenses should decrease as well. However, while poor out-
time and thought into creating a personalized website which comes may be decreasing in frequency, bariatric claims are
58 A.S. Wu and D.M. Herron
typically of high severity with potential payouts of $500,000 nurses, therapists, social workers, and surgeons who can
or more [29]. Since there is significant time lag between an provide an obese population with a specialty center, specifi-
occurrence and any subsequent legal action, this decrease cally a bariatric Center of Excellence dedicated to achieving
may not be reflected in reduced premiums for a number of weight loss through bariatric surgery.
years, if at all.
A recent study reported the results of a survey of surgeon
members of the ASMBS in which they were queried regard- References
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6
Essential Bariatric Equipment: Making Your
Facility More Accommodating to Bariatric
Surgical Patients
Hector Romero-Talamas and Stacy A. Brethauer
During the last few decades, the epidemic of obesity has Definition
been on the rise. Recent data suggests that in 2009–2010,
over one-third of the adult population of the United States Broadly speaking, the term “bariatric equipment” refers to
were obese [1]. Consequently, the number of specialized all of the “technology” utilized to administer health care to
bariatric centers has also increased. Persons with morbid the morbidly obese population. Technology is the knowledge
and super morbid obesity have special needs, which are and application of principles involved in the production of
often not met by conventional hospital equipment and furni- objects for the accomplishment of specific ends [6].
ture. Apart from the obvious size- and weight-related diffi- In this chapter, we will further restrict our discussion to
culties, the bariatric patient is often afraid of facing the equipment used in caring for patients undergoing bariat-
embarrassing situations that result from the distortion of ric surgical procedures, although much of the information is
their body contour and composition. This can be a great psy- broadly applicable to caring for obese patients in any health-
chological burden, which in turn, prevents the patient from care setting. Equipment can be categorized with respect to its
seeking medical attention when required. Moreover, there is function: diagnostic and/or therapeutic. Equipment may
reasonable evidence that despite the continuous implemen- have a specific role in the bariatric surgical process: preop-
tation of antidiscrimination laws and policies, bariatric erative, operative, and postoperative. The focus of this chap-
patients undergoing surgery continue to feel ignored and ter will be on the preoperative and postoperative needs. We
misinterpreted by those, who in theory, understand the gen- will also discuss the needs for the bariatric patient in the
esis and mechanisms of the disease [2]. Hospitals with pro- emergency setting. Operative equipment and instruments are
grams specifically addressing the surgical and medical reviewed in Chap. 9.
needs of this population have an obligation to provide for
their patients comfort and safety throughout their entire hos-
pital experience. Anticipating the needs of the bariatric Rationale
patient requires some experience, and meeting those needs
requires some familiarity with what is available. Further, the The concept that healing takes place in a “therapeutic patient
reader is encouraged to consider this to be an ongoing environment” and by “putting the patient in the best condition
endeavor of prioritizing essential and less necessary expen- for nature to act upon him” has been recognized for more than
ditures and of evaluating the results of these decisions. one century [7]. The increasing prevalence of obese and mor-
Guidelines and other publications are available as an aid for bidly obese persons essentially mandate that healthcare facili-
the new or establishing centers or practices [3–5]. ties of all levels work toward making their facilities safe and
This chapter is structured to answer the questions: What is effective for the specific needs resulting from large patient
bariatric equipment? Why does our facility or program need size and its accompanying comorbid conditions [8]. The com-
bariatric equipment? How can our program go about making bination of large size and often-limited mobility must also be
our facility more accommodating to bariatric surgery patients taken into consideration. Moreover, there is a generalized
with bariatric equipment? What are the essential equipment conception that the severely obese patient has a different psy-
items that we should consider? chosocial profile, presumably as a result of a higher incidence
of depression and isolation. This condition is frequently man- TABLE 1. Bariatric facility infrastructure
ifested by a high level of dependency and the presence of Essential equipment recommendations
unrealistic expectations [9]. Safety is the most compelling • Inpatient units (floor, ICU, PACU)
reason for making your facility more accommodating to the • Wide beds
needs of the morbidly obese patient [10, 11]. Better therapeu- Standard to 440 lb
Automated/adjustable to full sitting position
tic and diagnostic outcomes can also be achieved with Built-in scale
advanced planning [8, 12]. Modifications which safely Low air loss mattress
enhance mobility have the additional benefit of preventing Lifting/transferring equipment
morbidity [13]. Safety for the healthcare staff is based on the Wide commodes
need to prevent musculoskeletal injuries significantly associ- Wide wheelchairs, stretchers, walkers
Monitoring devices
ated with moving and physically caring for the morbidly Wide BP cuffs
obese patient. Many of these accidents and injuries are related Biphasic defibrillators
to use of conventional but inadequate equipment especially Sequential compression devices
for transferring and transporting patients [14–16]. Emergency airway equipment
Decreasing morbidity, especially that related to immobility, • Ambulatory facility
Wide examination tables, bolted to floor
will enhance outcomes. Complications related to immobility Appropriately sized scales
include respiratory insufficiency, atelectasis, pneumonia, • Radiology
venous thromboembolic events, decubitus ulcers, hygiene- Automated wide tables with appropriate weight capacity
related skin problems, and falls [10, 11]. Other parameters that CT, MRI, and interventional capability within 60 min
may also be affected by use of improved equipment include • Physical plant
decreasing LOS, accidents involving obese family members, Dedicated floor, ICU, and PACU for bariatric patients
Wide entrance doors to room and bathroom
and excess nursing time used to improvise for the needs of the
Floor-mounted toilets
obese because of lack of bariatric equipment or because of Elevators with wide doors and adequate weight capacity
inadequate space [17]. Optional equipment recommendations
Diagnostic testing may also be hampered by inadequate • Patient safety
equipment. Failure to perform routinely ordered tests because Inpatient units (floor, ICU, PACU)
of patient size puts the bariatric patient at risk. Problems may Wide beds
be encountered in the simple measurement of blood pressure Available to 880 lb
Lifting/transferring equipment
or weight without appropriate bariatric tools. Accurate Ceiling mounted
results from UGI, CT scan, polysomnogram, or cardiac Monitoring equipment
stress test all depend on meeting the specific needs resulting BP glove cuffs/wireless monitoring system
from patient size, weight, and limited mobility. Selective cardiac and apnea telemetry
Efficiency of care is related to the availability of bariatric Ambulatory facility
Wide automated examination tables
equipment. Prolonged waiting time for transport may be Radiology
related to availability of adequate staff or equipment and In-house wide CT, MRI, and interventional facilities
wastes time, energy, and money. Enhanced satisfaction of the
Adapted from: Lautz DB, et al. (2009) Obesity (Silver Spring) 17:911-917
patient, families, and staff is clearly related to readily avail-
able and properly sized equipment. A patient who is cared
for safely, efficiently, appropriately, and in a timely manner
will see the facility and the caregivers as being prepared and Investigation and Planning
competent. The caregivers will be better able to focus on the
patient’s clinical and personal needs without the distraction The first step in initiating a bariatric clinic should be the cre-
or even resentment generated by an increased risk of injury ation of a multidisciplinary committee in which all the
[13–18]. Rehabilitation may be possible only with special- appropriate areas and stakeholders are represented. The
ized equipment including walkers or parallel bars, which committee should be in charge of evaluating the characteris-
accommodate the extra space and durability needed. tics of the expected population and adapt the design of the
In 2009, an update on “Best Practice Guidelines for facilities and the equipment to its specific needs. The
Specialized Facilities and Resources Necessary for Weight approach that has worked the best in our experience to coor-
Loss Surgical Programs” was released. This document dinate the implementation in bariatric equipment was the
extends several recommendations that were written based on development of a bariatric task force (BTF). This can be a
a thorough review of the available evidence, built in its temporary problem-oriented group but most likely should
majority by consensus and expert opinions. For the readers function as a permanent committee that reviews the concerns
who are planning to or are in the process of starting a new relating to bariatric patients. Equipment and physical plant
center for the surgical management of obesity, these guide- issues, in particular, will require ongoing attention (evalua-
lines may prove to be an asset. They are divided into essen- tion, updating, new construction, etc.). Prior to establishing
tial and optional recommendations [3] (Table 1). the BTF, a fundamental presentation by a knowledgeable
6. Essential Bariatric Equipment: Making Your Facility More Accommodating to Bariatric Surgical Patients 63
individual or group may provide an introduction to bariatric (147–182 kg). This led to the protocol that all patients with a
patients, equipment, surgical procedures, and surgical results weight over 325 lb (147 kg) and/or a BMI greater than 55 (to
for the hospital. Inclusion of department administrators goes capture the width parameter) would require a bariatric bed
a long way toward engendering some empathy and helps [19]. Criteria-based protocols help to utilize the hospital’s
them to see why a BTF is needed. The task force should have resources most effectively and allow for preplanning as the
a broad representation from all aspects of the facility— patient population changes [12, 13].
administration, parking, environmental services, transport,
purchasing, nursing (intensive care units, intermediate care
units, medical-surgical floors, clinics, administration, home Essential Bariatric Equipment
care, bariatric coordinators, case managers, enterostomal
therapy, outpatient surgery units, postanesthesia care units, Utilization of bariatric equipment does not ensure proper
operating room, and emergency room), nutrition, social health care but can greatly improve the quality and safety of
work, physical therapy, radiology, cardiology, pulmonology, care [13]. Both caregivers and patients should receive spe-
surgeons, and midlevel practitioners. cific instructions for using specialized bariatric equipment
The first commission of the task force is to investigate the properly in order to fully benefit from the advantages, which
facility’s assets and limitations with respect to the physical this equipment offers.
structural layout and available conventional and bariatric This review of bariatric furniture and equipment which
patient care equipment [8, 10]. Questions to ask are: How should be considered is based on available literature and the
have you managed with morbidly obese patients up to this authors’ experience in caring for over 4,000 bariatric surgical
point? Which practitioners have had an interest in these patients [8, 11, 12, 14, 19–24]. The following discussion will
patients (e.g., nurses, enterostomal therapist, physical thera- follow the surgical patient through the entire hospital course,
pist, pulmonologist)? What are the weight and width limita- from “home to home” which is divided clinically into the
tions of the currently available equipment starting with chairs preoperative, operative, and postoperative periods. Since the
in waiting rooms and hospital beds? Who are the vendors of operative period is discussed in detail elsewhere (see Chap.
bariatric equipment items already in use? What are the pres- 10), this chapter reviews the equipment needs of the preop-
ent policies for the utilization of bariatric equipment? What erative and postoperative morbidly obese patient.
distances must the patients travel from the clinic and the Table 2 lists the bariatric equipment items discussed along
acute care areas and to the diagnostic testing areas? The with contact information for some of the vendors.
committee should systematically review each step of the
patient’s hospital experience from “home to home.”
A second area of investigation should focus on what Preoperative
bariatric equipment is available for purchase. There are a
number of reputable sources of information on products and At times, patients will not be able to come to the facility by
companies. Vendors typically have websites with listings of independent means and require an ambulance. The team
a wide range of bariatric products with links. should collect information on the ambulance services in the
A third area of investigation should focus on the character- surrounding area and how they are equipped for the transpor-
istics of the patients expected to make up the service popula- tation of morbidly obese patients. A number of modifications
tion in view of the hospital’s prior experience with morbidly can be made to ambulance equipment and to transportation
obese patients. The bariatric surgeons should be questioned protocols to assure that the service provided is a safe, effi-
with respect to their expectations for maximum and median cient, comfortable, and dignified experience [18].
weight and BMI. In our practice, the first 500 patients had a
weight range from 190 to 473 lb (86–215 kg) with BMIs from
35 to 69. Thus contingency plans for patients greater than 500 Transportation Equipment
lb (227 kg) and BMIs greater than 70 were needed, recogniz- When considering the transportation of obese individuals,
ing that these would represent a relatively small number. different scenarios call for different devices. Several ques-
One of the goals of these investigations will be to priori- tions should be considered by the caregiver in charge: are
tize purchases and other adaptations in the environment. The there enough personnel to move the patient? Is there a weight
task force should develop criteria for their utilization. For limit to be considered for the use of the available transporta-
example, in our institution, we did not have a dedicated bar- tion device? Will the maneuver be safe for the team and the
iatric surgical floor, and there were hospital beds in the patient? A number of devices have been designed to better
facility of a variety of vintages and models. The standard address these issues.
hospital beds had a variety of weight limits, 350–500 lb
(159–227 kg) and widths of 34–36 in. (86–91 cm). The low-
Temporary Transfer
est of these weight limits had to become the maximum per-
mitted for the use of a standard hospital bed. Similarly, the The first step for transporting the patient is to safely get the
mattresses on the beds also had weight ratings, 325–400 lb subject to the definitive device. In many cases, the patient is
64 H. Romero-Talamas and S.A. Brethauer
found to be lying on the floor or in other difficult positions as Wheelchairs and Stretchers
a result of a fall or an accident. In this scenario, one recom-
In the past, many facilities invested in oversized wheelchairs,
mendation is the Transfer-Flat (Stryker) (Fig. 1). This vinyl
as this was one of the first areas where it was recognized that
device has a maximum weight capacity of 1,600 lb (727 kg)
one size does not fit all. Initially, manufacturers simply took
and can be operated by a maximum of 12 persons. This is a
standard wheelchair design and made them wider to accom-
versatile aid in minimizing injuries to the transporting per-
modate the larger patients’ needs. However, a good bariatric
sonnel. Another clever alternative for patient lifting is the
wheelchair is specifically engineered for the extra weight as
HoverJack™ Air Patient Lift. This is a great option to lift a
well as size of the morbidly obese patient. It should come in
patient without the need of a team. This item is constructed
a number of widths, 24–30 in. (60–76 cm), and have a weight
with multiple independent air compartments that can be
capacity of at least 750 lb (340 kg) (Fig. 4).
inflated separately until the desired height is reached (Fig. 2).
Similarly, stretchers were not designed for the morbidly
Another transfer device is the HoverMatt™ Air Transfer
obese patient and increasing weight limit modifications have
System for lateral transfers. Since this product eliminates the
been incorporated over the years. A good stretcher for the
necessity to lift, the caregivers’ safety is ensured while main-
bariatric patients will have the appropriate weight rating in
taining patient’s comfort (Fig. 3).
6. Essential Bariatric Equipment: Making Your Facility More Accommodating to Bariatric Surgical Patients 65
FIG. 5. (a) Stryker’s Prime Series Stretcher plus Zoom Motorized Drive System. (Courtesy of Stryker, Kalamazoo, MI). (b) Bariatric
gurney (Courtesy of Stryker, Kalamazoo, MI)
FIG. 6. (a) Bariatric waiting room (Courtesy of Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, OH). (b) Bariatric chair in
vital signs area (Courtesy of Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, OH)
used for extended periods due to pressure concerns. All facil- the chair causing them extreme embarrassment or even
ities should have the availability of a bariatric stretcher for injury. Typically the chairs in medical office waiting rooms
those instances where these limitations are exceeded. A bar- are not weight rated specifically or are rated up to only 300 lb
iatric stretcher will have a weight limit of 1,000 lb (454 kg) (136 kg). Their widths are usually from 20 to 24 in. (50–
and a patient surface width of 39 in. (99 cm) (Fig. 5b). These 60 cm) and often have limiting arms. A bariatric chair should
dimensions make it more difficult to negotiate in tight halls, have a width of between 28 and 44 in. (72 and 112 cm) and a
elevators, and rooms, and the patient’s route to critical areas weight rating of 600–750 lb (272–341 kg) (Fig. 6a, b).
should be tested in advance, including potential routes for Another important factor is the height of the chair. Some
diagnostic testing and emergencies. morbidly obese persons are also of short stature. Adjustability
of the chair height is a feature offered on some models. These
chairs can be used in waiting rooms, hallways, and in the
Chairs patients’ rooms postoperatively.
One of the common concerns of a morbidly obese patient is For group information sessions or support groups, a por-
that they will break furniture, especially chairs or get stuck in table and relatively inexpensive folding chair is especially
6. Essential Bariatric Equipment: Making Your Facility More Accommodating to Bariatric Surgical Patients 67
helpful. There are folding chairs that have weight capacities require adequate surrounding space to accommodate the
of up to 500 lb (227 kg), are without arms, and offer flexibil- morbidly obese (Fig. 8c).
ity in seating arrangements for discussions (Fig. 7).
Scales and Height-Measuring Devices
Commodes Easy and accurate measure of weight and height in bariatric
Another important facility/clinic item is the availability of an patients is essential to calculate body mass index (BMI) and
appropriate commode. The standard wall-mounted model is to track clinical changes associated with fluid management.
not safe (Fig. 8a). Additional structural support can be added A number of manufacturers have responded to this challenge
under an existing wall-mounted commode to provide suffi- with an array of products. Our team has used Scale-Tronix
cient weight-bearing capacity. Beginning April 2000, the models. The important features of a scale are: accuracy, sta-
ANSI standard for pedestal commodes was increased to bility, ample standing platform, a weight limit above 750 lb
500 lb (227 kg) (Fig. 8b). In addition, the commode will (340 kg), portability, attachable height gauge, and wheel-
chair accessibility. These models have weight limits of
1,000 lb (445 kg). Many products come with a height mea-
sure attached. The most recent models combine all of these
virtues thus offering better accessibility and portability in
low-profile, heavy-duty devices (Fig. 9a, b).
FIG. 8. (a) Wall-mounted commode. (b) Pedestal commode. (c) Handrails and adequate space around the commode (Courtesy of Bariatric
and Metabolic Institute, Cleveland Clinic, Cleveland, OH)
68 H. Romero-Talamas and S.A. Brethauer
Examination Tables
Morbidly obese persons may have difficulty ascending the
examination table. Both height and stability must be taken
into account. Standard examination tables are often about
33 in. (84 cm) in height with a 7 in. (18 cm) step. The obese
person can destabilize the table using the step. Extra width is
also required. The needs of a majority of patients are met by
bariatric tables like the Midmark® Model 405 which has
height adjustments from 26 to 37 in. (68–94 cm), a weight
limit of 600 lb (273 kg), and a width of 26 in. (68 cm) FIG. 11. Bariatric examination room and table (Courtesy of
(Fig. 11). However, the power functions of tilt and lift serve Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, OH).
only up to 300 lb (137 kg). For those super obese patients,
the availability of a bariatric examination table like the surgery have elevated the need for adequate imaging equip-
Hausmann Inc. Model 4795 is helpful. It offers a 600-lb ment [28].
(273 kg) weight limit, a powered height range of 20–29 in. When obtaining standard radiographic studies in obese
(51–74 cm), a width of 32 in. (81 cm), and a powered back subjects, a number of problems, such as difficult positioning,
rest that rises to 75°. attenuation of the X-ray beam, the presence of artifacts, and
low-quality images, can arise. Certain strategies, such as
increments of the radiological parameters, the use of multi-
X-Rays and Other Imaging Modalities
ple cassettes, and cassette-mapping techniques, can be useful
The increased prevalence of obesity and associated comor- [29]. Ultrasonography is frequently used as part of the avail-
bidities mixed with the rapid spread and success of bariatric able diagnostic tests for the management of the obese patient.
6. Essential Bariatric Equipment: Making Your Facility More Accommodating to Bariatric Surgical Patients 69
It is considered brief, inexpensive, and free of radioactivity. these patients may be troublesome. The body habitus of these
However, a thick abdominal wall may null all of these advan- patients makes positioning and intravenous access especially
tages. It is estimated that in a patient with 8 cm of subcutane- difficult. In addition, the size of the display and the quality of
ous fat, 94 % of the original sound wave is attenuated before the image may not be appropriate [29]. Fortunately, new tech-
it reaches the peritoneal cavity. A possible solution to this nologies, such as the multidetector CT with larger gantry
issue is the use of harmonic imaging. This device generates entries (up to 90 cm) and extended field of view, are now avail-
the waves within the tissue, thus increasing the penetrance of able. Another, better example is the SOMATOM Sensation
the beam. This results in better resolution and reduced Open scan by Siemens, which combines the latest imaging
artifacts [28]. technology with a large 82 cm gantry opening, ideal for
Preoperative and postoperative upper GI studies and CT-guided interventions in bariatric patients (Fig. 13a). The
abdominal CT scans are frequently required to assess comor- mixture of these technologies with appropriate obesity CT
bid conditions, variant anatomy, and complications such as protocols has resulted in significant improvements in this
leak of the anastomosis [30]. Even in the best of circum- aspect of care [32] (Fig. 13b). Even though the magnetic
stances, the quality of these studies may be inferior, but it is
important that the patients size can be accommodated by the
diagnostic facilities and equipment [31].
Fluoroscopy equipment has limitations in the image
quality and weight limits regarding articulation of the table.
Full articulation of most tables has a weight limit of 300 lb
(137 kg). The footboards on the tables have weight limits of
between 300 and 350 lb (137–159 kg) depending on the
model. Larger patients’ studies are often obtained in the
standing position (on the floor) with a sacrifice of optimal
image control. The Luminos Agile by Siemens offers a high-
capacity (606 lb/275 kg) static table with a full-tilt function
and high-quality imaging (Fig. 12).
The limitations with abdominal CT scanning in the bariat-
ric patients relate to the weight limitations of the power table,
the diameter of the entry port, as well as the overall imaging
power. Exceeding the recommended parameters may produce
considerable damage to the equipment and may be hazardous FIG. 12. The Siemens Luminos Agile Fluoroscopy System offers a
for the patient. Although CT may be considered the best imag- high-capacity platform with full-tilt function. (Courtesy of Siemens
ing modality for severely obese patients, accommodating Corporation).
FIG. 13. (a) The SOMATOM Sensation Open scan by Siemens Sensation Open scan by Siemens. Different dosages are automati-
allows for simplified scanning of bariatric patients. (Courtesy of cally tailored according to the patient’s body shape in the topogram.
Siemens Corporation). (b) Clinical images from SOMATOM (Courtesy of Siemens Corporation).
70 H. Romero-Talamas and S.A. Brethauer
Postoperative
wheelchair for those patients 325 lb (150 kg) or a BMI of 55
or greater.
Beds and Mattresses Special bariatric beds offer a number of options requiring
Beds and mattresses are considered a cornerstone of the in- choices at the time of purchase or rental. There are two types
hospital experience for the bariatric patient. Their impor- in regard to entry—the side entry (as with standard beds) and
tance lies not only in the concept of comfort but also in the those that allow bottom entry and some easily allow both.
fact that complications such as rhabdomyolysis and skin- The side entry looks more like the standard hospital bed and
related problems can be prevented [33, 34]. Standard hospi- may have fewer stigmas for the majority of bariatric surgical
tal beds have weight ratings between 350 and 500 lb patients who are, for the most part, free to ambulate. The bot-
(159–227 kg). It is important to check with the manufacturer tom entry beds can often be converted into a chair position to
for the weight rating according to the model(s) and vintage(s). facilitate ambulation and possibly lead to fewer staff injuries
Most recent models have weight ratings of up to 500 lb related to patient ambulation. Special bariatric beds, like
(227 kg), and this would serve the majority of patients. The Stryker’s Bari 10A, offer a 1,000 lb weight capacity and are
standard mattress on the bed also will have a weight rating expandable. This particular item is able to go from 80″ to 88″
often between 300 and 500 lb (136–227 kg). They also are in. length and from 36″ to 48″ in. width. It also includes an
available in a number of different types of surfaces. It is very in-bed scale that can be quite useful when the patient experi-
reasonable to routinely use a pressure reduction mattress rec- ences a prolonged hospital stay (Fig. 14). Other features to
ognizing the high risk for developing pressure ulcerations take into consideration are: the type of side rail adjustment,
[13, 35]. the wheels and locks, the height adjustment parameters, abil-
The width of the patient and bed must be considered. ity to attach over-bed trapezes, and the complexity and ease
Standard hospital beds are typically from 34 to 36 in. (86– of use of the hand controls. Another important consideration
91 cm) often with the critical care beds tending to be the is that the bed should be able to be placed in at least 45° of
narrowest. Manufactures recommend often that a patient be reverse Trendelenburg easily; this is the optimum position
fitted for the need for a bariatric bed by having the patient for pulmonary function given that many of the patients have
measured lying flat. This is not often practical prior to sur- ventilatory comorbid conditions (obstructive sleep apnea,
gery. We and others have adopted utilization of a BMI obesity hypoventilation syndrome, and restrictive lung
parameter to take into account the width of the patient [36]. disease) and may in some cases require tracheotomy and
Our criteria-based protocol calls for a bariatric bed and ventilatory support [37].
6. Essential Bariatric Equipment: Making Your Facility More Accommodating to Bariatric Surgical Patients 71
FIG. 15. (a) Bariatric inpatient room with adequate space around Institute, Cleveland Clinic, Cleveland, OH). (c) HoverTrans®
bed. (Courtesy of Bariatric and Metabolic Institute, Cleveland Roomer ceiling lift for horizontal room-to-room transfer. (Courtesy
Clinic, Cleveland, OH). (b) Bariatric recliner chair in inpatient of HoverTech International, Bethlehem, PA).
room and patient lift (right). (Courtesy of Bariatric and Metabolic
Hospital Patient Room Layout, Equipment, staff and patient-related injuries associated with patient
and Fixtures lifting and transfer [39]. They recommended that a mobile
portable lift is most applicable due to the flexibility to accom-
The design of a bariatric facility should not be solely focused modate the patient in any portion of the room (Fig. 15b). One
on making everything “supersized.” Concepts like function- example of a mobile lift is the Invacare Reliant 600 that fea-
ality, ergonomics, dignity, and other ideas are to be consid- tures an electric motor and a lift of up to 660 lb (300 kg).
ered. The layout of the hospital room is the basic building Another option is the HoverTrans® Roomer ceiling lift. This
block of a bariatric nursing unit and most influential in the alternative is especially valuable when it comes to room-to-
administering of nursing care postoperatively. A dedicated room transport. It has a weight maximum capacity of 480 lb
unit with a dedicated staff is most preferable but at present is (Fig. 15c).
not the norm. The driving force in the design and layout is
the large patient size and weight requiring many pieces of
oversized and extremely durable equipment (already noted) Hygiene Items: Toilets, Showers,
and safety in negotiating around the patient by the staff. The and Gowns/Pants
American Institute of Architects has recommended to plan Personal hygiene can be difficult for the bariatric surgical
the design, taking into consideration the following parame- patient due to space issues, limited mobility, and the need for
ters: (a) average patient, 330 lb; (b) bariatric visits of 450– a durable environment. Toileting will require a bathroom
510 lb; (c) design target, “minimum” of 500 lb; and (d) with an opening to tolerate 60 in. (152 cm) in width, the
design drop weight, 700 lb [38]. width of the widest wheelchair. Commodes will require
In an effort to establish industry standards, the Hill-Rom handrails to enable the patient to self-assist (b). For those
Company formed a Bariatric Room Design Advisory Board patients with minimal mobility but able to weight bear and
(BRDAB). They made a number of recommendations with transfer, a bedside commode is an excellent option over use
respect to room space, target maximum weight tolerance for of a bedpan. These especially allow for increased safety,
room equipment and fixtures, and which equipment a patient comfort, and dignity. These should have a width of at least
room should have [17]. They recommended 5 ft (152 cm) of 30 in. (76 cm) and a weight capacity of at least 750 lb
space around a bed to allow for the passage of oversized (341 kg).
equipment (Fig. 15a) that necessitates an overall room size The BRDAB recommends that a shower space be at least
of at least 13 ft (4 m) in width and 15 ft (4.6 m) in depth from 45 square feet (4.17 m2), large enough to accommodate the
the corridor. The opening for this space should be ideally assistance of two caregivers and accommodate wheelchair
60 in. (152 cm) with an unequally divided leaf-swinging access. Each patient room may not be able to have this space
door, one leaf being 42 in. (107 cm). The BRDAB sets a tar- available, and a reasonable option for showering is a com-
get maximum of 1,000 lb (454 kg) as a recommendation for munal shower; we have utilized this concept with excellent
room equipment and fixture weight tolerance. In many cases, review from the patients. The BRDAB also recommend
this would not be possible at present. They recommended waterproof walls and floor, with a drainage sloping floor
that other room equipment for consideration would be a bed- without curbs for easy entry and exit (Fig. 16a). A portable
side chair (specification as noted in earlier section) and a lift. shower chair/bench either a commode chair combination
Lifts are essential to have available due to the high number of model or a stand-alone is a necessity (Fig. 16b).
72 H. Romero-Talamas and S.A. Brethauer
FIG. 16. (a) Large shower room with unobstructed access to shower. (Courtesy of Bariatric and Metabolic Institute, Cleveland Clinic,
Cleveland, OH). (b) Shower chair (Courtesy of Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, OH).
Periodic Reevaluation
It is important to revaluate patient anthropometric data, the
equipment utilization numbers, comorbidity related to
immobilization, accidents or falls involving patients, staff
injuries, and overall surgical outcome data. Bariatric surgical
programs including surgeons, staff, patient characteristic,
and facilities will mature over time and require further evalu-
ation of equipment needs and use criteria.
Summary
Bariatric equipment includes all of the “technology” utilized
to administer health care to the morbidly obese patient. This
equipment is essential in providing quality bariatric surgical
care by providing for safety, reducing morbidity, and enhanc-
ing mobility thereby promoting the best possible outcomes.
Further, adequately sized accommodations and equipment
allow for accurate diagnostic testing and reduce stress and
wasted time. These benefits promote dignity of the patients,
FIG. 17. A walker designed for bariatric patients has a deep and improving satisfaction of patient, family, and staff. To
wide frame, adjustable height, and can support up to 700 lb. A achieve this, a facility must investigate their own resources
wheel kit can be added on if needed. (© Invacare Corporation. Used
and limitations, based on their current management of mor-
with permission).
bidly obese patients, survey the market in bariatric equip-
ment, and evaluate their patient base. A BTF is a good
The availability of appropriate fitting hospital clothing is organizational structure to coordinate this activity. Ultimately,
essential to safety, hygiene, and dignity. Since the morbidly criteria-based protocols will be developed to guide the appro-
obese are also not all the same size or shape, a few sizes of priate utilization of bariatric equipment resources. These will
gowns (3X–10X) and pants (X–4X) should be readily avail- need intermittent revision as the program matures and
able. The gowns should accommodate peripheral intrave- technology advances. The process requires and ongoing
nous lines. communication among clinicians and administrators and
Many severely obese patients have chronic osteoarthritis between equipment manufacturers and clinicians in the fur-
affecting their back, hips, and knees. Postoperatively and ther refinement and development of additional technology to
upon discharge from the hospital, these patients may tempo- better care for the morbidly obese patient [8, 12].
rarily require a walker to avoid falls during their recovery
from surgery. A walker designed specifically for the bariatric
patient should be obtained. These walkers have a wide base, References
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7
Patient Selection: Pathways to Surgery
Monica Dua, Eric P. Ahnfeldt, and Derrick Cetin
foods in the first 3–6 months. Regular visits with the nutri- complications observed in this population [24]. Morbid
tionist can provide guidance to the patient on meal plan pro- obesity (BMI > 40) is positively associated with incidence of
gression, protein supplementation, and adherence to depression, and preoperative clinical interviews suggest that
recommended nutrient supplementation. approximately 50 % of patients seeking weight-loss surgery
Our standard practice after bariatric surgery is to provide report a lifetime history of depression [24–26]. Population
supplementation with a multivitamin, vitamin B12, iron, vita- studies demonstrate that up to 60 % fulfill criteria for an Axis
min C, and calcium citrate with vitamin D. Laboratory val- I psychiatric disorder inclusive of mood disorders, general
ues are drawn every 6 months for the first 2 years and anxiety disorders, and substance abuse disorders [12, 27].
continued annually unless patient presents with poor oral Contributing to this statistic is the fact that bariatric patients
tolerance, evidence of dehydration, or symptoms attributable often report physical ailments, emotional toll, and a signifi-
to nutrient deficiency. cant alteration in quality of life measures. Many obese indi-
Preoperative weight loss of about 10 % is frequently viduals have suffered stereotypes throughout their life that
advocated prior to bariatric surgery [15, 16]. Whether preop- have potential to discriminate in three important areas of liv-
erative weight loss is associated with improved postoperative ing—employment, education, and health care [28]. Increased
weight loss has been controversial. Still and colleagues were dissatisfaction with body image can also negatively impact
able to demonstrate in a large cohort of 884 patients under- marital relationships and sexual functioning. Eating behav-
going bariatric surgery that preoperative weight loss of at iors and habits should also be reviewed with specific atten-
least 10 % was achieved in 48 % of subjects. These patients tion toward binge-eating disorders. Binge-eating disorder is
were more likely to have a decreased length of stay in the commonly identified in bariatric surgery candidates and can
hospital postoperatively and achieve a 70 % loss of excess contribute to postoperative weight regain if not appropriately
body weight at follow-up of 1 year [16]. Another retrospec- addressed and treated [29].
tive study of 90 subjects undergoing laparoscopic gastric Despite the necessity and frequency of preoperative
bypass surgery demonstrated that a preoperative weight loss psychological evaluations for bariatric surgery, consensus
of 1 % of initial weight correlated with an increase of 1.8 % guidelines as to what constitutes an appropriate evaluation or
of postoperative excess weight loss at 1 year [17]. In addi- psychological reasons for denial of surgery have not been
tion, preoperative weight loss of greater than 5 % also cor- established. At our institution, a multidimensional Cleveland
related significantly with shorter operative times [17]. In Clinic Behavioral Rating System (CCBRS) was developed
contrast, other studies have not demonstrated an association to assess patients across a variety of domains identified in
between pre- and postoperative weight loss with the concern published reports to be important in the preoperative psycho-
that these preoperative requirements may delay surgery and logical assessment [30]. At entry into the bariatric program,
contribute to patient dropout rates [18]. psychiatric interviews and objective psychological testing
A separate functional aspect of preoperative weight loss using either the Millon Behavioral Medicine Diagnostic or
relates to the technical aspect of bariatric surgery. Laparoscopic Minnesota Multiphasic Personality Inventory-2 Restructured
procedures in morbidly obese patients can be technically chal- Form are used to assess behavioral comorbidities [30].
lenging given the small amount of working space in the setting The initial interview consists of a query of specific domains
of a large fatty liver and increased amount of intra-abdominal which are then assessed on a Likert rating scale from 5
adiposity. The enlarged liver can cause difficulty with expo- (excellent—no concerns and no follow-up with psychology
sure at the gastroesophageal junction and is reported to be one recommended unless future problems develop) to 1 (poor—
of the more common causes for conversion to open procedure inappropriate risk that very likely outweighs benefits). These
[19]. Acute preoperative weight loss has been associated with ratings are given for the following nine domains of interest:
less intraoperative blood loss and a decreased frequency of (1) Consent—assessment of cognitive functioning, under-
deviation from the standard laparoscopic procedure [20]. standing of procedure, and capacity to consent.
Several studies have shown a reduction in liver size with (2) Expectations—inclusive of transition of surgery, weight-
different variations of low-calorie diets over a 2- to 4-week loss goals, and long-term outcomes.
period [21–23]. Although short-term weight loss is not a (3) Social support—assessment of patient support circle
prerequisite for surgery, our practice is to place patients on a including spouse or significant other, family members,
800–1,000 kcal/day liquid diet with protein shake supplemen- coworkers, and bariatric support group attendance.
tation starting 2 weeks prior to their bariatric procedure. (4) Mental health—assessment of psychiatric diagnosis and
severity and duration of diagnosis.
(5) Chemical/alcohol abuse/dependence—inclusive of use,
Mental Health Evaluation abuse, and dependency of substance, history and present
use, and tobacco assessment.
The mental health evaluation is an essential component to (6) Eating behaviors—inclusive of binge eating, night eating,
the preoperative evaluation of bariatric surgery candidates compensatory behaviors, problematic outcomes from
due to the high prevalence of psychiatric and behavioral previous diet attempts.
7. Patient Selection: Pathways to Surgery 77
(7) Adherence—inclusive of adherence to previous dietary postoperative marginal ulcer and gastrointestinal bleeding
attempts, past psychological/psychiatric interventions, may be higher in patients infected with H. pylori [34, 35].
medical recommendations, and tobacco prohibition. Preoperative ultrasonography of the abdomen is employed
(8) Coping/stressors—assessment of coping resources in the primarily to assess for gallbladder disease; obesity is a cause
context of situational stressors. for the higher incidence of gallstones in bariatric patients. In
(9) Overall impression addition, rapid weight loss after bariatric surgery is a well-
The CCBRS has been demonstrated to be an internally con- known risk factor for gallstone formation and exacerbation;
sistent and useful tool for multidimensional psychologi- therefore, ultrasound is used to screen for patients that may
cal assessment of bariatric surgery candidates with benefit from concurrent cholecystectomy. Although previ-
favorable inter-rater reliability between examining psy- ously, prophylactic simultaneous cholecystectomy was often
chologists. In a study of 389 bariatric surgery candidates performed with gastric bypass, this has largely been aban-
using this rating system, most candidates (71.7 %) were doned. The more conventional approach is to perform chole-
deemed psychologically acceptable, a smaller subset cystectomy in the presence of symptomatic gallstones, as the
(25.7 %) were considered guarded requiring additional incidence of subsequent cholecystectomy after bariatric sur-
treatment of requirement fulfillment prior to gaining gery is reported to be less than 15 % in most studies [36].
clearance for surgery, and finally a very small percentage Our practice is to also use the preventative administration of
(2.6 %) of candidates were unable to reach candidacy ursodeoxycholic acid for 6 months postoperatively which
[30]. Our experience using the CCBRS has improved has been shown to decrease gallstone formation during rapid
communication between the multidisciplinary team weight loss [37].
allowing surgeons and treating physicians to review the
summary of a patient’s strengths and weaknesses.
Cleveland Clinic Protocol
Labs and Procedures An overview of the steps to weight-loss surgery at the
Cleveland Clinic Bariatric and Metabolic Institute (BMI)
Selection of preoperative laboratory tests should be based on are presented in Table 1. The initial patient worksheet ques-
specific clinical indication; however, routine fasting blood tionnaire is a 16-page health document that requests the
glucose, lipid profile, complete blood count, and a metabolic patient to fill out sections regarding demographics, insur-
panel are considered reasonable for the bariatric patient [12]. ance information, and weight and diet history inclusive of
Baseline micronutrient and vitamin levels are useful to mon- any previous behavioral or medical treatment for weight
itor and treat any subsequent deficiencies that may develop loss, current medications, medical and surgical history, prior
as a result of malabsorptive procedures. Female patients of bariatric surgery, psychological or emotional disorders,
childbearing age should have a pregnancy test. recent diagnostic examinations, review of systems, social
Routine upper gastrointestinal (UGI) evaluation or history with substance abuse information, sleep apnea
abdominal ultrasound are not recommended universally and screen, ambulatory status, and expectations for weight loss.
are typically at the discretion of the surgeon or treating insti- This questionnaire is submitted on paper or via the pro-
tution. UGI contrast studies and esophagogastroduodenos- gram’s website and is then evaluated by the BMI staff for
copy (EGD) are often used by surgeons in the preoperative
evaluation of bariatric patients to assess for any preexisting
TABLE 1. Basic steps through the program
anatomical variations or upper GI pathology. The most com-
mon findings on UGI include gastroesophageal reflux and Description
hiatal hernia; however, typically these findings rarely lead to Step 1 Complete initial patient worksheet questionnaire
a change in the proposed surgical plan or cancellation [31]. Step 2 Send initial patient worksheet questionnaire to Cleveland
Clinic Bariatric and Metabolic Institute Program office
Routine use of EGD for preoperative evaluation has also
(paper or via website)
been controversial. The majority of findings include hiatal
Step 3 Insurance coverage for weight-loss surgery
hernias, gastritis, esophagitis, gastric or esophageal ulcer-
Step 4 Medical qualification for weight-loss surgery
ation, and Barrett’s esophagus [32, 33]. Opponents of nonse-
Step 5 Appointment for the weight-loss surgery patient workshop
lective preoperative EGD suggest that in asymptomatic
Step 6 Weight-loss surgery workshop or online informational seminar
patients, these findings are infrequently clinically significant.
Step 7 Visit with the surgeon
However, considering that gastric bypass procedures pre-
Step 8 Medical consultations and assessments
clude endoscopic evaluation of the gastric and duodenal
Step 9 Acquiring insurance pre-approval
mucosa postoperatively, supporters of preoperative EGD have
Step 10 Scheduling the surgery date and pre-op clinic visit
used endoscopy to obtain baseline gastric pathology and
Step 11 The surgery
concurrent investigation of the gastric mucosa for H. pylori.
Step 12 Follow-up visits
A small number of studies have indicated that incidence of
78 M. Dua et al.
determination of eligibility for weight-loss surgery accord- complete blood count, comprehensive metabolic profile,
ing to the National Institutes of Health guidelines and cur- type and screen, coagulation studies, liver function, lipid
rent recommendations of the American Diabetes Association profile, thyroid function, glycosylated hemoglobin, ferritin
and International Diabetes Federation Task Force on levels, and vitamins. Ultrasonography of the abdomen is per-
Epidemiology and Prevention [12, 38, 39]. Once medical formed to assess for biliary tract pathology and cholelithia-
qualification for weight-loss surgery has been established sis. Patients in the high-risk medical group are referred for
and insurance coverage verified, patients are scheduled for a additional investigations or consultations from other subspe-
2-h bariatric surgery workshop program. At this point, they cialties as medically indicated, with special emphasis on car-
are also triaged into one of six different clinical preoperative diopulmonary assessment. Standard investigations will at
pathways, designated by color code and based on objective minimum include a chest X-ray and electrocardiogram.
medical criteria as described in Table 2. The specific path- Patients that demonstrate a significant cardiac history or
ways of potential bariatric patients include (1) general path- major clinical predictors for a cardiac event (unstable coro-
way, (2) high-risk medical, (3) high-risk psychology, (4) nary syndromes, decompensated CHF, significant arrhyth-
high-risk medical/psychology, (5) adolescent/pediatric, and mias, or severe valvular disease) are referred to cardiology
(6) revision pathway [40]. Common to all these pathways is for preoperative evaluation. Patients with poor functional
a thorough history and physical examination by the bariatric capacity (<4 METS) or have at least intermediate clinical
surgeon and bariatric medical internist as well as the nutri- predictors for a cardiac event (mild angina pectoris, prior
tional and psychology assessments. myocardial infarction, compensated or prior CHF, diabetes
Consultation with the bariatric surgeon includes discus- mellitus, and renal insufficiency) are often evaluated with an
sion of the recommended procedure with explanation of the echocardiogram or dobutamine stress echocardiogram as
risks and benefits. The final decision whether treatment is indicated as well as consideration for the use of perioperative
offered is then based on completion of the cumulative multi- beta blockade. Patients with a BMI > 50 or an Epworth sleep-
disciplinary evaluation. Baseline laboratory studies include a iness scale > 10 are routinely referred for polysomnography
7. Patient Selection: Pathways to Surgery 79
and consultation with sleep medicine to evaluate need for a shown in Table 4. Routine follow-up appointments after
continuous positive airway pressure (CPAP) device [41]. bariatric surgery are scheduled at 1 week postoperatively,
The number of nutritional sessions (range 3–6 months) is followed by 1 month postoperatively, and then every 3
typically designated by different insurance carriers. Each ses- months until 18 months at which time they return annually.
sion should document weight, diet, exercise regimens, and Surgeons visit with the patients at the 1 week, 1 month, and
overall compliance. With regard to the psychological assess- annual visit. The remainders of the visits starting at the
ment, patients under the age of 18 years are evaluated by ado- 1-month visit consist of appointments held with nutrition,
lescent medicine or pediatric behavioral health. Adults are psychology, and the bariatrician. Patients receive individual
seen by a team of psychologists, and recommended follow-up monitoring of diet progression, medications and nutritional
visits are determined depending on pathway classification supplements, exercise, blood work as needed, and disease
after the initial interview and brief questionnaire. Patients may management. The bariatrician then leads a shared appoint-
also be referred to behavioral health groups (Table 3) to help ment of patients in groups of 10–12 for 90 min to discuss
change behavioral, emotional, or psychological patterns that relevant health-care issues in a relaxed and supportive group
may interfere with a good surgical outcome. setting, allowing for patients to have the opportunity to talk
Revisional bariatric surgery patients are at higher risk for with each other about their own experiences or concerns.
operative complications; therefore, a specific pathway was Patient feedback from this type of follow-up visit has been
created for their preoperative assessment. Available previous positive as it provides companionship within the group for
medical records and diagnostic studies are obtained and supportive reassurance and encouragement.
reviewed. In addition to the above mentioned evaluation, all
patients undergo upper endoscopy and UGI barium swallow
studies for complete understanding of patient anatomy and Conclusion
physiology prior to selecting the appropriate revision or
staged procedure indicated. Candidates for bariatric surgery include patients with a
Regular follow-up visits after surgery serve as a continu- BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with significant
ation of the initial assessment to help patients maintain their obesity-related comorbidities. Recent guidelines also sug-
personal and health goals as well as evaluate compliance gest the benefits of bariatric surgery for the treatment of
with lifestyle changes. The outpatient follow-up scheme is diabetes refractory to medical treatment in lower BMI
21. Colles SL, Dixon JB, Marks P, Strauss BJ, O'Brien PE. Preoperative 32. Sharaf RN, Weinshel EH, Bini EJ, Rosenberg J, Sherman A, Ren
weight loss with a very-low-energy diet: quantitation of changes in CJ. Endoscopy plays an important preoperative role in bariatric sur-
liver and abdominal fat by serial imaging. Am J Clin Nutr. gery. Obes Surg. 2004;14(10):1367–72.
2006;84(2):304–11. 33. Zeni TM, Frantzides CT, Mahr C, Denham EW, Meiselman M,
22. Fris RJ. Preoperative low energy diet diminishes liver size. Obes Goldberg MJ, et al. Value of preoperative upper endoscopy in
Surg. 2004;14(9):1165–70. patients undergoing laparoscopic gastric bypass. Obes Surg.
23. Edholm D, Kullberg J, Haenni A, Karlsson FA, Ahlstrom A, 2006;16(2):142–6.
Hedberg J, et al. Preoperative 4-week low-calorie diet reduces liver 34. Schirmer B, Erenoglu C, Miller A. Flexible endoscopy in the man-
volume and intrahepatic fat, and facilitates laparoscopic gastric agement of patients undergoing Roux-en-Y gastric bypass. Obes
bypass in morbidly obese. Obes Surg. 2011;21(3):345–50. Surg. 2002;12(5):634–8.
24. Wadden TA, Sarwer DB. Behavioral assessment of candidates for 35. Hartin Jr CW, ReMine DS, Lucktong TA. Preoperative bariatric
bariatric surgery: a patient-oriented approach. Surg Obes Relat Dis. screening and treatment of Helicobacter pylori. Surg Endosc.
2006;2(2):171–9. 2009;23(11):2531–4.
25. Onyike CU, Crum RM, Lee HB, Lyketsos CG, Eaton WW. Is obe- 36. Swartz DE, Felix EL. Elective cholecystectomy after Roux-en-Y
sity associated with major depression? Results from the Third gastric bypass: why should asymptomatic gallstones be treated dif-
National Health and Nutrition Examination Survey. Am J ferently in morbidly obese patients? Surg Obes Relat Dis. 2005;
Epidemiol. 2003;158(12):1139–47. 1(6):555–60.
26. Dixon JB, Dixon ME, O’Brien PE. Depression in association with 37. Uy MC, Talingdan-Te MC, Espinosa WZ, Daez ML, Ong
severe obesity: changes with weight loss. Arch Intern Med. JP. Ursodeoxycholic acid in the prevention of gallstone formation after
2003;163(17):2058–65. bariatric surgery: a meta-analysis. Obes Surg. 2008;18(12):1532–8.
27. Sarwer DB, Cohn NI, Gibbons LM, Magee L, Crerand CE, Raper 38. Schauer PR, Rubino F. International Diabetes Federation position
SE, et al. Psychiatric diagnoses and psychiatric treatment among statement on bariatric surgery for type 2 diabetes: implications for
bariatric surgery candidates. Obes Surg. 2004;14(9):1148–56. patients, physicians, and surgeons. Surg Obes Relat Dis. 2011;
28. Puhl R, Brownell KD. Bias, discrimination, and obesity. Obes Res. 7(4):448–51.
2001;9(12):788–805. 39. Rubino F, Kaplan LM, Schauer PR, Cummings DE. The Diabetes
29. Kalarchian MA, Marcus MD, Wilson GT, Labouvie EW, Brolin Surgery Summit consensus conference: recommendations for the
RE, LaMarca LB. Binge eating among gastric bypass patients at evaluation and use of gastrointestinal surgery to treat type 2 diabe-
long-term follow-up. Obes Surg. 2002;12(2):270–5. tes mellitus. Ann Surg. 2010;251(3):399–405.
30. Heinberg LJ, Ashton K, Windover A. Moving beyond dichotomous 40. Eldar S, Heneghan HM, Brethauer S, Schauer PR. A focus on surgi-
psychological evaluation: the Cleveland Clinic Behavioral Rating cal preoperative evaluation of the bariatric patient—the Cleveland
System for weight loss surgery. Surg Obes Relat Dis. 2010; Clinic protocol and review of the literature. Surgeon. 2011;9(5):
6(2):185–90. 273–7.
31. Sharaf RN, Weinshel EH, Bini EJ, Rosenberg J, Ren CJ. Radiologic 41. Vana KD, Silva GE, Goldberg R. Predictive abilities of the STOP-
assessment of the upper gastrointestinal tract: does it play an Bang and Epworth Sleepiness Scale in identifying sleep clinic
important preoperative role in bariatric surgery? Obes Surg. 2004; patients at high risk for obstructive sleep apnea. Res Nurs Health.
14(3):313–7. 2013;36(1):84–94.
8
The Role of Behavioral Health
in Bariatric Surgery
Leslie J. Heinberg and Janelle W. Coughlin
statement, three of four of the listed contraindications relate in working with these patients pre- and postoperatively [16].
to psychosocial risk. These contraindications include: revers- The care of bariatric patients would undoubtedly be improved
ible endocrine or other disorders that can cause obesity; cur- by better standardization across the field.
rent drug or alcohol use; uncontrolled, severe psychiatric
illness; and lack of comprehension of risks, benefits, expected
outcomes, alternatives, and lifestyle changes required with Presurgical Evaluation
bariatric surgery.
Extreme obesity is associated with considerable psycho- As previously noted, despite the almost universality of psy-
social comorbidity, and patients who present for bariatric chological evaluation for bariatric surgery candidates, 20 years
surgery are considered to be a psychiatrically vulnerable of guidelines suggesting the need for such evaluations and a
population [2, 3]. Moreover, a number of studies have dem- substantial literature on psychosocial risk factors in this pop-
onstrated that patients burdened by depression and other ulation, there is no consensus regarding how an evaluation
psychiatric difficulties may have greater difficulty with should be conducted; the role, need, and utility of objective
weight loss after surgery [6, 13, 14]. As a consequence, psy- psychological testing [17]; or reasons for denial. Unfor-
chological evaluation of bariatric surgery candidates has tunately, this has limited the ability of bariatric behavioral
become the norm within the majority of programs. Finally, health to fully engage in empirical trials and has, at times,
the majority of insurance companies require an assessment diminished the perceived value of these clinicians’ roles.
by a mental health professional prior to approving weight In reviewing the literature, there does appear to be general
loss surgery [15]. agreement upon important factors to assess [18, 19]. Gene-
rally, researchers agree that a standard psychiatric interview
focusing on diagnostic comorbidities is necessary but not
Qualifications of the Behavioral sufficient for evaluating candidacy. In addition, a detailed
Health Professional assessment of eating behaviors, stress and coping, and social
support are considered essential points of evaluation. Further,
The practice of behavioral health related to surgical weight loss capacity to consent, understanding of risk and benefits of the
is slowly evolving into a specific subspecialty. The 2004 surgery, knowledge of surgery, and expectations for weight
Suggestions for the Pre-Surgical Psychological Assessment of loss, health outcomes, and psychosocial impact are largely
Bariatric Surgery Candidates was published by the ASMBS accepted as being of additional importance.
and outlined minimum standards for this specialty which There also appears to be consensus regarding psychosocial
include: knowledge of the nature and mechanics of the various contraindications for weight loss surgery including: current
bariatric surgical procedures, the expected postoperative course, illicit drug abuse, active/under-controlled schizophrenia or
and the physiology of obesity, dieting, and weight loss [4]. other overt psychiatric illness, severe intellectual disabilities,
In addition, they suggest that an understanding of how these heavy alcohol use, severe and untreated eating disorder, lack
factors can interact in the postoperative course is essential. of knowledge about surgery, severe situational stress, insuffi-
Given the importance of evaluating and addressing psychiatric cient motivation, and lack of significant support. In studies
comorbidities, practitioners should be licensed practitioners examining rates for psychological denial of weight loss sur-
who can assess and treat psychological conditions. Further, gery, refusals for psychosocial reasons tend to range between
practitioners should have a thorough understanding of the bio- 2 and 6 % [9, 11, 20–22]. Beyond such denials, patients may
logical, psychological, and social causes and consequences of be required to complete additional treatment or delay surgery
morbid obesity and of behavioral factors that may impact in order to stabilize a condition. Studies suggest that programs
weight loss and weight loss maintenance. A background in eat- do not immediately approve patients due to psychosocial rea-
ing disorders is also preferred. Finally, we would add that pro- sons up to 25 % of the time [11]. A survey of 103 psycholo-
fessionals should be competent in weight sensitivity and present gists who conduct presurgical psychological evaluations
a bariatric-friendly patient environment (e.g., appropriate size indicated significant variability in such decision making.
furniture, scales). Although respondents noted delaying or denying surgery for
Unfortunately, although most programs require one, there an average of 14.3 % of candidates, the range was 0–60 % [9].
is significant variability in the quality of such psychosocial Further, the benefits of delaying surgery as well as the costs
evaluations. Unlike specialized certifications for nursing or due to potential loss of patients as a result of delays are largely
physicians, a standardized exam for mental health prof- unknown [12].
essionals has not yet been established. A recent study of Beyond clear-cut contraindications, patients may be consid-
ASMBS members found that the majority felt that mental ered high risk psychiatrically and may be triaged into differing
health professionals working with bariatric populations should pathways which may require more in-depth assessment and/or
have extensive and specific knowledge of weight loss surgery, treatment. Within the Cleveland Clinic’s program, patients are
obesity, and nonsurgical management of obesity and experience triaged as high risk if they have a history of: schizophrenia,
8. The Role of Behavioral Health in Bariatric Surgery 85
bipolar disorder, past suicide attempt, inpatient psychiatric from the DSM-5 [23]. Patients should be queried regarding
hospitalization, substance abuse/dependence, history of objective binge episodes, subjective lack of control over
anorexia nervosa or bulimia nervosa, cognitive dysfunction, eating during the binge episode, as well as the associated
developmental delay, personality disorder, or multiple psy- distress related to binge eating. Other disordered eating
chiatric medications. These patients are seen initially by the behaviors such as excessive graze eating patterns or night
psychologist rather than potentially having their visit later in eating should also be assessed.
the preoperative process (e.g., after initiating an insurance- Next, we review medical comorbidities related to obesity as
mandated supervised diet). Thus, patients who may not be well as currently prescribed medications. This can lead to fur-
candidates, or who may be delayed, can be identified prior to ther discussion regarding a patient’s adherence with prescribed
numerous appointments with other program providers (e.g., medications or other medical recommendations (e.g., adher-
surgical consult, sleep study, etc.). ence with CPAP). Capacity to consent (and brief cognitive
screen if needed) should also be determined with a review of
memory and concentration difficulties, history of learning dif-
Elements of the Psychological ficulties, special education, traumatic brain injuries, and other
Evaluation cognitive issues that could impact decisional capacity.
The next part of the evaluation is more consistent with a
For illustrative purposes, we describe the elements that traditional psychiatric diagnostic interview. Patients are que-
we utilize within our evaluations. Many patients are very ried on their current mental state, and relevant diagnostic
concerned about the requirement for a psychological evalua- symptoms of psychiatric disorders are assessed. Past and
tion. Often they believe that if the professional uncovers current outpatient, inpatient, and psychotropic treatments are
something negative, it will adversely affect their ability to reviewed as well as past history of suicide attempts and self-
undergo surgery. Thus, the evaluation is seen as an obstacle injurious behavior. Family mental health history is deter-
between them and a very strongly desired outcome. As a mined and a brief trauma history is conducted. Further, a
result, it is often important to first build rapport and discuss standard mental status examination is conducted.
the collaborative role of the evaluation (e.g., identifying Next, the patient’s current use of nicotine, alcohol, and
strengths to build upon and addressing obstacles that could illicit and prescription drugs are determined. Symptoms of
impact their ability to have an optimal outcome). We begin abuse and dependence should be determined, and any past
by asking what surgery they are interested in and what led to history of alcohol and/or drug abuse/dependence or treatment
their decision to pursue weight loss surgery. Next, an assess- should be evaluated. Other potentially problematic habits
ment of their understanding of the mechanics of their sur- such as caffeine use, carbonation, and sugar-sweetened bev-
gery, expected experience, and recovery time as well as their erages can also be determined. All patients, including those
knowledge regarding risks vs. benefits should be determined. considered low risk for alcohol abuse, should be educated
Next, we assess their weight loss expectations; beyond about the risk for increased sensitivity and potential increased
weight loss, what do they expect will be different, improved, risk for abuse following surgery [24]; additional information
etc. following weight loss surgery? This allows the evaluator on conducting an alcohol history in the bariatric presurgical
to not only assess consent and expectations but also to pro- patient can be found in a review by Heinberg et al. [25].
vide education about what to expect and what surgery can— Support plays a crucial role in patient’s adjustment
and cannot—alter. and success; thus, a thorough psychosocial history is taken
A comprehensive evaluation should also include a thorough beginning with a review of the patient’s family of origin and
eating and weight history. The patient’s weight history childhood. Next, the patient’s current living situation and
should be determined, including lowest and highest adult relationship status should be evaluated. The impact that sur-
weight and how these relate to current weight as well as fac- gery, altered eating and activity behaviors, and weight loss
tors that led to obesity. A thorough assessment of past weight may have on relationships should be discussed. Patients
loss strategies should be conducted focusing on what was should be queried regarding who they will share the decision
beneficial, difficulties with adherence, and length of mainte- with, how they will address negative commentary, and who
nance. During the assessment of past dietary attempts, his- will help care for them following surgery. A psychosocial
tory of purgative attempts such as vomiting and laxative and history should also include information about patients’ edu-
diuretic abuse should be determined. Although most patients cational level and achievement, work history, and their plans
will also see a dietitian, some assessment of the patient’s for time off following surgery. Interpersonal, occupational,
typical eating pattern can be informative—particularly with financial, legal, and other stressors should be reviewed with
focus on abnormal timing of eating, skipping of meals, etc. an assessment of coping strategies. Often, eating is listed as
Such assessment segues well into an assessment of binge a primary coping method, and this can lead to early discus-
eating disorder. We currently follow the diagnostic criteria sion about the need to identify alternative coping resources.
86 L.J. Heinberg and J.W. Coughlin
Physical and sedentary activity should be assessed. If patients is psychiatrically vulnerable with approximately one-third
are not currently active, it is helpful to identify any past exer- having a current Axis I psychiatric diagnosis. Further, the
cise attempts, degree of adherence, and intention to exercise medically compromised state of surgery may exacerbate a
following surgery. number of symptoms and disorders. C/L behavioral health
Following this interview, the evaluator should be able to provides a comprehensive analysis of the patient’s response to
at least provisionally provide a DSM-5 diagnosis and make illness and surgical course, can help identify mental disorders
an initial impression about the patient’s relative strengths or psychological response to surgery that is in need of further
entering into weight loss surgery and make recommenda- intervention, and can help identify effective coping mechanisms
tions about the plan of care pre- and postoperatively. We find to improve outcomes and postoperative adjustment. Common
it most helpful to delineate between requirements—those reasons for consultation include: depression, agitation, halluci-
tasks that are necessary prior to writing a clearance letter nations, sleep disorders, confusion, suicidal ideation, nonadher-
(e.g., smoking cessation, adherence with psychiatric medica- ence or refusal to consent to a procedure, and a lack of organic
tions, abstinence from drugs and/or alcohol) and recommen- basis for symptoms (e.g., conversion, malingering, somatiza-
dations that are not necessary but determined to be helpful tion). Finally hospitalized patients are particularly vulnerable to
(e.g., attendance at a support group, importance of bringing acute confusional states. Delirium is surprisingly common and
a support person to future appointments, wean off of carbon- can seriously complicate the postoperative course and can lead
ated beverages). Finally, as a means of summarizing the find- to significant management problems.
ings in a more consistent and empirical manner, the Cleveland Another concern is managing patient’s psychotropic
Clinic Behavioral Rating Scale can be utilized [18]. This medications following surgery. In examining bariatric popu-
measure has evaluators rate patients on a 5-point scale (poor, lations, 72.5 % of surgical candidates report a lifetime his-
guarded, fair, good, excellent) across 8 domains of interest tory of psychotropic medication use—almost 90 % of which
(consent, expectations, social support, mental health, chemical/ were antidepressants. Further, 47.7 % were currently on at
alcohol abuse/dependence, eating behaviors, adherence, and least one psychiatric medication [20]. Unfortunately, many
stress/coping) with a final overall rating ranging from excel- patients are NPO for at least 24 h. If complications occur,
lent candidacy to poor noncandidacy. patients may be off of important psychiatric medications for
a number of days.
depression which may worsen pain complaints. In the first mentally and can even be excited about the changes to come;
6 months following surgery, overeating, rapid eating, brief however, the physiological and mental changes that occur
impaction (i.e., plugging), and inadequate chewing are com- after surgery can collide to produce “postsurgical blues.”
mon. To identify behavioral explanations for pain and other As with postpartum blues, it is important for this low, or
gastrointestinal symptoms, a full and detailed assessment of blue, period to be carefully monitored and treated appropri-
symptoms in relation to eating behaviors is necessary. Fortu- ately; however, it is our experience that patients typically
nately, behaviorally induced symptoms typically resolve in move through this period within the first few postoperative
the first 6 months, as patients identify the relationship weeks or months, and many do not experience it at all.
between their eating behaviors and discomfort and correct Research on the relationship between psychiatric symptoms
the problems. During this period of adaptation and relearn- and postsurgical outcomes, though not always easy to inter-
ing, behavioral support is important and should be a standard pret when considered collectively, suggests that psychiatric
component of postsurgical care. comorbidity is associated with less favorable weight loss
outcomes following bariatric surgery. This appears to be par-
ticularly true for those with more than one psychiatric diag-
Postoperative Follow-Up nosis [6, 13], those with a bipolar disorder [14], and those
with symptoms in the first 9 months following surgery [37].
It is recommended, at a minimum, that patients who undergo For example, Semanscin-Doerr and colleagues found that
bariatric surgery return to the bariatric surgery program for patients who had a clinically diagnosable mood disorder at
follow-up within 1–2 weeks of surgery, 6 months postopera- the time of their initial evaluation experienced less weight
tively, and annually thereafter. Those who undergo AGB loss 1, 3, 6, and 9 months following VSG as compared to
may return more frequently for adjustments to the band. those without a psychiatric condition [14]. These findings
Patients are also encouraged to participate in postoperative were no longer significant at 1 year post-VSG, nor were they
support groups, which are a common component of most significant when removing those with a bipolar disorder
established bariatric surgery programs. Some programs rec- from the analyses. Kalarchian and colleagues found that a
ommend more frequent follow-up with the surgical team, lifetime history of a mood or anxiety disorder was associ-
particularly in the first postoperative year, and offer additional ated with less weight loss 6 months following RYGB [8].
services to augment postsurgical support, including support However, a current diagnosis of mood, anxiety, substance, or
groups, nutrition groups, and shared medical and shared psy- eating disorder at the time of presurgical psychological eval-
chological appointments. These groups allow for support, uation was not significantly associated with 6-month out-
normalizing of experiences, and sharing of knowledge and comes nor was a diagnosis of a personality disorder. In a
lead to greater efficiencies within a program as providers can prospective study following patients up to 3 years after
see a number of similar patients and impart similar infor- RYGB, current or lifetime history of a depressive disorder
mation in a single setting. Importantly, both follow-up with did not relate to weight loss outcomes [13]. However, having
the surgical program and attendance at support groups are more than one past or current psychiatric diagnosis (e.g.,
associated with better postoperative outcomes [35, 36]; there- both an affective disorder and an anxiety disorder) was asso-
fore, strong recommendations should be made for ongoing ciated with poorer weight loss outcomes. Collectively, these
follow-up, and programs should do their best to offer easily studies suggest that psychiatric comorbidity, particularly
accessible postsurgical services. multiple comorbidities or a diagnosis of bipolar disorder,
Guidelines for postsurgical behavioral health services are may be associated with less favorable weight loss and that
not as well defined as presurgical guidelines; however, it is lifetime history, rather than diagnosis at the time of the pre-
advised that patients have available to them a psychologist or surgical evaluation, may be associated with poorer short-
other specialized mental health professional to provide support term outcomes. It is important to note, however, that this
during the psychological, behavioral, and interpersonal adjust- association may not exist at longer-term follow-up and that
ments that can occur with surgery. This is particularly true for even those with less weight loss may likely be experiencing
individuals who have psychiatric conditions and could experi- clinically significant improvements in health and will lose
ence a worsening of psychiatric comorbidity postsurgically. more weight with surgery than with more conservative inter-
ventions. Moreover, there is evidence that weight loss follo-
wing surgery is associated with significant improvements
Psychosocial Adjustments in mood and quality of life [13]. Although improvements in
health-related quality of life (vs. mental health-related qual-
Although not well studied, it is not unusual for patients ity of life) are more likely to occur early on (in the first
to experience some regret after surgery, particularly when 3 months following surgery) [38, 39], studies have shown
experiencing pain and discomfort in the initial postoperative improvements in a wide range of quality-of-life dimensions,
weeks and while reestablishing eating patterns. The process including psychosocial and sexual functioning domains, 1–2
can be somewhat akin to having a baby—patients can prepare years following surgery [40, 41].
88 L.J. Heinberg and J.W. Coughlin
Research on interpersonal changes that occur after surgery A sizeable minority (10–25 %) of bariatric surgery patients
is limited; however, clinically patients often share both posi- experience suboptimal weight loss, often defined as failure to
tive and negative changes in their relationships. Whereas lose at least 40 or 50 % EWL [49–53]. Although a number of
patients often find that they relate better to their family mem- physiological explanations can be offered, a commonly pur-
bers, peers, and coworkers as they experience improvements sued explanation for less optimal weight loss following bar-
in their sense of self and quality of life, they may also find iatric surgery is failure to adhere to and adopt the recommended
that they struggle with their new identify and find that others lifestyle and dietary modifications required for success [54].
treat and relate to them differently. A qualitative study by Weight regain following bariatric surgery is also common.
Bocchieri and colleagues nicely summarizes these issues The most commonly cited and longest study of bariatric
and identifies a number of “tension-generating changes” that surgery outcomes, the Swedish Obese Subjects Trial, has
occur after surgery, including increased feelings of vulnerabil- shown that, on average, RYGB and AGB patients lose ~30 %
ity, conflicted emotions regarding new reactions from others, and 20 % of their IBW in the first 2 years following surgery,
and the need to develop and implement new, non-dietary means respectively [55]. After this period of time, weight regain is
of coping with emotions [42]. Perhaps the best approach to common in both procedures, with an average regain of 6–7 %
helping patients adjust to these changes is attendance at support of IBW at 10-year follow-up, most of which occurs between
groups and participation in interpersonal, familial, or couples the second and sixth postsurgical years [52, 55, 56].
therapy. As discussed in our summary of the presurgical evalu- Only a few studies have assessed lifestyle behaviors
ation, assessing support is an important component of the following bariatric surgery. A recent study found that most
presurgical assessment, and enlisting patients’ support system patients adhere to the recommendation not to drink while
can be very important postsurgically. Moreover, patients can be eating, and most take their vitamins and medications as pre-
empowered to understand how their behaviors and success can scribed (95 %, 86 %, and 90 %, respectively) [57]. However,
impact significant others in their lives. few (5 %) eat the recommended 5–6 meals per day, most
Interestingly, bariatric surgery can also have a positive exceed recommended portion sizes during meals and snacks
impact on family members’ health. One study has shown that (100 % and 72 %, respectively), and less than half consume
mothers who have had surgery tend to model better eating the recommended servings of fruits and vegetables (≥5 per
behaviors for their children [43], and another found that fam- day). Furthermore, only 16 % regularly consume adequate
ily members of those undergoing surgery often experience liquids, and less than a quarter engage in ≥30 min of moder-
weight loss and improved health behaviors, such as increased ate to vigorous physical activity (MVPA) per day [57]. One
exercise, even though they themselves did not undergo sur- study of objectively measured accelerometry data revealed
gery [44]. Furthermore, surgical patients who have a family that only 5 % of bariatric surgery patients are compliant
member who has also undergone surgery tend to have better with physical activity recommendations (≥150 min/week of
weight loss and follow-up than those without a family mem- MVPA in bouts ≥ 10 min) after surgery [58].
ber who has also undergone surgery [45]. These studies Recently, investigators have started to develop and assess
underscore the importance and bidirectionality of family behavioral and psychosocial interventions for patients who
support in bariatric surgery. have undergone surgery with the goal of improving postop-
erative outcomes. A meta-analysis of this literature found
that patients who receive postoperative interventions experi-
ence larger weight losses as compared to those who receive
Weight Loss Outcomes, Weight Regain, usual postoperative care, which does not typically include a
and Behavioral Adherence level of ongoing behavioral support that many need to make
sustained behavioral modifications necessary for success
Weight loss outcomes are often expressed as percentage of [59]. One of the most important contributions those who spe-
excess weight loss (% EWL = weight loss/excess weight × 100), cialize in the behavioral health management of bariatric sur-
and, on average, between the first and third postoperative gery patients can make to the field is to develop and study the
years, patients lose ~70 %, 60–65 %, 55 %, and 45–50 % efficacy of postsurgical programs designed to optimize
EWL (BPD/DS, RYGB, VSG, and AGB, respectively) [5, 46, weight and health outcomes and to ensure that patients main-
47]. Less data is available on shorter-term weight loss out- tain psychiatric stability.
comes; however, a recent study conducted at Duke University
examined weight loss patterns at earlier postoperative visits
for those having RYGB [48]. They found that individuals who Special Psychiatric Considerations
lost > 2 % EWL/week during the first 14 weeks postsurgically
had the greatest chance of having better weight loss outcomes Psychiatric Medications
at 1 year. Moreover, they found that % EWL at month 1 sig-
nificantly predicted % EWL at 12 months. Thus, identifying Anatomical and physiological changes that occur during and
“underperformers” early on is important so that appropriate after bariatric surgery, particularly RYGB, likely affect the
interventions can be identified to optimize early weight loss. pharmacokinetic properties (e.g., absorption, distribution, and
8. The Role of Behavioral Health in Bariatric Surgery 89
elimination) of medications. Alterations in these properties were unable to determine whether participants were at
could affect the efficacy and tolerability of medications, higher risk of committing suicide preoperatively. Given the
which may be a point of particular concern when thinking high prevalence of psychopathology among morbidly obese
about psychiatric medications. While a great majority of individuals and the high prevalence of past suicide attempts
postsurgical patients are able to discontinue or decrease in bariatric candidates, it is unclear if this reflects a vulne-
medications they were taking presurgically for many medi- rable population or something more specifically about the
cal conditions (e.g., T2DM, hypertension), there is no evi- surgery [64].
dence that patients should decrease or come off of psychiatric Other than presurgical psychological distress, potential
medications postsurgically. Moreover, though research in reasons for higher suicide rates among bariatric patients in
this area is limited, there is evidence of decreased absorp- the postoperative period include dissatisfaction with body
tion of a single dose of sertraline in post-RYGB patients in image, alterations in metabolic biomarkers such as a decrease
comparison to weight-matched nonsurgical controls [60]. in serum cholesterol, and changes in the pharmacokinetics
Fortunately, research in this area is growing; however, to date of psychotropic drugs resulting in reduced efficacy [65].
there are no established clinical guidelines for psychiatric Although research should continue to identify the underlying
medication changes and/or dosage adjustments in bariatric reasons for suicide among bariatric patients, clinicians
surgery patients. In the absence of such guidelines, the fol- should absolutely continue to assess suicidality in this popu-
lowing are actions that are sometimes considered by those lation and institute appropriate management as necessary.
prescribing psychiatric medications to patients who are con-
sidering or have undergone bariatric surgery: (1) switching
to an immediate-release medication vs. sustained release; Postsurgical Alcohol Abuse
(2) when available, using liquid vs. tablet form; (3) when
appropriate, crushing a medication vs. using in solid form; Research indicates that individuals pursuing bariatric sur-
(4) when available, using an injectable medication vs. an oral gery have rates of lifetime alcohol use disorders (AUD) that
medication; and (5) as possible, monitoring plasma levels of are fairly comparable to the general population (35 % vs.
medications. While these medication adjustments could be 30 %, respectively) [24, 66]. However, current alcohol and
considered, close and ongoing psychiatric management is substance abuse at the time of preoperative assessment
always recommended. is remarkably low (<1 %) compared to population norms
(8.9 %), even in studies in which data collection is separate
and confidential from the presurgical psychological evalua-
Suicide Rates tion [2]. Many patients continue to consume alcohol after
surgery. A web-based questionnaire study indicated that
The reported higher rate of suicide among bariatric patients 83 % of respondents continued to consume alcohol after
postoperatively has been a source of significant concern within RYGB, with 84 % of those drinking one or more alcoholic
the field. These studies find a higher rate of suicide among beverages a week and 28.4 % indicating a problem control-
bariatric patients postoperatively, compared to the population ling alcohol use [17]. Suzuki and colleagues found that about
as a whole or to obese individuals who do not undergo weight 10 % of patients who had undergone AGB and RYGB met
loss surgery. Although overall mortality declines following current diagnosis for an alcohol abuse disorder 2–5 years
weight loss surgery, increased deaths by accident, drug over- after surgery, rates that are similar to those in the general
dose, and suicide have all been documented following weight population [66]. The majority of these cases had a lifetime
loss surgery [61–63]. history of alcohol abuse disorders, suggesting relapses rather
One of the best controlled studies by Adams et al. com- than new cases, and all occurred among those who had
pared long-term mortality rates and causes of death among undergone RYGB, consistent with knowledge that physio-
over 7,000 gastric bypass patients and obese controls [61]. logical changes that occur with RYGB may change vulnera-
At a mean follow-up of 7.1 years, they found 15 suicides in bility to problematic alcohol use. More recently, longitudinal
surgery group vs. 5 in the control group. However the hazard data across 10 bariatric programs and over 2,000 patients
ratio for suicide in the surgery group as compared to the con- demonstrated a significant increase in AUD in the second
trol population was not significantly different. This suicide (but not first) postoperative year and higher when compared
rate among surgical patients certainly appears to be consider- to the year prior to surgery. A number of related risk factors
ably higher than the general US suicide rate of ~11/100,000. were found including male gender, younger age, smoking,
Bariatric surgery-related deaths in Pennsylvania have also regular preoperative alcohol use, recreational drug use, and
been extensively studied over the last decade. Most recently, lower scores on social support [24]. In a study of longer-term
Tindle et al. reported an overall suicide rate of 6.6/10,000 in outcomes (13–15 years) [67], an increase in alcohol abuse
post-bariatric patients with highly differing rates for men and over time (2.6 % presurgery to 5.1 % postsurgery) but a
women (13.7 per 10,000 among men vs. 5.2 per 10,000 decline in alcohol dependence was noted (10.3 % presurgery
among women) [62]. However, in both studies the authors vs. 2.6 % postsurgery). In a study examining substance abuse
90 L.J. Heinberg and J.W. Coughlin
treatment center admissions, 2–6 % of admissions were Surgery Version of the Eating Disorders Examination
positive for a bariatric surgery history [68]. (EDE-BSV) to help differentiate between eating behaviors
We recently described assessment techniques and stra- influenced by anatomical alterations that occur with surgery
tegies to provide informed consent and education on alcohol (e.g., vomiting due to food getting stuck/plugging) and those
among patients preparing to having surgery [25]. Little that are aberrant behaviors motivated by body image con-
guidance, however, has been offered regarding how to con- cerns (e.g., vomiting to promote weight loss or avoid weight
duct postoperative screening nor how to provide specialized gain) [71]. When the EDE-BSV was administered to 59
treatment for those who develop alcohol problems after patients 18–35 months after RYGB surgery, 12 % of patients
surgery, nor has research yet addressed alcohol abuse rates reported self-induced vomiting for weight purposes, 30 %
following SG. reported chewing and spitting out food, 12 % reported
nocturnal eating, and 32 % reported picking or nibbling at
food. No other compensatory behaviors (e.g., laxative
Body Image Concerns and diuretic use) were reported, and chewing and spitting
was not reported for weight reasons but to avoid plugging.
Although overall body image is rated more positively after When pathological eating behaviors are suspected, referral
bariatric surgery, studies suggest that both men and women to an eating disorder specialist is recommended, and in the
remain dissatisfied with specific body areas associated with case of extreme weight loss, inpatient treatment may be
redundant skin [69]. Rapid and substantial weight loss is often necessary.
associated with hanging, redundant skin, which is aesthetically
displeasing to patients and often leads to skin irritation, skin
breakdown, infection, and ulcerations. Further, patients often Summary
note its effects on physical functioning, sexual functioning,
posture, and difficulties with urination. Thus, patients often Mental health professionals are considered an essential com-
consider body contouring surgery to address excess skin; ponent of the multidisciplinary assessment and treatment
however, this surgery is not always covered by third-party team at most bariatric surgery treatment centers. These prac-
payers and may be too expensive for patients to pursue. titioners should have a thorough understanding of the bio-
Setting realistic expectations about both positive and negative logical, psychological, and social causes and consequences
aesthetic changes following surgery should be part of patient’s of morbid obesity and of behavioral factors that impact
preparation. Further, helping patients adjust to significant weight loss and weight loss maintenance following weight
body image disturbance (vs. dissatisfaction that does not loss surgery. We have provided a detailed overview of com-
cause interference) may be an important aspect of postsurgi- ponents of the presurgical psychosocial evaluation of bariat-
cal psychological care. ric surgery patients and have summarized the literature on
pre-, peri-, and postoperative management of bariatric sur-
gery patients as related to behavioral and psychosocial risk
Development of Eating Pathology factors. It is our strong belief that behavioral health should
and Eating Disorders be an essential focus of all bariatric surgery programs and
that guidelines for efficacious postoperative psychiatric
Research on the emergence of eating pathology following behavioral support are needed to further impact bariatric sur-
bariatric surgery is limited and is complicated by uncertainty gery outcomes, including optimizing weight loss, resolving
over when to classify postsurgical eating behaviors as patho- medical comorbidities, and improving quality of life and
logical, since eating behaviors in postsurgical bariatric mental health status.
patients will differ from the “normal” population and, thus,
may appear aberrant (e.g., avoidance of certain foods to
avoid dumping, markedly slowing down chewing, etc.). Review Questions
A recent review of pathological eating following bariatric
surgery concluded that the development of full-syndrome 1. Which of the following is NOT a common psychological
eating disorders following surgery is rare, though serious [70]. reason for denying candidates bariatric surgery?
As the rate of bariatric procedures increases nationwide, eat- a. Current illicit drug abuse or dependence
ing disorder treatment programs are increasingly faced with b. Binge eating disorder
the challenge of developing protocols for post-bariatric c. Active/under-controlled schizophrenia or other psy-
patients presenting with a clinically diagnosable eating dis- chotic illness
order and, more frequently, eating problems that do not meet d. Lack of capacity to consent
classic eating disorder criteria. Although a few assessment e. None of the above
tools exist, De Zwaan and colleagues developed a Bariatric Answer: b
8. The Role of Behavioral Health in Bariatric Surgery 91
2. Problematic alcohol use following bariatric surgery has of Clinical Endocrinologists, the Obesity Society, and American
been linked to Society for Metabolic & Bariatric Surgery. Obesity. 2013;21:S1–27.
13. de Zwaan M, Enderle J, Wagner S, Muhlhans B, Ditzen B, Gefeller
a. RYGB procedures O, et al. Anxiety and depression in bariatric surgery patients:
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c. Food addiction J Affect Disord. 2011;133(1–2):61–8.
d. a and b 14. Semanscin-Doerr DA, Windover A, Ashton K, Heinberg LJ. Mood
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obesity and those who have undergone bariatric surgery. Surg Obes LH. Risk of suicide after long-term follow-up from bariatric sur-
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44. Woodard GA, Encarnacion B, Peraza J, Hernandez-Boussard T, 63. Omalu BI, Ives DG, Buhari AM, Lindner JL, Schauer PR, Wecht
Morton J. Halo effect for bariatric surgery: collateral weight loss in CH, et al. Death rates and causes of death after bariatric surgery
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45. Rebibo L, Verhaeghe P, Cosse C, Dhahri A, Marechal V, Regimbeau 142(10):923–8.
JM. Does longitudinal sleeve gastrectomy have a family “halo 64. Windover AK, Merrell J, Ashton K, Heinberg LJ. Prevalence and
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loss outcomes for laparoscopic adjustable gastric banding and lapa- 65. Heneghan HM, Heinberg L, Windover A, Rogula T, Schauer PR.
roscopic gastric bypass. Obes Surg. 2009;19(10):1447–55. Weighing the evidence for an association between obesity and sui-
47. Clinical Issues Committee of the American Society for Metabolic cide risk. Surg Obes Relat Dis. 2012;8(1):98–107.
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48. Mor A, Sharp L, Portenier D, Sudan R, Torquati A. Weight loss at 67. Mitchell JE, Lancaster KL, Burgard MA, Howell LM, Krahn DD,
first postoperative visit predicts long-term outcome of Roux-en-Y Crosby RD, et al. Long-term follow-up of patients’ status after gas-
gastric bypass using Duke weight loss surgery chart. Surg Obes tric bypass. Obes Surg. 2001;11(4):464–8.
Relat Dis. 2012;8(5):556–60. 68. Saules KK, Wiedemann A, Ivezaj V, Hopper JA, Foster-Hartsfield
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50. DiGiorgi M, Rosen DJ, Choi JJ, Milone L, Schrope B, Olivero- Bohdjalian A, et al. The prevalence of body contouring surgery
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patients with mid- to long-term follow-up. Surg Obes Relat Dis. 70. Marino JM, Ertelt TW, Lancaster K, Steffen K, Peterson L, de
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9
Operating Room Positioning, Equipment,
and Instrumentation for Laparoscopic
Bariatric Surgery
Stacy A. Brethauer and Esam S. Batayyah
FIG. 2. Patient positioning and application of sequential compres- compromise, neutral positioning of extremities, and patient security
sion device (a). Padded bed extensions should be used for larger to table prior to prepping and draping the abdomen (c).
patients (b). Inspect for areas of significant pressure, circulatory
Pneumatic compression devices that accommodate the Prior to prepping and draping the patient, a “final check”
super-obese patient are placed on the patient prior to induc- is important to be sure that all pressure points are avoided,
tion of anesthesia [12]. especially along the side, arms, hands, head, and feet.
After the induction of general anesthesia and endotra- Sequential compression devices should be placed and turned
cheal intubation, a urinary catheter is inserted (often requiring on (Fig. 2a). Table attachments must be padded appropri-
two staff members, one for retraction of skin folds and one ately to avoid pressure or nerve injuries (Fig. 2b). Security of
for insertion), and a bovie grounding pad is placed usually on the patient on the table and neutrality of joint positioning of
the anterior thigh. A foot board is placed on the table so the the extremities are also confirmed again (Fig. 2c). Of special
feet will have a secure base to rest when the patient is in note is to be certain there is no undue pressure on the gluteal
extreme reverse Trendelenburg position. area. A rare complication of rhabdomyolysis has been
The surgeon stands on the patient’s right side along with reported, especially with patients with a BMI 60 or greater.
the scrub nurse; the first assistant and the camera operator Consequences of rhabdomyolysis include renal failure and
are on the patient’s left side. The arms may be left out if death [13, 14]. Heating blankets are helpful in preventing
adequate room is available or one or both may be tucked. hypothermia related to heat loss from evaporation and con-
Occasionally, when tucking an arm, a metal or plastic limb tinuous insufflation, particularly during operations of long
holder (sled) may be required to secure the arm at the side. duration.
This approach also serves to protect the arm. After prepping and draping the abdomen, setting up the
The base of a stationary retractor-holding device may be equipment on the field, and assembling the OR team, the
attached to the table at this time. Care must be taken that it working field will appear as depicted in Fig. 3. Some surgeons
does not come in direct contact with the patient’s skin to prefer the “French” or “between the legs” positioning in
avoid pressure injury or electrocautery conduction. which the patient’s legs are abducted and the surgeon stands
9. Operating Room Positioning, Equipment, and Instrumentation for Laparoscopic Bariatric Surgery 95
FIG. 5. (a) A 5-mm optical viewing trocar can be used to obtain direct (Endopath Xcel, Ethicon Endosurgery, Cincinnati, OH). (b) 5- and
access to the peritoneal cavity without pneumoperitoneum. The 12-mm trocars (100 and 150 cm lengths) (Endopath Xcel, Ethicon
distinct layers of subcutaneous fat, fascia, muscle, preperitoneal fat, Endosurgery, Cincinnati, OH). These clear-tipped bladeless trocars
and the peritoneum are identified as the trocar passes through them can also be used for optical entry into the peritoneal cavity.
performance of a laparoscopic procedure is dependent upon Standard laparoscopes have a length of approximately
the quality of visualization. Since the surgeon is not able to 32 cm and have diameters that range from 2 to 10 mm.
touch and palpate, a clear crisp bright image is mandatory at Scopes are angled to various degrees, most commonly from
all times. There are no “blind” maneuvers in laparoscopy. a 0° to 45° orientation. Angled scopes provide more flexibil-
Components that create and maintain the image have steadily ity in viewing internal structures and provide access to areas
improved. that would be “blind” to 0° scopes. However, they require
There are several conditions specific to laparoscopic bar- some additional skill to operate and the angling decreases
iatric surgery that make obtaining an adequate image chal- light transmission slightly.
lenging. In the morbidly obese patient, the voluminous For our bariatric procedures, we have a variety of laparo-
abdominal cavity expanded by the pneumoperitoneum scopes available: 30° and 45° with 5 and 10 mm diameters
requires more light for visualization than that required for (Fig. 8a, b) (Stryker Endoscopy). Typically we use a 5-mm
the non-obese patient. Copious adipose tissue covering mes- 45° scope, initially at the 5-mm entrance site, to visualize the
entery, omentum, and viscera may crowd the view and other port placements. A 10-mm diameter, 45° angled lapa-
obscure the landmarks of interest. Instrumentation that will roscope is used for the rest of the procedure as we have found
allow viewing around or over or under such objects is neces- that it provides the best field of view especially in extremely
sary. Additional instruments are needed to enable adequate obese patients. An extra-long laparoscope (45–50 cm) is
exposure. sometimes necessary and very helpful in super-obese
patients. Excessive abdominal wall thickness, together with
a large expanded abdominal cavity, does not allow for a
Laparoscope close-up view of distant sites (e.g., the esophagogastric junc-
tion) using the standard-size scopes. Extra-long scopes are
The laparoscope uses the Hopkins rod lens system which also helpful during the use of any type of scope-holding
consists of a series of quartz rod lenses and a fiber bundle instrument or robot which takes up functional scope length
surrounding the rod lens for transmission of light [5, 6]. The in establishing the connection.
eyepiece of the laparoscope is connected to the camera by An important scope accessory is a stainless steel scope
means of a coupler adapter. warmer canister filled with hot sterile water for cleaning the
scope and preventing lens fogging (Applied Medical) (Fig. 9).
Video Camera
Miniature lightweight cameras, weighing as little as 40 g, are
now in use providing excellent resolution and color rendition
which are essential for laparoscopic bariatric surgery. The
miniature camera uses an LCD chip containing approxi-
mately 300,000 light-sensitive pixels on the chip surface
measuring only about ½ inch on the diagonal. Three-chip
cameras have become the industry standard; each chip
provides one of the three primary colors: red, green, and blue.
FIG. 7. High flow insufflator. Stryker.
FIG. 8. Laparoscopes: angled 45° (inset) and 30°, 5 and 10 mm diameters and standard and long lengths.
98 S.A. Brethauer and E.S. Batayyah
FIG. 13. 5-mm, flexible liver retractors: standard and “Big D” type.
FIG. 16. Endo Stitch™ (US Surgical) and in-line laparoscopic nee-
dle driver.
Suturing Instruments
Standard laparoscopic needle drivers and sutures and suturing
devices such as the Endo Stitch are suitable for laparoscopic
bariatric surgery. We utilize the Endo Stitch™ (Covidien) to
facilitate endoscopic suturing. The 10-mm diameter, dispos-
able Endo Stitch™ has a double-pointed shuttle needle with
the thread mounted at the center of the needle (Fig. 16).
Double action jaws allow the needle to be passed back and
forth by squeezing the handle and maneuvering the toggle
switch eliminating regrasping and repositioning the needle.
The Endo Stitch is compatible with a variety of absorbable
FIG. 14. Table-mounted instrument holding device used for liver
(i.e., Polysorb™) and nonabsorbable sutures (i.e.,
retractor.
Surgidek™). The Endo Stitch is used during the RYGBP for
approximating the bowel for the enteroenterostomy and for
oversewing the gastrojejunostomy (two-layer closures).
FIG. 19. Suture passer device facilitates closure of trocar sites and
can be used to close small ventral hernias.
FIG. 18. Fenestrated articulating grasper helps with dissection at Energy Sources for Transecting
the angle of His. and Coagulation
Suture Passer for Trocar Site Closure In general laparoscopy, dividing tissues and achieving hemo-
stasis, can be obtained with standard unipolar or bipolar
To prevent trocar site hernias, we close all ports 10 mm or electrocautery. Ultrasonic transaction and coagulation may
greater with a strong absorbable suture such. There are a be preferable for extremely vascular tissue such as mesen-
number of devices available for passing sutures through the tery. These devises are ultrasonically activated instruments
abdominal wall fascia. We use the Carter-Thomason that provide excellent tissue transection and hemostasis
CloseSure System (Inlet Medical Inc.) (Fig. 19) which facili- while eliminating the problem of electrical arc injury associ-
tates full-thickness closure. It is a disposable device that ated with unipolar electrocautery. The instruments have a
comes with guides (pilots) of varying diameters and in a stan- stationary jaw and blade that vibrate at a frequency of
dard and long length to accommodate very thick abdominal between 55,000 and 60,000 Hz. The mechanical action of a
walls. The angle projected by the guide allows for an ade- stationary jaw and blade that vibrate at that frequency dena-
quate purchase of fascial tissue. The suture passer can also be tures collagen. This allows the formation of a coagulant
used without the guide to ligate abdominal wall bleeders and which instantly seals small blood vessels. Minimal heat is
to repair small umbilical, ventral, and incisional hernias noted generated in the tissue through friction; the lateral spread of
at the time of laparoscopic bariatric surgery. thermal energy is 1–2 mm.
Ultrasonic instruments are available in 5 mm diameter and
come in short (15.7-cm working length) and long lengths (45-cm
Other Hand Instruments working length) with finger-controlled rotating shaft (Fig. 20).
They are activated by foot switch or by a finger-controlled
We use disposable endoscopic shears for cutting tissues button, which adjusts the blade frequency and the speed of
when a laparoscopic scissor is needed. These shears are cutting through tissue and the degree of hemostasis. These
5 mm with a rotating shaft and a 16-mm curved blade. A reli- instruments produce water vapor that can obscure vision
ably sharp blade is one of its major advantages. requiring intermittent evacuation of the vapor.
102 S.A. Brethauer and E.S. Batayyah
Both camera systems are fed through a digital mixer pro- These operating rooms employ boom technology for efficient
ducing the two images on the same monitor as a “picture- space utilization and integrate electrical, fiber optic, computer,
in-picture” format or on adjacent screens allowing both the communication, digital, video, voice activation, and piped gas
surgeon and the endoscopist to visualize both activities technologies. These have been called “fully integrated” or
simultaneously. “intelligent” operating rooms. Efficient design of these operat-
At the completion of the LRYGB, a flexible endoscope is ing rooms will likely improve overall operating efficiency and
useful to examine the gastrojejunal anastomosis (Olympus safety [16]. The advantages in efficiency and safety appear to
GIF XQ40, Exerna CLV-160). The scope is inserted prior to justify the cost as these complex procedures become increas-
completion of the closure of the gastrojejunostomy common ingly frequent in many medical centers.
opening when using the linear stapler anastomosis technique.
This maneuver serves to stent the opening and to help gauge
the diameter of the anastomosis. After the anastomosis is Robotics
completed, intraluminal insufflation of the submerged anasto-
mosis is used to inspect for air leaks. The endoscope is further Robotic Assistance
useful in gauging the size and patency of the anastomosis and
to examine for bleeding and viability of the gastric pouch. Because of the complex scope maneuvering in the upper and
mid-abdomen, surgeons must allow for a learning curve.
Preliminary studies have shown that the benefit of the robotic
Voice Activation Technology arm is improved efficiency of motion and improved ergo-
nomics for the surgeon at the console [17–19].
A major new innovation in operating room procedure has The da Vinci Surgical System is an FDA-approved laparo-
been the introduction of voice control technology (Intuitive scopic surgical robot that is used by many surgical specialties
Surgical and Stryker Endoscopy). This technology provides a (Fig. 23). The system is capable of performing surgical cut-
centralized and simplified interface for a surgeon to medical ting, dissecting, suturing, tissue retraction as well as provid-
devices through voice commands. The system requires a ing visualization. It provides improved dexterity, greater
computer control unit associated with other accessory units surgical precision, improved minimal access, increased range
which are networked with multiple devices. The surgeon, of motion due to the articulation of the arm wrist joints, three-
who wears a wireless headphone/microphone transmitter dimensional image drawing, and reproducibility. A number of
(ATW-T75 Transmitter) (Audio-Techniques/Stryker clinical investigators have been involved with trial of this
Endoscopy) is able to control and operate the devices robot in laparoscopic bariatric surgery [20, 21]. These early
throughout the procedure saving time and dependency on studies note that laparoscopic bariatric surgery using the da
human intermediaries. This technology allows the surgeon to Vinci robot is safe and feasible but will require further inves-
voice control the camera, light source, insufflator, video/ tigation. Currently there is no clear outcome advantage dem-
image recorder, printer, telephone, operating table, and oper- onstrated with the use of the robot in bariatric surgery, though
ating room lights. many groups throughout the country use it routinely and
Voice-activated control is especially appropriate to bariat- attest to its value in performing these complex operations.
ric laparoscopic procedures because of the multiple adjust-
ments and readjustments of multiple complicated medical
devices during the course of the operation. Safety and quality
of patient care appear to be enhanced by returning focus
from the technology to the patient [15].
8. Prescher T. Video imaging. In: Toouli J, Gossot D, Hunter JG, edi- HERNES-assisted versus non-HERMES-assisted laparoscopic
tors. Endosurgery. New York: Churchill Livingstone; 1996. antireflux surgery. Surg Endosc. 2002;16(9):1264–6.
p. 41–54. 16. Kenyon TAG, Urbach DR, Speer JB, Waterman-Hukari B, Foraker
9. Melzer A. Endoscopic instruments—conventional and intelligent. GF, Hansen PD, Swanstrom LL. Dedicated minimally invasive
In: Toouli J, Gossot D, Hunter JG, editors. Endosurgery. New York: surgery suites increase operating room efficiency. Surg Endosc.
Churchill Livingstone; 1996. p. 69–95. 2001;15:1140–3.
10. AORN Bariatric Surgery Guideline. AORN J. 2004;79(5):1026–52. 17. Kavoussi LR, Moore RG, Adams JB, et al. Comparison of robotic
11. Schauer PR, Gourash W, Hamad G, Ikramuddin S. Operating set up versus human laparoscopic camera control. J Urol. 1995;154:2131–6.
and patient positioning for laparoscopic gastric bypass. SAGES 18. Omote K, Feussner H, Ungeheuer A, Arbter K, Wei GQ, Siewert
Manual. Springer (in press). JR, Hirzinger G. Seof-guided robotic camera control for laparo-
12. Nguyen NT, Cronan M, Braley S, Rivers R, Wolfe BM. Duplex scopic surgery compared with human camera control. Am J Surg.
ultrasound assessment of femoral venous flow during laparoscopic 1999;177:321–4.
and open gastric bypass. Surg Endosc. 2003;17:285–90. 19. Dunlap KD, Wanzer L. Is the robotic arm a cost effective tool?
13. Collier B, Goreja MA, Duke BE. Postoperative rhabdomyolysis AORN J. 1998;68:265–72.
with bariatric surgery. Obes Surg. 2003;13(6):941–3. 20. Nguyen NT, Hinojosa MW, Finley D, Stevens M, Paya
14. Mognol P, Vignes S, Chosidow D, Marmuse JP. Rhabdomyolysis M. Application of robotics in general surgery: initial experience.
after laparoscopic bariatric surgery. Obes Surg. 2004;14:91–4. Am Surg. 2004;70(10):914–7.
15. Luketich JD, Fernando HC, Buenaventura PO, Christie NA, 21. Jacobsen G, Berger R, Horgan S. The role of robotic surgery in mor-
Grondin SC, Schauer PR. Results of a randomized trial of bid obesity. J Laparoendosc Adv Surg Tech A. 2003;13(4):279–83.
10
Anesthesia for Minimally Invasive
Bariatric Surgery
Cindy M. Ku and Stephanie B. Jones
can reverse the abnormal ventilatory drive in patients with (NSAIDs), and the presence of left ventricular dysfunction [8].
obese hypoventilation syndrome in 2 weeks [14], improve The type of bariatric surgery and the expected duration are
cardiovascular function in 3–4 weeks [15, 16], and normal- also important to take into account. In gastric banding, for
ize pharyngeal soft tissue anatomy in 4–6 weeks [17]. OSA example, some may consider limiting intraoperative fluids
patients also benefit from continuation of CPAP therapy due to concerns with tissue edema. In laparoscopic gastric
in the immediate postoperative period, when residual anes- bypass, patients are at higher risk of developing rhabdomy-
thetic and requirement for analgesia may cause hypopnea or olysis because of prolonged immobilization and fluid shifts;
decrease in respiratory drive [18], without significant nega- maintaining euvolemia is therefore paramount to prevent the
tive effect on surgical outcome [19]. development of acute renal failure.
resting LV function is not a consistent predictor of perioperative bidities (e.g., severe valvular heart disease or high suspicion
ischemic events [21]. It is also important to note that trans- of coronary artery disease) make such monitoring prudent,
thoracic echocardiography is often limited by the body habi- or when frequent blood sampling may be required. One
tus of the bariatric patient and echocardiogram findings may advantage of continuous arterial blood pressure monitoring
be inaccurate. Therefore functional capacity may offer a bet- is the ability to better estimate the patient’s volume status
ter understanding of the patient’s cardiopulmonary status. using stroke volume variation or pulse pressure variation cal-
Pulmonary function tests (PFTs) may be obtained in patients culations during positive pressure ventilation, assuming the
with a history of poorly controlled pulmonary diseases such presence of a sinus rhythm. Stroke volume variation can be
as asthma or chronic obstructive pulmonary disease, and are calculated by cardiac output sensor systems; pulse pressure
often used to monitor the medical management of such variation is often a built-in function in newer anesthesia
patients. It is unlikely, however, that random PFTs in bariat- monitoring systems.
ric patients without such history would change perioperative Accurate monitoring of depth of neuromuscular blockade is
management of the patient. of high importance in minimally invasive bariatric surgery
and is also often difficult to achieve. Anesthesiologists
understand that the body habitus of the bariatric patient
Intraoperative Concerns and Adaptations requires maximum neuromuscular blockade to achieve opti-
mal operating conditions within the abdominal cavity. The
Vascular Access restrictive pulmonary physiology and the increased intra-
abdominal pressure from the pneumoperitoneal insufflation
Patients should arrive to the preoperative holding area with also make a high degree of neuromuscular blockade a key
ample time for preparation, as obtaining peripheral vascular factor in optimizing intraoperative ventilation. Many anes-
access can be challenging because of excessive subcutane- thesia providers, however, are limited to subjective measure-
ous adipose. A peripherally inserted central catheter (PICC ment of the depth of neuromuscular blockade. The most
line) should be considered in patients with an extensive his- common and widely available peripheral nerve stimulators
tory of extremely difficult peripheral intravenous catheter require the observer to recall the magnitude of repeated
placement. nerve stimulation to determine the degree of blockade [22].
Preoperative area nursing staff can assist by applying warm It has been shown that many patients who were deemed to be
compresses to the upper extremity early in the preparation “adequately reversed” from neuromuscular blockade have
process to aid the vasodilation and visualization of peripheral residual weakness in the recovery room [23]. While some had
veins. Ultrasound-guided peripheral venous catheter place- no discernable symptoms, others required varying degree of
ment can be valuable in these challenging patients; long respiratory support, ranging from placement of oral or nasal
peripheral venous catheters, soft-tip guidewires, transducing airways to CPAP or noninvasive ventilation to reintubation.
gels, and other equipment for ultrasound imaging should be In the obese patient with OSA, residual neuromuscular
readily available. Lastly, a central venous catheter via inter- blockade can lead to upper airway obstruction, rapidly result-
nal jugular or subclavian approach can be placed prior to ing in hypoxemia given these patients’ limited pulmonary
induction if needed; ultrasound guidance can again be help- reserve. Acceleromyography is an objective method to mea-
ful with either approach to visualize structures given body sure neuromuscular blockade based on Newton’s second law
habitus and the loss of surface landmarks. of motion (force equals mass multiplied by acceleration).
Using a small piezoelectric ceramic wafer attached to the
thumb, the device measures the electrical signal proportional
Monitoring to the acceleration of the thumb as a result of an evoked
mechanical response (Fig. 1). The objective measurement
All bariatric patients require standard ASA monitoring: allows the anesthesiologist to more accurately assess the
5-lead ECG, blood pressure, continuous pulse oximetry, end- depth of neuromuscular blockade and administer additional
tidal carbon dioxide, and temperature. Automated noninvasive doses of neuromuscular blocking agents. Several models of
blood pressure monitoring can be problematic because stan- acceleromyography devices with a simple user interface and
dard rectangular blood pressure cuffs may not fit the cone- setup are commercially available.
shaped upper arm of the obese patient. Appropriate cuff Urine output should be monitored and causes of oliguria
sizing is paramount for accurate blood pressure monitoring. should be investigated, but it should be noted that transient
One can consider using commercially available conical or oliguria in the setting of peritoneal insufflation and increased
V-shaped blood pressure cuffs that may be compatible with abdominal pressure is common. The patient’s core or near-
preexisting anesthesia monitoring systems. Using a rectan- core temperature should be monitored throughout the proce-
gular cuff on the forearm is a commonly accepted alterna- dure. The most easily accessible core temperature site is the
tive. Invasive blood pressure monitoring via arterial esophagus; however, esophageal temperature probes must
cannulation may be necessary when noninvasive blood pres- often be removed for the surgical procedure. Alternative sites
sure measurements are not acceptable, when patient comor- for continuous temperature monitoring include nasopharynx,
10. Anesthesia for Minimally Invasive Bariatric Surgery 111
FIG. 1. Acceleromyography.
(a) Monitor indicates TOF
(train-of-four) ratio of 17 % as
the depth of neuromuscular
blockade. (b) Placement of
electrodes. Source:
AnaesthesiaUK http://www.frca.
co.uk/article.
aspx?articleid=101113. With
permission of Blue Starent.
oropharynx, or rectum. Many anesthesiologists utilize bispectral able to cooperate fully with preoxygenation. The operating
index (BIS) monitoring to assess the depth of the anesthetic. room staff, including the surgeon, should be available to
While clinical trials have shown that BIS monitoring does assist with securing the airway, especially in the event of
not reduce the incidence of intraoperative awareness under unanticipated difficult airway. Bariatric operating room per-
anesthesia [24], it can be helpful to provide guidance if total sonnel should be educated on the basics of the difficult air-
intravenous anesthesia is utilized, especially in the United way algorithm and the location of various airway devices in
States where target-controlled infusion of intravenous anes- order to assist the anesthesiologist should such a situation
thetic agents is not widely available. arise. In addition to various direct laryngoscopy blades, an
assortment of laryngeal mask airways (LMA) should be
available. LMAs provide a means for manual ventilation as a
Positioning rescue device and can also act as a conduit for intubation using
an intubating LMA or via fiberoptic intubation using the
Prior to induction of anesthesia, the bariatric patient should Aintree catheter. Video laryngoscopes such as the GlideScope
be positioned on a ramp (Fig. 2) on the operating table so that and the McGrath have become popular airway management
the neck can be optimally extended for direct laryngoscopy. alternatives to awake fiberoptic intubation. Though most
A slight head-up or reverse Trendelenburg position for pre- commonly used after induction of anesthesia, successful
oxygenation can be helpful in recruiting additional func- awake GlideScope intubations have also been reported [26].
tional residual capacity, in conjunction with CPAP [25]. The As a last resort in the difficult airway algorithm, cricothy-
ramp for intubation can be made with multiple blankets; rotomy kits should be available to the surgeon and the anes-
there are also commercially available foam and inflatable thesiologist. In our institution, the bariatric operating room
ramps. The ramp should be easily removable after the patient has a dedicated difficult airway cart with some of the afore-
is anesthetized to provide good operating position; ideally mentioned devices, and cricothyrotomy kits are stocked in
the ramp should also be easily repositioned at emergence in every anesthesia workstation.
the event of a need for reintubation. If the plan for airway
management is an awake fiberoptic intubation, the patient
may be placed in a sitting position for optimal oxygenation; Communication Between Operating
adequate space must be available for the anesthesiologist and Room Personnel
the necessary equipment. The patient’s extremities should be
properly padded and positioned to avoid positional neuropa- Communication between the surgeon and the anesthesiologist
thy; patients at extremes of weight are known to be at higher is of utmost importance in minimally invasive bariatric sur-
risk of developing perioperative neuropathies. gery, particularly at several critical points in the procedure.
Peritoneal insufflation can lead to sudden dysrhythmias, with
severe bradycardia being the most common [27]. Instrumenta-
Induction of Anesthesia and Airway tion of the esophagus—such as the removal of the nasogastric
Equipment tube and esophageal temperature probe, or insertion of sizing
bougies—should also be a concerted effort between the sur-
Induction of anesthesia should begin with ample time for geon and the anesthesiologist. In addition, any concerns of
preoxygenation to optimize the patient’s apneic reserve and bleeding on the surgical field should immediately be relayed to
minimize hypoxemia during the apneic period. Excessive the anesthesiologist, as obtaining additional IV access may be
premedication should be avoided as the patient should be difficult in the bariatric patient. An unanticipated conversion to
112 C.M. Ku and S.B. Jones
trolled by parenteral means, and in patients who have under- provide a head-up position that can be helpful for both
gone open bariatric procedure, bearing in mind that the preoxygenation/denitrogenation and positioning the
procedure may be more challenging in these patients due to patient’s head and neck into a hyperextended “sniff-
body habitus and patients’ difficulty with cooperation given ing” position for laryngoscopy. It would be helpful
their level of discomfort in the postoperative period. to replace the ramp underneath the patient at the end
of the case and prior to extubation in the event that the
patient fails to maintain adequate spontaneous ventilation
Conclusion after extubation and has to be reintubated urgently.
3. You are about to place the gastric band when the pneumo-
The bariatric population is heterogenous; morbidly obese peritoneum appears to be inadequate. While the circulator
patients cannot be treated on a one-size-fits-all basis. However, checks the insufflation pressure, you ask your anesthesi-
certain key issues should be kept in mind throughout the ologist to administer additional muscle relaxant. Your
perioperative period. These include OSA and postoperative anesthesiologist replies that there is no twitch on the
respiratory complication risk, the presence of systemic comor- peripheral nerve monitor, and he wants to know approxi-
bidities including cardiovascular disease and diabetes mellitus, mate duration of the remainder of the case. Why does the
the potential challenge of postoperative pain management, and anesthesiologist want to know this information?
the need for close communication between all members of the • “No twitch” implies greater than 95 % neuromuscular
perioperative care team. It is our belief that meticulous and blockade. Administering additional muscle relaxant
systematic attention to the above will lead to better outcomes without a detected twitch on the train-of-four monitor
for the obese patient undergoing bariatric, or other, surgical is unlikely to detectably increase the depth of neuro-
procedures. muscular blockade. Administering neuromuscular
reversal agents at this point will not result in adequate
muscle strength for extubation. At least one twitch
Review Questions and Answers (85–90 % blockade) in train-of-four monitoring is
needed for successful reversal of neuromuscular block-
1. List four reasons why airway and ventilation are signifi- ade. Your anesthesiologist would like to provide as
cant concerns for the anesthesiologist in minimally inva- much muscle relaxation as possible so that pneumo-
sive bariatric surgery. peritoneum can be maintained without losing the ability
• Bariatric patients have limited pulmonary reserve and to successfully reverse the blockade when needed.
will desaturate very quickly following induction of Therefore depending on the type of muscle relaxant
anesthesia. used, the known pharmacodynamics of the drug, the
• Mask ventilation and intubation can be difficult in effects demonstrated thus far in this patient, and the
many bariatric patients due to alterations in body duration of the case, your anesthesiologist may tell you
habitus. that additional relaxant is not needed and that he would
• Obese patients have impaired respiratory mechanics like to plan ahead for relaxant reversal later in the case.
which can be worsened when under general anesthesia. 4. Your bariatric patient has a diagnosis of OSA for which
• Many obese patients have obstructive sleep apnea he uses a CPAP (continuous positive airway pressure)
(OSA), which can complicate the administration of device, and has undergone a laparoscopic gastric bypass
anesthetic agents and postoperative pain management. procedure about 2 h ago. Your assistant had written the
2. Your institution has purchased disposable foam position- patient’s admission orders. You are now informed by the
ing ramps for the operating room, one of which has been recovery room nurse that the patient has significant pain
placed on the operating table. After the anesthesiologist not well controlled by the PCA (patient-controlled anal-
intubates the patient with a video laryngoscope, you ask gesia). His spouse had also forgotten to bring in his home
her and other operating room personnel to remove the CPAP device. He is on 2 L of oxygen by nasal cannula
ramp in order to position the patient supine for the proce- with an oxygen saturation of 95 %, and has had two epi-
dure. The anesthesiologist asks that the ramp be kept sodes of apnea, both of which occurred when the he dozed
nearby and be inserted underneath the patient at the end of off after receiving some intravenous hydromorphone
the case. Explain her rationale. bolus per the anesthesiologist’s order. You have reviewed
• Video laryngoscopes and other advanced airway your assistant’s order and note the PCA order to be intra-
equipment are often used when a difficult intubation is venous hydromorphone 0.12 mg per bolus with a lockout
expected or when a rapid intubation is desired so that interval of 6 min and a maximum dose of 1.2 mg/h. The
the patient is apneic for the least amount of time, both nurse is wary of giving additional hydromorphone boluses
common in bariatric patients. One of the keys to opti- because of the apneic episodes. What can be done to
mize intubating conditions is positioning. A ramp can improve the patient’s analgesia?
114 C.M. Ku and S.B. Jones
• The patient suffers from OSA and should resume 16. Golbin JM, Somers VK, Caples SM. Obstructive sleep apnea,
CPAP therapy in the immediate postoperative period. cardiovascular disease and pulmonary hypertension. Proc Am
Thorac Soc. 2008;5:200–6.
You should order CPAP from the hospital’s respiratory 17. Ryan CF, Lowe AA, Li D, Fleetham JA. Magnetic resonance imag-
service and try to obtain home CPAP settings for ing of the upper airway in obstructive sleep apnea before and after
quicker titration. Patients with OSA are sensitive to chronic nasal continuous positive airway pressure therapy. Am Rev
opioids, and therefore intravenous opioid boluses may Respir Dis. 1991;144(4):939–44.
contribute to the apneic episodes. Once the CPAP ther- 18. Neligan PJ, Malhotra G, Fraser M, Williams N, Greenblatt EP,
Cereda M, Ochroch EA. Continuous positive airway pressure via
apy is initiated, one can increase dosage of the hydro- the Boussignac system immediately after extubation improves lung
morphone PCA bolus while the patient is continuously function in morbidly obese patients with obstructive sleep apnea
monitored in the recovery room. Once recovery room undergoing laparoscopic bariatric surgery. Anesthesiology. 2009;
discharge criteria are met then the patient should be 110(4):878–84.
discharged to the ward with continuous pulse oximetry 19. Weingarten TN, Kendrick ML, Swain JM, Liedl LM, Johnson CP,
Schroeder DR, Johnson BD, Sprung J. Effects of CPAP on gastric
monitoring. The need for continuous pulse oximetry pouch pressure after bariatric surgery. Obes Surg. 2011;21(12):
monitoring can be reassessed the following day. Non- 1900–5.
opioid analgesics such as acetaminophen should be 20. Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S,
included in the pain regimen as well. Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to
screen patients for obstructive sleep apnea. Anesthesiology. 2008;
108(5):812–21.
21. Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL,
Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten
References JR, Riegel B, Robb JF. 2009 ACCF/AHA focused update on
perioperative beta blockade incorporated into the ACC/AHA 2007
1. Schumann R. Anaesthesia for bariatric surgery. Best Pract Res Clin guidelines on perioperative cardiovascular evaluation and care for
Anesthesiol. 2011;25:83–93. noncardiac surgery: a report of the American college of cardiology
2. Woodall N, Frerk C, Cook TM. Can we make airway management foundation/American heart association task force on practice guide-
(even) safer?—lessons from national audit. Anaesthesia. 2011;66 lines. Circulation. 2009;120(21):e169–276. Epub 2009 Nov 2.
Suppl 2:27–33. 22. Kopman A. Chapter 22: perioperative monitoring of neuromuscular
3. Brodsky JB, Lemmens HJ, Brock-Utne JG, et al. Morbid obesity function. In: Reich DL, et al., editors. Monitoring in anesthesia and
and tracheal intubation. Anesth Analg. 2002;94:732–6. perioperative care. Cambridge: Cambridge University; 2011.
4. Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin Cambridge Books Online. doi:10.1017/CBO9780511974083.
JL, Desmonts JM. Difficult tracheal intubation is more common in 23. Murphy GS, Brull SJ. Residual neuromuscular block: lessons
obese than in lean patients. Anesth Analg. 2003;97(2):595–600. unlearned. Part I: definitions, incidence, and adverse physiologic
5. Benumof JL. Obstructive sleep apnea in the adult obese patient: effects of residual neuromuscular block. Anesth Analg. 2010;
implications for airway management. J Clin Anesth. 2001;13(2): 111(1):120–8.
144–56. 24. Mashour GA, Shanks A, Tremper KK, Kheterpal S, Turner CR,
6. Siyam M, Benhamou D. Difficult endotracheal intubation in patients Ramachandran SK, Picton P, Schueller C, Morris M, Vandervest
with sleep apnea syndrome. Anesth Analg. 2002;95:1098–102. JC, Lin N, Avidan MS. Prevention of intraoperative awareness with
7. Neligan PJ, Porter S, Max B, et al. Obstructive sleep apnea is not a explicit recall in an unselected surgical population: a randomized
risk factor for difficult intubation in morbidly obese patients. comparative effectiveness trial. Anesthesiology. 2012;117(4):
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8. Nguyen L, Jones SB. Chapter 6: obesity. In: Vacanti CA, Sikka P, 25. Gander S, Frascarolo P, Suter M, et al. Positive end-expiratory pres-
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Cambridge University; 2011. nonhypoxic apnea in morbidly obese patients. Anesth Analg. 2005;
9. Frey WC, Pilcher J. Obstructive sleep-related breathing disorders 100:580–4.
in patients evaluated for bariatric surgery. Obes Surg. 2003;13: 26. Doyle DJ. Awake intubation using the GlideScope video laryngo-
676–83. scope: initial experience in four cases. Can J Anaesth. 2004;51(5):
10. O’Keeffe T, Patterson EJ. Evidence supporting routine polysom- 520–1.
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11. Pashayan AG, Passannante AN, Rock P. Pathophysiology of arrest and laparoscopic cholecystectomy: a case report and review
obstructive sleep apnea. Anesthesiol Clin North America. 2005; of the literature. JSLS. 2004;8(1):65–8.
23:431–43. 28. Ahmad S, Nagle A, McCarthy RJ, Fitzgerald PC, Sullivan JT,
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sleep apnea and its implications for anesthesiologists. Anesthesio- with and without obstructive sleep apnea undergoing laparoscopic
logy. 2008;107:1543–63. bariatric surgery. Anesth Analg. 2008;107(1):138–43.
13. Marshall NS, Wong KKH, Liu PY, et al. Sleep apnea as an indepen- 29. Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT,
dent risk factor for all-cause mortality: the Busselton Health Study. Coté CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM,
Sleep. 2008;31:1079–85. Ydens L, Yu S, American Society of Anesthesiologists Task Force
14. Cartagena R. Preoperative evaluation of patients with obesity and on Perioperative Management. Practice guidelines for the periop-
obstructive sleep apnea. Anesthesiol Clin North America. 2005; erative management of patients with obstructive sleep apnea: a
23:463–78. report by the American society of anesthesiologists task force on
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98:2269–75. obese patient. Best Pract Res Clin Anaesthesiol. 2011;25(1):73–81.
11
Postoperative Pathways in Minimally Invasive
Bariatric Surgery
Rebecca Lynch, Debbie Pasini, and Adrian G. Dan
switch (BPD-DS), laparoscopic sleeve gastrectomy (LSG), to order additional hematocrit levels and coagulation studies.
and laparoscopic adjustable gastric banding (LAGB) (see Patients with known diabetes mellitus or elevated perio-
Table 1). perative blood glucose should undergo glucose level
testing while on NPO and when diet is begun. Insulin regi-
mens frequently need to be adjusted due to altered dietary
Laboratory Tests intake, highlighting the importance of close glucose moni-
toring [6].
Blood work should be obtained immediately following
surgery to assess the patient’s electrolyte and blood counts.
In addition, patients with super morbid obesity or extended Pain Management
operative times should have a creatine phosphokinase level
checked to rule out the possibility of gluteal compartment Inadequate pain control in the postoperative period may lead
syndrome and rhabdomyolysis. In such patients, early inter- to patient discomfort, dissatisfaction, and increased length of
vention could be lifesaving and decrease the potential for stay. It can also limit the patient’s ability to take deep breaths
renal damage [5]. and attain early ambulation. This can consequently contrib-
It is critical in the immediate postoperative period to ute to other complications such as atelectasis, pneumonia,
ensure that patients are adequately hydrated. Laboratory val- and VTE. Tachycardia may result, which can unnecessarily
ues, along with urine output and fluid balance assessment, confound the clinical picture for the surgeon and trigger
aid the clinician in assessing adequate hydration. Routine an unnecessary work-up. There must be a balance between
blood work including complete blood count, basic metabolic appropriate pain management and over-sedation of the
panel, and magnesium levels should be obtained on morning patient. Clinicians and ancillary staff must have a high index
rounds during the inpatient stay. The suspicion of intralumi- of suspicion for over-sedation and the potential cardiopul-
nal or intraperitoneal hemorrhage may prompt the clinician monary consequences.
11 Postoperative Pathways in Minimally Invasive Bariatric Surgery 117
TABLE 2. Potential nutritional deficiencies and postoperative monitoring after bariatric surgery [6, 17]
Nutritional deficiency Laboratory test Considerations
Vitamin A Retinol Deficiency is more likely in BPD-DS
Vitamin B1 (thiamine) Serum thiamine Have high index of suspicion in patients with symptoms consistent
of Wernicke’s encephalopathy (which may result in irreversible
neurologic deficits)
Vitamin B9 (folate) RBC folate Must check RBC folate. A serum folate level reflects PO folate intake
Vitamin B12 (cobalamin) Serum B12 Deficiency is common and most likely in LRYGB
Vitamin D 25 (OH) vit D Deficiency is more likely in LRYGB and BPD-DS
Vitamin K PT More common in BPD-DS
Iron Ferritin, serum iron, total iron body content Deficiency is common
Zinc Plasma zinc More likely in LRYGB and BPD-DS
Protein Serum albumin, serum total protein
standardized postoperative pathways may consistently provide 8. Shearer E, Magee CJ, Lacasia C, Raw D, Kerrigan D. Obstructive
a way to ensure optimal outcomes. Programs should strive to sleep apnea can be safely managed in a level 2 critical care setting
after laparoscopic bariatric surgery. Surg Obes Relat Dis. 2013;
structure postoperative clinical pathways supported by the 9(6):845–9.
best available evidence. 9. Stein PD, Beemath A, Olson RE. Obesity as a risk factor in venous
thromboembolism. Am J Med. 2005;118:978–80.
10. Stein PD, Goldman J. Obesity and thromboembolic disease. Clin
Chest Med. 2009;30:489–93.
References 11. Longitudinal Assessment of Bariatric Surgery (LABS) Consortium,
Flum DR, Belle SH, King WC, Wahed AS, Berk P. Perioperative
1. Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide safety in the longitudinal assessment of bariatric surgery. N Engl J
2011. Obes Surg. 2013;23:427–36. Med. 2009;361(5):445–54.
2. Müller MK, Dedes KJ, Dindo D, Steiner S, Hahnloser D, Clavien 12. Agarwal R, Hecht TE, Lazo MC, Umscheid CA. Venous thrombo-
PA. Impact of clinical pathways in surgery. Arch Surg. 2009; embolism prophylaxis for patients undergoing bariatric surgery:
394:31–9. a systematic review. Surg Obes Relat Dis. 2010;6(2):213–20.
3. Huerta S, Heber D, Sawicki MP, Liu CD, Arthur D, Alexander P, 13. The American Society for Metabolic and Bariatric Surgery Clinical
et al. Reduced length of stay by implementation of a clinical path- Issues Committee. ASMBS updated position statement on prophy-
way for bariatric surgery in an academic health care center. Am lactic measures to reduce the risk of venous thromboembolism in
Surg. 2001;67(12):1128–35. bariatric surgery patients. Surg Obes Relat Dis. 2013;9(4):493–7.
4. Yeats M, Wedergren S, Fox N, Thompson JS. The use and modifi- 14. Wu EC, Barba CA. Current practices in the prophylaxis of venous
cation of clinical pathways to achieve specific outcomes in bariatric thromboembolism in bariatric surgery. Obes Surg. 2000;10(1):7–14.
surgery. Am Surg. 2005;71(2):152–4. 15. Lee SD, Khouzam MN, Kellum JM, DeMaria EJ, Meador JG,
5. Chakravartty S, Sarma DR, Patel AG. Rhabdomyolysis in bariatric Wolfe LG, et al. Selective, versus routine, upper gastrointestinal
surgery: a systematic review. Obes Surg. 2013;23(8):1333–40. series leads to equal morbidity and reduced hospital stay in laparo-
6. Mechanick JI, Youdim A, Jones DB, Garvey WT, Hurley DL, scopic gastric bypass patients. Surg Obes Relat Dis. 2007;3(4):
McMahon MM, et al. Clinical Practice Guidelines for the periop- 413–6.
erative nutritional, metabolic, and nonsurgical support of the bariat- 16. Frezza EE, Mammarappallil JG, Witt C, Wei C, Wachtel MS. Value
ric surgery patient-2013 update: cosponsored by the American of routine postoperative gastrographin contrast swallow studies
Association of Clinical Endocrinologists, the Obesity Society, and after laparoscopic gastric banding. Arch Surg. 2009;144(8):766–9.
American Society for Metabolic and Bariatric Surgery. Surg Obes 17. Allied Health Sciences Section Ad Hoc Nutrition Committee, Aills
Relat Dis. 2013;9(2):159–91. L, Blankenship J, Buffingtong C, Furtado M, Parrott J. ASMBS
7. Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I Allied health nutritional guidelines for the surgical weight loss
COUGH: reducing postoperative pulmonary complications with a patient. Surg Obes Relat Dis. 2008;4(5 Suppl):S73–108.
multidisciplinary patient care program. JAMA Surg. 2013;148(8): 18. Favretti F, O’Brien PE, Dixon JB. Patient management after LAP-
740–5. BAND placement. Am J Surg. 2002;184(6B):38–41.
12
Bariatric Surgery: Patient Safety
and Quality Improvement
John M. Morton and Dan E. Azagury
are actually more accurate in evaluating quality [8, 9]. They • A multidisciplinary specialized team must be available
did confirm, however, a relationship with hospital volume, a including nursing staff, registered dieticians, psychologists/
metric in all accreditation programs including the Michigan psychiatrists, and physical therapists.
Collaborative. In addition, the recent publication by Jafari Standard 3: Appropriate equipment and instruments
et al. demonstrated a benefit for bariatric surgery outcomes • This includes every aspect of care from appropriate
rendered by accreditation that is independent of volume sta- operating room tables and imaging equipment to blood
tus [10]. Also, in a 2014 American Surgical Association pre- pressure cuffs and adequate bedding, showers, toilets, etc.
sentation by Morton et al., a precise advantage of accreditation Standard 4: Critical care support
was demonstrated by accredited centers having superior • Required Advanced Cardiac Life Support (ACLS)-
rates of “failure to rescue” than nonaccredited centers [11]. qualified provider, stabilization and transfer capabilities,
This advantage makes intuitive sense in that experienced and arrangements made if they cannot provide the level of
centers with appropriate personnel and resources can readily care required by a medical event.
recognize and treat complications before any potentially • This also requires established protocols and availability
fatal event. for bariatric patient management of nonsurgical services:
anesthesia, 24/7 critical/intensive care unit, endoscopy,
diagnostic and interventional radiology, and/or written
Resources Needed transfer agreement to transfer patients to a facility provid-
ing these services.
As mentioned previously, MBSAQIP has recently released
Standard 5: Continuum of care
the inaugural standards for their joint accreditation program,
• Use of clinical education and perioperative protocols
( http://www.mbsaqip.org/docs/Resources%20for%20
• Long-term follow-up and available support groups
Optimal%20Care%20of%20the%20MBS%20Patient.pdf).
Standard 6: Data collection
The requirements for accreditation fall under nine stan-
• Data entry and reporting of all procedures
dards and essentially define two tiers in general bariatric
Standard 7: Continuous quality improvement process
accreditation: low-acuity centers and comprehensive centers.
• Maintain a collaborative between all bariatric surgeons in
Low-acuity centers perform a minimum annual volume of
the institution.
25 approved metabolic and bariatric stapling operations on
• Perform at least one quality improvement initiative per year.
low-acuity patients: i.e., adults under the age 65, males with
• Continuously monitor safety and outcomes.
a BMI < 55 and females with a BMI < 60, and those who do
not have either organ failure or history of organ transplant.
These centers are not accredited to perform non-emergent
revisional procedures but can perform all other approved
Optimal Preoperative Evaluation
bariatric procedures in this specific patient population.
If national guidelines have been used to frame the indications
Comprehensive centers may perform all approved proce-
for bariatric surgery, they remain vague as to evaluating
dures including high-risk patients as well as revisional
patients in order to safely provide the best surgery to each
procedures.
patient. Current National Institutes of Health (NIH) guide-
Of the 9 described standards, 7 are core standards and 2
lines for bariatric surgery date back over 20 years—1991
pertain to specific patient age (i.e., adolescents) or proce-
consensus conference on gastrointestinal surgery for severe
dures (gastric banding). The 7 core standards are applicable
obesity [12]—and do not provide guidance toward adequate
to both tiers of accreditation. The differentiation in low-
patient evaluation. These guidelines require a BMI > 40 or a
acuity vs. comprehensive centers is solely based on volume:
BMI > 35 and either high-risk comorbid conditions such as
low-acuity centers need to perform a minimum of 25 bariat-
life-threatening cardiopulmonary problems, severe diabetes
ric stapling cases per year, whereas comprehensive centers
mellitus, or obesity-induced physical problems interfering
are required to perform at least 50 cases annually.
with lifestyle. They state that patients should be able to dem-
The 7 core standards are:
onstrate failed attempts at diet and exercise, be motivated
Standard 1: Case volume—see above
and well informed, and be free of significant psychological
Standard 2: Commitment to quality care
disease.
• Centers must have an established bariatric committee includ- The extent of the preoperative workup in order to assist
ing a director/surgeon, a coordinator, and a clinical reviewer. patient/procedure selection is therefore extremely variable
• The center must maintain general facility accreditation. depending on the provider. In our view, an extensive pre-
• Surgeons must be credentialed in bariatric surgery accord- operative multidisciplinary workup is necessary to assess
ing to society guidelines, must undergo annual verifica- the extent of each patient’s comorbidities and guide appro-
tion, and must provide a bariatric call schedule. priate preoperative management or procedure selection.
• A designated clinic and inpatient area must be available Details of the preoperative evaluation are presented in the
and include trained nursing staff. previous chapters.
12 Bariatric Surgery: Patient Safety and Quality Improvement 123
rates are an important quality metric. Readmission rates are MBSAQIP. With proven processes, the national goal for
a meta-outcome, which touch upon patient/physician satis- MBSAQIP will be to reduce readmissions within 30 days. In
faction, cost, coordination of care, and complications. In addition, MBSAQIP will work with establishing standard-
addition, the Centers for Medicare and Medicaid Services, ized preoperative educational modules in surgery, nursing,
along with other payors, have made readmission rate nutrition, psychology, and pharmacology. Other national ini-
reduction a leading initiative. tiative processes will include: website, toolkit, webinars/
audio conferences, discharge checklist cards, and regional
initiatives for large hospital chains.
Decreasing Readmission Rates Plans are for the MBSAQIP project to begin in July 2014.
The name of the quality improvement project is termed DROP
The first aspect of process change is definition and measure- (Decreasing Readmission through Opportunities Provided).
ment. There should be a distinction between 23 h readmis- Quality improvement is a lasting legacy for bariatric surgery.
sions and readmissions greater than 24 h given the difference
in acuity and intervention between both types of readmis-
sions. In addition, the readmission capture rate should Conclusion
include readmissions to not only the index hospital but other
hospitals as well. MBSAQIP is able to accomplish both of Deeply embedded in bariatric surgery’s DNA are patient
these tasks as well as provide an opportunity to benchmark safety, quality improvement, and innovation. It is a remark-
individual hospital results to national rates. able American surgical success story that bariatric surgery
Within our program at Stanford, we determined that our has written so far. With mortality falling tenfold and 90 % of
30-day readmission rates were higher than the national aver- cases performed laparoscopically, it may appear that bariat-
age at 8 %. At the inaugural Obesity Week 2013, we presented ric surgery has accomplished much. More remains to be
our quality improvement program for readmission reduction done, though, and no field is better suited to the changes in
[32]. Preventable causes for readmission are listed here: healthcare than bariatric surgery. Bariatric surgery with its
multidisciplinary team has its eye on the future, chin for-
• Medication side effects
ward, and head held high with the one effective and enduring
• Patient expectations
therapy for obesity.
• Dehydration
• Nausea
Next, the following quality improvement measures were added: References
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11. Morton JM, Garg T, Nguyen NT. Does Hospital Accreditation gastric bypass: results of an international survey. Obes Surg. 2013.
Matter for Bariatric Surgery? Ann Surg. 2014;260(3):504–9. doi:10.1007/s11695-013-1152-3.
12. Hubbard VS, Hall WH. Gastrointestinal surgery for severe obesity. 24. Warschkow R, Tarantino I, Ukegjini K, et al. Concomitant chole-
Obes Surg. 1991;1(3):257–65. cystectomy during laparoscopic Roux-en-Y gastric bypass in obese
13. Zevin B, Aggarwal R, Grantcharov TP. Volume-outcome associa- patients is not justified: a meta-analysis. Obes Surg. 2013;23(3):397–
tion in bariatric surgery: a systematic review. Ann Surg. 407. doi:10.1007/s11695-012-0852-4.
2012;256(1):60–71. doi:10.1097/SLA.0b013e3182554c62. 25. Sugerman HJ, Brewer WH, Shiffman ML, et al. A multicenter,
14. Gould JC, Kent KC, Wan Y, Rajamanickam V, Leverson G, Campos placebo-controlled, randomized, double-blind, prospective trial of
GM. Perioperative safety and volume: outcomes relationships in prophylactic ursodiol for the prevention of gallstone formation
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2011;213(6):771–7. doi:10.1016/j.jamcollsurg.2011.09.006. 1995;169(1):91–6. Discussion 96–7.
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07.002. Gastroenterol Hepatol. 2013. doi:10.1016/j.cgh.2013.11.031.
16. Nguyen NT, Goldman C, Rosenquist CJ, et al. Laparoscopic versus 27. Merkow RP, Hall BL, Cohen ME, et al. Validity and feasibility of
open gastric bypass: a randomized study of outcomes, quality of the American college of surgeons colectomy composite outcome
life, and costs. Ann Surg. 2001;234(3):279–89. Discussion quality measure. Ann Surg. 2013;257(3):483–9. doi:10.1097/
289–91. SLA.0b013e318273bf17.
17. Paxton JH, Matthews JB. The cost effectiveness of laparoscopic 28. Dimick JB, Osborne NH, Hall BL, Ko CY, Birkmeyer JD. Risk
versus open gastric bypass surgery. Obes Surg. 2005;15(1):24–34. adjustment for comparing hospital quality with surgery: How many
doi:10.1381/0960892052993477. variables Are needed? J Am Coll Surg. 2010;210(4):503–8.
18. Banka G, Woodard G, Hernandez-Boussard T, Morton doi:10.1016/j.jamcollsurg.2010.01.018.
JM. Laparoscopic vs open gastric bypass surgery: differences in 29. Dimick JB, Staiger DO, Hall BL, Ko CY, Birkmeyer JD. Composite
patient demographics, safety, and outcomes. Arch Surg. measures for profiling hospitals on surgical morbidity. Ann Surg.
2012;147(6):550–6. doi:10.1001/archsurg.2012.195. 2013;257(1):67–72. doi:10.1097/SLA.0b013e31827b6be6.
19. Lujan JA, Frutos MD, Hernandez Q, et al. Laparoscopic versus 30. Dimick JB, Birkmeyer NJ, Finks JF, et al. Composite measures for
open gastric bypass in the treatment of morbid obesity. Ann Surg. profiling hospitals on bariatric surgery performance. JAMA Surg.
2004;239(4):433–7. doi:10.1097/01.sla.0000120071.75691.1f. 2014;149(1):10. doi:10.1001/jamasurg.2013.4109.
20. Azagury DE, Abu Dayyeh BK, Greenwalt IT, Thompson 31. Balsiger BM, Kennedy FP, Abu-Lebdeh HS, et al. Prospective eval-
CC. Marginal ulceration after Roux-en-Y gastric bypass surgery: uation of Roux-en-Y gastric bypass as primary operation for medi-
characteristics, risk factors, treatment, and outcomes. Endoscopy. cally complicated obesity. Mayo Clin Proc. 2000;75(7):673–80.
2011;43(11):950–4. doi:10.1055/s-0030-1256951. doi:10.4065/75.7.673.
21. Moon RC, Teixeira AF, Goldbach M, Jawad MA. Management and 32. Morton JM, Sell T, Garg T, Rivas H. Utilizing national clinical data
treatment outcomes of marginal ulcers after Roux-en-Y gastric to drive quality improvement. Atlanta: Obesity Week; 2013.
13
Data Management for the Bariatric
Surgery Program
M. Logan Rawlins
was required. It was easily accessed through the internet or and publish related results may elect or may be required to
could be managed on a local workstation platform with elec- obtain approval though their own hospital IRB.
tronic data transmission. All data was encrypted and de-
identified to protect the confidentiality of the surgeons and
patients. Programs did not incur any additional cost for the MBSAQIP
database as it was included in their credentialing fees. Post
surgical guidelines were established and standardized for a In the years that followed the initiation of two separate data
minimum follow-up of 30 days, 6 months, and annually collection and accrediting agencies (ACS-BSCN and SRC-
thereafter. If an institution already participated in the ASMBS BOLD), questions were raised why there was not
National Surgical Quality Improvement Project (NSQIP), one centralized database and credentialing agency. There
this data would auto-populate into the bariatric surgery data- were also criticisms of a lack of evolution of the BOLD data-
base. However, more fields were required in the bariatric base. There were also concerns about the exclusive nature of
database specific to these types of patients requiring more “centers of excellence” creating a two-tiered system imply-
data entry than what is required into NSQIP. It was mandated ing superiority and inferiority. Common goals of quality,
that data entry be done by a trained data collector, a position over a simple volume-based threshold, became the new
ideally filled by a medically trained person or dedicated bar- focus. This eventually led to the creation of the new ASMBS-
iatric staff member. The data entry person could not be a sur- ACS quality program known as the Metabolic and Bariatric
geon or mid-level provider with direct patient care Surgery Accreditation and Quality Improvement Program
responsibilities in an attempt to avoid reporting bias in the (MBSAQIP) [6, 7]. The fusion of these two programs began
data. While outcomes were monitored for the safety of the in April 2012. This transition was spearheaded by Robin
program, accreditation was closely tied to institution and Blackstone, MD, president of the ASMBS at that time. It was
surgeon volume. felt that the ACS database, which was a second-generation-
type registry with many improvements over BOLD, would
be maintained as the new centralized data collection registry.
ASMBS-SRC and BOLD This second-generation database was considered progressive
and changed over time as unnecessary data points were
In 2007, the American Society for Metabolic and Bariatric removed. Any data collected which did not impact quality
Surgery (ASMBS) joined forces with the Surgical Review and was not needed was no longer included. With fewer ele-
Corporation (SRC) to form a separate and distinct accredit- ments to report, primarily through yes and no questions, it
ing agency and bariatric database [4]. Their goals were simi- became much easier for the program to comply. Data remains
lar to those of the ACS. The database they created was known tied to NSQIP, which theoretically should strengthen it.
as BOLD (Bariatric Outcomes Longitudinal Database). The New requirements for data collection were also instituted
guiding principles of database management and program under MBSAQIP with significantly important changes [8].
organization were very similar to those of the ACS- Data entry is required to be completed by a designated per-
BSCN. There were even features which interfaced with elec- sonnel who is not a patient care provider. This requirement
tronic medical records to expedite the entry of data and for a single data collector at each site who was medically
prevent duplication or errors in the transcription of data. One trained or an experienced chart abstractor became stricter
key difference in this database was the intention to use with the addition of a web-based certification process. The
blinded data for research purposes accessed by third parties. program also created stricter definitions for adverse events
It was thought that a large database such as this should be so it was easier for the “Bariatric Surgery Clinical Reviewer”
used to provide size and statistical power needed to study (BSCR) to enter this data. It was also recognized that the
both high- and low-frequency occurrences. The database preferred method of data collection is by chart abstraction,
could also be easily accessed by each individual surgeon to not encounter forms, third-party data transmission, or real-
query their own outcomes. time entry during patient visit. This does, however, create
There were also many questions initially regarding how more work for the BSCR but will hopefully provide data
these databases could be used for research studies and with higher fidelity. The updated database also fixes prob-
whether they required institutional review board (IRB) lems such as how to correctly code comorbidity severity,
approval to exist and/or be accessed. Eventually it was deter- complications, and revisional surgery, known to be common
mined that according to 45 CFR Part 164.501, 506, these complaints of the BOLD database. One goal was to limit the
activities are implemented solely for the purpose of assess- amount of free text entries by standardizing definitions. The
ing the quality of care and do not require review by an IRB program also decreased the number of reportable complica-
[5]. The BOLD database did undergo review through the tions and limited them to those which have an impact on risk
Copernicus Group Independent Review Board prior to its adjustment. The comorbidity severity scale was changed to
inception. Nevertheless, it is still recommended that each simplify the presence or absence of remission. Maintaining a
institution wishing to review their own data via this database patient on medications for preventative health, such as a
13 Data Management for the Bariatric Surgery Program 129
statin or metformin, is no longer considered treating a comor- both for ongoing studies and for those wishing to access it in
bidity as these types of medications are now commonly con- the future. BOLD data is also being used for state by state
tinued on patients even when their comorbidities have comparisons to evaluate access to care issues.
significantly improved. Likewise, treatment of atrial fibrilla-
tion with a beta blocker or calcium channel blocker in a
patient with previous hypertension does not preclude them MBSC (Michigan Bariatric Surgery
from being in remission. Outcome reporting is still required Collaborative)
at 30 days, 6 months, 12 months, and annually thereafter.
New time constraints have been enforced with data entry There has been interest by some groups in the country to
required within 120 days of each entry data point with a sys- obtain a more detailed bariatric database that can be used for
tem lockout after that time. Follow-up windows are also quality improvement and optimal outcome-based cost con-
lengthened after the initial 30 days to provide some flexibil- tainment. The best example of this type of program is the
ity in actual visit dates. For instance, the annual follow-up MBSC, which is a clinical outcome registry formed from a
data can include 6 months on either side of the surgery regional, voluntary consortium of hospitals and surgeons
anniversary. that perform bariatric surgery in Michigan [9]. The project is
Another common problem with BOLD was data auditing funded by Blue Cross and Blue Shield of the Michigan/Blue
[8]. BOLD data auditing used to only check the 1 year prior Care Network and coordinated at the University of Michigan
to recertification and only those surgeons who were COE under the lead direction of Nancy Birkmeyer, PhD. Over 40
surgeons at a facility were required to report. In the new sys- hospitals participate and data is not excluded from low-
tem, facility certification takes greater precedence. In the volume centers which differentiate it from the other larger
past, BSCOE program individual surgeons were credentialed national databases. Given that the guiding principle for the
separately from the institution. Program certification could program is quality improvement, the group meets multiple
exclude particular surgeons at a facility and their data was times per year to examine their data and to design and imple-
not included. Now all surgeons’ data must be included and ment changes in care that result in better outcomes for their
reported at each facility. Program data audit previously only bariatric patients. Quality improvement projects resulting
occurred every 3 years with site inspection, but programs from this database have led to reduction in the use of preop-
may now also be subject to closer interval or random audit- erative inferior vena cava (IVC) filter placement, as well as
ing to keep programs honest. risk stratification for VTE prophylaxis [10, 11]. Their data
Tracking patient follow-up is another improvement of has also contested the notion that high-volume COEs have
MBSAQIP database over BOLD. BOLD has incomplete fol- improved outcomes compared to low-volume non-COEs
low-up data, as the definition of lost to follow-up only includes [12]. This has pushed credentialing agencies to move toward
patients that died while all others were still considered “eligi- outcome-based certification rather than strictly volume
ble” for follow-up years after their last data entry [8]. The new based.
system also has an easier way to track patient follow-up with
specific tracking reports. These reports show which patients are
due for follow-up and when. It will also allow programs to Creating the Ideal Internal Database
track when patients are contacted to attempt to reestablish care
and document discharge or transfer from the practice or inabil- It is likely that bariatric surgeons may wish to track their
ity to contact. Both data systems still suffer from the lack of outcomes locally on an institutional database for easier
being able to track patients as they may switch practices or access and customizability. This section is dedicated to how
have a complication treated by another provider. to design the ideal internal database. While listing every cus-
The new program will also report a program’s risk- tomizable database program is beyond the scope of this
adjusted outcomes compared to national risk-adjusted chapter, certain factors should go into the decision of which
benchmarks, a feature not available in BOLD [8]. program to choose. The software should be easy to use for
Comorbidity remission data is also now provided in a useful both input and data extraction. A modifiable entry form with
table that providers can use for quality improvement, appli- user designed prompts for each different patient encounter
cation for hospital certifications, or insurance coverage. makes data entry easier. Search functions should allow the
Many questions have been raised regarding the fate of user to identify and sort data with multiple tiers of data points
BOLD data [8]. While demographics were rather easy to and create a spreadsheet from these desired data points. The
transfer from BOLD to the new MBSAQIP database, adverse program would ideally be made by a manufacturer that is
event data was too unreliable to transfer over. Data from well established and will continue to be in business for some
BOLD will be returned to programs for their internal use. A time so the product can be serviced and grow as platforms
public-use file will also be maintained for research purposes, and operating systems change over time, as opposed to one
130 M.L. Rawlins
TABLE 1. (continued)
Stress incontinence
Renal failure (creatinine, dialysis, transplant patient/candidate)
Cirrhosis (cause, CTP class, MELD score, transplant patient/candidate)
DVT/PE (history, previous/current treatment)
Psychological (anxiety, depression, substance abuse, suicidal, bipolar, eating disorder)
Connective tissue disorder (which one?)
Bleeding disorder (which one?)
TABLE 3. Operation
Procedure performed + date
Approach (open, laparoscopic, converted to open)
Procedure changed or aborted (+reason)
OR procedure time (incision to closure) Additional OR procedures (cholecystectomy, hiatal hernia, liver biopsy, abdominal wall hernia)
Intraoperative complications
Procedure specifics
Adjustable gastric band
Band type
Allergan LAP-BAND AP standard or large
Ethicon REALIZE Band or REALIZE Band-C
Gastro-gastric sutures placed?
Gastric bypass
Roux limb length (cm)
Estimated pouch size (cc)
Banded pouch
GJ anastomosis
Linear staple (Length in cm)
Circular staple (21 vs. 25 mm EEA)
Ante-ante or retro-retro Roux limb position
Close Peterson’s defect?
Intraoperative leak test (method and result)
Drain placed?
Duodenal Switch
Alimentary limb length (cm)
Common channel limb length (cm)
Sleeve bougie size (Fr)
Duodenoileostomy anastomosis
Linear staple (length in cm)
Circular staple (21 vs. 25 mm EEA)
Intraoperative leak test (method and result)
Drain placed
Sleeve gastrectomy
Initial staple fire length from the pylorus (cm)
Sleeve bougie size (Fr)
Staple line reinforcement (none vs. SEAMGUARD vs. suture imbrication)
Intraoperative leak test (method and result)
Drain placed
13 Data Management for the Bariatric Surgery Program 133
TABLE 5. (continued)
Yearly Labs (in order of importance depending on the type of procedure
performed)
Complete blood count
Basic metabolic panel
Iron
Vitamin D
PTH
Vitamin B12
Vitamin B1
Vitamin A
Copper, selenium, zinc (for malabsorptive procedures or clinically indicated)
FIG. 1. (a, b). Patient is positioned split leg on the table as shown above with arms abducted and legs split.
Based on a recent systematic review, the leak rate is anywhere TABLE 2. Postoperative complications
between 2 and 3 % [6]. In the same review, staple line Postoperative complications
reinforcement did not affect the incidence of leaks. Leaks Acute leak (within 7 days)
are usually diagnosed on upper gastrointestinal series. Early leak (within 1–6 weeks)
Postoperative patients with no abnormalities on upper gas- Late leak (after 6 weeks)
trointestinal series, but with tachycardia and fever, require Chronic leak (after 12 weeks)
immediate operative intervention for exploration. Leaks can Stricture
be classified based on timing of presentation [7]. Early leaks Bleeding
occur within the first 1–6 weeks. Late leaks occur after New-onset gastroesophageal disease
6 weeks while chronic leaks occur after 12 weeks. Most
early leaks can be adequately treated with a stent in stable
patients. Leaks that fail to close following exclusion with a AP: Is a consultant, speaker and receives honoraria from W L Gore &
Associates and also Covidien
stent after 30 days have a very low likelihood of sealing.
Unstable patients with contained or uncontained leaks
require immediate operative intervention. Stenting is less References
likely to be successful in chronic leaks; typically these
patients need operative re-intervention as often these leaks 1. Marceau P, Hould FS, Simard S, et al. Biliopancreatic diversion
with duodenal switch. World J Surg. 1998;22:947–54.
are exacerbated by a high intraluminal pressure created by a 2. Gumbs AA, Gagner M, Dakin G, Pomp A. Sleeve gastrectomy for
relative stenosis at the incisura. Options include bringing morbid obesity. Obes Surg. 2007;17(7):962–9.
a Roux limb up to the leak site or conversion of the sleeve 3. Clinical Issues Committee of the American Society for Metabolic
gastrectomy to a Roux-en-Y gastric bypass. and Bariatric Surgery. Updated position statement on sleeve gastrec-
Strictures are another complication that can occur following tomy as a bariatric procedure. Surg Obes Relat Dis. 2010;6(1):1–5.
4. Klok MD, Jakobsdottir S, Drent ML. The role of leptin and ghrelin
laparoscopic sleeve gastrectomy. The incisura angularis is the in the regulation of food intake and body weight in humans:
site at greatest risk for stricture formation. Strictures occurring a review. Obes Rev. 2007;8:21–34.
within the first 6 weeks following surgery tend to be symptom- 5. Frezza EE, Chiriva-Internati M, Wachtel MS. Analysis of the results
atic. The initial treatment of a stricture is simple observation if of sleeve gastrectomy for morbid obesity and the role of ghrelin.
patients are minimally symptomatic. The next step can be Surg Today. 2008;38:481–3.
6. Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A,
endoscopic dilation. If that fails after 6 weeks, a seromyotomy Gagner M. Surgical strategies that may decrease leak after laparo-
is a surgical option [8]. The last resort is conversion of the scopic sleeve gastrectomy: a systematic review and meta-analysis of
sleeve gastrectomy to a Roux-en-Y reconstruction. 9991 cases. Ann Surg. 2013;257(2):231.
Bleeding can occur anywhere along the staple line. It is gen- 7. Rosenthal RJ, International Sleeve Gastrectomy Expert Panel, Diaz
AA, Arvidsson D, Baker RS, Basso N, et al. International sleeve
erally accepted to reinforce staple lines by oversewing the staple gastrectomy expert panel consensus statement: best practice guide-
line or buttressing the staple line. Based on a recent review, the lines based on experience of >12,000 cases. Surg Obes Relat Dis.
overall postoperative bleeding rate is between 1 and 3 % [9]. 2012;8(1):8–19.
In the same review, the use of reinforcement did not signifi- 8. Vilallonga R, Himpens J, van de Vrande S. Laparoscopic manage-
cantly change the incidence of bleeding (Table 2) (Video. 1). ment of persistent strictures after laparoscopic sleeve gastrectomy.
Obes Surg. 2013;23(10):1655–61.
9. Knapps J, Ghanem M, Clements J, Merchant AM. A systematic
Acknowledgements CA: No financial disclosures and no conflicts of review of staple-line reinforcement in laparoscopic sleeve gastrec-
interest to declare. tomy. JSLS. 2013;17(3):390–9.
15
Laparoscopic Sleeve Gastrectomy: Outcomes
Stacy A. Brethauer and Esam S. Batayyah
Indications for Sleeve Gastrectomy high risk for general anesthesia. These include patients with
Crohn’s disease, the need for chronic antiinflammatory
There are a wide variety of circumstances in which LSG medication use, or the need for reliable absorption of spe-
(Fig. 1) has been used, and this can make outcome assess- cific medication such as immunosuppressants after organ
ment difficult when reviewing the literature. These can be transplantation. Unlike laparoscopic Roux-en-Y gastric
categorized according to anatomical limitations, the patient’s bypass (LRYGB), LSG allows continued endoscopic access
overall risk profile, and specific medical considerations that to the common bile duct for patients with biliary disease or
make other bariatric procedures suboptimal. Additionally, liver transplants.
preference for this operation among lower-risk patients and LSG as a revisional procedure has also been reported and
revisional patients is increasing as many surgeons and is discussed in Chap. 17. This is mostly described after failed
patients find this operation meeting their criteria from a risk/ laparoscopic adjustable gastric bands (LAGB), particularly
benefit standpoint. if there have been a complication (e.g., esophageal dilation,
Anatomical considerations include super obesity chronic prolapse, or paraesophageal hernia) related to the
(BMI > 60 kg/m2) in which there is massive hepatomegaly, a band. Most of the reported studies include small numbers of
foreshortened small bowel mesentery, and bulky visceral fat patients with limited follow-up. Converting an uncompli-
and omentum. This combination of intraoperative findings cated LAGB to LSG for failed weight loss has been reported
results in severely limited working space or tension on the gas- [2–4], but the best revision procedure after failed restrictive
trojejunal anastomosis and severe torque on the laparoscopic procedure is still debated. Foletto et al. [5] performed 41
instrumentation and may be prohibitive for proceeding with band removals and simultaneous LSG, and 16 patients had
laparoscopic gastric bypass. Multiple prior abdominal surger- interval LSG after the band was removed. The mean preop-
ies, particularly prior small bowel resections, can also limit the erative body mass index (BMI) was 45.7 ± 10.8 kg/m2 and
surgeon’s ability to complete a bypass procedure safely. In decreased to 39 ± 8.5 kg/m2 with a mean excess BMI loss of
patients with massive abdominal wall hernias with loss of 41.6 % ± 24.4 % after 2 years. The postoperative complica-
domain, it is challenging to complete a gastric bypass as they tions included perigastric hematoma (n = 3, 5.7 %), staple-
frequently have had abdominal sepsis and open abdomen in line leakage (n = 3, 5.7 %), mid-gastric stenosis (n = 1), and
the past. The decision to proceed with LSG in these settings is death due to septic shock (n = 1). Two patients required DS
often made intraoperatively based on the limitations encoun- for insufficient weight loss after LSG.
tered at the time of surgery. The American Society for Metabolic and Bariatric
Patients who are very high-risk surgical candidates due to Surgery’s (ASMBS) 2011 updated position statement on
advanced age, severe cardiopulmonary disease, pre- or post- LSG [6] recognizes this operation as a primary bariatric pro-
organ transplant status, poor functional status, or inability to cedure and as a first-stage procedure in high-risk patients as
ambulate due to joint paint or a very high body mass index part of a planned staged approach.
are potential candidates for LSG [1]. Depending on the ini- The ASMBS also recognizes that as with any bariatric
tial BMI, some of these patients will require a second-stage procedure, long-term weight regain can occur and can be
operation (gastric bypass or duodenal switch) after their managed effectively with re-intervention. Reoperations for
weight loss from the LSG plateaus. failed weight loss after LSG are necessary in 6.8 %
There are also specific medical circumstances in which (range, 0.7–25 %) of cases with patients receiving LSG as a
LSG has been used, even if the patient is not at particularly stand-alone procedure and in 9.6–28.5 % of cases with
patients undergoing LSG as a planned first-stage procedure weight loss, and comorbidity improvement for LSG were
[7], but the updated statement does not address LSG as a intermediate between LAGB and LRYGB in this large study
revisional procedure. (Figs. 2 and 3).
regarding the effectiveness and durability of LSG for severe number of patients in that series did not permit statistically
obesity, even in high-risk patients. meaningful comparison at additional intervals. For the entire
Sarela et al. [13] reported 8–9-year follow-up data for cohort, the median % EWL was 68 % (range, 18–85 %) at 8
LSG as a definitive bariatric procedure for 13 out of 20 or 9 years.
patients. Of the remainder, 4 patients underwent revision D’Hondt et al. [14] had 83 patients (81.4 %) who were
surgery and 3 were lost to follow-up after 2 years. The small eligible for long-term follow-up evaluation. Their mean
146 S.A. Brethauer and E.S. Batayyah
FIG. 3. COMPLICATIONS AND WEIGHT LOSS OF LSG COMPARED TO LAGB AND LRYGB (FROM CARLIN ET AL. ANN SURG MAY 2013 WITH PERMISSION).
TABLE 2. Sleeve gastrectomy durability prevalence. T2DM is challenging to control with current
Preoperative Follow-up therapies that include diets, drug therapy, and behavioral
Patient BMI duration % EWL modification, especially in obese patients. Bariatric surgery
Author (n) (kg/m2) (years) (%) has become a powerful tool in the management of these
Himpens et al. [10] 41 39 6 53 closely related disease processes.
Bohdjalian et al. [31] 26 48 5 55 Schauer et al. [16] published a randomized controlled,
Sarela et al. [13] 20 46 8–9 69 single-center trial, evaluating the efficacy of intensive med-
D’Hondt et al. [14] 23 39 6 56 ical therapy (IMT) alone versus medical therapy plus
Eid et al. [12] 69 66 6–8 48 LRYGB versus IMT plus LSG in 150 patients with a BMI
Adapted from the updated ASMBS position statement on sleeve gastrec- of 27–43 and an uncontrolled type 2 diabetes. Ninety-one
tomy [3] with modification percent of patients completed 36 months of follow-up. The
proportion of patients achieving the primary end point (gly-
initial body mass index (BMI) was 39.3 kg/m2. No major cated hemoglobin level of 6.0 % or less at 36 months) was
complications occurred. At a median follow-up point of 49 5 % in the medical-therapy group versus 38 % in the gas-
months (range, 17–80 months), the mean % EWL was tric-bypass group (P < 0.001) and 24 % in the sleeve-gas-
72.3 % ± 29.3 %. For the 23 patients who reached the 6-year trectomy group (P = 0.01). The use of glucose-lowering
follow-up point, the mean % EWL was 55.9 % ± 25.55 %. medications, including insulin, was lower in the surgical
The overall success rate (% EWL > 50 %) was 85.7 % after 4 groups than in the medical group. Patients in the surgical
years, 64.3 % after 5 years, and 54.5 % after 6 years. The groups had greater total weight loss, with reductions of
% EWL reported by the surgeons in a survey at the Third 24.5 ± 9.1 % in the gastric-bypass group and 21.1 ± 8.9 % in
International Summit for LSG 4 and 5 years was 57.3 % and the sleeve-gastrectomy group, as compared with a reduc-
60.0 %, respectively [15]. tion of 4.2 ± 8.3 % in the medical-therapy group (P < 0.001
for both comparisons).
Lee et al. [17] evaluated in RCT the effects of mini-gas-
Comorbidity Reduction tric bypass versus LSG for type 2 diabetes mellitus on lower
BMI patients (mean BMI, 31.0 ± 2.9 kg/m2) with diabetes. Of
Diabetes is currently a major public health problem in both the 60 patients enrolled, all completed the 12-month follow-
developed and developing countries. Like obesity, type 2 up. Remission of T2DM was achieved by 28 (93 %) in the
diabetes mellitus (T2DM) is a chronic disease, with increasing gastric-bypass group and 14 (47 %) in the sleeve-gastrectomy
15. Laparoscopic Sleeve Gastrectomy: Outcomes 147
group (P = 0.02). In this study, preoperative C-peptide levels evaluated the safety profile of sleeve gastrectomy in high-
directly correlated with remission of diabetes. risk patients as well as in average-risk bariatric patients.
Vidal et al. [18] performed a 12-month prospective study Although most of the data available suggest that morbid-
including 39 LSG patients and 52 LRYGB patients who ity related to LSG is lower than in LRYGB, results vary
matched for duration and severity of T2DM. Diabetes according to different studies. Results confirm that morbidity
remission was 84.6 % for both the LSG and the LRYGB is significantly lower in patients undergoing LSG, in a non-
patients, and there were comparable remission rates of meta- randomized, retrospective comparison of patients who
bolic syndrome (62 % and 67 %, respectively (NS)) 1 year underwent LSG (n = 216), LAGB (n = 271), LRYGB
after surgery. Neither weight loss nor decrease in waist cir- (n = 303), and DS (n = 56). Lee [23] and colleagues reported
cumference was associated with T2DM remission after LSG the major complication rates for these procedures as 4.6 %,
or LRYGB. 4.8 %, 10.6 %, and 39.3 % respectively (P < 0.03). The reop-
Shorter duration of T2DM and lower presurgical fasting eration rate for LSG was the lowest of the four procedures
plasma glucose or HbA1c were associated with T2DM (2.8 %). Reoperation rates for the other procedures increased
remission. Rosenthal et al. [19] performed a retrospective with the complexity of the operation (LAGB (4.8 %),
review of 30 diabetic patients whom had undergone LRYGB (8.6 %), and DS (32.1 %)). One potential weakness
LSG. Diabetes remission at 6 months was 63 %. Patients of this nonrandomized study is that patient selection bias
with diabetes <5 years were found to have an 87.5 % chance may have affected the results for the different procedures.
of DM resolution, while those >5 years only had 35.7 % Brethauer et al. [22] who performed a systematic review
remission (P = 0.004). of sleeve gastrectomy outcomes reported that the complica-
Kehagias’[9] randomized trial showed an overall preva- tion rate among the 36 studies (2,570 patients) ranged from 0
lence of obesity-related comorbidities of 72 % (43 out of 60 to 23.8 %. Studies with >100 patients reported a major post-
patients). In the LRYGB group, 23 of the 30 patients had at operative complication rate from 0 to 14 %. The overall
least one comorbidity compared to 20 of the 30 patients who 30-day mortality rate was 0.19 %. The overall rate of major
were randomized to LSG. At 3 years postoperatively, a sig- complication rates were low including leaks (2.2 %), bleed-
nificant improvement or resolution of comorbidities was ing requiring reoperation or transfusion (1.2 %), and stric-
recorded. Dyslipidemia improved at a higher rate after tures requiring endoscopic or surgical intervention (0.6 %).
LRYGB and hypertension resolved at a higher rate following The analysis of weight loss and complications varied depend-
LSG. The rest of the studied comorbidities resolved or ing on the patient group studied. The differences between
improved equally between groups. Sarkhosh [20] did a sys- complication rates for patient undergoing sleeve gastrectomy
tematic review evaluating the impact of sleeve gastrectomy as a risk-reduction strategy and those undergoing LSG as a
on hypertension, and LSG resulted in resolution of hyperten- primary procedure are highlighted in Table 3.
sion in 58 % of patients. On average, 75 % of patients expe- Gastric leak and hemorrhage are the most important chal-
rienced resolution or improvement of their hypertension. lenges after LSG . The long staple line of the LSG in con-
A systematic review by Chiu [21] studied the effect of LSG junction with an increased intraluminal pressure offers a
on gastroesophageal reflux disease (GERD) and included 15 possible explanation. Shi’s [24] systematic review reported
studies. Two reports analyzed GERD as a primary outcome, the rate of major complications after LSG, such as staple-
and 13 included GERD as a secondary study outcome. Of the line leakage and internal bleeding (1.17 % ± 1.86 %,
15 studies, 4 showed an increase in GERD after SG, 7 found 3.57 % ± 5.15 %, respectively). Leaks were more common in
reduced GERD prevalence after LSG, 3 included only the the proximal staple line close to the gastroesophageal junc-
postoperative prevalence of GERD, and 1 did not include data tion (1.6 % of cases) than at the distal staple line 0.5 % [6].
on prevalence of GERD. The evidence of the effect of SG on Intraluminal bleeding occurred in 2.0 % of cases and the
GERD did not consolidate to a consensus. mortality rate was 1 %.
A previous systematic review of the sleeve gastrectomy in Parikh et al. [25] analyzed the effect of various surgical
literature revealed >60 % rates of remission or improvement techniques for LSG on the leak rate by systematically
in many other obesity-related comorbidities including gas- reviewing the literature and conducting a meta-analysis focus-
troesophageal reflux, degenerative joint pain, sleep apnea, ing on the relationship between leak rate and bougie size, and
leg edema, hypertension, and hyperlipidemia [22]. distance from the pylorus, and the use of buttressing material
on the staple line. Hundred and ninety-eight leaks in 8,922
patients (2.2 %) were identified. The general estimating equa-
Complications tion (GEE) model was used to calculate the odds ratio (OR)
for leak and revealed that the risk of leak decreased with bou-
One of the potential advantages of LSG is a lower complica- gie ≥ 40 Fr (OR = 0.53, 95 % CI = [0.37–0.77]; P = 0.0009).
tion rate compared to duodenal switch and RYGB. The Buttressing did not influence leak. There was no difference in
effective use of LSG as a first-stage procedure in high-risk % EWL between bougie <40 Fr and bougie ≥ 40 Fr up to 36
patients has provided evidence for its safety and utility in this months (mean % EWL 70.1; P = 0.273), and distance from the
patient population [1]. Several recent publications have pylorus did not affect leak or % EWL.
148 S.A. Brethauer and E.S. Batayyah
Dapri [26] and Albanopoulos [27] compared techniques lower acylated ghrelin and des-acylated ghrelin levels but
of reinforcing the staple line in LSG with suturing versus greater concentrations of resistin than the LRYGB group.
buttressing or neither. There was no significant difference in In addition to evaluations of ghrelin, there are now several
leak rates between groups. However, buttressing statistically small studies demonstrating that gastric emptying is
reduced blood loss during stomach sectioning as well as increased after sleeve gastrectomy. The loss of a large res-
overall blood loss. ervoir in the gastric fundus and body and preservation of the
Management of LSG leak patients mainly depend on their antral pump provide a reasonable explanation for this find-
clinical condition and this is discussed in Chap. 16. Patients ing. A secondary effect of earlier distal bowel stimulation
presenting with hemodynamic instability and uncontrolled with nutrients after meals due to increased gastric emptying
sepsis require immediate operative management. Stable time may be similar to the effects seen after gastric bypass.
patients can be managed with percutaneous drainage, endo- Several mechanistic studies have demonstrated early and
scopic therapy including stenting, and nutritional support. exaggerated postprandial peak levels of Peptide YY3–36 and
The type and duration of therapy must be individualized to GLP-1 after LSG. GLP-1 is an incretin that stimulates insu-
allow closure of fistulas and to avoid recurrent episodes of lin production and releases from pancreatic islet cells, and
sepsis or leak. the increased PYY3–36 results in satiety and reduced food
intake. Karamanakos et al. [9] have independently shown
that the sleeve gastrectomy does have the effect of increasing
Mechanisms of Action the transit time of chyme despite an intact pylorus as mea-
sured by increased postprandial PYY levels.
The evidence suggests that LSG effects gut hormone secre- Peterli et al. [29] performed a randomized prospective
tion and satiety pathways in addition to creating gastric trial with 13 LRYGB and 14 LSG patients to investigate the
restriction. One of the first gut hormones evaluated with LSG potential mechanism of LSG focusing on foregut and hindgut
was ghrelin. Since ghrelin is primarily produced in the fun- mechanisms. They found marked improvement in glucose
dus of the stomach (completely resected during LSG), it is homeostasis 1 week after surgery in both groups. This
logical that ghrelin would decrease after LSG. Karamanakos improvement was associated with early, exaggerated
et al. [9] showed that LSG suppressed fasting and postpran- increases in GLP-1 secretion at 1 week, 3 months, and 1 year
dial ghrelin levels and attributed this decrease in ghrelin to postoperatively in both groups. In addition to changes in
improved postoperative satiety and greater weight loss at 1 GLP-1, PYY3–36 increased significantly and ghrelin was sup-
year compared to LRYGB. The LRYGB group in this study pressed in both groups. It is unclear whether PYY3–36 has a
had an initial decrease in ghrelin levels after surgery, but direct effect on glucose homeostasis or if its effects are
these levels returned to normal levels within 3 months. exhibited via appetite reduction and concomitant weight
Lee et al. [28] studied the treatment of patients with a low loss. Preoperatively, some patients had a blunted PYY3–36
body mass index and type 2 diabetes mellitus between the and GLP-1 response suggesting some “resistance” to these
two groups. LRYGB is reportedly more effective than LSG; gut hormones in obese patients. These findings suggest that
they conclude that both procedures have strong hindgut the LSG should not be viewed merely as a restrictive proce-
effects after surgery, but LRYGB has a significant duodenal dure but also as a procedure that has neurohormonal and
exclusion effect on cholecystokinin. The LSG group had incretin effects.
15. Laparoscopic Sleeve Gastrectomy: Outcomes 149
Ramon et al. [30] compared the effects of LRYGB and 3. Dapri G, Cadière GB, Himpens J. Feasibility and technique of lapa-
LSG on glucose metabolism and levels of gastrointestinal roscopic conversion of adjustable gastric banding to sleeve gastrec-
tomy. Surg Obes Relat Dis. 2009;5(1):72–6. doi:10.1016/j.
hormones such as ghrelin, leptin, GLP-1, peptide YY (PYY), soard.2008.11.008. Epub 2008 Nov 27. PMID: 19161936.
and pancreatic polypeptide (PP) in morbid obese patients. 4. Iannelli A, Schneck AS, Ragot E, Liagre A, Anduze Y, Msika S,
This prospective, randomized study confirmed that the post- Gugenheim J. Laparoscopic sleeve gastrectomy as revisional proce-
prandial response of ghrelin, GLP-1, and PYY was main- dure for failed gastric banding and vertical banded gastroplasty.
tained in patients undergoing LSG for 12 months after Obes Surg. 2009;19(9):1216–20. doi:10.1007/s11695-009-9903-x.
Epub 2009 Jun 27. PMID: 19562420.
surgery and was similar to the LRYGB group results. 5. Foletto M, Prevedello L, Bernante P, Luca B, Vettor R, Francini-
Adipokines are cytokines produced by adipose cell and Pesenti F, Scarda A, Brocadello F, Motter M, Famengo S, Nitti
closely linked to obesity and insulin resistance. To date, it is D. Sleeve gastrectomy as revisional procedure for failed gastric
unclear whether the different anatomical changes of the vari- banding or gastroplasty. Surg Obes Relat Dis. 2010;6(2):146–51.
ous bariatric procedures have different effects on hormones doi:10.1016/j.soard.2009.09.003. Epub 2009 Sep 15.
6. ASMBS. Updated Position Statement on Sleeve Gastrectomy as a
of adipocyte origin. A prospective, randomized study by Bariatric Procedure. Revised 10/28/2011. http://asmbs.org/2011/12/
Woelnerhanssen et al. [11] compared the 1-year results of sleeve-gastrectomy-as-a-bariatric-procedur/
LRYGB and LSG for weight loss, metabolic control, and 7. Fischer L, Hildebrandt C, Bruckner T, Kenngott H, Linke GR,
fasting adipokine levels. The authors confirmed a close asso- Gehrig T, Büchler MW, Müller-Stich BP. Excessive weight loss
ciation of specific adipokines with obesity and with the after sleeve gastrectomy: a systematic review. Obes Surg.
2012;22(5):721–31. doi:10.1007/s11695-012-0616-1.
changes observed with weight loss after two different bariat- 8. Kehagias I, Karamanakos SN, Argentou M, Kalfarentzos
ric surgical procedures. The concentrations of circulating F. Randomized clinical trial of laparoscopic Roux-en-Y gastric
leptin levels decreased by almost 50 % as early as 1 week bypass versus laparoscopic sleeve gastrectomy for the management
postoperatively and continued to decrease until 12 months of patients with BMI < 50 kg/m2. Obes Surg. 2011;21(11):1650–6.
postoperatively and adiponectin increased progressively. No 9. Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides
TK. Weight loss, appetite suppression, and changes in fasting and
differences were found between the LRYGB and LSG groups postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric
regarding adipokine changes. bypass and sleeve gastrectomy: a prospective, double blind study.
Ann Surg. 2008;247(3):401–7.
10. Himpens J, Dapri G, Cadière GB. A prospective randomized study
Conclusion between laparoscopic gastric banding and laparoscopic isolated
sleeve gastrectomy: results after 1 and 3 years. Obes Surg.
2006;16(11):1450–6.
The current evidence regarding sleeve gastrectomy demon- 11. Carlin AM, Zeni TM, English WJ. The comparative effectiveness
strates that it can be used safely as a primary procedure or as of sleeve gastrectomy, gastric bypass, and adjustable gastric band-
part of a staged approach for high-risk bariatric patients. ing procedures for the treatment of morbid obesity. Ann Surg.
Published early postoperative complication rates are accept- 2013;257(5):791–7.
12. Eid GM, Brethauer S, Mattar SG, Titchner RL, Gourash W, Schauer
ably low, and there are few long-term complications or reop- PR. Laparoscopic sleeve gastrectomy for super obese patients:
erations reported after this procedure. Early and medium-term forty-eight percent excess weight loss after 6 to 8 years with 93 %
weight loss is better than laparoscopic adjustable gastric follow-up. Ann Surg. 2012;256(2):262–5.
banding and is comparable to or slightly less than gastric 13. Sarela AI, Dexter SP, O’Kane M, Menon A, McMahon MJ. Long-
bypass in most studies. There are growing numbers of long- term follow-up after laparoscopic sleeve gastrectomy: 8–9-year
results. Surg Obes Relat Dis. 2012;8(6):679–84. doi:10.1016/j.
term studies supporting the durability of LSG, but some soard.2011.06.020.
patients will have weight regain that can be managed with a 14. D’Hondt M, Vanneste S, Pottel H, Devriendt D, Van Rooy F,
bypass procedure. Mechanistic studies suggest some neuro- Vansteenkiste F. Laparoscopic sleeve gastrectomy as a single-stage
humoral effects of sleeve gastrectomy that may contribute to procedure for the treatment of morbid obesity and the resulting
rapid weight loss and improved glucose metabolism. quality of life, resolution of comorbidities, food tolerance, and
6-year weight loss. Surg Endosc. 2011;25(8):2498–504.
15. Deitel M, Gagner M, Erickson AL, Crosby RD. Third International
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16
Laparoscopic Sleeve Gastrectomy: Management
of Complications
Pornthep Prathanvanich and Bipan Chand
Table 1. Complications of laparoscopic sleeve gastrectomy Table 2. Incidence of gastric leak after LSG
Early complications Proportion of
• Gastric leak Authors Year Patients (n) gastric leaks (%)
• Gastric fistula Johnston et al. 2003 100 1
• Bleeding Hann et al. 2005 130 0.7
• Obstruction/stricture Hamoui et al. 2006 118 0.8
Late complications Cottam et al. 2006 126 2
• GERD Roa et al. 2006 62 2
• Nutrient deficiencies Lalor et al. 2007 148 1
Nocca et al. 2007 163 6
Weiner et al. 2007 120 3
suture or staple line [8]. Gastric leak has also been Lee et al. 2007 216 1
described in terms of: Serra et al. 2007 993 0.6
Mui et al. 2008 70 1
1. Time to diagnosis Rubin et al. 2008 120 0
Skrekas et al. 2008 93 4.3
Poujoulet et al. classified these leaks based on the period in Lalor PF et al. 2008 148 0.7
which they appear: Moy et al. 2008 135 1.4
Kasalicky et al. 2008 61 0
Early: leaks that appear between the first and third day after Arias et al. 2009 130 0.7
surgery Burgos et al. 2009 214 3.2
Casella et al. 2009 200 3
Intermediate: leaks that appear between the fourth and sev- Stroh C et al. 2009 144 7
enth day after surgery Sanchez et al. 2009 540 2
Frezza et al. 2009 53 3.7
Late: those that appear more than eight days after surgery [8] Menenakos et al. 2009 261 4
Armstrong et al. 2010 185 0
Regimbeau et al. [9] also classified gastric leak, post-LSG as Ser et al. 2010 118 3.39
either early onset (postoperative day 1–7) or delayed Csendes et al. 2010 343 4.66
onset (after postoperative day 8) Dapri et al. 2010 75 5
2. Site of leakage Lacy et al. 2010 294 4
Identification of the gastric leak site is based on anatomic Ser et al. 2010 118 3
Srinivasa et al. 2010 253 2
thirds (upper, middle, or distal third of the remaining Bellanger et al. 2011 529 0
stomach)
3. Clinical aspect
The clinical presentation has been described in terms of reported on 4,888 patient records. The mean BMI ranged
systemic signs of inflammation and sepsis (tachycardia from 34 to 65.4 kg/m2, and all 29 studies documented a leak
>100/min, hyperthermia >38 °C), peritonitis (diffuse rate, which ranged from 0 to 7 %. The mean leak rate for all
abdominal tenderness), pulmonary symptoms (cough and 29 studies was 2.4 %, which accounted for 115 leaks in 4,888
expectoration), and intra-abdominal abscess (localized cases of sleeve gastrectomy. There did appear to be a higher
abdominal tenderness). A clear treatment algorithm should leak rate in patients with a BMI > 50 kg/m2.
be established based on the patient’s status: stable or Six studies specifically addressed super-obese patients
unstable and controlled or uncontrolled leak. Patients who with a mean BMI > 50 kg/m2. In the super obese, the mean
are manifesting signs of sepsis or instability should be leak rate was 2.9 % or 23 leaks of 771 patients compared
managed operatively. Laparoscopy or laparotomy should with the leak rate of only 2.2 % (92/4,117) for those with
include drainage and washout of the infected collection mean BMI < 50 kg/m2 (not significant P > 0.05).
Causes of Post-LSG GL
Incidence of Postoperative Laparoscopic Sleeve
It is possible that these types of proximal leaks (i.e., those at
Gastrectomy Gastric Leak (Post-LSG GL)
the gastroesophageal junction or near the angle of His) have
Gastric leaks represent one of the most dangerous complica- multiple different etiologies. One plausible theory is that the
tions of bariatric surgery. In the literature, the incidence of final staple line is placed across the gastroesophageal junction
GL after LSG ranges from 0 to 7 % [9–11] (Table 2). Most or distal esophagus causing poor staple-line configuration.
leaks appear in the proximal third of the stomach, close to Another more likely is the vascular theory. As Basso et al.
the gastroesophageal junction or near the angle of His. explains [13], the cardias (distal esophagus and esophagogastric
Burgos et al. [12] reported 85.7 % of leaks in the proximal junction) are supplied in the right and anterior side by branches
third and only 14.3 % in the distal third. A.A. Saber et al. of the left gastric artery and left inferior phrenic artery.
[11] analyzed 29 publications using a MEDLINE search and The posterior left side is vascularized mainly by fundic
16. Laparoscopic Sleeve Gastrectomy: Management of Complications 153
Investigation
If the surgeon becomes concerned about a leak and a drain
was left in place at the time of surgery, the drain fluid can be
Fig. 6. Oversewing causing leaks when the pouch is distended and sent for an amylase level. If the fluid amylase level is much
suture bowstrings and tissue tear. higher than normal serum levels (in the 1,000s), this suggests
that saliva is entering the drain. Regardless of the drain amy-
Table 3. Potential signs of post-LSG GL lase level, early imaging is warranted if clinical suspicion of
a leak exists. An upper gastrointestinal contrast study is fre-
A high index of suspicion
quently used postoperatively to assess the presence of a gas-
1. SIRS tric leak as well as demonstrate patency of the sleeve
– Unexplained tachycardia (>100/min)
– Fever (>38 °C)
gastrectomy. In general, a water-soluble contrast material is
used (Gastrografin). While standing, the patient swallows
2. Abdominal pain
– Diffuse abdominal tenderness (diffuse peritonitis) 20 mL of Gastrografin and radiographs are taken. The char-
– Intra-abdominal abscess (localized peritonitis) acteristics of a tubularized stomach (i.e., dimensions, empty-
3. Pulmonary symptoms (subphrenic abscess or complex bronchogastric ing, and the presence or absence of leak or stricture) are then
fistula) evaluated (Figs. 7 and 8). In case of doubt, or in order to
– Cough increase sensitivity, abdominal computerized tomography
– Expectoration (CT) scan can be performed. CT scan can provide additional
– Persistent hiccups
information in regard to fluid collections or abscess in the
left upper quadrant (Figs. 9 and 10) or the presence of sub-
(identified by fluoroscopic study) to the presentation of peri- diaphragmatic air (Fig. 11).
tonitis, septic shock, multiorgan failure, and death. Burgos Abdominal CT scan should be performed with intrave-
et al. report a series of 7 leaks in 214 patients (3.3 %), of nous and oral contrast material. It is useful to identify the
which 5 patients presented abdominal pain, fever, tachycar- postoperative normal anatomy and the presence of complica-
dia, tachypnea, and increased laboratory signs of infection. tions after sleeve gastrectomy. Findings suggestive of GL are
They observed that tachycardia is an initial sign of early leak extravasation of contrast agent through the wall of the gastric
[12]. Casella et al. reported leaks in 3 % of 200 patients. In sleeve, accumulation adjacent to the sleeve, free intra-
general, the symptomatology was abdominal pain, vomiting, abdominal liquid, free intra-abdominal gas, and residual
and fever; only one patient was asymptomatic [19]. contrast agent in the drainage tube.
According to Tan et al. [20] and de Aretxabala et al. [21],
early-onset GL presents with severe, sudden abdominal pain
Management of Post-LSG GL (Fig. 12)
(together with fever, nausea, and vomiting), whereas delayed-
onset GL is usually of a more insidious nature (with gradu- Interventional options include surgery (laparoscopy or
ally increasing abdominal discomfort and fever). Patients laparotomy with abdominal washout, abdominal drainage
with early-onset GL show signs of sepsis caused by gastroin- close to the staple line, and feeding jejunostomy), endo-
testinal contents in the peritoneal cavity, and they require at scopic procedures (self-expandable metallic stents
least a surgical lavage and the placement of drains. For (SEMS), clips, biological glue, pigtail drains, and T-tube
patients with delayed-onset GL, fluid frequently collects gastrostomy drain), and radiological procedures (percuta-
near to the stomach and does not spread to the rest of the neous drainage).
cavity. Four clinical presentations have approximately the The management of the leak depends on the patient’s
same frequency: systemic signs of inflammation, peritonitis, clinical condition. The surgeon managing this complication
156 P. Prathanvanich and B. Chand
must have a clear treatment strategy or algorithm based on results can be variable depending on the size and duration of
the patient’s status, the duration of the leak, and the resources the leak. Although placement of self-expanding, covered, or
available. partially covered stents (Polyflex or WallFlex stents, Boston
If the leak presents as a well-defined abscess several days Scientific, Natick, MA) may be beneficial, the current stent
or weeks after surgery and the patient is clinically stable, per- technology is not ideal for this anatomy. The difficulty is in the
cutaneous image-guided drainage (Fig. 13) or pigtail drainage two different lumen diameters and the curvature of the gastric
(Fig. 14), antibiotics, and nutritional support with parenteral lumen (Fig. 16). Before attempts at stenting, the extraluminal
nutrition or a nasojejunal tube is appropriate. If drainage is collection must be adequately addressed in all cases, and sur-
adequate, endoluminal therapies can be used to facilitate clo- gical placement of drains with washout of the infected field is
sure of the leak. This process often includes placement of often warranted to promote closure of the leak. Because suc-
endoscopic clips, fibrin glue (Fig. 15), or bioabsorbable fistula cessful outcomes after stenting often occur in carefully
plugs and endoluminal stenting across the leak. Stenting has selected patients, evidence is currently insufficient to make
been shown to be effective in small series of selected cases, but any broad claims that stenting accelerates or promotes closure
16. Laparoscopic Sleeve Gastrectomy: Management of Complications 157
Casella et al. [25] reported the use of endoscopic stent for leak
at the gastroesophageal junction after sleeve gastrectomy in
five patients with complete healing occurring in all patients,
suggesting that the staple-line leak can be safely and suc-
cessfully managed without reoperation in patients with
hemodynamic stability (rate of success of 100 %). Eubanks
et al. [24] reported a success rate of 84 %. Tan et al. reported
a success rate for closure of only 50 % due to stent-related
complications. Other studies have suggested routine stent
removal no later than 6 weeks in order to avoid tissue hyper-
plasia and difficult extraction. Tolerance to stents is variable
(nausea, vomiting, drooling, and retrosternal discomfort) but
tends to disappear after the first few days. Covered SEMS
also present significant morbidity–mortality, with migration
being one of the main concerns (Fig. 22). The high migration
rate has been explained by the “abnormal” placement of the
stent along the last portion of the esophagus and the gastric
Fig. 13. Percutaneous drainage to drain a collection adjacent to the pouch. The type of stent used may also lead to higher rates of
remnant stomach. Reproduced with permission from OBES SURG migration. Fully covered stents will have the greatest degree
2011;21:1232-1250. Gastric Leak After Sleeve Gastrectomy: of migration while less covered stents will have a greater
Analysis of Its Management. degree of tissue ingrowth.
Gastric Fistula
A chronic fistula (Fig. 23) after LSG is a challenging prob-
lem. If a leak or gastrocutaneous fistula persists for months
despite adequate surgical drainage, endoluminal therapy, and
nutritional support, the patient’s gastrointestinal anatomy
should be evaluated for a distal obstruction or stricture.
Reoperation may be the only solution. Several surgical
options have been reported. Therapy may include resection
of fistula and proximal stomach with the creation of a Roux-
en-Y esophagojejunostomy, bringing a Roux limb up and
creating a gastrojejunal anastomosis directly on the leak site,
placing a jejunal patch over the leak site, or placing a T tube
into the leak site. Evidence is insufficient to support one
approach over another, and the type of salvage procedure
should be determined by the patient’s anatomy and the sur-
geon’s judgment and experience.
Fig. 14. Delayed-onset gastric leak. (a) A fluid collection bulging
in the stomach (white arrow). (b) Fluid collection bulging in the
stomach (black arrow). (c) A pigtail drain. (d) Abdominal X-ray Bleeding Complications
showing two pigtail drains after the endoscopic procedure.
Reproduced with permission from OBES SURG 2012:22;712-720.
The incidence of staple-line hemorrhage has been reported
Is There a Place for Pigtail Drains in the Management of Gastric
to be 0–8.7 % [27]. Common sites of bleeding include the
Leaks After Laparoscopic Sleeve Gastrectomy?.
sleeve staple line, the short gastric vessels, the spleen, and
the omental vessels that have been divided during the dis-
section of the greater curvature. When bleeding is identi-
migration is to use a longer stent whereby the distal aspect of fied, conservative management including stopping
the stent is rested along the wall of the gastric antrum which anticoagulation and appropriate fluid or blood resuscita-
preclude the stent from luminal migration (Table 4). tion is usually sufficient in most of cases [28, 29]. Bleeding
Serra and colleagues [23] reported on the use of coated self- complications requiring reoperation occur less than 2 %
expanding stents for management of leaks after sleeve gastrec- of the time after LSG [30]. Laparoscopic stapling devices
tomy in three patients with control of leaks in 66 % of cases. have become pivotal tools in the field of laparoscopic
160 P. Prathanvanich and B. Chand
Fig. 15. Endoscopic placement of (a) fibrin glue and (b) clips across a small leak at the gastroesophageal junction after sleeve gastrectomy
followed by placement of a stent across the leak.
Table 4 Endoscopic stent for gastric leak after laparoscopic sleeve gastrectomy
Author Year Number of patients Number of covered SEMS Success rate (%) Migration rate (%)
Serra et al.[23] 2007 3 7 66 14
Eubanks et al. [24] 2008 19 34 84 58
Casella et al. [19] 2009 5 11 100 9
Tan et al. [20] 2010 14 8 50 25
Pequignot et al. [10] 2011 25 50 84 8
Chand et al. [26] 2010 6 6 66 17
developed to improve staple-line strength by increasing the In a subgroup analysis of this meta-analysis, reinforcing
tissue thickness, resulting in decreased bleeding and risk of the staple line with a buttress may decrease the risk of
leak. In the bariatric literature their use remains controver- staple-line hemorrhage and overall complications, but it is
sial. Few published papers exist that compare the incidence not clear whether it decreases the risk of staple-line leak
of staple-line leakage or hemorrhage to that of nonreinforced after LSG. It was also unclear if the effect of reinforcing the
staple lines in LSG procedures. staple line with oversewing showed any advantage when
Choi et al. [31] performed a meta-analysis of eight arti- compared to the control group in regard to leak, hemor-
cles (two RCTs and six cohort studies; Table 5). There were rhage, and overall complications. In addition, it could lead
1,335 patients in the eight studies (507 patients in the control to strictures of the gastric sleeve and cause tears of the
groups and 828 patients in the intervention groups). Although suture line (Fig. 7). In practice, according to Gagner’s
there was no significant effect of overall reinforcement of the report [27], 65.1 % of 106 surgeons who participated in the
staple line in this meta-analysis, reinforcement with a but- Second International Consensus Summit for Sleeve
tress seemed to decrease staple-line hemorrhage (Fig. 24). Gastrectomy in 2009 answered that they reinforced the
On the other hand, reinforcing the staple line with oversew- staple line of the gastric tube. Of these, 50.9 % reinforced
ing may increase the risk of staple-line hemorrhage, although the staple line with oversewing, 42.1 % used a buttress, and
this result had no statistical significance. 7 % did both.
16. Laparoscopic Sleeve Gastrectomy: Management of Complications 163
Fig. 24. The forest plot shows the OR of staple-line hemorrhage after LSG of the reinforcing staple-line group and the control group with
fixed-effect-model meta-analysis (OR, odds ratio). Reproduced with permission from OBES SURG 2012;22:1206-1213. Reinforcing the
Staple Line During Laparoscopic Sleeve Gastrectomy: Does It Have Advantages? A Meta-analysis.
Obstruction and Strictures because early published series of LSG tended to use larger
bougies with the intention of two-stage weight loss. In a
Sleeve stenosis can occur due to unintentional narrow tubu- recent review of 36 studies evaluating LSG as a primary and
larization of the stomach. It currently is reported to occur in staged procedure, Brethauer et al. [7] demonstrated that the
0.26–4 % of LSG operations [7, 32, 33]. This may underes- rate of postoperative strictures requiring endoscopic or oper-
timate the true incidence of stenosis in current practice ative intervention was 0.6 % in studies with more than 100
164 P. Prathanvanich and B. Chand
patients. The most common site of luminal narrowing is at A twisted or spiral sleeve is another cause of symptomatic
the incisura (Fig. 25). stenosis. Progressive rotation of the staple line in an anterior
Some authors have reported that the stenosis rate does not to posterior plane can lead to a narrowing despite a fairly
correlate with bougie size used. For example, Cottom et al. normal luminal diameter. This curve can make passage of
[34] reported using 46- to 50-Fr bougies with a stenosis rate enteric contents difficult, resulting in a functional stenosis.
of 3.9 %, whereas Lalor et al. [35] reported using either a This often is demonstrated by easy passage of the endoscope
44- or 52-Fr bougie with a stenosis rate of only 0.7 %. This or balloon dilator through the narrowed area. Much like a
suggests another technical cause independent of bougie size clown twisting a straight balloon, an anterior twist at the
contributing to the stenosis rate. Notably, Cottom et al. [34] incisura can result in a functional stenosis (Fig. 4). An endo-
stated that by changing their overall technique from imbri- scope can pass through by pushing and twisting in the same
cating the staple line to covering it with fibrin glue caused direction, and a balloon dilator can be used to open the ste-
their stenosis rate to disappear. nosis. However, the stenosis returns at withdrawal of the
This type of stenosis most likely occurred due to overnar- endoscope or deflation of the balloon dilator. A functional
rowing of the sleeve at the incisura. Care must be taken to sleeve stenosis also can result from external sources such as
leave plenty of tissue anteriorly in this area, especially when a hematoma (Fig. 26) that causes the sleeve to scar in a
the sleeve starts closer to the pylorus. Narrowing here can kinked manner. Such complications should be promptly
occur as the clinician begins to “cut the corner” even with a treated (Video 3).
larger bougie in place due to over-retraction of the greater The management algorithm (Fig. 27) of patients who have
curvature during stapling. The process of retracting the undergone LSG with persistent nausea, vomiting, or dyspha-
greater curvature where tension is progressively applied can gia. First, an UGI contrast study should be obtained. If this
cause stretch on the stomach during division. Once the bou- study demonstrates an abnormal finding or if the symptoms
gie is removed, the stomach will recoil, resulting in a nar- persist over time, an esophagogastroduodenoscopy should be
rowing. Although true strictures can occur, this problem after performed with anticipation of performing a dilation. Repeat
LSG is typically not a true mucosal or luminal stricture as dilation can be performed as long as the patient demonstrates
much as it is an angulation or kinking of the stomach in this improvement in oral tolerance. Placement of a stent also can
area. This functional obstruction presents as persistent dys- be considered, although a stent often is poorly tolerated by
phagia to solids and liquids, with nausea and vomiting. When the patient due to pain and discomfort. Failure of progression
creating the SG initially, this complication can be prevented to a normal diet warrants consideration of operative revision
through avoiding sharp angulation of the staple line and to an RYGB. Clinical significant short-segment stenoses may
allowing for adequate lumen size as the stapler approaches be treated successfully with endoscopic balloon dilation and
the incisura. stent. Long-segment stenoses are less likely to respond to
16. Laparoscopic Sleeve Gastrectomy: Management of Complications 165
endoscopic techniques and may ultimately require conversion medications, and behavioral and lifestyle changes) (Fig. 28).
to Roux-en-Y gastric bypass. Severe symptoms may also include an inability to ingest oral
food requiring hospitalization for assisted feeding and pos-
sible reoperation. Therefore, the true incidence of this com-
Post-LSG GERD plication after sleeve gastrectomy is unknown. The works
that do report the incidence cite numbers from as low as
GERD remains a concern after LSG and has a very wide 0.1 % for prolonged vomiting and 0.2 % for delayed gastric
clinical spectrum of manifestation. There is probably a con- emptying [36] to as high as 13–30 % [37]. Symptomatic
tinuum from mild reflux that may respond well to PPIs, GERD has been reported to occur in 7.8–20 % of patients at
through severe symptomatic reflux that may need a deploy- 12–24 months after LSG in a selected series of more than
ment of full treatment options (high-dose PPIs, propulsive 100 patients. At the Second and the Third International
166 P. Prathanvanich and B. Chand
Consensus Summits for Sleeve Gastrectomy, reflux disease early improvement of GERD symptoms occurs after LSG,
was reported to occur in 6.5 % and 17 % of patients, respec- but late onset of GERD symptoms has also been reported.
tively, after sleeve gastrectomy. Most studies reported an In a report by Himpens and colleagues [38] with 6-year
increase in reflux symptoms during the first year following follow-up, the overall incidence of new-onset GERD
sleeve gastrectomy, followed by a gradual decrease in symp- (defined as symptoms requiring proton pump inhibitor use)
toms up the third postoperative year. was 26 %. The investigators attribute some of the new-
Even Wernicke–Korsakoff syndrome has been reported onset GERD symptoms to the appearance of a neofundus
after sleeve gastrectomy (SG) due to prolonged vomiting (dilated pouch of fundus at the proximal sleeve) (Fig. 29)
[38]. This wide variation in incidence may also lead to vari- that occasionally requires reoperation. In patients in whom
ations in diagnosing criteria. Most authors report prescrib- this dilated fundus was resected, GERD symptoms
ing PPIs for different periods of time to SG patients. Often improved. Anatomical changes in the angle of His and GEJ
area and retention of the fundus may play an important role
in postoperative sleeve emptying. The more fundus left
behind, the higher the propensity of the stomach to distend,
especially in view of a functional obstruction. Larger
retained fundus will produce more gastric acid, and this in
turn may result in larger amount of acid available for reflux-
ing into the esophagus (Fig. 30). It is clear that in cases
where the fundus has been left behind, the anatomy of the
gastroesophageal junction was disturbed to a lesser degree.
The fundal dilatation probably represents the retention of
the fundus at the operation while trying to avoid injury to
the area of the esophagogastric junction or incomplete
release of the posterior fundus.
Since sleeve gastrectomy is still a relatively recent tech-
nique, the knowledge regarding the true incidence of new-
onset GERD is still evolving. More investigations regarding
the physiology of the procedure in terms of emptying, acid
production, and reflux mechanisms are needed to draw
more conclusions. Until that knowledge is available, a cau-
tious approach to patients with preoperatively suspected
Fig. 28. UGI study revealing a dilated upper part of the sleeve
motility disorders should be exercised. Patients suspected
(black arrow), with an immediate passage to the lower part. The
contrast has retained in the fundus area and reflux up to the mid
to have this kind of dysfunction should be studied by
esophagus was observed (white arrow). Reproduced with permis- esophageal manometry or nuclear emptying studies and
sion from OBES SURG 2010;20:140-147. Dilated Upper Sleeve may be better candidates for alternative operations, such as
Can be Associated with Severe Postoperative Gastroesophageal the gastric bypass. Patients should be advised preopera-
Dysmotility and Reflux. tively about the possibility of this complication. If this
Fig. 30. (a) Virtual CT after sleeve gastrectomy third postoperative day: normal finding after calibration with 42-Fr tube. (b) Virtual CT
after sleeve gastrectomy: surgical mistake with fundus in place (uncompleted resection).
complication has occurred, conservative approach is usu- alternative for the mechanical and anatomical stenosis of the
ally successful, but sometimes, a conversion to other proce- sleeve (Fig. 31).
dure (RYGB) can be curative. Seromyotomy [38] is a difficult procedure but may resolve
the problem of symptomatic dysphagia and appearance of de
novo GERD symptoms. During this procedure, dissection is
Treatment Post-LSG GERD performed by hook electrocautery.
Treatment options are divided into conservative therapy, This tool and technique allows for a meticulous dissection
endoluminal modalities, and surgical options. Obviously, of the successive muscular layers of the stomach, with very
the simple fibrotic stricture or complete obstruction should short electrical bursts near the submucosa area. Usually,
be excluded by swallow study or endoscopy. But even in bleeding encountered during dissection can be controlled by
the absence of complete anatomical occlusion, there may applying pressure with a closed blunt grasper. The goal is to
be a functional obstruction, where the propulsive force of achieve a myotomy 1 cm beyond the stenosis both proxi-
the stomach and esophagus is not enough to clear the con- mally and distally. If gastric perforation occurs, it can be
tent downstream. In those cases, endoscopic dilatation treated by interrupted intracorporeal absorbable sutures and
may be beneficial. Conservative measures are directed at omentoplasty. The efficacy of the treatment should be
reducing acid production and improvement of gastric and assessed by insufflation of air in the stomach. The edges of
esophageal motility and acid clearance. Psychological and the myotomized region should easily open up with air insuf-
diet counseling are of utmost importance on the way to flation at the end of the procedure. Symmetry of the SG, by
success. observation of a cylindrical gastric tube, should be achieved
Surgical options can be directed at improvement of gas- (Figs. 32 and 33). If after the seromyotomy, an hourglass
tric emptying and decrease of acid production. Since there is deformation still remains, and conversion to another bariatric
no fundic tissue available, the possibility of fundoplication is procedure should be considered.
nonexistent. Ligamentum teres cardiopexy has been Jorge et al. [37] identified three technical errors that
described. Re-sleeve will decrease the acid production, but explain most cases of GERD after sleeve gastrectomy: rela-
there are no studies reporting objective data of the gastric tive narrowing at the junction of the vertical and horizontal
acidity before and after the sleeve gastrectomy. The best pos- parts of the sleeve, dilation of the fundus, and persistence of
sible operation is probably a conversion to Roux-en-Y gas- a hiatal hernia. When they routinely removed the fundus
tric bypass. This will improve emptying and divert the acid (leaving only enough to allow oversewing), they corrected
gastric content to the small bowel. A seromyotomy is an hiatal hernias when found and avoided relative narrowing or
168 P. Prathanvanich and B. Chand
pump inhibitor) use might have played an additive role in the PTH levels should be determined to diagnose secondary
development of vitamin B12 deficiency by reducing acidity. hyperparathyroidism.
Folate can be absorbed throughout the intestine, espe- Moreover, supplementation of zinc should be based on
cially in the jejunum, and therefore folate deficiency is less symptoms (hair loss, immune deficiency, dry skin). High
common after LSG [42]. A very small amount of folate is zinc intake reduces absorption of copper and iron. Zinc and
stored by the body, and a constant supply of a diet contain- calcium should be taken at different times because zinc
ing foods that are sources of folic acid is necessary to reduces calcium absorption. Supplementation of selenium is
maintain serum concentrations. The best sources of folate not generally necessary because postoperative deficiencies
are viscera, beans, and green leafy vegetables. Some inves- normalize on their own without supplementation, and an
tigators have reported that low folate levels reflect nonad- adequate, varied food intake seems to be sufficient.
herence to multivitamin supplementation because the Regular determination of laboratory parameters should
amount of supplemented folic acid properly corrects low be performed 3 and 6 months after the operation and semian-
serum folate levels. Hakeam et al. reported folate deficiency nually thereafter; if the patient’s weight stabilizes, laboratory
after surgery, and though patients in this study received a parameters should be determined once a year.
daily supplement containing 0.2-mg folic acid following
LSG, folate levels deteriorated throughout the study
period. Therefore, patients undergoing LSG might require Conclusion
more than the RDA of folic acid to maintain normal folate
levels. This could be attributed to the diet changes after LSG is an accepted bariatric procedure that can be used for
surgery [43]. Also, more attention has to be directed to many different patient populations. It has been effectively
folic acid and vitamin B12 in females planning to get preg- used as part of a staged risk-management strategy for high-
nant after LSG, as folic acid and vitamin B12 deficiency risk patients and has gained popularity as a primary bariat-
during pregnancy in general population has been linked to ric procedure. The evidence supporting the safety and
the increased risk of neonatal neural tube defects. Close efficacy of SG continues to increase and long-term data are
monitoring of vitamin B12 and folate levels is important, emerging that report excess weight loss greater than 50 %.
and an adequate supplementation is necessary to maintain There is not yet a standard technique for this procedure.
these parameters in the normal range for all the follow-up Heterogeneity includes the size of the bougie, beginning
period. site of resection, and reinforcement of the staple line. The
Hakeam et al. found a low incidence of iron deficiency solution may lie in finding a suitable size at which the pres-
(4.9 %) and of anemia (1.6 %) 12 months after surgery [43]. sure of the tube is not excessive and the restriction is suffi-
After 1 year, the impact of this bariatric surgery on iron indi- cient for obtaining good weight loss results without
ces was negligible. Therefore, iron supplementation appears increasing the risk of complications.
unnecessary in nonanemic patients undergoing LSG at least Attractive features of LSG are rapid weight loss, comor-
in the interval of 6–12 months after surgery. bidity reduction, and avoidance of long-term complications
Bone metabolism can change during the first year after of bypass procedures or implantable devices. Concerns
LSG. Part of this change is explained by the weight loss remain regarding the risks of leaks, the long-term incidence
itself due to the loss of pressure on the weight-bearing of GERD symptoms, and the weight loss durability beyond 5
bones, thus losing a potent stimulant for bone preservation. years. Management of leaks after LSG is a formidable chal-
Furthermore, normal levels of vitamin D are essential for lenge for the bariatric surgeon, and early diagnosis followed
an adequate intestinal calcium uptake. A shortage in vita- by a multidisciplinary treatment strategy is key.
min D eventually leads to a negative calcium balance and
causes a compensatory rise in PTH to promote bone resorp-
tion. Aarts et al. reported normal calcium levels 1 year after Review Questions and Answers
LSG but suboptimal levels of vitamin D, although on daily
multivitamin supplementation [44]. Calcium supplementa-
Questions
tion is important in the first 6 months in the multivitamin
formula and it is sufficient to maintain normal plasma val- 1. What are the potential causes of post-LSG gastric leak?
ues during the follow-up period. Patients with deficiencies (a) Large hiatal hernia
in albumin, vitamin D, or calcium have a higher risk of (b) Use of a large-size bougie
developing osteoporosis; therefore, it is recommended that (c) Mid-sleeve stenosis
appropriate supplementations be initiated, even if the con- (d) Staple line near GE junction
centrations of these parameters are only slightly decreased. (e) Staple on the migratory crotch staple
170 P. Prathanvanich and B. Chand
2. What are the signs and symptoms of post-LSG GL? 12. Burgos AM, Braghetto I, Csendes A, et al. Gastric leak after
(a) Persistent hiccups and chronic cough laparoscopic-sleeve gastrectomy for obesity. Obes Surg. 2009;19:
1672–7.
(b) Persistent dysphagia with nausea and vomiting 13. Basso N, Casella G, Rizzello M, et al. Laparoscopic sleeve gastrec-
(c) Diffuse abdominal tenderness tomy as first stage or definitive intent in 300 consecutive cases. Surg
(d) Unexplained tachycardia (>100/min) Endosc. 2011;25(2):444–9.
(e) Localized abdominal tenderness 14. Nocca D, Krawczykowsky D, Bomans B, et al. A prospective mul-
ticenter study of 163 sleeve gastrectomies: results at 1 and 2 years.
3. What are the common sites of post-LSG bleeding? Obes Surg. 2008;18(5):560–5.
(a) Mesocolon 15. Bellanger DE, Greenway FL. Laparoscopic sleeve gastrectomy,
(b) Sleeve staple line 529 cases without a leak: short-term results and technical consider-
ations. Obes Surg. 2011;21(2):146–50.
(c) Short gastric vessels 16. Yehoshua RT, Eidelman LA, Stein M, et al. Laparoscopic sleeve
(d) Spleen gastrectomy—volume and pressure assessment. Obes Surg. 2008;
(e) Liver 18(9):1083–8.
17. Baker RS, Foote J, Kemmeter P, et al. The science of stapling and
4. What are the treatment options of post-LSG obstruction? leaks. Obes Surg. 2004;14(10):1290–8.
(a) EGD + dilatation ± stent 18. Heniford BT, Matthews BD, Sing RF, et al. Initial results with a
(b) Laparoscopic strictuloplasty stapled gastrojejunostomy for the laparoscopic isolated Roux-en-Y
(c) Laparoscopic RYGB gastric bypass. Am J Surg. 2000;179:476–81.
19. Casella G, Soricelli E, Rizello M, et al. Nonsurgical treatment of
(d) Laparoscopic feeding jejunostomy staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg.
(e) Laparoscopic seromyotomy 2009;19:821–6.
20. Tan JT, Kariyawasam S, Wijeratne T, et al. Diagnosis and manage-
Correct Answers ment of gastric leaks after laparoscopic sleeve gastrectomy for mor-
1. c, d, e bid obesity. Obes Surg. 2010;20:403–9.
21. de Aretxabala X, Leon J, Wiedmaier G, et al. Gastric leak after
2. a, c, d, e sleeve gastrectomy: analysis of its management. Obes Surg. 2011;
3. b, c, d 21:1232–7.
4. a, b, c, e 22. Court I, Wilson A, Benotti P, et al. T-tube gastrostomy as a novel
approach for distal staple line disruption after sleeve gastrectomy
for morbid obesity: Case report and review of the literature. Obes
Surg. 2010;20:519–22.
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17
Sleeve Gastrectomy as a Revisional Procedure
Raul J. Rosenthal
TABLE 1. Indications of revisional laparoscopic sleeve gastrectomy area and right and left upper quadrants. The access port of
Reasons of performing revisional LSG the band is removed during placement of the left upper quad-
Weight loss failure rant trocar. Adhesiolysis is performed particularly between
Intolerable symptoms the left liver lobe and the anterior wall of the stomach until
Band slippage the liver is retracted cranially. It is our recommendation to
Band erosion keep the band in place until the band capsule has been
Band infection
Esophageal dilatation
divided, the fundoplicature has been taken down, and both
Esophageal motility disorder right and left crus of the diaphragms have been clearly dis-
Good candidates for revisional LSG sected. Then, the posterior band capsule that is on the gastric
Patients who prefer the procedure wall is dissected and excised in order to facilitate staple clo-
Patients considered high risk sure and transection of the stomach.
Patients contraindicated for malabsorptive procedure (inflammatory
bowel disease, severe small bowel adhesions)
The greater curvature of the stomach is dissected with a
Patients on anticoagulants harmonic scalpel dividing the short gastric vessels from 2 to
Heavy smokers 6 cm proximal to the pylorus up to the gastroesophageal
Patients with a BMI of 35–40 without comorbidities junction. A bougie is inserted transorally to the level of the
Patients with a BMI of 30–35 with associated comorbidities distal stomach to size the sleeve, and 32–36 F is generally
Morbidly obese adolescent or elderly
Patients requiring a second surgical procedure (e.g., kidney or liver
thought to be an optimal bougie size [2]. Linear cutting sta-
transplantation, joint replacement) plers are used to vertically transect the stomach, creating a
Relative contraindications for revisional LSG gastric sleeve with an estimated capacity of 100–
Severe GERD with aspiration pneumonia, Barrett’s dysplasia, chronic 150 mL. When transecting the stomach, it is important to
cough start 2–6 cm proximal to the pylorus and to maintain a rea-
Eroded band
sonable distance from the gastrointestinal junction on the last
firing [2]. Many surgeons usually prefer to start 6 cm proxi-
performed as the first choice, because of the presence of mal to the pylorus to leave most of the gastric antrum for its
various feasible options and the lack of comparative studies or pumping and emptying action [12]. Although the stapler
long-term results after LSG. When it comes to failed GB, re- heights can vary according to tissue thickness, nothing less
banding or band removal in the case of band-related problems than green load (2.0 mm) should be used when performing
and conversion to RYGB are the most frequent revisional revisional LSG [2]. The staple line is oversewn by absorb-
strategies currently used [26]. Although consensus on the use able suture or buttressed with a collagen-like material to pre-
of LSG for weight loss failure after GB was not reached at the vent bleeding and leaks. After thorough hemostasis, a drain
recent expert panel meeting [2], many surgeons still consider is placed in the subhepatic space. The stomach specimen and
LSG as a valid option for failed GB due to its level of technical band are removed through the supraumbilical trocar site.
ease, safety, and effectiveness. Furthermore, there is a group of Then the trocar sites are closed.
patients that would be good candidates for conversion to LSG as In patients with previous LAGB, special attention should
listed in Table 1 [2, 4, 16]. As a result, revisional LSG can be be given to the upper third of the sleeve [4], where the tissue
performed for various reasons of failure and helpful for some is thickened due to the fibrous capsule around the band.
patients in particular, although more studies are needed. Transecting the stomach at this point can result in either poor
union with leakage or poor healing [15]. If a surgeon shifts
the transection plane laterally to avoid stapling the thickened
Surgical Procedure scar tissue, LSG may not guarantee the complete removal of
the gastric fundus. However, it is important to remove the
The aim of this operation is to create a restriction and reduce whole gastric fundus to expect nonrestrictive benefits of
the size of the stomach to about a 150 cm3 tube by resecting LSG. Therefore, stapling the thickened scar tissue when
the greater curvature [27]. Surgical technique of revisional making the upper part of the sleeve is unavoidable, and using
sleeve gastrectomy is basically similar to that of the primary the tallest staples is strongly recommended to make it a safe
sleeve gastrectomy except for a few points, and it is per- procedure [4]. There is a hypothesis that removal of the band
formed laparoscopically unless severe intraoperative compli- with an interval of 3–6 months prior to LSG could reduce the
cations occur. Patients need perioperative antibiotics and complications, because this interval can help to reduce the
thromboprophylaxis with preoperative subcutaneous heparin chronic inflammatory response around the previously banded
injection and pneumatic anti-embolic stockings. In the oper- area and prevent incomplete stapling or complications.
ating room, patients are placed in the supine position and Nevertheless, consensus is not yet reached because there has
receive general anesthesia via endotracheal intubation. The been no strong data so far to support it [4]. It is our opinion
abdominal cavity is accessed through a 1 cm supraumbilical that an absolute contraindication to a one-step conversion of
incision using an optical trocar. Pneumoperitoneum is GB to LSG is when bands are eroded or patients developed
created using carbon dioxide insufflation to a pressure of severe GERD with episodes of aspiration pneumonias.
15 mmHg. Accessory trocars are placed in the subxiphoid
17. Sleeve Gastrectomy as a Revisional Procedure 175
LYGB and BPD-DS are currently thought to be more effec- was previously placed, serious complications can occur,
tive in achieving adequate weight loss after failed GB than such as leak and bleeding. Another problem is that complete
LSG. These are the reasons why many surgeons use RYGB resection of the fundus during LSG can be challenging in the
as a primary revisional option for failed GB, even with the patients with failed GB, because gastro-gastric sutures some-
several advantages of LSG. Upcoming studies with longer times can create strong adhesions between the inferior aspect
follow-up results will help us to arrive at a more definitive of the liver and the anterior gastric wall in the fundal region
conclusion on the effectiveness of revisional LSG. [15]. Furthermore, GERD is more common in LSG than the
bypass surgery. Therefore, careful attention to these issues is
necessary when performing this procedure and managing the
Pros and Cons patients postoperatively. Last but not least, long-term effec-
tiveness of revisional LSG has not yet been reported.
The following are advantages of LSG. It might be safer than
gastric bypass since the procedure is less technically demand-
ing, does not require several anastomoses, and does not alter Conclusion
the bowel continuity. The operative time and hospital stay
are shorter, and the rates of mortality and morbidity are lower Recently, LSG has been performed as a revisional option for
than those of malabsorptive surgeries [1, 3, 4, 12, 13, 15, failed GB, VBG, and BPD-DS. LSG as a revisional treat-
17–25]. Problems related to small bowel tension do not occur ment modality has been performed most often after failed
after LSG. LSG can be generally done laparoscopically, even gastric banding, as a result of the fact that gastric banding has
in the case of an extremely obese patient. It can preferably be been the most popular bariatric procedure performed world-
used for the patients with conditions that preclude gastric wide. Performing revisional LSG for patients who failed to
bypass. Furthermore, as the procedure preserves the pylorus lose weight after receiving restrictive procedures is reason-
of the stomach, patients are less likely to have dumping syn- able because LSG facilitates weight loss through a nonre-
drome and it maintains access to the biliary tract. There are strictive as well as a restrictive mechanism. Although GB is
so far no reports that have documented malabsorptive prob- currently regarded as the best option for failed GB, advan-
lems or deficiencies of minerals and vitamins other than vita- tages of LSG, such as level of technical ease and relative
min B12. safety, make it a promising alternative. Furthermore, LSG
However, there are also disadvantages. Because the staple can preferably be performed on patients with conditions that
line is long and involves thickened scar tissue where the band preclude gastric bypass. Short-term results support that LSG
17. Sleeve Gastrectomy as a Revisional Procedure 177
is a feasible revisional procedure for failed GB. More studies Surg. 2012;22(2):330–4. PMID: 21866377, Pubmed Central
are required to evaluate its safety and effectiveness in the PMCID: 3266499, Epub 2011/08/26. eng.
14. Gagner M, Rogula T. Laparoscopic reoperative sleeve gastrectomy
long term (Video 1). for poor weight loss after biliopancreatic diversion with duodenal
switch. Obes Surg. 2003;13(4):649–54. PMID: 12935370, Epub
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18
Laparoscopic Gastric Plication
Almino Cardoso Ramos, Lyz Bezerra Silva, Manoel Galvao Neto,
and Josemberg Marins Campos
FIG. 1. Sequence of intraoperative pictures of initial suture line with interrupted nonabsorbable suture (modified from 15).
80 80
60 60
40 40
20 20
0 0
Pre-op 1m(42p) 3m(33p) 6m(20p) 12m(15p) 18m(9p) Pre-op 1m(42p) 3m(33p) 6m(20p) 12m(15p) 18m(09p)
FIG. 3. Mean percentage of total weight loss and excess weight loss with LGCP procedure, in 1, 3, 6, 12, and 18 months (modified from 15).
already described. Brethauer et al. had to reoperate on the that still allowed passage of the endoscope. Despite a feeding
first patient in their series due to a gastric obstruction 2 days tube being placed, symptoms persisted and the patient was
after surgery [8]. reoperated. Laparoscopy revealed two gastrogastric hernias
Tsang et al. report a case of complete gastric obstruction protruding through the imbrication stitch. The stitch was
after LGCP. At laparoscopy, no evidence of gastric necrosis removed, showing viable tissue, allowing for a reimbrica-
or suture line leak/perforation was found. The plication tion, done with an 11 mm gastroscope in place, acting as a
sutures were removed and the stomach unfolded [20]. bougie. Patient was discharged tolerating diet. The probable
In one analysis of early complications in 120 patients sub- causes of this complication were plication done too tight,
mitted to LGCP, the major intraoperative complication was with vomiting creating a high intraluminal pressure, and
bleeding, with hemostasis achieved in all cases without the placement of too widely separated plication sutures. The
need for blood transfusion (n = 13). During postoperative authors recommend that gastric plication should be per-
week 1, nausea, vomiting, sialorrhea, and minor hemateme- formed over a bougie, with sutures placed 1–2 cm apart [23].
sis occurred in 40 %, 25 %, 22 %, and 15 % of patients, A gastric perforation was described in a patient with a
respectively. Symptoms disappeared spontaneously within prior Nissen fundoplication (not taken down during LGCP
4–5 days and patients returned to normal activities 5–7 days procedure), happening immediately after discharge due to
postoperatively. In the first postoperative month, complica- noncompliance with suggested food restrictions. The patient
tions were mainly due to the complete obstruction of the was not able to vomit, likely due to the intact Nissen fundo-
residual gastric pouch by fold edema (5 %), extrinsic com- plication and the substantial increase in intragastric pressure.
pression by intramural gastric hematoma (2 %), or elastic On emergency reoperation, the stitches were found to be bro-
gastric effect of suturing and gastric tube distortion (0.8 %). ken, with gastric leak and peritonitis. In the same study,
Peritonitis, which occurred in one patient on POD 3 from another major complication happened in a patient who had a
gastric leak, was managed laparoscopically by suturing the gastric band and underwent LGCP to correct weight regain.
leak hole and cleaning the whole peritoneal cavity [17]. An abundance of fibrous tissue adherent to the band and
Watkins published a case report of a 29-year-old patient scarring surrounding the band area were observed. The band
who underwent LGCP, with intraoperative EGD showing a was removed and plication performed below the affected
symmetric plication with an appropriately sized lumen. region. Three days following discharge patient returned with
Postoperatively, the patient experienced liquid dysphagia, symptoms of peritonitis. On reoperation an area of partial
consistent with gastric edema. She was discharged home on stomach wall necrosis below the original band site was
the second POD after slight improvement. On POD 3, she found. The authors suggest that previous surgery may limit a
returned to the emergency room with severe abdominal pain patient’s ability to vomit and should be considered a relative
and dyspnea. An abdominal CT showed free intraperitoneal contraindication to subsequent LGCP [10].
air, and the patient suffered respiratory failure. Surgical
exploration revealed significant gastric necrosis in the fun-
dus of the stomach, extending from high on the cardia down LGCP as an Adjuvant of AGB
along the greater curvature to the midbody of the stomach,
with a large perforation. The plication was converted to a The possibility of postoperative weight regain after LGCP
stapled sleeve gastrectomy. Patient was discharged in good still remains debatable, with most studies only showing
conditions. The likely cause of this complication was a lack short-term follow-up. A novel technique developed aiming
of blood flow to the gastric wall due to edematous compres- to increase weight loss and prevent weight regain is the lapa-
sion, similar to the high pressures of abdominal compart- roscopic adjustable gastric banded plication (LAGBP) [24].
ment syndrome. Although the endoscopic appearance of the Twenty-six morbidly obese patients underwent LAGBP,
initial operation was good, it likely became too tight with the preoperative mean BMI of 39.4 kg/m2 (35–50.7). Swedish
edema that ensued [19]. band placement was performed using the standard pars flac-
Hii et al. report an unusual complication after LGCP: gas- cida technique. The band was wrapped around the proximal
trogastric herniation. The patient had an AGB, with unsatis- gastric pouch, and two anterior gastrogastric sutures were
factory weight loss, and after analysis, it was decided to do a placed to prevent slippage. A gastric plication was done
plication below the band. At operation, the peri-band gastro- using a 36 Fr bougie as calibration, with continuous sero-
plasty was undone and the greater curvature mobilized muscular nonabsorbable sutures creating a single-layer pli-
before being plicated, from below the existing band to 6 cm cation along the greater curvature. Mean total operative time
from the pylorus with a single row of interrupted nonabsorb- was 87.3 ± 22.6 min. There were no intraoperative complica-
able monofilament sutures, without the use of a bougie. tions. One patient presented prolonged vomiting, treated
Postoperatively the patient experienced severe nausea and conservatively. Two patients required reoperation, due to
vomiting, treated with antiemetics and dexamethasone to gastrogastric intussusception and tube kinking at the subcu-
minimize edema in the intraluminal fold of stomach. The taneous layer. Mean EWL at 6 months was 41.3 % (n = 18)
symptoms persisted, and an EGD showed a tight plication, and 59.5 % at 12 months (n = 5) [24].
184 A.C. Ramos et al.
Swedish Adjustable Gastric Band in 1-, 3-, and 5-year follow-up treatment of morbid obesity. Ann R Coll Surg Engl. 2012;
cohorts. Surg Obes Relat Dis. 2009;5(5):598–609. 94(2):e76–8.
22. Taha O. Efficacy of laparoscopic greater curvature plication for 24. Huang CK, Lo CH, Shabbir A, Tai CM. Novel bariatric technology:
weight loss and type 2 diabetes: 1-year follow-up. Obes Surg. laparoscopic adjustable gastric banded plication: technique and
2012;22(10):1629–32. preliminary results. Surg Obes Relat Dis. 2012;8(1):41–5.
23. Hii MW, Clarke NE, Hopkins GH. Gastrogastric herniation: an 25. Clinical Issues Committee. ASMBS policy statement on gastric
unusual complication following greater curve plication for the plication. Surg Obes Relat Dis. 2011;7(3):262.
19
Laparoscopic Adjustable Gastric Banding:
Technique
George Fielding
Fig. 4. The tubing is pulled through the tunnel to position the band
in place. Copyright CCF, with permission.
Fig. 2. Exposure of the right crus. Hiatal hernia, if identified,
should be reduced and repaired. Copyright CCF, with permission.
There are two schools of thought about band fixation,
either none at all or to use gastrogastric sutures.
been adequately mobilized off the left crus. The key maneu- Martin Fried, from Prague, has advocated using no
ver is for the surgeon to keep their left hand grasper com- sutures. From January to September 2006, he randomized
pletely horizontal. There is a natural tendency for the tip of 100 patients undergoing banding to group 1 (n = 50, ≥2
the grasper to slide anteriorly, a tendency that should be imbrication sutures) or group 2 (n = 50, no imbrication
avoided. sutures).
The tubing of the band is brought up and grasped, then The 3-year EWL was 55.7 % ± 3.4 % and 58.1 % ± 4.1 %
drawn behind the esophagus (Fig. 4). The band is locked for groups 1 and 2, respectively. The body mass index at 3
(Fig. 5). The end of the tubing should come across in front of years was 34.0 ± 5.8 kg/m2 and 30.3 ± 6.4 kg/m2 (range 1.2–
the liver like a spear, going easily into its socket. The key to 6.2) for groups 1 and 2, respectively (P < 0.01). He found that
locking the band is to do it gently, keeping the parts in the slippage occurred in 1 patient (2.2 %) and 1 patient (2.0 %)
same plane. Any rotation will cause the silicon to lock. and migration in 1 patient (2.2 %) and 1 patient (2.0 %) in
19. Laparoscopic Adjustable Gastric Banding: Technique 189
Fig. 5. The band is locked in place. Copyright CCF, with Fig. 6. Completion of anterior fixation with avoidance of bringing
permission. the gastric wall against the buckle of the band. Copyright CCF, with
permission.
groups 1 and 2, respectively (P = NS). Martin concluded that
the band is effective and safe with and without imbrication (LAGB), sleeve gastrectomy, and Roux-en-Y gastric bypass
sutures. (RYGB) through single incision laparoscopic surgery (SILS)
Paul Super, from Birmingham, England, has taken the or, in the case of gastric procedures, a single working inci-
opposite view. Between April 2003 and June 2007, he per- sion, and another for liver retraction. The obvious benefit is
formed banding in 1,140 consecutive patients. He used a cosmesis, especially if the incision is placed inside the
gastropexy suture in addition to the two routine gastro-gastro umbilicus.
tunnel sutures in all cases. The gastropexy picks up four bites At NYU, we performed a retrospective review of 1,644
of fundus and brings it to the diaphragm near the left crus. LAGBs performed at our institution between November 1,
Excess percent BMI loss in these patients at 36 months was 2008 and November 30, 2010. Of these, 756 were performed
58.9 %. Slippage with urgent readmission occurred in one as SILS bands (46 %) and 888 as non-SILS (54 %) with the
patient (0.08 %) at 5 months. Two partial slippages were standard 4–5 trocar incisions.
noticed at 12 and 18 months, respectively. In our initial experience, we limited SILS to women with
Both these approaches have delivered great results. Our lower BMIs. As our experience grew, we included men and
choice has been to incorporate what Paul Super does by women with higher BMIs. We excluded patients with any
using a 2-0 Prolene to do a gastropexy, then another to do a incision at the umbilicus. A relative exclusion was a long
running gastrogastric suture over the band, stopping 1 cm torso, where the distance from xiphoid process to umbilicus
from the buckle (Fig. 6). I then add another gastropexy below was greater than 26 cm, as it would impact on the ease of
the band, the Patterson stitch, devised by Emma Patterson, of instruments reaching the diaphragm with any mobility. We
Portland, Oregon. It’s definitely belt and braces, but if it still prefer standard technique in men with BMI over 50 due
helps reduce slip, it’s worth it. to the difficulty retracting omentum and peri-gastric fat.
The tubing is then brought out through the 15 mm port When starting to use SILS, we did it in a stepwise fashion,
and attached to the port. A small disk of mesh is sutured to gradually removing ports and moving to the umbilical
the back of the port. The port is then placed on the deep fas- approach over at least 20 cases. This allowed us to develop
cia, where the mesh sticks and fixes the port in position. some facility with the crossed-hands and limited angulation
The wounds are closed with Monocryl and the patient technique required for SILS.
sent to the recovery room, ready to start their weight loss Our SILS technique uses a single periumbilical 3–4 cm
journey. incision with placement of a 12 mm trocar via the Hassan
technique under direct vision. The band is placed through a
1 cm incision at the base of the umbilical stalk. This is
Single Incision Band Surgery exactly the same incision we have used for thousands of lap-
aroscopic general surgery operations. The band is inserted
Surgeons have recently been performing many surgical pro- into the abdomen prior to placement of the 12 mm trocar
cedures, including appendectomy, cholecystectomy, fundo- through the 1 cm umbilical defect. Then, two 5 mm ports are
plication, Heller myotomy, distal gastrectomy, segmental placed to the right and left of the 12 mm trocar to minimize
colon resection, laparoscopic adjustable gastric band clashing. These trocars are staggered in length: on the right
190 G. Fielding
side a long trocar and the left side a short one, flush with the laparoscopic operations for over 20 years, and there is
skin. Liver retraction is obtained either via the same infraum- minimal risk of umbilical hernia. It needs to be 1 cm to allow
bilical incision (Genzyme liver retractor) or via a subxiphoid nontraumatic insertion of the lap band. This is in contrast to
percutaneous method (Nathanson liver retractor). the incision size needed for all available SILS ports.
The band is placed via the standard pars flaccida tech- The key with SILS is to become comfortable with
nique. Once all ports are inserted, a left-handed grasper is crossed-hands operating and operating with hands almost in
used to retract the greater curvature, exposing the angle of parallel. SILS is definitely more difficult than standard lapa-
His. Electrocautery, held in the right hand, is used to divide roscopy, and many surgeons will think it’s not worth the
the phrenoesophageal ligament and mobilize the angle of extra time and trouble. That being said, when you have
His, exposing the left crus. If a hiatal hernia or dimple in the developed those skills, it’s very satisfying to be able to offer
crura is appreciated, the hiatus is fully dissected and the her- a patient an operation with scars that are almost invisible at
nia is repaired. The gastrohepatic ligament is then divided, 3 months. Given that the only benefit of this technique
and the right crus exposed. A flexible grasper held in the seems to be cosmetic, we prefer to hide the incision in the
right hand is then curved and inserted at the base of the right umbilical crease, rather than place it in a more visible supe-
crus into a retrogastric tunnel, exiting at the angle of His. The rior position. The addition of a tiny xiphoid incision for the
band is pulled through, locked, and fixed using a 2-0 nonab- Nathanson liver retractor barely diminishes this benefit,
sorbable gastrogastric running plication suture. Finally, the especially in men with body hair.
tubing is pulled out through the left-sided 5 mm trocar. The It must seem strange that a SILS operation can be
fascial defect is closed using a 0 Vicryl suture in a figure-of- quicker than a 4- or 5-port technique. We gradually accu-
eight manner and the port is attached and fixed to the anterior mulated our skill set, such that by the second year, we were
fascia, to the right of the umbilicus. able to perform these surgeries in a very timely manner.
The mean operating time of an SILS band was The lower time probably reflects having to place fewer
44.7 ± 20 min (12–179 min), compared to 51.1 ± 19.6 min for ports and close fewer wounds. We have no explanation as to
non-SILS bands (15–147 min). This difference was found to why the SILS group did better with weight loss. One pos-
be statistically significant (P < 0.001). Over the 2-year fol- sible, though very nebulous, idea is that they were more
low-up, 37 patients (5 %) in the SILS group and 22 patients motivated and enthusiastic in their follow-up after they saw
(3.7 %) in the non-SILS patients had reoperations for port their good cosmetic outcome.
complications and band slip. One SILS patient developed an SILS is a step forward for patients if they are worried
umbilical hernia. about their scars. The main benefit is that the total experience
Can SILS LAGB be done? Certainly. The data in our for the patient is better. This is especially so for women who
study confirm that the two techniques are equitable in terms don’t have body hair to hide incisions. This is important after
of operating time, complications, and outcomes. bariatric surgery and it removes the need to explain incisions
Should it be done? Yes, but only if the surgeon finds the until patients are comfortable discussing their surgery,
technique interesting, is prepared to carefully accumulate the enhancing their privacy and comfort zone. This cosmetic
necessary skill set, and feels that the cosmetic benefit is worth benefit is also very valuable for African-Americans who are
the extra trouble and difficulty. Triangulation of instruments more prone to keloid scarring.
is the key to an easy day in the operating room doing laparo- Many patients comment favorably on the incision at fol-
scopic surgery. It becomes second nature and governs all port low-up, feeling that it has enhanced their overall experience.
positions. SILS does away with triangulation. The jump from The joy of laparoscopic surgery is that we help people with-
5-port LAGB placement to one or two ports is challenging. To out hurting them too much. Now we can do it without leaving
this end, we recommend a staged approach to starting SILS them easily visible incisions. Using what we have learned
LAGB surgery. This explains why we have so many non- from SILS bands, we have extended our experience to
SILS cases over the time period, most from the first year. Our include Roux-en-Y gastric bypass, sleeve gastrectomy,
practice now is to perform SILS in the majority of our cases. Heller myotomy, and Nissen fundoplication.
In an attempt to maximize triangulation, our preference is We have found the SILS band placement is a valid tech-
to use individual ports in the same incision. We have tried all nique, with outcomes at least as good as those with standard
available SILS port systems and found that they all restrict LAGB. If time is taken to gradually accumulate the different
movement much more than do individual ports. It is also nice skill sets required to operate this way, by starting in a staged
to use one’s normal ports and instruments. This technique fashion, and excluding patients with a very long torso, or
also reduces fascial incision size. The incision we use is 1 cm males with a high BMI, there would seem to be a benefit to
at the base of the umbilical stalk. We don’t incise fascia at all. the patients, in an improved overall experience. Its difficulty,
We have used the same incision for thousands of general though, should not be underestimated.
19. Laparoscopic Adjustable Gastric Banding: Technique 191
Introduction with the pars flaccida approach than the perigastric approach
along with a shorter operating time [10].
The laparoscopic adjustable gastric banding (LAGB) proce- As the understanding of the mechanism of action of the
dure involves the placement of an adjustable silicone band LAGB has improved, so have aftercare programs. An opti-
around the very upper part of the stomach immediately mal program will provide regular follow-up focusing on
below the gastroesophageal junction. The level of restriction educating patients about correct food choices, small serv-
can be adjusted by adding or removing saline from the band ing sizes, and emphasizing the importance of eating slowly
via a subcutaneous port fixed to the anterior rectus sheath. and chewing the food well. Band adjustments should focus
LAGB is the safest of the bariatric procedures [1, 2] with on the induction of early and prolonged satiety and when
minimal mortality and morbidity. It can be performed as an this is achieved, weight loss is optimal. Hunger and food
overnight stay or same-day procedure in even the largest of seeking behavior suggests that the band is under-filled.
patients. Symptoms of reflux and an inability to eat solid food sug-
The mechanism of action of the LAGB is the induction of gest the band is over-adjusted and that fluid should be
early satiation (food satisfaction) with a small meal followed removed [3].
by a longer period of satiety (between-meal lack of hunger). Outcomes of LAGB surgery can be measured by change
Studies have shown that delay in gastric emptying is not the in weight, comorbidity, quality of life, long-term survival,
main mechanism of action and there is a lack of correlation and cost-effectiveness. The need for revisional surgery is
between over-restriction and satiety [3]. Similarly, the band another important outcome, and this must be considered in
should not physically limit significantly food transit and the context of the safety of the revision as well as the effect
there should be negligible food found above the band after a of the revision on weight, health, and well-being.
meal if the band is correctly adjusted [4]. A range of hor-
mones including insulin, leptin, ghrelin, pancreatic polypep-
tide, and peptide YY do not play a significant role in LAGB Weight Loss Outcomes
function [5, 6]. It is hypothesized that the mechanical effects
of the band and the passage of food bolus through this area Weight loss after gastric banding is typically very steady at
of band resistance can generate myoenteric pressure signals 0.5–1 kg/week. This means that weight loss progresses over
[7]. Signals from these receptors may be important in both a 2- to 3-year period and then stabilizes, usually in the range
meal termination and satisfaction, and provide an important of 40–55 % EWL. Medium- and long-term (4- to 15-year
sense of well-being, although the functional roles of these follow-up) outcomes have been reported by individual series
receptors remain poorly understood [8]. showing a great variation in weight loss results from 33 to
Ongoing improvements in band placement and postopera- 70 % EWL [11, 12] (Tables 1 and 2).
tive management have reduced morbidity as well as short- The weight loss following LAGB is gradual, 0.5–1 kg per
term and long-term complications. There have been a number week, and optimal outcomes require lifelong follow-up [13].
of changes to the procedure of LAGB placement and after- Follow-up is more intensive in the first year, with most
care since the original description. The surgical technique patients requiring 6–8 visits [14, 15]. After the first year,
has been modified, and the majority of LAGB are now placed most patients only require six monthly or annual visits. This
by the pars flaccida approach rather than the perigastric model of care fits with the management of obesity as a
approach [9]. A randomized controlled trial comparing these chronic disease, and has been shown to be cost-effective
techniques demonstrated fewer long-term complications [16–18].
There have been two prospective multicenter Food and There have been two prospective randomized clinical
Drug Administration-monitored clinical trials in the United studies comparing gastric banding with the gastric bypass.
States. The Lap-Band trial A [19] recruited patients from 1995 Angrisani [21] randomized 51 patients and allocated them to
to 1998 in eight centers; 259 out of 292 patients had the band undergo either banding (n = 27) or gastric bypass (n = 24). At
implanted laparoscopically by perigastric dissection. The aver- 5 years after the procedure, the band patients had an average
age EWL was 26.5 % at 6 months, 34.5 % at 12 months, 37.8 % % EWL of 47.5 % vs. 66.6 % for the gastric bypass group. In
at 24 months, and 36.2 % at 36 months. The very high inci- a similar study, Nguyen [22] randomized and followed 86
dence of gastric prolapse and slippages was attributed to the patients with gastric banding and 111 with gastric bypass.
learning curve, as most of the surgeons involved were inexpe- The % EWL at 4 years was 45 % vs. 68 %, respectively.
rienced laparoscopic surgeons, as well as the use of the perigas- There have been four randomized controlled trials assess-
tric dissection rather than pars flaccida. There was also a lack of ing the effectiveness of LAGB with conservative weight loss
effective follow-up, with an average of only 1.2 adjustments in programs, with all showing substantially better weight loss
the first year. The majority of patients were adjusted by radiolo- and comorbidity resolution in the surgical arm [23–26]. In
gist based on a contrast swallow evaluation rather than tailoring the initial trial, patients with a body mass index between 30
the adjustment to the patient’s sensation of satiety. There was and 40 kg/m2 the gastric banding group showed 87 % EWL
no good band-specific patient education program. compared with the conservative arm 22 % EWL at 2 years of
The Swedish Band clinical study [20] recruited 276 patients follow-up [23].
in 12 centers in 2003. All patients were implanted laparoscopi- There have been several meta-analyses and systematic
cally by pars flaccida technique. This trial included centers reviews of the literature that included a significant number of
with both large and no experience with gastric banding man- gastric band patients. Buchwald et al. [27] published a large
agement. The mean % EWL at 3 years was 41.1 %. bariatric surgery meta-analysis and systematic review that
included 136 studies with 3,873 LAGB patients with the
majority of the studies having 2 years or less follow-up
TABLE 1. Gastric banding short- and medium-term weight loss reported. The mean EWL was 47.5 %. O’Brien et al. [13]
(1–8 years) extracted reports out of the English literature with more than
% Excess weight loss 100 patients and at least 3-year follow-up. 4,456 band patients
were analyzed, and EWL at 1, 3, 5, and 8 years was 42.6 %,
Study 1 year 2 years 3 years 4 years 5 years 8 years
57.5 %, 54 %, and 59.3 %, respectively. Finally, Cunneen
FDA trials
Lap-Band Aa [19] 36
et al. [28] published a systematic review comparing data
(1995–2001) available on the two bands: a total of 129 studies (33 with
Swedish Band [20] 41 Swedish band data and 104 with Lap-Band data). The 3-year
(2003–2006) mean Swedish and Lap-Band EWL was 56.4 % and 50.2 %,
Randomized studies respectively, without statistically significant difference.
Angrisani et al. [21] 47
Nguyen et al. [22] 45
There have been seven case series reporting long-term
O’Brien et al.b [23] 87 (≥10 year) outcomes [29–34]. The weighted mean at maxi-
Dixon et al.b [25] 62 mum follow-up was 51.7 % EWL (Table 2) [12].
O’Brien et al. [24] 73
Dixon et al. [26] 40
Systematic reviews Comorbidity and Quality of Life
Buchwald et al. [27] 47
O’Brien et al. [13] 43 57 54 59 Outcomes
Cunneen et al. [28] 50–56
alcoholic fatty liver disease, sleep disturbance including per hour in the conservative group and 25.5 events per hour
obstructive sleep apnea and daytime sleepiness, ovulatory in the surgical group [26].
function and fertility in women with polycystic ovary syn-
drome, reflux disease, joint disease, hypertension, and
depression among others. The degree of resolution or Quality of Life
improvement is variable depending on several factors includ-
ing percentage of weight loss, severity, and duration of the One large prospective study evaluated QOL after LAGB sur-
disease [35, 36]. gery using the Medical Outcome Study Short Form-36 (SF-
The improvement in diabetes following weight loss after 36) health survey, which includes both physical and
LAGB is related to the combined effects of improvement in psychosocial dynamics [40]. Among the 459 patients, all of
insulin sensitivity and pancreatic beta-cell function associ- these areas significantly improved after surgery. The patients’
ated to weight loss and decreased caloric intake [37]. As QOL within 1 year of LAGB was closer to that of normal
beta-cell function deteriorates progressively over time in community values, and this finding was sustained through-
those with type 2 diabetes, early weight loss intervention out the 4 years of the study. Similarly in QOL measured as
should therefore be a central part of initial therapy in severely part of an RCT comparing LAGB to conservative weight
obese subjects who develop type 2 diabetes [38]. loss, major benefits were seen across all domains [23].
In a randomized controlled trial of LAGB versus optimal
conventional therapy in recently diagnosed (<2 years) type 2
diabetes, a clear benefit was shown for the surgical approach Long-Term Mortality Outcomes
[25]. There was remission of diabetes (normal serum glu-
cose, HbA1c < 6.2 % while taking no hypoglycemic therapy) There are several studies that have examined long-term mor-
in 73 % of the surgical group and 13 % of the conventional tality in patients undergoing bariatric surgery, including
group. There were no serious adverse events in either group. LAGB, and comparing this to matched community controls.
A large series of 102 type 2 diabetic patients with an aver- The range of reduction of medium-term mortality is 64–72 %
age BMI 46.3 kg/m2 documented 40 % resolution (no medi- giving a combined reduction in medium-term mortality of
cation requirement, with HbA1c <6 and/or glucose <100 mg/ approximately 50 % [44].
dL) at 5 years follow-up after LAGB. The mean duration of An Australian group of 966 patients achieved a mean
the diabetes before surgery was 6.5 years [39]. weight loss of 22.8 % 2 years after LAGB and, when com-
There is evidence of a reduction in both systolic and dia- pared with a matched community cohort at a mean of 5 years
stolic blood pressure (BP) following weight loss in associa- follow-up, had an adjusted 72 % lower risk of death [45].
tion with LAGB [40]. The outcomes of 147 consecutive Similarly, an evaluation of 821 LAGB patients in Italy docu-
hypertensive patients at 12 months after LAGB demonstrated mented a 64 % lower risk of death 5 years post-LAGB [46].
that 80 patients (55 %) had resolution of the problem (i.e.,
normal BP and taking no antihypertensive therapy), 45
patients (31 %) were improved (less therapy and easier con- Cost-Effectiveness Outcomes
trol), and 22 patients (15 %) were unchanged [35]. In a study
of 189 hypertensive patients treated by LAGB [41], there was There are a number of studies that have demonstrated that over
resolution of hypertension (normal pressures, off therapy) in time LAGB surgery is not only cost-effective, but is delivering
60 % at 12 months and 74 % at 2 years. The fall in blood pres- direct health cost savings [16, 17, 47]. In a recent study using
sure is sustained to at least 4 years after surgery [42]. US health care claims data from over 7,000 LAGB patients
There are major improvements in sleep quality, excessive compared with a propensity score matched control group with
daytime sleepiness, snoring, nocturnal choking, and observed a BMI greater than 35 kg/m2, there were modest sustained sav-
obstructive sleep apnea with weight loss following LAGB ings in the LAGB group, but continuing cost increases in the
surgery. Obstructive sleep apnea and other sleep disturbances control group. The net costs of banding had been reduced to
have been studied in 313 patients prior to LAGB and repeated zero in 4 years after band placement. In a subgroup with type
at one year after operation in 123 of the patients [43]. There 2 diabetes having LAGB surgery, net costs reduced to zero in
was a high prevalence of significantly disturbed sleep in both just over 2 years [48]. Similar analyses in Europe have also
men (59 %) and women (45 %). Observed sleep apnea was demonstrated cost savings following band placement [49].
decreased from 33 to 2 %, habitual snoring from 82 to 14 %,
abnormal daytime sleepiness from 39 to 4 %, and poor sleep
quality from 39 to 2 %. However, in a recent randomized Revisional Surgery
controlled trial comparing LAGB to conservative weight
loss, despite a marked difference in weight loss, the change The long-term need for revisional procedures following
in the apnea-hypoxia index (AHI) was not statistically sig- LAGB is 8–60 % [12]. In a published series of 3,227 patients
nificantly different between groups, reducing by 14 events who had undergone LAGB from 1994 to 2011 [12], there
196 J. Ponce and W.A. Brown
was 47.1 % EWL at 15 years (N = 54; 95 % CI = 8.3) and slippage. No gastro-gastric imbrication sutures are placed.
62 % EWL at 16 years (N = 14; 95 % CI = 13.6). Revisional Slow and very gradual adjustments with careful monitor-
procedures were performed for proximal enlargement ing to avoid vomiting may help to prevent band
(26 %), erosion (3.4 %), and port and tubing problems displacement.
(21 %). The band was explanted in 5.6 %. The need for revi- Two randomized control studies comparing this technique
sion decreased as the technique evolved, with 40 % revision with the traditional placement with imbrication plication
rate for proximal gastric enlargements in the first 10 years, sutures have been published with opposite results. In the first
reducing to 6.4 % in the past 5 years. The revision group one, Fried et al. [50] compared 50 patients in each group show-
showed a similar weight loss to the overall group beyond 10 ing no difference in band slippages or erosions at 3-year follow-
years. There was no perioperative mortality for the primary up. In the second one, Lazzati et al. [51] studies 81 patients
placement or for any revisional procedures. divided into two groups and early termination of the study
was documented secondary to three early slippages in the non-
plication group. This technique needs to be studied further and
Impact of Different Methods it is not well accepted within the bariatric surgery community.
of Band Placement
21. Angrisani L, Lorenzo M, Borrelli V. Laparoscopic adjustable gas- 37. Dixon JB, Dixon AF, O’Brien PE. Improvements in insulin sensi-
tric banding versus Roux-en-Y gastric bypass: 5-year results of a tivity and beta-cell function (HOMA) with weight loss in the
prospective randomized trial. Surg Obes Relat Dis. 2007;3:127–32; severely obese. Diabet Med. 2003;20:127–34.
discussion 32–3. 38. Buchwald H, Estok R, Fahrbach K, et al. Weight and type 2 diabe-
22. Nguyen NT, Slone JA, Nguyen XM, Hartman JS, Hoyt DB. A pro- tes after bariatric surgery: systematic review and meta-analysis. Am
spective randomized trial of laparoscopic gastric bypass versus laparo- J Med. 2009;122:248–56.
scopic adjustable gastric banding for the treatment of morbid obesity: 39. Sultan S, Gupta D, Parikh M, et al. Five-year outcomes of patients
outcomes, quality of life, and costs. Ann Surg. 2009;250:631–41. with type 2 diabetes who underwent laparoscopic adjustable gastric
23. O’Brien P, Dixon J, Laurie C, et al. Treatment of mild to moderate banding. Surg Obes Relat Dis. 2010;6:373–6.
obesity with laparoscopic adjustable gastric banding or an intensive 40. Dixon JB, Dixon ME, O’Brien PE. Quality of life after lap-band
medical program: a randomized trial. Ann Intern Med. 2006; placement: influence of time, weight loss, and comorbidities. Obes
144:625–33. Res. 2001;9:713–21.
24. O’Brien PE, Sawyer SM, Laurie C, et al. Laparoscopic adjustable 41. Ponce J, Haynes B, Paynter S, et al. Effect of Lap-Band-induced
gastric banding in severely obese adolescents: a randomized trial. weight loss on type 2 diabetes mellitus and hypertension. Obes
JAMA. 2010;303:519–26. Surg. 2004;14:1335–42.
25. Dixon JB, O’Brien PE, Playfair J, et al. Adjustable gastric banding 42. O’Brien PE, Brown WA, Dixon JB. Obesity, weight loss and bariat-
and conventional therapy for type 2 diabetes: a randomized con- ric surgery. Med J Aust. 2005;183:310–4.
trolled trial. JAMA. 2008;299:316–23. 43. Dixon JB, Schachter LM, O’Brien PE. Sleep disturbance and obe-
26. Dixon JB, Schachter LM, O’Brien PE, et al. Surgical vs conven- sity: changes following surgically induced weight loss. Arch Intern
tional therapy for weight loss treatment of obstructive sleep apnea: Med. 2001;161:102–6.
a randomized controlled trial. JAMA. 2012;308:1142–9. 44. Dixon J. Survival advantage with bariatric surgery: report from the
27. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a 10th international congress on obesity. Surg Obes Relat Dis. 2006;
systematic review and meta-analysis. JAMA. 2004;292:1724–37. 2(6):585–6.
28. Cunneen SA, Phillips E, Fielding G, et al. Studies of Swedish 45. Peeters A, O’Brien PE, Laurie C, et al. Substantial intentional
adjustable gastric band and Lap-Band: systematic review and meta- weight loss and mortality in the severely obese. Ann Surg. 2007;
analysis. Surg Obes Relat Dis. 2008;4:174–85. 246:1028–33.
29. Favretti F, Segato G, Ashton D, et al. Laparoscopic adjustable gas- 46. Busetto L, Mirabelli D, Petroni ML, et al. Comparative long-term
tric banding in 1,791 consecutive obese patients: 12-year results. mortality after laparoscopic adjustable gastric banding versus non-
Obes Surg. 2007;17:168–75. surgical controls. Surg Obes Relat Dis. 2007;3:496–502.
30. Himpens J, Cadiere GB, Bazi M, Vouche M, Cadiere B, Dapri 47. Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE,
G. Long-term outcomes of laparoscopic adjustable gastric banding. Buessing M. A study on the economic impact of bariatric surgery.
Arch Surg. 2011;146:802–7. Am J Manag Care. 2008;14:589–96.
31. Lanthaler M, Aigner F, Kinzl J, Sieb M, Cakar-Beck F, Nehoda 48. Finkelstein EA, Allaire BT, Burgess SM, Hale BC. Financial impli-
H. Long-term results and complications following adjustable gas- cations of coverage for laparoscopic adjustable gastric banding.
tric banding. Obes Surg. 2010;20:1078–85. Surg Obes Relat Dis. 2011;7:295–303.
32. Miller K, Pump A, Hell E. Vertical banded gastroplasty versus 49. Anselmino M, Bammer T, Fernandez Cebrian JM, Daoud F,
adjustable gastric banding: prospective long-term follow-up study. Romagnoli G, Torres A. Cost-effectiveness and budget impact of
Surg Obes Relat Dis. 2007;3:84–90. obesity surgery in patients with type 2 diabetes in three European
33. Naef M, Mouton WG, Naef U, Kummer O, Muggli B, Wagner countries(II). Obes Surg. 2009;19:1542–9.
HE. Graft survival and complications after laparoscopic gastric 50. Fried M, Dolezalova K, Sramkova P. Adjustable gastric banding
banding for morbid obesity—lessons learned from a 12-year expe- outcomes with and without gastrogastric imbrication sutures: a ran-
rience. Obes Surg. 2010;20:1206–14. domized controlled trial. Surg Obes Relat Dis. 2011;7:23–31.
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21
Laparoscopic Adjustable Gastric Banding:
Long-Term Management
Christine Ren Fielding
Immediate Postoperative Management 48 h. These patients can usually swallow their saliva. It is
advised to keep the patient NPO with intravenous hydration
Postoperative care after LAGB is usually straightforward. and anti-inflammatory medication (i.e., ketorolac, steroids).
Most patients are observed in a regular ward room. Patients In contrast, complete obstruction on the film is always associ-
with documented or suspected obstructive sleep apnea may ated with inability to swallow saliva, and these patients do not
require additional monitoring or a continuous positive air- recover with conservative measures. They must return to the
way pressure (CPAP) device. Prophylaxis for thromboembo- operating room for laparoscopic revision. Most commonly,
lism may include sequential compression devices, cutting the gastrogastric sutures, manipulating the band, and
compression stockings, and/or anticoagulation therapy. Early removing more perigastric fat give a good result. Placement
ambulation is always encouraged. of a larger band (LAPBAND™ APL) may also be helpful in
Early postoperative retching and vomiting by the patient these circumstances. In addition, an unrecognized hiatal her-
should be avoided. Just as in Nissen fundoplication, acute nia may result in a greater amount of gastric tissue incorpo-
vomiting after surgery can result in an acute gastric prolapse rated into the band, leading to obstruction. In this case, the
with band slip. Anterior gastrogastric suture disruption may hernia must be mobilized and reduced, the crura repaired, and
be a potential sequela. Aggressive antiemetic therapy should the band placed in the proper position; otherwise the patient
be instituted in the operating room. An intraoperative intra- will be unable to tolerate adjustments in the future.
venous cocktail of ondansetron (Zofran)/metoclopramide Patients are seen in the office 10–14 days after surgery for
(Reglan)/ketorolac (Toradol)/acetaminophen is administered their first follow-up, to check their wounds and reiterate
prior to extubation. An additional intravenous antiemetic is dietary guidelines.
given liberally during the first 24 h. Both the patient and the
nursing staff are instructed on the importance of emesis pre-
vention after surgery. Pain management involves subcutane- Postoperative Dietary Guidelines
ous injection of skin incisions with 0.25 % Marcaine.
Intravenous ketorolac and acetaminophen are administered Due to the possible correlation between early vomiting and
as a standing order every 6 h, with subcutaneous or oral nar- gastric prolapse [1, 2], patients are placed on a diet that pro-
cotic for breakthrough pain. gresses from liquids to solids over the first 6 weeks after
Patients may be kept in the hospital overnight or discharged surgery. For weeks 1 and 2 the diet is thin liquids—any fluid
the same day, depending on their medical status, pain control, that is thin enough to go through a straw. For weeks 3 and 4
and presence or absence of nausea. A postoperative esopha- the diet is pureed foods—foods that do not need to be
gram documents normal, rapid esophageal emptying, no chewed, as if the patient did not have teeth. For weeks 5 and
extravasation of contrast, and adequate band placement, lying 6 the diet is soft and flaky solid foods and crunchy foods,
in an 8 o’clock to 2 o’clock position (Fig. 1). In addition, it specifically excluding dry/tough chicken, overcooked steak,
provides the surgeon with a baseline esophagram to document and doughy bread, which tend to form a large bolus that
band positioning for comparison with future studies. cannot traverse through the narrow band stoma. Patients are
Gastrografin is used in case a perforation is found. A gastric counseled to eat very slowly, chew their food thoroughly,
pouch should not be seen since the band is not filled. and to avoid eating and drinking simultaneously, as to not
If the esophagram shows delayed emptying, the normal outpace the emptying of the food through their band, which
clinical progression is for increased swelling to occur over if occurs will result in regurgitation or vomiting.
Band Adjustments
The mechanisms by which LAGB works include decreas-
ing appetite, creating satiety with a smaller amount of food,
and behavior modification [3]. This is a direct function of a
small gastric pouch (10–15 mL) and a narrow stomal open-
ing that slows gastric emptying (12 mm). The LAGB acts in
this capacity through external constriction of the stomach,
which is gradually tightened in accordance with each indi-
vidual’s needs. If no constriction is created, no satiety is
reached, and no weight is lost. Therefore, weight loss after
LAGB is contingent on band adjustment. The band is use-
less if adjustments are not performed. Both patient and sur-
geon must understand this; otherwise weight loss will be
suboptimal, the operation ineffective, and the surgery a
wasted effort.
The band is left empty when initially placed. The first
adjustment is performed 6 weeks postoperatively. This
allows time for a capsule to form around the band and makes
its position around the stomach more secure. Adjustments
should be made while patients are eating solid food. The
band is meant to work with solid food, specifically to main-
FIG. 1. NORMAL POSTOPERATIVE ESOPHAGRAM. tain stretching of the gastric pouch to create an early sense of
satiety. An appropriately adjusted band also acts as an appe-
tite suppressant. A sense of hunger, increased appetite, and
Nutritional deficiencies have not been reported after LAGB, increased snacking are signs that the band is not appropri-
perhaps because the operation is purely restrictive. However, ately tightened. Soft and liquid foods empty faster than sol-
patients are encouraged to take a fortified daily chewable or ids, and thus more can be ingested before the feeling of
liquid multivitamin. More importantly, patients should already satiety is reached. Thus, a band that is too tight will make
have the nutritional knowledge and skills to make healthy food solid food ingestion difficult, but easy for creamy sugary liq-
choices before any bariatric surgery, including LAGB. Patients uids. This is an example of maladaptive behavior and may
are told that high-calorie liquids and soft foods, such as choco- necessitate band loosening.
late and ice cream, are physically easy to eat but will lead to There are two general strategies to band adjustment: in-
weight regain or weight loss failure. office adjustment using a clinical algorithm and radio-
The most important dietary counseling that LAGB patients graphic adjustment under fluoroscopic guidance. Each has
need is how to eat—slowly and chewing thoroughly. They its advantages and disadvantages. In-office adjustments are
must learn how to put the fork down between bites. Most quick and inexpensive, but require frequent visits due to
importantly, they must recognize when they are full, and then inaccuracy of the adjustment. Radiographic adjustments
stop eating. This is a new skill for morbidly obese patients. are more cumbersome and expensive, but require fewer
Even an extra bite will make them regurgitate. Counseling on visits due to the more accurate adjustment visualized under
social eating and food choices is greatly appreciated by fluoroscopy.
patients, since this is usually their greatest source of anxiety, The maximum recommended amount of saline that a
particularly in young adults and teenagers as they start dating. gastric band accommodates depends on the band type. The
Diurnal variation in esophageal motility may play an impor- Lap-Band System™ (Allergan, Irvine, CA) comes in five
tant role in dysphagia and appears to vary according to time of different types of bands which hold various maximum rec-
day and amount of emotional stress. Dysphagia is common ommended volumes as shown in Table 1. Similarly, the
when patients are eating in a stressful situation, mostly because Realize™ Band System (Ethicon Endosurgery, Cincinnati,
they are typically distracted and have eaten quickly without OH) comes in two types and sizes. In addition to maximum
chewing. They are counseled to have a yogurt, soup, or a pro- recommended volume capacity, Table 1 shows the typical
tein drink during stressful times. Breakfast is sometimes dif- average volume range where a patient would eventually be
ficult; therefore a liquid meal is encouraged. when optimally adjusted.
21. Laparoscopic Adjustable Gastric Banding: Long-Term Management 201
Office-Based Adjustment
FIG. 2. IN-OFFICE PERCUTANEOUS ACCESS OF PORT (SALINE-FILLED SYRINGE
There are two aspects to band adjustments: locating the ATTACHED TO NON-CORING NEEDLE).
access port and determining the volume of saline to be
used. When the procedure is performed in the office, the
port is located by palpation. The band is adjusted by percu-
taneously accessing the port with a non-coring needle and
subsequently injecting sterile saline, which tightens the
band. Withdrawal of saline results in band loosening with
subsequent decreased restriction. The skin is cleansed with
alcohol, and a non-coring needle on a pre-filled syringe
filled with the desired amount of saline is introduced
through the skin into the access port (Fig. 2). Successful
port access is confirmed by feeling the needle hit the metal
base of the access port and having free reflux of saline back
into the syringe. Use of any needle other than a non-coring
needle may result in damage to the access port septum and
subsequent leak of saline. Local anesthetic is unnecessary,
as it is more painful than the needle itself. Having the
patient lie on the examination table and lift his or her head
up off the examination table while tensing the abdominal
FIG. 3. X-RAY USED TO FIND ACCESS PORT.
muscles can assist in feeling the port. Sometimes having
the patient stand up will use gravity to drop the pannus and
make the port more apparent. The decision to tighten, loosen, or leave the band alone is
Locating the port can be challenging in patients who have based on three variables: hunger, weight loss, and restriction. A
a large amount of subcutaneous fat, particularly women and properly adjusted band induces the lack of hunger and appetite
individuals with a body mass index (BMI) greater than 60. suppression. It should also induce a prolonged sense of satiety
An extra-long needle may be necessary to reach the port. An that lasts longer than 2 h after a meal. Weight loss should be
X-ray can be obtained to localize and mark the port (Fig. 3). constant and gradual over the course of 18–36 months.
The learning curve for port localization using palpation is The goal rate of weight loss is 6–10 lb/month. Lack of
surprisingly long and may take up to 100 cases. Our experi- weight loss reflects too large a portion intake, and subopti-
ence has shown that on review of our first 200 consecutive mal satiety and hunger control, indicating the band needs
gastric band patients (69 % female, mean BMI 48.7), 660 tightening. The Green Zone chart (Fig. 4) [5] is an invaluable
adjustments were performed in the office (74 % by a nurse visual chart which educates the patient on the role of the
practitioner and 26 % by a physician) [4]. Twenty-eight band as a tool towards weight loss, and involves the patient
(4.2 %) adjustments were unsuccessfully performed by a in the decision-making process towards band adjustment. As
nurse practitioner and required physician assistance. Twelve shown, the Yellow Zone describes the patient as hungry
of those attempts (1.8 %) on nine patients required radio- between meals, eating large portions and not losing weight.
graphic guidance to localize the access port. All nine patients The patient in the Yellow Zone requires an adjustment to
were women who were in the first 75 patients adjusted. move him/her towards the Green Zone which represents the
202 C.R. Fielding
optimal situation: good appetite control, satiety with small should be present in the syringe, and only a small amount of
portions, and weight loss. A patient in the Green Zone saline should be allowed to reflux into the syringe in order to
requires no band tightening or loosening. However if a confirm access into the port. Therefore, complete aspiration
patient experiences night cough, frequent regurgitation of all saline in the band system should be reserved for times
despite eating very slowly, and subsequent maladaptive eat- when a device leak is suspected.
ing of high-calorie soft foods, then he/she is in the Red Zone After each adjustment, patients drink a cup of water to
and needs to have the band loosened. Having a large framed ensure that they do not have outlet obstruction. Any gurgling
poster of the Green Zone in the exam room is very helpful noises will likely lead to obstruction in the next 1–3 days.
and an excellent investment towards patient education and Interestingly, we have found that the band gets slightly
care. It is also important for both clinician and patient to tighter 1–2 days after an adjustment. Therefore, we have our
understand that the band can be adjusted at any time through- patients stay on liquids for 2 days, pureed foods for 2 days,
out the lifetime of the banded patient, and is not limited to a and then solid foods by the fifth day after adjustment.
certain amount of time since surgery. For example, if a At NYU, we perform our adjustments in the office and
patient has been in the Green Zone for 5 years, but progres- see our patients every 4–6 weeks for weight and appetite
sively develops increased hunger, he/she can have an adjust- evaluation. The program is structured for patients to return
ment in order to return to the Green Zone. for regular weigh-ins, progress evaluation, adjustments,
The amount of saline to inject when the patient is in the nutritional reinforcement, and most importantly, behavioral
Yellow Zone is based on experience based on trial and error. counseling. We have found that frequent patient follow-up
In order to provide a template for new clinicians, a clinical has a significant impact on percent excess weight loss (%
algorithm was designed at NYU and is used as a basic gen- EWL) achieved in just 1 year. Patients who return more
eral guide to use for the 9.75 cm LAPBAND SYSTEM than six times in the first year after LAGB lose an average
(Allergan, Irvine, CA) (Table 1) [6] which holds a maximum of 50 % EWL, as compared with those who return six times
recommended capacity of 4 mL. With experience, the clini- or less, who lose 42 % EWL [6]. The average number of
cian can modify this algorithm in regard to volume of saline adjustments in the first year was 4.5 and in the second year
added, particularly depending on the type of band the patient was 2 (Fig. 5).
has. For example, in a band with 10 mL maximum recom- High patient volume resulting from this postoperative
mended capacity, the first adjustment may be 3 mL, with follow-up regimen is accommodated with the use of a dedi-
subsequent increments of 1 mL. cated nurse practitioner. This may reflect not only utilization
If saline is already present, it can be aspirated into the of the restrictive properties of the band to its full potential but
syringe to document any loss of volume that may have also the added behavioral counseling and emotional support
occurred. However, routine aspiration of all saline from band that patients receive with each visit. The typical patient
is not recommended due to the increased restriction patients requires an average of 4–10 adjustments in the first year, and
can feel soon after. Instead, the pre-planned volume of saline then 1–3 adjustments each year thereafter.
21. Laparoscopic Adjustable Gastric Banding: Long-Term Management 203
FIG. 5. IN-OFFICE ADJUSTMENT ALGORITHM. RTC, RETURN TO CLINIC. SOURCE: SHEN ET AL. [6] WITH PERMISSION.
Radiographically Guided Adjustment confirms successful access. Fluoroscopy also allows for
visualization of the esophagus, gastric pouch, band, diameter
Real-time fluoroscopy allows for rapid localization of the of outlet, and integrity of tubing/port system. There is no
port to assist in percutaneous access. The needle can be standardized rate of esophageal emptying or outlet diameter
observed simultaneously as the skin is punctured and the that correlates with the perfect adjustment. There is also no
port accessed. Again, free reflux of saline into the syringe evidence to suggest that a given outlet diameter correlates
204 C.R. Fielding
TABLE 2. Radiographic criteria for adjustment noncompliant behaviors. Chest pain from acute esophageal
Consider fluid removal Consider fluid addition dilation will occur every time. This becomes very unpleasant
Stenosis of the outlet (with Wide outlet (>8 mm) for the patient and can be difficult for the surgeon to manage.
maladaptive eating behaviora) Figure 6 reviews recommended management of some com-
Esophageal dilatation (>2×) Immediate passage of the mon complaints.
barium swallow (one Stomal obstruction from food causes pain. Initially, this
peristaltic wave)
Esophageal atony
severe central chest pain and salivation can be frightening.
Esophageal emptying of the barium Once patients recognize it, though, they are much less con-
swallow in >4–5 peristaltic waves cerned. The simplest course of action is to induce vomiting,
Reflux which will liberate the obstructing plug. It is actually regur-
Pouch dilatation with gitation that occurs, rather than vomiting. Immediate resolu-
insufficient emptying
tion of pain is experienced. Patients should then stay on
a
Consumption of high-calorie liquid or soft foods, often induced by an liquids for the rest of the meal, as mucosal swelling within
overly tight band
Source: Favretti et al. [7], with permission
the band can occur. Use of carbonated drinks to free the
obstructing plug is to be avoided, as the pain becomes severe
when the gas expands within the obstructed esophagus.
with dysphagia or clinical symptoms. Table 2 shows sug- Recurrent regurgitation or vomiting can result in local
gested radiographic criteria for adjustments as published by mucosal edema within the outlet; patients are advised to stay
Favretti et al. [7]. on clear liquids for the following 24 h after any such event.
However, what fluoroscopy does show is outlet obstruc- If the food remains stuck and they are unable to tolerate any
tion, esophageal dilatation, gastric pouch dilatation, band liquids, even their own saliva, they must call their surgeon.
slippage/prolapse, reflux, and malfunctioning band or mal- The band requires immediate deflation, with removal of
positioned band. These are situations that would require saline to allow passage of the obstructing bolus. The band
immediate intervention such as loosening the band. This may can be readjusted after 2 days.
be helpful since not all of these abnormalities are necessarily Dysphagia and regurgitation is often worst early in the
reflected in clinical symptoms. morning, improves during the day, and is rarely present in
Although the number of follow-up visits and adjustments the evening. This relates to the diurnal function of esopha-
are much fewer, the cost and effort required are greater. The geal motility. Many patients are best served by having a liq-
surgeon must coordinate with a radiology facility for use of uid breakfast, such as a cup of coffee followed by a protein
the fluoroscopy; this can be time-consuming and costly. shake, that they can sip slowly on the way to work. This
Unless the surgeon’s office has a mobile fluoroscopy unit eliminates much of the early morning stress. Explanations of
such as a C-arm, the average time to perform an adjustment these mechanisms greatly assist band patients to understand
is 15–20 min. High-volume centers can decrease this time to some of the difficulties they may experience and reduce the
10 min. In addition, the patient does not receive the repetitive ever-present fear of failure.
emotional and behavioral counseling from the caregiver. Dysphagia is certainly affected by emotional issues.
Anger, anxiety, or state of upset can cause esophageal spasm.
Often patients who experience a death in the family, an ill
Complaints and Symptoms loved one or loss of a job, will notice increased food intoler-
ance. Temporary loosening of the band will relieve the
Dysphagia to solid food is the most common postoperative dysphagia, and the band can be re-tightened once the stress
complaint. It usually relates to the patient’s (1) eating too passes. Sex hormones can also affect esophageal motility
quickly; (2) swallowing too large a bolus of food; (3) swal- and lower esophageal sphincter pressure whereby female
lowing poorly chewed food; (4) eating food that does not patients may notice a correlation between dysphagia and a
break down with chewing, especially steak; (5) eating food certain time in their menses. Again, making the patient aware
that congeals together, such as white bread; and (6) eating of these variations in perceived band “tightness” can reduce
while anxious or angry. Most patients inadvertently forget frustration and help develop strategies to avoid vomiting.
that they have a band, eat too quickly but subsequently pay One very important subgroup is young people who are dat-
more attention to the behavioral modification of eating more ing; their newfound confidence after weight loss will evapo-
mindfully. Reinforcement of behavioral modification can be rate if they are seen to be having difficulty eating or actually
accomplished with techniques such as using a 30-s timer to vomiting. These young people need special advice: start with
prolong the time between swallowed bolus and taking the a beverage to help relax; choose foods they know they can
next mouthful. Educating the patient to avoid performing eat, such as soup, risotto, or flaky fish; and resist pressure to
other tasks such as talking on the phone or driving while eat- eat more. Eat slowly. They may have a sip of wine as they
ing can help with mindful eating. However, some patients eat, just as they would do normally. This allows them to fit in
simply fail to learn from these experiences and persist with with their friends and to be more comfortable dating.
21. Laparoscopic Adjustable Gastric Banding: Long-Term Management 205
Reflux is not uncommon and occurs when (1) the band is (1) pills or (2) chronic regurgitation. Due to the narrowed
too tight, (2) there is gastric prolapse with band slip, (3) there stoma outlet into the stomach created by compression of the
is an undiagnosed hiatal hernia, or (4) there is abnormal band, pills larger than 1 cm will have delayed transit through
esophageal motility. These are indistinguishable clinically the band and increased contact with the esophageal mucosa.
but can be diagnosed by esophagraphy. The severe end of the Large pills (>2 cm), pills with an acidic pH foundation (i.e.,
spectrum is nocturnal regurgitation, reflux, and night cough, doxycycline, ferrous sulfate, ascorbic acid, NSAIDs, antide-
often presenting as sleeplessness combined with recent- pressants), sustained-released pills, and gelatin-coated pills
onset asthma, or even aspiration pneumonia. This is more are all common causes of pill esophagitis [8]. Behavioral
commonly seen with gastric prolapse/band slip. Initial contributors include taking several pills in a handful, drinking
appropriate treatment entails removing fluid from the band, minimal or no fluid when taking pills, and taking pills prior
and then diagnosing the etiology of reflux. Upper endoscopy to lying down for sleep. In the case of pill esophagitis in the
is often necessary to diagnose a hiatal hernia, and if present LAGB patient, the band should be loosened for 1–3 weeks,
requires surgical reduction and repair with or without mesh. and the patient treated with sucralfate elixir. Offending pills
Occasionally, a band slip or a hiatal hernia cannot be diag- should be changed to smaller size, non-sustained release, or
nosed by either esophagram or upper endoscopy and require liquid formulation, to be taken one at a time with plenty of
exploratory laparoscopy. Band slippage and pouch dilation liquid at least 2 h prior to bedtime, preferable before a meal.
require surgical reduction of the gastric prolapse and reposi- The band can be re-tightened with resolution.
tioning of the band if the patient has had a satisfactory weight Chronic regurgitation from an overtightened band or from
loss. However, if the patient has experienced suboptimal behavioral non-modification (i.e., eating too fast) can simi-
weight loss at the time of band slippage, pouch dilation, or larly result in esophagitis. With esophagitis contributing to
hiatal hernia diagnosis, consideration should be made to con- esophageal dysmotility, esophageal dilation may be seen on
vert the patient to Roux-en-Y gastric bypass. esophagram and requires band loosening. Proton-pump
Reflux or heartburn not associated with a band slippage or inhibitors or histamine blockers can be helpful. Patients who
hiatal hernia is suspected to be caused by esophagitis due to: cannot tolerate the restriction of the band and adopt a
206 C.R. Fielding
maladaptive eating behavior may benefit from band removal TABLE 3. Postoperative eating tips
and possible revision to a bypass procedure. 1 Eat when hungry
Weight loss outcomes after LAGB are subject to greater 2 If not hungry, do not eat
variation due to the many factors which contribute to weight 3 Eat slowly
loss. The most common reason for poor weight loss is a sub- 4 Chew thoroughly
5 Learn to put your fork down between bites
optimally adjusted band as mentioned earlier, followed by 6 Size of the meal should be the same as the palm of your hand
device leak either from the port, the tubing, or the band itself. 7 Do not try to finish everything on the plate
Presuming that the device system is intact and the patient is 8 Do not eat and drink at the same time
in the “Green Zone,” other factors may come into play. 9 All beverages should have 0 calories
Eating due to emotional reasons, most commonly depres- 10 Order an appetizer instead of an entree at a restaurant
sion, rather than physical hunger is a common culprit. Colles
et al. found that LAGB patients who have less physical hun-
ger have a reduced total energy intake and greater weight Support groups and ongoing psychotherapy can be helpful
loss, as compared to those who reported minimal hunger after any bariatric surgery for the patient to adjust to the loss
control [9]. However, “emotional” hunger, eating in response of food, new self-image, and change in eating behavior.
to negative emotional states, and continuing to eat despite However, the greatest help can come from the surgeon listen-
feeling full were forms of “non-hungry eating” related to ing to the patient and applying some of these basic principles
higher reports of hunger and poorer weight outcomes. Eating (Table 3).
may become “self-medication” to avoid confronting difficult
feelings, which can subsequently have negative effects on
weight loss after any type of bariatric surgery [10]. These Conclusion
patients would benefit from psychological counseling to
identify and manage this disorder as a means to optimize The LAGB is the safest surgical tool available to assist mor-
weight loss outcomes and emotional health. bidly obese patients in losing weight. The keys to its success are
appropriate surgical technique, prolonged follow-up, regular
adjustments, and, perhaps most importantly, an understanding
Nutritional Evaluation of the changes that go with having a band. Its adjustability is its
greatest strength. When the patient attends regularly for follow-
Nutritional deficiencies have not been identified to be a prob- up, and the surgeon uses adjustments wisely based on satiety,
lem after LAGB due to the purely restrictive nature of the weight loss, and any other symptoms, the LAGB will deliver
operation. However, it is good practice to check a full battery very satisfactory weight loss results.
of laboratory tests including iron, folate, thiamine, vitamin
B12, vitamin D, and calcium on an annual basis. Menstruating
females are at highest risk of anemia due to decreased food Review Questions and Answers
and nutrient intake. Pregnancy or illness may change the
nutritional requirements and can be addressed with band 1. The best place to adjust a gastric band is:
loosening.
a. In the operating room
b. In the office
Counseling c. In the radiology suite
d. b and c
Patients should understand that achieving weight loss The answer is (d). Band adjustments can be performed
requires commitment to follow-up and behavioral modifica- either in the office or in the radiology suite under fluoros-
tion. They need to make changes to their nutrition, their man- copy. Both are valid ways to perform adjustments as long
ner of eating and levels of activity. While LAGB is not as as they are done on a regular basis until the patient reaches
“foolproof” as Roux-en-Y gastric bypass (RYGBP) or sleeve the Green Zone.
gastrectomy, it can be just as effective in the long term.
Patients must understand that they cannot have it both ways: 2. A patient who is 3 years after LAGB comes in complain-
They will not be able to eat the same way or the same things ing of coughing in her sleep for the past 3 weeks. Her last
after surgery and still lose weight. The weight loss is gradual, band adjustment was over a year ago. What is the first test
due to the gradual nature of the restriction. A program you order?
approach is the most successful way of achieving significant a. Chest CT
maintained weight loss. b. CBC
21. Laparoscopic Adjustable Gastric Banding: Long-Term Management 207
c. Esophagram References
d. Upper endoscopy
The answer is (c). Night cough means that the band is too 1. Fielding GA. Reduction in incidence of gastric herniation
with LAP-BAND: experience in 620 cases. Obes Surg. 2000;
tight and the patient is suffering from reflux. Since she did 10:136.
not have her band recently tightened, the cause of band 2. Dargent J. Pouch dilatation and slippage after adjustable gastric
obstruction is from either a band slippage, a hiatal hernia, banding: is it still an issue? Obes Surg. 2003;13:111–5.
or from decreased esophageal motility secondary to 3. Dixon AF, Dixon JB, O’Brien PE. Laparoscopic adjustable gastric
esophagitis. An esophagram is a simple test which will banding induces prolonged satiety: a randomized blind crossover
study. J Clin Endocrinol Metab. 2005;90(2):813–9.
show the band position, pouch size, pouch emptying, 4. Dugay G, Ren CJ. Laparoscopic adjustable gastric band (Lap-
esophageal diameter, and emptying. Band) adjustments in the office is feasible-the first 200 cases. Obes
Surg. 2003;13:192 [abstr].
3. The most common cause of vomiting after gastric band- 5. Dixon JB, Straznicky NE, Lambert EA, Schlaich MP, Lambert
ing is: GW. Laparoscopic adjustable gastric banding and other devices for
a. Eating too fast the management of obesity. Circulation. 2012;126(6):774–85.
6. Shen R, Dugay G, Rajaram K, Cabrera I, Siegel N, Ren CJ. Impact
b. Not chewing thoroughly of patient follow-up on weight loss after bariatric surgery. Obes
c. Having the band too tight Surg. 2004;14:514–9.
d. Eating tough meat 7. Favretti F, O’Brien PE, Dixon JB. Patient management after LAP-
e. All of the above BAND placement. Am J Surg. 2002;184:38S–41S.
8. Winstead NS, Bulat R. Pill esophagitis. Curr Treat Opt
The answer is (e). Vomiting in an LAGB patient is more Gastroenterol. 2004;7:71–6.
regurgitation of undigested food rather than vomitus, and 9. Colles SL, Dixon JB, O’Brien PE. Hunger control and regular
is most often due to behavioral causes such as eating too physical activity facilitate weight loss after laparoscopic adjustable
fast and not chewing properly. Reinforcement of behav- gastric banding. Obes Surg. 2008;18:833–40.
10. Beck NN, Mehlsen M, Stoving RK. Psychological characteri-
ioral modification is helpful. Sometimes the band is over- stics and associations with weight outcomes two years after
tightened, and this creates a very small stoma which may gastric bypass surgery: postoperative eating disorder symptoms are
even be too tight for liquids to pass. In this case the band associated with weight loss outcomes. Eat Behav. 2012;13(4):
needs to be loosened. 394–7.
22
Laparoscopic Adjustable Gastric Banding:
Management of Complications
Paul O’Brien
revisional LAGB procedures without any 30-day mortality Laparoscopy should follow if the imaging does not reveal a
or any later death related to the LAGB procedure. problem but the suspicion remains. Remove the band when-
The most definitive evaluation of mortality currently ever an abnormal fluid collection is present. Unless there is
available is derived from the Longitudinal Assessment of an obvious defect visible, do not explore further trying to
Bariatric Surgery (LABS) study report in 2009 [5]. This find and repair a defect as you are more likely to make mat-
NIH-sponsored study of bariatric surgery involved 10 sites, ters worse. Better to irrigate, place a closed drainage system
carefully selected for their expertise and experience. The and get out. The band can be replaced at 3 months after the
30-day rate of death was monitored closely. There were problem has settled.
4,776 patients who had RYGB (N = 3412), LAGB (N = 1198) Infection around the access port should be separated from
or other procedures unspecified in the report (N = 166). There a superficial cellulitis of the access port incision. The latter
were 15 deaths in the RYGB group, 6 after a laparoscopic will settle with antimicrobial therapy. The infection around
approach and 9 after an open approach. There were no deaths the access port will not settle until the port is removed.
in the LAGB group of patients. The difference was highly Clinically it is not usually a florid infection with elevated
significant. temperature and marked swelling and redness. More likely, it
presents as an initial mild local inflammatory picture, fol-
lowed by a discharge from the wound that will persist until
Early Complications the port is removed. It carries the risk of an ascending con-
tamination along the tubing, leading to low grade inflamma-
The Longitudinal Assessment of Bariatric Surgery study tion around the band itself and eventual erosion of the band.
serves also to inform on early adverse events for the two Early but not urgent removal of the access port is indi-
major bariatric procedures of RYGB and LAGB. Not sur- cated. At operation wash the area copiously with an appro-
prisingly, the incidence of adverse events mirrored the peri- priate antiseptic, plug the tubing with the plug available in
operative mortality rates. Using a composite end point of the tubing repair kit, push the tubing well back into the peri-
death, DVT or pulmonary embolism, re-intervention or fail- toneal cavity and leave the wound open to heal by secondary
ure to be discharged by 30 days, they identified 189 who intention. Replace the port after all healing has occurred,
were positive to that end point, 177 in the RYGB group usually at 2–3 months.
(5.2 %) and 12 in the LAGB group (1.0 %), a difference that
was highly significant [5].
The adverse events after LAGB include infection at the Late Adverse Events
access port site, infection in the region of the band, intra-
abdominal haemorrhage and perforation of the upper stom- All bariatric procedures have a maintenance requirement. In
ach. With good knowledge of the anatomy, careful dissection a systematic review of all bariatric surgical reports with 10 or
and appropriate prophylaxis against infection and deep more years of follow-up [6], the revisional surgery rate was
venous thrombosis, perioperative adverse events should a median of 24 % and it was not different between proce-
remain very uncommon. dures. Eight LAGB reports provided data on revisional sur-
gery. The median value was 26 % with a range of 8–60 %.
The median rate for the six RYGB reports that provided data
Management was 22 % with a range of 8–38 %.
Late adverse events after LAGB can be divided into three
Adverse events that are specific to the band include perfora- groups of problems: proximal gastric enlargements which
tion of the upper gut and infection at the access port site. include anterior and posterior prolapse and symmetrical
Other complications are part of the general range of events enlargement, erosion of the band into the stomach, and tub-
that can occur with abdominal surgery and are covered ade- ing and port problems.
quately elsewhere. Late adverse events have been relatively common after
Perforation of the upper stomach or distal esophagus is a LAGB but are decreasing. Table 1 shows the total revisional
rare but potentially lethal event. Suspicion of such an event procedure in 3,227 patients treated by myself and my col-
should be raised whenever a patient is unwell after the proce- league, Dr. Wendy Brown, over a 15-year period [6]. The
dure. Clinical features could include tachycardia, elevated total period has been subdivided into three, a perigastric era,
temperature, abnormal level of pain and signs of marked a pars flaccida era and a Lap-Band AP era. For proximal
upper abdominal tenderness or even of peritonitis. There is enlargements, there was no difference between the first and
usually an elevated white cell count and C-reactive protein second era and a dramatic reduction with the introduction of
level. Do not hesitate to investigate such a patient. CT scan the Lap-Band AP system. The incidence of erosion decreased
with a Gastrografin meal is the initial test of choice. progressively through the three eras.
22. Laparoscopic Adjustable Gastric Banding: Management of Complications 211
TABLE 1. Total revisional procedures during the follow-up period (adapted from O’Brien et al., Ann Surg 2013 [6])
Total period Perigastric era Pars flaccida era Lap-Band AP era
Dates and numbers 1994–2011 (N = 3227) 1994–2000 (N = 931) 2001–2005 (N = 926) 2006–2011 (N = 1370)
Enlargements 840 (26 %) 375 (40 %) 377 (41 %) 88 (6.4 %)
Erosions 110 (3.4 %) 79 (8.5 %) 20 (2.2 %) 11 (0.8 %)
Port/tubing 666 (21 %) 281 (30 %) 304 (33 %) 81 (5.9 %)
Explanations 181 (5.6 %) 92 (9.9 %) 59 (6.4 %) 30 (2.2 %)
Etiology
Proximal gastric enlargements occur because the band has
been placed incorrectly, a part of the gastric wall slips
through the band or there is stretching of the stomach or
esophagus above the band. The central driver for all enlarge-
ments, whether they are posterior prolapse, anterior prolapse,
and symmetrical enlargement, is the pressure generated by
eating too quickly or taking too big a bite. It is essential that
each bite must transit the area of the band before another bite
is taken. With correct placement of the band, there is only a FIG. 1. The four components of the lower esophageal contractile
virtual stomach present. A typical barium study after place- segment (LECS) (© CORE under licence, with permission).
ment shows no actual volume reservoir. With eating, space
needs to be created for the food before it transits the band is by the induction of a sense of satiety, a lack of appetite or
into the stomach below. This will generate a force. The two hunger [8]. There are two components to this—satiety and
key variables that determine that force are the volume of satiation.
food present and the rapidity of eating. As the force seeks to Satiety is the state of not being hungry. It is achieved for
create space, any weakness in fixation will be displayed. the LAGB patient by adding or removing of fluid from the
Posterior prolapse was seen with the perigastric pathway system to change the degree of compression of the band on
of placing the band, which often passed across the upper the gastric wall. When this compression is optimal, it induces
reaches of the lesser sac. The smooth and extensive peritone- a sense of satiety which is present throughout the day.
alized posterior gastric surface was the most likely to slip Although some hunger may develop at times during the day,
under the stress of eating, creating a posterior slip. This there is a general reduction of appetite, less interest in food
greater level of posterior weakness protected any deficiency and less concern about not eating.
in the anterior fixation and so anterior slips were relatively Satiation is the resolution of hunger with eating. For the
rare at that time. A randomized controlled trial involving 200 LAGB patient, it is induced by each bite of food as it passes
LAGB patients in which the perigastric pathway was com- across the band. When the band is optimally adjusted, each
pared with the pars flaccida pathway, which always places bite is squeezed across by esophageal peristalsis, generating
the band above the lesser sac, showed complete prevention increased pressure on that segment of the gastric wall. This
of posterior prolapse by the pars flaccida approach [7]. reduces any appetite that may have been present and induces
a feeling of not being hungry after eating a small amount.
The combination of these effects allows the person to eat
Physiology and Pathophysiology three or less small meals per day.
of the LAGB Figure 1 shows the components of the lower esophageal
contractile segment (LECS), an entity first described by Dr.
An understanding of the anatomy and physiology of the Paul Burton from extensive study of the physiology of the
upper stomach when a band is present is needed to under- gastric band [9]. It brings together the key elements that
stand the mechanisms for proximal gastric enlargements and together generate early onset of satiation after eating. The
thereby to prevent them. distal esophagus squeezes each bite of food to the stomach
The LAGB should be placed at the very top of the stom- proximal to the band. The lower esophageal sphincter relaxes
ach, around the cardia and within 1 cm of the esophagogas- to allow passage and then contracts to maintain the forward
tric junction. The primary mechanism of action of the LAGB pressure. The proximal segment of stomach maintains tonic
212 P. O’Brien
Treatment: Nonsurgical
The first two steps in all patients having symptoms are the
reduction of fluid in the band and reinforcement of the
need to eat small bites slowly. If the clinical suspicion is
that the last adjustment was too much, reduction of a
small volume, perhaps 0.3 mL or less is sufficient to give
relief, and the patient can proceed with their weight loss
process. For the more severe symptoms of an acute block,
such as a bolus of food sticking and copious vomiting
FIG. 3. The bite is too large or a second bite has been taken before being present, it is preferable to remove a greater volume
the first bite has completed transit. There is a proximal enlargement of fluid, 2–3 mL, check that normal swallowing now
disrupting the action of the lower esophageal contractile segment occurs and then begin to replace the fluid after a period of
(© CORE under licence, with permission). rest for several days. If symptoms are not relieved or
recur, proceed to barium meal.
If the barium meal shows a proximal enlargement, remove
Focal Esophageal Enlargement all fluid from the band, wait 1 month and repeat the barium
A variant of the symmetrical enlargement that is important to study. Generally there will be a return to normal anatomy.
recognize is the focal enlargement of the distal esophagus. Reinforce the eating rules with the patient, advise of the
This will occur in the same setting as symmetrical gastric tendency to recurrence if they are not very careful and then
enlargement when there is too little stomach proximal to the begin the stepwise replacement of the fluid to a level to
band to expand. The importance of its recognition lies in its achieve satiety. Approximately 50 % of our patients need
management. Revision with replacement of the band above no further action and continue on their weight loss program.
the enlargement is not appropriate and removal of the block- If recurrence of symptoms occurs in the months or years
ing effect of the band by removal of fluid or possibly removal after the conservative approach, we will generally discuss
of the band is required. revision of the band with repositioning along a new pathway
above the enlargement.
Anterior gastric slips are more likely to cause acute prob-
Diagnosis of Proximal Enlargements lems and are less likely to resolve with a conservative
approach. Although we will seek to relieve the problem in
Each of the forms of proximal gastric enlargement presents some by removal of all fluid and review with barium meal at
clinically as a problem of stasis at the distal esophagus, the one month, we are more likely to proceed directly to surgical
principal symptoms being reflux, especially at night, heart- revision. If there is a marked enlargement and upper abdomi-
burn, vomiting, and food intolerance. There are no “normal” nal tenderness, this should be done urgently as perforation of
symptoms after LAGB. If your patient has the symptoms the acute anterior slip has occurred. If the symptoms are
mentioned above, there are only three possibilities. The band more modest, early elective revision is planned.
is too tight, they are eating too quickly or too big a bite and
they have a proximal enlargement. All three may be present.
Diagnosis of proximal enlargements is generally achieved Treatment: Surgical
by barium meal. A small volume of dilute barium will demon-
strate the anatomy as present. However, the abnormal anatomy The primary approach to revisional surgery is for removal of
may be intermittent, occurring only with eating. A stress bar- the band and replacement of the band along a new pathway
ium meal is needed to define this problem [16]. For symmetri- just below the esophagogastric junction. If the primary band
cal enlargements, upper gastrointestinal endoscopy is required was a Lap-Band AP, the same band is generally used. All
to separate the esophageal and gastric enlargements. other bands are converted to a Lap-Band AP.
214 P. O’Brien
There are several key technical points in the revisional pro- Some key points in minimizing the problem of proximal
cedure to which we attach the acronym NERD: enlargements:
• New: Always remove the band and create a new pathway. • Use a proven LAGB. There are many on the market (out-
Do not seek to undo the previous anterior fixation. It is not side the USA). Only use a device that has been proven to
necessary as the new pathway will be well above that be effective and safe.
area. Sometimes, especially with anterior slips, you will • Do anterior fixation. There is a conflicting literature. It is
be tempted to simply reduce the slip. It can often be simple and almost certainly harmless. Why save a few
reduced quite easily and everything looks fine. But a minutes in the operating room and risk having to reoper-
recurrence is likely [17]. Don’t even consider it. ate later.
• Explore the hiatus. Always dissect the crura. Approximate • Adjust the band to a level of satiety sufficient to achieve
the crura if laxity is present. your weight loss targets over a 2- to 3-year period. Do not
• Reduce any hiatal hernia fully. Be sure you can see intra- tighten excessively or push for rapid weight loss.
abdominal esophagus. • The patient must eat small amounts—three or less meals
• Dissect the soft tissue membrane in front of the upper a day, half a cup volume of food (125 mL; 125 mg) at
stomach down to visible gastric wall sufficient to provide each meal, use a small plate, fork, and spoon. Enjoy the
a path for the band. As you have already dissected the flavours, the tastes and the textures of the food during that
esophagus, you can now see the transition from esopha- time.
gus to stomach and therefore are able to correctly position • The patient should eat good food that is protein contain-
the band, the upper margin of which should be at 1 cm ing, nutritious, tasty and attractive. They should enjoy eat-
below that point. You need to be sure to maximize the ing more after the band than before—by focussing on the
compressive effect of the band on the vagal afferents in quality of the food, not the quantity.
the underlying gastric wall by removing the buffering • The patient should eat slowly. Each bite should be chewed
effect of that soft tissue layer. until it is mush, usually 15–20 s of chewing. Swallow it
and then wait 1 min for that bite to completely cross the
band before another bite is taken. Use a timer if necessary
to reinforce the slowness that is essential.
Prevention of Proximal Enlargements
There will always be a need for some revisional surgery and
all who care for bariatric surgical patients should be able to Erosions
diagnose and manage adverse events as they arise. Yet the
need for revision can be reduced and this is particularly so Erosion of the LAGB into the lumen of the stomach is an
for the proximal enlargements. Although there are technical uncommon and surprisingly mild and manageable in most
factors that have an influence, proximal enlargements pri- cases. As the cause is still unclear, erosion can be expected to
marily arise when the patient eats too big a bite or eats too continue albeit at a low rate. Nevertheless, the bariatric sur-
quickly. Every bite must pass the band before the next bite is geon performing LAGB will see the patient with an eroded
swallowed. band occasionally and needs to know how to make the diag-
The optimal result from LAGB will come from an effec- nosis, how to determine an appropriate management path-
tive partnership between you and your patient. You both have way and what outcomes can be expected.
three responsibilities. You must place the band safely and
securely in the correct position. You must make sure your
patients have access to a competent aftercare program and Incidence
you must be sure your patients are appropriately instructed in
what they must do. Your patients must follow the rules Erosion of the gastric band into the lumen of the stomach
regarding eating, they must follow the rules regarding exer- was initially described as a complication of LAGB in 1998
cise and activity and they must come back to the aftercare [19]. Subsequent reports have varied widely in their descrip-
program permanently. tions of possible etiology, incidence, clinical presentation,
We have brought together all the information that the and management options.
patient needs into a book, “The Lap-Band Solution: A In 2011, we reported a systematic literature review of ero-
Partnership for Weight Loss” [18]. The book details the sions after LAGB [20]. We focussed on incidence, etiology,
“Eight Golden Rules” and includes a DVD of these rules clinical presentation, treatment, complications, and weight
showing, through animations, how the band works and why loss. Twenty-five studies of LAGB reported 231 erosions in
the rules are what they are. This book/DVD has proved to be 15,775 patients (overall incidence of 1.46 %). The mean
very valuable in developing the partnership we seek and in number of patients per study was 631 (±486) and the mean
reducing the problems of proximal enlargements. follow-up was 3.73 (±2.4) years. There was a wide variation
22. Laparoscopic Adjustable Gastric Banding: Management of Complications 215
the cause and replace the port and adjacent tubing. We pro- 2. Flum DR, Dellinger EP. Impact of gastric bypass operation on
ceed to band replacement only if there is a leak demonstrated survival: a population-based analysis. J Am Coll Surg. 2004;199:
543–51.
to be present but is occurring proximal to the exposed port 3. Chapman A, Kiroff G, Game P, Foster B, O’Brien P, Ham J,
and tubing after full mobilization. Maddern G. Laparoscopic adjustable gastric banding in the
treatment of obesity: a systematic review. Surgery. 2004;135:
326–51.
Review Questions and Answers 4. Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman
HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L,
Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treat-
1. An optimal tightness of the adjustable band occurs when: ment of obesity. Ann Intern Med. 2005;142:547–59.
5. Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W,
(a) Solid food sits above the band to give a sense of Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E,
fullness Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative
(b) Liquids can pass with some resistance across the safety in the longitudinal assessment of bariatric surgery. N Engl J
Med. 2009;361:445–54.
band 6. O’Brien P, McDonald L, Anderson M, Brennan L, Brown WA. Long
(c) There is little appetite for food throughout the day term outcomes after bariatric surgery: fifteen year follow up after
(d) Barium imaging shows slow transit gastric banding and a systematic review of the literature. Ann Surg.
(e) A small amount of food satisfies any hunger 2013;257(1):87–94.
(c) and (e) are correct 7. O’Brien PE, Dixon JB, Laurie C, Anderson M. A prospective ran-
domized trial of placement of the laparoscopic adjustable gastric
2. The following are true regarding proximal gastric enlarge- band: comparison of the perigastric and pars flaccida pathways.
ments above the band: Obes Surg. 2005;15:820–6.
8. Dixon AF, Dixon JB, O’Brien PE. Laparoscopic adjustable gastric
(a) All enlargements are associated with slippage of the banding induces prolonged satiety: a randomized blind crossover
stomach from below study. J Clin Endocrinol Metab. 2005;90:813–9.
(b) Anterior prolapse can develop into an acute surgical 9. Burton PR, Brown WA, Laurie C, Hebbard G, O’Brien
PE. Mechanisms of bolus clearance in patients with laparoscopic
emergency adjustable gastric bands. Obes Surg. 2010;20:1265–72.
(c) Posterior prolapse is largely prevented by use of the 10. Burton PR, Brown WA, Laurie C, Richards M, Hebbard G, O’Brien
pars flaccida pathway PE. Effects of gastric band adjustments on intraluminal pressure.
(d) Symmetrical enlargement of the stomach can be dis- Obes Surg. 2009;19:1508–14.
tinguished from a symmetrical enlargement of the 11. Burton PR, Yap K, Brown WA, Laurie C, O’Donnell M, Hebbard G,
Kalff V, O’Brien PE. Changes in satiety, supra- and infraband transit,
esophagus by barium swallow and gastric emptying following laparoscopic adjustable gastric band-
e. Most symmetrical enlargements will resolve by ing: a prospective follow-up study. Obes Surg. 2011;21:217–23.
removing fluid from the band 12. Pournaras DJ, Le Roux CW. The effect of bariatric surgery on gut
(b), (c) and (e) are correct hormones that alter appetite. Diabetes Metab. 2009;35:508–12.
13. Berthoud HR. Vagal and hormonal gut-brain communication: from
3. Erosion of the gastric band into the lumen of the satiation to satisfaction. Neurogastroenterol Motil. 2008;20 Suppl
stomach: 1:64–72.
14. Zagorodnyuk VP, Chen BN, Brookes SJ. Intraganglionic laminar
(a) Is likely to occur in about 1 % of patients endings are mechano-transduction sites of vagal tension receptors
(b) Is due to adjusting the band too tightly in the guinea-pig stomach. J Physiol. 2001;534:255–68.
(c) Is the commonest cause of an acute abdomen in 15. O’Brien PE, McMurrick P. Posterior gastric wall prolapse after lap-
someone with a gastric band band placement. Obes Surg. 1995;5:247 [Abstract].
16. Burton PR, Brown WA, Laurie C, Korin A, Yap K, Richards M,
(d) Can be effectively treated by removal of the band and Owens J, Crosthwaite G, Hebbard G, O’Brien PE. Pathophysiology
later replacement of laparoscopic adjustable gastric bands: analysis and classification
(e) Removal of the band by endoscopic technique is sim- using high-resolution video manometry and a stress barium proto-
pler and safer than laparoscopic approach col. Obes Surg. 2010;20:19–29.
(a) and (d) are correct 17. Manganiello M, Sarker S, Tempel M, Shayani V. Management of
slipped adjustable gastric bands. Surg Obes Relat Dis. 2008;4:534–
8; discussion 538.
18. O’Brien P. The lap-band solution: a partnership for weight loss.
References Melbourne: Melbourne University Publishing; 2011.
19. Weiner R, Emmerlich V, Wagner D, Bockhorn H. Management and
1. Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, therapy of postoperative complications after “gastric banding” for
Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. morbid obesity. Chirurg. 1998;69:1082–8.
Who would have thought it? An operation proves to be the most 20. Egberts K, Brown WA, O’Brien PE. Systematic review of erosion
effective therapy for adult-onset diabetes mellitus. Ann Surg. after laparoscopic adjustable gastric banding. Obes Surg. 2011;21:
1995;222:339–50. 1272–9.
22. Laparoscopic Adjustable Gastric Banding: Management of Complications 217
21. Ren CWM. Favorable early results of gastric banding for morbid 24. Neto M, Ramos AC, Campos JM, Murakami AH, Falcao M, Moura
obesity: the American experience. Surg Endosc. 2004;18:543–6. EH, Evangelista LF, Escalona A, Zundel N. Endoscopic removal of
22. Westling A, Bjurling K, Ohrvall M, Gustavsson S. Silicone-adjustable eroded adjustable gastric band: lessons learned after 5 years and 78
gastric banding: disappointing results. Obes Surg. 1998;8:467–74. cases. Surg Obes Relat Dis. 2010;6:423–7.
23. Brown W, Egberts KJ, Franke-Richard D, Thodiyil P, Anderson MA, 25. O’Brien P. Comment on: Endoscopic removal of eroded adjustable
O’Brien PE. Erosions following laparoscopic adjustable gastric band- gastric band: lessons learned after 5 years and 78 cases. Surg Obes
ing: diagnosis and management. Ann Surg. 2013;257(6):1047–52. Relat Dis. 2010;6:427–8.
23
Laparoscopic Adjustable Gastric
Banding: Controversies
George Fielding
Bariatric surgery is a blessing for morbidly obese people. every year. There are more morbidly obese people in the
Nothing else really works. All the currently available bariat- USA than the total population of Australia. There are more in
ric procedures work to varying degrees and all have their India than the total population of the USA. It’s over-
problems. I currently perform all these procedures, and my whelming. Surgery is currently the most effective proven
patients have reaped the rewards of surgery and suffered the treatment to control this epidemic, yet so few people who
tribulations that can go with them—leaks after bypass and need it come for it.
sleeve, band slips and erosions, malnutrition after BPD, LAGB surgery, and its postoperative management, as it
weight regain, and failure after all of them. In the main is done today, bears very little resemblance to how it was
though, most patients do well and are happy. Patients play an done 10 years ago. Successful modification in the tech-
important role in the selection of their operation and the risks nique of band implantation, especially use of the pars flac-
and benefits of all procedures should be explained to help cida technique, and hiatal hernia repair/cruroplasty at the
them make this sometimes difficult decision. initial operation, has substantially reduced the need for
Laparoscopic adjustable gastric banding (LAGB) has reoperation after band placement [1, 2]. Changes in band
been a successful choice for the treatment of morbid obesity technology, especially use of wider, lower pressure bands
by many bariatric surgeons around the world, since its intro- result in further reductions. We understand that the band
duction in 1994. After its approval in 2001 in the USA by the works primarily by controlling hunger and increasing feel-
Food and Drug Administration (FDA), the use of the lap ings of satiety, rather than as a punitive, restrictive proce-
band increased and has given patients an alternative treat- dure [3, 4]. We have modified our adjustment strategies
ment to the Roux-en-Y gastric bypass (RYGBP) and more accordingly, aiming to keep patients in the “Green Zone,”
recently the sleeve gastrectomy. The LAGB does not involve as described by Dixon and O’Brien. We teach patients to
any bowel anastomosis, staple line complications, or risk of eat slowly, telling them that they can’t live with a band as if
leaks. It is also adjustable and easily removable, both charac- they don’t have one. With all this, long-term patient satis-
teristics that are appealing to patients considering bariatric faction has matched the reduction in need for band revision
surgery. After its introduction to the USA in 2001, LAGB and removal, compared to patients who had their bands
had similar popularity to that achieved in Australia and inserted in the late 1990s and early 2000s.
Europe, rivaling gastric bypass as the most common bariatric The LAGB delivers satisfactory weight loss, provided
operation. In recent years though, that popularity has some- the band is adjusted properly. The percentage excess weight
what declined, particularly with the increasing interest in loss (%EWL) after LAGB has been reported at 55 % after 5
sleeve gastrectomy. Several factors have influenced that years [5]. Lanthaler et al. report %EWL of 64 % out to 10
change, some real, some due to different perceptions of the years [6]. O’Brien reviewed 3,227 patients treated by
value of gastric banding. laparoscopic adjustable gastric band placement between
September 1994 and December 2011 [7]. Seven hundred
fourteen patients had completed at least 10 years of follow-
The Main Controversy: Should up. Follow-up was intact in 78 % of those beyond 10 years.
We Still Do the Band? There was no perioperative mortality for the primary place-
ment or for any revisional procedures. There was a mean of
Obesity is currently the second largest cause of preventable 47.0 % EWL (n = 714; 95 % CI = 1.3) for all patients who
death in the USA and a devastating disease, with its inci- were at or beyond 10-year follow-up. The band was
dence and associated complications rising exponentially explanted in 5.6 %. In Weichman et al.’s recent study of
2,909 patients from New York, %EWL after 6 years was of the affected patients, but, surprisingly, 27.9 % developed
47 % [8]. The %EWL 3 years after surgery was 52.9 %, new-onset diabetes.
which was sustained thereafter to 47 % at 6 years. In multi- Long-term data for the sleeve tells a similar story.
variate models, increased number of office visits, younger Himpens has published his data on 53 patients who had lapa-
age, female gender, and Caucasian race were significantly roscopic sleeve gastrectomy between November 2001 and
associated with a higher maximum %EWL. Of these October 2002 [12]. There were 41 patients in follow-up, and
patients, 363 (12.2 %) experienced one or more complica- 11 received an additional malabsorptive procedure at a later
tions. The most common complications were band slip stage because of weight regain. In the 30 patients receiving
(4.5 %) and port-related problems (3.3 %). Other complica- only sleeve gastrectomy, there was a 3-year %EWL of
tions were rare. Only 7 patients (0.2 %) had band erosion. 77.5 % and 6+ year %EWL of 53.3 %. The differences
Eleven patients (0.4 %) underwent reoperation for weight between the third and sixth postoperative year were statisti-
gain. A total of 10 deaths (0.34 %) occurred during the study cally significant in both groups. New gastroesophageal reflux
period. Three patients died within 30 days of surgery. Two complaints appeared in 21 % of patients.
of these deaths (0.06 %) were related to surgery, and 1 In another study, Sarela found, in 20 patients out to 9
resulted from a motor vehicle accident. Seven patients died years, that 3 were lost and 4 converted to another procedure
of causes unrelated to surgery during the course of the study. [13]. Of the remaining 13 patients, 55 % had 50 % EWL.
LAGB is a safe procedure with few early or late complica- Surgery for massive super obesity is a formidable chal-
tions. Mortality is very rare. lenge. No existing open or laparoscopic procedure reduces
In 2003, Weiner published data on 984 LAGB patients, mean BMI below 30 from a starting point above 55. Eid and
including 100 patients with over 8-year follow-up, for whom Schauer recently presented a group of 74 super obese
he had 90 % follow-up [9]. They had 59 % EWL, and their patients, with a mean BMI of 66 (43–90) having sleeve gas-
body mass index (BMI) fell from 47 to 32 kg/m2. He showed trectomy between January 2002 and February 2004, with a
that it is an effective treatment. mean 6-year follow-up [14]. Mean EWL at 72, 84, and 96
If one reviews the literature concerning longer follow-up months after LSG was 52 %, 43 %, and 46 %, respectively,
of LAGB, it seems that one can expect about 50 % EWL out with an overall EWL of 48 %. The mean BMI decreased
to 10 years, with 50 % of patients achieving 50 % EWL, with from 66 (43–90) to 46 kg/m2 (22–73).
very low risk to the patient. Years ago, I presented a group of 76 super obese patients,
We often hear that the gastric bypass (RYGB) is the “gold with a mean BMI of 69 (60–104) having had LAGB [15].
standard” for bariatric surgery. There is actually very little Five patients had a BMI > 100 kg/m2. BMI fell from 69 ± 6.2
long-term data for gastric bypass. The best 10-year follow- to 49 ± 7.73 at 1 year to 37 ± 4.45 at 3 years and this was
up is from Kelvin Higa [10]. A total of 242 patients under- maintained at 4 and 5 years. BMI in 13 patients with >5-year
went RYGB surgery from February 1998 to April 1999. The follow-up was 35.09 ± 5.3 kg/m2 (27–44).
office follow-up rate was 33 % at 2 years and only 7 % at 10 Weight loss with LAGB in this group of massive super
years. An additional 19 % had telephone follow-up at 10 obese patients was similar to all other surgical techniques. In
years. The mean excess weight loss was 57 % at 10 years. total contrast, Marmuses’s group from France has just pub-
Only 67 % of patients had 50 % EWL. Furthermore, 86 lished very disappointing results in a group of 35 men
(35 %) had ≥1 complication during follow-up. The internal (18.8 %) and 151 women (81.2 %), with a mean BMI of
hernia rate was 16 %, and the gastrojejunal stenosis rate was 55.06 kg/m2 (range: 50–74.4) who had LAGB between
4.9 %. Of the 242 patients, 136 (51 %) had nutritional testing September 1995 and December 2007 [16]. The mean follow-
at least once after postoperative year 1. Of these 136 patients, up was 112.5 months with a minimum of 28 months and a
only 24 (18 %) had remained nutritionally intact during fol- maximum of 172 months. The follow-up rate was maintained
low-up. The weight loss is not that dissimilar to LAGB at 89 % at 10 years. At 10 years there was a band removal
patients, there is a high long-term complication rate, and rate of 52.2 % (47 of 90 patients), a failure rate of 22 % (7 of
most patients had nutritional deficiencies. What’s more, this 33 patients) of those who still had their band in place, and a
is in the 26 % with documented follow-up. median BMI of 43.43 kg/m2. No one really knows why there
Himpens et al. reviewed 126 consecutive patients treated is such disparity in reported outcomes with the band. It may
with RYGB between January 1, 2001, and December 31, be due to a preference to remove bands rather than revise
2002 [11]. Seventy-seven patients (61.1 %) were available them when there is reflux or variations in follow-up.
for evaluation after 9.4 ± 0.6 years. Initial BMI was Weiner performed 937 sleeves between October 2001 and
40.3 ± 7.5 kg/m2. There was no postoperative mortality. December 2010, with 0.4 % mortality [17]. Of the 937
Some 9 % of the patients suffered from internal herniation, patients, 17 (1.8 %) experienced staple line leakage. From
despite the closure of potential hernia sites. With time, the 2005 to 2010, 106 secondary procedures were performed.
patients regained weight; percentage of excess BMI lost was Insufficient weight loss or weight regain was the indication
56.2 ± 29.3 %, down from a maximum of 88.0 ± 29.6 % at in 88 cases. Sixteen (15 %) patients had severe gastroesopha-
2.0 years. RYGB was effective for diabetes control in 85.7 % geal reflux which was resolved by RYGB.
23. Laparoscopic Adjustable Gastric Banding: Controversies 221
In conclusion, long-term data for LAGB, sleeve, and which happened after discharge [26]. Weiner showed a leak
RYGB demonstrates a remarkable similarity—about 50 % rate of 1.8 % in 937 patients [ 15 ]. Sakran showed 44
EWL—and a substantial need for reoperation. (1.5 leaks in 2,834 patients, all but 1 after discharge [27].
This then leaves patients with a choice. Many patients The leaks had a median closure of 40 days (1–270 days).
base that choice on safety, if there is a similar benefit. In What a patient has to be told, quite simply, is that if you
2004, Ren et al. asked 469 consecutive patients what was the have a sleeve, based on current data, the chance of dying
reason for their choice of operation [18]. Safety of the opera- after a sleeve is five times that of a band. The patient will have
tion (43 %) was the highest rated factor in choosing a 1/40 chance of a leak, which takes an average of 40 days to
LAGB. RYGB was preferred due to “lack of a foreign body,” close. You also have a 1/5 chance of needing a conversion to
“inability to cheat,” and “dumping.” Duodenal switch (BPD/ another procedure by 5 years. After all that, the weight loss at
DS) was selected in 11 % of patients, primarily because of 5 years is the same as with a well-adjusted band.
“durability of the weight loss” (51 %).
Patients care about safety. The one indisputable feature
that separates the LAGB from other procedures is its safety Follow-Up
with operative mortality in the order of 1/2,000. Nguyen
et al. recently reviewed 10,151 bands admitted in University Given that it’s much safer and delivers similar weight loss
Healthcare Consortium (UHC) hospitals between January long term as a bypass or a sleeve, why is there controversy
2007 and December 2009 [19]. There was a mean length of about using the band? The answer lies in the need for a high
stay of 1.2 days and 3 deaths (0.03 %). level of long-term maintenance and the need for band revi-
Chakraverty et al. performed a search of all comparative sion. Long-term follow-up is the weak point of all bariatric
studies of LAGB and other procedures and found five level operations. With the band, far more than the other proce-
one randomized controlled trials [20]. Their conclusion was dures, it determines success or failure. In 2004, Shen et al.
that LAGB delivered satisfactory weight loss and was much reviewed 216 LAGB and 139 RYGB operations performed
safer, with fewer complications and shorter stay, and thus between October 2000 and September 2002 [28]. Of these
may be preferable to patients. Gould reviewed 32,509 bariatric patients, 186 LAGB patients and 115 RYGBP patients were
procedures, of which 58 % were laparoscopic RYGB and available for 1-year follow-up. Of the LAGB patients, 130
21 % LAGB. Mortality was 0.09 % vs. 0.02 % (P < 0.05) and (70 %) returned 6 or less times in the first year and achieved
inpatient complications 4 % vs. 1.6 % (P < 0.1) [21]. Finks, 42 % EWL, and 56 patients (30 %) returned more than 6
reviewing the Michigan Bariatric Collaboration data of 25,469 times and had 50 % EWL (P = 0.005). Overall %EWL after
patients found that 644 patients had a serious complication RYGBP was 66.1 %. Some 53 patients (46 %) returned 3 or
and that sleeve was 2.46 times and RYGB 3.58 times as likely less times in the first year, achieving 66.1 % EWL. A further
as LAGB to have a complication [22]. In a review of 322 super 62 patients (54 %) returned more than 3 times after surgery
obese patients, Parikh found that 27 patients had a major com- and achieved 67.6 % EWL (P = NS). They showed that
plication. LAGB had 4.7 % and RYGB 11.3 % [23]. patient follow-up plays a significant role in the amount of
If one was to apply mortality rates of 0.02 % and 0.3 % to weight lost after LAGB, but not after RYGBP. It still holds
the 23 million people in the USA with a BMI over 35, the true today. Patient motivation and surgeon commitment for
difference is 4,500 dead people after surgery with a band, long-term follow-up is critical for successful weight loss
compared to 70,000 after a bypass. It is the fear of death after after LAGB surgery.
bypass or sleeve that prevents so many people from coming This is the key to the whole issue of band vs. other pro-
for bariatric surgery. cedures. A successful outcome after LAGB requires a
Saunders et al. reviewed 2,823 consecutive bariatric substantial input from patient and surgeon. An unadjusted
patients. Of these 165 (5.8 %) patients required 184 (6.5 %) band won’t work. There needs to be relatively open access to
readmissions within 30 days of their operation [24]. LAGB the surgeon and their team. Patients need to be able to come
had the lowest patient readmission rate of 3.1 % compared to in if they are hungry or have a problem. This open-door pol-
RYGB 7.3 %. LAGB decreased the odds for readmission. icy is somewhat at odds with the traditional surgical model,
The same authors then assessed 1-year readmission rates for as is the long-term follow-up. At NYU, we see patients once
1,939 patients and found that LAGB was 12.7 % and RYGB a month for the first 18 months, and then in reducing inter-
24 % [25]. vals after that. We see them yearly after 5 years. We have
The issue with band vs. sleeve is slightly different. There peripheral clinics to make access easier. Adjustments are
is a similar safety differential as with a bypass. The real done by the surgeons and by practice extenders such as RNs,
problem is leak after the sleeve, a complication that typically PAs, and NPs. It’s a lot of work. It’s probably the main issue
has a very protracted recovery, unlike anything seen after facing bariatric surgeons who wish to do LAGB surgery.
LAGB and only rarely after bypass. In published literature With the newer bands, modern surgical techniques, and
up to 2012, leak rates range from 0 to 2.5 %. Aurora reviewed understanding of the Green Zone, more and more patients
4,888 sleeve patients, with a leak rate of 2.4 %, most of are doing well, with fewer problems. Eventually there is a
222 G. Fielding
very large patient load. One simply needs to decide if one Achieving 65 % EWL with the LAGB is excellent—it repre-
wants it. The payoff is the low morbidity, low risk, effective sents 100 lb weight loss for the 5′5″, 270 lb woman, with a
surgery one can offer our patients. But if you want successful BMI of 45.
outcomes, you have to do the work. If this is daunting or The other issue arising from these two excellent papers is
cannot be accommodated into practice, then it’s probably the need for revision, and whether to revise the slipped band
best not to do LAGB surgery. or remove it. It’s important to distinguish band removal due
to weight loss failure from band removal due to symptoms of
reflux, or, more rarely, erosion. Many centers have taken the
Revisions position of removing the band to treat reflux and a slip, as
well as failure and performing bypass or sleeve. Our position
The major long-term concern with the LAGB is the need for at NYU has been to revise bands for reflux and remove them,
reoperation, usually due to severe reflux following band slip if the patient wants, for weight loss failure. Beitner has
or pouch dilatation. Several European papers have shown recently reviewed 3,876 patients treated by LAGB at NYU
high band removal/revision rates at 10 years. This has led from January 1, 2001, to June 30, 2009 [31]. There were 411
these authors to suggest that surgeons should abandon the patients that had the band revised for pouch-related problems
LAGB. The two strongest publications suggesting the band (10.6 %). Of these, 9 subsequently had the band removed
is less satisfactory are from Himpens and Romy. and 12 were converted to another bariatric procedure. An
Himpens et al. reviewed 151 consecutive patients who had additional 31 patients were converted to another bariatric
LAGB between January 1, 1994, and December 31, 1997, procedure without a revisional procedure beforehand. Thus
with follow-up of 54.3 % (82 of 151 patients) at 12 years 390 patients were included in the analysis of weight outcomes
[29]. The biggest surprise was that 28 % experienced band after revision. There were no procedure-related deaths. The
erosion, which is markedly outside all other reported ranges. 30-day patient complication rate for all reoperations was
Seventeen percent of patients had their procedure switched 0.5 %. Late complications (erosion) occurred in 0.5 % and
to laparoscopic RYGBP. Thirty-six patients (51.4 %) still 29 patients (7.4 %) required a second revision. The initial
had their band, and their mean excess weight loss was 48 % weight and BMI were 124.06 ± 21.28 kg and 44.80 ± 6.12 kg/
(range: 38–58 %). Overall, the satisfaction index was good m2. At reoperation, weight, BMI, and %EWL were
for 60.3 % of patients. It is crucial when contemplating this 89.18 ± 20.51 kg, 32.25 ± 6.50 kg/m2, and 54.13 ± 21.80 %.
paper to realize that this was at the very start of the band Reoperation occurred at a mean of 33.67 ± 33.27months after
experience, with small high pressure bands, placed low on the primary procedure. Mean operating time was
the stomach, without hiatal hernia repairs, and before any 67.02 ± 30.50 min and length of hospital stay was
real understanding of Green Zone adjustment theory. That 1.11 ± 0.92 days. The band was repositioned in 252 patients
being said, many patients in this group continue to do well (64.6 %) and replaced in 109 patients (27.9 %). Twenty-nine
with their band. patients (7.4 %) had hiatal hernia repair alone. Weight, BMI,
In a very well-structured paper, Romy et al. reviewed 422 and %EWL were 92.24 ± 20.22 kg, 33.32 ± 6.41 kg/m2, and
matched patients after LAGB and RYGB [30]. Follow-up 48.81 % 12 months post revision and 92.42 ± 19.91 kg,
was 92.3 % at the end of 6 years, which is extraordinary. 33.53 ± 6.25 kg/m2, and 47.50 ± 22.91 % 24 months post revi-
Early morbidity was higher after RYGB than after LAGB sion. Weight loss was sustained both at 12 months and 24
(17.2 % vs. 5.4 %; P < 0.001). Weight loss was quicker, max- months after reoperation and did not differ from those with-
imal weight loss was greater, and weight loss remained sig- out reoperation at the same length of time after primary
nificantly better after RYGB until the sixth postoperative banding. Importantly, we found that if a patient has lost
year. However, both groups did very well. RYGB patients weight with a band, they will maintain that weight loss after
had 78.5 % EWL and LAGB patients 64.8 %. Maximal revision. If they have done less well, revising the band will
weight loss was achieved 18 months after a gastric bypass not change that. The choice to remove the band and convert
procedure, while maximum weight loss was achieved on to another procedure is then the patient’s. Patient satisfaction
average 36 months after gastric banding. At 6 years, there with the band was not affected by reoperation. Reoperation
were more failures (BMI > 35 or reversal of the procedure/ for pouch-related problems after LAGB can be achieved
conversion) after LAGB (48.3 % vs. 12.3 %; P < 0.001). with minimal morbidity. Reoperation neither affects weight
There were more long-term complications (41.6 % vs. 19 %; loss nor patient satisfaction after LAGB.
P 0.001) and more reoperations (26.7 % vs. 12.7 %; We also found that incidence of band revision has fallen
P < 0.001) after LAGB. There was very little description of significantly over the last 5 years, with the newer bands, and
what the complications were. improved understanding of band physiology. O’Brien has
At first blush, there seems to be a major difference found the same thing in his series of 3,227 patients, of whom
between the two groups in Romy’s paper—78.5 % vs. 65 % 714 were at more than 10 years [7]. Revisional procedures
EWL. However, in a 5′5″, 270 lb woman (BMI 45), it is a were performed for proximal enlargement (26 %), erosion
difference of 17 lb. Is 17 lb, at 6 years, worth the risk? (3.4 %), and port and tubing problems (21 %). The need for
23. Laparoscopic Adjustable Gastric Banding: Controversies 223
revision decreased as the technique evolved, with 40 % uncontrolled type 2 diabetes and an average HBA1C l of
revision rate for proximal gastric enlargements in the first 10 9.2 ± 1.5 %. The primary end point was the proportion of
years, reducing to 6.4 % in the past 5 years. The revision patients with an HBA1C level of 6.0 % or less 12 months
group showed a similar weight loss to the overall group after treatment. The proportion of patients with the primary
beyond 10 years. end point was 12 % (5 of 41 patients) in the medical therapy
Revising a band is a safe procedure. It is certainly much group vs. 42 % (21 of 50 patients) in the RYGB group
safer than converting to bypass or sleeve. Worni et al. reviewed (P = 0.002) and 37 % (18 of 49 patients) in the sleeve group
66,303 patients after RYGB—63,171 (95.3 %) having a pri- (P = 0.008). The use of drugs to lower glucose, lipid, and
mary bypass and 3,132 patients (4.7 %) RYGB after removal blood pressure levels decreased significantly after both sur-
of LAGB [32]. Patients having bypass after a band had more gical procedures but increased in patients receiving medical
intraoperative complications (OR: 2.3, P = 0.002) and postop- therapy only.
erative complications (OR: 8.0, P < 0.001), were at higher risk Can LAGB offer anything similar? Parikh et al. analyzed
of reoperations/reinterventions (OR: 6.0, P < 0.001), and had 282 bariatric patients with diabetes mellitus (218 LAGB, 53
increased length of hospital stay. RYGB, and 11 BPD/DS) [37]. Preoperative age (46–50
Rebibo et al. compared primary sleeve gastrectomy (259) years), BMI (46–50; calculated as kg/m2), race and gender
with sleeve and band removal (46) [33]. The indication for breakdown, and baseline oral hypoglycemic (82–87 %) and
surgery was renewed weight gain or insufficient weight loss insulin requirements (18–28 %) were comparable among the
in 68 % of these cases. The complication rate was 8.6 % in three groups (P = NS). Percentage excess weight loss at 1, 2,
the band out group and 8 % in the primary sleeves. The fis- and 3 years was 43, 50, and 45 % for LAGB and 66, 68, and
tula rates in the two groups were 4.3 and 3.4 %, respectively 66 % for RYGB. At 1 and 2 years, the proportion of patients
(P = 0.56). Foletto et al. reviewed 41 patients who had con- requiring oral hypoglycemics postoperatively was 39 and
current band removal and sleeve, and 16 who had band 34 % for LAGB and 22 and 13 % for RYGB (P = NS). At 1
removal followed by an interval sleeve. One patient died of and 2 years, the proportion of patients requiring insulin post-
multiple organ failure from septic shock [34]. Three patients operatively was 14 and 18 % for LAGB and 7 and 13 % for
(5.7 %) developed a perigastric hematoma, 3 (5.7 %) had RYGB (P = NS). Despite the disparity in %EWL between
leaks, and 1 had mid-gastric short stenosis. The median hos- LAGB and RYGB, the authors found that the rate of resolu-
pital stay was 5 days. The mean BMI at revisional sleeve was tion of diabetes mellitus is equivalent.
45.7 and had decreased to 39 after 2 years. Two patients Dixon et al. performed a randomized controlled trial in 60
required a duodenal switch for insufficient weight loss. obese patients (BMI >30 and <40) with recently diagnosed
Iannelli et al. reviewed 41 patients who had conversion of (<2 years) type 2 diabetes, between conventional diabetes
LAGB to sleeve [35]. Indication for revisional surgery was therapy with a focus on weight loss by lifestyle change and
insufficient weight loss in all the cases. There was no mortal- LAGB [38]. Remission of type 2 diabetes was achieved by
ity, but 5 patients (12.2 %) developed complications (high 22 (73 %) in the surgical group and 4 (13 %) in the conven-
leak, 1 patient; intra-abdominal abscess, 3 patients; and com- tional therapy group. Surgical and conventional therapy
plicated incisional hernia, 1 patient). At 13 months, %EWL groups lost a mean of 20.7 % and 1.7 % of weight, respec-
was 42.7 %, and 6 patients needed a further procedure due to tively, at 2 years (P < 0.001). Remission of type 2 diabetes
failed weight loss. was related to weight loss (R2 = 0.46, P < 0.001) and lower
What should a surgeon offer their patient who has prob- baseline HbA1c levels (combined R2 = 0.52, P < 0.001).
lems after a band? If the issue is failed weight loss and the Participants randomized to surgical therapy were more likely
patient wants further help, the band should be removed and to achieve remission of type 2 diabetes through greater
another procedure offered, with the understanding that there weight loss.
is a real risk of substantial complications. However, if reflux Dixon then sourced 35 studies from Scopus, MEDLINE,
secondary to slip or pouch dilatation or hiatal hernia is the and EMBASE published from 2000 through May 2011 that
issue, the band can be safely revised, and the patient can con- provided some details of diabetes status before and after
tinue to have a successful outcome. LAGB [39]. Weight loss was progressive over the first 2
years with a weighted average of 47 % excess weight loss at
2 years. Remission or improvement in diabetes varied from
Does the Band Work in Diabetics? 53 to 70 % over different time periods. Results were broadly
consistent, demonstrating clinically relevant improvements
There is little doubt that BPD/BPDDS is the most effective in diabetes outcomes with sustained weight loss in obese
procedure for diabetics, but it is only rarely performed, due people with type 2 diabetes following LAGB surgery.
to its complexity and long-term malnutrition issues. The Sultan et al. assessed 102 patients with type 2 diabetes
RYGB is also very effective. Schauer has recently described mellitus who had LAGB between January 2002 and June 2004
this very clearly [36]. Medical therapy alone was compared [40]. During that time, 631 patients had a band surgery,
to RYGB or sleeve gastrectomy in 150 obese patients with giving an incidence of diabetes of 16.2 %. Of the 102 patients,
224 G. Fielding
7 were excluded because 2 had had the band removed early, 4. Colles SL, Dixon JB, O’Brien PE. Hunger control and regular
and 5 patients had died; 2 of cancer and 3 of unknown causes. physical activity facilitate weight loss after laparoscopic adjustable
gastric banding. Obes Surg. 2008;18(7):833–40. doi:10.1007/
The mean duration of the diabetes diagnosis before surgery s11695-007-9409-3.
was 6.5 years. The mean preoperative BMI was 46.3 and had 5. Biagini J, Karam L. Ten years experience with laparoscopic adjust-
decreased to 35.0 by 5 years, an EWL of 48.3 %. Of 94 able gastric banding. Obes Surg. 2008;18(5):573–7.
patients, 83 (88.3 %) were taking medications preopera- 6. Lanthaler M, Aigner F, Kinzl J, Sieb M, Cakar-Beck F, Nehoda
tively, with 14.9 % taking insulin. At 5 years postoperatively, H. Long-term results and complications following adjustable gas-
tric banding. Obes Surg. 2010;20(8):1078–85.
33 (46.5 %) of 71 patients were taking medications, with 7. O’Brien PE, Macdonald L, Anderson M, Brennan L, Brown
8.5 % taking insulin. The mean fasting preoperative glucose WA. Long-term outcomes after bariatric surgery: fifteen-year fol-
level was 146.0 mg/dL, and it decreased to 118.5 mg/dL at 5 low-up of adjustable gastric banding and a systematic review of the
years (P = 0.004). The mean HbA1c level was 7.53 preop- bariatric surgical literature. Ann Surg. 2013;257(1):87–94.
eratively and was 6.58 at 5 years (P < 0.001). Overall, diabe- 8. Weichman K, Ren C, Kurian M, Heekoung A, Casciano R, Stern L,
et al. The effectiveness of adjustable gastric banding: a retrospective
tes had resolved (no medication requirement, with HbA1c 6-year U.S. follow-up study. Surg Endosc. 2011;25(2):397–403.
<6 and/or glucose <100 mg/dL) in 40 % and had improved 9. Weiner R. Outcome after laparoscopic adjustable gastric band-
(use of fewer medications and/or fasting glucose levels of ing—8 years experience. Obes Surg. 2003;13(3):427–34.
100–125 mg/dL) in 43 %. The combined improvement/ 10. Higa K, Ho T, Tercero F, Yunus T, Boone KB. Laparoscopic
remission rate was 83 %. roux-Y gastric bypass: 10 year follow up. Surg Obes Relat Dis.
2011;7(4):516–25.
Even though it may not be quite as effective as RYGB, 11. Himpens J, Verbrugghe A, Cadière GB, Everaerts W, Greve
LAGB is an excellent tool for the treatment of morbidly JW. Long-term results of laparoscopic Roux-en-Y gastric bypass:
obese patients with diabetes. evaluation after 9 years. Obes Surg. 2012;22(10):1586–93.
12. Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic
sleeve gastrectomy for obesity. Ann Surg. 2010;252(2):319–24.
13. Sarela AI, Dexter SP, O’Kane M, Menon A, McMahon MJ. Long-
Conclusion term follow-up after laparoscopic sleeve gastrectomy: 8-9-year
results. Surg Obes Relat Dis. 2012;8(6):679–84.
It’s now 18 years since the LAGB was first used to help mor- 14. Eid GM, Brethauer S, Mattar SG, Titchner RL, Gourash W, Schauer
bidly obese patients. Much has changed in that time. Larger, PR. Laparoscopic sleeve gastrectomy for super obese patients:
softer, lower pressure bands are placed higher on the stom- forty-eight percent excess weight loss after 6 to 8 years with 93%
follow-up. Ann Surg. 2012;256(2):262–5.
ach, often with a concomitant crural or hiatal hernia repair. 15. Fielding GA. Laparoscopic adjustable gastric banding for massive
Bands are adjusted slowly, aiming to control hunger, and superobesity (>60 body mass index kg/m2). Surg Endosc.
increase satiety, rather than act purely as a restrictive tool. 2003;17(10):1541–5.
All bariatric operations have their strengths and weaknesses. 16. Arapis K, Chosidow D, Lehmann M, Bado A, Polanco M, Kamoun-
The band’s strength is it’s safety, adjustability, and ease of Zana S, Pelletier AL, Kousouri M, Marmuse JP. Long-term results
of adjustable gastric banding in a cohort of 186 super-obese patients
removal. Its weakness is the need for reoperation. However, with a BMI≥ 50kg/m2. J Visc Surg. 2012;149(2):e143–52.
that problem is decreasing in frequency with the changes 17. Weiner RA, Theodoridou S, Weiner S. Failure of laparoscopic
mentioned above. Band revision is safer than alternate proce- sleeve gastrectomy-further procedure? Obes Facts. 2011;4 Suppl
dures. A band can be safely revised, and patients then con- 1:42–6.
tinue their journey to control their weight. All the various 18. Ren CJ, Cabrera I, Rajaram K, Fielding GA. Factors influencing
patient choice for bariatric operation. Obes Surg. 2005;15(2):202–6.
procedures can and do fail. If a band fails, alternate proce- 19. Nguyen N, Hohmann S, Nguyen XM, et al. Outcome of laparo-
dures can be offered. LAGB is still a very effective weight scopic adjustable gastric banding and prevalence of band revision
loss tool. Given the enormous surge in obesity, it will remain and explantation at academic centers, 2007–2009. Surg Obes Relat
attractive to many patients who are nervous of more aggres- Dis. 2012;8(6):724–8.
sive procedures and their complications. Adequate band 20. Chakravarty PD, McLaughlin E, Whittaker D, Byrne E, Cowan E,
Xu K, Bruce DM, Ford JA. Comparison of laparoscopic adjustable
adjustment in long-term follow-up is the cornerstone of suc- gastric banding (LAGB) with other bariatric procedures; a system-
cess with a lap band. atic review of the randomised controlled trials. Surgeon.
2012;10(3):172–82.
21. Gould JC, Kent KC, Wan Y, Rajamanickam V, Leverson G, Campos
GM. Perioperative safety and volume: outcomes relationships in
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24
Gastric Bypass: Transoral Circular-Stapled
Gastrojejunostomy Technique
Abdulrahim AlAwashez and Matthew Kroh
Introduction Technique
Denans invented the first mechanical device designed for After standard preoperative preparation, access to the
bowel anastomosis. It consisted of an inner cylinder and two abdominal cavity is accomplished using an optical 10-mm
shorter outer rings that when placed together resulted in trocar under vision with a zero-degree laparoscope in the left
necrosis of the compressed tissue and bonding of the adja- upper periumbilical area. Once the peritoneal cavity is
cent healthy tissue. Much has changed since this initial entered, carbon dioxide is insufflated, and the optic is
description of stapling devices and currently there are many changed to a 45° camera. A brief diagnostic laparoscopy
types of surgical staplers [1]. examination is performed and additional four trocars are
In 1969 Mason reported the first application of gastric placed as well as a Nathanson liver retractor. The left upper
stapling as a surgical procedure-induced weight loss [2]. quadrant trocar is 15 mm in size and this is the site that the
The maturation of stapling devices and bariatric surgery as a circular stapler is eventually inserted through (Figs. 1 and 2).
field has been facilitated by the minimally invasive era. In
1993 Wittgrove et al. reported the first laparoscopic gastric
bypass. For the most critical step of their procedure, cre- Pouch Reconstruction
ation of the gastrojejunal anastomosis (GJ), they used the
smallest (21-mm) circular stapling device on the market The patient is placed in extreme reverse Trendelenburg posi-
with a transorally placed anvil. This technique was partly tion and attention is turned to the hiatus. We start the proce-
derived from placement of the percutaneous endoscopic dure by dissecting off the phrenoesophageal fat to expose the
gastrostomy (PEG) tube [3]. left pillar of the diaphragm using hook electrocautery. With
Laparoscopic Roux-en-Y gastric bypass (LRYGB) is the the help of the pneumoperitoneum, dissection continues
most commonly performed operation for morbid obesity in laterally closer to the greater curvature until the first branch
the United States. Three main different techniques are widely of short gastric vessel is reached. This limited dissection
used with good results for performing the gastrojejunal anas- facilitates pouch construction by mobilizing the most ceph-
tomosis, including the linear-stapled anastomosis, hand- aled part of the lateral pouch. We then open the pars flaccida
sewn anastomosis, and circular-stapled anastomosis [3–5]. and perform a blunt dissection to expose the posterior gastric
Though practice patterns are always in flux, most sur- wall. A 3.5-mm cartridge load of 60-mm linear stapling
geons use the circular stapler technique (66 %) to create the device with staple-line buttress material is used to take the
gastrojejunal anastomosis, followed by the hand sewn (18 %) descending branch of the left gastric vessels. The buttress
and linear stapler (16 %) [6]. allows for easy maneuverability of the pouch without actu-
The selection of a particular anastomotic technique is ally grasping tissue. A single load of 60-mm (3.5-mm car-
usually based on the surgeon’s preference and none of these tridge) stapler in a horizontal orientation, and 2–3 vertical
approaches are considered as a standard. The circular-stapled applications typically complete the pouch. It is important
anastomosis has been our preference. Our technique as well when firing the vertical loads to avoid crossing the previous
as outcomes of this technique is discussed in this chapter. staple line and to ensure that the stapler is lateral to the angle
of His when firing the final load. This approximately 30 cm3 small-bowel mesentery is further divided with ultrasonic
vertically oriented pouch will be sufficient in size to admit shears with care taken to avoid devascularizing the biliopan-
the anvil of the 21-mm circular stapler. The staple line is creatic limb or to approach too close to the root of the mes-
inspected for quality of staple application and for any bleed- entery. A 150-cm Roux limb is then measured out and a
ing. Hemostasis is important as hematoma formation on the side-to-side jejunojejunostomy is fashioned between the bil-
staple line could cause staple-line dehiscence and gastric iopancreatic limb and the common channel. After stay
pouch leak. sutures are placed, a single firing of a white 60-mm linear
stapler makes the anastomosis and the common enterostomy
is closed with hand-sewn running absorbable suture. The
The Roux and Biliopancreatic Limb mesenteric defect is closed with a hand-sewn running, lock-
Constructions ing permanent suture. The omentum is then split with ultra-
sonic shears in preparation for transmission of the Roux limb
Once the pouch is completed, we construct the Roux and in an antecolic position.
biliopancreatic limbs. The patient is placed in a supine posi-
tion. The omentum and transverse colon are gently swept
cephalad to identify the ligament of Treitz. The duodenum is Gastrojejunostomy Anastomosis
identified and confirmed by the adjacent IMV. We then mea-
sure 40–50 cm from the ligament of Treitz and divide the For transoral placement of the anvil, we use the Orvil pack-
small bowel using a linear cutter stapler with 2.5-mm car- age (Covidien, Mansfield, MA), which consists of a 21-mm
tridge load. To achieve more mobility of the Roux limb, the anvil with the head pre-tilted and the tip attached to an oral
24. Gastric Bypass: Transoral Circular-Stapled Gastrojejunostomy Technique 229
Gentle insufflation also allows for laparoscopic detection drainage of the contaminated area and providing enteral
of leak by examining for any bubbles. We routinely leave a access for feeding. Percutaneous drainage of a contained fluid
channel drain at the gastrojejunostomy. collection may be an option in patients who are stable [10].
Giordano et al. performed a meta-analysis comparing
linear versus circular stapler technique with a primary out-
Outcomes come of gastrojejunal anastomosis leak. Eight studies
involving 1,321 patients were retrieved and included in this
The overall 30-day mortality for bariatric surgical proce- study. All eight studies reported results on gastrojejunos-
dures is less than 1 % [7]. tomy leakage, and pooled analysis did not show significant
Among both early and late complications, anastomotic difference between the two groups (RR, 1.03; 95 % CI,
leaks remain one of the most challenging complications. The 0.36–2.93; p 0.95) [11].
rate of anastomotic leak in RYBG is 1.5–6 % and can be as
high as 35 % in revisional surgery [8].
Carrasquilla et al. have reported a low incidence of leaks Bleeding
at 0.1 %. Their technique involves the antecolic and antegas-
tric approach and the use of a circular stapler for the gastro- Significant bleeding after gastric bypass was observed more
enterostomy [9]. following laparoscopic versus open GBP. The overall rate is
Most leaks occur early in the first week after surgery but 0.6–4 % [12].
can occur up to a few weeks later. If not diagnosed in a timely Early bleeding typically occurs from one of the anastomotic
fashion, the mortality rate increases dramatically. Early clin- or staple lines. It is most commonly intraluminal. Tachycardia,
ical symptoms of a leak are subtle and require clinical vigi- a decreased hematocrit, and melena are the most common pre-
lance for signs such as low-grade fevers, sustained sentations. Intraluminal bleeding typically resolves without
tachycardia, or respiratory distress. If a leak is suspected surgical intervention, but may require transfusion of blood
clinically, emergent surgical exploration should be per- products. For ongoing bleeding with high transfusion require-
formed even if imaging is negative, given the rapid progres- ments, endoscopic intervention is appropriate. Laparoscopic
sion to sepsis in the severely obese patient. exploration and oversewing of the staple line, occasionally
The surgical principles in treating a leak include providing with concomitant endoscopy, is the definitive treatment in
broad-spectrum antibiotic coverage, identification and repair patients who fail endoscopic management or for intraluminal
of the defect, irrigation and control of contamination, wide bleeding not amenable to endoscopic therapy.
24. Gastric Bypass: Transoral Circular-Stapled Gastrojejunostomy Technique 231
Nguyen et al. reported that 3.2 % of patients who under- may be partly explained by how the stricture is defined or
went a LRYGB with creation of the gastrojejunostomy diagnosed among the surgeons and the endoscopists [14, 18].
anastomosis with a circular stapler developed postoperative The etiology of stricture formation is uncertain, although tis-
hemorrhage in 24 h after surgery. Recent meta-analysis sue ischemia, excessive scarring from undetected leakage, gas-
comparing linear versus circular stapler technique to evalu- tric acid hypersecretion, and increased tension on the
ate this issue showed no significant differences between the gastrojejunal anastomosis are believed to have major roles.
groups in the incidence of stomal ulcer or postoperative Gastroesophageal reflux disease and age have been shown to be
bleeding [11]. statistically significant independent predictors of stricture [19].
With circular staplers, several studies have published
higher rates of GJ strictures, with the highest rates specifi-
Wound Infection cally with the 21-mm circular staplers. However, we believe
that the most important factor that influences potential stric-
Some authors have reported an increased frequency of ture development is surgeon experience and technique.
wound infection with circular stapler, related to the extrac- Carter et al. describe a series of 654 consecutive RYGB
tion of the contaminated handpiece through a port [13]. performed open or laparoscopically. Univariate analysis
The rate of infection at the abdominal wall site could be revealed that surgeon experience was a risk factor for stric-
reduced down to 1 % by protecting the wound with a plastic ture formation for the first 50 gastric bypasses [20].
sheet and this is our preferred technique [14]. Perugini et al. reported a decrease in the rate of anasto-
motic stricture from 17 to 4 % from their first 100 patients
compared with their second 100 patients with the same anas-
Gastrojejunal Strictures tomotic technique [21].
Suter and his group were able to reduce their stricture
Among the most significant postoperative complications rates to 0.8 % after introducing a slight modification of their
are gastrojejunal (GJ) anastomotic strictures. There is con- surgical technique by encompassing the pouch horizontal
siderable variability in stricture rates between different sur- staple line in the circular staple line [18].
gical techniques with an incidence of 1–31 % in some Whether the higher stricture rate with circular staplers
series [13, 15]. reflects procedures performed on the steep portion of the
Overall, the gastrojejunal stenosis rate is higher in laparo- laparoscopic gastric bypass learning curves is another con-
scopic gastric bypass compared with open technique [12]. sideration. Investigators from McGill looked at a series of
Creation of the GJ anastomosis can be accomplished via 201 consecutive LRYGB performed by a single surgeon.
a hand-sewn technique or utilization of a linear or circular They noticed that the anastomotic stricture rates decreased
stapler (either 21 or 25 mm in diameter). from 11.9 % in the first 67 patients to 3.0 % in the remaining
A 2008 online survey of American Society for Metabolic patients (p 0.01) [21].
and Bariatric Surgery revealed that the circular stapler tech- Since 1993 and throughout their program’s history,
nique is the most commonly used technique by bariatric sur- Wittgrove and his group have maintained a rate around 3.8 %
geons to construct the gastrojejunostomy. Furthermore, an utilizing the 21-mm circular stapler [23].
increasing number of surgeons use this technique compared This rate of stricture is among the lowest seen with the
with a prior survey [16]. 21-mm circular stapler and is comparable to the lowest rates
In an Internet-based survey, Madan et al. reported on the of all techniques reported in the recent literature. With early
preferred surgical technique for GJ: 43 % of the surgeons dilation of 12–15 mm proving to be an effective and safe
performed a circular-stapled technique, while 41 % prefer treatment for strictures, most patients have resolution of
linear stapling, and 21 % prefer the totally hand sewn. symptoms after only one therapeutic endoscopy [24–26].
Selection of a particular technique to create the gastroje- Nontechnical factors have also been implicated in
junal anastomosis is based on a range of factors. The 21-mm postoperative stricture formation. Takata et al. propose that
circular-stapled anastomosis has been our preference. It ischemia, excessive scar formation, and gastric hypersecre-
gives a uniformly reproducible 12-mm diameter stoma that tion can all promote stricture formation. Importantly, smok-
delays gastric pouch emptying. The success of the gastric ing and NSAID use are considered modifiable risk factors
bypass as a weight loss procedure depends somewhat on its for gastrointestinal strictures.
restrictive component that results from creation of a small Several other factors may lead to a higher stricture rate,
pouch to restrict food intake combined with a narrow outlet including demographic attributes, comorbid disease, and the
to limit pouch emptying and hence, inducing the feeling of use of nonabsorbable Lembert sutures to reinforce the gas-
the satiety. This involves the appearance of stenosis with an trojejunostomy [27].
incidence ranging from 3 to 27 % [17]. Patients typically present several weeks after surgery with
Even within anastomotic technique categories, there is nausea, vomiting, dysphagia, gastroesophageal reflux, and
significant variability in stricture rates. This variation in rates eventually an inability to tolerate oral intake.
232 A. AlAwashez and M. Kroh
The majority of strictures occur within the first 4–6 weeks and then later the groups switched to a 25-mm stapler. This
after surgery, and some strictures occur later and are generally introduces potential bias of a learning curve [32].
related to smoking or medication usage [28]. For patients who developed a stricture, no significant dif-
The diagnosis is usually established by endoscopy or with ference was found in the requirement for postoperative endo-
an upper gastrointestinal series. The definition of a stricture scopic balloon dilation in both groups [28].
varies between clinicians, which could explain the variability The internal anastomotic diameter of a 21-mm versus
in the reported stricture rates. 25-mm circular stapler is approximately 12 and 16 mm,
Endoscopic balloon dilation is usually successful, with respectively. The 4-mm difference in diameter changes the
dilation at 15 mm proving to be an effective and safe treat- cross-sectional area from 113 to 201 mm [33].
ment for strictures; most patients have resolution of symp- Also, differences in circular staplers should be consid-
toms after only one therapeutic endoscopy [29]. ered. Depending on the manufacturer, there may be a differ-
Peifer et al. reported their experience with endoscopic ence in internal diameter of 1 mm between similarly sized
management of anastomotic strictures in 43 of 801 patients staplers. For example, the Ethicon Endosurgery Inc.
receiving open or laparoscopic RYGB [30]. Strictures were (Cincinnati, OH) 25-mm circular stapler has an internal
dilated to 15 mm with no perforations or clinically signifi- diameter of 16.4 mm compared with the 15.3-mm diameter
cant bleeding. Ninety-three percent of the strictures were of a Covidien (Norwalk, CT) circular stapler. The difference
managed with 1 or 2 endoscopic sessions. Dilation to at least of 1.1-mm diameter between the two 25-mm staplers corre-
15 mm did not affect weight loss at 1 year compared with lates to a 14.7 % larger cross-sectional area (211 mm2 versus
weight loss in the group without a stricture. 184 mm2). Whether this difference is important enough clini-
Nguyen and his group noticed no difference in the per- cally to affect the stricture rate or restrictive component of
centage of excessive body weight loss 1 year postoperatively weight loss is unclear.
when comparing stricture versus non-stricture groups and The Orvil (Covidien, Mansfield, MA) EEA stapler, which
between 21-mm and 25-mm groups [28]. has been available since 2006, also has an outer diameter of
25 mm but an internal diameter of 16.9 mm [34].
Despite the possible advantage of a lower stricture rate
Modification and Alternative Techniques using 25-mm circular staplers, there are some drawbacks
with its use. It requires a larger skin and fascial incision that
Most of the technical modifications of circular-stapled gas- may result in more postoperative pain. Also placing the
troenterostomy involve anvil placement. The major difficulty 25-mm circular stapler into the end of the small intestine can
in the transoral technique is passage of the anvil through the be challenging because of the larger diameter. Additionally,
upper esophageal sphincter. Multiple maneuvers have been the larger anvil may carry a higher risk of pharyngeal or
used to facilitate the transoral passage of the anvil including esophageal injury from the transoral placement of the anvil.
neck extension, jaw thrust, and deflation of the endotracheal Another modification that was suggested to reduce the
tube balloon. It is very rare that maneuvers fail or anvil pas- anastomotic complication was the reinforcement of the
sage results in injury. Wittgrove et al. reported no esophageal gastrojejunal anastomosis staple line utilizing buttressing
injury in the first 1,400 patients using this technique. material. Jones and associates found a significant reduction
However, complications including hypopharyngeal perfora- in anastomotic strictures using a 25-mm circular-stapled
tion have been reported [31]. gastrojejunal anastomosis with a bioabsorbable material.
With this concern and in an attempt to improve the tran- They suggest that the staple-line reinforcement reduces
soral technique for placement of the anvil, Gagner and col- anastomotic complications by reducing tension on the sta-
leagues manually tilted the head of the anvil to facilitate its ple line by the even distribution of force and by buttressing
passage through the hypopharynx and upper esophageal against small defects that may have been present within the
sphincter. The tilted configuration of the anvil improved the staple line [35].
ease of transoral passage. In 2006, a pre-tilted anvil (Orvil, When Hope and his group analyzed circular-stapled anas-
Autosuture, Norwalk, CT, USA) was developed specifically tomoses with and without Seamguard (Gore, Flagstaff, AZ)
for the purpose of transoral delivery. in a porcine model, they found a decrease in collagen content
Several studies have looked at anastomotic complications with Seamguard-stapled anastomosis and no difference in
between 21-mm and 25-mm circular staplers and their suc- vascularity, adhesions, or inflammation at 1 week. It is
cessful endoscopic management. Analysis of individual unknown whether the decrease in collagen at 1 week has an
small trials comparing 21-mm and 25-mm circular-stapled impact on a future anastomotic stricture formation [36, 37].
laparoscopic gastrojejunal (GJ) anastomosis demonstrates Another technique that some bariatric surgeons used to
that 21-mm technique was associated with increased symp- avoid the transoral route is the transabdominal technique for
tomatic stenosis. However, most of these studies have lim- placement of the anvil [38, 39].
ited demographic data and methodology concerns that make However, this technique has some drawbacks including
it difficult to assess the effect of confounding variables. the need to enlarge the trocar site to accommodate the anvil
These series began with the use of a 21-mm circular stapler and construction of the gastrotomy for anvil insertion and
24. Gastric Bypass: Transoral Circular-Stapled Gastrojejunostomy Technique 233
subsequently its closure. Due to limitations of transoral and 4. Schauer PR, Sayeed I. Laparoscopic surgery for morbid obesity.
transgastric anvil passage, some surgeons use linear and Surg Clin North Am. 2001;81(5):1143–79.
5. Higa KD, Bone KB, Ho T. Complications of the laparoscopic
hand-sewn gastrojejunostomy techniques [40]. Roux-en-Y gastric bypass1,040 patients—what have we learned?
First described by Higa in 2000, the hand-sewn gastroje- Obes Surg. 2000;10(6):509–613.
junostomy anastomosis is becoming more common as sur- 6. Finks JF, Carlin A, Share D, O’Reilly A, Fan Z, Birkmeyer J, et al.
geons improve their laparoscopic technical skills [41]. Effect of surgical techniques on clinical outcomes after laparo-
In addition to being less expensive and less prone to ste- scopic gastric bypass—results from the Michigan Bariatric Surgery
Collaborative. Surg Obes Relat Dis. 2011;7(3):284–9.
nosis, the advantage of lower bleeding rate compared with 7. DeMaria EJ, Pate V, Warthen M, Winegar DA. Baseline data from
the mechanically performed anastomosis makes it preferable American Society for Metabolic and Bariatric Surgery-designated
in spite of its technical high demands [41]. Bariatric Surgery Centers of Excellence using the Bariatric
The evidence comparing linear-stapled versus circular- Outcomes Longitudinal Database. Surg Obes Relat Dis. 2010;6(4):
stapled laparoscopic gastrojejunostomy anastomosis in mor- 347–55.
8. Gonzalez R, Murr MM. Anastomotic leaks following gastric bypass
bid obesity surgery is only documented in a few small trials. surgery. In: Jones DB, Rosenthal R, editors. Weight loss surgery: a
Recently Penna et al. performed a pooled analysis of these multidisciplinary approach. Edgemont: Matrix Medical
individual small trials. They included 9 trials comprising Communications; 2008. p. 369.
9,374 patients (2,946 linear versus 6,428 circular). They 9. Carrasquilla C, English WJ, Esposito P, Gianos J. Total stapled,
noticed an increase in the rate of GJ stricture associated with total intra-abdominal (TSTI) laparoscopic Roux-en-Y gastric
bypass: one leak in 1000 cases. Obes Surg. 2004;14(5):613–7.
circular-stapled anastomosis and a reduced rate of wound 10. Gonzalez R, Sarr MG, Smith CD, Baghai M, Kendrick M,
infection, bleeding, and operative time associated with linear Szomstein S, et al. Diagnosis and contemporary management of
stapling. No significant differences appeared for the other anastomotic leaks after gastric bypass for obesity. J Am Coll Surg.
outcomes. The author suggests these results need to be inter- 2007;204(1):47–55.
preted cautiously with a number of potential biases influenc- 11. Giordano S, Salminen P, Biancari F, Victorzon M. Linear stapler
technique may be safer than circular in gastrojejunal anastomosis
ing these findings [42]. for laparoscopic Roux-en-Y gastric bypass: a meta-analysis of
Several retrospective studies comparatively analyzed the comparative studies. Obes Surg. 2011;21(12):1958–64.
three anastomotic techniques. The advantage of one tech- 12. Nguyen NT, Goldman C, Rosenquist CJ, Arango A, Cole CJ, Lee
nique over another is determined mainly by the surgeon’s SJ, Wolfe BM. Laparoscopic versus open gastric bypass: a random-
skill and experience. When such an anastomosis is per- ized study of outcomes, quality of life, and costs. Ann Surg.
2001;234(3):279–89.
formed, the classic general surgical principles are probably 13. Gonzalez R, Lin E, Venkatesh KR, Bowers SP, Smith
still the most important ones [13]. D. Gastrojejunostomy during laparoscopic gastric bypass. Analysis
Regardless of the technique used to construct the anasto- of 3 techniques. Arch Surg. 2003;138(2):181–4.
mosis, unnecessary manipulation of the small bowel and 14. Alasfar F, Sabnis AA, Liu RC, Chand B. Stricture rate after laparo-
gastric pouch, improper positioning of the gastrojejunal scopic Roux-en-Y gastric bypass with a 21-mm circular stapler: the
Cleveland Clinic experience. Med Princ Pract. 2009;18(5):364–7.
anastomosis, added tissue dissection, poor stapler manipula- 15. Lujan JA, Frutos MD, Hernandez Q, Cuenca JR, Valero G, Parrilla
tion, and improperly placed Lembert sutures may all lead to P. Experience with the circular stapler for the gastrojejunostomy in
early technical errors causing anastomotic complications. laparoscopic gastric bypass (350 cases). Obes Surg. 2005;
15(8):1096–102.
16. Madan AK, Harper JL, Tichansky DS. Techniques of laparoscopic
gastric bypass: on-line survey of American Society for Bariatric
Conclusion Surgery practicing surgeons. Surg Obes Relat Dis. 2008;4(2):
166–73.
The creation of the gastrojejunal anastomosis is a challenging 17. Frutos MD, Luján J, García A, Hernández Q, Valero G, Gil J,
step during LRYGB. There are several effective techniques for Parrilla P. Gastrojejunal anastomotic stenosis in laparoscopic gas-
performing the gastrojejunostomy in bariatric surgery. None tric bypass with a circular stapler (21 mm): incidence, treatment
and long-term follow-up. Obes Surg. 2009;19(12):1631–5.
of these techniques are considered as a standard. However, the 18. Suter M, Donadini A, Calmes JM, Romy S. Improved surgical tech-
transoral circular-stapled gastrojejunostomy is an efficient and niques for laparoscopic Roux-en-Y gastric bypass reduces compli-
reproducible construct for use in LRYGB. cations at the gastrojejunostomy. Obes Surg. 2010;20(7):841–5.
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25
Gastric Bypass: Transgastric Circular
Stapler Technique
Jaisa Olasky and Daniel B. Jones
Since the first description of laparoscopic Roux-en-Y It has been suggested that various anvil stem lengths and
gastric bypass in 1994, surgeons have performed the gastro- the use of a spiked anvil may contribute to difficulty passing
jejunal anastomosis using a circular end-to-end anastomosis the EEA anvil and to esophageal injury [4]. Trouble navigat-
(EEA) stapled technique. The circular stapled method may ing the anvil at the level of the cricopharyngeus muscle as
be favored as it allows for construction of a very small gas- well as complications including esophageal perforation and
tric pouch and represents a safe, consistent, and relatively gastric wall injuries have led surgeons to develop a transgas-
simple method of anastomosis. In a study published in 2007, tric technique for anvil placement [6–9]. In addition to safety,
authors surveyed bariatric surgeons on their usual practice other potential advantages of the transgastric technique
for creating the gastrojejunal anastomosis. The percentage include obviating the need for the surgeon to perform endos-
of surgeons using the circular stapler, linear stapler, and copy, avoidance of wound contamination with oral flora, and
hand-sewn technique was 43 %, 41 %, and 21 %, respec- reduced risk of inadvertent endotracheal tube migration or
tively. Surgeons using the circular stapler used either a 21- dislodgment during manipulation of the anvil through the
or 25-mm size anvil. This particular report, however, did not esophagus.
investigate whether the anvil was placed transabdominally A number of transgastric techniques have evolved. Among
or transorally [1]. the alternatives, transgastric anvil placement may be per-
Initially, the gastrojejunostomy was created by a transoral formed either by using a balloon cholangiogram catheter to
technique in which the circular stapler anvil was introduced position the anvil as described by De la Torre [7] and Scott
orally using endoscopic guidance [2, 3]. This technique et al. [6], or by first creating the gastric pouch and opening
required an experienced endoscopist to advance the endo- the end [7, 9]. We prefer the latter technique, in which the
scope into the gastric pouch. Next, a venous catheter was anvil, attached to a suture is inserted directly into the pouch.
used to pass a guidewire into the gastric pouch for endo- The needle of the attached suture is passed from within the
scopic retrieval. The pull wire was then attached to the EEA stomach to a selected site on the gastric pouch. The suture is
anvil and advanced in an antegrade fashion from the mouth then used to pull the anvil through the pouch wall and the
through the esophagus and into the gastric pouch in a tech- pouch gastrotomy is closed.
nique similar to that used to perform a percutaneous endo- In a simplified technique, the intended gastric pouch may
scopic gastrostomy (PEG) tube. This required temporary be first sized by inflating a 15-mL gastric balloon at the level
deflation of the balloon of the endotracheal tube and lifting of the gastroesophageal junction (Fig. 1). A gastrotomy is
the patient’s head and jaw anteriorly to allow the anvil to performed on the anterior wall of the stomach. A 25-mm
pass into the distal esophagus. Although large series have EEA anvil with an attached looped suture is placed within
reported no anvil-related complications, other surgeons have the abdominal cavity through one of the port sites. The suture
noted significant injuries associated with the transoral tech- is then held with a 45-cm, modified Maryland grasper (Jones
nique [4, 5]. Proprietary differences among EEA manufac- Perforator, Stryker Endoscopy, San Jose, CA) and advanced
turers may prevent universal application of the transoral through the gastrotomy (Fig. 2) [10]. Using the tip of the
approach. grasper to penetrate the gastric wall, the suture is advanced at
the selected anastomotic site within the area of the proposed
gastric pouch. The suture is pulled anteriorly to allow the
Electronic supplementary material: Supplementary material is
available in the online version of this chapter at 10.1007/978-1-4939-
anvil spike to advance through the gastric wall.
1637-5_25. Videos can also be accessed at http://www.springerimages. Next, the pouch is fashioned using several firings of a
com/videos/978-1-4939-1636-8 . laparoscopic gastrointestinal anastomosis (GIA) stapler.
FIG. 1. Sizing the pouch and the intragastric balloon. Reprinted with FIG. 3. Gastric division. Reprinted with permission, Ciné-Med
permission, Ciné-Med Publishing, Inc. Adapted from Atlas of Publishing, Inc. Adapted from Atlas of Metabolic and Weight Loss
Metabolic and Weight Loss Surgery, Copyright © 2010. Surgery, Copyright © 2010.
We currently use the articulating Endo GIA Ultra Universal FIG. 4. EEA placement. Reprinted with permission, Ciné-Med
Stapler with the 3.5-mm purple tri-staples (Covidien, Publishing, Inc. Adapted from Atlas of Metabolic and Weight Loss
Mansfield, MA) (Fig. 3). As with any stapled gastrojeju- Surgery, Copyright © 2010.
nostomy, care must be taken to ensure that no tubes, such as
nasogastric tubes or temperature probes, remain within the CEEA Stapler, Covidien, Mansfield, MA). Before deploying
stomach before creating the pouch, as they are at risk for the EEA, the mesentery of the Roux limb should be inspected
division by the GIA stapler. Such an oversight may result in to ensure that it is oriented properly. The EEA is fired and
staple-line disruption, leak, and retained tube fragment. removed.
The gastrotomy is approximated with three tacking The open end of the Roux limb is then excised again using
sutures and closed with an application of the Endo GIA the Endo GIA Universal Stapler but with the shorter, 2.5-mm
Universal Straight Stapler with the blue 3.5-mm load white staples (Fig. 5). The anastomosis is reinforced with
(Covidien, Mansfield, MA). Finally, the EEA is placed several absorbable horizontal mattress sutures in order to
through a port site and once within the Roux limb it is mated decrease tension. The gastrojejunostomy is then tested for
with the anvil (Fig. 4). We use a 25-mm anvil with the Tilt- leaks by injecting methylene blue via a nasogastric tube.
Top feature that increases the ease of removal (Premium Plus Alternatively, endoscopic insufflation may be performed,
25. Gastric Bypass: Transgastric Circular Stapler Technique 237
12. Hamilton EC, Sims TL, Hamilton TT, Mullican MA, Jones DB, stenosis after laparoscopic gastrojejunal anastomosis in morbid
Provost DA. Clinical predictors of leak after Roux-en-Y gastric obesity. Surg Obes Relat Dis. 2012;8(2):230–5.
bypass. Surg Endosc. 2003;17:679–84. 20. Alasfar F, Sabnis AA, Liu RC, Chand B. Stricture rate after laparo-
13. Nguyen NT, Goldman C, Rosenquist CJ, et al. Laparoscopic versus scopic Roux-en-Y gastric bypass with a 21-mm circular stapler: the
open gastric bypass: a randomized study of outcomes, quality of Cleveland Clinic experience. Med Princ Pract. 2009;18(5):364–7.
life, and costs. Ann Surg. 2001;234:279–91. 21. Nguyen NT, Stevens CM, Wolfe BM. Incidence and outcome of
14. Higa KD, Boone K, Ho T. Complications of the laparoscopic Roux- anastomotic stricture after laparoscopic gastric bypass. J
en-Y gastric bypass: 1,040 patients: what have we learned? Obes Gastrointest Surg. 2003;7(8):997–1003.
Surg. 2000;10:509–13. 22. Suggs WJ, Kouli W, Lupovici M, Chau WY, Brolin
15. De Maria EJ, Sugerman HJ, Kellum JM, Meador JG, Wolfe RE. Complications at gastrojejunostomy after laparoscopic Roux-
LG. Results of 281 consecutive total laparoscopic Roux-en-Y gas- en-Y gastric bypass: comparison between 21- and 25-mm circular
tric bypass to treat morbid obesity. Ann Surg. 2002;235:640–7. staplers. Surg Obes Relat Dis. 2007;3(5):508–14.
16. Schauer PR, Ikramuddin S, Gourash W, Ramanathan R, Luketich 23. Fisher BL, Atkinson JD, Cottam D. Incidence of gastroenterostomy
J. Outcomes after laparoscopic Roux-en-Y gastric bypass for mor- stenosis in laparoscopic Roux-en-Y gastric bypass using 21- or
bid obesity. Ann Surg. 2000;232:515–29. 25-mm circular stapler: a randomized prospective blinded study.
17. Barba CA, Butensky M, Lorenzo M, Newman R. Endoscopic dila- Surg Obes Relat Dis. 2007;3(2):176–9.
tion of gastroesophageal anastomosis stricture after gastric bypass. 24. ACS BSCN Bariatric Surgery Database.
Surg Endosc. 2003;17:416–20. 25. Scott JD, Cobb WS, Carbonell AM, Traxler B, Bour ES. Reduction
18. Gonzalez R, Lin E, Venkatesh KR, Bowers SP, Smith in anastomotic strictures using bioabsorbable circular staple line
CD. Gastrojejunostomy during laparoscopic gastric bypass: analy- reinforcement in laparoscopic gastric bypass. Surg Obes Relat Dis.
sis of 3 techniques. Arch Surg. 2003;138:181–4. 2011;7:637–43.
19. Markar SR, Penna M, Venkat-Ramen V, Karthikesalingam A, 26. Jones DB, Maithel SK, Schneider BE. Atlas of minimally invasive
Hashemi M. Influence of circular stapler diameter on postoperative surgery. Woodbury: Cine-Med; 2006. p. 298–332.
26
Laparoscopic Gastric Bypass: Hand-Sewn
Gastrojejunostomy Technique
Kelvin D. Higa and Cyrus Moon
The minimally invasive revolution began in 1993 when a hand-sewn anastomosis to the Roux limb can be performed.
Wittgrove, Clark, and Tremblay first performed a proximal This technique has been reproduced and adopted by many
gastric bypass laparoscopically [1]. Later, they were able to centers, but is not as popular as the stapled techniques. The
show that this technique was viable and produced weight long learning curve and inexperience with advanced laparo-
loss and reduction in comorbidities equal to or better than scopic suturing are the major drawbacks. However, once
many open series [2]. Discussed elsewhere in this text, the mastered, these techniques enable the surgeon to resolve
laparoscopic/endoscopic anvil placement technique for cre- almost all complications related to bariatric surgery, or other
ation of the gastrojejunal anastomosis was the foundation for complex foregut surgery for that matter, laparoscopically,
most other procedures that followed. Initial anastomotic and with a greater degree of precision. This technique also
leakage rates of up to 5 % were observed [3]; however, the allows the surgeon to achieve an operative efficiency that
rates decreased with experience [4]. surpasses the open equivalent.
In 1999, de la Torre and Scott [5] published a series of With the discovery and delineation of enteric hormones,
laparoscopic Roux-en-Y gastric bypass procedures using a such as gastrin, GLP-1, and PYY, the hypothesized mecha-
totally intra-abdominal approach for the formation of the nisms of action of the gastric bypass fit better with our long-
gastrojejunal anastomosis with a circular stapler [5]. standing clinical observations [10]. The effect on the
Champion, and later Schauer et al. [6], developed the linear individual patient, by whatever means, is reproducible—but
cutter technique that obviates the need for transoral passage these proposed mechanisms also explain the variability of
of instrumentation, thus avoiding the potential for esopha- the response of each individual as well as the consistent
geal injury while creating a stable, calibrated anastomosis. response of the group given the wide range of anatomic vari-
In 1996, my group began the development of the hand- abilities in the anatomic construct.
sutured technique because of our concerns regarding failure Gastric reservoir volumes can vary widely among differ-
rates of stapled anastomoses; we performed our first proce- ent surgeons, as much as 500 %; yet, this variance does not
dure in 1998 [7]. The design of the procedure paralleled the appear to affect weight loss outcomes. Likewise, creating a
open Roux-en-Y procedures that we were performing. Based 150-cm Roux limb does not impart greater effect than that
on this experience and extrapolation of theories of gastric one of 75 cm. Although there are studies that have shown the
pouch formation [8], we adopted the basic configuration short-term benefit of pouch and/or stoma reduction and
described by MacLean et al. [9]. Knowing that small changes lengthening of the Roux limb to enhance weight loss, results
in anatomy or technique might have pronounced effects in have been inconsistent, without long-term benefit.
short- and long-term results and complications, it was impor- The best predictor of success seems to be the genetic sim-
tant for us to emulate the open configuration as closely as ilarity among related individuals, rather than environmental
possible, given the limitations of available laparoscopic factors [11]. The performance of the gastric bypass may not
instrumentation at that time. be influenced as strongly by the compliance of the patient as
The basis for this technique is the formation of a linear, it seems to be with the adjustable gastric band and may be
vertically oriented pouch excluding the distensible fundus of predetermined by the genetic and biological nature of each
the stomach. This provides a serviceable platform for which individual patient.
had previous procedures, pelvic or otherwise—this area is than perpendicular to the abdominal wall. It must be
rarely affected with intra-abdominal adhesions from com- 12 mm to accommodate the stapler that will define the
mon open procedures. This allows dissection of midline inferior gastric pouch.
adhesions, inspection of the size of the liver, and determi- 4. Left-inferior trocar (12 mm)—This is often at the same
nation of the best level for the primary optical port. This level as the primary optical trocar and in the same line as
will also be the primary port for vertical stapling of the the initial trocar. This will be the primary stapler entry site
gastric pouch. Once adhesions are mobilized, then the opti- for the jejunojejunostomy and, along with the right upper
cal port can be thoughtfully placed as to see the ligament of quadrant trocar, will triangulate very well for a comfort-
Treitz as well as the hiatus without having to “turn around.” able manual gastrojejunostomy.
Also, by keeping the initial entry away from the midline, 5. Liver retractor—The most consistent placement appears
the vena cava and aorta are not as vulnerable to injury. to be the subxiphoid. A 5-mm trocar can be used here,
2. Primary optical trocar (12 mm)—Its placement has been depending on the liver retractor of choice. We have found
described above. Optimal placement allows for forward that a simple 5-mm instrument or similar device will pro-
visualization of the proximal small bowel and the hiatus. vide excellent exposure and therefore is often placed
Once this trocar is placed, the camera is moved to this port without a trocar, through direct puncture, as it will not be
for subsequent trocar placement. I have not found the current removed until the end of the case.
5-mm scopes to provide enough light delivery and therefore
resolution for optimal visualization in most patients.
3. Right-sided trocar (12 mm)—This trocar must be placed
thoughtfully just as all others. Exterior landmarks are The Bypass
irrelevant. It must come in below the liver edge, just to the
right of the midline so as to be able to triangulate on the The omentum is displaced cephalad to expose the ligament
hiatus as well as the ligament of Treitz; therefore, it of Treitz. In patients whose omentum is adherent to pelvic
should be angled toward the root of the mesocolon, rather structures or involved in an incarcerated ventral hernia, we
242 K.D. Higa and C. Moon
enter the lesser sac through the gastrocolic omentum and free an already complicated procedure. Our studies have not
the posterior gastric adhesions up to the esophageal hiatus. shown that preoperative endoscopy accurately predicts the
This protects the pancreas and the occasional tortuous absence of a hiatal hernia; the only way to determine its pres-
splenic artery from inadvertent injury. After this, the lesser ence is through circumferential dissection of the esophagus.
curve, perigastric dissection can be performed with more The absence of the “anterior” dimple is not reliable as the
confidence and placement of the stapler more precisely as hernia space is often taken up by a large paraesophageal
not to “twist” the stomach pouch. This occurs when posterior lipoma that can be easily reduced into the abdomen once
gastric adhesions prevent the initial horizontal stapler from identified. Once identified, the hiatal hernia is best repaired
capturing equal amounts of anterior and posterior gastric posteriorly.
wall. The resultant twist is not as critical as in the gastric The question remains: “Is it important to repair every hia-
sleeve but is not aesthetically pleasing. tal hernia at the time of gastric bypass?” The answer is not
Controversy exists as to whether or not to dissect the hia- clear. If one assumes that precise dissection and formation of
tus and repair a hiatal hernia when present. Autopsy studies the gastric pouch is important to limit postoperative compli-
show that a hiatal hernia is present in up to 70 % of individu- cations, then it would be appropriate to absolutely identify the
als, similar to our observations. However, dissection of the location of the gastroesophageal junction, often hidden in a
hiatus can add additional time and potential complications to “sea of fat,” to better perform more consistent reconstruction.
244 K.D. Higa and C. Moon
It has been our observation that almost 100 % of patients we secondary to nausea [19]. A normal postoperative upper gastro-
have reoperated after gastric bypass have a significant hiatal intestinal (UGI) study should not preclude the surgeon’s inter-
hernia at the time of reoperation—something not appreciated vening based on clinical suspicion of a leak [20].
at the time of the first intervention. Patients are started on clear liquids on the day of surgery
Dissection of the hiatus and repair of the hiatal hernia and are required to ambulate with assistance. Preoperative
along with removing the fat pad overlying the angle of His oral medications can be resumed as soon as the patient can
may allow for more precise and consistent pouch formation tolerate clear liquids. Almost all patients are discharged by
and subsequent better long-term performance and lower the second postoperative day; the majority leave on the first
complications, but this has not been proven. Although this postoperative day.
may add up to 5–10 min of operative time, which is signifi- Patients are continued on a clear liquid diet for 1 week
cant, the added exposure may make for a safer operation. and slowly advanced to solids over a 3- to 4-week period.
Each surgeon will need to evaluate this perception in the con- Patients are instructed to take either an H2 blocker or proton
text of his or her individual experience and skill level. Suffice pump inhibitor for 30 days. Routine follow-up visits are at 1,
it to say, to perform a good laparoscopic gastric bypass, the 3 weeks, and quarterly for the first year and then on a yearly
surgeon must be expert at hiatal dissection. basis. Ongoing nutritional, emotional, and exercise counsel-
ing and support groups are provided. Complete nutritional
assessment occurs on a yearly basis or when symptoms or
The Anastomosis clinical suspicion dictates.
TABLE 2. Complications of 242 study patients and 65 patients evalu- These may occur immediately postoperatively or many years
ated during POY 10 after the procedure. Primarily due to migration of bowel
242 study 65 patients evaluated through an open mesenteric defect, this phenomenon can be
Morbidity patients, n (%) during POY 10, n (%) difficult to detect in the absence of overt bowel obstruction.
Early Often, patients complain of intermittent, severe, postprandial
Incomplete division of the 4 (1.7) abdominal pain, but noninvasive radiographic studies are
stomach completely normal in at least 50 % of cases. Diagnostic lapa-
Staple-line failure 2 (0.8)
Thermal injury with perforation 1 (0.4)
roscopy must be performed based on clinical suspicion, and
Marginal ulcer perforation 1 (0.4) reduction and repair of the defects are straightforward [28].
Bleeding, observation 1 (0.4) 1 (1.5) The prevention of internal hernias requires meticulous
Deep venous thrombosis 1 (0.4) closure of all potential defects with a nonabsorbable suture
Stenosis, gastrojejunostomy 12 (5.0) 4 (6.2) material. Some surgeons have brought the Roux limb
Stenosis, mesocolon 1 (0.4)
Fever 1 (0.4)
antecolic in hopes that the most common cause of small
Readmission 5 (2.1) 1 (1.5) bowel obstruction, that of transmesocolic herniation, is elim-
Hypoglycemia 1 (0.4) 1 (1.5) inated. However, the large resulting Petersen’s space and the
Central pontine myelinolysis 1 (0.4) jejunal mesentery defects are still potential sites that need to
Subtotal 31 (12.8) 7 (10.8) be addressed [29]. Our current internal hernia rate has stabi-
Late
Internal hernia 39 (16.1)
lized at 1 %, utilizing nonabsorbable continuous closure of
Marginal hernia 11 (4.5) 5 (7.7) all potential hernia spaces.
Gastrogastric fistula 1 (0.4) 1 (1.5) Proximal anastomotic leaks or staple-line disruptions are
Biliary requiring 17 (7.0) 12 (18.5) tolerated poorly by the bariatric patient. Leaks are often sub-
cholecystectomy tle in their initial presentation; the only indication may be
Alcohol dependency 6 (2.5) 5 (7.7)
Other substance abuse 1 (0.4)
sustained tachycardia (>120/min). Typical symptoms of
Hernia, trocar 3 (1.2) 1 (1.5) abdominal pain, fever, or leukocytosis can be indistinguish-
Subtotal 78 (32.2) 24 (36.9) able from cardiac events, pulmonary embolism, acute gastric
Total 109 (45.0) 31 (47.7) distention, or hemorrhagic shock. Morbidly obese patients
Data in parentheses are percentages have little cardiopulmonary reserve; therefore, time to treat-
POY postoperative year ment is critical. Workup and evaluation must be expeditious
and directed by clinical suspicion. If a leak is suspected,
TABLE 3. Incidence of gastrojejunal stenosis reexploration, usually laparoscopically, is the only definitive
Author n Stenosis: n (%)
method to rule it out.
At surgery, there should be an attempt to identify and
Wittgrove et al. [4] 1,000 40 (4.0)
Schauer et al. [6] 275 13 (4.7) repair the defect, knowing that it will sometimes fail.
Higa et al. [33] 1,500 73 (4.9) Operative endoscopy is often helpful in identifying the leak
Champion et al. [34] 63 4 (6.3) and evaluating the repair. Drainage is essential, and enteric
De Maria et al. [35] 281 18 (6.6) access via a gastrostomy tube in the gastric remnant can be
established at this time. This prevents gastric distention and
TABLE 4. Internal hernia data (2,805 patients) can later be used as a conduit for nutritional support.
Venous thromboembolism is the primary cause of death
Location n Percent
in most series. Surprisingly, given the physical attributes
Mesocolon 61 2.2 of the patient population, comorbid conditions, and nature
Jejunojejunostomy 41 1.5 of the operation (position, prolonged operative times, and
Petersen’s 13 0.5 so forth), this is a rare occurrence. The use of both mechan-
Multiple sites 13 0.5 ical and pharmacologic prophylaxis along with early
Total 128 4.6 mobilization made possible by the elimination of incisional
246 K.D. Higa and C. Moon
pain likely contributes to these outcomes. The use of pro- 2. Wittgrove AC, Clark GW. Laparoscopic gastric bypass: a five-year
phylactic vena cava filters should be limited to patients prospective study of 500 patients followed from 3–60 months. Obes
Surg. 1999;9:123–43.
with previous pulmonary embolism or significant pulmo- 3. Wittgrove AC, Clark GW, Schubert KR. Laparoscopic gastric
nary hypertension. bypass, Roux-en-Y: technique and results in 75 patients with 3–30
month follow-up. Obes Surg. 1996;6:500–4.
4. Wittgrove AC, Endres JE, Davis M, et al. Perioperative complica-
Management of Late Complications tions in a single surgeon’s experience with 1,000 consecutive lapa-
roscopic Roux-en-Y gastric bypass operations for morbid obesity.
Obes Surg. 2002;12:457–8 (abstr L4).
The use of tobacco or nonsteroidal analgesic agents contrib- 5. de la Torre RA, Scott JS. Laparoscopic Roux-en-Y gastric bypass:
utes to marginal ulceration. Patients present with abdominal a totally intra-abdominal approach: technique and preliminary
pain, dyspepsia, and occasionally bleeding. The diagnosis report. Obes Surg. 1999;9:492–8.
can be made radiographically, but endoscopy is often 6. Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after lapa-
roscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg.
required for evaluation and treatment of an associated gastro- 2000;232:515–29.
jejunal stenosis or for control of bleeding. 7. Higa KD, Boone KB, Ho T, et al. Laparoscopic Roux-en-Y gastric
Perforated marginal ulcers are amenable to laparoscopic inter- bypass for morbid obesity: technique and preliminary results of our
vention. The absence of significant intra-abdominal adhesions first 400 patients. Arch Surg. 2000;9:1029–33.
and the anterior location of the anastomosis allow for a rela- 8. Mason EE, Maher JW, Scott DH, et al. Ten years of vertical banded
gastroplasty for severe obesity. In: Mason EE, guest editor; Nyhus
tively simple closure and omental patch. Operative endoscopy LM, editor-in-chief. Surgical treatment of morbid obesity. Problems
is helpful in these cases to rule out gastrogastric fistulas and to in general surgery series, Vol. 9. Philadelphia: Lippincott, 1992.
evaluate the gastrojejunal anastomosis and repair. p. 280–9.
Protein, vitamin, and mineral deficiencies are relatively 9. MacLean LD, Rhode BM, Forse RA. Surgery for obesity: an update
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10. Evans S, Pamuklar Z, Rosko J, Mahaney P, Jiang N, Park C,
vented by simple vitamin and calcium supplementation, few Torquati A. Gastric bypass surgery restores meal stimulation of the
patients are compliant. This continues to be a challenge as anorexigenic gut hormones glucagon-like peptide-1 and peptide
well as long-term follow-up for most programs. YY independently of caloric restriction. Surg Endosc. 2012;26(4):
Inadequate initial weight loss and weight recidivism are 1086–94.
often attributable to the lack of patient compliance and/or 11. Hatoum IJ, Greenawalt DM, Cotsapas C, Reitman ML, Daly MJ,
Kaplan LM. Heritability of the weight loss response to gastric
participation in postoperative programs. However, as the bypass surgery. J Clin Endocrinol Metab. 2011;96(10):1630–3.
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individual is irrational. The durability of our interventions, 13. Higa KD, Boone KB, Ho T. Complications of the laparoscopic
alone, indicates a biological rather than mechanical mecha- Roux-en-Y gastric bypass: 1,040 patients—what have we learned?
Obes Surg. 2000;10:509–13.
nism—we should expect a response curve similar to all inter- 14. Westling A, Bergvist D, Bostrom A, et al. Incidence of deep venous
ventions. This is exactly what we observe—up to 20 % of thrombosis in patients undergoing obesity surgery. World J Surg.
patients fail to obtain their target weight or resolve their 2000;26:470–3.
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nary results. This is unpredictable and adds to the frustration bypass in the super obese: a prospective randomized trial. Ann
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shared by the patient and surgeon. 16. Champion JK. Small bowel obstruction after laparoscopic Roux-
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18. Iannelli A, Facchiano E, Gugenheim J. Internal hernia after laparo-
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intestinal Gastrografin swallow after laparoscopic Roux-en-Y gas-
the proximal gastric bypass. tric bypass. Obes Surg. 2003;13:66–72.
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27
Laparoscopic Gastric Bypass Using Linear
Stapling Technique
Bruce D. Schirmer
Roux-en-Y gastric bypass (RYGB), originally described by account for the changes (Pories article [5]). RYGB causes
Mason [1] as a loop technique, was later modified by him to loss of the pyloric restriction of slow release of food into the
a Roux limb, the technique of which was further popularized duodenum. Rapid passage of food into the Roux limb will
by Griffin [2]. MacLean [3] and others confirmed that divid- produce dumping syndrome if the food is highly osmotic
ing the stomach was superior to simply stapling it, eliminat- (sweets especially). It has also been shown that the rapid pas-
ing the potential for staple line breakdown causing loss of sage of food into the more distal gut will cause the release of
restrictive capacity of the operation. Gastric bypass then GLP-1 with consequent improvement of insulin sensitivity
underwent few major revisions until Wittgrove and Clark [4] and thereby type II diabetes (Mason or some other articles
first described the operation being performed laparoscopi- about GLP-1 release and action [6, 7]). The complete picture
cally. That is the approach now used in the vast majority of of the metabolic effects of RYGB on carbohydrate metabo-
procedures. lism, fat metabolism, and gut adjustments to digestion is still
The operation has been the gold standard procedure for being studied, and certainly will be more complex than just
bariatric surgery since the 1970s in the United States. It has the changes in GLP-1 release. Effects on satiety, gut flora
proven to provide durable weight loss through largely a alteration, and changes in the inflammatory response con-
restrictive mechanism. The small proximal gastric pouch tributing to metabolic syndrome are all areas that will
restricts food intake dramatically initially. Adaptation allows contribute to understanding the effectiveness and changes
the pouch to empty more quickly, and later patients may and that occur after performance of RYGB.
do eat more. Long-term success is maintained only with a While it would be optimal for comparing outcomes to
change in patient diet and exercise habits. These are often have all RYGB operations performed in a standard fashion,
easily adapted during the first year after surgery when weight unfortunately that has not been the evolution of the opera-
loss is dramatic, appetite is suppressed, food intake is lim- tion. Surgeons all have some variability in how they perform
ited, and patients experience a major change in overall well- the procedure. Some have placed a restrictive band [8] or an
being, body habitus improvement, improvement of major adjustable band [9] around the proximal gastric pouch. Other
associated medical problems, and improvement in activities variables include the length of the Roux limb, anatomic posi-
of daily living. Most patients are motivated enough by these tioning of the Roux limb relative to the stomach and trans-
improvements to maintain these gains through revised eating verse colon, size of the proximal gastric pouch, size of the
and exercise habits. A minority, however, may regain weight gastrojejunal anastomosis between that pouch and the Roux
as time passes. limb, and the way in which this anastomosis is created.
While simple restriction certainly explains the major rea- Despite these variations in the actual performance of
son for weight loss and thereby improvement of weight- RYGB, the main principles that are important to the success-
associated medical problems, the anatomy of RYGB also ful performance of the operation have emerged as being food
produces profound improvement in some medical problems, restriction and bypassing the proximal gut with rapid pouch
especially type II diabetes, that weight loss alone cannot emptying. Anatomically, then, the operation should be con-
structed so as to maximize these principles. The performance
of the operation as I perform it at the University of Virginia
will now be briefly described, emphasizing the use of the
Electronic supplementary material: Supplementary material is available
in the online version of this chapter at 10.1007/978-1-4939-1637-5_27. linear stapling technique for performance of the proximal
Videos can also be accessed at http://www.springerimages.com/videos/ anastomosis (the gastrojejunostomy) of the operation. This
978-1-4939-1636-8. technique is now my standard method of performing the
Port Placement
The advent of articulating linear staplers has caused us to FIG. 1 Placement of ports for laparoscopic Roux-en-Y gastric
modify our port placement slightly. The surgeon now may bypass with linear stapling technique
more easily use a right-hand-dominant stapling technique,
and the left-hand port does not need to be a 12-mm size. The
adjustability of the stapler now allows the surgeon to more
easily work with both ports located in the right upper quad-
rant. The assistant still benefits from having one 12-mm port
in the left upper quadrant, as we do a double-stapling tech-
nique for the distal anastomosis (jejunojejunostomy). A sec-
ond 5-mm port for the assistant is located lower in the left
upper quadrant. The 12 mm camera port is located in the
umbilical region, with some variability based on body habi-
tus. For a longer torso individual, for example, a supraum-
bilical location is needed. A liver retractor is placed in the
epigastric region. Port placement is shown in Fig. 1.
Distal Anastomosis
This is performed first, as the patient is already supine. A vari-
able-length Roux limb is created, based on patient BMI and FIG. 2 Passing the Roux limb through the transverse colon mesen-
visceral adiposity. Greater levels of one or both parameters are tery for a retrocolic-retrogastric placement of the Roux limb
an indication for a longer Roux limb (150 cm or longer range).
The linear stapler (white load) is used to divide the bowel and
the harmonic scalpel is used to divide the mesentery down to
near its base, mobilizing the Roux limb as much as possible yet ligament of Treitz is often relatively avascular, being to the
avoiding too deep a division of the mesentery to cause hemor- patient’s left of the middle colic vessels. Variability in the
rhage from major and larger proximal mesenteric vessels. Once mesenteric arcade exists, and this step is performed with a
the length of Roux limb is determined, a linear double-stapling harmonic scalpel. Once the mesenteric opening has been cre-
technique (two white loads) with suturing of the stapler defect ated, the stomach is grasped and pulled down to the level of
is used for the distal anastomosis. The mesenteric defect is then the defect, and the retrogastric space is cleared of adhesions
closed using a running permanent suture. if present. Then the Roux limb is passed into the retrogastric
space (Fig. 2). It is critical to keep the mesentery of the Roux
limb correctly oriented and prevent the limb from twisting,
Passing the Roux Limb which would result in ischemia and breakdown of the anas-
tomosis. We usually attach a Penrose drain to the most proxi-
In order to create a retrocolic and retrogastric anastomosis, a mal end of the Roux limb to help with this passing of the
defect is created in the transverse colon mesentery as it is Roux limb into the retrogastric space as well as later retrieval
displayed on a stretch. The area just to the left and above the from that space.
27. Laparoscopic Gastric Bypass Using Linear Stapling Technique 251
Once the gastric pouch has been created, the distal stomach
is elevated along its newly created staple line to look into the
retrogastric region. This allows identification of the Penrose
drain and the Roux limb. The drain is used to draw the limb
up adjacent to the proximal gastric pouch, with the staple
line facing inferiorly toward the patient’s feet (Fig. 4). The
very end of the Roux limb is usually less mobile than the
several inches beyond it, and thus this slightly more distal
FIG. 3 Creation of the proximal gastric pouch starts 1–3 cm above part of the Roux limb is more easily brought up adjacent to
the incisura on the lesser curvature side of the stomach. (a) First the proximal portion of the gastric pouch. Beginning 6–7 cm
staple firing; (b) subsequent staple firing from the end of the Roux limb, the side of the Roux limb
adjacent to the gastric pouch is sewn to the gastric pouch
staple line, with the suture ending at the proximal end of the
Roux limb and the inferior end of the gastric pouch, which
Creation of the Proximal Gastric Pouch are now adjacent to each other (Fig. 5). The Penrose drain is
removed as this suturing occurs. The end of the suture line
is left long temporarily.
This step is performed using the linear stapler, beginning by Once the Roux limb is thus secured to the proximal pouch,
first stapling at right angles to the lesser curvature above the then the anesthesiologist passes an Ewald tube, which is a
incisura, with the length of the pouch determined by each gastric lavage tube that is 36 Fr in size. This tube is advanced
patient’s anatomy. Excellent mobilization of the Roux limb carefully under monitored observation by both the surgeon
and a smaller patient allow the pouch to be created begin- and the anesthesiologist, so it can be positioned with the tip
ning more proximal on the lesser curvature, perhaps 5–6 cm at the distal end of the proximal gastric pouch and no further
below the gastroesophageal junction (Fig. 3). However, we (to avoid injury to the pouch). Then the harmonic scalpel is
have found with larger patients or patients with less mobile used to create a gastrotomy, using the Ewald tube as a back-
Roux limbs that creation of a longer proximal gastric pouch, stop (Fig. 6). We have found that creation of a full-thickness
even down to the incisura if necessary, is safer and allows gastrotomy of adequate size is essential to facilitating the
a tension-free anastomosis while still preserving excellent insertion of the jaw of the stapler for the anastomosis. One
weight loss. Indeed, the proximal gastric pouch in these must avoid creation of a false passage within the wall of the
patients begins to resemble the proximal portion of a sleeve stomach which may occur if an inadequate opening not com-
gastrectomy. The surgeon and anesthesiologist must remem- pletely through the mucosa is created. An opening is made in
ber that removal of all tubes within the gastric lumen is the Roux limb directly opposite the gastrotomy. Then a blue
mandatory before the initiation of gastric stapling and load of the 45-mm linear stapler is inserted full length into
division. the two openings (Fig. 7), creating an anastomosis with one
FIG. 4 Passing the Roux limb using the Penrose drain to bring the proximal end of the Roux limb down and adjacent to the distal end of
the proximal gastric pouch
252 B.D. Schirmer
FIG. 5 The Roux limb has now been sewn to the side of the proximal FIG. 8 The stapler defect is now closed beginning at the end where
gastric pouch to align them appropriately for the anastomosis the stapler was inserted, as this area of the defect is most difficult to
expose and best closed first. A running suture is used to close the
defect
TABLE 1. Outcomes for bariatric operations represent diseases among the spectrum of comorbid medical
LAGB RYGB BPD/DS problems which have been hypothesized by Sugerman to
% EWL 47.5 61.6 70.1 arise from increased abdominal pressure [25]. The fact that
% mortality 0.1 0.5 1.1 there is an inflammatory component to many of these comor-
% morbidity 10–25 13–38 27–33 bid problems, as a result of the pressure, further supports this
% nutritional morbidity 0–10 15–25 40–77 hypothesis. Metabolic studies have now shown inflammatory
LAGB laparoscopic adjustable gastric banding, BPD/DS biliopancreatic components to the cardiovascular, glucose intolerance, renal
diversion/duodenal switch. Adapted from Buchwald et al. [7] dysfunction, and hyperlipidemia dysfunction present in the
severely obese patient population. The metabolic syndrome
much symptom based without objective parameters of is characterized by a constellation of medical conditions, all
measurement. Certainly, however, all bariatric surgeons are of which are felt to include an inflammatory component in
witnesses to frequent testimonies by patients of marked their etiology. The metabolic syndrome is well treated by
improvement in their joint and back pain. Improved mobility RYGB, with resolution in 45 % of patients reported in one
is enjoyed by many of the patients and often conversions large series of diverse backgrounds [26].
from wheelchair-bound to ambulatory status are not infre- In one recent study, LRYGB was shown to decrease the
quently seen in this patient population after RYGB. measured amount of urinary and serum inflammatory mark-
Gastroesophageal reflux disease (GERD) is symptomati- ers, as well as mean arterial pressure. It is hypothesized by the
cally present in mild degrees in approximately one half of authors that the improvements seen in renal function, protein-
patients with severe obesity and has been objectively proven uria, and hypertension after RYGB are related to weight loss-
to be present in 55 % in one study [21]. In another study in induced decrease in these inflammatory factors [27].
which anatomic and physiologic assessments were done of Overall quality of life has been measured in numerous
patients planning RYGB, the incidence of GERD was 64 % reports of patients undergoing open and LRYGB. Schauer
[22]. In that study, the incidence of postoperative GERD et al. [28] showed an improved quality of life for patients
decreased to 33 % and median acid exposure of the esopha- undergoing LRYGB, and Nguyen et al. [29] showed that
gus from 5.1 to 1.1 %. The improvement postoperatively was SF-36 and BAROS score improvement was even greater than
somewhat decreased by a persistent and new onset of the improvement seen after open RYGB.
regurgitation in some patients. RYGB offers an anatomic Open gastric bypass has traditionally provided patients
advantage to treating this disease, in that the large-volume with weight loss in the range of 60–70 % of excess weight at
stomach is no longer connected to the esophagus. Instead, 1 year after surgery. Studies looking at outcomes from the
the very-small-volume proximal gastric pouch can be the era of open surgery reported this figure to be in the 60–65 %
only source of acid reflux. As a result, the incidence of reso- range [7]. Longer-term follow-up data show that some
lution or improvement of GERD after RYGB is quite high. patients regain weight. However, the recidivism of weight
This has actually made RYGB the treatment of choice for regain tends to decrease after 10 years, and studies have
patients with severe GERD and a BMI over 40. Resolution of shown that RYGB and other procedures produce long-term
symptoms in that patient population postoperatively is high durable weight loss [5, 8].
and moreover is higher in the long term than patients treated Mortality after open RYGB was traditionally reported as
with antireflux surgery, who due to their obesity and its between 1 and 2 % in the literature [30, 31]. A combination
associated increase in intra-abdominal pressure develop of many factors has now caused that number to have dropped
recurrence of symptoms and hiatal hernia more frequently to one-tenth its value in current practice.
than normal-weight individuals. Complications after open RYGB were also reported as
Venous stasis ulcers were shown by Sugerman et al. [23] being higher than they are today. The differences, however,
to be effectively treated with RYGB in over 90 % of cases. could be variable depending on whether a study included
These patients, however, were noted to have higher risk fac- long-term complications such as incisional hernia, bowel
tors, more severe comorbidities, and higher death and com- obstruction, and marginal ulcer, to name a few common
plication rates than the general population of patients ones. The transition from open surgery to laparoscopic sur-
undergoing RYGB. gery drastically reduced the serious wound complications
and virtually eliminated the problem of incisional hernia
Pseudotumor cerebri is present in perhaps 1 % of patients
after RYGB. The latter, in our institutional experience, was
with morbid obesity. However, when present, it is especially
approximately 33 % if patients were followed carefully for a
well treated with bariatric surgery. Reports of its almost
decade. Table 2 shows data from the University of Virginia
100 % resolution of RYGB have been documented in the
comparing the first 5 years of our laparoscopic experience
literature [24]. The key to its treatment is appreciation by a
with performing gastric bypass versus the previous 15 years’
neurologist or neurosurgeon of the value of weight loss in
experience with open surgery. Notable is the decrease in
eliminating the condition.
postoperative wound and incisional hernia complications,
Pseudotumor cerebri as well as stress urinary incontinence, which consequently results in a huge difference in the overall
another condition which responds well to weight loss therapy, complication rates of RYGB versus LRYGB. The second
28. Outcomes After Laparoscopic Gastric Bypass 257
TABLE 2. Outcomes for laparoscopic versus open RYGB (University TABLE 3. Factors which are likely responsible for the improvement
of Virginia 1994–2004) in outcomes of gastric bypass over the past decade
Characteristics LRYGB ORYGB p value 1. Use of a laparoscopic approach to perform the operation
Number of patients 765 363 2. Change in patient population to include patients with lower BMI and
Preoperative BMI (kg/m2) 50.9 ± 0.3 57.5 ± 0.5 <0.001 less comorbidities
Number of comorbidities 2.7 ± 0.1 3.6 ± 0.1 <0.001 3. Increased volume of the procedure resulting in increased surgeon
30-day mortality 2 (0.3 %) 6 (1.7 %) <0.02 experience
Overall complications 111 (14.5 %) 208 (57.3 %) <0.001 4. Increased institutional experience
Reoperation 67 (8.8 %) 150 (41.3 %) <0.001 5. Centers of excellence programs monitoring outcomes
Incisional hernia 13 (1.7 %) 123 (33.9 %) <0.001 6. Centers of excellence programs improving facilities and practicing
Wound infection 14 (1.8 %) 27 (7.4 %) <0.001 quality improvement
7. Perioperative protocols and best practices to limit complications
LRYGB laparoscopic Roux-en-Y gastric bypass, ORYGB open Roux-en-Y
gastric bypass. Adapted from Schirmer B, Schauer P. The Surgical
Management of Obesity. In: Schwartz’s Principles of Surgery. 9th edition.
McGraw Hill Medical, New York, 2010, pp. 949–978 of patients receiving medical therapy achieving a glycated
hemoglobin level of 6.0 % or less, while 38 % of patients
important observation is that patients who underwent open undergoing LRYGB achieved it, a highly significant differ-
RYGB were generally heavier and had more comorbid medi- ence. In the Diabetes Surgery Study randomized trial,
cal problems than those undergoing LRYGB. This phenom- patients who had LRYGB added to maximal medical therapy
enon likely has, to some extent, contributed to the decrease for diabetes, hypertension, and hyperlipidemia achieved a
in incidence of morbidity and mortality after gastric bypass 49 % rate of achieving goal objectives of treatment for those
as well as other bariatric and metabolic operations. diseases, whereas the medically treated patients achieved
Institutions besides our own reported an open RYGB only a 19 % rate of success [36].
complication rate in the 15–25 % range, depending on how LRYGB has produced equal or in some reports even
such complications were defined and classified. Recent data- superior weight loss to open RYGB. In the first large series
bases on LRYGB give the complication rates as being reported on the use of laparoscopy to perform gastric bypass,
between 11.79 % for the BOLD database [32] and 15 % for Schauer et al. [28] reported an 83 % excess weight loss
the NSQIP database for cases done from 2007 to 2010 [19]. (EWL) at 2 years after surgery. Since the operation is virtu-
Current NSQIP 30-day complication rates for gastric bypass ally the same as the open procedure, it is likely that any
are as low as 4.7 % for 21,557 entered cases [20]. improvements in this parameter are due in part to patient
population changes, as well as improvements in surgeon
experience and the technology to be able to perform the pro-
Laparoscopic RYGB cedure efficiently. Studies that have looked at weight loss
relative to BMI have usually shown patients in the higher
Outcomes after LRYGB are remarkably improved over those BMI categories will not lose as high a percentage of their
of open RYGB of a decade ago by a decrease in the compli- excess weight as those in lower BMI categories [24]. This
cation rates associated with performance of the procedure. observation persists today with the most recent such reports
The effectiveness of LRYGB in resolving comorbid medical [26]. This likely relates to decreased mobility, increased
problems has also been more carefully documented in larger medical problems, and other issues relative to the larger
patient populations. Metabolic syndrome resolved in 48.7 % patients. LRYGB produces an average BMI loss of 11.87 for
of cases in one large database of over 4,000 patients from the the first year after surgery based on the ACS BSCN data [19].
Kaiser Permanente system [26]. A large meta-analysis of the Our institutional 5-year follow-up data have shown an EWL
bariatric literature that included open gastric bypass (57 % of of 64 % at 5 years after surgery for LRYGB. Studies in the
cases) showed resolution of type 2 diabetes in 80.3 % of literature are generally in this range.
patients who had that condition preoperatively [33]. The The marked decrease in operative mortality and morbid-
ACS BSCN database for cases performed from 2007 to 2010 ity for LRYGB over the past decade is likely multifactorial.
showed a resolution or improvement of diabetes in 83 % of Potential contributing factors are listed in Table 3. Mortality
patients, hypertension in 79 %, OSA in 66 %, and GERD in after LRYGB has decreased significantly from 1 to 2 %
70 % of patients undergoing LRYGB at 1-year follow-up for reported a decade ago for open surgery to the most recent
14,491 cases [19]. Current MBSAQIP database reduction in reports of databases from centers of excellence programs.
morbidities over time for the year 2012 demonstrated com- The most recent report from the BOLD database showed a
parable reductions, within 10 % for all the above parameters. mortality of 0.15 % for gastric bypass, both open and laparo-
The reduction in hyperlipidemia was 61 % and for musculo- scopic, from a database of 81,751 reported RYGB patients
skeletal disease 61.5 % [34]. with 30-day follow-up [37]. The LABS database showed it to
Surgical therapy has been measured against best medical be 0.2 % [38]. Nguyen et al. [39] reported the rate of in-
therapy in treating type 2 diabetes in the STAMPEDE trial hospital mortality for 23,812 patients undergoing LRYGB at
[35]. In that trial, best medical therapy resulted in only 5 % accredited centers of excellence to be 0.06 %.
258 B.D. Schirmer
TABLE 4. Incidence of complications specific to gastric bypass cases being internal hernias. Failure to close mesenteric
Anastomotic leak [19] 0.8 % defects increases the chance of such hernias, but unfortu-
Hemorrhage [42] 1% nately doing so does not preclude their occurrence either
Marginal ulcer [40] 1–3 % [41]. It must be emphasized that, due to the risk of inter-
Internal hernia obstruction [41] 3.8–8.5 % nal hernias, a patient who has had a LRYGB and who
Stenosis of gastrojejunostomy [43] 1–17 %
Iron deficiency [44, 45] 15–50 %
presents with abdominal pain and signs of a mechanical
Vitamin B12 deficiency [44] 11 % bowel obstruction must be emergently evaluated for likely
bowel obstruction, and urgent surgery is indicated.
Conservative therapy is inappropriate and risks the
The BSCN database report showed the 30-day complica- potential for severe bowel ischemia. When surgery is per-
tion rate for nearly 15,000 LRYGB cases to be 5.91 % [19]. formed, the approach is to define the intestinal anatomy
Bariatric-specific complications listed in that report were all retrograde, beginning at the terminal ileum, to allow posi-
low, generally lower than those reported in single-center tive identification of loops of bowel and their relationship.
reports from the previous decade. This may be largely a fac- Bowel obstruction is the single most concerning long-
tor of the 30-day limit in collecting data on complications. term complication after LRYGB.
The only complications noted to be above 1 % within the Postoperative hemorrhage after LRYGB is usually intra-
first month were fluid and electrolyte disturbances and steno- abdominal and of small enough quantity that it is self-limited,
sis causing obstruction. The most concerning complications with a transfusion incidence of approximately 3–4 %.
which do occur after LRYGB include a 1 % incidence of Hemodynamic instability obviously warrants reoperation,
anastomotic leak (0.78 % in the BSCN database) [19], a and hematemesis is also an indication for return to the oper-
1–2 % incidence of venous thromboembolism, and a less ating room for endoscopic injection of bleeding from the
than 1 % incidence of pulmonary embolism. Pulmonary Gastrojejunostomy. Revising the anastomosis is not usually
embolism and sepsis are the leading causes of postoperative necessary or desirable as a treatment for this complication.
death after LRYGB. Table 4 gives a summary of major com- Hemorrhage was observed in approximately 1 % of patients
plications seen after LRYGB based on data from the litera- in review of a large series of over 4,000 patients undergoing
ture. Given the lower overall complication rates that are now LRYGB [42].
being reported in the past 5 years, these numbers may be an The incidence of anastomotic stenosis is variable and is
overestimation of the incidences of the various complica- related to the type of anastomotic stapler used. Circular sta-
tions. Some of them are also derived from reports where plers have a significantly higher risk of postoperative steno-
open and laparoscopic RYGB were performed. sis than do linear staples. Our institutional experience to this
Although large databases such as the BSCN and the effect is given in detail in the chapter on Linear Stapling
BOLD databases are not as accurate in capturing adverse Technique for Gastrojejunostomy in this book. We observed
events and complications after 30 days, the new MBSAQIP a decrease in the incidence of stenosis from 17.4 to 1 % with
database does report the incidence of reoperations for a linear stapling technique. Stenosis at the gastrojejunostomy
LRYGB for successfully followed patients. For the year is amenable to endoscopic balloon dilatation as an effective
2012, that number was 5.9 % [34]. therapy in most cases [43].
A few of the complications specific to and common after Postoperative nutritional complications after LRYGB are
LRYGB warrant slight further discussion. Anastomotic leaks largely based on patient compliance with taking recom-
are the most feared complication after LRYGB, because they mended vitamins and vitamin supplements postoperatively.
can at times present initially with a single unalarming symp- Patients are at risk for iron deficiency after LRYGB.
tom such as tachycardia. A high index of suspicion is always Traditionally there has been a reported incidence of iron defi-
appropriate when a leak is being considered, and operative ciency of 20–40 % after gastric bypass. Recent studies have
therapy is the safest option if in doubt in terms of treatment. shown between a 15 % [44] and a 50 % [45] incidence of
Operative drainage, repair if possible, and provision of an postoperative iron deficiency after RYGB. Vitamin B12 has
enteral feeding access are the hallmarks of the operative been noted to be deficient after LRYGB as well, at 11 % in
treatment of an anastomotic leak. one study [44]. Actual neurologic deficit from B12 defi-
Marginal ulcers have been reported at an incidence ciency is extremely rare after LRYGB. Vitamin D is low in a
between 3 and 15 %, with this wide variability likely based high percentage of the population in general—it was defi-
on the degree to which the problem is investigated. Treatment cient in 57 % of patients at baseline in a review by Toh et al.
is usually medical, but smoking inhibits ulcer healing rates [44]. The incidence is felt to be even higher in the morbidly
dramatically [40]. Preoperative smoking is a contraindica- obese. Thus its routine measurement and supplementation
tion for performing LRYGB in some surgeons’ practices. when levels are low is an appropriate guideline. There is no
The long-term risk of bowel obstruction appears to be clear evidence that LRYGB worsens the incidence of vita-
approximately in the 5–7 % range, with at least half of min D deficiency.
28. Outcomes After Laparoscopic Gastric Bypass 259
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29
Laparoscopic Gastric Bypass: Management
of Complications
Emanuele Lo Menzo, Samuel Szomstein, and Raul J. Rosenthal
Introduction Technical
Roux-en-Y gastric bypass (RYGB) remains the gold stan- Staple Misfiring
dard for surgical weight loss, constituting over half of the
procedure performed. In fact, the number of RYGBs Not accounting for the manufacturing defects of the actual
increased by 125 % from 2004 to 2007 in US academic cen- stapling device, the rest of the staple line misfiring is due to
ters [1]. Also, the approach to gastric bypass changed over- incorrect choices or inappropriate use of the device itself.
time with currently an excess of 85 % of gastric bypasses The key elements in avoiding these problems are adequate
performed laparoscopically. The extensive number of proce- choice of cartridge staple heights (especially if buttressing
dures performed via the laparoscopic approach as well as the material is used), avoidance of bunched up tissue within the
implementation quality improvement initiatives has contrib- jaws of the stapler, careful evaluation of the crossing of sta-
uted to increase the safety and has improved outcomes. ple lines, and appropriate tissue compression time. In gen-
Nevertheless, several complications are still commonly eral, all the staple lines should be carefully evaluated, and
encountered after RYGB, not only by the bariatric surgeon, when in doubt, redo stapling or oversewing should be
but also by the general surgeon, gastroenterologist, and pri- implemented.
mary care provider.
This chapter will review some of the most common com-
plications encountered after gastric bypass surgery, with Positive Air Leak Test
complications divided into intraoperative and postoperative.
Intraoperative air leak test of the Gastrojejunal anastomosis
is currently considered the standard of care during gastric
Intraoperative bypass surgery. The different types of leak test include pneu-
matic (either by gastric tube or endoscope) or blue dye (usu-
The intraoperative complications include technical prob- ally methylene blue).
lems such as bleeding, staple misfiring, positive air leak As previously described by others, the reproducible air leak
test, and nontechnical and anesthesia complications such as is the one that requires intervention [2]. If the actual location
myocardial infarction, deep vein thrombosis, arrhythmias, of the air leak is clearly recognized, suture closure with
allergic reactions, peripheral neuropathies, and rhabdomy- adjuncts of omental patch or fibrin glues or sealants is accept-
olysis (Table 1). able. However, if the site is not clearly identifiable, or the
former intervention is ineffective, redoing the anastomosis is
mandatory. Furthermore, drainage of the area should be con-
Electronic supplementary material: Supplementary material is
available in the online version of this chapter at 10.1007/978-1-
sidered even by surgeons who do not routinely drain anasto-
4939-1637-5_29 . Videos can also be accessed at http://www. mosis. Under these circumstances the need for remnant
springerimages.com/videos/978-1-4939-1636-8 . gastrostomy tube should be individualized, and it should be
TABLE 1. Intraoperative complications of RYGB skeletal muscle and resulting in the release of proteins and
Technical renal tubules damage. Besides the well-known acute renal
Bleeding insufficiency, RML can cause severe hyperkalemia, hypocal-
Staple misfire cemia, compartment syndrome, disseminated intravascular
Positive air leak test coagulation, cardiac arrhythmias, and even death. Its inci-
Anesthesia/medically related complications
Peripheral neuropathy
dence has been reported between 12.9 and 37.8 % [4].
Rhabdomyolysis Contributing risk factors for the development of RML are
Venous thromboembolism male gender, higher BMI (>50 kg/m2), current therapy with
Cardiac arrhythmias, CAD statins, operative time >4 h, and the use of propofol injection.
Hypertensive crisis Propofol infusion syndrome is very rare, but it is more fre-
Hypoxia, hypercarbia
Malignant hyperthermia
quent in obese patients due to the lipophilic characteristics of
Allergic reaction the drug. Careful padding of all pressure points, early patient
mobilization, and reduction of operating room time can con-
tribute to the prevention of this syndrome. The diagnosis is
both clinical and biochemical (increased CPK levels five
considered in the reoperative cases. Also, it is the authors’ times higher than the normal and the presence of myoglobin
strong belief that a postoperative upper gastrointestinal (GI) in the urine). The treatment is mostly supportive with aggres-
study is beneficial in this scenario both from a clinical and sive fluid resuscitation, correction of electrolytes abnormali-
medical legal standpoint. ties, and, in some cases, alkalinization of the urine.
Other common early complications related to anesthesia
and the medical aspects of obesity, such as cardiac complica-
Anesthesia/Medically Related tions, venous thromboembolic events, hypoxia/hypercarbia,
Complications hyperglycemia, and hypertensive crisis, are outside the scope
of this chapter and will be addressed elsewhere.
Peripheral Neuropathies
Postoperative
Most of these perioperative peripheral neuropathies are due
to traction or compression injuries at the time of patient posi- The postoperative complications of gastric bypass surgery
tioning in the operative table. The most common locations can be divided into acute (7 days), early (7 days–6 weeks),
are the brachial plexus (overextension of the arms on the arm late (6–12 weeks), and chronic (>12 weeks).
boards), ulnar neuropathy (from compression at the elbow),
and lower extremities neuropathy. The main symptom is usu-
ally paresthesia. The mechanism of nerve injury is usually Acute (7 Days) and Early
neuropraxia, due to the injury to the endoneurial capillaries
with resulting edema and conduction block. Since there is no (7 Days–6 Weeks)
degeneration of the axon, the return of sensation is rapid and
usually complete within 1 week or less. When the trauma is Leaks
more significant and causes segmental demyelinization, the
functional recovery occurs within few months. Leaks remain the second leading cause of death after RYGB
A rare but typical peripheral neuropathy is meralgia pares- surgery. Potential sites of leaks include the Gastrojejunal
thetica [3]. This is caused by the compression of the lateral anastomosis, gastric pouch, gastric remnant, the jejunal blind
cutaneous nerve against the inguinal ligament. Symptoms end, and the Jejunojejunal anastomosis. Approximately
vary from hypersensitivity and paresthesia to pain in the lat- 70–80 % of the leaks occur at the Gastrojejunal anastomosis,
eral anterior aspect of the thigh. This typically occurs after 10–15 % at the gastric pouch, 5 % at the Jejunojejunal anas-
laparoscopic procedures and tends to resolve spontaneously tomosis, and 3–5 % at the excluded stomach. Factors
with conservative treatment. Occasionally a local nerve involved in the development of these leaks include tension,
block may be helpful in reducing symptoms. ischemia, and staple misfiring. Different techniques have
been described for the Gastrojejunal anastomosis using a cir-
cular stapler, linear stapler (with stapled or hand-sewn clo-
Rhabdomyolysis (RML) sure of the anterior wall), and completely hand sewn. The
available data comparing the techniques has never been able
Rhabdomyolysis is a syndrome caused by injury to the skel- to convincingly show the difference in leak rates of the three
etal muscle. In most cases the pathogenesis is due to ischemia- techniques. A recent collaborative study showed an increased
reperfusion syndrome causing sarcolemmal damage of the incidence of hemorrhage and wound infection with the circular
29. Laparoscopic Gastric Bypass: Management of Complications 263
stapled technique [5]. The other variable potentially involved TABLE 2. Etiology of gastrogastric fistulae. Modified frovm
in the degree of tension on the anastomosis is the route of the R. Rosenthal et al. [10]
Roux limb. Although it is true that the retrocolic-retrogastric Iatrogenic
route is the shortest one, leak rates between this technique Previous anastomotic leaks
and the antecolic-antegastric one have not been definitively Type of operation
Gastric tissue migration
proven to be different. Only one study was able to demon-
Marginal ulcer and perforation
strate a significant difference with higher leak rates of the Foreign body erosion
antecolic (3 %) versus the retrocolic (0.5 %) [6]. Some of the
risk factors associated with higher incidence of leaks include
male gender, super morbid obesity, age >55 years, and revi-
sional procedures [6].
Gastrogastric (GG) Fistula
Unquestionably, an early diagnosis and treatment signifi-
Gastrogastric fistula (GGF) refers to an abnormal communi-
cantly affects the patient outcome, not only in terms of hos-
cation between the excluded gastric pouch and the gastric
pital, and in particular ICU stay, but also in terms of survival.
remnant. The incidence of GGF varies between 0 and 46 %
It is then important to have a degree of suspicion, even when
in the literature [9]. In our own experience, the incidence has
the workup remains negative. Common, but not uniformly
been 1.2 % [10]. Overall the incidence of GGF, similar to
present, signs and symptoms of leak include sustained tachy-
other complications after gastric bypass, has been steadily
cardia, abdominal pain, fever, nausea and vomiting, oliguria,
decreasing. Reasons for the dramatic reduction include bet-
hemodynamic instability, and sense of impending doom. The
ter instrumentation, improved techniques, and increased
diagnosis can be obtained or confirmed by radiographic
experience among surgeons performing these procedures.
modalities such as contrast upper gastrointestinal fluoro-
Common presenting symptoms include nausea, vomiting,
scopic evaluation (UGI) or CT scan. Although the specificity
and epigastric pain, which are present in approximately 80 %
of the UGI is very high for GJ leaks, its sensitivity is only in
of patients. Up to 53 % of patients will have a marginal ulcer or
the 20 % range [7]. CT scan adds sensitivity to the diagnosis
a complication of it (bleeding, perforation) as presenting symp-
of GJ leaks because of the ability to show not only contrast
toms. Another subset of patients will present with failure of
extravasation and extraluminal collections but also indirect
weight loss or weight regain. The latter category of patients,
signs of leak, such as surrounding inflammatory changes,
upon further questioning, always report some element of nau-
intra-abdominal free air, and left pleural effusion. Also, the
sea or vomiting, epigastric pain, or a history of marginal ulcers.
CT scan is able to show additional sites of potential leaks,
The time of onset and location of GGF vary significantly
such as the gastric remnant, JJ anastomosis, gastric remnant
depending on etiology (Table 2). In fact, GGF can be classi-
distention, etc. Occasionally, the diagnosis of leak is made
fied into 6 categories based on their etiology [11], including
by the character of the fluid obtained from the intraoperative
the following:
drain. In these circumstances a specific, but not sensitive,
adjunct diagnostic modality is the use of oral dye, such as 1. Iatrogenic. This is the result of a technical error and omis-
methylene blue. sion of completely dividing the gastric pouch from the
The goals of treatment are antibiotic treatment, bowel gastric remnant. They typically occur near the gastro-
rest, control of secretions, wide drainage, and early nutrition. esophageal junction, where the angle of His could be dif-
Although the standard means of obtaining these goals is by ficult to visualize, especially in larger male patients.
operative intervention, the hemodynamic status of the patient 2. Previous leaks at the Gastrojejunal anastomosis. This is
and the time of occurrence of the leak might dictate a nonop- the result of a contained or subclinical leak treated nonop-
erative approach. During the operative approach, the key eratively. Consequently, the inflammatory cavity can
steps include extensive irrigation; repair of the leak, if feasi- eventually erode into the gastric remnant. Due to the eti-
ble and safe; placement of enteral access distal to the leak ology of this particular complication, the fistulae are
site; and extensive closed suction drain placement. Based on located at the level of the Gastrojejunal anastomosis.
the surgeon’s individual skills and experience, these steps 3. Type of operation. This type of fistula is now rarely seen
can be either accomplished laparoscopically or via an open since the accepted method of gastric pouch creation is
approach. Whenever the patient’s hemodynamic status complete division of the gastric pouch from the remnant.
allows, the local sepsis control can be accomplished via per- 4. Gastric tissue migration. In this case gastric tissue will
cutaneous drainage or with the drains previously placed at migrate and reattach to the remnant, even in the absence
the time of surgery. It is important in these cases to continue of an inflammatory process. This is shown to be the case
to monitor symptom progression, as failure of nonoperative even when interposed omentum or jejunum is being uti-
treatment has been reported in 12 % of the cases [7]. lized as a barrier.
Regardless of the approach utilized, the mortality of a leak 5. Marginal ulceration and perforation. The presence of a
remains high (10 %) [8]. deep ulcer will result in tissue injury and ischemia.
264 E.L. Menzo et al.
This, in addition to potential migration of foreign bodies previous gastric bypass, as well as a review of the previous
such as staples, might create a path for passage of cells in operative reports, helps in strategizing the surgical approach.
both directions, which eventually will lead to a communi- Whenever Gastrojejunal anastomosis resection has to be car-
cation between the pouch and the excluded stomach. ried out, it is important to have information about the length
6. Foreign body erosion. This type of GGF might occur in of the Roux limb and its location in relationship to the stom-
patients who had, at the time of their primary bypass, ach and colon. In fact, resecting the pouch and the anastomo-
placement of a ring to prevent anastomotic dilatation. sis without having enough Roux limb length to achieve a
Over time the ring can erode in the pouch and/or in the tension-free new anastomosis will require revision of the
adjacent gastric remnant. Jejunojejunostomy to a more distal position as well. It is then
important to have a thorough preoperative evaluation both by
The diagnosis of GGF is usually based on symptoms and
EGD and upper GI study to acquire as much information as
confirmed either by endoscopy or upper GI study. The upper
possible concerning the gastric pouch size, the anastomotic
endoscopy is unfortunately positive in approximately half of
status, and the Roux limb length.
the patients. The most sensitive test, however, remains the
upper GI study. This is commonly performed in different
patient’s positions, including decubitus. Additional informa-
tion can also be obtained by an abdominal CT scan, such as Postoperative Hemorrhage
gastric remnant distention with gas and contrast.
The initial treatment is medical and consists of protein Postoperative hemorrhage has been reported in 1.9–4.4 % of
pump inhibitors, with the addition of sucralfate in case of a gastric bypass procedures [13]. The bleeding could be either
documented concomitant ulcer. The aim of the treatment is intraluminal or extraluminal, and it usually originates from
to reduce the acid production in the gastric remnant, which is the staple lines of the GJ or JJ anastomosis, gastric remnant,
now enhanced by the presence of food. In the presence of a or gastric pouch. Although some mostly retrospective studies
marginal ulcer responding to medical therapy and in the showed decreased incidence of postoperative bleeding with
absence of additional symptoms, observation and reevalua- staple line reinforcement, a recent meta-analysis of three
tion in 6 weeks is acceptable. The minority of patients that randomized trials reports no difference in bleeding episodes
do not respond adequately to medical treatment and present [14]. It is important to use standardized postoperative proto-
with weight regain or failure of weight loss will require addi- cols to avoid system errors and automatic DVT prophylaxis
tional interventions. Some authors advocate endoscopy as a anticoagulation administration before a full patient assess-
first-line therapeutic intervention, claiming no increased ment. The signs and symptoms vary based on the entity of
complication if a future revisional surgery is necessary [12]. the bleeding from mild tachycardia to signs of hypovolemic
Unfortunately, although often technically feasible, endo- shock with hypotension and oliguria. It is important to
scopic closure has a very high recurrence rate. The success remember that intraluminal bleeding can also determine
rate is inversely proportional to the diameter of the fistula intestinal obstruction and devastating complications (anasto-
itself. Fistulae larger than 1 cm have a much less chance of motic leak, gastric remnant perforation) even if the bleeding
remaining closed after endoscopic treatment. Endoscopic is self-limiting. Whenever intestinal obstruction is suspected,
techniques include injection or fibrin glue, plasma coagula- imaging studies with upper GI contrast study and CT scan
tion, clipping, stenting, and various endoscopic suturing are warranted. Although most of the immediate postopera-
techniques. tive hemorrhages are self-limiting and can be managed with
A much more effective treatment, although more invasive, blood product transfusion, stopping anticoagulation, and
is surgical intervention. The type of approach is dictated by aggressively correcting coagulation derangements, the pres-
the type of fistula. It is important to not only address the ana- ence of hemodynamic instability or the continuous require-
tomic abnormality but also to understand the physiologic ment of blood transfusion is an indication for immediate
derangement, if any, that led to the fistula in the first place. In intervention. In the early postoperative period, the role of
the case of acid hypersecretion and chronic marginal ulcer, endoscopy for the evaluation of intraluminal bleeding is lim-
pouch trimming and redo Gastrojejunostomy are fundamen- ited to the evaluation and potential treatment of the
tal. In the case of refractory marginal ulcer with proven acid Gastrojejunal anastomosis. More aggressive endoscopic pro-
hypersecretion in the pouch, a truncal vagotomy might be cedures (enteroscopy and double-balloon enteroscopy) to
added. Remnant gastrectomy has also been advocated by our evaluate Jejunojejunostomy and gastric remnant should be
group as a treatment option for GGF [12]. In the cases of fis- reserved for late postoperative bleeding. Whenever endo-
tulae related to the failure of separation of the remnant from scopic intervention is not feasible or appropriate, operative
the gastric pouch, simple stapling across the previously undi- intervention should not be delayed. The hemodynamic status
vided gastric bridge will be appropriate. This is especially of the patient along with the surgeon’s comfort level will
true when the fistula is not in proximity of the Gastrojejunal determine if a laparoscopic or laparotomic approach is cho-
anastomosis. A thorough knowledge of the anatomy of the sen. Often the intra-abdominal source of bleeding is not
29. Laparoscopic Gastric Bypass: Management of Complications 265
found, but hematoma evacuation and washout expedites the distal obstruction, and the intraluminal fluid will likely leak
patient’s recovery. In the presence of an intraluminal bleed- around the insertion site, as this is typically not buttressed
ing source, the affected anastomosis can be approached against the abdominal wall. Acute Gastrojejunostomy stric-
directly or intraluminally via an adjacent enterotomy. tures are rare and they are mostly related to technical errors.
The initial treatment is observation to allow edema resolu-
tion. If after a reasonable waiting period (4–5 days) there is
Small Bowel Obstruction no improvement, endoscopic dilatation or redo anastomosis
is indicated. Early endoscopic dilatation might be necessary
Although small bowel obstruction can occur at anytime after but has to be conservative in the immediate postoperative
gastric bypass, up to 48 % occur within the first month [15]. period. There is no data to establish when it is too early to
Based on the location the obstruction can be classified into perform endoscopic dilatation. Our group has safely per-
the following: type A, when the alimentary limb is affected; formed endoscopic dilatation as early as 7 days postopera-
type B, when the biliopancreatic limb is obstructed; and type tively [16]. Usually the patient can then be kept on a mostly
C, common channel obstruction [13]. liquid diet until 4–6 weeks after surgery and be submitted to
Early postoperative obstruction can further be divided a more aggressive and safer endoscopic dilatation. Early
into mechanical or functional. strictures (7 days–6 weeks) are usually ischemic in origin or
due to foreign bodies (suture or staples extrusion) or mar-
ginal ulcers.
Mechanical
Internal hernias can cause mechanical obstruction in the
Common sites of mechanical obstruction are the Gastroje- early/acute phase, or more likely, late/chronic after the vis-
junostomy, the Jejunojejunostomy, the mesenteric defects, ceral fat diminishes as a result of effective weight loss. They
and the port sites. are the most common cause of bowel obstruction after lapa-
Stenosis at the anastomotic site is usually due to postop- roscopic RYGB. Their incidence has been reported in up to
erative edema and tends to resolve in 24–48 h. It is important 9 % of the cases. The potential mesenteric spaces through
to avoid vomiting and retching during this phase in order to which internal hernias occur vary based on the configuration
prevent aspiration and anastomotic disruption. Antiemetics, of the bypass reconstruction. Typically after retrocolic-
inhibitors of acid secretions, and possible tube decompres- retrogastric bypass, three defects are present, including
sion, with nasogastric tubes carefully placed under fluoro- transverse mesocolon, Petersen’s (between the Roux limb
scopic guidance, are helpful in the expectant management and the transverse mesocolon), and mesenteric defect at the
of these patients. This is especially true if a non-complete Jejunojejunostomy. One of the advantages claimed by the
obstruction is present. In cases of complete obstruction or proponents of the antecolic-antegastric reconstruction tech-
whenever the clinical picture does not improve, technical nique is the decreased incidence of internal hernias, as a
issues are involved and anastomotic revision is necessary. mesocolic defect is not created. Although it is widely
Intraluminal clots from recent staple line bleeding have also accepted to close some or all of the defects with nonabsorb-
been described as a cause of early mechanical obstruction. able sutures, other authors report similar incidence of hernias
Radiographic evaluation is essential in the diagnosis. It is without any closure. Other important factors that likely affect
important to evaluate not only the site of obstruction but also the incidence of internal hernias are the division of the mes-
the status of the proximal bowel or stomach. In fact, certain entery, the length of the limbs, and the orientation of the
obstructions can determine a closed loop obstruction picture Jejunojejunostomy. In fact, some authors have suggested that
and cause gastric remnant perforation. The presence of gas- the counterclockwise rotation of the Roux limb reconstruc-
tric remnant distention has to be carefully evaluated, and it tion causes fewer internal hernias (in particular at the
can be the only apparent sign of a distal obstruction. The Petersen’s space) than the clockwise rotation [17].
intervention varies based on the type and degree of disten- If the ability to perform gastric bypass laparoscopically
tion. Purely air-filled remnant without any bowel dilatation has significantly decreased the incidence of wound infection
can be observed with sequential X-rays, as long as the patient and hernias, it has opened the possibility for potential acute
is asymptomatic. Most of the time this finding is related to postoperative port site hernias with obstruction. The reported
a transient “vagal stunning” and it is self-limited. incidence of port site hernias is 0.74 % for all laparoscopic
Metoclopramide can be utilized with variable results in this procedures and 0.57 % after bariatric surgery [18]. Current
case, as long as distal obstruction has been ruled out. If the recommendations call for closure of trocars >10 mm in
patient is symptomatic, left shoulder pain, hiccups, retching, diameter. However, in obese patients, 12 mm ports from
or percutaneous or operative decompression is in order. radially dilating non-bladed trocars, especially if off the mid-
Whenever the gastric remnant is fluid filled, the most likely line, are not routinely closed, based on level II data. Port site
cause is the presence of a distal obstruction. Early interven- hernias are often difficult to diagnose simply by physical
tion is usually recommended in this case. Percutaneous exam because of the patient body habitus and the common
decompression is not advised because it will not resolve the presence of port site tenderness and occasional seromas.
266 E.L. Menzo et al.
A liberal use of CT scan can reliably identify the condition, IH is clearly greater after laparoscopic gastric bypass than
which requires prompt re-exploration. open, likely secondary to the paucity of intra-abdominal
Also, reconstruction configuration errors (Roux-en-O) adhesions after the former approach. The symptoms can be
determine mechanical obstruction. This type of configura- those of a typical bowel obstruction or more subtle of inter-
tion error occurs when the biliopancreatic limb is mistakenly mittent crampy abdominal pain episodes. The imaging study
anastomosed to the gastric pouch. The typical presentation of choice is the CT scan, which often reveals evidence of
includes abdominal pain, nausea, bilious vomiting, and rapid partial bowel obstruction and more direct signs of IH (swirl
weight loss. Although sometimes the clinical presentation is sign of the mesentery, malposition of the Jejunojejunostomy
quite dramatic with a picture of proximal small bowel either supramesocolic or to the right of the midline). Imaging
obstruction, at times all the diagnostic modalities (contrast studies could be normal in up to 30 % of cases, which is
upper GI and CT scan) can be normal. Additional radio- probably due to the intermittent nature of the herniation.
graphic studies that can assist in the diagnosis are fluoro- Whenever enough clinical suspicion exists, diagnostic explo-
scopic examination with contrast directly injected in the ration should not be delayed even in the presence of negative
gastric remnant (when access via a gastrostomy tube if pre- preoperative imaging evaluation. In fact, the potential conse-
set) and hepatobiliary iminodiacetic acid scan (HIDA). The quences of a missed internal hernia with volvulus around the
latter test can unequivocally show the radionuclide excreted SMA and potential central mesenteric ischemia are cata-
in the duodenum reflux back into the gastric pouch and strophic. During the exploration, especially if done laparo-
esophagus. scopically, even if the site of IH herniation is apparent, the
direction of the volvulus might not be. The safest approach is
to run the small bowel retrograde from the terminal ileum, in
Functional order to sort out the orientation of the mesentery and derotat-
Besides the mild generalized ileus that can be encountered ing the volvulus. In the presence of permanent vascular
after laparoscopy, the majority of functional obstructions impairment of the small bowel, prompt conversion to open
occur at the level of the gastric remnant. The severity varies and appropriate resection is indicated. After reduction of the
from just mild dilatation of the remnant in an asymptomatic hernia is reduced, the mesenteric defects should be closed
patient to impending remnant perforation with nausea, hic- with permanent sutures.
cups, shoulder pain, and secondary vomiting. Most of the
cases are self-limiting and are due to the previously men-
tioned “vagal stunning.” In these cases, medical treatment Marginal Ulcers (MU), Stricture
with metoclopramide and close observation with follow-up
imaging are sufficient. In the cases of symptomatic remnant Marginal ulcers and stricture are analyzed together due to the
distention, percutaneous or operative drainage is mandatory. frequent coexistence and similar etiology. The incidence of
As previously mentioned, the drainage method has to be dic- marginal ulceration has been reported between 1 and 16 %,
tated by the clinical scenario and the imaging findings. whereas the incidence of strictures has been estimated in up
to 27 % [20]. Several factors have been associated with their
pathogenesis, including ischemia, acid exposure, foreign
Late (6–12 Weeks) and Chronic body at the anastomotic site, medications, and tobacco. Acid
hypersecretion could either be primary or secondary to a
(>12 Weeks) GGF, as previously mentioned. The technique utilized to
construct the anastomosis might play a role in the incidence
Late complications after gastric bypass could be secondary of stricture. Some evidence exists that an anastomosis done
to surgical or anatomical abnormalities or secondary to nutri- with a circular stapler has a higher incidence of stricture. The
tional or metabolic derangements. antecolic-antegastric route of the Roux limb has been sug-
gested to create more tension and tissue ischemia, but has
never definitely been proven to affect the incidence of MU or
Surgical or Anatomical stricture. The use of absorbable sutures at the anastomosis
decreases the incidence of both MU and strictures compared
Internal Hernias (IH) to permanent ones.
In general, conflicting evidence exists on the role of
As previously reviewed, internal hernia can occur at any drugs—such as nonsteroidal anti-inflammatory agents, ste-
stage postoperatively. Although the etiology of the late types roids, and tobacco—on the pathogenesis of MU. Even
remains unclear, speculations exist on the role of loss of though the direct association between Helicobacter pylori
intra-abdominal fat after weight loss surgery. Interestingly, and MU is controversial, the number and severity of compli-
IH are reported by both authors who close mesenteric cations of MU in patients Helicobacter pylori negative or
defects, as well as those who do not [19]. The incidence of with eradicated infection is significantly inferior.
29. Laparoscopic Gastric Bypass: Management of Complications 267
The treatment of MU is primarily medical with acid sup- Roux limb can be temporarily decompressed, the biliopan-
pression with protein pump inhibitors combined with cyto- creatic limb and gastric remnant do not improve with such
protective agents (sucralfate). Approximately one third of intervention.
the patients will require surgical intervention either because As far as the preferred surgical approach, the surgeon’s
of intractability or complications (i.e., bleeding, perforation, experience and comfort level should dictate if the surgery is
or stricture) of MU. The type of procedure is dictated by the laparoscopic or open. If the laparoscopic approach is chosen,
indication. In general, the bleeding should be treated endo- prompt conversion to open laparotomy is necessary in the
scopically, and in case of failure or recurrence, oversewing presence of vascular compromised bowel, or in case of
the ulcer bed is the treatment of choice. In cases of hemody- massive bowel dilatation that prevents adequate visualiza-
namic stability, Gastrojejunal resection with reanastomo- tion. The goals of surgery include reduction of the intussus-
sis ± vagotomy might play a role. Perforations are usually ception and inspection of the viability of the intussusceptum
treated with Graham patch alone, or primary closure with and prevention of recurrence. No consensus exists on how to
omental patch, and only rarely anastomotic resection with decrease recurrences. If no additional procedures are done,
new anastomosis is feasible or indicated. Anastomotic stric- the chance of recurrence is nearly 100 %, whereas plication
tures are largely managed by endoscopic dilatation (either of the common channel to the biliopancreatic limb and resec-
using through-the-scope balloon dilators or bougie dilators) tion and reconstruction of the Jejunostomy decrease the
with a high success rate. The need for surgical revision has recurrence rates to 40 % and 12 %, respectively.
been reported in less than 1 % of cases [20].
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en-Y gastric bypass. Obes Surg. 2008;18(6):623–30. MA. Effect of gastric bypass surgery on kidney stone disease.
7. Gonzalez R, Sarr MG, Smith CD, Baghai M, Kendrick M, J Urol. 2009;181(6):2573–7.
Szomstein S, et al. Diagnosis and contemporary management of 20. Mathavan VK, Arregui M, Davis C, Singh K, Patel A, Meacham
anastomotic leaks after gastric bypass for obesity. J Am Coll Surg. J. Management of postgastric bypass noninsulinoma pancreatoge-
2007;204(1):47–55. nous hypoglycemia. Surg Endosc. 2010;24(10):2547–55.
30
Gastric Bypass as a Revisional Procedure
Luigi Angrisani and Michele Lorenzo
the band and the original staple lines. For open cases, a hand-
sewn gastrojejunostomy, using absorbable sutures, was per-
formed. In laparoscopic cases, the gastrojejunostomy is
created by passing the anvil to a 25-mm circular stapler (DST
Series™ EEA™ OrVil 25-mm device, Covidien, Norwalk,
CT) transorally. Several experiences reported the same limb
length as in primary LRYGB: a 50-cm biliopancreatic limb and
a 100- or 150-cm Roux limb, depending on the patient’s BMI.
The closure of the Peterson space with nonabsorbable VBG conversion to LRYGB was highly dependent on the
stitches is routine. Also, drainage of the gastroenteroanasto- indications for revision with better results in patients with
mosis and enteroenteroanastomosis is done in all cases. insufficient weight loss [23]. Several other experiences con-
Some authors have described a new technique with band firm this observation. Gagné and colleagues reported that
left in situ and the small bowel anastomosed with the stom- laparoscopic conversion of VBG in LRYGBP was feasible
ach above the band. with acceptable weight loss, but the rate of surgical complica-
tion was high (38 %) [16–18, 20].
Redo Timing
Laparoscopic Adjustable Gastric
The question of performing a revisional procedure from gas-
tric banding to gastric bypass in one or two steps is contro- Banding
versial. The authors supporting the two-step approach
indicate mainly technical reasons due to tissue quality and The results of redo LRYGB are largely studied in
adhesions [12]. A two-step approach is also indicated in case LAGB. Ardestani and colleagues compared band revision ver-
of LapBand complications as intragastric migration or gas- sus Roux-en-Y gastric bypass conversion [27]. After laparo-
tric pouch dilation because of the difficulty in finding ade- scopic adjustable gastric banding, they observed that patients
quate and healthy gastric tissue for the gastrojejunostomy. who have experienced successful weight loss with LAGB with
There are some reports suggesting that stricture rates are band complications will have satisfactory outcomes with band
higher when the anastomosis is created to thick, scarred gas- revisions (i.e., band repositioning) maintaining the excess
tric tissue [19, 30]. weight loss. Patients with inadequate weight loss with LAGB
The authors who support the single-step approach suggest after conversion to LRYGB can experience better weight loss.
that it is preferable because it avoids weight regain during Other authors have suggested that revisional procedure is less
the time between the band removal and the revisional bypass effective than primary LRYGBP [31, 32].
and avoids a second general anesthesia [11, 19, 30]. Moreover In a recent systematic review by Coblijn and colleagues,
the fibrosis resulting from gastric band seems not to influ- the perioperative mortality of LRYGBP after LAGB in 478
ence the technical results if the band is totally deflated 1 patients was zero [12]. The overall complication rate was
month before the conversion and if the fibrous band on the 8.5 % and ranged from minor complications as wound infec-
stomach is totally excised. tion to major complication as perforation and bleeding. The
most common short-term complication was wound infection
(3.5 %); less frequent were bleeding (1.8 %) and anastomotic
Results of Revisional LRYGB After leakage (0.9 %). Long-term complications were considered
by Coblijn and colleagues, those which occur later than 30
VBG and LAGB days postoperatively [12]. Overall rate of patients with one or
more complications was 8.9 %. The most common complica-
Vertical Banded Gastroplasty tion was the gastrojejunostomy stenosis (6.5 %), followed by
marginal ulceration (1 %). The rate of laparotomic conversion
Vertical banded gastroplasty was the most popular bariatric was 2.4 % mainly due to adhesions. The mean incidence in
procedure in the 1980s and early 1990s. It was largely aban- this review was 6.5 % and mainly due to bleeding, staple line
doned owing to the poor long-term weight loss results and the leakage, intestinal obstruction, stenosis, and internal hernia.
high rate of complications requiring revisional bariatric sur- Another advantage of the revisional bypass is the disap-
gery. The most common causes of failure of vertical banded pearance of esophageal motility disorders and gastroesopha-
gastroplasty requiring a redo surgery were the dehiscence of geal reflux symptoms related to restriction and diaphragmatic
the staple line, a switch to a wrong eating pattern with con- crus enlargement [19, 33, 34]. Moreover, after revision with
comitant weight regain, pouch dilation, and intractable gas- LRYGB, a radical improvement of several comorbidities as
troesophageal reflux [11]. In two studies with patients type II diabetes is observed [19, 35].
followed for 10 years or more, a high rate of revisional proce- These data indicates that LRYGBP as a revisional proce-
dure was reported. Marsk and colleagues observed that after dure after restrictive bariatric surgery is safe with low com-
a mean follow-up of 3 years almost 21 % of VBG-operated plication rate and mortality not different from LRYGBP as a
patients had required a revisional surgery either for insuffi- primary procedure. Potentially the revisional procedure can
cient weight loss or complications [22]. For the same reasons, be more difficult than primary procedure, above all for the
Belsiger and colleagues in 10 years reported the rate of 17 % adhesions. This is probably true for vertical banded gastro-
of revisional procedure [21]. The conversion in LRYGB was plasty, not for LAGB, because the area around the stomach
considered by most authors to be the most suitable procedure. can be damaged and scarred. The conversion rate varied
Shouten and colleagues found that weight loss following (0–23 %) according to several experiences [12, 19].
274 L. Angrisani and M. Lorenzo
Additionally, the rate of leakage of LRYGBP after LAGB 13. Gumbs AA, Pomp A, Gagner M. Revisional bariatric surgery for
was 0.9 %, and after primary bypass the rate is reported inadequate weight loss. Obes Surg. 2007;17:1137–45.
14. Angrisani L, Lorenzo M, Santoro T, et al. Videolaparoscopic treat-
between 0.4 and 5 % [12, 36]. The reoperation rate in revi- ment of gastric banding complications. Obes Surg. 1999;9:58–62.
sional LRYGBP was 6.5 %, higher than the reoperation rate 15. Angrisani L, Lorenzo M, Santoro T, et al. Follow up of lap-band
in primary procedures (3.2 %) [12, 36]. complications. Obes Surg. 1999;9:276–8.
16. Gonzales R, Gallagher SF, Sarr MG, Murr MM. Gastric bypass as
a revisional procedure. In: Schauer PS, Schirmer BD, Brethauer
SA, editors. Minimally invasive bariatric surgery. New York:
Conclusion Springer; 2007. p. 301–10.
17. Suter M. Revisional surgery for failed restrictive procedures in
Several options are available after failed and/or complicated morbidly obese patients. In: Parini U, Nebiolo PE, editors. Bariatric
bariatric restrictive procedures as vertical banded gastroplasty surgery. Multidisciplinary approach and surgical techniques. Aosta:
and laparoscopic adjustable gastric banding. LRYGB seems Musumeci Ed; 2007. p. 376–405.
18. Gagné DJ, Dovec E, Urbandt JE. Laparoscopic revision of vertical
at the moment to be the best surgical procedure in terms of banded gastroplasty to Roux-en-Y gastric bypass: outcomes of 105
safety and weight loss results. However, it must be underlined patients. Surg Obes Relat Dis. 2011;7:495–9.
that redo bariatric surgery results in higher morbidity and 19. Maud R, Poncet G, Boulez J, Mion F, Espalieu P. Laparoscopic gas-
reoperation rates than primary procedure. The timing and the tric bypass for failure of adjustable gastric banding: a review of
technical options of LRYGB are still a matter of concern, and 85 cases. Obes Surg. 2011;21:1513–9.
20. Tevis S, Garren MJ, Gould JC. Revisional surgery for failed vertical
long-term data in this field are poor or lacking. Based on the banded gastroplasty. Obes Surg. 2011;21:1220–4.
current evidence, these revisional procedures should be per- 21. Balisinger B, Poggio JL, Mai J, et al. Ten and more years after verti-
formed by experienced bariatric surgeons. cal banded gastroplasty as primary operation for morbid obesity.
J Gastrointest Surg. 2000;4:598–605.
22. Marsk R, Jonas E, Gartzios H, et al. High revision rates after lapa-
roscopic vertical banded gastroplasty. Surg Obes Relat Dis.
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23. Schouten R, van Dielen FMH, van Gemert WG, et al. Conversion of
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31
Laparoscopic Gastric Bypass: Nutritional
Management After Surgery
Kelli C. Hughes, Rebecca N. Puffer, and Mary B. Simmons
lean body mass while experiencing rapid weight loss, and to Liquids should be sugar-free, non-carbonated, and low fat.
minimize complications or undesirable symptoms while Foods in this stage of the diet have a thin, smooth consis-
maximizing weight loss [3, 4, 11]. Achieving these goals tency to minimize pressure on the staple lines and sutures.
requires consistent, long-term follow-up with the bariatric Solid foods can be blended with liquids to attain the pureed
dietitian to provide individualized education and support. consistency, or patients may choose to use baby foods. At
Current practice for postsurgical follow-up with the bariatric this stage, and for those that follow, high-quality protein
team is a postoperative check at 2–4 weeks and then routine intake is of utmost importance and should comprise the
follow-up at 3 months, 6 months, 12 months, and annually majority of each meal.
thereafter [3, 6, 7, 11, 12]. In addition, nutrition-focused The soft diet is introduced approximately 1 month after
individual or group meetings at more frequent intervals, surgery and prescribed for 1–4 weeks (see Table 3). Patients
especially within the first 2 years after surgery, are essential should be able to tolerate all full liquids and pureed foods
for optimal health and weight loss [6, 12]. Table 1 outlines without pain or regurgitation before advancing to soft foods.
the suggested components of nutrition follow-up. Soft foods must be well cooked, moist, ground, shredded, or
otherwise able to be chewed into mush when eaten. Protein
foods are the priority at meals and can be supplemented with
Nutrition Management Guidelines small amounts of fruit, vegetable, or starch.
The regular bariatric diet incorporates all consistencies of
Diet Texture Progression foods and is begun 4–8 weeks after surgery (see Table 4).
Tolerance of the regular diet will vary widely among patients.
The postoperative diet is a staged progression to ensure ade- Introduction of solid foods should be monitored carefully by
quate nutrient intake and tolerance after RYGB. While no both the patient and the bariatric team and done over a period
standardized recommendations exist across bariatric surgery of weeks and months. It is helpful to try one new solid food
programs, the need for standardization has been recognized at a time when the regular diet is first introduced. Once a
[12]. Typically, patients are given a sugar-free, clear liquid wide variety of foods are well tolerated, choosing solid,
diet after surgery and advanced to full liquid/pureed food, dense foods will result in greater satiety from small portions,
then mechanical soft foods followed by solid food/regular thus maximizing weight loss. Meals continue to be predomi-
diet over a period of time, taking into consideration individ- nantly protein based.
ual tolerance and needs [3, 6, 10–14].
Clear liquids are recommended for 1–2 days after RYGB,
as is common with many types of surgery, and should be Calorie Balance and Macronutrients
sugar-free, low calorie, and non-carbonated. The clear liquid
diet is not intended to meet nutrition needs as patients are In all stages of the post-RYGB diet, the goal is to produce a
typically still in the hospital and getting intravenous fluids. substantial caloric deficit while maintaining an adequate
After clear liquids, a combination of full liquids and intake of essential macro- and micronutrients [6]. Because
pureed foods are recommended for 3–4 weeks (see Table 2). the patient’s intake is significantly restricted and the absorp-
tion of the nutrients they ingest is hindered by RYGB, the
diet must be well designed to meet nutrient needs and pre-
TABLE 1. Suggested nutrition follow-up assessment vent deficiencies. As mentioned above, it is essential that
Anthropometric Current height, weight, body mass index patients are thoroughly educated about the ways in which
Total weight loss since surgery their diet can both keep them healthy and optimize weight
Total percent of excess weight loss since surgery loss before they proceed with surgery.
Supplements Compliance with vitamin and mineral recommendations
Diet Usual diet recall
Diet progression and consistency of foods
Protein intake Protein
Fruit and vegetable intake
Fluid intake Protein intake after surgery should be the primary nutrition goal
Meal schedule for a number of reasons. During periods of rapid weight loss, the
Portion size
Food tolerance
body will lose not only fat but also lean body mass. In order to
Behavior Separate eating and drinking
preserve as much lean body mass as possible, patients must
Eating habits (speed, size of bites, chewing) ingest a much higher percentage of their diet as protein than
Physical hunger vs. psychological hunger either fat or carbohydrate. The benefits of preserving muscle
Coping mechanisms and stress management mass are increased metabolism and ability to burn calories.
Weight maintenance strategies Additionally, high-quality protein sources in the diet provide the
Physical activity Type, amount, and frequency components for protein synthesis in the body, prevent protein
Goal setting Patient-directed goals deficiency, slow digestion, and therefore increase satiety [15].
31. Laparoscopic Gastric Bypass: Nutritional Management After Surgery 279
TABLE 2. Blended/pureed
Foods allowed Foods to avoid
Protein Lean fish, tuna, poultry, beef or pork; tofu; eggs or egg substitute; Fried or breaded meat; meat with visible fat;
cooked beans; reduced-fat, smooth peanut butter; liquid protein processed meat
supplements
Dairy Fat-free (skim) or 1 % milk; light yogurt; nonfat powdered milk; Flavored milk; 2 % or whole milk; ice cream;
low-fat cottage cheese; low-fat or nonfat cheese; low-fat soymilk regular yogurt with sugar; regular cheese
Fruit and vegetables Applesauce; mashed potatoes; other cooked fruit and vegetables Raw fruit and vegetables
without seeds or skins
Starches Oatmeal; grits; cream of wheat Bread and rolls; cold cereals; pasta and rice
Other Sugar-free gelatin; sugar-free fat-free pudding; sugar-free popsicles Chewing gum; sweets and desserts
TABLE 4. Solids
Foods allowed Foods difficult to tolerate Foods to avoid
Protein Lean, moist meats; beans; nuts; eggs or Tough or dry meat Fried or breaded meat; fast-food
egg substitutes; tofu; vegetarian meat meat; meat with skin or visible fat;
substitutes processed meat
Dairy Fat-free (skim) or 1 % milk; light yogurt; Flavored milk; 2 % or whole milk;
low-fat cottage cheese; low-fat or nonfat ice cream; regular yogurt with
cheese; low-fat soymilk sugar; regular cheese
Fruit Fresh; canned in juice; frozen; cooked Fruits with skin or tough peels; Fruit with added sugar; canned in
without sugar dried fruit syrup
Vegetables Fresh; no salt added canned; frozen; Raw vegetables with tough Fried or breaded vegetables;
cooked without added fat skins or seeds vegetables with sauces or added fat
Starches Dry or toasted whole grain bread; whole Soft breads and rolls; breads Doughnuts; pastries; white bread;
grain crackers; baked tortillas; oatmeal; with nuts, seeds, or dried sugary cold cereal; instant noodle
grits; cream of wheat; cold cereal fruit; cold cereal with dried or potato dishes; French fries
without added sugar; soft cooked fruit or nuts; rice; pasta
potatoes, whole wheat pasta; brown rice
Other Sugar-free gelatin; sugar-free fat-free Chewing gum; popcorn; spicy Fried or greasy foods; cream-based
pudding; sugar-free popsicles; light foods soups; fast food; sweets and
mayonnaise; light or fat-free salad desserts; butter; oils; regular
dressing; cooking spr mayonnaise; regular salad dressing
It is generally recommended that patients consume 60–80 g meat per day or the equivalent of other high-protein foods.
of protein per day as soon as their diet has been advanced from While this may be possible in later stages of the diet, for several
clear liquids [3, 8, 9, 11, 12, 14]. Some programs use 1.0–1.5 g/ weeks or months immediately after surgery, liquid protein sup-
kg ideal body weight to calculate protein needs which gener- plements will likely be necessary to meet this goal. The 60–80 g
ally results in a similar total protein intake [3, 13]. This is daily protein intake is ideally distributed evenly throughout the
slightly higher than the current Dietary Reference Intake of day at 3–5 h intervals and at least three meals [16].
46–56 g per day for normal adults. In order to meet this protein An important consideration to promote optimal health
goal, a patient would need to eat approximately 8–10 oz of lean after RYGB is the type and quality of protein. Not all sources
280 K.C. Hughes et al.
or types of protein will be digested or absorbed equally after as is popular in many weight loss programs. Complex, high-
surgery, and patients will benefit greatly from choosing the fiber carbohydrate foods such as fruit, vegetables, and whole
highest quality proteins, especially with regard to protein grains are recommended as a small part of every meal for the
supplements. Two factors that influence protein quality are RYGB patient. These foods will slow digestion and increase
their indispensable (essential) amino acids (IAA) content satiety as well as provide essential vitamins and minerals.
and their branched-chain amino acids (BCAA) content. The By contrast, simple, rapidly digested carbohydrate foods
nine IAAs are those which the body cannot synthesize and such as sweets, processed or refined grains, added sugars,
therefore must be supplied from the diet. Three of these and sugar-sweetened beverages should be avoided. Not only
IAAs are called BCAAs due to their structure and uniquely do these foods contribute significant calories with no real
contribute to both protein synthesis and metabolic function, nutrient benefits but the digestion of these after RYGB can
as compared to the other IAAs that are involved in only one result in dumping syndrome. Dumping syndrome occurs
of those functions [16]. This distinction makes the BCAAs when a meal containing large amounts of sugar empties
protein powerhouses for bariatric patients. quickly into the small bowel which causes a fluid shift into
Given these factors, the highest quality whole food pro- the bowel. This results in symptoms such as nausea, bloat-
tein sources are low-fat milk products (whey and casein pro- ing, abdominal cramps, and explosive diarrhea [6]. In order
teins), soy, and eggs (egg-white protein). Meat, fish, poultry, to avoid dumping syndrome and excess calories, all food
beans, and legumes have slightly lower IAA and BCAA con- should have <10 g of sugar per serving. Patients can obtain
tents but are still high-quality protein sources. Grains and this information by reading food labels. Artificial sweeteners
nuts also contribute protein to the diet, but are not the best such as NutraSweet®, Splenda®, Sweet’N Low®, and stevia-
sources of high-quality proteins [16]. With respect to protein based sweeteners are acceptable substitutes for real sugar.
supplements, those made from whey, casein, or soy proteins, They will not cause dumping syndrome and will help with
either as the whole protein or protein isolates, are the gold weight loss and maintenance since they contain very few
standard for bariatric patients. Whey protein supplements calories.
especially contain all the IAAs and therefore BCAAs are
soluble in the stomach and rapidly digested [3]. These types
of protein supplements are widely available and affordable Behavior Modification
for patients and should be used to help patients meet protein
goals immediately after surgery. Collagen-based protein sup- RYGB surgery necessitates a whole lifestyle transformation.
plements do not contain the necessary IAAs and may not be The gastrointestinal system must be retrained with the diet
easily digested and absorbed in RYGB patients and so should progression as the body adjusts to altered digestion and
not be recommended [3]. metabolism. Perhaps more challenging though is the psycho-
logical retraining involved in learning new eating habits and
patterns, recognizing hunger signals, and establishing a new
Fat relationship with food. Bariatric patients will benefit greatly
from understanding what specific habits and guidelines to
For optimal food tolerance and weight loss, dietary fat should follow as well as the rationale behind those guidelines in lan-
be limited in the post-RYGB diet. The fat in foods contrib- guage and concepts they can understand. This education will
utes more than twice as many calories as the equivalent improve compliance with the complex guidelines and pro-
amount of either protein or carbohydrate, thus hindering vide motivation to make the best possible nutrition choices
weight loss. High-fat foods, especially those that are greasy after surgery [3].
or fried, are often poorly tolerated after RYGB and can cause The goal of behavior guidelines is to promote optimal
a number of unpleasant gastrointestinal symptoms. Patients nutrient intake while minimizing adverse side effects from
should be advised to limit added fats such as butter, marga- food intolerance and maximizing weight loss. Some details
rine, regular mayonnaise and salad dressing, gravy, cream of nutrition guidelines will vary between bariatric programs;
sauce, oils, cream cheese, and sour cream and choose low- however, general recommendations are well established and
fat, light, or fat-free versions when possible [14]. A helpful widely used [6, 7, 9, 11–14]. The key nutrition guidelines are
guideline is to read food labels and avoid all foods with >5 g summarized in Table 5.
total fat per serving. Overall, the RYGB diet requires planning and scheduling.
Meal times and content should be planned in order to meet
nutrient goals, avoid grazing or mindless eating, regulate
Carbohydrates metabolism, and ensure that the meal plan is realistic and
feasible for an individual patient’s lifestyle. It is very diffi-
Like protein, the type and quality of carbohydrate in the bar- cult, for example, to guarantee an intake of 60 g of protein
iatric diet is important. While a patient’s meals will be pre- with a restricted meal size without planning which foods and
dominantly protein, the goal is not a carbohydrate-free diet what amounts will be eaten throughout a given day. The diet
31. Laparoscopic Gastric Bypass: Nutritional Management After Surgery 281
TABLE 5. Nutrition behavior guidelines for RYGB TABLE 6. Guidelines for supplementation after RYGB
Meal planning Eat every 3–5 h Supplement Dose
Eat 4–6 times a day Multivitamin complete Twice daily
Schedule meal times Calcium citrate with vitamin D 1,500 mg daily
Plan meal content ahead of time Iron (ferrous gluconate)a 325 mg daily (36 g elemental iron)
Keep a food journal Vitamin B12 500 mcg daily
Diet content 60–80 g protein per day, distributed evenly throughout a
Only if menstruating or advised by bariatric team
the day
Limit added fats and sugars
Choose foods with < 5 g total fat and < 10 g sugars per signs and symptoms of nutrient deficiencies, laboratory
serving assessment, and causes and prevalence of deficiency as well
When diet has progressed to solid foods, choose moist, as treatment. Table 6 outlines recommended supplementa-
solid foods and limit soft, mushy foods
tion after RYGB.
Portion size 1/4–1/2 cup meals during pureed and soft food stages
1/2–1 cup meals during solid food stage
Measure foods before eating
Eating habits Eat protein foods first
Patient Instructions
Include 1/8–1/4 cup fruit and/or vegetables at all meals
Meals should last 20–30 min; eat slowly • Avoid men’s formula vitamins and “silver” vitamins.
Cut food into small bites • Calcium should be taken in 500 mg doses.
Chew food very well • Avoid taking iron and calcium together because they
Fluids Drink 48–64 oz sugar-free, non-carbonated fluids per day compete for absorption.
Do not drink from 30 min before until 30–60 min after • Avoid taking calcium and multivitamin together because
eating the multivitamin contains iron.
Thiamine Zinc levels are not assessed on a regular basis among the
RYGB population. Studies have reported a rate of zinc defi-
Thiamine is absorbed in the jejunum and proximal ileum. ciency of 6–36 % following RYGB [31, 51]. There is limited
One may suspect thiamine deficiency with memory changes, data on appropriate treatment levels for a zinc deficiency.
paresthesia, muscle cramps, irritability, neuropathy, and gait Supplementing elemental zinc with 30–50 mg daily or every
ataxia. The most severe form of a thiamine deficiency is other day has been suggested [36, 52, 53]. Sixty milligrams
Wernicke’s encephalopathy which includes ataxia, ophthal- of elemental zinc twice per day has also been suggested [3].
moplegia, nystagmus, and confusion. The effects of a thia- More research is needed to determine an appropriate supple-
mine deficiency may be irreversible, so early detection is mentation level for zinc.
key. Serum thiamine is most often used for diagnostic pur-
poses. Erythrocyte transketolase has been recommended as a
more accurate marker of thiamine levels; however, access to Folate
this test may be limited [3, 27].
Thiamine deficiency is most commonly seen in the setting Folate is absorbed mainly in the duodenum; however, adap-
of protracted vomiting following RYGB [44]. Multiple vita- tation after RYGB can allow absorption throughout the small
min noncompliance and malabsorption are other causes of bowel [3]. Folate functions in the body in red blood cell mat-
deficiency. A diagnosis of SBBO is another potential cause uration, DNA synthesis, and prevention of neural tube
of thiamine deficiency [27]. defects. Folate deficiency may be suspected with megalo-
Clements reported the incidence of thiamine deficiency blastic anemia, diarrhea, cheilosis, glossitis, and thrombocy-
as 11–18 % [22]. Two reviews have been published report- topenia. Red blood cell folate is preferred as a marker of
ing 32 and 84 cases of Wernicke’s encephalopathy respec- deficiency compared with serum folate [3]. In addition, it has
tively [45, 46]. There are a few points to note with diagnosis been proposed that homocysteine will be elevated with a
and treatment of a thiamine deficiency. First, results of a folate deficiency which can aid in diagnosis [3].
serum thiamine may take up to a week to obtain. Additional A folate deficiency following RYGB may be caused by
damage may be done between the time blood is drawn and multiple vitamin noncompliance and avoidance or intoler-
until the results are received. Given that thiamine is a ance of enriched starches. Stores of folate can be depleted in
water-soluble vitamin, one may consider treating a defi- as short as a few months without supplementation [3].
ciency if it is suspected before receiving confirmation via A wide range of folate deficiency has been reported in the
blood work. Secondly, thiamine plays an important role in RYGB population with rates of 0–35 % [19, 23, 25]. Of note,
energy metabolism and has a short half-life of 9–18 days folate levels can be elevated with SBBO [18, 52]. Treatment
[3]. Thiamine deficiency is often seen with intractable of a deficiency has been proposed at 400 mcg to as high as
vomiting. Patients presenting with this symptom will fre- 5 mg daily [3, 25, 27, 52].
quently be given IV fluid, often dextrose. The infusion of
dextrose will further deplete thiamine stores, so thiamine
repletion should be started before infusing carbohydrate- Additional Nutrients
containing fluids. Treatment includes 50–200 mg per day
IV or IM for 5–7 days or until symptoms resolve [3, 43, Much less common micronutrient deficiencies have also
47, 48]. Koch has suggested repletion with doses as high been reported in the RYGB population to include selenium,
as 250 mg IM [27]. vitamin C, and vitamin A [22, 53–56] There is limited data
on these deficiencies, but since they have been reported fol-
lowing RYGB, one should be aware and monitor for signs of
Zinc deficiency.
The ASMBS defines a successful surgery as weight loss Baseline predictors of postoperative weight regain [58, 59]:
of at least 50 % of excess weight 18–24 months after surgery
• Increased food urges and binging
[4]. Surgical failure rates range from 5 to 7 % and increase
• Decreased sense of well-being/depression
with super-obese patients to 20–33 %. Follow-up studies
• Addictive behaviors
also indicate that weight regain increases with additional
• Presence of binge-eating disorders
years out from surgery [60]. Surgical failure and excessive
• Higher BMI
weight regain are associated with the return of comorbidi-
ties, decreased physical activity, and decreased quality of Ongoing predictors of successful weight maintenance
life. With data beyond 5 years lacking, it is difficult to assess [58, 59, 61–63]:
the long-term ability of patients to maintain their weight
• Involvement with support groups
loss. However, current data indicate a need for bariatric sur-
• Self-monitoring
gery programs to develop and implement maintenance proto-
• Regular follow-up
cols in order to support patients’ long-term efforts to keep
• Diet quality
excess weight off.
• Physical activity
Maintenance programs directed at helping patients stay at
• Nutrition counseling and RD contact
a healthy weight after their postsurgical weight loss has
ceased should include a plan for long-term nutrition counsel-
ing, continued contact with the healthcare team, and account-
ability [61]. This type of follow-up should continue to Involvement with Support Group
include the basic nutrition tenants that have been taught and
reinforced prior to surgery and during the weight loss phase. Regular attendance at support group meetings results in
Below is an example of a maintenance program implemented greater weight loss and increased chances of long-term
at a large university hospital (see Table 7). maintenance according to several studies [65–69]. Research
The predictors below should be assessed and addressed shows that continued contact and accountability with other
prior to surgery, during the weight loss phase, and in the patients and healthcare providers as well as additional behav-
long-term maintenance phase. The remainder of this section ioral and emotional support help patients stay on track with
will be dedicated to looking at each ongoing predictor of following program guidelines and sustaining behavior
successful weight maintenance and how it might be addressed change after surgery. Bariatric centers of excellence are
as part of the patients’ maintenance efforts. required to provide a support group for their patients;
however, all programs, no matter the size, would benefit
from providing ongoing programming outside of medical
visits. Ideally, a support group would involve all profession-
TABLE 7. Outline of maintenance program als that are part of the healthcare team including doctors,
Time out from surgery Healthcare team follow-up action nurses, RDs, behavioral health, and exercise physiology.
12 months Standard follow-up visit With new technologies and increasing availability of Internet
Referral to outpatient nutritionist for access, online support groups provide a meaningful way to
maintenance meal planning connect for patients who live too far to engage in physical
Maintenance packet given to patient meetings.
Schedule 6-month follow-up phone call
18 months RD follow-up call to patient—check weight,
protein intake, supplements, maintenance
plan, exercise, 24-h food recall. Assess and Self-Monitoring
make recommendations for improvements
and set goals Self-monitoring of weight, food intake, and physical activity
24 months Standard follow-up visit are key mechanisms for weight maintenance according to
Check on progress with goals set on the phone patients who have lost large amounts of weight, surgically
Problem solve and set new goals as needed and through diet and exercise. The necessity of all forms of
Schedule six-month follow-up phone call
self-monitoring has been consistently demonstrated in the
30 months RD follow-up call to patient—check weight,
literature, as an invaluable part of any weight loss and main-
protein intake, supplements, maintenance
plan, exercise, 24-h food recall. Assess and tenance effort [60, 70–77]. Weight loss surgery alone, with-
make recommendations for improvements out personal responsibility for monitoring and behavior
and set goals with patient. Determine need change, results in weight regain in many patients. Regular
for additional support and follow-up self-weighing helps patients stay in touch with the reality of
3–5 years and beyond Standard follow-up visit what they are eating and what is happening with their weight.
31. Laparoscopic Gastric Bypass: Nutritional Management After Surgery 285
Keeping food records and measuring portions assists with more likely to eat larger portions and return to poor eating
tracking calorie, fat, and protein intake, which is important habits, resulting in weight regain. The idea of permanent
for good nutrition but also for staying within an appropriate behavior change should be introduced and supported during
calorie level to maintain a stable weight. Activity records all stages of the program in order to facilitate the mainte-
help with planning exercise and making it a regular habit. nance effort.
During pre- and postoperative education, weight graphs and
food and activity records should be provided for patient ref-
erence and use. The role of self-monitoring should be pre- Physical Activity
sented as an essential part of the patients’ responsibility from
the first education session and regularly thereafter. There are Regular physical activity is another component of a success-
also many electronic tools and web sites for self-monitoring ful maintenance effort. The importance of regular, sustained
that have helped patients be more successful in this area. physical activity is widely supported in the literature, as well
as in practical evidence, as an essential part of weight loss
and maintenance. In studies of those maintaining a large
Regular Follow-Up weight loss, exercise and self-monitoring are consistently
reported as behaviors of successful maintainers [59, 64, 70–
Adherence to regular follow-up protocol is directly linked to 73, 76, 77, 79]. The NWLR data show that 90 % of partici-
long-term success with bariatric patients [58, 59, 78]. Most pants who have kept off large amounts of weight exercise
programs schedule regular follow-up with patients after their approximately one hour daily and engage in higher intensity
surgery, but the length between visits varies and patient activities [64, 80]. This increases the expenditure of overall
adherence decreases over time. calories, which can offset the increase in calorie intake and
Continued contact, accountability, repetition of guide- supports the overall commitment to healthy lifestyle choices.
lines, and reinforcement of patient success all play a vital According to the American College of Sports Medicine
role in continued motivation and success. Presenting follow- (ACSM) expending >2,000 kcal per week is recommended
up requirements prior to surgery so patients understand the for prevention of weight regain [81].
commitment involved helps create “buy-in” for multiple A large portion of the bariatric population is unable to
appointments and increases commitment to following the exercise safely or comfortably. Many are awaiting other sur-
program. At each visit, the patient should see the doctor and geries that will allow them to exercise more regularly, such
RD. If other healthcare professionals such as behavioral as joint replacement or back surgery. For some, body habitus
health or exercise physiologist are a part of the bariatric is all together preventative of activity outside of daily living
team, patients should see them regularly as well. If not, (ADLs), and others cannot even perform ADLs without
appropriate referrals should be made as needed. assistance. For the population who legitimately cannot
exercise, seated exercise and physical therapy are viable
options. It is important to have these patients engage in some
Diet Quality sort of presurgery mobility to assist with conditioning as
well as establish a routine and habits that can be built upon
Diet quality should be examined at each visit and assessed and continued after surgery. For other patients, embarrass-
for adherence to program guidelines. The National Weight ment or dislike of exercise can inform a host of excuses for
Loss Registry (NWLR) compared the eating habits of not being physically active. Problem solving and setting real-
patients who lost weight with diet and exercise vs. patients istic goals to begin and continue with regular physical activ-
who had bariatric surgery. Surgical patients reported more ity is important. Many programs utilize an exercise
fast food, increased fat intake, and less dietary restraint. They physiologist to work with their patients in overcoming barri-
were also more likely to skip breakfast [64]. Other studies ers to exercise.
have shown post-bariatric patients to have increased con- It is important to emphasize regular exercise and provide
sumption of sweets as well as excessive intake of calories. guidelines as a nonnegotiable part of a bariatric program.
These patients also report insufficient intake of high-quality Continued support and accountability in this area is directly
foods such as lean meats, eggs, fruits, and vegetables [58, 59]. related to successful maintenance [59, 64, 70–74, 76, 77, 79].
Nonsurgical weight loss patients must practice and maintain The ACSM recommends moderate intensity cardiovascular
dietary restraint and consistently eat a high-quality diet while exercise for ≥30 min ≥5 times a week for a total of ≥150 min
restricting calories in order to produce weight loss, while per week. Resistance training of major muscle groups and
patients who undergo weight loss surgery may not need stretching is recommended at least twice a week [81]. Setting
to follow diet guidelines as strictly in order to lose weight. smaller goals for patients to work up to this level of exercise is
However, when weight loss ceases, if these patients have helpful. The ACSM position on exercise states, “Behaviorally
not implemented a permanent lifestyle change, they may be based exercise interventions, the use of behavior change
286 K.C. Hughes et al.
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32
Laparoscopic Malabsorptive Procedures:
Technique of Duodenal Switch
Giovanni Dapri, Guy-Bernard Cadière, and Jacques Himpens
FIG. 1. Sleeve gastrectomy and beginning of duodenal switch: patient and team’s positioning.
Medial-to-Lateral Approach top and vice versa; the stomach is sectioned placing the
stapler lateral to the left pillar and without tension. The
After the stomach is marked between the crow’s foot and greater omentum is dissected from the transected greater
the pylorus, the lesser sac is opened just enough to allow curvature of the stomach, using the coagulating hook, bipo-
the introduction of linear stapler through the T4. Two fir- lar shears, or harmonic shears. The resected stomach and
ings of the linear stapler (green/black load) are fired taking the staple line are managed as described above.
the extremity of the stapler close to the terminations of the
gastric vessels on the lesser curvature. After sectioning the
stomach at the level of the incisura angularis, the anesthesi- Duodenal Switch
ologist pushes down the 36 Fr orogastric tube to guide the
gastric transection in the direction of the angle of His. Laparoscopic duodenal switch is a technically difficult pro-
Further firings of the linear stapler (T3) (gold/purple load) cedure, demanding considerable laparoscopic skill, accom-
are kept parallel to the lesser curve (Fig. 3b), and all the panied by the possibility of intraoperative complications and
posterior gastric adhesions are divided. Before the last fir- characterized by postoperative morbidity. Superobese
ing of the stapler, the angle of His is freed from bottom to (50 < BMI < 60 kg/m2) and super-superobese (BMI > 60 kg/m2)
32. Laparoscopic Malabsorptive Procedures: Technique of Duodenal Switch 291
patients are often affected by arterial hypertension, diabetes and reduce the severity of obesity-related comorbidities,
type II, sleep apnea, degenerative joint, cardiovascular, and after an interval time between 6 months and 2 years,
pulmonary, and metabolic diseases that put them at the procedure of duodenal switch can be performed under
adversely increased surgical risks. In order to decrease safer conditions [6].
the morbidity and mortality, and the overall risk of periop-
erative complications, it has been reported [5] to separate
this procedure into two steps: sleeve gastrectomy first and Cholecystectomy and Duodenal Section
biliopancreatic diversion later. In this way, patients submit-
ted to sleeve gastrectomy can achieve a sustained weight loss Cholecystectomy is performed and the specimen is extracted
in a plastic bag through the T3 at the end of the procedure.
The duodenum can be sectioned using two methods:
– Posterior approach: the antrum is held up and all the ret-
rogastric adhesions from the antrum to the pylorus are
divided by the coagulating hook. A passage just anteriorly
to the pancreatic head and gastroduodenal artery is cre-
ated with gentle dissection in the direction of the common
bile duct. The superior and inferior edges of the duode-
num are freed and a piece of cotton tissue tape is used to
encircle the duodenum. The tape facilitates in holding the
first duodenum upwards for insertion and firing of the
linear stapler (blue/purple load) through the T3 (Fig. 4a).
The duodenum is divided.
– Anterior approach: after identification of the pylorus, the
anterior peritoneal sheet at the superior border of the first
duodenum, across from the common bile duct, is dis-
sected by the coagulating hook. A passage between the
above first duodenum and the pancreatic head is created
under vision. The first duodenum is encircled by a piece
of cotton tissue tape. The tape is taken up in order to per-
mit the introduction of the linear stapler (blue/purple
load) through the T3, and the duodenum is transected
(Fig. 4b). The gastroduodenal artery is usually visible
FIG. 2. Duodenal switch: trocars’ positioning. under the first duodenum after this section.
Common, Alimentary and A temporary clip is placed just distal to this point and repre-
sents the proximal end of the alimentary limb, which will be
Biliopancreatic Limbs’ Measurement used for the duodenoileostomy. A firing of linear stapler (T3)
(white/tan load) divides the small bowel between the bilio-
The patient is positioned in the Trendelenburg position with pancreatic limb and the proximal end of the alimentary limb
a right tilt. The surgeon, camera person, and assistant moved (Fig. 6). The common and alimentary limbs are fashioned
to the patient’s left (Fig. 5). Appendectomy is performed and and measured at 75–100 and 175–150 cm, respectively.
retrieved in a plastic bag at the end of the procedure through
the T3. The cecum is dissected off the parietal wall by the
coagulating hook, in order to facilitate subsequent lifting of Jejunoileostomy
the alimentary loop for the duodenoileostomy. From the ileo-
cecal valve, the small bowel is measured for a distance of 75 This anastomosis can be performed through three different
or 100 cm (common limb) (Fig. 6). The measurements are methods:
made by stretching the bowel along a 25 cm cotton tissue
tape. A stitch (polydiaxone 2/0) is placed on the small bowel – Totally handsewn side-to-side: the stitch parked into the
wall at this measured level (Fig. 6) and temporarily parked parietal peritoneum is used to join the common limb to
into the parietal peritoneum. The small bowel distal to the the biliopancreatic limb in a continuous layer (polydiax-
stitch, and going in the direction of the ileocecal valve, is one 2/0), which represents the posterior layer of the
superficially marked by the coagulating hook and constitutes jejunoileostomy. The running suture is held by a grasper
the common limb. From this point, another 175 or 150 cm is (T2) and the common limb by another grasper (T4) in
measured and constitutes the alimentary limb (Fig. 6). The the opposite direction, in order to place the bowel
bowel proximal to the measured segment of 175-150 cm, and loops under traction. A new running suture is started
going in the direction of the angle of Treitz, is marked by the (polydiaxone 2/0), and both bowel loops are opened by
coagulating hook and constitutes the biliopancreatic limb. the coagulating hook (Fig. 7a). The new running suture
294 G. Dapri et al.
is used for the anterior layer of the jejunoileostomy. The (white/tan load) is introduced through the T3 and fired to
posterior running suture, taken along the inferior angle of join both limbs (Fig. 8a). The enteric openings are closed
the anastomosis, is continued on for a short distance by two running sutures using absorbable materials (polyd-
onto the anterior layer of the anastomosis (Fig. 7b). The iaxone 2/0) (Fig. 8b), and the temporary stitch is removed.
posterior and the anterior running sutures are finally tied – Totally mechanical side-to-side: the common limb is
halfway on the anterior layer. positioned beside the biliopancreatic limb. Both small
– Linear mechanical side-to-side: the small bowel at the bowel loops are opened by the coagulating hook. A first
75–100 cm marking (the marks will help to remain ori- firing of linear stapler (white/tan load), introduced through
ented) is sutured to the biliopancreatic limb, using the same the T4, joins the common limb to the biliopancreatic limb
stitch (polydiaxone 2/0) that was parked into the parietal in one direction. A second firing of the linear stapler limb
peritoneum. The stitch is maintained under tension by a (white/tan load), introduced through the T3, joins the two
grasper (T4), and the common and biliopancreatic limbs loops in the opposite direction (Fig. 9a). Finally, the
are opened with the coagulating hook. A linear stapler enteric openings are closed by a third firing of the linear
32. Laparoscopic Malabsorptive Procedures: Technique of Duodenal Switch 295
Duodenoileostomy
The patient is replaced in the reversed Trendelenburg posi-
tion. The surgeon returns between the patient’s legs, the
camera person to the patient’s right, and the assistant to the
patient’s left (Fig. 1). The proximal end of the alimentary
limb is maintained cephalic by the grasper (T6).
The duodenoileostomy can be performed through two
main methods:
– Totally handsewn end-to-side: a running suture (polyd-
iaxone 2/0) is begun on the superior corner of the tran-
sected duodenum and successive bites are taken
alternatively on the duodenum and on the proximal end of
the alimentary limb in order to perform the end-to-side
duodenoileostomy (Fig. 11a). This suture, which consti-
tutes the posterior layer of the anastomosis, is continued
around the inferior corner and onto the anterior layer for
a short distance, and the duodenum and the alimentary
limb are opened with the coagulating hook (Fig. 11b). A
new running suture (polydiaxone 2/0) starting on the
FIG. 10. Mesenteric defect closure. superior corner constitutes the anterior layer of the duo-
denoileostomy. Finally the two running sutures are tied
stapler (white/tan load), introduced through the T3 and together halfway on the anterior layer.
positioned perpendicular to the first two firings (Fig. 9b). – Linear mechanical end-to-side: the duodenum is opened
Regardless of the type of the jejunoileostomy, the mesen- at its inferior angle by the coagulating hook, and the ali-
teric defect, between the common and the biliopancreatic mentary limb at the same level as well. A linear stapler
limbs, is closed after the anastomosis. A nonabsorbable (blue load) is introduced through the T3 and advanced
purse-string suture (polypropylene 1) is used to close this into the duodenum and the alimentary limb and fired
defect in order to prevent internal hernia (Fig. 10). The prox- (Fig. 12a). The enteric openings are closed using two con-
imal end of the alimentary limb is taken by a grasper (T6) in verting running sutures (polydiaxone 2/0), starting at both
the direction of the first duodenum. angles and tied together halfway (Fig. 12b).
296 G. Dapri et al.
Regardless of the type of duodenoileostomy, Petersen’s of air bubbles is testimony of the integrity of the sleeve
space, a potential defect formed as a result of the procedure gastrectomy and of the duodenoileostomy. This maneuver
between the mesentery of the alimentary limb and the trans- allows assessing good symmetry of the sleeve. Moreover,
verse mesocolon, is closed to prevent an internal hernia. A the advantage of using compressed air is also to check the
nonabsorbable purse-string suture (polypropylene 1) is used jejunoileostomy distally.
to close the defect (Fig. 13).
Specimens’ Removal
Leak Test
The stomach, gallbladder, and appendix are extracted in
The leak test is performed both to test the sleeve gastrec- plastic bags through the enlargement of the T3, which is sub-
tomy and the duodenoileostomy (Fig. 14). The patient is sequently closed in layers. The procedure is concluded with
placed in the Trendelenburg position and the operating field the placement of a drain along the sleeve gastrectomy, up to
is immersed under saline solution. Compressed air is insuf- the upper pole of the spleen, and another drain close to the
flated into the stomach by the anesthesiologist. The absence duodenoileostomy.
32. Laparoscopic Malabsorptive Procedures: Technique of Duodenal Switch 297
Postoperative Management
A nasogastric tube is left in place for the first 24 h. A peroral
methylene blue test is performed on the second postoperative
day, and if negative, the patient is allowed to start a liquid
diet on the third postoperative day. The patient is discharged
from the hospital on the fifth postoperative day.
The patient is restricted to a liquid diet for the first 4 weeks,
then to a semiliquid diet for another 4 weeks, followed by a
pureed diet for another 4 weeks. At that time if there are no
problems, the patient is advanced to a regular diet. Exercising
is encouraged from the second postoperative week onwards.
Patients are instructed to take either an H2 blocker or proton-
pump inhibitor for at least 3 months.
Patients are followed up by the surgeon, nutritionist, and
psychologist. The first follow-up visit is at 1 month after the
procedure. Following that, the patient is reviewed at
3-monthly intervals in the first year, followed by two
6-monthly visits in the second year, and by further annual
visits for the next 3 years.
early period, eat enough, and have the bowel hypertrophy that would limit surgical effectiveness. Furthermore, gastric
and compensate. Unfortunately, we have learned that with restriction has been plagued by ulcers, strictures, esophageal
obesity you have excess fat and increased inflammation, not dysfunction, and decreased satisfaction with eating and
increased nutritional reserve. choice of food. This debate remains a sentinel issue in bariat-
While weight loss was acceptable, there were many issues. ric surgery. Whether vertical banded gastroplasty versus gas-
tric bypass or, in the laparoscopic era, gastric bypass versus
1. Inadequate Bowel Length
adjustable banding and now sleeve gastrectomy, gastric-only
While the stomach was left unchanged, the JIB shortened
procedures reduce the risk of the manifestations of short
overall bowel length drastically. There is a wide range of
bowel syndrome. The cost is that they also do not offer the
total bowel length in individuals with average ranging
intestinal mechanisms that help cause weight loss.
from 20 to 23 ft. The JIB reduced total bowel length to
By definition, every bariatric procedure produces an
approximately 18 in. This led to poor absorption of all
abnormality. The more the anatomy is altered, i.e., the more
classes of food. With an ileal segment of only 12 in., there
stomach removed and intestine bypassed, the greater the
was often inadequate length to absorb bile salts. The high
weight loss. The corollary of this statement is that the more
food content was passed into the colon. The bile salts irri-
that is altered, the greater the chance of nutritional defi-
tated the colonic mucosa causing colitis adding to water
ciency. How these factors are balanced in aggressive opera-
and protein loss.
tions that add an intestinal component is the emphasis of this
2. Bacterial Overgrowth chapter. We realize that our operations are more than the sum
Whereas in patients with standard short bowel syndrome of making the stomach smaller and the intestine shorter.
the bowel is absent, in JIB the majority of the small bowel However, while we know that radically shortening bowel
was present but did not have bile or food coming through. length causes weight loss, albeit with unacceptable side
This stagnation led to bacterial overgrowth that entered effects, we do not know exactly what our shorter bypass
the portal system and occasionally caused hepatic failure. lengths do. Additionally, little is known about what the ideal
In addition, immune complexes formed secondary to bac- lengths should be for a Roux limb, biliopancreatic limb, or
terial overgrowth lodged into joints causing arthritis. common channel. Few meaningful studies have evaluated
these issues. A recent systematic review of short versus long
In 1976, Payne reported his experience with 230 jejunal-
Roux limb length examined a total of eight studies. A trend
ileal bypass surgeries since 1962. A total of 19 (8 %) deaths
was identified supporting the early efficacy of longer Roux
were reported, of which 10 were related to hepatic failure.
limbs in the super obese patient category. However, the
Electrolyte abnormalities were common, with hypokalemia
authors questioned the overall quality of the data due to
and hypocalcemia being present in over 20 % of patients.
inconsistent data reporting [5].
Other reported complications included hypoalbuminemia,
What are the most important variables? It would seem
metabolic acidosis, arthritis, urinary calculi, cholelithiasis,
that the total intestinal length in contact with food and the
liver impairment, and major emotional upset. Overall rehos-
common channel length are critical factors. In traditional
pitalization for complications was approximately 50 % [3].
gastric bypass, both of these values vary between patients
and certainly between centers. Despite this, reported results
Evolving Dangerous Concepts into seem to be consistent, thus further adding to our need for
knowledge and understanding about what happens when an
Successful Bariatric Procedures intestinal bypass is added to a gastric restriction (with or
without pyloric preservation).
The original bariatric procedures came from the fact that
For the intestinal component there are several points that
patients who underwent gastric resection subsequently lost
must be remembered from the knowledge obtained from the
weight. Additionally, it was known that the intestine was
JIB and early bariatric procedures:
adaptable, but at a certain level, when shortened, weight loss
would occur. Thus, the issue became whether these concepts 1. Total bowel length must be adequate. It is generally
could be titrated and balanced to offer those with severe obe- believed that most individuals require 6 ft or 2 m of small
sity procedures that would effectively allow them to lose bowel. A competent ileocecal valve may reduce this to
weight and not become malnourished or symptomatically some degree. But as a starting point, in young individuals
micronutrient deficient. it would seem that all operations should preserve at least
Edward Mason, who performed the first gastric bypass for a minimum of 2–3 m of intestinal length.
obesity, argued that any manipulation of the bowel would 2. There must be adequate length of intestine in the bilio-
result in an unacceptable rate of anemia and bone loss and pancreatic limb and common channel to absorb enough
only gastric reduction procedures should be performed [4]. bile salts and prevent bile-induced colitis.
The alternative viewpoint was that gastric-only procedures 3. Long segments of small bowel should not be left without
would not allow the majority of patients to reach their weight flow of food or pancreatic and biliary secretions or stag-
loss goals. Many would develop a maladaptive eating pattern nation and bacterial overgrowth will occur.
302 M.S. Roslin and R. Sung
compared to controls with similar weight loss and size, resting 10 of 440 patients requiring revision for either protein
energy expenditure decrease was lower than would be expected malnutrition or diarrhea. The duodenal switch has become
in the surgical group. Recently, Kaplan highlighted that this, the most common version of biliopancreatic diversion. Within
not malabsorption, is the significant contribution in an experi- North America, Dr Gary Anthone [10] and Drs Marceau and
mental model of gastric bypass [8]. Biron [11] have published extensive series with lengthy fol-
Of course the BPD was not without issue. There was a low-up. In contrast, to Hess, they have used fixed bowel
2 % rate that required reoperation for protein malnutrition. length rather than calculating based on total intestinal length.
Scopinaro highlights that the likelihood of this increases if In the late 1990s and early 2000s, bariatric surgery rap-
patients consume excessive carbohydrates. When that occurs idly increased in popularity. The increasing obesity epi-
insulin is stimulated which results in an increased amount of demic, combined with the development of laparoscopy, led
endogenous protein breakdown exacerbating the protein to this growth. With the movement to laparoscopy, tech-
deficiency. During the first year frequent bowel movements niques were developed to perform the duodenal switch in a
are common, which are reduced to 2–4 more than a year fol- minimally invasive nature.
lowing surgery. The marginal ulcer rate reported was greater
than 8 %. Deficiencies of the fat-soluble vitamins and iron
exceed 25 %. Calcium deficiency and bone demineralization Laparoscopic Duodenal Switch
can occur. Scopinaro shows that this stabilizes. Countering
these adverse effects, there was a 100 % resolution of diabe- The first major report of laparoscopic duodenal switch came
tes and hypercholesterolemia. from Ren and Gagner [12] in 2000. This report discussed
In summary, there is much that can be learned from this their technique for laparoscopic bypass and highlighted an
incredible data set. Obviously, the long-term data was quite increased complication rate for those with a BMI greater
impressive. Yet, there are many reasons why this operation did than 60. It was the basis of this study that made Dr Gagner
not expand in popularity and become an international stan- postulate that staging the procedure and doing the vertical
dard. The list of side effects was numerous. In the setting of gastrectomy and then following weight loss proceed to the
100 % follow-up, many of these could be simply handled. In intestinal bypass. Interestingly, despite the fact that Scopinaro
the United States and many other places, this level of follow- always felt that the gastric aspect caused much of the early
up cannot be expected. Furthermore, the duodenal switch, weight loss, many trained in North America felt that in BPD
which reduced the marginal ulcer rate to near zero, became the the major component was from the intestine. Now with
preferential method for the performance of a biliopancreatic sleeve gastrectomy accepted as a stand-alone weight loss
diversion. Even with this adaption and potential improvement, procedure, it is clear that the gastric resection is an impor-
duodenal switch and other forms of BPD represent a small tant, if not dominant, component.
minority of bariatric procedures currently performed. Following Gagner’s report, Baltazar [13] published his
series of laparoscopic duodenal switch in 2001. At our cen-
ter, vertical sleeve gastrectomy and duodenal switch have
Development of the Duodenal Switch become our preferential stapling procedures (Fig. 4).
Contrary to many reports, a significant proportion of our
In 1998, Dr Douglas Hess became interested in the research patients are super morbidly obese, and we do not find this to
of Dr Thomas DeMeester on duodenal gastric reflux and his be a contraindication for surgery.
concept of attaching a small segment of duodenum to the The technical aspects that need comment are the duodenal
Roux limb of the small bowel. Hess wanted to utilize a simi- dissection, the duodenal enteral anastomosis, and the distal
lar approach to Scopinaro on revisions but encountered anastomosis. At this point, the majority of bariatric surgeons
dense adhesions and, following these challenging revisions, are comfortable with the vertical gastrectomy. For the duode-
a high rate of marginal ulceration. As a result, Hess devel- nal dissection, it is imperative to elevate the pylorus and take
oped the concept of combining a vertical gastrectomy of the the posterior adhesions. A cuff of the duodenum, of at least
greater curvature with a duodenal division preserving a small 2 cm, needs to be dissected. Care must be taken to avoid any
cuff of the duodenum. dissection of pancreatic attachments. If the pancreas needs to
Hess calibrated his gastrectomy using a 40 Fr bougie or dila- be taken off the duodenum, the surgeon has moved too distal.
tor. The length of the small bowel was determined by mea- Trauma to the pancreas can cause prolonged postoperative
suring the total intestinal length from the stomach to the fluid collections and a duodenal stump leak.
cecum. Then, 40 % of the total length was used to create the We currently perform our sleeve gastrectomy over a 38 Fr
alimentary limb, and 10 % of the total length to create the bougie and start the staple line 3–4 cm from the pyloric
common channel [9]. valve. Our total intestinal length is 3 m with a common chan-
Advantages of the duodenal switch include preservation nel of 125 cm. With these parameters, our average patient
of the pylorus and the reduction of marginal ulcer rates. In a moves their bowels 1–3 times daily. In over 400 cases, we
1998 report, Hess reported an 85 % excess weight loss with have had to place only 2 patients on TPN; both had other
304 M.S. Roslin and R. Sung
inflammatory bowel conditions and were able to be weaned greater weight loss was shown following duodenal switch.
and maintained adequate protein levels without further support. There was a tendency for a higher rate of nutritional compli-
We have not had to surgically revise any patient for persistent cations in DS; however this difference was not significant.
hypoproteinemia. Alverdy et al. [14] compared the resolution of comorbidities
In our initial duodenal switch procedures more than 5 between RYGB and DS. All major comorbidities, except
years ago, we utilized a side-to-side stapling technique with GERD, were more likely to be resolved following DS,
a linear stapler. After several cases where we experienced including diabetes, hypercholesterolemia, sleep apnea, and
issues, we have changed to hand-sewn and end-to-end two- hypertension. Potentially, even more important is a report
layered anastomoses using PDS. With this approach, we from Germany that studied the DS in patients with insulin-
have had less than a 1 % leak rate. Additionally, with this dependent type 2 diabetes, who were on injectable therapy for
technique and preservation of an adequate cuff, we have not many years [15]. This subset has been shown to be least likely
encountered either stricture or marginal ulcer. to have diabetes remission with bariatric surgery. All were
According to statistics from the BOLD database, weight able to be weaned from injectable insulin and remained off
loss is greater than gastric bypass and is better maintained. for 1 year of follow-up. A subgroup in this study had a BMI
Offsetting these results is the technical difficulty of the pro- under 40. Similarly, the Scopinaro BPD was compared to
cedure. Thirty-day reoperation rates are estimated to be from RYGB in a randomized trial conducted by Rubino et al. [16].
3 to 5 %. Few surgeons have mastered the technical aspects This study, published in the New England Journal of
of laparoscopic duodenal switch. Besides increased periop- Medicine, showed a substantial advantage for BPD.
erative complications, the extended operative times poten- Recently our group has compared glucose regulation in
tially increase the likelihood of venous thrombosis and the RYGB, VSG, and DS. The DS group had the greatest
pulmonary embolism. weight loss and lowest HgbA1c. RYGB had a reduction in
fasting insulin but with glucose challenge had a rapid rise in
glucose that corresponded to a 1 h insulin level that was
Comparing Duodenal Switch to Gastric greater than baseline [17]. In comparison, DS patients main-
Bypass tained euglycemia without the abrupt rise in insulin level,
and thus less likely to cause hypoglycemia. VSG results were
In addition to the BOLD data, several recent studies have in between, meaning that preservation of the pylorus is not
compared gastric bypass to duodenal switch. In a randomized the only reason for this more balanced glucose control. As
trial in patients with a BMI greater or equal to 55, significantly control of insulin levels is considered an objective in medical
efforts to control weight, it is probable this is also true for
surgical approaches and may be part of the reason that weight
loss is better maintained following duodenal switch.
Both Sugerman [18] and Fobi [19] have published series known if the effects are additive. It is possible that the com-
that discuss this approach. Both showed an unacceptable risk bination of gastric reduction and intestinal bypass acts syner-
of protein malnutrition and a substantial number required gistically. Only further study will resolve these issues.
revision. Additionally, when these cases are revised, there is
abrupt weight gain, as they have had to eat supranormal
quantities to attempt to handle the malabsorption. As a result, Patient Instructions
we do not recommend this approach. If selected the surgeon
must make sure that the total intestinal length is at least 3 m It is essential that patients following duodenal switch eat a
and/or there is retained fundus. When earlier trials of this high-protein diet and require 70–90 g of protein daily.
procedure were performed, many patients had transverse Additionally, fatty foods will lead to malodorous and more
staple lines that did not exclude the fundus. During this frequent stools. Simple carbohydrates will be absorbed and
period, many still did not tolerate the distal bypass. also increase insulin levels and further increasing the amount
of protein required. Supplements containing high levels of
vitamins A, D, E, and K as well as vitamin B complex and
Conversion of Sleeve Gastrectomy B12 need to be taken. Iron and calcium supplementation are
to Duodenal Switch required. We also advise taking two zinc tablets daily.
Some of the rules we advise are:
As vertical sleeve gastrectomy grows in frequency, an 1. Eat protein first and stick to a high-protein low-fat diet.
increasing number of patients will consider revision for 2. Avoid simple sugar and alcohol. These will be absorbed
either inadequate weight loss or weight regain. For these normally.
patients options include redoing the sleeve, conversion to 3. To avoid malodorous stools, avoid fatty foods, and you
gastric bypass, or conversion to duodenal switch. For many can use chlorophyll stool deodorant such as Devrom.
reasons, we believe that conversion to duodenal switch is the 4. Take your vitamins and supplements daily.
most attractive option. A major benefit is that rather than 5. Have blood work twice in first year and then annually.
revision, this conversion is really doing a second primary
procedure, as the duodenal area should not be affected by the Patient complaints of flatulence and diarrhea can usually
initial operation. Re-sleeving and gastric bypass would be handled by adjustment of food intake. At times, patients
involve dissection in the original surgical field. It is also logi- may benefit from short course of metronidazole. Similarly,
cal to introduce an intestinal operation in a patient that failed low protein levels should be treated by reintroducing high-
a gastric or restrictive procedure. There are many concerns protein shake or powder. There are a greater variety of high-
for conversion to gastric bypass. The sleeve pouch has been protein low-fat and low-carbohydrate supplements now
shown to exist at higher pressure than the gastric bypass available which can potentially improve outcomes.
pouch. Thus, there is potentially less restriction. Additionally,
the exact contribution of the intestinal component of a gastric
bypass is unknown. The average bypass has a common chan- Future Directions
nel greater than 4 m and intestinal length longer. It is unlikely
that much malabsorption occurs. Thus, there is probably It seems that since there has been bariatric surgery, the debate
some early weight loss caused by food entering almost of whether to perform a gastric-only procedure or combina-
immediately into the intestine causing a postprandial reac- tion gastric and intestinal procedure has existed. Gastric-
tion. Nominal weight loss and even regain will be seen only operations have a much lower incidence of anemia,
shortly after. If this option is considered, the bypass will bone demineralization, hypoproteinemia, and vitamin defi-
need to be very aggressive, and the patient is at risk for the ciency. However, consumption gradually increases, and
issues discussed above. weight regain commonly occurs. If too tight or overly restric-
It is our belief that conversion to duodenal switch from sleeve tive, the likelihood of maladaptive eating increases. Healthy
gastrectomy will grow in popularity and cause growth in the choices are replaced by fatty greasy alternatives and simple
popularity of duodenal switch. Once surgeons become com- carbohydrates. Despite removing 70 % of the stomach, at 1
fortable with doing these second-stage procedures, more pri- year, Scopinaro reported normal meal size.
mary DS will also be performed. Several recent studies Today’s gastric sleeve attempts to reduce gastric volume to
support the efficacy and safety of a single-stage procedure 100 cc or less. Thus, there is perhaps a more lasting reduc-
[20–22]. However, studies thus far have been limited to case tion of gastric volume. In addition, the impact of gut peptides
series, and a randomized controlled trial has yet to be per- such as ghrelin is unknown. However, in all probability, an
formed. While staging is attractive, as the second stage is increasing number of patients will have inadequate weight
done after there is loss of adiposity in the abdomen and loss or weight regain.
the patient has already adjusted to gastric volume reduction There are many attractive aspects to adding malabsorption.
making nutritional sequelae potentially less likely, it is not But certain rules must be remembered. Total intestinal length
306 M.S. Roslin and R. Sung
has to be adequate and be at least 2–3 m. The biliopancreatic 4. Revision of gastric bypass to distal bypass
limb has to be long enough to allow for the majority of bile (a) Is an effective procedure with no long-term issue
salts to be reabsorbed and not irritate the colon. The impact (b) Must leave the patient with adequate bowel length to
of the gastric pouch must be understood. It should be small avoid consequences of short bowel syndrome
enough to cause early weight loss but allow adequate intake (c) Works exactly the same as duodenal switch or
of protein supplements. It cannot empty too rapidly, and thus Scopinaro procedure
increase the likelihood of diarrhea. Additionally, it must be (d) Is more effective as there is no pylorus or fundus
remembered that total intestinal length determines the
Answer: B
amount of protein and total energy absorbed. Common chan-
nel length is important in determining the percentage of fat
that is absorbed. References
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(e) Blood work twice in the first year and then annually 17. Roslin MS, Oren JH, Polan BN, Damani T, Brauner R, Shah PC.
Abnormal glucose tolerance testing after gastric bypass. Surg Obes
Answer: A Relat Dis. 2013;9:26–31.
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Birkenhauer R, Fletcher P, Sawyer MJ. Gastric bypass for treating 531–8.
severe obesity. Am J Clin Nutr. 1992;55(2 Suppl):560S–6. Review. 21. Topart P, Becouarn G, Ritz P. Should biliopancreatic diversion with
19. Fobi MA, Lee H. SILASTIC ring vertical banded gastric bypass for duodenal switch be done as single-stage procedure in patients with
the treatment of obesity: two years of follow-up in 84 patients. J BMI > or = 50 kg/m2? Surg Obes Relat Dis. 2010;6(1):59–63.
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20. Iannelli A, Schneck AS, Topart P, Carles M, Hébuterne X, 22. Buchwald H, Kellogg TA, Leslie DB, Ikramuddin S. Duodenal
Gugenheim J. Laparoscopic sleeve gastrectomy followed by duode- switch operative mortality and morbidity are not impacted by body
nal switch in selected patients versus single-stage duodenal switch mass index. Ann Surg. 2008;248(4):541–8.
34
Laparoscopic Malabsorption Procedures:
Management of Surgical Complications
Fady Moustarah, Frédéric-Simon Hould, Simon Marceau, and Simon Biron
limb length variations are practiced in attempts to alter the hemorrhage. These conditions, in themselves, may pose
side effect profile of the operation, but evidence for the added diagnostic challenges in the obese patient after abdominal
safety and efficacy of such practice is lacking. Surgical, phys- surgery, and they mandate different and timely management
iologic, and nutritional complications related to the BPD ± DS plans as will be reviewed below.
are not simply limited to the approach used for surgical
access, the particular anatomic reconfiguration employed,
and the perioperative period: they can occur years after surgery General Complications Related
and require lifelong attention and follow-up. to Laparoscopy in the Obese
Reducing complications of malabsorptive bariatric proce-
General Postoperative Complications dures starts with safely offering these procedures, and lapa-
Related to Obesity roscopically when possible, by well trained specialists.
Believed to contribute to lower morbidity, laparoscopic
Diversionary procedures induce weight loss by limiting techniques were used in bariatric surgery since the early
nutrient absorption, and they are generally recommended to 1990s, and they have been increasing in popularity and scope
patients whose body mass index (BMI) exceeds 50 kg/m2; of application with both surgeons and patients ever since
yet, they are also performed on patients with lower BMI [25–28]. One study estimates that the proportion of laparo-
[17]. Procedural complications can, therefore, be related to scopic bariatric operations in the United States increased
the obesity itself and to the complexity of surgical interven- from 20.1 % in 2003 to 90.2 % in 2008 [ 10 ]. Today all
tions in settings of extreme obesity [18, 19]. Obese patients major bariatric procedures are performed laparoscopi-
often have a number of cardiovascular and pulmonary cally, including what is viewed as the most complex weight
comorbidities. Conditions such as ischemic heart disease, loss procedure: the laparoscopic BPD ± DS. Gagner per-
hypertension, hypercoagulability, venous stasis, obstructive formed the first laparoscopic BPD-DS in July of 1999 [18].
sleep apnea, restrictive lung disease, and diabetes are often The procedure was offered to high-risk super-morbidly
present; and any one of them alone or together may increase obese patients, with BMIs >50 kg/m2, and complication rates
the risk of perioperative cardiopulmonary and/or wound- were high [18, 29, 30]. The technical aspects of the proce-
related complications. Preoperative optimization of these dure have since been refined, reducing complications [31],
patients from a cardiopulmonary standpoint is, therefore, and concepts of staging the laparoscopic BPD-DS over time
paramount to reduce perioperative risk during anesthesia and to reduce perioperative risk were also introduced [32–34].
early during postoperative recovery [20]. The laparoscopic approach offers real benefits to bariatric
In addition, the obese abdomen presents substantial techni- patients, but it comes with its own set of technical challenges
cal challenges relating to surgical exposure, retraction, and related to access, exposure, and bowel handling, thus influ-
bowel manipulation [18, 21]. A high BMI (particularly in the encing both the intraoperative and the early and delayed
form of excessive visceral obesity), male gender, and advanced postoperative complication profile. The principal benefits of
age have been identified as predictors of increased periopera- laparoscopy relate to lowering the incidence of wound prob-
tive morbidity and mortality [22–24]. In a large patient sam- lems in comparison to procedures performed by laparotomy,
ple from a US national database, independent predictors where wound infections and delayed incisional hernias con-
associated with significantly increased mortality after bariat- tribute to significant morbidity in up to 15 % and 20 % of
ric surgery included the following: age >45 years, male gen- open cases, respectively [35–37]. A number of small ran-
der, a BMI of 50 kg/m2 or higher, open bariatric procedures, domized control studies and larger observational series have
diabetes, functional status of total dependency before surgery, all pointed to the benefits associated with laparoscopic bar-
prior coronary intervention, dyspnea at preoperative evalua- iatric surgery [38]. In addition to reducing the physiologic
tion, more than 10 % unintentional weight loss in 6 months, insult related to incision size, laparoscopic surgery offers
and bleeding disorders [24]. These factors should be taken bariatric patients other advantages: improved postoperative
into consideration as surgeons select and counsel patients for pulmonary function, reduced atelectasis, lower blood loss,
complex abdominal weight loss procedures to minimize risk lesser postoperative pain, improved early mobility, and pos-
of complications and guide perioperative management. sibly shorter hospital stay.
Regardless of the surgical approach used, postoperative Safe abdominal access is the first surgical challenge in
management of the obese patient focuses on aggressive and morbidly obese patients undergoing laparoscopy. The goal is
early mobilization and pulmonary physiotherapy to reduce to avoid injury to abdominal organs or retroperitoneal ves-
pulmonary complications. Vigilance in following vital signs sels. The main ways to access the abdomen for laparoscopic
and careful attention to symptoms in the early postoperative surgery include the closed technique using a Veress needle,
period can help detect potentially life-threatening complica- the open technique with a blunt Hasson trocar, and the direct
tions such as anastomotic leaks, pulmonary embolism, or trocar insertion technique without pneumoperitoneum [39].
34. Laparoscopic Malabsorption Procedures: Management of Surgical Complications 311
All have been used safely [40], but mortality from access TABLE 1. Important early and late surgical postoperative complica-
injury has been reported, and certain surgical principles can tions related to BPD
minimize complications, especially in the obese. Early (<30 days) Late
In patients with high BMI undergoing laparoscopic BPD, Anastomotic leak Stomal stenosis
BPD ± DS
it is usually difficult to lift the skin at the umbilicus to facili- with peritonitis
tate safe Veress needle insertion or even perform a cutdown Abdominal abscess Marginal ulcer
for the Hasson technique. If the Hasson technique is chosen at Pulmonary embolism Dumping syndrome
Bleeding Intestinal obstruction
the umbilicus, care must be taken to avoid excessive gas leak- Intestinal obstruction Internal hernia
age during the procedure after trocar placement. The weight Pulmonary Incisional hernia
of the abdominal wall can be a limiting factor in creating a complications
pneumoperitoneum with adequate working space, and gas Wound infection Complicated cholelithiasis
leakage from poor access technique and port placement can Acute renal failure Poor weight loss or weight regain
Cardiovascular events Liver failure
result in poor exposure and, thereby, increase operative risk. Nutritional:
We prefer placing the first port in the midline above the Anemia
umbilicus (about 15–20 cm from the xiphoid process) using Hypocalcemia
an optical trocar, after having raised a pneumoperitoneum Hypoalbuminemia
with a Veress needle inserted under the left costal margin Hyperparathyroidism
(secondary)
(between the midclavicular and anterior axillary lines). The Fat-soluble vitamin
needle is inserted perpendicular to the skin and is then aspi- deficiencies
rated to ensure that blood, succus, or stool is not present. Vit. A: night blindness
Then 5 mL of sterile saline can be injected to assess resis- Vit. D: secondary
tance to flow, and finally a water drop test can be performed hyperparathyroidism
Vit. E: dry skin
to observe a drop of saline descend through the hub of the Vit. K: increased
needle without resistance. These signs are reassuring and prothrombin time
observable even in the obese with increased abdominal pres- Vitamin B12 deficiency
sures. Finally, the needle is hooked up to the insufflator, and Osteoporosis
pressure readings are noted. Intra-abdominal pressure may Protein-calorie malnutrition
be elevated in bariatric patients, but expected readings are
usually between 9 and 13 mmHg. Loss of hepatic dullness on Anastomotic or suture line leakage, pulmonary embolism,
percussion after insufflation of 100 cc of CO2 is another reas- and hemorrhage remain among the most serious and poten-
suring sign of intra-abdominal needle placement. The tially life-threatening early complications and will receive
abdominal cavity is then evaluated, and trocars are placed special mention. In general, morbidity rates after BPD ± DS
under direct vision to minimize injury. range from 2.9 to 16.3 % as reported in large series of greater
Because exposure remains a challenge in obese patients, than 100 patients, some of which also included open cases
the surgeon should not hesitate to use additional 5 mm ports [3, 15]. Major complications account for ≤8 % in institu-
to improve retraction and tissue handling as needed. An addi- tions where BPD-DS is the principal procedure performed
tional insufflator may sometimes help in lifting a heavy [17, 31].
abdominal wall and improving the working space. While
conversion to laparotomy to deal with complications difficult
to address with laparoscopy remains an option every surgeon Anastomotic Leakage
should be ready to take, we tend not to resort to conversion
simply to complete a BPD-DS. If exposure, anatomic, or Leaks occur with a reported incidence of 0–8 % in different
medical variables are limiting at the time of surgery, we pre- series of laparoscopic BPD [31, 41–43]. Leaks are a serious
fer to stage the procedure and perform a primary sleeve gas- source of morbidity and are a leading cause of mortality after
trectomy first with plans to perform a duodenal switch as bariatric procedures. Leakage has been implicated in mortal-
needed in about 18 months, after weight loss and improve- ity in up to 29 % of deaths after bariatric surgery [23].
ments in the risk profile have occurred. Despite advancements in supportive care, mortality after
intra-abdominal leakage is often due to delayed diagnosis, so
a high index of suspicion allows for early detection and
Surgical and Acute Postoperative timely intervention.
Complications Leaks at any staple or suture line can result from technical
factors at the time of surgery. Such factors may include any
Some complications after bariatric surgery are procedure or all of the following: division of blood supply during
specific. Important early and late postoperative complica- dissection, anastomotic tension, tissue injury from poor
tions associated with BPD ± DS are summarized in Table 1. handling with laparoscopic instruments, or stapler misuse or
312 F. Moustarah et al.
malfunction. In a BPD ± DS, anastomotic leaks can occur at more difficult to resolve than early ones, and to date a gen-
the following areas: (1) the gastric staple or suture line, (2) erally accepted algorithm for the management of gastric
the gastroileostomy (Scopinaro procedure) or the duodenoil- leaks is yet to be described [47]. Surgical or percutaneous
eostomy (BPD-DS), (3) the duodenal stump, or (4) the ileo- drainage of leaks presenting in the early postoperative
ileostomy. Leaks, however, have also resulted from small course is needed. In select stable patients, contained leaks
bowel injuries due to intestinal handling with graspers dur- can be managed nonoperatively with adequate percutane-
ing laparoscopic surgery, and this source of peritonitis should ous drainage, bowel rest, total parenteral nutrition, and
be considered when evaluating or treating postoperative antibiotics. A nasojejunal gavage tube may be temporarily
patients. utilized for nutritional support. When leaks are not con-
The most common and serious site of leakage after a tained, diffuse peritonitis results; and if left untreated, sep-
BPD ± DS is from the gastroileostomy/duodenoileostomy. sis will follow with possible multisystem organ failure.
The foot anastomosis, or ileoileostomy, leaks infrequently. Surgical treatment, on the other hand, involves early reop-
When leakage occurs at this site, however, it tends to be high eration, copious irrigation, and wide drainage, while suture
in output and associated with rapid deterioration of the repair is avoided or reserved for cases where tissue is
patient, leading to potentially higher morbidity and mortal- clearly amenable to manipulation without increasing the
ity. In the BPD-DS with sleeve gastrectomy, another impor- risk of further damage [48]. Omental patching may be help-
tant (and often difficult to manage) area of leakage is the ful, but the key is effective drainage. For large gastric or
gastric staple line. upper anastomotic leaks requiring surgical drainage for
A leak can be immediate or may present up to 1–2 weeks sepsis, a jejunal feeding tube is best placed at the time sur-
postoperatively. A negative intraoperative leak test and an gery in the biliopancreatic limb for nutritional support. The
UGI swallow on the first postoperative day, if performed, feeding tube allows for outpatient management before com-
offer some reassurance regarding the integrity of the upper plete healing of the leak site is achieved. For early leaks,
anastomosis in a BPD, but these tests can be falsely negative, endoscopically placed covered stents may be utilized to
and a leak from ischemia at an anastomosis may take some allow early oral intake, reduced hospitalization, and pro-
time to manifest. We do not routinely perform an UGI swal- mote tissue healing [49, 50]. Any endoscopic treatment
low postoperatively in our patients after a BPD-DS. In addi- modality must be an adjunct to adequate drainage and
tion, we do not routinely place drains intraoperatively. broad-spectrum antibiotic therapy, as clinically indicated,
However, if a functioning drain had been appropriately posi- along with appropriate nutritional support. For a late leak,
tioned at the time of surgery, a change in the character of the which often manifests as a subphrenic abscess, percutane-
drainage or an elevated amylase content of the drain fluid ous drainage is first performed. If the fistula does not heal
may be the first and only sign of anastomotic disruption in an after a few weeks (which is often the case), endoscopic
otherwise well appearing patient. placement of clips, stents, sutures, and glue products may
Diagnosing postoperative peritonitis is often difficult in be appealing options but are often unsuccessful. Eventually,
obese patients, and this is more so in the early postoperative surgical intervention may be required to treat chronic per-
state where pain and other cardiopulmonary conditions can sistent fistulas. Many approaches have been attempted with
cloud the presentation. Although fever, tachycardia, and varying success: (a) placement of a gastrostomy tube
abdominal pain are common, often the only sign is tachycar- through the leak site, (b) a serosal patch with the small
dia in the absence of classic peritoneal signs such as guarding intestine pulled up to cover the leak, (c) a Roux-en-Y pull-
and rebound tenderness. A heart rate greater than 120 beats/ up of the small bowel anastomosed to the leak site, (d) con-
min should alert the evaluating clinician to consider a leak, version from sleeve to gastric bypass with resection of the
even if the patient feels and looks well [44]. Tachycardia alone, leak area, (e) a gastric seromyotomy, or (f) resection of the
however, may not be a reliable early indicator of leakage [45]. gastric sleeve with an esophagojejunostomy [51–53].
A proximal gastric leak often results in left shoulder pain on
deep inspiration. This is a sign of diaphragm irritation medi-
ated by the phrenic nerve (C3–C5) and referred to the shoulder Venous Thromboembolism
region (Kehr’s sign). Computed tomography (CT) can be very
useful in all patients with unexplained tachycardia, fever, or Pulmonary embolism is another common cause of mortal-
abdominal pain after BPD ± DS. If a CT scan is unavailable, ity after bariatric surgery, and death from this condition
emergency re-laparoscopy should be offered for diagnosis and can occur after discharge from hospital. Because of the
timely management. type of resection and reconstruction involved in BPD ± DS,
Gastric leaks in a BPD-DS procedure tend to occur high operative times are longer than other commonly performed
on the neo-greater curve of the stomach near the GE junc- bariatric procedures. Long times on the table and pro-
tion, resulting in a perigastric collection or subphrenic longed postoperative immobilization, along with the
abscess. Their treatment depends on the timing of presenta- underlying state of obesity, place morbidly obese patients
tion and patient stability [46]. Late gastric leaks are often at elevated risk of deep venous thrombosis (DVT). The
34. Laparoscopic Malabsorption Procedures: Management of Surgical Complications 313
incidence of pulmonary emboli after bariatric surgery is judgment and risk of bleeding. Although there is some low-
about 1 %. A recent outcome study from the Michigan col- level evidence to support using only mechanical prophylaxis,
laborative group establishes a baseline for the incidence of the weight of the data supports using a combination of che-
venous thromboembolic complications following bariatric moprophylaxis and mechanical prophylaxis in bariatric
surgery in recent years. In their multicenter review, the patients to lower overall VTE rates to less than 0.5 %. In the
Michigan group reported that the prevalence of DVT not absence of contraindications, extended post-discharge VTE
accompanied by pulmonary embolism (PE) was 6,480 events prophylaxis for patients deemed to be at high risk should be
in 508,230 bariatric cases (1.3 %), and venous thrombo- considered; evidence to support a dose and duration of ther-
embolism (VTE), either PE or DVT, occurred in 10,980 of apy remains lacking, however.
508,230 (2.2 %). The prevalence of PE was 0.9 %. The
reported in-hospital mortality among patients with PE was
130 of 508,231 (0.03 %) in the same study [54]. Hemorrhage
Patients with a PE may become hypotensive and tachy-
cardic with signs similar to those of sepsis. Nevertheless, in Bleeding is not an infrequent complication after laparo-
patients with signs of sepsis and hypoxia, the diagnosis of a scopic BPD ± DS surgery. It is often self-limited, and life-
PE and leak should be simultaneously considered, and threatening hemorrhage is rare. In a series of 1,000 patients,
appropriate imaging studies to guide diagnosis and treatment gastrointestinal hemorrhage after BPD-DS was reported at
should be ordered promptly. An angio-CT of the thorax and a rate of 0.5 % [31]. Higher rates, however, have been
a CT scan of the abdomen with oral contrast are helpful. In reported after laparoscopic bariatric procedures involving
patients whose body size precludes them from undergoing anastomoses [56]. Bleeding can occur at port sites, intra-
diagnostic spiral CT imaging, a pulmonary V/Q scan may be abdominally, or intraluminally in the gastrointestinal tract.
helpful; but serious consideration should be given to imme- Intraoperative and postoperative bleeding can be minimized
diate exploration in the operating room. If no intra-abdominal and prevented with measures that include deliberate port
pathology is found at surgery, therapeutic anticoagulation placement and removal techniques, careful dissection, and
can be initiated thereafter on clinical grounds. appropriate utilization of energy sources for controlling
Early ambulation is the key element of VTE prophylaxis. blood vessels.
Difficult cases expected to require prolonged operative times Carefully placed single absorbable stitches are recom-
due to poor exposure and difficult dissection are either better mended to close laparoscopic port sites greater than 10 mm
staged laparoscopically or converted to open to avoid unnec- in size, and all port sites should be removed under vision at
essary time on the OR table just to complete the procedure the end of the procedure. Postoperatively, any significant
under laparoscopy. Sequential compression devices are used port site bleed will either result in discoloration around the
intraoperatively and in the early postoperative period to port site on the first or second postoperative day or abdom-
decrease VTE risk. This is often done in addition to pharma- inal pain with or without hypotension or a drop in hemo-
cologic prophylaxis with an appropriate dose of low molecu- globin (Hb). If a port site bleeds intra-abdominally, a
lar weight heparin (LMWH). It is our practice to discharge hematoma requiring surgical evacuation may result. A
patients on subcutaneous LMWH injections for 20 additional postoperative drop in Hb associated with bruising around a
days at a dose of 7,500 units of dalteparin. port site or abdominal pain may indicate a significant
To date, there are no high quality data favoring one DVT bleed, but such bleeds are often self-limited and do not
prophylaxis approach over another. In early 2013, the require a transfusion.
American Society for Metabolic and Bariatric Surgery The gastrosplenic area can pose a hemostatic challenge,
(ASMBS) Clinical Issues Committee released its recommen- especially in cases where the gastric fundus is large, poste-
dations for VTE prophylaxis [55]. The committee considers rior, and sometimes closely intimate with the spleen near its
all bariatric surgery patients as being at elevated risk for upper pole. Bleeding from short gastric vessels or the splenic
VTE. Factors that increase risk include high BMI, advanced capsule can be difficult to control. It is best to avoid bleeding
age, immobility, prior VTE, known hypercoagulable condi- in this area by carefully using laparoscopic energy sources
tion, hormonal therapy, expected long operative time or open such as ultrasonic or bipolar devices with the judicious aid of
approach, and male gender. In the absence of evidence sup- metallic clips.
porting any one regimen for VTE prophylaxis and recogniz- After performing a sleeve gastrectomy in a BPD-DS, the
ing that the risk cannot be completely eliminated, the long staple line on the vascular stomach is prone to bleeding,
committee recommended that individual bariatric practices and this can be exacerbated by subcutaneous heparin. Oozing
should develop and adhere to a protocol for prophylaxis to from the staple line can be controlled with clips or suturing.
reduce the risk of thromboembolic disease. While mechani- Some surgeons use suture or biosynthetic strips to reinforce
cal compression devices and early postoperative ambulation the gastric staple line and reduce hemorrhage [57, 58].
are encouraged, the combination of mechanical prophylaxis Fortunately, staple-line bleeding is usually self-limited, but
and chemoprophylaxis is to be considered based on clinical any large intra-abdominal hematomas resulting from such
314 F. Moustarah et al.
bleeds may require evacuation to reduce the risk of gastric Marginal ulcers can present any time after surgery but
obstruction and/or leak formation due to a compressive effect seem to be more common after the first few months. The
of a large hematoma and to facilitate recovery and discharge anastomotic technique is not clearly related to the ulceration
from hospital. rate. Patients usually present with upper epigastric pain.
Postoperative bleeding may cause tachycardia, hypoten- Nausea, vomiting, and food intolerance can also be present.
sion, oliguria, persistent hypothermia, a decrease in hemato- Evaluation includes an upper GI endoscopy or a barium
crit (late sign), or possibly blood collecting in the drains swallow. Treatment often involves conservative measures
placed at the time of surgery. Intraluminal gastrointestinal such as smoking cessation, stopping NSAID use, and starting
hemorrhage can present with hematemesis or melena. The PPI therapy; revision of the anastomosis is infrequently
source can be from the gastric mucosa or the upper or lower needed in recalcitrant cases.
anastomosis. Upper endoscopy may enable direct visualiza-
tion and coagulation of the bleeding point. Managing hemor-
rhage after bariatric surgery depends on the cause and Stenosis
persistence of bleeding, and sometimes endoscopy or surgi-
cal exploration is needed for definitive diagnosis and treat- Stenosis can occur at the proximal or distal anastomosis in the
ment [59]. Bleeding at the mesentery can occur but is often BPD ± DS operation. Stenosis at the foot enteroenterostomy is
self-limited. It may, however, contribute to a prolonged post- less common but can occasionally present with bowel obstruc-
operative ileus or an early small bowel obstruction. tion as discussed in the section on “Intestinal Obstruction”
below. Proximal stenosis can present with food intolerance,
nausea, vomiting, and dehydration. It occurs at a reported rate
Delayed Postoperative Complications of 0–11 % in laparoscopic series of BPD ± DS and often occurs
in the first few months after surgery [31, 42, 61]. Workup
BPD ± DS can result in surgical complications long after the includes an UGI endoscopy or an UGI series. Occasionally, the
procedure is performed. With appropriate recognition and patient may require admission to the hospital for rehydration
management, these potential complications can be resolved and definitive treatment. In the case of dehydration due to
without significant morbidity or mortality. Common delayed excessive vomiting, we start intravenous vitamin and mineral
gastrointestinal complications after BPD ± DS include mar- repletion, particularly thiamine, prior to administration of intra-
ginal ulcers, anastomotic stenosis, intestinal obstruction, venous glucose containing rehydration solutions to minimize
dumping syndrome, cholelithiasis, changes in bowel habits, the risk of neurologic sequelae. Stenoses respond well to endo-
and intestinal bacterial overgrowth. scopic dilation, although more than one session is often
required. Surgery is rarely needed to resolve a stenosis unless
the endoscopic dilatation is complicated with perforation at or
Marginal Ulcer around the site of stenosis [62, 63].
Intestinal Obstruction sutures tearing out of the weak mesenteric peritoneum early
after suture placement or due to suture resorption or migra-
Intestinal obstruction after laparoscopic BPD surgery can tion over time.
occur as a result of a number of conditions: (1) internal her- While antecolic Roux limb placement and closure of sur-
nias, (2) adhesions, (3) intestinal anastomotic stenosis, (4) gical defects with suture may decrease internal hernias, it
port site hernias, (5) ventral abdominal wall hernias, and (6) may increase adhesive small bowel obstructions or acute
incorrect bowel limb anastomosis. Measures can be taken to angulation at the ileoileostomy. The technique of mesenteric
reduce postoperative intestinal obstruction by understanding defect closure can predispose to angulation at the ileoileos-
the different causes and paying attention to the surgical tech- tomy. Anti-obstructive sutures placed here between the two
niques used to perform the operation. Adhesions can occur segments of the small bowel can minimize angulation.
after the primary bariatric procedure, and some may be due Obstruction at the ileoileostomy can occur more often if the
to subclinical postoperative leaks; they can also be second- enteroenterostomy is closed with a stapler, narrowing the
ary to other prior operations, particularly pelvic or gyneco- lumen. This complication can be minimized with careful sta-
logic surgery, and this must be kept in mind to guide pler placement or with the use of suture to close the roof of
management. No current treatment exists to prevent adhesive the mechanically created foot anastomosis.
bowel obstruction. Incorrect bowel limb anastomosis (Roux-en-O) is not
A potentially serious complication after bariatric surgery often reported, but may occur sporadically. The incorrect
is that of intestinal obstruction secondary to internal hernia limb is anastomosed to the duodenum/stomach. It is impor-
formation. In malabsorptive procedures, the creation of mes- tant to prevent this complication intraoperatively by system-
enteric defects during surgical reconstruction of the gastro- atically labeling and verifying intestinal limbs prior to
intestinal tract with the upper and lower anastomoses reconstruction. It is also preferable to recognize this situation
predisposes patients to internal hernias through these defects and repair it at the time of the initial surgery, as detection in
in the short and long term, especially after weight loss. the postoperative period may be delayed and early radiologic
Bowel obstruction in this context, unlike other general surgi- images may be nondiagnostic. In our experience of about
cal conditions, can be devastating due to the tendency of the 5,000 patients, this complication occurred twice. One was
obstruction to be closed loop and ischemic in nature rather recognized intraoperatively and repaired without conse-
than a simple adhesive intestinal obstruction. Laparoscopic quences. Another was recognized 3 months postoperatively
techniques create fewer adhesions postoperatively and in a patient who had excessive weight loss and vomiting in
decrease the risk of adhesive obstruction to 0.3 % [67]. This, the absence of gastric obstruction or anastomotic stenosis,
however, has not translated into an overall lower incidence of and reoperation in this patient was associated with lethal
small bowel obstruction after laparoscopic bariatric proce- complications. A HIDA scan provided the best imaging of
dures compared to open ones (about 3.6 % versus 2 %), and the condition as the radioactive label was traced from the
this is explained by the greater tendency of the bowel to BPL back to the stomach.
move and herniate through surgically created defects [68]. Because bowel obstruction after bariatric surgery can be a
Proper closure of these defects with permanent suture is gen- real surgical emergency, timely recognition of clinical signs
erally recommended despite data in the Roux-en-Y gastric and symptoms and appropriate utilization of diagnostic tests
bypass literature showing low internal hernia rates in some can reduce morbidity and mortality [70]. The surgeon must
series where defects are left unclosed. The enteroenteric have a high index of suspicion for serious conditions (closed-
mesenteric defect is usually more amenable to safe closure loop obstruction and intestinal strangulation) and a low
and should be closed in all instances. The defect between the threshold for surgical exploration of any postoperative
alimentary limb (or Roux limb) mesentery and the mesoco- BPD ± DS patient who presents with persistent or recurrent
lon (Petersen defect) is usually more challenging to close, GI complaints such as abdominal pain, nausea, or vomiting.
but attempts should be made to safely do so. It is believed The small bowel may become ischemic in as little as 6 h after
that antecolic placement of the Roux limb is associated with the onset of closed-loop obstruction. Symptoms vary in
a lower incidence of internal hernia and bowel obstruction severity from mild intermittent epigastric abdominal pain
than the retrocolic passage of this Roux limb through the and cramping to severe incapacitating pain radiating to the
transverse colon mesentery [68]. Champion et al. noted a back and associated with persistent nausea and vomiting.
decrease in the incidence of small bowel obstruction from While obstruction of the alimentary limb or common
4.5 to 0.4 % after changing to the antecolic approach [69]. channel presents with the typical symptoms of nausea, vom-
Internal hernias observed with the retrocolic technique tend iting, and/or obstipation, obstruction of the BPL is more
to be more related to the mesocolic defect than to the true difficult to diagnose. It may cause abdominal fullness and
Petersen defect itself, and closure of mesocolic defects, bloating and pain from visceral distention or from pancre-
when created, is preferred. One must keep in mind that her- atitis. Yet, the patient may eat, pass gas, and have bowel
nias can occur even after closure of mesenteric defects due to movements. One must always be aware of obstructions
316 F. Moustarah et al.
involving the BPL, leading to duodenal distention with bile conversion to open surgery may be needed. Adhesions should
and pancreatic enzymes and possible blowout of the duode- be lysed and mobilized, especially around the ileoileostomy.
nal stump. If detected late in its clinical course, closed-loop Stenosis of this anastomosis may be managed with resection
obstruction from internal hernias can lead to ischemia and and revision. A feeding jejunostomy placed in the proximal
necrosis of a significant length of intestine with perforation BPL may be required to decompress the small bowel and
resulting in peritonitis, short bowel syndrome post resection, later provide nutritional support, especially if hypoprotein-
or even death. Laboratory test such as serum lipase or amy- emia is present preoperatively or if ischemic bowel or perfo-
lase and liver enzymes may be elevated with ischemic bowel ration with peritonitis is diagnosed and a protracted recovery
or BPL obstruction, and this may be confused with pancre- is expected.
atitis or gallstone disease.
Diagnostic imaging is very helpful in the evaluation of
stable patients. It is worth noting that obstruction in the BPL Cholelithiasis
segment does not necessarily show on the flat and upright
abdominal radiographs routinely used to diagnose small Rapid weight loss, whether surgical or after lifestyle changes,
bowel obstruction because air-fluid levels are often absent. has been associated with gallstone formation [72–74].
Abdominal CT scans are generally more helpful in bariatric Performing a cholecystectomy at the time of a bariatric pro-
patients. However, if the patient is unstable, immediate sur- cedure to prevent cholelithiasis and related complications is
gical exploration may be the best diagnostic and therapeutic not sufficiently addressed in the literature, and surgical prac-
modality. Spiral helical CT scanning with only small amounts tices vary. Many series describe performing a routine chole-
of oral contrast can be the most accurate diagnostic tool out- cystectomy at the time of open BPD ± DS surgery [75]. This
side of the operating room, and it should be performed with practice evolved in the absence of a good evidence base and
the shortest delay possible in relatively stable patients [71]. has started to change in the era of laparoscopic surgery with-
Radiologic signs on CT include dilated bowel, thickened out availability of consensus or guidelines [76, 77]. In
bowel wall, contrast or fluid in the BPL, increased free Scopinaro’s early reports on BPD, a high incidence of gall-
intraperitoneal fluid, a preponderance of bowel on one side stones was diagnosed in their patients after surgery; simulta-
of the abdomen, and mesenteric vascular congestion or neous routine cholecystectomy was, therefore, recommended
twisting (the “swirl” or “twirl” sign, which may be enhanced [78]. We have also adhered to this practice from 1994 to
with the addition of IV contrast to the study). Bariatric 2008 in open BPD-DS surgery. In 1995, Sugerman et al.
surgeons should ideally review all the abdominal CT scans described the effectiveness of ursodeoxycholic acid as a pro-
with radiologists to improve image interpretation at the time phylactic treatment of gallstone formation after weight loss
of presentation. surgery [79].
Since clinical and radiologic signs can be nonspecific and Recently a large population-based study from Sweden
CT scans may be nondiagnostic or falsely interpreted as neg- reviewed a cohort of over 13,000 patients and confirmed the
ative, surgeons must keep a high index of suspicion for increased occurrence of cholecystectomy after bariatric sur-
pathology best evaluated in the operating room. Non- gery [80]. It suggested that this might be more related to gall-
operative management of small bowel obstruction should be stone detection bias than to an elevated risk of symptomatic
utilized with caution. The majority of adhesive small bowel gallstones. In this study, an individual’s risk of symptomatic
obstructions resolve with conservative management. In con- cholelithiasis mandating cholecystectomy after bariatric sur-
trast, obstruction from internal hernia is a surgical emer- gery remained low, making prophylactic cholecystectomy
gency, needing reduction of herniated small bowel and during bariatric surgery questionable.
possible revision of the anastomosis, resection of nonviable In the setting of BPD-DS surgery, a recent publication
bowel, and repair of the defect. described selectively performing a cholecystectomy in
Surgical exploration requires a systematic and compre- patients with gallstones [81]. Patients who did not undergo a
hensive examination of the entire abdomen and pelvis, cholecystectomy were placed on ursodeoxycholic acid for 6
regardless of the suspected etiology. Having access to the months. Of these patients, 8.7 % subsequently required a
bariatric operative record is helpful in clarifying how the GI cholecystectomy. This led the investigators to conclude that
tract was reconstructed. Laparoscopic evaluation should a routine cholecystectomy in the context of a BPD-DS is
include running the small intestine from the cecum to the unwarranted and that selective gallbladder removal is more
foot anastomosis identifying the common channel and then appropriate.
to the duodeno-ileal/gastroileal anastomosis and to the When we perform laparoscopic BPD-DS, we are liberal
ligament of Treitz to evaluate the rest of the alimentary limb yet selective in our decision to remove the gallbladder. The
and the BPL, respectively. All potential defects should be presence of asymptomatic gallstones on preoperative ultrasound
evaluated and closed. There may be a role for intraoperative is one indication for removing the gallbladder, especially in
endoscopy to examine the proximal anastomosis. In case of younger patients who have a greater lifetime risk of compli-
internal hernias with significant distortion of the anatomy, cated cholelithiasis and in women of childbearing age. In
34. Laparoscopic Malabsorption Procedures: Management of Surgical Complications 317
brief, other factors that influence our decision, however, [82]. Symptoms after BPD ± DS also include frequent
include the following: (1) procedure time, (2) gallbladder abdominal bloating, often reported in association with
size and position, (3) technical difficulty in achieving the excess carbohydrate intake. Bacterial overgrowth is thought
critical view for gallbladder dissection, and (4) other advan- to contribute to these gastrointestinal symptoms of abdomi-
tages of performing a concomitant cholecystectomy. To nal distension, diarrhea, foul stools and gas, and proctitis.
avoid prolonging surgical time under anesthesia in difficult Although, there is no blind limb in the standard BPD ± DS
cases, the gallbladder may be left in situ. The gallbladder is operations, symptomatic bacterial overgrowth can occur,
also left in place if the dissection and identification of the and this is evidenced by the response of related symptoms
cystic duct and common bile duct junction appear problem- to intermittent brief pulses of antibiotic therapy mostly in
atic. On the other hand, if the gallbladder size and position the form of oral metronidazole [82–84]. When no improve-
hinder adequate exposure for dissection and division of the ment is reported after such therapy, dietary factors must be
duodenum and subsequent creation of the duodenoileos- evaluated and adjusted.
tomy, the gallbladder is removed. If the gallbladder is left in
place, our routine is to prescribe ursodeoxycholic acid for 6
months postoperatively. We feel that after weight loss, and if Weight Recidivism
gallstone symptoms develop, the favorable anatomy and
better exposure can reduce the risk of bile duct injury. BPD ± DS is a very effective surgical weight loss procedure.
Nevertheless, real advantages of performing a concomitant It is among the most potent treatments for morbid obesity as
cholecystectomy at the time of BPD ± DS cannot be ignored, far as weight loss and sustained results are concerned [1–3].
even when preoperative ultrasound does not show choleli- Nevertheless, insufficient weight loss can occasionally
thiasis: the chances of gallstone formation after a BPD ± DS result, but much less so than with other bariatric procedures,
may be higher than with other less malabsorptive bariatric and weight loss failure or recidivism does not pose a frequent
operations because of the reduction in enterohepatic circula- problem after BPD ± DS surgery [85]. In 2007, Marceau
tion and greater loss of bile salts as well as the greater cho- et al. summarized their 15-year experience with BPD ± DS as
lesterol excretion seen with greater weight loss. A subsequent a primary (open) procedure in 1,423 patients [82]. Revision
urgent cholecystectomy may also be more difficult in the surgery for weight loss failure was needed in only 1.5 % and
presence of an inflamed gallbladder and adhesions in the resulted on average in an additional 14 kg weight loss. When
area of the duodeno-ileal anastomosis. Also, if patients revision surgery was offered in this series, it included short-
develop choledocholithiasis after a BPD ± DS, access to the ening of the intestinal channels to the conventional
bile duct by endoscopic retrograde cholangiopancreatogra- 250/100 cm, as alimentary limb elongation was observed at
phy is more challenging and impossible in the routine fash- repeat surgery and was deemed secondary to intestinal adap-
ion. Management of symptomatic and complicated tation over time. Interestingly, this phenomenon was also
choledocholithiasis will, therefore, be more involved and observed in a rodent BPD-DS model [86]. In a few of the
often percutaneous or surgical in nature with transintestinal revised patients, a repeat sleeve gastrectomy was also per-
ERCP or direct common bile duct exploration. formed. Re-sleeve alone has been shown to work in the short
term [87]. Revisional bariatric surgery for weight loss failure
must be considered carefully as it is not clear which patients
Changes in Bowel Habits and Intestinal will benefit from further surgical intervention [88]. In mal-
Bacterial Overgrowth absorptive surgery, shortening the common channel to less
than 75 cm is generally not recommended as it can result in
For patients, increased stool frequency and malodorous increased rates of protein-calorie deficiency [8]. In evaluat-
stools and gas can be one of the most annoying side effects ing patients with insufficient weight loss and weight regain,
of malabsorptive procedures. The odor is typical of pancre- the presence of certain surgical situations or medical condi-
atic insufficiency, and pancreatic enzymes taken orally with tions should be considered and evaluated with appropriate
meals can improve this symptom but can be associated with investigational modalities. These conditions may include (1)
weight regain. These side effects or symptoms are reported a residual large gastric pouch, (2) a long common channel, (3)
by about 1/3 of patients and forces them to decrease fat uncontrolled eating disorder, (4) wrong choice of initial
intake and to avoid certain food altogether; nevertheless, operation for the patient, (5) alcohol addiction, (6) drug side
over 90 % consider their eating habits after BPD-DS as nor- effects, and (7) undiagnosed medical condition leading to
mal. The problems with stools and gas subside over the secondary obesity. Binge eating behavior, for example,
years but can remain intermittent and annoying for some which is common among the morbidly obese, may recur
individuals. The number of stools after surgery is about 3 after surgery and is associated with weight regain [89].
per day [3, 82], and stools were loose more than three times Addressing nonsurgical factors contributing to weight loss
a week in 30 %, while constipation was reported by 12 % failure is, therefore, important before subjecting patients to
318 F. Moustarah et al.
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35
Laparoscopic Malabsorption Procedures:
Management of Nutritional Complications
After Biliopancreatic Diversion
Fady Moustarah and Frédéric-Simon Hould
malabsorptive bariatric procedure. Medical conditions, a decrease in the incidence of protein malnutrition to about
nutritionally related illnesses such as preoperative anemia, or 2 % [22]. This points to the importance of limiting the degree
lifestyle habits that may influence surgical outcomes are of gastric restriction in patients undergoing malabsorptive
addressed. Micronutrient replacement is initiated as indi- procedures, like BPD ± DS, so as not to interfere with ade-
cated by results of testing. Low serum 25-hydroxy vitamin quate oral nutrient intake. While restriction is desired, the
D3 levels are commonly encountered, and preoperative “sleeve” gastrectomy component of a BPDDS should not be
replacement is started with a daily oral dose of 10,000 IU of the same as in a stand-alone “sleeve gastrectomy” procedure,
vitamin D for 1 month, followed by a daily dose of 800 IU for it should provide patients with adequate gastric capacity
until surgery. Patients are on a low residue diet up till the day to enable easy eating and sufficient protein intake and diges-
of surgery, and they are allowed oral intake on the first post- tion, keeping up with increased protein needs after surgery.
operative day. They are quickly advanced from a liquid to a Beyond gastric restriction, reduced protein intake can
pureed diet within their short 3–5-day hospital stay. During result from decreased consumption of meats, which patients
their admission, patients are seen again by a nutritionist to may tolerate poorly in the early period after surgery, or from
review and reinforce important postoperative dietary educa- gastrointestinal problems like anastomotic stenosis or gastric
tion prior to hospital discharge. narrowing that may decrease food tolerance and lead to food
One month after BPDDS, patients are started on a daily aversion or poor food choices. Clinically, protein deficiency
multivitamin regimen that includes the following: 1 fortified manifests as fatigue, loss of muscle strength, alopecia,
multivitamin complex; 50,000 IU of vitamin D2; 1,000 mg of edema, and occasionally greater than expected weight loss.
calcium carbonate; 20,000 IU of vitamin A; and 300 mg of Patients often develop hypoalbuminemia or anemia, and they
iron sulfate. In addition, patients are advised to consume about may have suffered from repeated infections prior to clinical
75–90 g of protein per day, and they are followed postopera- presentation, possibly due to a degree of immunosuppression
tively every 4 months during the first year with blood work resulting from a protein deficient state [22].
and then yearly thereafter, unless otherwise indicated. The Diminished visceral protein markers such as albumin and
routine blood work panel is similar to that obtained preopera- prealbumin are helpful in diagnosing protein malnutrition,
tively and includes a complete blood count, creatinine, mea- keeping in mind that these biomarkers are also acute phase
surements of serum glucose, albumin, calcium, phosphate, reactants that are suppressed by acute or critical illness [23].
magnesium, folate, serum iron panel including transferrin, Other signs of malnutrition or protein-calorie deficiency
vitamin B12, 25 (OH) vitamin D3, vitamin A, parathyroid hor- must, therefore, be considered. After BPDDS, lower serum
mone, liver enzyme panel, and INR. On follow-up, patients albumin levels are expected; albumin decreases but remains
are carefully evaluated to identify signs and symptoms or risk within normal limits and relatively constant over time.
factors for potential nutritional complications that may develop Reporting on the long-term results of the duodenal switch in
in the early or late postoperative period. Specific testing is then 1,028 patients with pre- and post-op serum albumin levels,
requested as deemed appropriate. Important clinical concerns the Québec group observed that the prevalence of moderate
after BPD surgery include: protein malnutrition, anemia, neu- hypoalbuminemia (30–36 g/L) increased from 4.6 % at
rologic conditions, fat-soluble vitamin deficiencies, and meta- baseline to 8.5 % postoperatively at a mean follow-up time
bolic bone disease. of about 7 years. Severe hypoalbuminemia (<30 g/L) was
seen in only 0.9 %, and this was similar to the observed pre-
operative prevalence of this condition [20]. In their same
Protein and Energy Deficiency cohort, 70 out of 1,423 patients were reported to require
hospitalization for malnutrition and 9 patients in total
Protein-calorie malnutrition is considered one of the more required revision surgery. A recent report from the same
serious complications of malabsorptive procedures and may group on BPDDS in patients with BMI < 50 kg/m2 suggests
require hospitalization for nutritional support [19, 20]. The that the hospitalization rate for malnutrition (4–5 % of stud-
degree of protein malnutrition following bariatric surgery is ied cohorts), although not always related to protein-calorie
uncertain because reports vary in procedures performed and deficiency, remains consistent over time and in different
defining diagnostic criteria. In Scopinaro’s series of 958 groups undergoing BPDDS [24].
patients, an 11.9 % incidence of protein-calorie malnutrition Factors contributing to protein-calorie malnutrition vary
was reported, with 4.1 % requiring surgical revision/restora- and may be related to the time of clinical presentation. If the
tion between 14 and 63 months postoperatively [19]. Such condition is observed in the first year after surgery, it is often
incidence and associated need for hospitalization or revision a consequence of poor protein intake due to the restrictive
surgery seem to have decreased with the duodenal switch- component of surgery at the level of the stomach or proxi-
type BPD described by Marceau et al., which has a longer, mal anastomosis, exacerbated by poor nutritional choices
100 cm, common intestinal channel [21]. By modifying the patients may make in reaction to the restriction they experi-
Scopinaro procedure since its inception and leaving a larger ence. Occasionally, poor patient compliance with nutritional
300–500 mL gastric reservoir, the Italian team also observed advice may be the culprit. In either case, after anatomic
35. Laparoscopic Malabsorption Procedures: Management of Nutritional Complications After Biliopancreatic Diversion 325
complications such as stenosis or obstruction are ruled out, Revision surgery is also needed in cases of malnutrition
the problem can usually be successfully corrected with diet and advanced liver failure nonresponsive to corrective
modification, nutritional re-education, and oral or enteral nutritional therapies. In general, steatosis and nonalcoholic
nutritional therapy. The restrictive effect of the operation steatohepatitis improve after malabsorptive surgery as
also decreases over time as the stomach and anastomosis shown by overall improvements in liver histology after
stretch, contributing to further ease of eating and overall weight loss [26, 27]. Nevertheless, a few cases of hepatic
improvement. Late or recurrent cases may, on the other failure out of the thousands of BPD ± DS surgeries per-
hand, be related to decreased protein intake, impaired intes- formed over the past 50 years have been reported [28–30],
tinal absorption due to the persistent and excessive effect of with some being serious enough to receive liver transplants
the operation, or both; and late cases are more likely to [31, 32]. The frequency of hepatic complications following
require revision surgery to elongate the common channel or, BPD ± DS surgery is difficult to estimate, given the rarity of
in exceptional cases, to reverse the procedure completely the condition and possible underreporting; yet the link
[19, 21]. between contemporary BPD ± DS surgery, protein malnutri-
After BPD surgery, patients are routinely advised to tion, and the development of cirrhosis or liver failure is
increase their protein intake and favor protein food sources even more difficult to establish, as confounding factors
over carbohydrates. Obligatory protein losses are observed have often been present in reported cases [33, 34].
after BPD, and compensating for this with increasing protein Alcoholism, poor diet, drug reactions, and infectious hepa-
intake is thought to be important in avoiding the hypoalbu- titis are examples of important confounders that may
minemic form of protein-calorie malnutrition; this form can become a problem at any point in life, and bariatric patients
compromise visceral function leading to decreased visceral are no exception even if these problems did not exist preop-
protein synthesis, low circulating albumin, edema, decreased eratively. Close follow-up of patients after surgery with
intestinal absorption, and worsening malnutrition [25]. Good liver enzyme panels at regular intervals is recommended.
management starts with prevention by increasing the amount Transient elevations of liver enzymes in the early postop-
of protein consumed in the postoperative state to at least erative period are expected [35], but when observed, they
90 g/day. As consuming sufficient amount of protein from warrant closer follow-up and evaluation of patients’ overall
meat sources can be difficult in the early period after sur- nutritional status. Focus is on ensuring compliance with
gery, protein supplements in the form of soluble protein food nutritional counseling, avoidance of excessive weight loss
additives or shakes are often provided with or between meals due to poor dietary choices or substance abuse, treatment of
as snacks. Postoperatively, patients are followed at regular any gastrointestinal symptoms suggestive of bacterial over-
intervals with blood testing and are encouraged to see the growth, and achieving normalization of liver enzymes. If
dietitian if hypoalbuminemia or maladaptive eating patterns specialized transplant teams who evaluate patients with
are identified. Increasing protein intake to 100–120 g/day liver failure after BPD ± DS commit to liver transplantation,
should correct most mild to moderate cases of protein defi- involving bariatric surgeons, or better yet, the patient’s bar-
ciency and avoid the need for hospital admission. iatric surgical team if possible, is always advisable. Serious
Clinicians should be alert to any excessive early and rapid consideration should be given to reversing the patient’s
weight loss, as it is an important diagnostic sign for malnour- malabsorptive procedure, or at the very least inserting a
ishment that may be missed due to the presence of edema. feeding jejunostomy tube in the biliopancreatic limb. This
Fluid retention secondary to hypoalbuminemia must be eval- serves to (1) remove any unknown underlying bariatric sur-
uated at the time of clinical presentation, as it tends to under- gical factor that may continue to damage the grafted liver
estimate the true body weight loss. Improving intestinal and to (2) improve absorption of immunosuppressive agents
absorptive function starts with addressing the edematous needed after transplantation. Concerns regarding weight
state. In cases where hypoproteinemia with edema and asthe- regain and recurrent hepatic steatosis in this context are
nia are identified, the patient is admitted to the hospital, valid, but they need to be balanced against the risk of repeat
where IV albumin and diuretic therapy (e.g., furosemide) is cirrhosis or graft rejection. Weight management issues can
started to treat the initial edema. Shortly thereafter, enteral be addressed after patient recovery from transplantation.
gavage or total parenteral nutrition can be started. Enteral Although quite rare, cases of advanced hepatic failure may
feeding with oligo-protein containing solutions is preferred be life threatening and can occur anytime after surgery [36].
to parenteral nutrition due to its safety profile and trophic Therefore, the importance of lifelong follow-up cannot be
effect promoting intestinal absorptive adaptation. Most overemphasized; and even though there is insufficient evi-
patients respond well to this treatment, and enteral gavage dence to etiologically link liver failure to protein malnutri-
can be continued for 6–12 weeks on an outpatient basis. Oral tion and the type of BPD ± DS surgery practiced today,
pancreatic enzymes can be used to improve digestion and preoperative informed consent should include a discussion
absorption in the alimentary limb during this phase of treat- about hepatic improvements seen after surgery as well as
ment. In rare cases where protein-calorie malnutrition recurs, the potential for rare, serious liver failure, possibly requir-
revision surgery is considered. ing transplantation and reversal of the bariatric procedure.
326 F. Moustarah and F.-S. Hould
In general, bariatric studies have suggested that biomarker routinely measured perioperatively. Conditions causing
levels of folate are not necessary [44, 45]. Needs increase chronic diarrhea can increase zinc losses [55]. Like copper,
during pregnancy, and women who express interest in child- low serum zinc levels have been documented and persist over
bearing should have supplementation to ensure normal the years after BPD surgery in 10–50 % of patients, although
serum folate levels to minimize the risk for neural tube symptomatic cases have not been reported [52, 56, 57]. Zinc
defects [46]. as part of a daily multivitamin complex is recommended for
patients after malabsorptive surgery. Documented deficiency
can be treated with separate zinc supplementation in the
Copper form of zinc (30–50 mg of elemental zinc every other day)
[58]. Care must be taken not to prescribe high doses of zinc
Like vitamin B12, copper deficits can lead to hematological to avoid toxicity and interference with copper transport and
abnormalities like normocytic or macrocytic anemia and to metabolism [50]. When ingested in excess, zinc can result in
neurologic problems. Myelopathy and neuropathy in the anemia, as it contributes to decreased copper and ceruloplas-
lower extremities with spastic ataxic gait, symmetrically min levels.
brisk reflexes, and loss of pinprick and light touch sensation
have been seen after malabsorptive surgery of the RYGB
type [47–50]. In patients with neurologic symptoms and Vitamin B1 (Thiamine) Deficiency
whose serum B12 level are normal, copper measurement to
confirm the diagnosis is helpful, and administration of IV Thiamine is also essential in neural function as well as carbo-
copper can result in improvement. We do not routinely mea- hydrate metabolism. Being the first B vitamin to be identified,
sure copper in our patients before or after BPDDS, and we thiamine is also known as vitamin B1. Mild deficiency causes
have not diagnosed isolated symptomatic hypocupremia. In anorexia, irritability, apathy, and generalized weakness.
our patients, copper and other mineral micronutrients are Major deficiency can lead to the recognized beriberi heart or
administered postoperatively as part of the daily dose of for- nerve diseases [59]. In both conditions, patients experience
tified multivitamin complex taken by patients who comply pain and neurologic symptoms. Wet beriberi involves the
with the treatment. Recent evidence points to a high preva- heart and results in an edematous state. Dry beriberi presents
lence of zinc and copper deficiencies in morbidly obese with a symmetrical mixed motor and peripheral neuropathy.
patients seeking bariatric surgery, and these deficiencies Involvement of the central nervous system can result in a
increase on follow-up over the years after BPD even when Wernicke-type encephalopathy, characterized by nystagmus,
copper supplements are given intermittently [51, 52]. A rapid ophthalmoplegia, cerebellar ataxia, and mental impairment.
review of the literature, however, failed to identify any The presence of memory loss and confabulation is known as
reported cases of neurologic deficits from copper deficiency the Wernicke-Korsakoff syndrome. This syndrome is classi-
after BPD; and others have also recently confirmed this cally associated with alcohol-related malnutrition [60], but it
observation [52]. An intriguing finding of one study is that no is also a serious nutritional complication that has been
BPD patient developed hematologic problems or evidence of reported after bariatric surgery [61].
neurological deficits, even though some patients in their Thiamine is primarily absorbed in the proximal small
cohort suffered hypocupremia for a long time. Serious cases bowel and is stored in the body in small amounts with its
of hypocupremia related to bariatric surgery reported in the biologic half-life being about 2–3 weeks. Humans cannot
literature have been mostly observed in patients after RYGB make thiamine and must receive it in their diet. Thiamine is
[52, 53]. This may be a reflection of the fact that many more also a good substrate for bacteria [62]. Procedures or condi-
RYGB procedures are performed worldwide than are BPD tions that exclude the proximal bowel from nutrient exposure
operations [9], but it also adds to the importance of ongoing or that are associated with intestinal bacterial overgrowth
follow-up after any bariatric procedure with a malabsorptive syndromes can, over a short period of time, contribute to
component to ensure overall patient well-being and prevent thiamine deficiency and occasionally even the Wernicke-
prolonged malnourishment. Bariatric patients that have had Korsakoff encephalopathy (WE) syndrome. This syndrome
their clinical follow-up interrupted should undergo a com- has been seen after BPD surgery [25]. It must be emphasized
prehensive evaluation and blood testing for micronutrients that WE can occur after all commonly performed bariatric
and minerals including copper and zinc. procedures [61], including restrictive ones; and it has been
noted as early as a few weeks after surgery [63]. Poor adher-
ence (involuntary or voluntary) to the recommended postop-
Zinc erative dietary and supplement regimen may result in
unusually rapid weight loss seen at the time of diagnosis.
Zinc deficiency can cause hair loss, dermatitis, impaired Most cases have presented with poor oral intake due to pro-
immunity, and delayed wound healing. Plasma zinc levels fuse nausea and vomiting preceding the development of neu-
are poor biomarker for zinc status [54], and they are not rological symptoms. Prompt recognition and administration
328 F. Moustarah and F.-S. Hould
of high-dose thiamine can virtually eliminate the develop- values are observed as early as the first year after surgery, even
ment of neurologic symptoms [25]. with supplementation; this was especially remarkable for defi-
A complex oral multivitamin, containing thiamine, should ciencies in fat-soluble vitamins A and D after duodenal switch
prevent thiamine deficiency in bariatric patients. Some have surgery [18]. It is currently well accepted that lifelong patient
advocated a dose of 25–50 mg/day in addition to the recom- compliance with postoperative vitamin supplementation is
mended daily allowance [64]. If deficiency is suspected, it essential to minimize deficiencies and their potential clinical
can be confirmed by measuring serum transketolase activity effects after BPD ± DS [20, 25]. Symptomatic fat-soluble vita-
before and after administration of vitamin B1, since thiamine min deficiency, however, is either uncommon or underre-
is a cofactor for the reaction. Laboratory testing, however, is ported, yet it is easily treated with vitamin supplementation
less important than keeping a low threshold for diagnosis when it occurs, highlighting the importance of early recogni-
and initiating early parenteral thiamine therapy in the acute tion before potentially serious complications result.
postoperative period when patients present with a history of
poor eating or gastrointestinal symptoms that interfere with
adequate nutrient intake, even before significant weight loss Vitamin A
has occurred.
Recognition of the clinical presentation becomes impor- Vitamin A is a name for a group of compounds with the bio-
tant to avoid serious neurologic problems. Managing medi- logic activity of retinol and consists of retinoids and some
cal conditions or surgical complications that contribute to carotenoids (provitamin A). These substances are hydropho-
reduced food intake or persistent nausea and vomiting bic and depend on micelle formation for efficient intestinal
involves aggressively addressing the underlying cause of the absorption. Vitamin A deficiency has been reported after
problem but without delaying early parenteral vitamin B1 BPD ± DS [20, 25], with increasing incidence and severity of
supplementation. Patients often present with weakness and this deficiency observed over time. In a retrospective review,
dehydration, and giving them thiamine is recommended where BPDDS was performed with a 175–200 cm alimen-
prior to the administration of intravenous glucose-containing tary limb and a 50–75 cm common channel, the prevalence
hydration solutions to minimize worsening of neurologic of vitamin A deficiency was found to be 52 % at 1 year after
symptoms and progression towards the Wernicke syndrome surgery and 69 % for patients 4 years after their operation
[65]. Initiating intravenous thiamine on presentation in the [56]. The Québec group also reported an increase in the prev-
emergency department, regardless of symptom severity, is alence of vitamin A deficiency on long-term follow-up in
far more practical than laboratory testing for deficiency. In BPDDS patients who had a 250 cm total alimentary limb and
the acute setting, deficiency is treated with parenteral thia- a 100 cm common channel, but lower rates were observed.
mine at a dose of 300 mg/day for 3 days followed by continu- Summarizing their 15-year experience, they documented an
ation of oral supplementation at a dose of 10 mg/day until increase in vitamin A deficiency from 8 % of 807 patients
symptoms resolve. Patients with advanced neuropsychiatric before surgery to 23 % on last follow-up, with their mean
beriberi symptoms should be treated as medical emergencies follow-up being just over 7 years. In another cohort reviewed
requiring hospital admission. In this context, high-dose IV by the same group, Marceau et al. reported that 10 years after
thiamine of at least 300–500 mg given daily for 3–5 days is DS, the proportion of patients with vitamin A levels below
recommended as initial therapy [50, 58]. 1.2 μmol/L was 10 % [21]. Adjusting levels as needed by
changing the oral supplement dose of vitamin A was
sufficient, and intramuscular administration was rarely used.
Fat-Soluble Vitamins Vitamin A deficiency can result in poor night vision, itching,
dry hair, and skin lesions. A few cases of impaired vision and
Designed to induce fat malabsorption, BPD ± DS also leads to skin problems due to vitamin A deficiency after BPD have
decreased absorption of fat-soluble vitamins A, D, E, and K, been reported, and symptoms resolved with treatment [66–
resulting in deficiencies [25, 56]. There remains a lack of high- 68]. Initial treatment is by administering vitamin A in higher
quality studies evaluating the true incidence of vitamin defi- doses than those used for routine supplementation. High-
ciencies after malabsorptive surgery and how these deficiencies dose vitamin A has known toxicities, but daily doses as high
can best be prevented with optimal supplementation protocols. as 60,000–90,000 IU have been used in cases of symptom-
Reports are also difficult to compare or generalize because of atic deficiencies [66, 69].
variation in patient populations, lengths and segments of
bypassed intestine, and regularity of patient vitamin supple-
mentation and blood testing intervals. What has been docu- Vitamins E
mented is that despite regular nutritional counseling and
empiric supplementation, the incidence of vitamin deficiency Vitamin E levels have not been very well studied in the con-
can increase with time after malabsorptive surgery [56]. One text of bariatric surgery, but symptomatic deficiency is quite
randomized study showed that decreased serum vitamin uncommon, even after malabsorptive procedures. One group
35. Laparoscopic Malabsorption Procedures: Management of Nutritional Complications After Biliopancreatic Diversion 329
documented that vitamin E levels adjusted for serum lipid of BPD ± DS surgery are, therefore, best discussed with
changes were noted to be increased 1 year after BPDDS, and patients before surgery as part of the informed consent
this is deemed related to routine supplementation [18]. Other process.
series have revealed asymptomatic low serum vitamin E lev-
els more than 2–4 years after BPD ± DS with a short common
channel [56, 57]. Complaints of ataxia, muscle weakness, and
visual symptoms, or findings of anemia or dysarthria are Vitamin D, Calcium, and Metabolic
indicative of vitamin E deficiency and should be evaluated Bone Disease
and treated appropriately. Again, with anemia after malab-
sorptive procedures, one should keep in mind the contributory Vitamin D is better absorbed in the jejunum and ileum, while
role of other potential micronutrient deficiencies like vitamin calcium is preferentially absorbed in the duodenum and
B12, copper, and zinc already mentioned. Oral vitamin E at proximal jejunum. Calcium absorption is facilitated by vita-
800–1,200 IU can be given daily as initial therapy in cases of min D in an acid environment [74]. Low vitamin D levels can
symptomatic deficiency [58]. Some have recommended an lead to a decrease in dietary calcium absorption but are not
additional supplement of 10 mg/day of vitamin E [64], but always accompanied by a reduction in serum calcium, as
this has not been universally adopted nor is it our practice. parathyroid hormone is released to maintain serum calcium
levels. Chronic insufficiency in calcium, vitamin D, or both
can lead to secondary hyperparathyroidism. In addition to
Vitamin K increasing intestinal calcium and vitamin D absorption and
decreasing calcium loss in the urine, parathyroid hormone
Vitamin K is required for blood clotting, bone formation, and maintains serum calcium levels at the cost of bone resorp-
other functions [70]. tion. This can lead over time to osteoporosis and increased
In addition to good absorption in the ileum, vitamin K can risk of fractures.
be absorbed in the rest of the intestine and depends on biliary Bone, therefore, becomes an important source of calcium
secretions and micelle formation [71]. Due to rapid metabo- in the setting of malabsorptive procedures where the effi-
lism, vitamin K is not stored in the body. For humans, usable ciency of intestinal calcium absorption is altered by the oper-
sources are either dietary or products of biosynthesis from ation and affected by the length and region of bypassed
intestinal flora. Perhaps this explains why serious cases of intestine, intestinal absorptive capacity, dietary sources of
symptomatic vitamin K deficiency are rare after malabsorp- calcium, and patient compliance with supplementation in the
tive surgery, since intestinal bacteria may provide enough of long-term. Special attention should also be given to patients
this vitamin for absorption in the colon when dietary sources with health conditions and taking medications that interfere
are low. Low serum levels of vitamin K have been docu- with calcium absorption such as antiepileptic agents, long-
mented in a high proportion of patients after malabsorptive term glucocorticoids or thyroid hormone, methotrexate, hep-
procedures years after their surgery [56, 57]. While symp- arin, or cholestyramine [75]. Symptoms of metabolic bone
toms rarely develop, attention is still warranted in pregnant disease secondary to hyperparathyroidism in adults are often
patients who require closer monitoring. A few case reports nonspecific and the diagnosis is commonly delayed.
linking a history of remote BPD to perinatal complications, Generalized skeletal pain, muscle weakness, and bony ten-
although non-definitive in establishing causation, do warrant derness are usual symptoms; and pathologic fractures may
attention given the seriousness of the reported problems. occur. Those who care for patients after bariatric surgery
Serious neonatal hemorrhage and long lasting neurologic should have a low threshold for the exclusion of metabolic
deficits in children born to mothers after bariatric surgery bone disease when vague but suspicious symptoms are pres-
have been observed [72]. A more recent case report emerged, ent, especially if patient follow-up had been interrupted.
placing further emphasis on the need to consider vitamin K In principle, malabsorptive surgery can increase the risk
deficiency and replacement in pregnant mothers after BPD to of bone disease over time, but to date evidence to this effect
minimize the rare but serious risk of hemorrhage in the is poor, difficult to interpret, or nonconclusive, as demon-
mother and child at the time of delivery [73]. We do not rou- strated by a recently published review on the link between
tinely measure vitamin K postoperatively on follow-up, but bariatric surgery, bone loss, and osteoporosis [76]. The extent
PT-INR is measured. Prior to any major operation with a of reviewed evidence will not be repeated here; but suffice it
high risk for blood loss or where bleeding is not well toler- to say that, although imperfect, available evidence is reassur-
ated, we do recommend that patients take oral vitamin K ing and is in fact a testament to the ability of calcium and
supplementation for a week before their planned elective vitamin D supplementation after surgery to keep parathyroid
procedure, even if a patient’s INR is normal or only slightly hormone levels from rising excessively and leading to bone
elevated. Personal experience with patients after BPDDS has disease. While severe metabolic bone disease has been
also shown that warfarin dosing can be more challenging in reported long after bariatric surgery [77], many observa-
those requiring chronic anticoagulation. These implications tional reports have suffered from lack of nonoperated groups,
330 F. Moustarah and F.-S. Hould
controlled for age and gender. In their review, Scibora et al. day) from our routine supplement dose of 50,000 IU
report that in evaluated cross-sectional and retrospective daily. Alternatively, vitamin D3, which tends to have better
studies, age-related bone loss seen in bariatric patients is no absorption, can be tried.
greater than what would normally be expected for age and
gender. They did note that longitudinal studies, however,
showed a relationship between declining bone density Conclusion
(mostly in the hip and spine region in women) and malab-
sorptive procedures. While mineral density decreased over The BPD ± DS is a potent metabolic and weight loss proce-
time in patients who had DEXA scores, osteoporosis was not dure with durable effects. By design, the procedure is
present at the time of last evaluation [76]. intended to achieve its clinical benefits by inducing caloric
The Québec group reported prevalence of hypocalcemia malabsorption. The objective is to achieve controlled malab-
in 22 %, low vitamin D in 45 %, and elevated parathyroid sorption, balancing the desired clinical effects against the
hormone in 49 % on a mean follow-up of 7.3 years after risks of complications and potentially serious acute or long-
BPDDS [20]. Increasing oral calcium lowered parathyroid term nutritional problems. Empiric evidence from thousands
hormone levels and kept bone from excessive exposure to of patients who have received BPD ± DS procedures over the
high levels of this hormone. Marceau et al. had also previ- last several decades continues to be reassuring as to the effi-
ously reported that a greater increase in bone markers and cacy and safety of this type of malabsorptive surgery. With
bone turnover after BPDDS was associated with an increased increasing experience and modification of the BPD proce-
risk of bone loss, but the overall bone density remained dure since its original introduction, there have been signifi-
remarkably stable at 10 years in their study [78]. As evi- cant reductions in the incidence of serious nutritional
denced by more recent investigations into serum calcium, complications, even when the procedure is offered to patients
vitamin D, and parathyroid hormone levels after malabsorp- with relatively lower body mass indices. Traditional con-
tive surgery, bone turnover is an active process, more so cerns regarding the nutritional risks of the BPD ± DS proce-
early postoperatively and persisting for at least 2–5 years dures, arising mostly from observations made in patients
thereafter [79, 80]. It is of interest to note that bone demin- who underwent other, now obsolete or rarely practiced, mal-
eralization appears to peak around 4 years after surgery, and absorptive procedures should no longer be a hindrance to
that this has not been found to be an increasing clinical referring patients for BPD ± DS surgery. The great majority
problem afterwards in large clinical series of BPD ± DS of patients now derive metabolic improvements, sustained
surgery [19, 25]. weight loss, and an improved quality of life, with a high level
Although the bone seems to be relatively tolerant to the of global satisfaction after BPD ± DS, without suffering sig-
metabolic changes following malabsorptive procedures, nificant protein-calorie malnutrition, metabolic bone disease,
this should not encourage complacency with adequate sup- or irreversible neurological problems secondary to vitamin
plementation of both calcium and vitamin D for life after or mineral deficiencies. Revision surgery for nutritional
surgery. Perhaps there is an adaptation process that occurs complications after BPD ± DS has also become the exception
in bone with time making it more resilient to osteoporosis. rather than the rule. Nevertheless, because the surgery suffi-
This effect has intriguingly been observed after the more ciently alters anatomy and physiology, serious problems can
drastic, previously practiced jejuno-intestinal bypass pro- result if patients are not well prepared and followed, and if
cedures, where spontaneous healing of osteomalacia was serious signs and symptoms are not recognized early by
noted on long-term follow-up [81]. Besides potential adap- patients and their healthcare providers. To maintain good
tation, the confounding effects of vitamin supplementa- outcomes, patients must be committed to participating in
tion, improved diet and physical activity, smoking their own health maintenance by adhering to good dietary
cessation, and overall better health of patients cannot be habits, taking lifelong multivitamin and mineral supple-
eliminated as contributing to the relative stability of bone ments, and keeping their follow-up. The introduction of the
after BPD ± DS surgery. Markedly elevated levels of para- multidisciplinary team approach to patient assessment and
thyroid hormone levels (>100 ng/L) on follow-up, espe- the commitment to lifelong follow-up strategies are also key
cially if associated with elevated alkaline phosphatase to the continued success of BPD ± DS surgery in properly
levels, is a good sign of active bone turnover and provides selected and well-prepared patients.
a good reason for aggressive therapy with oral calcium and
vitamin D and close surveillance to ensure compliance and
normalization of serum levels [20]. After BPDDS, we Review Questions and Answers
increase oral calcium dosing to 1–2 g of calcium carbonate
per day as long as there is no renal dysfunction. Calcium Questions
citrate can also be used, as it tends to be better absorbed. Question 1: Which of the following statements about periop-
Plus, if vitamin D deficiency is present, oral vitamin D2 erative nutritional management of the bariatric patient is
dosing is increased to 50,000 IU BID (max 150,000 IU per true?
35. Laparoscopic Malabsorption Procedures: Management of Nutritional Complications After Biliopancreatic Diversion 331
1. Malabsorptive procedures are limited to the biliopancre- 4. The routine administration of oral iron supplementation
atic diversion, and only patients awaiting this surgery postoperatively to minimize the incidence of iron defi-
need preoperative assessment with a multidisciplinary ciency anemia, given that it is the most common form of
team that includes a dietitian. nutritional anemia encountered after bariatric surgery
2. Currently, there is strong conclusive evidence that Answers
addressing preexisting conditions such as eating disor- Q1: #3
ders and vitamin deficiencies preoperatively is associated Q2: #2
with improved postoperative outcomes after malabsorp- Q3: #4
tive surgery.
3. Initiating the therapeutic process preoperatively for
patients seeking biliopancreatic diversion surgery offers References
many advantages such as an opportunity to address preex-
isting eating disorders and vitamin deficiencies and assess 1. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W,
patient compliance and candidacy for surgery. Fahrbach K, et al. Bariatric surgery: a systematic review and meta-
analysis. JAMA. 2004;292(14):1724–37.
4. Multidisciplinary teams have little role in the assessment 2. Demaria EJ, Jamal MK. Surgical options for obesity. Gastroenterol
of patients receiving malabsorptive surgery as long as a Clin North Am. 2005;34(1):127–42.
dietitian is involved in the preoperative assessment and 3. Anthone GJ, Lord RV, DeMeester TR, Crookes PF. The duodenal
preparation of patients with the surgeon. switch operation for the treatment of morbid obesity. Ann Surg.
2003;238(4):618–27. discussion 27-8.
4. Scopinaro N. Thirty-five years of biliopancreatic diversion: notes
Question 2: Protein energy malnutrition is an important on gastrointestinal physiology to complete the published informa-
potential complication of malabsorptive procedures. tion useful for a better understanding and clinical use of the opera-
Which of the following regarding protein-calorie malnu- tion. Obes Surg. 2012;22(3):427–32.
trition after biliopancreatic diversion is true? 5. Marceau P, Biron S, Bourque RA, Potvin M, Hould FS, Simard
S. Biliopancreatic Diversion with a New Type of Gastrectomy.
1. Protein-calorie malnutrition is a rare but serious compli- Obes Surg. 1993;3(1):29–35.
cation of biliopancreatic diversion surgery and is not 6. Marceau P, Hould FS, Simard S, Lebel S, Bourque RA, Potvin M,
encountered in the duodenal switch variant of the et al. Biliopancreatic diversion with duodenal switch. World J Surg.
1998;22(9):947–54.
procedure. 7. Nguyen NT, Masoomi H, Magno CP, Nguyen XM, Laugenour K,
2. The presence of edema may underestimate the degree of Lane J. Trends in use of bariatric surgery, 2003-2008. J Am Coll
weight loss, clouding the diagnosis and influencing the Surg. 2011;213(2):261–6.
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3. Regardless of when protein malabsorption presents in the makeup of bariatric surgery: a national increase in use of laparo-
scopic sleeve gastrectomy. J Am Coll Surg. 2013;216(2):252–7.
postoperative period after biliopancreatic diversion sur- 9. Buchwald H, Oien DM. Metabolic/Bariatric Surgery Worldwide
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the administration of enteral protein, without needing to 10. Dumon KR, Murayama KM. Bariatric surgery outcomes. Surg Clin
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necessity to systematically assess micronutrient status prior to bar-
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folate present in a single complex multivitamin tablet 14. Botella Romero F, Milla Tobarra M, Alfaro Martinez JJ, Garcia
because folate levels consistently decrease with time after Arce L, Garcia Gomez A, Salas Saiz MA, et al. [Bariatric surgery in
biliopancreatic diversion with duodenal switch. duodenal switch procedure: weight changes and associated nutri-
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15. Ashton K, Heinberg L, Windover A, Merrell J. Positive response to
or monthly basis, since vitamin B12 deficiency is an binge eating intervention enhances postoperative weight loss. Surg
important cause of anemia after biliopancreatic diversion Obes Relat Dis. 2011;7(3):315–20.
and prevention involves. 16. Wadden TA, Faulconbridge LF, Jones-Corneille LR, Sarwer DB,
3. Empiric oral iron therapy for patients with low hemoglo- Fabricatore AN, Thomas JG, et al. Binge eating disorder and the
bin, recognizing that iron deficiency anemia is the only outcome of bariatric surgery at one year: a prospective, observa-
tional study. Obesity (Silver Spring). 2011;19(6):1220–8.
important anemia resulting in clinical symptoms warrant- 17. Scholtz S, Bidlake L, Morgan J, Fiennes A, El-Etar A, Lacey JH,
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332 F. Moustarah and F.-S. Hould
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36
Alternative Minimally Invasive Options: Neural
Modulation
Sajani Shah, Elizabeth A. Hooper, and Scott A. Shikora
Current estimates are that there are over 300 million obese gastric stimulation and has progressed to include meal-
people worldwide, which is a substantial increase from the activated gastric stimulation and vagal nerve blocking.
estimated 200 million 10 years ago [1]. In the United States, Currently, all forms of neuromodulation are extremely attrac-
nearly two-thirds of the adult population is overweight or tive to both patients and clinicians in that there is no alteration
obese, and one-third of the adult population is obese. The to the anatomy of the gastrointestinal tract and no dietary
most recent US National Health and Nutrition Examination restrictions. Research efforts thus far have demonstrated
Survey (NHANES) report compared the age-adjusted preva- impressive safety but inconsistent but improving weight loss.
lence of overweight and obese adults in the United States This chapter reviews the current state of the research involv-
20–75 years of age. Their figures demonstrated that from ing neuromodulation therapies for weight loss and improve-
1976 to 2004, the percentage of overweight and obese adults ments of the associated metabolic disorders.
increased from 47.0 to 66.3 %. Alarmingly, obesity more
than doubled during this period (from 15.0 to 32.9 %). The
increase in obesity was more common in men than in women: Gastric Electrophysiology and Motility
Between 1999 and 2004, women’s obesity rates did not
change significantly (from 33.4 to 33.2 %) [2]. Most signifi- Normal motility is crucial to the physiologic preservation of
cantly, based on standard criteria, over 20 % of the popula- the normal human gut function. With dysmotility, either
tion is likely eligible for bariatric surgery for weight loss and slowed or hypermotility, absorption of nutrients is altered
resolution of comorbidities. and may not take place.
More than 177,000 people underwent bariatric surgery in Gastric electrical activity (GEA) is a complex phenomenon
the United States in 2006; however, this is only a fraction resulting in gastric motility, which in turn leads to gastric
(<1 %) of the persons in the United States who currently emptying [5]. The stomach is only active intermittently. For
meet the clinical criteria for surgery [3, 4]. Research efforts this reason, gastric electrical activity is more complex than
to identify factors that limit the utilization of bariatric sur- cardiac electrical activity. The stomach has a component,
gery are needed to ensure that all patients who qualify receive known as the electrical control activity (ECA), which has a
the optimal treatment for their obesity. frequency of repetition in humans of only about 0.05 Hz or 3
Although some potential candidates are denied surgery cycles per minute (cpm) and 5 cpm in dogs. This activity
because of lack of medical insurance coverage or other dis- originates somewhere in the proximal stomach, but no dedi-
qualifying factors, a great number will simply avoid surgery cated or anatomically modified pacemaker cells have been
out of fear of potential operative complications and the long- identified to clearly establish a pacemaker region similar to
term consequences of these operative procedures. Therefore, the sine node in the heart [6, 7]. The electrical control activ-
there is a critical need to develop effective therapeutic ity is established by opening of the sodium and the potas-
options that are less invasive, less complex, and safer. Such sium channels on smooth muscle cellular level, and the
options may be more widely accepted and broadly used. resulting depolarization wave propagates distally with an
Further understanding of the anatomic and physiologic increasing velocity [8]. The gastric slow wave determines the
mechanisms underlying bariatric surgery will facilitate the maximum frequency, propagation velocity, and propagation
development of novel therapies that meet these criteria. direction of gastric contractions (Fig. 1). Spike potentials
Since the 1990s, there has been a growing interest in the occur on top of the gastric slow wave and function much like
concept of neuromodulation for obesity treatment. an action potential. When superimposed on the gastric slow
Research effort began in the mid-1990s with continuous wave, a strong lumen-occluding contraction occurs.
FIG. 1. Normal gastric slow waves. Gastric slow waves recorded from electrodes implanted on the serosal surface of the stomach along the
greater curvature in a healthy dog (1.5 min recording). The top tracing was obtained from a pair of electrodes 16 cm above the pylorus, and
the bottom one was from the electrodes 2 cm above the pylorus (Courtesy of Jiande Chen, Ph.D).
Similar to the arrhythmias of cardiac electrical function, Phase I lasts 40–60 min with no contraction activity, phase II
dysrhythmias are irregularly timed and located and/or inef- lasts 20–40 min with intermittent contractions, and phase III
fective myoelectrical activity. For example (Fig. 2), there can involves regular rhythmic contractions lasting 2–10 min. In
be an ectopic pacemaker in the distal stomach in addition to the fed state, the contraction begins in the proximal stomach
the normal pacemaker in the proximal stomach. The ectopic and follows the propagation of the spike potential as it
pacemaker generates slow-wave potentials at a higher rate continues toward the pylorus. In healthy subjects 2 h after a
than normal, leading to tachygastria along with retrograde meal, 50 % or more of a meal is cleared by the contractions
propagation toward the proximal stomach. This may inter- of the stomach, and at 4 h, 95 % of the meal should be
fere with normal waves and lead to disruption of the normal cleared. Once emptied the motility pattern of the stomach
gastric contractions. changes [10].
The prevalence and origin of various gastric dysrhythmias Gastric emptying plays an important role in food intake
have been investigated in canine models. Most bradygastric regulation. Distension of the stomach acts as a satiety signal
impulses originate in the proximal stomach (80.5 ± 9.4 %) [11]. Meanwhile, rapid gastric emptying can be directly
and propagate to the distal antrum. Therefore most bradygas- linked to some episodes of overeating and obesity. There have
tria is attributed to a decrease in the frequency of the normal been numerous animal studies linking lesions in the hypo-
pacemaker of the myoelectrical activity of the stomach. thalamus to overeating and obesity [12]. There are also mul-
Tachygastria by contrast originates in the distal antrum tiple studies which report higher rates of gastric emptying in
(80.6 ± 8.8 %) and propagates in a reverse fashion toward the obese subjects without a clear explanation at this point [13].
proximal stomach. In the setting of tachygastria, the normal Innervation of the stomach comes from two sources: para-
proximal pacemaker slow waves may or may not be present. sympathetic fibers via the vagus and sympathetic fibers via
This can lead to slow waves in one direction and distal tachy- the celiac plexus. The vagus nerve has both efferent and
gastria, leading to overall dysrhythmia [9]. afferent fibers, but it has predominately afferent fibers. The
Gastric motility is different in fed and fasting states. In the efferent fibers originate in the medulla and synapse with neu-
fed state, the human stomach contracts at the maximum fre- rons located in the myenteric and submucosal plexus of the
quency of 3 cpm as discussed earlier. In the fasting state, stomach. This leads to acetylcholine release and increased
there are periodic fluctuations divided into three phases. gastric motor function and gastric secretions. The afferent
36 Alternative Minimally Invasive Options: Neural Modulation 337
FIG. 2. Tachygastria. Gastric slow waves recorded from electrodes implanted on the serosal surface of the stomach along the greater cur-
vature showing the ectopic tachygastrial activity in the distal stomach (arrow). The top tracing was obtained from a pair of electrodes
16 cm above the pylorus, and the bottom one was from the electrodes 2 cm above the pylorus (Courtesy of Jiande Chen, Ph.D).
fibers are predominant, making up approximately 90 % of showed weight reduction in a rat model but a statistically
the fibers. And they carry stimuli signals from the gut back to higher rate of weight loss for complete vagal interruption
the brain. Multiple gastric peptides have also been impli- (19 % for total vagotomy, 7 % for selective deafferentation).
cated in this pathway including serotonin, substance P, ghre- The study also revealed a significant difference in the decrease
lin, cholecystokinin (CCK), and somatostatin [14]. in the amount of visceral fat (52 % vagotomy vs. 18 % deaf-
The true mechanism of action for weight loss from ferentation) [21].
vagotomy is not completely elucidated. This technique was Vagal interruption in humans has been shown in a few
first indicated in epilepsy [15] and severe, therapy-resistant studies to result in weight loss. This has been demonstrated
depression [16]. Vagal pacing showed to diminish food over the last 35 years including early reported experiences of
intake, fat mass, and weight in pigs [17], rats [18], and vagotomy for refractory obesity [22]. The effects of truncal
obese minipigs [17], suggesting that VNS induces satiety vagotomy include preferential emptying of liquids and early
signals. Body weight was found to be reduced mainly at the satiety secondary to reduced receptive relaxation. However,
expense of body fat, whereas metabolic rate remained unaf- dumping syndrome and diarrhea can result.
fected [19]. Depressed patients undergoing VNS were also Aside from a few published studies, the clinical benefits
reported to have less sweet cravings [20] and to lose weight of vagotomy have not been widely appreciated. Many sur-
[19, 20]. However, discussion remains on both the ideal geons have included truncal vagotomy with gastric bypass
positioning of the electrode and the frequency of the block- surgery; there are no reports which have shown that vagot-
ing algorithm. omy increased the weight loss achieved with gastric bypass.
Animal studies have looked at the effect of destruction of There are many explanations for this inconsistency. Firstly,
just the afferent fibers of the vagus in comparison to complete gastric bypass is such a robust weight loss procedure that it
vagal interruption for weight loss. The blockade of afferent shadows any potential benefit of vagotomy. Secondly, the
fibers was previously shown to downregulate the intestinal physiologic changes after gastric bypass negate the effects
sodium-glucose cotransporter SGLT-1. Both treatments of vagotomy. Lastly, ligation of the vagus nerves activates
338 S. Shah et al.
BaroScreenTM to screen participants as responders and non- hypoglycemic agents with a hemoglobin A1c (HgbA1c)
responders [30]. averaging between 7.5 and 9.5 % [35]. Thirteen patients were
In 2004, following the satisfactory results of safety and enrolled and underwent laparoscopic placement of the
efficacy in carefully selected patients, a double-blinded mul- TANTALUSTM. At 3 months, the HgbA1c significantly
ticenter study was undertaken comparing active devices to reduced from an average of 8.0–6.9 %. Fasting glucose
inactive devices. Potential participants met stringent inclu- decreased from 175 to 127 mg/dL. Weight reduction was also
sion criteria as well as prospective BaroScreenTM scores that significant but modest from a mean weight of 104 kg down to
suggested >15 % weight loss would occur with electrical 99.7 kg (−4.1 %). Two mechanisms of action were postulated
stimulation. 190 patients were enrolled and all underwent for the results of meal-activated gastric stimulation. First, the
laparoscopic implantation of the Transcend II (Medtronic, increased vagal afferent stimulation led to the neural signals
Minneapolis, MN) implantable gastric stimulator. There was for early satiety and the resulting weight loss. Second, the
no statistical difference in percent of excess weight loss gastric electrical stimulation improved glycemic control via
between the treatment and control groups at 12 months. The direct effects on neurohormonal mechanisms [35].
excess weight loss was 11.7 % for the treatment group and The US experience was similar. The study was part of a
11.9 % for the control group. It appears that low battery life 2-year, open-label trial intended to test the safety and feasi-
may have contributed to lower weight loss in the active group bility of the TANTALUS system. Fourteen obese T2DM
in addition to positive weight loss in the control group patients (10 females) participated in the 6-month study. They
through screening for highly motivated individuals coupled had a mean age of 42 years (range, 32–54), mean weight of
with a reduced-calorie diet [31]. 107.3 ± 20.1 kg, and mean body mass index of 39 ± 1 kg/m2
Reflecting on the worldwide clinical experience with (range, 31–45). At enrollment, mean HbA1c was 8.4 %.
implantable gastric stimulation, the data could be interpreted HgbA1c levels fell from the average of 8.5–7.6 %. Weight
to suggest that this technology is inadequate for achieving decreased on average from 107.7 to 102.4 kg [36]. There was
significant or reproducible weight loss in severely obese per- fasting glucose improvement although not clinically signifi-
sons. However, a wealth of good animal studies that exists cant. In addition, there was no correlation between weight
has found that electrical stimulation of the stomach [32] or loss and glucose improvement. Though a reduction of mean
intestine [33], or a combination of both [34], has consistently HbA1c was seen in all studies, HbA1c normalized only in
resulted in reduced food intake and/or weight loss. about 50 % of patients in one study, with other studies report-
Additionally, all the previous studies of an implantable gas- ing less impressive outcomes.
tric stimulator, as well as a pilot trial with a meal-activated
gastric electrical stimulator [35], have reported that some
subjects responded extremely well and achieved both mean- Intestinal Electrical Stimulation
ingful and sustainable weight loss.
Intestinal electrical stimulation (IES) is a novel potential ther-
apy that has been shown to reduce gastric emptying and
TANTALUSTM: Meal-Activated Gastric increase intestinal motility. IES affects intestinal slow waves,
Stimulation contractions, and transit through vagal, and cholinergic, and
adrenergic pathways. Duodenal electrical stimulation (DES)
Unlike conventional gastric pacing, where electrical signals is thought to successfully delay gastric emptying and reduces
are continuously delivered, typically at rates higher than that water intake [37]. Kelly and Code [38] demonstrated that
of the intrinsic pacemaker, the TANTALUSTM (Metacure duodenal electrical stimulation slowed gastric emptying and
Ltd. Bermuda) enhances smooth muscle contractions by increased duodenogastric reflux in dogs. Recently, Liu et al.
delivering signals in synchrony with sensed spontaneous [39] demonstrated that intestinal pacing decreased absorption
electrical activity. Stimulation is applied on demand using a of nutrients and accelerated bowel transit in healthy humans.
specialized algorithm to detect the onset of a meal by mea- Khawaled et al. [40] in 2009 studied intestinal electrical
surements of electromechanical parameters in the gut. By stimulation and the effect on postprandial glucose levels in
enhancing spontaneous gastric contractions in an early stage rats. ES applied immediately after the glucose tolerance test
of the meal before reaching full gastric distension, early sati- caused a significant decrease in the rising phase slope and the
ety is induced through stimulation of distal stretch receptors, maximal serum blood glucose level. Additionally, the area
eliciting an increased afferent input to the CNS to convey under the curve of the blood glucose levels was reduced by
satiety [32]. approximately 50 %. Insulin secretion decreased by 21 %.
In Europe, an open-label, five-center study was under- The main reduction in insulin secretion was during the first
taken to primarily study the effect of meal-activated gastric 30 min after the glucose tolerance test. IES also caused a
stimulation on diabetes with weight loss considered as a sec- nearly 80 % decrease of the gastric emptying rate and a 40 %
ondary outcome [35]. A previous study suggested that the increase in the flow rate of nutrients inside the intestine. The
patients with the best potential to benefit were those on oral effect was immediate after IES activation and reversible [40].
340 S. Shah et al.
Preliminary data suggests that modulating intestinal transit therapy. Fifteen centers enrolled a total of 294 subjects. The
time and gastric emptying might play a role in treatment of methods of implantation of the Maestro system (EnteroMedics
diabetes and obesity. There still need to be comprehensive, Inc, St Paul MN) were the same as described for the open-
long-term, and placebo-controlled clinical trials on a signifi- label study. All patients had the VBLOC system implanted.
cant number of patients. Patients were randomized to a study group that received
active therapy versus a control group with inactive but
implanted devices. Randomization and activation of the
Vagal Blocking for Obesity Control external controller occurred one to three weeks post-
Therapy implantation. Like the open-label trials, the transmit coil and
battery pack were housed in a belt apparatus designed to be
Directly targeting the vagal nerves as a means for weight loss worn for 9–16 h by the treatment group. The control group
has begun to again gather interest. The philosophy of inter- received low-dose short-burst activation when wearing the
mittent vagal interruption comes from the knowledge that battery pack/transmitter as well.
complete (or permanent) truncal vagotomy has decreased The active therapy group had 17 % weight loss.
effectiveness over time, presumably as compensatory mech- Surprisingly, the control group weight loss was 16 % com-
anisms to offset the responses develop. Therefore, intermit- pared to the pretest expected loss of 8 %. The weight loss in
tent vagal interruption that would allow the return of normal the control group was greater than expected based on pretest
vagal function may prevent the activation of compensatory statistical analysis and raises the question of an unanticipated
mechanisms. effect of vagal manipulation alone with low-frequency
An intermittent vagus nerve blocking technology is cur- changes contributing to the effects of vagal blocking [42].
rently under investigation. VBLOC system (Enteromedics This effect was subsequently demonstrated in a study using a
Inc, St. Paul, MN), as it is called, involves the laparoscopic rat sciatic nerve model which demonstrated a decrease of
placement of electrodes onto the anterior and posterior vagal 31 % in the amplitude of the compound amplitude potential
nerve trunks at the gastroesophageal junction. The electrodes of the nerve. This suggests that the safety checks and low-
are connected by wire leads to an electrical pulse generator dose frequency and amplitude checks may have altered the
called a neuromodulator. The neuromodulator is placed in function of the vagal nerve stimulation of the stomach in the
the subcutaneous tissue. In early investigations, the power control group [43].
source was externally imbedded in a belt that was worn Therefore, it has been postulated that the control group
around the waist. Patients were instructed to wear the belt was possibly a low-energy treatment group instead of a non-
10–14 h daily. When on, the device was charged and the treatment group. Further post hoc analysis of the data
vagus nerves blocked. During the hours that the belt was not supported this theory because weight loss seen in both groups
worn, the device was inactive and the vagus nerves quickly was directly dependent on the number of hours that the belt
resumed normal function. was worn. Analysis also suggests the device is effective
The VBLOC system is currently undergoing extensive because the weight loss is greater for both groups than the
human investigations. An open-label, three-center study expected nonintervention rate of 8 % [42].
assessed its safety and weight loss efficacy. Thirty-one To eliminate the effects of patient noncompliance with
patients participated in the trial. Patients were instructed to wearing the belt, the VBLOC system was modified to include
wear the belt for at least 12 h per day. While activated, the a fully programmable and implantable energy source. Human
neuromodulator alternated 5 min of blocking with 5 min of investigation has shown that the fully implantable device was
inactivity. Excess weight loss was evaluated at multiple time equivalent in function to the first generation device with a
points: 4 weeks (7.5 %), 12 weeks (11.6 %), and 6 months belt [44]. It is possible that the overall results of vagal block-
(14.2 %). For one-quarter of participants, excess weight loss ing will improve as patients can no longer inadvertently
was greater than 25 %. The device itself was demonstrated to reduce therapy by neglecting to wear the externally applied
be safe, and no major complications were recorded. However, power source.
one subcutaneous pocket seroma occurred, one patient was The benefits of vagal blocking may go beyond just weight
admitted for a respiratory infection, and one patient was loss. The vagus nerve is also involved with blood pressure
admitted with Clostridium difficile infection, which resolved regulation and hepatic gluconeogenesis. In 28 type 2 dia-
[41]. Through interpretation of the best weight loss data, an betic subjects fitted with the active implanted Maestro
optimal time frame of 120 s of blockade has been utilized to rechargeable system, excess weight loss at 12 months was
improve excess weight loss to 22.7 % at 6 months [41]. 25 %. In addition, the HgbA1c dropped from 7.8 to 6.6 %,
With safety and efficacy established, a double-blind, mul- and mean arterial pressure (MAP) fell from a baseline of
ticenter study (EMPOWER) was undertaken using VBLOC 98–91. All three categories were statistically significant [45].
36 Alternative Minimally Invasive Options: Neural Modulation 341
Interestingly, the decrease in blood pressure was only noted While there is still much to be learned about this technology,
in the hypertensive patients, and the improvements in blood it is clear that less invasive and simpler procedures are desir-
pressure and HgbA1c occurred early and potentially inde- able, and those proven to be efficacious may introduce a
pendent of the weight loss. paradigm shift in the surgical management of moderate and
A new multicenter double-blinded study (ReCharge Trial) severe obesity.
is currently underway using VBLOC therapy. To prevent the
potential confounding variables including noncompliance
that may have adversely affected the results of the Review Questions and Answers
EMPOWER trial, the current study only uses the implantable
power source. Additionally, to prevent any possibility that
1. The vagus nerve is the longest cranial nerve. It contains
electrical impulses (even ambient electrical activity) could
motor and sensory fibers and, because it passes through the
reach the vagus nerves of the patients in the control group,
neck and thorax to the abdomen, has the widest distribution
only the subcutaneous neuromodulator was implanted, and
in the body. It contains somatic and visceral afferent fibers,
no electrodes or leads are placed around the vagus nerves.
as well as general and special visceral efferent fibers.
The trial is ongoing and the preliminary results should be
Which of the following is not a function of the nerve?
available in the near future.
(a) Swallowing and phonation
(b) Involuntary muscle and gland control of the digestive
tract
Conclusion (c) Responsible for taste
(d) Ocular movement (Answer)
The battle against the obesity epidemic has given rise to
many new interdisciplinary developments and an increas- 2. Which is true of gastric myoelectrical activity?
ingly important role for more noninvasive treatment modal- (a) It consists of an uninterrupted sequence of electrical
ities. For morbidly obesity, conventional bariatric surgery potential variations called “slow waves” that spring
is considered to be the only effective and best studied ther- out continuously, at a frequency of about 3/min in
apy. However, the current era also demands effective thera- man, from a small zone of the proximal gastric cor-
pies for the relatively moderate obese population. In pus near the great curvature (pacemaker area).
addition, partially due to costs and the fear of complica- (b) The origin of slow waves lies in the interstitial cells
tions, only a small percentage of the eligible candidates of Cajal type I (ICC), a series of highly ramified cells
undergo bariatric surgery. Therefore, novel less invasive located between the longitudinal and circular muscle
treatment options are a focus in research. The need for coats.
effective minimal invasive treatments will continue to (c) In gastroparesis, there are more or less severe altera-
increase, but a sound critical attitude toward these novel tions in gastric myoelectrical activity, which may be
techniques. As previously stated by the expert panel on recorded with intraluminal, serosal, and cutaneous
weight loss surgery, the golden standard to investigate the electrodes.
safety and efficacy of interventions for the treatment of (d) All of the above (Answer)
obesity and its complications should be by means of ran-
3. Which of the following is not true regarding vagal
domized, blinded, sham-controlled clinical trials.
stimulation/blockage?
Some techniques/devices have been or will be failures,
(a) Leads are placed around the vagus nerve that delivers
some will be revisited, and some will turn out to be suc-
high-frequency, intermittent low-energy electrical
cessful in only a specific patient population. Even though
signals.
short-term results of some of the recently developed tech-
(b) Increase in transmission of vagal signals has been
niques and devices are promising, it is important to con-
shown to reduce hunger, increase satiety, and possi-
sider them as experimental until convincing evidence is
bly has neuroendocrine effects on the liver and pan-
published.
creas. (Answer)
Neuromodulation, including gastric stimulation and vagal
(c) The vagus is responsible for contraction of the stom-
blocking, is an exciting new surgical technology that may
ach pump (the antrum) which grinds up food and
offer safe and effective weight loss alternatives. Worldwide
mixes it with stomach enzymes, acid secretion, stom-
investigation is encouraging but still very preliminary. Many
ach emptying, secretion of digestive enzymes by the
questions remain unanswered such as what is the exact
pancreas and emptying of the gallbladder, and modu-
mechanisms of action, which patients will respond to it, how
lation of sensations of being full (satiation), hunger,
to program the device, will the benefits be sustainable, and
nausea, dull pain, and discomfort
lastly will it be safe long term?
(d) All of the above
342 S. Shah et al.
24. Lin ZY, McCallum RW, Schirmer BD, et al. Effects of pacing param-
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37
Intragastric Balloon
Manoel Galvao Neto, Josenberg Marins Campos,
and Lyz Bezerra Silva
Contraindications
Relative Contraindications
• Severe reflux esophagitis (higher risk for complications)
• GEJ conditions or diseases
• Chronic use of NSAIDs
FIG. 1. BIB® (reproduced with permission of Apollo Endosurgery,
Austin, TX).
by puncturing the balloon with a needle and simply remov- Absolute Contraindications
ing it with a foreign-body grasper or a customized one.
In 2004, an air-filled balloon, the Heliosphere® (Helioscopie, • Previous gastric surgery (especially Nissen fundoplica-
Vienne, France), was approved for use in Europe, Canada, tion and gastrectomy)
South America, and other countries, but not in the USA [9]. It • Gastric or duodenal active ulcer
is a double-bag polymer balloon covered with a smooth exter- • Hiatal hernia >5 cm
nal pouch of biocompatible silicone with a radiopaque marker, • Collagen diseases
which must be filled with air to a final volume of 650 to • Hepatic cirrhosis, portal hypertension
750 ml. The Heliosphere® is a lighter balloon (30 g), a charac- • Cancer
teristic that possibly increases patient tolerability. • AIDS
• Crohn’s disease
• Anticoagulant chronic use
Indications • Drug and alcohol abuse
• Pregnancy and lactation
The balloon, an endoscopic approach to obesity, is positioned • Psychiatric disorder (uncontrolled)
in-between clinical and surgical treatment. It overcomes the
results of clinical treatment on inducing more effective and
durable weight loss and cannot be compared with the much
better and long-term efficacy of the bariatric surgery.
Technique
Traditionally, IGBs have been used on morbidly obese
patients and as a bridge to surgical procedures. More recently, Implant
there is a trend to its use on low-BMI patients even with cos-
metic purposes, for example, in Brazil, the BIB® is approved • Patient under deep sedation with anesthesiologist (can be
by the FDA-like agency (ANVISA, reg# 80143600103) to changed to anesthesia with intubation under anesthesiolo-
be used in patients with BMI of 27 and over. Another trend is gist’s discretion and patient’s clinical condition).
the use for specific achievements like effectively lose weight • Endoscopic evaluation of esophagus, stomach, and duo-
to have a more conservative treatment in orthopedic and spi- denum for planning of the procedure, measuring the dis-
nal surgery or effectively lose weight to get pregnant as it tance until the GEJ.
improves fertility, among other benefits. Other interesting • Aspirate gastric residues.
indication is on morbidly obese children and teenagers under • Removal of the endoscope.
a strict protocol. • Insertion of the deflated balloon into the stomach, in an
A list of indications follows below: orogastric manner until surpassing the previously mea-
sured GEJ (Fig. 2).
• Patient with BMI > 35 kg/m2, unresponsive to clinical • Confirm that the balloon is well positioned and if not,
treatment who refuses surgical therapy or has reposition it under endoscopic view in an optimal location
contraindications (between gastric fundus and body).
• Patient with BMI < 35 kg/m2, comorbidities, unresponsive • Removal of guidewire from insufflation catheter.
to clinical treatment in a period superior to 3 years • Connect unidirectional valve to the 0.9 % saline + methy-
• Super-obese presurgical preparation (bridge procedure) lene blue solution.
37. Intragastric Balloon 345
Results
In a systematic review, 15 articles (3,608 patients) were
evaluated to estimate BIB® effectiveness. The weight loss at
balloon removal were 14.7 kg, 12.2 % of initial weight,
5.7 kg/m2 drop from initial BMI, and 32.1 % of
EWL. However, data were scant after balloon removal.
Efficacy at balloon removal was estimated with a meta-anal-
ysis of two randomized controlled trials (75 patients) com-
paring balloon versus placebo, indicating the balloon group
lost more weight than the placebo group. Regarding BIB®
FIG. 9. Balloon removal at the end with the balloon close to the safety, the majority of complications were mild, and early
endoscope tip. removal rate was 4.2 % [9]. The 12.2 % estimated rate of
total weight loss at the end of treatment is an amount con-
• A therapeutic endoscope might be useful in more difficult sidered sufficient to obtain health benefits, according to the
cases. knowledge obtained with clinical treatment that a weight
• Scopolamine (with intention to relax the EGJ) should be loss of 10 % improves morbid conditions associated with
administered after the balloon has been captured and obesity (hypertension, diabetes, hyperlipidemia, among oth-
before retrieval. ers) and also reduces mortality [11].
• Keeping the balloon close to the endoscope tip makes A Brazilian multicenter study evaluated 483 overweight
removal easier. and obese patients treated with the BIB®. Of these, 323
• Traction must be uniform, without bumps or stops, under completed a 6-month follow-up and 85 of them completed a
visual control. 1-year follow-up. At 6 months, patients showed a global
• The GEJ offers certain resistance, demanding more weight reduction from baseline BMI of 38.2 ± 9.4 to a
attention. 6-month BMI of 32.9 ± 8.3 kg/m2. Super-obese patients
• In the esophageal body, the passage is easier. under preoperative preparation (n = 32) showed a mean
• When the balloon reaches the cervical region, the neck weight loss of 26.1 kg, mean % EWL of 23.5 %. Considering
must be hyperextended, deflating the orotracheal tube surgical risk, most patients showed a significant improve-
cuff (optional), increasing sedation as needed (Fig. 9). ment from ASA III–IV before placement of balloon to ASA
• After the balloon has been removed, a second-look endos- II, with easier control of comorbidities, enabling safer surgi-
copy is mandatory, to assure that the esophagus and the cal procedures. Patients with BMI < 35 kg/m2 (n = 148)
gastric wall have not been harmed. showed a %EWL of 63.4 ± 28.6 %, with a success rate of
• In cases of challenging removal, therapeutic scopes and 94 %. At 1-year follow-up, a subset of patients had main-
overtube are helpful. tained a substantial weight reduction. The 1-year % EWL
was 50.9 ± 28.8 [10].
Overall, 85 patients who showed up for the 1-year follow-
up maintained more than 90 % of their BMI reduction
Pre- and Post-explant Prescription observed at the 6-month follow-up. 17 patients followed at 2
and Recommendations years after BIB® placement have maintained more than 89 %
of their 6-month BMI reduction, but again, results in patients
• Pre-explant who did not come back remain speculative. Although this
– Prolonged fasting (16–18 h), decreasing solid food follow-up represents less than 50 % of patients, it suggests
residues. that when patients agree to multidisciplinary treatment and
– Liquid diet for 24–36 h. change their behavior, they can maintain the weight loss
– Prokinetics—start 5–7 days before. more than 1–2 years after BIB® removal [10].
– Patient must go through a consultation with nutrition- From 76 subjects evaluated under BAROS Qol score,
ist and psychologist to prepare for balloon removal. more than 85 % were satisfied with the treatment. However,
• Post-explant such results should be viewed with caution because the grati-
– Prokinetics—continue for 2 or 3 days tude for a good result in these patients could render them
– Ondansetron (optional) more motivated to reply to a questionnaire than others who
– Scopolamine—continue for 2 or 3 days did not have as good an outcome. Binge eaters have a large
348 M.G. Neto et al.
gastric capacity, less negative feedback, and therefore lose These results are similar to those found by Giardiello
less weight with the intragastric balloon. Identification and et al. In this study, 60 patients were randomized to receive
treatment of binge-eating disorders are essential to satisfac- either a BIB® or a Heliosphere® bag. In 3 patients of the
tory results with the BIB [10]. BIB® group, early balloon removal was performed for intrac-
Obese adolescents may be a promising indication for table nausea and vomiting. At time of removal, weight loss
intragastric balloon because the shorter duration of obesity was similar between groups. Significant longer extraction
allows a greater possibility for them to change their eating time, with high patient discomfort, was observed in the
behavior and lifestyle [10]. Heliosphere® group due to difficult passage through the car-
In a study done by Genco et al., 2,515 patients had a BIB® dia and lower pharynx. In 1 patient in the BIB® group and 10
implanted. Placement was uncomplicated in all, but two (33.3 %) patients in the Heliosphere® group, the balloon was
cases (0.08 %) with acute gastric dilatation were treated con- found partially deflated at removal time [14]. The self-
servatively. The balloon was removed before 1 month after deflation in the air-filled balloon without a marker like meth-
positioning in 11 patients (0.44 %) due to psychological ylene blue makes it an issue because it may not be
intolerance. Overall complication rate was 2.8 % (n = 70). recognizable, increasing the risk of balloon migration into
Gastric perforation happened in 5 patients (0.19 %), 4 of the intestinal loop.
whom had undergone previous gastric surgery: 2 died and 2 In the author’s experience with the BIB®, 320 patients had
were treated successfully by laparoscopic gastric repair after the device implanted and were effectively followed up [15].
BIB® removal. Gastric obstruction presented in 19 patients Mean weight loss was 38.1 % EWL at 6 months for patients
(0.76 %) during the first week after positioning and was with a previous BMI of 35–40 kg/m2, 42.5 % EWL in a BMI
treated by device removal. There was balloon rupture in nine of 40–50 kg/m2, and 45.3 %EWL in a BMI > 50 kg/m2. There
patients (0.36 %). In relation to comorbidities, there was was nausea and vomiting in 65 %, abdominal pain in 30 %,
improvement (less medication dosage required or shift to and dehydration in 9 % during the first week. There was also
other therapy) in 625/1,394 patients (44.8 %). After 6 one early removal due to intolerance and no complications
months, %EWL was 33.9 ± 18.7 (range 0–87) [12]. during implant or removal. A small subset of 20 female
A small double-blind randomized study compared the patients on this group selected among low-BMI (30–35 kg/
fluid-filled BioEnterics BIB® and air-filled Heliosphere® gas- m2) patients that gained weight after the second pregnancy
tric balloons. Eighteen subjects were given the Heliosphere® were enrolled in a prospective single-arm trial with intensive
and 15 the BIB®. Body weight significantly decreased at 6 multidisciplinary follow-up during implant period and after
months after balloon insertion in both groups, with no differ- removal up to 6 months, achieved 58.4 ± 13.4 %EWL and
ences between them. At 6 months, the mean %EWL was 28.7 ± 1.8 (25.2–32.5) BMI from its initial 33.6 ± 2.2 (30–
27 ± 16 for the Heliosphere® and 30.2 ± 19 for the BIB®. All 37.9) kg/m2 with 76.9 % protocol adhesion. At the end of
30 patients kept their balloons for 6 months. In relation to 6-month post-explant period, mean BMI was 29.5 ± 2 (25.3–
safety, endoscopic times were shorter for Heliosphere® bal- 33.7) kg/m2, with 68.3 % protocol adhesion [16].
loon at placement and retrieval. However, balloon insertion In the long term, intragastric balloon-induced weight loss
under conscious sedation was impossible in two Heliosphere® seems to be maintained in patients who comply with multi-
patients due to rigidity of the device at the pharynx, causing disciplinary treatment and undergo behavioral modifications
severe discomfort, requiring general anesthesia. System fail- since the beginning of treatment. A 5-year follow-up study
ure at positioning was observed in one BIB® due to impos- concluded that patients who lost 80 % of total weight loss
sibility of saline injection through the catheter, requiring a during the first 3 months of treatment succeeded in maintain-
new balloon placement. At the time of removal, two ing a % EWL > 20 long term after BIB® removal [17].
Heliosphere® bags had passed in the stool and were not Although it is not a routine, balloon reimplantation in order
found in the stomach. Balloon removal was more difficult in to extend the weight loss duration is feasible and had been
the Heliosphere® group: one patient required surgical used in some cases, but data are scarce.
removal of the balloon by laparoscopy, and in other three
patients, a rigid esophagoscopy was required following
attempted endoscopic extraction. In all these patients, the Complications
deflated balloons failed to be pulled out through the cardia,
as the hook forceps tore the external pouch of the balloon in Complications of the BIB® are less frequent than what was
every attempt. Altogether, 30 % of Heliosphere® bags had an seen with earlier balloons. They include intolerance to the
adverse event at removal. After these results, the study was balloon (which might result in early removal), gastric ero-
prematurely stopped for safety reasons. Regarding tolerance, sions and ulcers, esophagitis, spontaneous deflation, persis-
at 1 month after discharge, three patients had intolerance to tent vomiting, gastroesophageal reflux, and abdominal pain.
the BIB® balloon (20 %), requiring early removal. There was There have been reports of several gastric perforations,
no difference between devices for epigastric pain, gastro- small bowel obstructions, impaction, and significant gastric
esophageal reflux, or vomits [13]. dilatation [18].
37. Intragastric Balloon 349
Methylene blue is used together with saline for balloon A rare but serious complication is gastric perforation.
filling, minimizing the risk of bowel obstruction. If there is Ulcers and gastric erosions in the presence of a balloon may
spontaneous balloon deflation, the dye is systemically be related to gastric wall irritation and lack of cytoprotection
absorbed, turning patient’s urine green. As an observation, secondary to mucosal prostaglandins production. The pres-
propofol (sedative agent commonly used during endoscopic ence of food residues impacted between the gastric wall and
procedures) has a rare side effect of making urine green, and the balloon and/or the irregular surface of the filling valve
the clinician must be aware of this false-positive marker for can generate a high pressure and ischemia zone, which might
balloon deflation [19]. culminate in a perforation [24]. Previous gastric surgery is an
In a systematic review, early removed balloons were absolute contraindication to balloon placement, due to pos-
4.2 %, with 43 % of those being voluntary removals, a rate sibility of perforation [12, 25]. Intense and sudden abdomi-
that is much lower in isolated series. The reported adverse nal pain, days or months after balloon implant, must raise the
events, leading to removal or not, were nausea and vomiting possibility of gastric perforation, a complication that can
after first week (8.6 %), abdominal pain (5.0 %), deflation lead to sepsis and death if not treated early. The diagnosis is
and displacement (2.5 %), inflammation (2.1 %), gastro- clinical, with intense epigastric pain and an acute abdomen
esophageal reflux (1.8 %), dehydration (1.6 %), deflation on physical exam. Imaging exams may reveal pneumoperito-
without displacement (0.9 %), displacement and obstruction neum and intracavitary collections. The definitive and etio-
(0.8 %), diarrhea and/or constipation (0.7 %), gastric ulcer logic diagnosis is made through an endoscopy. The treatment
(0.4 %), gastric perforation (0.1 %), and mortality related is surgical, preferably laparoscopic, through laceration clo-
with balloon gastric perforation (0.1 %) [9]. sure [26].
In the Brazilian multicenter trial, the most prevalent side
effects were nausea/vomiting (39.9 %) and epigastric pain
(20.1 %) during the first week. Dehydration requiring intra- Multidisciplinary Follow-Up
venous saline infusion occurred in 4.6 %, and 3.4 % of
patients had early intolerance leading to BIB® removal. Before balloon placement, the patient must be evaluated by a
Minor complications were clinically controlled: reflux psychologist, searching for previous history of mood, anxi-
esophagitis in 12.4 % and symptomatic gastric stasis in ety or eating disorders, alcohol or drug abuse, and family
8.7 % from transient obstruction of the pyloric antrum by the history of psychological or neurological diseases that may
balloon. Major complications were balloon impaction interfere with the treatment.
(0.6 %) in the antrum with gastric hyperdistention, requiring Nutritional follow-up is needed in order to make the
removal of gastric content under general anesthesia. There patient aware of the necessary behavior and eating habit mod-
was one case of spontaneous deflation of the balloon and ifications. After IGB implant, there is an adaptation period in
migration into the small bowel, causing intestinal obstruc- which the diet gradually goes from liquid to solid. Usually,
tion 5 months after device placement [10]. only in the 3rd week after implant the patient starts eating
Balloon placement must be careful, and the esophagus solid foods. Also, it is important to know that the balloon only
must be evaluated after the procedure. If implant is difficult, restricts quantity of food ingestion, and awareness of the
there might be esophageal damage, and even esophageal quality of food is necessary, avoiding hypercaloric diet.
tear, a life-threatening condition [20]. Physical activity should be encouraged, since it is highly
Regarding the transient obstruction of the pyloric antrum important for IGB success. Before starting to exercise, all
by the BIB®, which may occur in up to 9 % of the cases, the patients must undergo a physical evaluation, adapting physi-
mechanical maneuver of putting the patient in left lateral cal activity to each subject, considering age, sex, physical
decubitus and progressive massage of epigastrium from the condition, and comorbidities. It is recommended that exer-
right to left hypochondrium usually results in migration of cising becomes a habit, going beyond the 6-month balloon
balloon to the gastric fundus with relief of symptoms [10]. period.
Spontaneous deflation can occur, and when the balloon is
fluid filled, there is a change in the color of urine and stools,
due to methylene blue [21, 22]. It is essential that the patient Future Perspectives
is aware of this possibility, decreasing the risk of an intesti-
nal obstruction. The diagnosis is usually straightforward, More recently, new fluid-filled balloons with the same char-
based on a clinical history and physical exam. The most use- acteristics of the BIB have been designed in Latin America
ful imaging exams are abdominal X-ray and ultrasound [23]. and Asia with scarce literature supporting it [27].
A computerized tomography may also be used. Even though Considering the early intolerance and complications asso-
some deflated balloons can be eliminated through the gastro- ciated with traditional IGBs, an adjustable balloon was devel-
intestinal tract without major problems, surgical therapy oped, the Spatz Adjustable Balloon System (ABS)® (Spatz
might be needed. Balloon removal can be done by a laparo- FGIA, Inc., NY, USA). It is composed of a silicone balloon
tomic, laparoscopic, or a combined way. An enteroscopic or mounted on a catheter on one surface. This catheter has two
colonoscopic removal can also be attempted. loops, one is a non-collapsible loop meant to prevent or delay
350 M.G. Neto et al.
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Double-blind, sham-controlled, crossover evaluation of Cave M, et al. Ultrasound as the imaging method of choice for
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5. Benjamin SB. Small bowel obstruction and the Garren-Edwards ings, pitfalls and diagnosis of complications. Obes Surg. 2004;
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38
Alternative Minimally Invasive Options:
Endoluminal Bariatric Procedures
Nitin Kumar and Christopher C. Thompson
FIG. 1. (a) Pattern of anterior to posterior plications utilized by the RESTORe Suturing System (© 2014 C. R. Bard, Inc; used with permis-
sion) for primary endoluminal procedure. (b) Plication placement.
circumference was 12.6 ± 9.5 cm. Additionally, a significant ≥ 40 and 41.3 % in BMI < 40 [10]. Hemoglobin A1c
decrease in systolic (15.2 mmHg) and diastolic (9.7 mmHg) decreased significantly, from 7.0 to 5.7 %; there were also
blood pressure was seen. On follow-up endoscopy, however, significant improvements in triglyceride levels and HDL. One
partial or complete release of plications was noted in 13 case of respiratory insufficiency and another of asymptom-
patients. atic pneumoperitoneum were noted.
The TransOral GAstroplasty (TOGA) system (Satiety The TERIS, or Trans-Oral Endoscopic Restrictive Implant
Inc, Palo Alto, CA) has been studied for endoscopic gastro- System (BaroSense, Menlo Park, CA), is an implanted dia-
plasty. The device is a flexible stapler capable of performing phragm containing a 10 mm orifice (Fig. 3). The device is
full-thickness tissue apposition. Vacuum is used to appose stapled into the gastric cardia. De Jong et al. studied 13
the gastric walls, and a partition is created parallel to the patients and reported 12 successful placements [11]. One
lesser curvature (Fig. 2). The device must be removed for patient was unsuccessful due to gastric perforation. Two
reloading. Deviere et al. reported TOGA in 21 patients with patients developed pneumoperitoneum. After these events,
BMI of 43.3 kg/m2 [8]. No serious adverse events were technical adjustments were made to the procedure, and no
noted, although vomiting, pain, nausea, and transient dys- further complications were seen. Average procedure time
phagia were reported. All patients had partially or fully intact was 142 min. Median BMI decreased from 42.1 to 37.9 kg/
stapled sleeves at 6 months, although gaps were noted in 13 m2 after 3 months. Weight loss of 16.9 kg, and EWL of
patients. Average weight loss was 12 kg after 6 months, or 22.2 %, was reported at 3 months.
24.4 % of EWL. Moreno et al. reported successful TOGA in
11 patients using a second-generation device and re-
treatment to create additional distal restrictions if necessary Space-Occupying Devices
[9]. No serious adverse events were reported. Average weight
loss was 17.5 kg at 3 months and 24.0 kg at 6 months. Mean Space-occupying devices offer a noninvasive option for
BMI decreased from 41.6 to 33.1 kg/m2 after 6 months. A weight loss. These include balloons and polymers. Space-
multicenter study including 67 patients (53 were available occupying devices result in volume displacement and gastric
for follow-up) reported EWL of 52.2 % in patients with BMI distention (Fig. 4). Additionally, changes in gastric motility
38. Alternative Minimally Invasive Options: Endoluminal Bariatric Procedures 355
FIG. 2. The TransOral GAstroplasty (TOGA) system was used to create a vertical stapled gastroplasty along the lesser curvature of the
stomach. The anterior and posterior walls of the stomach were drawn into the suction chamber and stapled together (Courtesy of Ethicon,
Cincinnati, OH, with permission).
tion in the United States over the past three decades. Devices
in use to date, primarily in Europe, have been utilized as a
bridge to definitive therapy.
The BioEnterics Intragastric Balloon, or BIB (Allergan,
Irvine, CA), is a silicone elastomer balloon that can be
implanted into the stomach endoscopically [12]. It can be
filled with saline and methylene blue dye, which leaks and
changes the color of urine if the balloon’s integrity is com-
promised. The balloon is resistant to gastric acid for approxi-
mately 6 months.
The BIB has been studied in a large number of patients
compared to other endoscopic bariatric therapies. A meta-
analysis of 3,698 patients reported weight loss of 14.7 kg and
32.1 % EWL after 6 months [13]. BMI decreased by 5.7 kg/
m2. Complications included nausea, vomiting, bowel
obstruction (0.8 %), and gastric perforation (0.1 %). 4.2 % of
patients had early removal. A retrospective study of 2,515
patients with mean BMI of 44.4 kg/m2 reported that BIB
placement resulted in two mortalities in patients with previ-
FIG. 3. The TERIS, or Trans-Oral Endoscopic Restrictive Implant ous gastric surgery. After 6 months, there was decrease in
System (BaroSense, Menlo Park, CA, with permission), places a BMI by 9.0 kg/m2 [14]. There was significant improvement
restrictive device across the gastric cardia.
in blood pressure and lipid profile, and fasting glucose. Of
488 diabetics, 87.2 % had significant decrease or normaliza-
and hormones have been noted. Notably, cholecystokinin tion in hemoglobin A1c.
may be released due to gastric distention, inducing pyloric A prospective study of the metabolic changes after BIB
constriction and delayed gastric emptying. The first intragas- placement included 130 patients with BMI of 43.1 kg/m2
tric balloon was approved for use in the United States in [15]. Ten patients required early balloon removal, 6 of which
1985, inspired by the observation that patients with bezoars were due to intolerance, abdominal pain, or vomiting.
lost weight. The technology has not seen widespread adop- During the 6-month follow-up period, patients were kept on
356 N. Kumar and C.C. Thompson
1,000–1,200 kcal per day. Weight loss after 6 months was Depression Inventory score. The groups were otherwise
13.1 kg, resulting in decrease of class IV obesity from 23 to similar. Weight loss of 39.3 % EWL in the depressed group
8 % in the cohort. Statistically significant metabolic was similar to weight loss of 36.1 % EWL in the non-
improvements were noted, with decrease in prevalence of depressed group. The depressed group had decrease in
hyperglycemia from 50 to 12 %. Hypertriglyceridemia depression score from 20.3 ± 8.5 to 7.9 ± 5.6 at the time of
decreased from 58 to 19 %. Prevalence of severe hepatic ste- balloon removal. Additionally, 70.8 % of the patients had
atosis decreased from 52 to 4 % in patients who had BMI resolution of depression; the rate of severe depression
decrease greater than 3.5 kg/m2. Follow-up after balloon declined from 27.7 to 1.5 %.
removal, for a median 22 months, found that 50 % of patients Repeat BIB insertion was studied prospectively by
regained some weight. Dumonceau et al. [19]. Of 118 patients, 8 had immediate bal-
The importance of dietitian counseling after balloon loon reinsertion, 11 had placement after a balloon-free inter-
placement was studied by Tai et al. [16]. Twenty-eight val, and 99 had no balloon replacement. Patients with second
patients with mean BMI of 32.4 ± 3.7 kg/m2 had BIB place- balloon after a balloon-free interval regained an average
ment for 6 months, with decrease in BMI to 28.5 ± 3.7 kg/m2 13.6 kg during that interval. The second balloon placement
at removal. Dietitian follow-up was scheduled at every week resulted in significantly less weight loss (9.0 kg versus
for 2 weeks, every 2 weeks for 1 month, and then monthly. 14.6 kg) and less EWL (18.2 % versus 49.3 %). The compli-
Good adherence was defined as appearance for 50 % of cation rate, including esophagitis and intolerance, was higher
scheduled visits. Responders were those who had at least with the second balloon (26 % versus 11 %), although this
20 % EWL. Twenty patients were responders and 8 were was not significant. There was no difference in weight loss
nonresponders. Of the responders, 85 % had good adherence with second balloon placement by the third year of follow-
versus 25 % of nonresponders. up. Second balloon placement had no effect on the propor-
A prospective single-blinded study examined histologic tion of patients having ≥ 10 % weight loss or bariatric surgery
improvement in nonalcoholic steatohepatitis [17]. Patients during the 4.9-year follow-up period. Another study reported
were randomized to BIB placement (11 patients) or sham 112 patients with second balloon placement within 1 month
endoscopy with gastric instillation of 500 mL of saline (10 of removing the first balloon [20]. Mean BMI loss was
patients). All patients were placed on the American Heart 6.5 kg/m2 with the first balloon, versus 2.5 kg/m2 with the
Association diet. Three BIB patients had removal due to epi- second balloon.
gastric discomfort and vomiting. BMI decreased by 1.6 kg/ Kotzampassi et al. studied long-term weight trends after
m2 in the BIB group versus 0.8 kg/m2 in the control group. At BIB removal in 500 patients with initial BMI of 43.7 kg/m2
the end of treatment, NAFLD activity score was significantly [21]. At the time of BIB removal, 83 % of patients were clas-
lower in the BIB group (2 versus 4), and there was a trend sified as successful, with EWL of at least 20 %. This group
towards improvement in median steatosis score in the BIB had mean weight loss of 23.9 ± 9.1 kg and BMI loss of 8.3 kg/
group. There was no change in median lobular inflammation, m2. At 5-year follow-up, including 41 % of the original
hepatocellular ballooning, or fibrosis. ALT and AST were cohort, mean weight loss was 7.3 ± 5.4 kg and BMI loss was
not significantly changed in either group. 2.5 kg/m2. Twenty-three percent of patients maintained
The effects of balloon placement on depression were weight loss of at least 20 % of EWL.
studied by Deliopoulou et al. [18]. One hundred consecu- BIB has been studied as a bridge to RYGB in super-
tive females were classified into depressed (65 patients) superobese patients [22]. Sixty consecutive patients with mean
and non-depressed (35 patients) groups based on Beck BMI of 66.5 ± 3.4 kg/m2 had either BIB placement (23 patients)
38. Alternative Minimally Invasive Options: Endoluminal Bariatric Procedures 357
or no BIB (37 patients). BIB was left in place for 155 ± 62 days The device slows the travel of food through the duodenum,
with BMI loss of 5.5 ± 1.3 kg/m2. The BIB group experienced altering satiety hormones and glucose metabolism. An early
significant decrease in systolic blood pressure and gamma- trial reported that all patients lost weight, with average EWL
glutamyl transpeptidase. Operative time for RYGB was signifi- of 12 % over the first month. Another trial of 31 patients with
cantly shorter in the BIB group (146 ± 47 versus 201 ± 81 min). mean BMI 41.3 kg/m2 compared 10 controls with 21
There were significantly fewer major adverse events, classified implanted patients. Device migration occurred in 10 of 21
as conversion to laparotomy, ICU stay over 2 days, and hospital implanted patients, requiring emergency surgery in two
stay over 2 weeks, in the BIB group (2 versus 13). Weight loss patients. Weight loss was 6.7 kg after 3 months in patients
was similar in both groups 1 year after RYGB. completing the trial versus 2.2 kg in controls. The device was
BIB, filled with 500 mL saline, has been compared with found to delay glucose absorption and insulin secretion and
Heliosphere BAG, which is filled with 950 mL of air [23]. to alter GLP-1 kinetics [26].
Thirty patients with mean BMI of 46.3 kg/m2 were random-
ized to each group. Decrease in BMI was 5.7 kg/m2 in the
BIB group versus 4.2 kg/m2 in the Heliosphere group. Malabsorptive Procedures
Patients in the Heliosphere group did experience significantly
longer extraction time and significantly more extraction Small intestinal bypass is a key component of many bariatric
discomfort during passage through the cardia and lower phar- surgical procedures. It is postulated to play an especially
ynx. A nonrandomized study by Caglar et al. compared the important role in the improvement of metabolic parameters
BIB with Heliosphere BAG [24]. Thirty-two patients nonre- after bariatric surgery. Endoluminal devices have been devel-
sponsive to 6 months of medical and diet therapy had BIB oped to bypass absorption of nutrients in the small intestine.
placement (19 patients, BMI 45.6 ± 9 kg/m2) or Heliosphere The EndoBarrier duodenal-jejunal bypass liner, or DJBL
BAG placement (13 patients, BMI 45.0 ± 8 kg/m2). After 6 (GI Dynamics, Lexington, Mass), is a self-expanding nickel-
months, weight loss was significantly higher in the BIB group titanium implant attached to a 60 cm tubular polymer sleeve
(19.0 kg versus 13.0 kg), as was EWL (38.3 % versus 21.9 %). that extends from the duodenal bulb into the jejunum (Fig. 5).
One patient in the BIB group had early removal due to persis- It prevents food from contacting the mucosa of the small
tent nausea and vomiting at 1 month. One patient in the BIB intestine, but allows biliary and pancreatic secretions to
group died 13 days after placement due to cardiac arrest travel along the outside of the sleeve to the jejunum. A mul-
related to aspiration of gastric contents. ticenter randomized trial of 41 patients assigned 30 patients
The silicone TransPyloric Shuttle (BAROnova, Goleta, with BMI 48.9 kg/m2 to DJBL placement and 11 patients
CA) comprises a large spherical bulb connected to a smaller with BMI 47.4 kg/m2 to diet control [27]. Four patients
cylindrical bulb by a flexible tether. The sphere is too large to required device removal due to migration, obstruction, pain,
traverse the pylorus, while the cylinder can pass into the duo- and dislocation of the anchor. There were no serious adverse
denal bulb during peristalsis. The device intermittently events. After 3 months, BMI decrease was significantly
blocks the pylorus, reducing gastric emptying rate. The higher in the DJBL group: 5.5 kg/m2 versus 1.9 kg/m2 in the
device is delivered via transoral catheter and is removed control group. Of 8 diabetics with DJBL placement, 7 had
endoscopically. A prospective single-center open-label study
of 20 patients with mean BMI of 36.0 kg/m2 reported weight
loss of 8.9 ± 5.2 kg and EWL of 31.3 ± 15.7 % after 3 months
[24]. Mean weight loss was 14.6 ± 5.7 kg and 50.0 ± 26.4 %
EWL after 6 months. Persistent gastric ulcer required early
removal in two patients.
The Duo balloon (ReShape, San Clemente, CA) com-
prises two silicone spheres filled with 900 mL of saline.
Deflation of one balloon alone will not result in migration.
According to company data, patients have experienced loss
of one-third of excess weight after 6 months. A 3-center pro-
spective trial included balloon placements in 21 patients and
9 control patients [25]. Both groups had similar diet and
exercise counseling. In the balloon group, 4 patients required
readmission for nausea. Two had gastritis at balloon removal.
At 48 weeks, 30 % of the balloon group reached the 25 %
EWL target versus 25 % of the control group.
The SatiSphere (EndoSphere, Columbus, OH) is a pre- FIG. 5. The EndoBarrier duodenal-jejunal bypass liner, or DJBL (GI
formed memory wire that self-anchors in the distal stomach Dynamics, Lexington, Mass, with permission), is anchored in the
and duodenum by conforming to the shape of the duodenum. duodenal bulb and extends 60 cm into the duodenum.
358 N. Kumar and C.C. Thompson
improvement in diabetes. Gersin et al. reported an open-label results in EWL of 56.7–66.5 % over 24 months after surgery;
randomized multicenter trial including 25 patients, with suc- additionally, there is commonly improvement in or resolu-
cessful implantation in 21 patients [28]. Implantation was tion of diabetes in 84 %, hypertension in 68 %, obstructive
not successful in patients with a small duodenal bulb. Seven sleep apnea in 81 %, and improvement in hyperlipidemia in
patients required device removal due to adverse events, 3 of 97 % [32–36]. The mechanisms by which RYGB induces
which were bleeding presenting as hematemesis. Weight loss weight loss and improvements in comorbidities are not
after 3 months was significantly higher in the DJBL group: entirely understood, but restriction induced by small gastric
8.2 ± 1.3 kg versus 2.0 ± 1.1 kg in the sham group. Another pouch size and stoma aperture likely results in reduced
randomized trial by Tarnoff et al. included 25 patients caloric intake. Bypass of portions of the gastrointestinal tract
implanted with DJBL and 14 control patients [29]. All likely results in decreased calorie absorption [37].
patients received baseline dietary and lifestyle counseling. Patients typically experience rapid weight loss for 12–18
After 12 weeks, EWL was 22 % for the device group versus months after RYGB and then reach a stable weight as energy
5 % for the control group. There was an adverse event rate of intake and expenditure reach equilibrium [37, 38].
20 %, including bleeding, migration, and obstruction. Approximately 20 % of patients fail to achieve >50 % EWL
A modified version of the DJBL with a restrictive (4 mm) within 1 year of surgery. Additionally, 30 % of patients have
proximal opening was studied by Escalona et al. in ten had weight regain at 18–24 months postoperatively; weight
patients with average BMI of 40.8 kg/m2 [30]. Weight loss regain of a mean 18 kg at 2 years has been reported [39, 40].
after 3 months was 16.7 ± 1.4 kg. Eight patients required bal- Another study reported weight regain in 63.6 % within 48
loon dilation of the restrictive orifice after developing months [41]. The superobese (BMI > 50 kg/m2) fail to
abdominal pain, nausea, and vomiting. Gastric emptying was achieve BMI < 35 kg/m2 in 60 % of cases [42, 43]. Weight
delayed in 84 % of patients at 3 months but generally regain can result in recurrence of comorbidities, decreased
improved after the device was removed. quality of life, and adverse effects on mental health.
Escalona et al. studied 1-year outcomes after DJBL The mechanisms of weight regain after RYGB are likely
implantation in an open-label prospective trial [30]. Thirty- multifactorial. Long-term outcomes after RYGB are influ-
nine patients with BMI 43.7 ± 5.9 kg/m2 had implantation of enced by preoperative BMI and postoperative dietary adher-
the device; 3 patients could not be implanted due to short ence [44]. Neuroendocrine-metabolic dysregulation may
duodenal bulb. There were 15 early removals, due to anchor result in a starvation response, increasing appetite and
movement (8), device obstruction (3), abdominal pain (2), decreasing metabolic rate [45, 46]. Decreased satiety may
acute cholecystitis (1), and patient request (1). In the 24 also be secondary to loss of restriction; larger pouch size and
patients with the device in place for 1 year, average weight larger diameter of the gastrojejunal anastomosis (GJA) cor-
loss was 22.1 ± 2.1 kg, BMI loss was 9.1 ± 0.9 kg/m2, and relate with increased postoperative weight regain [47–50].
EWL was 47.0 ± 4.4 %. Decrease in waist circumference Loss of malabsorptive bypass may be an issue if there is a
from 120.5 ± 6.8 to 96.0 ± 2.6 cm was significant. Statistically gastrogastric fistula [51].
significant decreases were also seen in blood pressure, hemo-
globin A1c, total cholesterol, LDL, triglycerides, and in the
prevalence of metabolic syndrome (83.3–41.6 % of patients). Treatment of Weight Regain
Rodriguez et al. randomly assigned patients with type II
diabetes and mean BMI of 38.9 kg/m2 to DJBL or sham There are multiple surgical procedures to address weight
endoscopy [31]. After 6 months, hemoglobin A1c fell by regain after RYGB, including reconstruction of the gastroje-
2.4 ± 0.7 % in the DJBL patients, versus a fall of 0.8 ± 0.4 % junal anastomosis, placement of adjustable gastric band over
in the sham arm. The result did not reach significance. the gastric pouch, revision of the pouch, and distal gastric
bypass [50]. However, none is ideal, and surgical revision is
relatively uncommon compared to the number of patients
Weight Regain with weight regain [52]. Patients requiring surgical revision
are older [53]. Complication rates are high, with patients
Bariatric Surgery experiencing greater intraoperative blood loss and longer
procedure times [53–55]. Mortality rates are over twice as
Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, high as that of the primary surgery [52]. The cost may not be
adjustable gastric band, vertical banded gastroplasty, duode- covered by insurance [56].
nal switch, and biliopancreatic diversion are the most com- Less invasive endoluminal revisions that reduce gastric
mon bariatric surgeries encountered by physicians treating pouches’ size and GJA diameter may have a more favorable
weight regain [32]. risk profile in this population, as well as lower cost. Many
Of these, RYGB is the most prevalent [33]. Additionally, techniques have been studied; of these, sclerotherapy, endo-
RYGB can be revised endoscopically. RYGB typically luminal suturing, and tissue plication will be discussed.
38. Alternative Minimally Invasive Options: Endoluminal Bariatric Procedures 359
Sclerotherapy tion mucosa and trap tissue; a needle is then passed through
the tissue. The EndoCinch has been used for transoral outlet
Endoscopic injection of sclerosant, such as sodium mor- reduction (TORe) by placement of interrupted stitches at the
rhuate, around the GJA can be used to reduce GJA aperture anastomotic margin. The rim of the GJA is pretreated with
and tissue compliance. Endoscopic sclerotherapy can be per- argon plasma coagulation.
formed under conscious sedation. The procedure begins with TORe using the EndoCinch was first described in 2004
injection of a test dose at the rim of the GJA, followed by [60]. The first published study included eight patients with
monitoring for adverse reactions. The sclerosant is then average weight regain of 24 kg and average GJA diameter of
injected into the submucosa around the circumference of the 25 mm [61]. An average of 2 interrupted stitches were used
GJA until a bleb forms. Overinjection can result in bleeding; to reduce stoma diameter to an average of 10 mm. There
this is preceded by dark red or black discoloration. Aliquots were no significant adverse events. Six of 8 patients lost an
are usually 2 mL, and the total injection is usually 10–25 mL average of 10 kg at 4 months. Of the 3 patients who had
[57]. Intravenous ciprofloxacin is usually given before the repeat TORe, 2 had weight loss of 19 kg and 20 kg after
procedure and a 5-day course of liquid ciprofloxacin or 5 months. Average BMI decreased from 40.5 to 37.7 kg/m2.
trimethoprim-sulfamethoxazole should be provided. The RESTORe, a randomized double-blinded sham-controlled
patient should be nil per os for a day after the procedure and multicenter trial, resulted in level 1 evidence for effective-
advance from liquid to regular diet over the following 4 ness of TORe [62]. There were 77 patients with GJA diame-
weeks. Repeat sclerotherapy sessions are scheduled every ter >20 mm and mean BMI of 47.6 kg/m2 included. GJA was
3–6 months with a goal GJA diameter of 12 mm; most reduced to <10 mm in 89 % of the TORe group. The rate of
patients require two or three sessions [58]. GJA measure- adverse events was similar to the sham group, and there were
ments should be performed at the beginning of the next no perforations. Mean weight loss in the TORe group was
sclerotherapy session as the diameter immediately after 3.8 % of body weight versus 0.3 % in the sham group
injection is transiently obscured by edema [57]. Injection (p = 0.02) in intent-to-treat analysis. Of the TORe group,
may be difficult during repeat procedures as tissue sclerosis 96 % achieved weight loss or stabilization during the 6-month
can make bleb formation challenging. follow-up period.
Endoscopic sclerotherapy has proven effective in revers-
ing weight regain after RYGB. The initial study reported
weight loss in 15/20 patients within 8 weeks [58]. A 2007 Incisionless Operating Platform
study of 28 patients reported weight loss of >75 % of
regained weight in 64 % of patients after an average 2.3 ses- The Incisionless Operating Platform (USGI Medical, San
sions; however, patients with GJA diameter >15 mm did not Clemente, CA) is a multichannel device that can perform
appear to have successful outcome [59]. Another 2007 study full-thickness plication. A 4.9 mm super-slim endoscope
including 32 patients reported that endoscopic sclerotherapy inserted through one of the accessory channels provides
arrested or reversed weight regain in 91.6 % of patients after endoscopic visualization. Two other channels are used for a
1 year, and a 2008 study of 71 patients reported weight main- tissue grasper and a tissue approximator. The grasper is used
tenance or loss in 72 % of patients at 1 year [57, 59]. to pull tissue in, and the tissue approximator is used to drive
Sodium morrhuate is not commercially available, and a needle through the tissue and then plicate the tissue together
alternative sclerosants are being investigated to measure with tissue anchors [63].
weight loss outcomes in patients with weight regain. The IOP has been prospectively studied in reduction of
dilated gastric pouch and GJA, called the Revision Obesity
Surgery Endoscopic (ROSE) procedure. Mullady et al. stud-
ied 20 patients with weight regain. Technical success was
Endoscopic Suturing achieved in 85 %, reducing GJA aperture by 65 % to a mean
16 mm and gastric pouch length by 36 %. Average weight
Endoluminal suturing has been studied for endoscopic revi- loss at 3 months was 8.8 kg. The second-generation device is
sion of dilated pouches and GJA. The EndoCinch Suturing able to function in smaller gastric pouches. A study by Ryou
System, Incisionless Operating Platform, StomaphyX, and et al. in five patients demonstrated weight loss in all patients,
OverStitch will be discussed below. with average weight loss of 7.8 kg [64]. A ROSE prospective
multicenter registry of 116 patients with dilated GJA and
gastric pouch demonstrated technical success in 97 % [65].
EndoCinch Suturing System GJA aperture was reduced by 50 %, and gastric pouch length
by 44 %. There were no procedural complications. Those
The Bard EndoCinch Suturing System (CR Bard, Murray patients achieving GJA aperture of less than 10 mm had
Hill, NJ) is a suction-based superficial-thickness suturing 24 % EWL. Overall, the group lost 32 % of regained weight
device. A hollow capsule at the endoscope tip is used to suc- during 6-month follow-up.
360 N. Kumar and C.C. Thompson
StomaphyX
The StomaphyX device (EndoGastric Solutions, Redmond,
WA) can create full-thickness plications using polypropyl-
ene H-fasteners. GJA aperture reduction can be performed
by circumferentially applying approximately 20 fasteners
around the anastomotic margin. A study of 39 patients with
BMI of 39.8 kg/m2 revealed average procedure time of
35 min and no significant adverse events [66]. Patients had
13.1 % EWL after 3 months and 19.5 % EWL after 1 year. A
subsequent study of 64 patients with mean BMI of 39.5 kg/
m2 reported use of 23 plications and average reduction of
GJA diameter from 22 to 9 mm [67]. Procedures took 50 min
on average. One patient had bleeding at the plication site,
although transfusion was not necessary; there were no other
significant adverse events. Average weight loss was 7.6 kg
after 5.8 months.
FIG. 6. (a) Apollo OverStitchTM device (Apollo Endosurgery, Inc.,
Austin, TX, with permission). (b) Suturing device is placed at the
end of a dual-channel endoscope with a catheter-based suture sys-
Apollo OverStitch tem that is placed through the working channel.
The OverStitch (Apollo Endosurgery, Austin, TX) is a full-
thickness endoscopic suturing system. It uses a catheter- ration and fistula closure. It is a nitinol clip attached to an
based needle to place interrupted or running stitches under applicator, which is placed on the endoscope tip. Opposite
direct endoscopic visualization (Fig. 6). The endoscope does sides of the GJA can be grasped with endoscopic forceps and
not need to be removed to reload sutures. A helical tissue pulled into the cap at the tip of the endoscope. Deployment
retractor accessory can also be used through one channel of of the clip apposes and secures the tissue. Heylen et al. stud-
the double-channel endoscope. ied OTSC for reduction of GJA aperture in a study of 94
OverStitch has recently been studied for TORe in 25 patients with mean BMI of 32.8 kg/m2 [70]. Mean GJA aper-
patients [68]. GJA aperture was reduced from 26.4 to 6 mm ture was reduced from 35 to 8 mm. Average procedure time
on average. No significant adverse events were noted. During was 35 min, and no major adverse events were reported.
the 6-month follow-up period, patients lost 69.5 % of the After 3 months, BMI had fallen to 29.7 kg/m2; 1 year after
regained weight. Six-month average weight loss was 11.7 kg, the procedure, BMI was 27.4 kg/m2.
and 1-year weight loss was 10.8 kg.
Superficial-thickness TORe using EndoCinch and full-
thickness TORe using OverStitch were directly compared in Olympus T-Tags
a matched cohort study by Kumar and Thompson [69]. There
were 118 patients, 59 in each group, who were matched T-tags (Olympus, Tokyo, Japan) have been used to reduce GJA
sequentially by pre-TORe GJA aperture, BMI, and age. Six- aperture [71]. Using a double-channel endoscope, multiple
month weight loss was 4.4 ± 0.8 kg in the EndoCinch group T-tags can be deployed around the anastomotic margin. The
versus 10.6 ± 1.8 kg in the OverStitch group (p < 0.01). One- T-tag comprises two T-bars, each in a hollow needle. Once the
year weight loss was 2.9 ± 1.0 kg in the EndoCinch group distal tag has been driven through tissue, a proximal tag is
versus 8.6 ± 2.5 kg in the OverStitch group (p < 0.01). advanced over the connecting suture and then secured. The
The interrupted stitch suturing method used in these stud- excess suture is cut with an endoscopic loop cutter. A nonsur-
ies has since been modified to a full-thickness purse-string vival study in pigs demonstrated average GJA aperture reduc-
technique, with superior early results; studies are ongoing. tion of 27 % in a mean time of 61 min [72]
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39
Innovative Metabolic Operations
Ricardo Cohen, Pedro Paulo Caravatto, and Tarissa Petry
FIG. 3. “Classic” duodenal-jejunal bypass. FIG. 4. Duodenal-jejunal bypass with sleeve gastrectomy.
The implication of such findings is that by rerouting the food of follow-up. Remission was not related to weight change in
passage (e.g., after DJB), endocrine factors present in the this study. We further assessed glucose and β-cell response to
duodenum and proximal jejunum that induce insulin resis- an oral glucose load before and at 6, 9, and 12 months after
tance may halt, causing an immediate and long-standing surgery [61] and compared the results with subjects with nor-
metabolic response. mal glucose tolerance. DJB improved β-cell function and
We reported the first two patients to undergo DJB with no glycemic control in overweight and class I obese subjects
gastric manipulation (“classic DJB”) [59]. The surgical tech- with T2DM. It did not normalize β-cell function when com-
nique involved Roux-en-Y duodenojejunostomy with a pared with the subjects with normal glucose tolerance but
50-cm biliopancreatic limb and 80-cm Roux limb. Both increased it two- to threefold compared with baseline.
patients showed a decrease in HbA1c with no correlation to Geloneze et al. [62] published their results on DJB in 12
weight variation. overweight diabetic patients. Remission (HbA1c < 6.5 %, no
Later, we published our experience with 36 non-morbidly medications) occurred in two (16.7 %) patients. This result
obese diabetic patients who underwent classic DJB [60]. was due to the selection of patients with a long history of
Diabetes remission (HbA1c < 7 % and fasting plasma glucose diabetes and/or established macrovascular disease, slightly
FPG < 126 mg/dL) was achieved in 40 % of patients at 1 year worsening their results regarding T2DM control. In their
39. Innovative Metabolic Operations 367
study, although all patients were undergoing insulin therapy Several other authors have reported their experience with
before surgery, 10 (83 %) patients began taking only oral DJB, as described in Table 2 [60, 62, 66–68].
medications 24 weeks after surgery and experienced a sig-
nificant decrease in HbA1c levels (8.78 to 7.84 %).
Seeking better outcomes and attempting to reproduce the DJB Liner
results found in class 1 or morbidly obese patients, we moved
forward with some technical and pathophysiological modifi- Finally, a new tool for T2DM control was introduced. The
cations as follows. We conducted our second protocol and DJB liner (DJBL) is an endoscopically placed device that
performed a “sleeved duodenal exclusion” or “short duode- prevents contact between partially digested nutrients and the
nal switch” by adding sleeve gastrectomy with a 50/60-F proximal intestine, mimicking the exclusion of the proximal
bougie in 47 patients. The primary end points were fasting bowel, which is a component of several effective metabolic
and postprandial glycemic control, and the secondary end surgeries [69]. Escalona et al. [70] implanted the DJBL in 39
points were lipid and hypertension control and carotid morbidly obese patients, and after 12 months, all achieved
intima-media thickness, an important surrogate marker for good loss of excess body weight (47.0 ± 4.4 %). The patients
atherosclerosis progression. In addition, based on our own also showed significant improvements in waist circumfer-
studies on better metabolic/diabetes outcomes with longer ence, blood pressure, total and LDL cholesterol, triglycer-
limb lengths in the morbidly obese population [63], we have ides, and fasting glucose.
increased the biliary limb to 100 cm and the alimentary limb The only report in the literature regarding low-BMI
to 150 cm. We believe that resecting the gastric fundus longi- T2DM was recently published by Cohen et al. [71]. Sixteen
tudinally, thus removing part of the major ghrelin production of 20 subjects implanted with the DJBL completed the 1-year
site, may lead to slower gastric emptying, decreasing the glu- study (mean BMI of 30 kg/m2). Ten of 16 subjects (62.5 %)
cose load to the intestine. Preserving the pylorus may be key who completed the study demonstrated HbA1c levels of
in decreasing the glycemic peaks after food ingestion, lead- <7 % at week 52, and statistically significant lipid control
ing to an improved first-phase insulin response and better was achieved (LDL and triglycerides). No significant corre-
glycemic outcomes. Ghrelin has the capability to decrease lations between changes in body weight and changes in FPG
pancreatic insulin secretion through direct and counter- or HbA1c were observed. Based on the results of that study,
regulatory mechanisms [64, 65]. Thus, removing the main the DJBL appears to reproduce some aspects of metabolic
ghrelin production site would allow for better control of dia- surgery in terms of its ability to improve HbA1c, FPG, and
betes. With an average follow-up of 1 year, we found that lipid parameters without a direct relation to weight modifica-
adding sleeve gastrectomy and increasing the limb lengths tion. Interestingly, after some mathematical modeling of data
does not add any excessive weight loss to this leaner group extracted from the oral test after a mixed meal challenge glu-
(total body weight loss of 6 %). In addition, so far we have cose excursions, C-peptide deconvolution, and insulin
seen diabetes resolution in approximately 71 % of patients, curves, we found almost immediate, weight loss-independent
and 100 % if we include patients from remission to improve- improved insulin sensitivity after the placement of the
ment (unpublished data). As secondary end points, we DJBL. Moreover, this effect was maintained throughout the
achieved control of hypertension in 67 % of patients at 12 year that the device was kept in place. No improvement in
months (≤130/80 mmHg, no or minimal medications), nor- insulin secretion was seen. This finding supports the animal
malization of triglycerides in 77 % of patients, and normal- studies of Breen and Jiao [57, 72]. The DJBL seems to be an
ization of low-density-lipoprotein (LDL) cholesterol in 81 % effective tool for metabolic control, allowing some potential
of patients. The carotid intima-media thickness was signifi- associations with GLP-1 analogues and DPP4 inhibitors
cantly reduced from baseline in 12 months. because the device itself possibly does not change insulin
368 R. Cohen et al.
secretion. It is an outpatient-based endoscopic procedure that issues such as the proper time for surgery, best selection
is associated with virtually no major complications, but the criteria, and optimal procedure [74].
main drawback is that its design is only safe for 1 year of Some accomplishments have been made, such as at the
implantation. It may be a good screening tool for the effec- Diabetes Surgery Summit held in Rome in 2007 [75], where
tiveness of duodenal exclusion before a surgical procedure or surgery was recognized as a beneficial tool for select patients
an excellent way to quickly improve glycemic and metabolic with diabetes and bariatric surgery was mentioned in T2DM
control in individuals with glucotoxicity and lipotoxicity treatment guidelines for the first time [76]. More recently,
who may need prompt, effective, and safe intervention. the 2011 IDF statement is a landmark in the future role of
metabolic surgery as an alternative therapy in patients with a
BMI of 30 to 35 kg/m2 and uncontrolled, higher-
Sleeve Gastrectomy with Transit cardiovascular-risk T2DM [77].
Bipartition In the context of an uncontrolled epidemic, gastrointesti-
nal interventions for metabolic control are here to stay pend-
Laparoscopic sleeve gastrectomy with transit bipartition was ing better definition of their place in the T2DM treatment
proposed by Santoro et al. [73] in an observational study of algorithm. Whereas bariatric surgery was conceived as a
1,020 morbidly obese patients. The surgical procedure mere weight loss intervention, the results of several studies
involves gastroileal anastomosis added to sleeve gastrec- mentioned in this chapter demonstrate that gastrointestinal
tomy, without exclusion of the duodenum and proximal jeju- surgery can also control and prevent T2DM, thereby reduc-
num. The mean BMI was 42.2 kg/m2, and excess BMI loss ing the incidence of cardiovascular disease and death.
was 91 % and 74 % in the first and fifth postoperative years, Accordingly, metabolic surgery is a more appropriate physi-
respectively. T2DM was diagnosed in 32.6 % of patients, and ological approach to treat disease rather than behavioral
86 % went into complete remission (HbA1c < 6.5 % without issues [16].
medication).
Although the authors emphasize the enterohormonal
pathways of metabolic surgery and the mechanisms involved References
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40
Venous Thrombosis and Pulmonary Embolism
in the Bariatric Surgery Patient
Brandon T. Grover and Shanu N. Kothari
clinically detected DVTs and PEs are fairly uncommon in on a change in their protocol for the prevention of VTE
the bariatric surgical patient. A survey of bariatric surgeons complications. Group A included 435 patients who were
in North America conducted in 1998 revealed that 86 % con- treated postoperatively with 40 mg enoxaparin subcutane-
sidered their patients to be at high risk for VTE complica- ously twice daily and sequential compression devices
tions [19]. A follow-up survey conducted in 2007, by one of (SCDs). Group B consisted of 1,257 patients who had SCDs
the same lead authors, found that 95 % of bariatric surgeons placed, but did not receive routine anticoagulation. This
are using some form of chemoprophylaxis to prevent VTE group of patients was required to ambulate within 2 h of
complications [20]. arrival to their inpatient bed. Several patients from each
In the modern era of bariatric surgery with a majority of group were excluded due to being considered high risk and
programs having VTE prophylaxis protocols in place, the receiving preoperative IVC filters. Other than Group A hav-
incidence of symptomatic DVT and PE ranges from 0 to ing a higher BMI, 51.6 ± 4 kg/m2 vs. 45.3 ± 3 kg/m2, other
5.4 % [21, 22] and 0 to 6.4 % [23, 24], respectively. Although demographics were similar. On average, Group B had
overall incidence is low, VTE events remain a leading cause 18 min shorter operative times. Findings of their study
of mortality after bariatric surgery [1, 25, 26]. A review of 10 revealed a DVT rate of 1.6 % in Group A and 0.4 % in Group
autopsies performed after bariatric surgery revealed PE was B with a PE rate of 1.1 and 0 %, respectively. Their intralu-
the direct cause of death in 30 % of patients; however, 80 % minal bleeding rate defined as melena or hematemesis was
were found to have PEs [27]. Additionally, studies have 4.8 % in Group A and 0.4 % in Group B. They reported two
shown that the risk of VTE complications continues to be non-VTE mortalities, both in Group A. Their conclusion
elevated for several weeks after surgery, long after the patient was that VTE prophylaxis can adequately be achieved with
has been discharged home from the hospital [28–30]. In his the routine use of SCDs, early ambulation, appropriate
2007 survey, Barba reported that 60 % of surgeons would hydration, and shorter operative times. They recommended
consider discharging higher-risk patients home with chemi- not using pharmacologic agents except in the highest-risk
cal prophylaxis. population—those with a personal or family history of
hypercoagulable state or prior VTE event.
Clements et al. reported a retrospective analysis of their
Prevention and Prophylaxis prospective database comprised of 957 consecutive patients
undergoing laparoscopic Roux-en-Y gastric bypass surgery
The ideal method of prophylaxis for VTE complications in who received no pharmacologic treatment for VTE preven-
bariatric surgery has yet to be elucidated. Patients undergo- tion [34]. They placed calf-length SCDs before surgery,
ing bariatric surgery are considered to be at moderate to high which the patients kept on during their hospitalization,
risk for having thrombotic complications. Published litera- unless they were ambulating. Additionally they educated
ture varies widely on optimal guidelines for the prevention of and encouraged all patients to ambulate the day of surgery.
perioperative VTE events. The major accepted forms of pro- Patients were excluded if they had a personal or strong fam-
phylaxis range from mechanical compression devices with ily history of VTE events, or known hypercoagulable state.
early ambulation alone to the addition of chemoprophylaxis The mean BMI of their patients was 49.1 with a 30-day
and finally to the use of inferior vena cava (IVC) filters. follow-up of 99.9 %. They reported DVT and PE rates of
0.31 % and 0.10 %, respectively, with one non-VTE-related
postoperative death. Bleeding complications occurred in
Mechanical Prophylaxis Alone 0.73 % of patients.
The conclusions drawn from their experience were that
Due to concerns for bleeding after bariatric surgery, there have pharmacologic anticoagulation is not mandatory in patients
been studies looking at the efficacy of preventing periopera- undergoing bariatric surgery who have no prior history of
tive venous thrombotic complications by mechanical means VTE events. Adequate prophylaxis can be obtained with the
alone. Significant postoperative bleeding may require blood use of SCDs, early ambulation, and short operative times.
transfusions, endoscopic treatment, re-operative treatment, Both of these studies excluded patients who were consid-
and significantly increased hospital stay and cost. The use of ered among the highest risk for VTE complications due to
pharmacologic anticoagulation agents has been associated either personal or family history of thrombotic complica-
with an increased risk of postoperative hemorrhage [31, 32]. tions. According to the authors of these two studies, these
Several retrospective studies have looked at rates of DVT, higher-risk patients were treated with chemoprophylactic
PE, and bleeding complications following bariatric surgery measures and/or IVC filters. Additionally, as with most stud-
with the routine use of mechanical prophylaxis alone. ies published on this topic, rates of VTE complications did
Frantzides et al. retrospectively reviewed their experi- not include potential asymptomatic patients. Imaging studies
ence of 1,692 patients undergoing bariatric surgery [33]. to evaluate for VTE events were only performed in patients
They divided their patient population into two groups based in whom there was a clinical suspicion.
40. Venous Thrombosis and Pulmonary Embolism in the Bariatric Surgery Patient 373
While there is a recognized risk of potential major bleed- and placed on UFH postoperatively until they were ambulat-
ing with the use of pharmacologic chemoprophylaxis in the ing. Another study looked at their 15 high-risk patients,
perioperative period, it is commonly believed that it is easier some of whom had an IVC filter placed and the other group
to manage bleeding than a major thrombotic event. Bleeding who were treated with continuous IV heparin intraopera-
will frequently stop with the cessation of anticoagulants. If tively [47]. Postoperatively all patients were treated with
continued bleeding occurs, there are several treatment weight-based enoxaparin for 15 days followed by warfarin
options available to include angiographic embolization, for ≥3 months. They reported no clinically evident DVT or
endoscopic treatment, and/or operative control of the hemor- PE. Two of the studies showed no significant difference in
rhage. Significant postoperative bleeding defined as either the incidence of PE between their two groups of patients,
requiring blood transfusions or an intervention occurs in IVC filter vs. no IVC filter [43, 50]. However, both of these
0.9–5.9 % of patients [28, 32]. Alternatively, patient mortal- studies compared high-risk patients who had an IVC filter
ity has been well described due to major bleeding after bar- placed with low-risk patients without IVC filters. It appears
iatric surgery and cannot be taken lightly [28, 38]. that by placing an IVC filter in the high-risk patients, the
risk of VTE became similar to the low-risk patient. In evalu-
ating the additional seven studies cited and performing a
Inferior Vena Cava Filters summation of their patients with outcomes, out of 227 high-
risk patients who received preoperative IVC filters, the DVT
With the introduction of retrievable IVC filters, there has and PE rates were 5.7 % and 1.3 %, respectively. This
been an increase use of these devices. In Barba’s 2007 survey excludes one patient who developed a PE after IVC filter
of ASMBS members, 55 % of bariatric surgeons reported removal. The indications for what was considered high risk
using IVC filters in their high-risk patients [20]. This was a and additional VTE prophylactic measures differed among
significant increase from their previously reported usage rate each of these studies. All 11 authors recommended the use
of 7 % in 1998 [19]. IVC filters act as a mechanical device to of IVC filters in the high-risk patient. Reported IVC filter
trap venous thromboemboli that originate in the lower complication rates ranged from 0 to 2.47 %. Despite the
extremities or pelvis, with the intent of preventing PEs. They unanimous agreement on the safety and benefit of IVC fil-
are typically placed through the femoral or internal jugular ters in the high-risk patient, Rajasekhar and colleagues con-
vein into the inferior vena cava. Multiple complications can cluded that there is insufficient evidence to support the use
occur with the placement of these devices including: bleed- of IVC filters at the time of surgery and recommended
ing, pneumothorax, filter migration, erosion through the against their routine use.
IVC, vena cava thrombosis, insertion site thrombosis, break- Several studies have shown an increased risk of periop-
through PEs, and increased long-term rate of DVT [39–41]. erative morbidity in bariatric patients who had a preopera-
Several case studies and single center case series have tive IVC filter placed, raising the concern for these devices
reported on the safety and efficacy of these devices in the causing more harm than good. Birkmeyer et al. performed
high-risk bariatric patient [42–45]. To date, there are no ran- a retrospective review of the Michigan Bariatric Surgery
domized controlled trials evaluating the efficacy of IVC fil- Collaborative database between 2006 and 2008 [53]. Out of
ters in bariatric surgery patients. What is deemed high risk is 6,376 patients undergoing gastric bypass surgery, 542
variable; however some common factors include: known patients (8.5 %) had a preoperative IVC filter placed. They
hypercoagulable state, prior VTE event, strong family his- used propensity scores in an attempt to control for selection
tory of VTE events, and immobility. Additional conditions bias related to IVC filter placement in higher-risk patients.
used to classify patients as high risk include: venous stasis In their review, patients receiving IVC filters were in fact
disease, obstructive sleep apnea, pulmonary hypertension, higher risk with significantly higher rates of multiple
use of oral contraceptives, and a BMI > 55–60 kg/m2. comorbidities to include: history of VTE, age > 50 years,
Rajasekhar and colleagues performed a systematic BMI > 50 kg/m2, male gender, mobility problems, lung dis-
review of the literature and reported results of an exhaustive ease, cardiovascular disease, diabetes, and sleep apnea.
search [46]. After filtering out low-quality publications, they Additionally these patients were more likely to undergo
identified 11 (level 2B) articles [24, 42–45, 47–52] that eval- open gastric bypass and have operative times >3 h. Without
uated the use of IVC filters for VTE prophylaxis in the bar- risk adjustment, the IVC filter group experienced signifi-
iatric patient (Table 1). Only four of these studies compared cantly higher complication rates including postoperative
an IVC filter group to a non-IVC filter group. One of these VTE events 2.03 % vs. 0.53 %, serious complications
compared two groups of high-risk bariatric patients and 7.56 % vs. 3.62 % (not specifically defined in the study),
found a significantly decreased incidence of PE and fatal PE and permanent disability/death 1.85 % vs. 0.51 %. After
between the cohort of patients who received an IVC filter applying risk-adjusted propensity scores, the statistical sig-
and the patients who did not have an IVC filter placed (PE nificance of these adverse outcomes was no longer present,
rate of 0 % vs. 28 % and fatal PE of 0 % vs. 11 %, respec- but there was a trend towards worse outcomes in the IVC
tively) [48]. All patients were given preoperative heparin filter group. There were two reported complications directly
40. Venous Thrombosis and Pulmonary Embolism in the Bariatric Surgery Patient 375
TABLE 1. Review of observational studies reporting venous thromboembolism with prophylactic inferior vena cava filter use after bariatric
surgery
References Definitions of high risk Bariatric patient groups Pharmacologic prophylaxis Outcomes
2
Frezza et al. [47] BMI 50 kg/m , prior DVT or PE, High risk + IVCF, Preop—LV 2 mg/kg SQ × 1 or No PE or DVT
prior pelvic surgery, cardiac n = 15 UFH 7,000 U SQ × 1
failure High risk + intraop POD#1—LV 1.5–2 mg/kg SQ
UFH, n = 9 BID × 15 days then
Coumadin ≥3 months
Gargiulo et al. [48] BMI > 55 kg/m2, prior DVT/PE, 1. High risk + IVCF Preop—UFH 50 U/kg SQ × 1 Decreased PE (28 % vs.
pulm HTN n = 17 0 %) and fatal PE (11 %
2. High risk, no IVCF, Postop—UFH 50 U/kg SQ vs. 0 %) favoring IVCF
n = 18 q12 h until ambulatory
Halmi et al. [49] Prior DVT/PE, hypercoag state, High risk, n = 27 Preop—UFH 5,000 U × 1 or LV No DVT or PE
severe OSA, pulm HTN, 40 mg SQ × 1
immobility, BMI > 65 kg/m2 Postop—UFH 5,000 U SQ
q 8 h or LV 40 mg SQ q12
h × 3 weeks
Kardys et al. [24] BMI > 50 kg/m2, venous insuff, High risk, n = 31 Preop—UFH 5,000 U SQ × 1 DVT 1/31, PE 2/31
hypercoag state, immobility, or POD#1—LV 40 mg SQ BID
prior VTE If BMI > 60 LV × 2 weeks
Keeling et al. [42] Prior PE/DVT, venous stasis High risk, n = 14 Periop—LV 40 mg SQ BID No PE
If BMI > 60—LV 30 mg SQ
BID
Obeid et al. [43] Immobility, prior DVT/PE, 1. High risk + IVCF Postop—LV dose not specified No difference in PE (0.81 %
venous disease, BMI > 60 kg/m2, n = 248 IVCF group—LV + Coumadin vs. 0.59 %), DVT
prior IVCF 2. Low risk, no IVCF 1 mg/d (1.21 % vs. 0.65 %), or
n = 1,851 death (0.81 % vs. 0.22 %)
Overby et al. [50] Thrombophilia, immobility, h/o 1. High risk + IVCF, Preop—UFH 5,000–75,000 U No difference in PE (3 %
venous stasis, pulm HTN, n = 160 SQ q8 h vs. 2 %) or DVT (0.6 %
severe OSA, BMI > 60 kg/m2, 2. Low risk, no IVCF, Postop—UFH 5,000–7,500 U vs. 3 %)
Prior DVT/PE n = 170 Q q8 h
Piano et al. [51] BMI > 55 kg/m2, hypercoagulable High risk n = 60 Preop—none PE 1/60 (received no
state, immobility, venous stasis, Intraop—IV UFH max pharmacologic
prior DVT/PE 750 U/h prophylaxis)
Postop—LV BID at discharge
(goal LMW level 0.3–0.5)
Schuster et al. [44] Prior DVT/PE, severe venous High risk, n = 24 Preop—SQ UFH DVT 5/24, PE 1/24 (after
stasis, sleep apnea, wt > 400 lbs IVCF retrieval)
Trigilio-Black et al. [45] Prior DVT/PE, venous stasis, High risk n = 41 Preop—LV 30 mg SQ × 1 DVT 1/41, no PE
pulmonary compromise, Postop—LV 30 mg SQ BID
immobility
Vaziri et al. [52] Prior VTE High risk n = 30 Preop—UFH 5,000 U SQ × 1 DVT 6/30, no PE
Postop—UFH 5,000 U SQ q8 h
Adapted with permission from: Rajasekhar A, Crowther M. Inferior vena cava filter insertion prior to bariatric surgery: a systematic review of the literature.
J Thromb Haemost. 2010;8(6):1266–70
PE pulmonary embolism, DVT deep vein thrombosis, VTE venous thromboembolism, OSA obstructive sleep apnea, BMI body mass index, UFH unfraction-
ated heparin, LV enoxaparin, NR not reported, HTN hypertension
related to the IVC filter to include a fatal IVC thrombosis Another concern with using IVC filters is the potential for
and an IVC filter migration to the heart. They concluded delayed mechanical and/or pharmacologic prophylaxis due
that prophylactic IVC filters in gastric bypass patients do to the perception of the patient being protected from a
not decrease the risk of PEs and may lead to additional PE. Caution must be taken to avoid this misconception as an
complications. IVC filter alone is not sufficient to safeguard against VTE
Despite the rare complications directly related to the IVC events including a significant and potentially fatal PE. The
filter, it is difficult to quantify the potential benefit in this American Society of Hematology consensus statements con-
high-risk group of patients who were perhaps protected from cluded that there is insufficient evidence to support the use of
major PEs and possible subsequent mortality. IVC filters at the time of bariatric surgery [54].
376 B.T. Grover and S.N. Kothari
IVC filter/pharmacologic 2006 Gonzalez et al. [65] Prospective, 660 Laparoscopic IVC filter; SQ heparin (dose NR); 1.4 0.9 NR 0.5
prophylaxis/mechanical uncontrolled Roux-en-Y enoxaparin 40 mg/d for BMI < 50 kg/m2
prophylaxis and 30 mg BID for BMI ≥ 50 kg/m2;
mechanical prophylaxis; extended
prophylaxis for high-risk factors
Intravenous heparin/ 2007 Cossu et al. [63] Pre–post 151 Biliopancreatic IV heparin 2,500–5,000 U, single dose; NR 3.1/1.2 0/0 4.6/0
mechanical prophylaxis comparison diversion or vertical mechanical prophylaxis/SQ heparin
study banded gastroplasty aPTT adjusted; mechanical prophylaxis
LMWH/mechanical 2007 Forestieri et al. [59] Prospective, 10 Biliointestinal bypass Parnaparin 3,200–6,400 IU/d; mechanical 0 10 0 NR
prophylaxis uncontrolled prophylaxis
IVC filter/pharmacologic 2007 Halmi et al. [49] Prospective, 652 Open Roux-en-Y IVC filter; SQ heparin 5,000 U TID or 0/1 0/0.3 NR NR
prophylaxis/mechanical controlled enoxaparin 40 mg BID; mechanical
prophylaxis prophylaxis; enoxaparin 40 mg/d for
3-week postoperative/SQ heparin 5,000
U tid or enoxaparin 40 mg BID;
mechanical prophylaxis; enoxaparin
40 mg/d for 3-week postoperative
LMWH/mechanical 2007 Kothari et al. [32] Retrospective, 476 Laparoscopic Enoxaparin 40 mg BID; mechanical 0/0 0/0 1.7/0 0/0
prophylaxis uncontrolled Roux-en-Y gastric prophylaxis/SQ heparin 5,000 U TID;
bypass mechanical prophylaxis
IVC filter/pharmacologic 2007 Obeid et al. [43] Retrospective, 2,009 Open or laparoscopic IVC filter; warfarin; enoxaparin (dose NR); 1.21/0.65 0.81/0.59 NR 0.81/0.22
prophylaxis/mechanical controlled Roux-en-Y mechanical prophylaxis/enoxaparin (dose
prophylaxis NR); mechanical prophylaxis
IVC filter/pharmacologic 2007 Piano et al. [51] Prospective, 59 Laparoscopic IVC filter; IV heparin continuous 500– NR 1.7 NR 0
prophylaxis/mechanical uncontrolled Roux-en-Y 750 U/h; mechanical prophylaxis; patients
prophylaxis discharged with enoxaparin (dose NR)
IVC filter/pharmacologic 2007 Schuster et al. [44] Prospective, 24 Laparoscopic gastric IVC filter; SQ heparin (dose NR); 21 (combined NR 0
prophylaxis/mechanical uncontrolled bypass mechanical prophylaxis DVT and
prophylaxis PE)
IVC filter/pharmacologic 2007 Trigilio-Black et al. Prospective, 41 Various IVC filter; enoxaparin 30 mg BID; 2.4 0 NR 2.4
prophylaxis/mechanical [45] uncontrolled mechanical prophylaxis
prophylaxis
LMWH 2008 Brasileiro et al. [57] Prospective, 126 Open or laparoscopic Nadroparin 9,500 IU/d/enoxaparin 40 mg/d 0/0.8 NR/0 6.7/3.2 NR/0.8
uncontrolled Roux-en-Y
IVC filter/pharmacologic 2008 Escalante-Tattersfield Retrospective, 618 Laparoscopic IVC filter; SQ heparin 5,000 U TID for first 0.16 0 1.6 0
prophylaxis/mechanical et al. [23] uncontrolled Roux-en-Y 24 h; enoxaparin 40 mg BID; mechanical
prophylaxis prophylaxis
IVC filter/pharmacologic 2008 Kardys et al. [24] Retrospective, 31 Unspecified IVC filter; SQ heparin (dose NR); 3.1 6.4 NR 6.5
prophylaxis/mechanical uncontrolled Roux-en-Y enoxaparin 40 mg BID; mechanical
prophylaxis prophylaxis; enoxaparin for 2 weeks
postoperative if BMI >60 kg/m2
Adapted with permission from: Agarwal R, Hecht TE, Lazo MC, Umscheid CA. Venous thromboembolism prophylaxis for patients undergoing bariatric surgery: a systematic review. Surg Obes Relat Dis.
2010;6:213–20
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41
Role of Flexible Endoscopy in the Practice
of Bariatric Surgery
Andrea Zelisko and Matthew Kroh
TABLE 1. Prevalence of pathologic findings during preoperative upper endoscopy in bariatric patients
Prevalence of pathologic
Source Year No. of patients Mean BMI (kg/m2) findings on endoscopy (%)
Madan et al. [10] 2004 102 48.2 91.0
Loewen et al. [8] 2008 448 48.6 29.2
de Moura Almeida et al. [9] 2008 162 44.1 77.2
Munoz et al. [12] 2009 626 42.0 46.0
Kuper et al. [6] 2010 69 47.6 79.7
Dietz et al. [11] 2012 126 51.2 57.9
BMI body mass index
41. Role of Flexible Endoscopy in the Practice of Bariatric Surgery 385
Flexible upper endoscopy traditionally examines the endoscopy to evaluate the staple line of all gastrojejunosto-
mucosa of the upper GI tract and allows biopsies for histo- mies during RYGB as well as to perform a leak test [22]. A
logic diagnosis. Supplemental techniques, such as the use of leak test is performed by clamping the Roux limb and sub-
a pH probe and manometry, can provide further objective merging the gastrojejunal anastomosis and pouch in saline,
measures to evaluate a patient and determine treatment. In while the lumen is inflated endoscopically. Leaks may be
addition, radiographic studies may enhance medical deci- evidenced as bubbles emanating from a staple line. If a leak
sions when used in combination with endoscopy. An upper GI is present, it can be directly repaired at that time. The utiliza-
series and a barium esophagram are two such examples. In a tion of intraoperative endoscopy identified a 3.7 % anasto-
retrospective series of patients presenting for weight regain motic leak rate in 290 patients in one study [23] and a 4.1 %
after previous bariatric surgery, Brethauer et al. demonstrated incidence of intraoperative technical errors in another,
that the use of both endoscopy and upper GI series allowed including 29 suture and staple line leaks, 2 bougie perfora-
for the detection of abnormalities in 90 % of patients [17]. tions, 2 inadvertent stoma closures secondary to the suture
line, and 1 mucosal perforation in a gastric pacemaker, dur-
ing 825 bariatric procedures [24]. Alaedeen and colleagues
Intraoperative Management performed a retrospective review of 400 bariatric cases that
and Techniques included intraoperative endoscopy or methylene blue to
identify leaks [25]. Postoperatively, all the patients under-
Applications of endoscopy during bariatric surgery vary went an upper GI series to evaluate for missed leaks, and the
depending on the operation and technique. It has been reported anastomotic leak rate was significantly lower after
described in the literature for many intraoperative applica- the use of endoscopy instead of methylene blue, at 0.4 % vs.
tions, including identification of anatomy and inspection of 4 %, respectively. Similar techniques can be applied to SG to
surgical technique, and is also widely practiced. assess the staple line construction with a leak test, to check
For RYGB, different techniques have been described for the for bleeding, and to identify any technical errors such as nar-
creation of the gastrojejunostomy, some utilizing endoscopy. rowing at the esophageal–hiatal junction or incisura or endo-
Wittgrove and Clark described the use of endoscopy to pass luminal twisting of the sleeve. A leak test in an SG is
the anvil of an end-to-end anastomosis (EEA) stapler into the performed by clamping proximally to the pylorus and sub-
gastric pouch during an RYGB [18]. Initial concerns for per- merging the stomach and staple line in saline while the
foration with transoral passage of the anvil led to modifica- lumen is inflated.
tions in this technique, including manipulating the anvil to Endoscopy also serves as a valuable technique when fac-
facilitate passage and also the development of a pre-tilted ing challenging surgical cases or when treating complicated
anvil [19]. Endoscopy also has a role in SG, and although patients. Intraoperative endoscopy can be used to control
sizing of the gastric tube is often done by means of a bougie, bleeding and to deliver instruments. It can also be used for
Diamantis and colleagues reported their experience of using direct, percutaneous placement of feeding or decompression
an endoscope to perform a laparoscopic SG safely and effec- tubes into the Roux limb if needed.
tively [20]. Intraoperative endoscopy during revisional surgery is
Anastomotic integrity is vital for a successful outcome often helpful as an adjunct to external, surgical views. Even
and is often evaluated endoscopically at the time of opera- after extensive preoperative evaluation, intraoperative endos-
tion. Failure to identify anastomotic leaks imposes signifi- copy is important to verify the distorted anatomy as well to
cant morbidity [21]. Methylene blue dye injected near the determine the placement of new anastomoses. Similarly to
gastrojejunal anastomosis via a nasogastric tube can identify an initial bariatric operation, endoscopy can be used to assess
leaks intraoperatively, and it has been used successfully in the integrity of anastomoses and to inspect for bleeding [26].
clinical practice. Unfortunately, positive leak tests stain the In reoperative bariatric surgery, a leak test may be performed
operative field, prohibit repeat exams, and may not precisely on the newly revised or created pouch prior to anastomosis
identify the area of leakage. Intraoperative endoscopy may creation, evaluating the staple line integrity before commit-
circumvent these pitfalls. Endoscopy allows for visualization ting to an anastomosis, thus allowing for immediate revision
of the GI tract, for direct placement of the endoscope near if needed. Intraoperative endoscopy during revisional bariat-
the anastomosis or staple line, and for multiple leak tests ric surgery can also decrease operating times by helping to
since it does not utilize methylene blue dye. It also provides locate and identify gastrogastric fistulas, stenotic lesions,
additional information about the pouch size and mucosal and gastrojejunal stoma locations [27].
perfusion and allows for treatment of bleeding that may Intraoperative endoscopy can also advance the training of
occur at staple lines. Intraoperative endoscopy can be used to future gastrointestinal and bariatric surgeons. It allows for
evaluate both the gastrojejunostomy as well as the jejunoje- the development and mastery of endoscopic skills under a
junostomy. Schauer and colleagues described the use of structured and supervised setting [28, 29].
386 A. Zelisko and M. Kroh
FIG. 1. Endoscopic appearance of (a) normal gastrojejunostomy and gastric pouch after gastric bypass, (b) normal compression from band
seen on retroflexed view after adjustable gastric banding, and (c) normal staple line after sleeve gastrectomy.
however, the rate of major adverse postoperative complica- however, some are more procedure specific (e.g., erosion after
tions has been demonstrated between 4 and 6 % [35, 37]. Early adjustable gastric banding). Several of these complications
complications such as bleeding, infection, and anastomotic can be managed successfully endoscopically.
leaks often require surgical intervention [37–39]. Furthermore,
if a leak is suspected shortly after surgery, a contrast radiologic
study can serve as the initial diagnostic test and is helpful to Endoscopic Management
delineate anatomy. Complications can also develop later in the of Postoperative Complications
postoperative period. Late complications, such as ulcers, ste-
nosis, gastrogastric fistulas, obstruction, band slippage or ero- Marginal Ulcers—Defined as ulcers that occur at the gastro-
sion, pouch dilation, and primary weight loss failure or weight jejunal anastomosis, they can occur in 1–16 % of patients fol-
regain, can occur with varying rates after any operation; lowing RYGB [40–43]. Marginal ulcers typically present with
388 A. Zelisko and M. Kroh
FIG. 2. (a) Endoscopic view of large marginal ulcer and (b) retroflexed view of marginal ulcer.
epigastric or abdominal pain, bleeding, or nausea, although pump inhibitor therapy, and liquid sucralfate and the elimina-
they may be asymptomatic [32]. Ulceration can occur at any tion of ulcerogenic medication [38]. If marginal ulcers are
time postoperatively, but most ulcers occur in the first several severe and persist despite these measures, surgical revision
months following surgery [44]. In a study conducted on all may be required to prevent complications such as perforation,
patients who underwent bariatric surgery, postoperative endo- recurrent bleeding, and anastomotic strictures.
scopic examination 1 month after surgery demonstrated ulcers
in 4.1 % of patients after open RYGB and in 12.3 % of patients Stenosis—Luminal stenosis or stricture is an important com-
after laparoscopic RYGB. 28 % of the demonstrated ulcers plication of bariatric surgery. After RYGB, postoperative stric-
occurred in the absence of symptoms [45]. Marginal ulcers are ture formation is around 3 % [28]. The gastrojejunal
frequently located on the jejunal side of the anastomosis, so anastomosis is the most common site of stenosis after bariatric
careful attention should be paid to this area during endoscopy surgery and has been reported in 5.1–6.8 % of patients after
(Fig. 2). When possible, a retroflexed view can identify a laparoscopic RYGB, typically within the first year [30]. Other
potentially missed location of an ulcer. Even though the exact locations where stenosis can develop include the gastric band,
etiology is unknown, ulcers may result from gastric acidity site of passage through the mesocolon, jejunojejunal anasto-
(due to staple line dehiscence or gastrogastric fistula), pouch mosis, and at adhesions. Anastomotic strictures are defined as
orientation and size (that may incorporate a greater parietal anastomoses that are smaller than 10 mm in diameter [1].
cell mass), H. pylori infection, the presence of staples and Stenosis may arise from ischemia or ulceration, but the rates
suture material (inciting a localized inflammatory reaction), of stenosis are also somewhat technique dependent; the use of
and local ischemia and tension at the anastomosis [41, 44, 46]. circular staplers has a higher rate of stricture than hand-sewn
Smoking and nonsteroidal anti-inflammatory drug use increase or linear staplers. Also, the use of 25 mm circular stapler
the risk of marginal ulcers, and the use of proton pump inhibi- reduced the rates of stricture when compared to the use of a
tors appears to decrease risk [1]. 21 mm circular stapler [47]. Patients may present postopera-
The role of endoscopy for marginal ulcers is primarily tively with nausea, emesis, dysphagia, malnourishment, or
diagnostic with limited therapeutic use. When identified dur- unhealthy weight loss. Stenosis can be diagnosed by contrast
ing endoscopy, the pouch must be carefully examined for a radiography, but direct endoscopic visualization is preferable
fistula. Staple line dehiscence and the formation of a gastro- because it has high sensitivity and therapeutic measures can
gastric fistula can result in an increase in acid exposure in the be performed (Fig. 3) [48]. Typical findings on endoscopy
pouch, stoma, and jejunum and make the mucosa more vul- include a narrowed orifice precluding the passage of the endo-
nerable to damage [26]. One study reported that stomal ulcers scope; however, other potential findings include gastric pouch
were associated with gastrogastric fistula in as many as 65 % dilatation, undigested food, or foreign material [49].
of cases [46]. Ulcers may also represent foreign body reac- Endoscopic treatment of strictures can be safely and effec-
tions to sutures or staples, and judicious removal of foreign tively performed by using through-the-scope (TTS) balloon
material with endoscopic tools may cause ulcer resolution dilators or wire-guided bougie dilators [30, 50, 51]. Although
[30]. If marginal ulcerations are not associated with staple initial success rates of up to 93 % have been reported, man-
line dehiscence or foreign body reaction, the management agement may require multiple dilations. The length of time
includes evaluation of the pouch for H. pylori status, proton from surgery to stricture formation and the diameter achieved
41. Role of Flexible Endoscopy in the Practice of Bariatric Surgery 389
FIG. 3. (a) Radiographic evidence of a stricture and (b) endoscopic appearance of stenosis after gastric bypass.
with the first dilation procedure are significant predictors of Stenosis can occur after SG with an incidence that ranges
the need for further dilations [52]. Repeat dilation with pro- from 0.2 to 4 % [59]. Strictures have a higher occurrence
gressively larger balloons may also be required to achieve with the use of a smaller bougie size and a tighter sleeve.
more durable results, and gradual dilations over multiple ses- They are generally seen in the proximal to mid stomach, at
sions may reduce the risk of perforation [53, 54]. Even still, the incisura, or at the esophagogastric junction. The incisura
some stenoses cannot be sufficiently dilated, and these is a common spot of narrowing resulting from stapling too
patients will require surgical revision. Overaggressive dila- close to the lesser curvature. Management options of stric-
tion should be avoided, not only to reduce perforation risk, tures and stenosis after SG include: observation, endoscopic
but also because dumping symptoms and weight regain can dilation with or without stent placement, seromyotomy, and
occur [49]. There have been reports of successful dilation up conversion to RYGB. If endoscopic dilation has failed for 6
to 20 mm [55] without weight regain, but data is controversial weeks, reoperation is typically recommended [60]. After SG,
on dilation greater than 15 mm, and many authors recom- torsion or rotation of the remnant sleeve may present simi-
mend against it [49]. When standard dilation is unsuccessful, larly to a stenosis with obstructive symptomatology and can
additional strategies can be utilized such as the removal of be managed with dilation, myotomy, or revisional surgery.
exposed sutures with endoscopic scissors, injection at the Gastrointestinal Bleeding—Bleeding in patients after
anastomosis with saline or steroids after dilation, needle- bariatric surgery may be acute or chronic or present as an
knife electrocautery of scar tissue, or even argon plasma iron deficiency anemia [61]. Bleeding can occur anywhere in
coagulation combined with diathermy [26, 30, 56]. the GI tract, including in the biliopancreatic limb and rem-
Stenosis following AGB may be due to fibrosis of gastric nant stomach after an RYGB. Significant upper GI bleeding
tissue in the region of the band, formation of adhesions, or occurs in about 1–4 % of patients after RYGB [62], about
band angulation or slippage. Endoscopic dilation may be 0.1 % after AGB [63, 64], and between 1 and 2 % after a
effective when the cause is fibrosis or adhesions but is rarely sleeve gastrectomy [65, 66]. Patients with signs or symptoms
useful in the setting of band angulation or rotation [26]. Such of acute or chronic bleeding should be evaluated with endos-
patients should not have repeated dilations but instead treated copy, preferably in close consultation with a surgeon, should
surgically with either band removal, removal and replace- complications arise or endoscopic interventions fail [62, 67].
ment, or conversion to another procedure. After a VBG, ste- The benefit of endoscopy is the ability to provide diagnosis
nosis is usually the result of stricturing and scarring of the and treatment simultaneously. However, endoscopy in the
outflow tract in the proximal stomach and thus the creation early postoperative period may be challenging, especially
of a hypertrophic scar or frank erosion. The incidence of after RYGB and BPD because of the inaccessibility of the
stricture has been reported at 13 % [57]. Endoscopic balloon biliopancreatic limb, remnant stomach, and the jejunojeju-
dilation is not durable in the long term but may transiently nostomy and the potential risks associated with early postop-
alleviate symptoms [58]. Operative revision is typically erative endoscopy such as perforation at the surgical
required due to the fixed nature of the mesh band or for ero- anastomoses [68]. If more advanced endoscopic techniques,
sion into the lumen. such as double-balloon enteroscopy, are unsuccessful at
390 A. Zelisko and M. Kroh
FIG. 4. (a) Illustration of common leak locations after Roux-en-Y gastric bypass (RYGB). (b) Upper gastrointestinal study showing leak
at gastrojejunal anastomosis after RYGB (white arrow pointing at leak). Reprinted with permission, Cleveland Clinic Center for Medical
Art & Photography © 2010–2013. All Rights Reserved.
accessing the bypassed anatomy, access may be gained to report anastomotic leak rates of less than 2 % [24, 74, 75].
through a surgically created gastrostomy [69]. Endoscopy Identification of a leak in the immediate postoperative period
after an SG, VBG, and AGB is relatively straightforward, suggests that either an intraoperative leak test with endos-
and standard flexible upper endoscopy is usually sufficient copy missed the defect or that the leak developed after the
for the management of endoluminal bleeding in this completion of the operation. Staple line disruption can result
situation. in extraluminal leaks or eventually gastrogastric fistulas
Numerous approaches for treating active upper GI bleeds (most common type). Extraluminal leaks tend to present
have been described in the literature. Techniques that involve early in the postoperative period and can result in peritonitis,
the use of thermal energy (electrocoagulation, heater probe, abscess, sepsis, organ failure, and even death [30, 76]. After
and argon plasma coagulation), mechanical application of RYGB, most leaks occur at the gastrojejunal anastomosis
clips, and local injections with epinephrine, sclerosants, and followed by the remnant stomach; leaks at the jejunojejunal
thrombin/fibrin glue have all been successfully reported anastomosis are rare but do occur and usually need reopera-
[70]. A retrospective review of 933 patients after RYGB tion (Fig. 4a). After SG, leaks are typically found in the prox-
reported a 3.2 % incidence of postoperative hemorrhage and imal third of the stomach and specifically at the areas of the
an 80 % rate of successful endoscopic intervention [71]. esophagogastric junction [73]. Upper GI studies are typically
Bleeding after an SG tends to occur at the staple line and is used to diagnose extraluminal leaks (Fig. 4b). CT scans are
usually self-limited. Rarely, the use of endoscopy to suction another common imaging modality used to examine the
out or push out a blood clot may be necessary [66]. anatomy of the anastomoses and staple lines. Typically, leaks
Leaks and Fistulas—Gastric leaks and fistulas are poten- with clinical signs of sepsis require operative repair, drain-
tially serious complications of bariatric surgery and cause age of infection, and establishment of enteral access.
significant morbidity. Overall, the occurrence of leaks is Endoscopy has an adjunct role in the operating room, for
between 0.4 and 6 % in gastric bypass patients [24, 50, 72] example, to define the precise location of the leak and,
and is 2.4 % in SG patients [73]. High-volume centers tend increasingly, to be used as a therapeutic measure. There have
41. Role of Flexible Endoscopy in the Practice of Bariatric Surgery 391
FIG. 5. (a) Sleeve gastrectomy with stent and radiographic appearance of stent after placement. (b) Roux-en-Y gastric bypass with stent
and radiographic appearance of stent. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography © 2010–2013.
All Rights Reserved.
been small series that have described endoscopic manage- polyester stent), demonstrated that endoscopic stent place-
ment of leaks using partially covered self-expanding metal ment successfully resolved anastomotic leaks in 85 % of
stents, Polyflex stents, argon plasma coagulation, endoscopic patients (Fig. 5) [79]. Such novel methods are still currently
clips, and fibrin glue [77, 78]. Merrifield and colleagues investigational, and further research is needed to define the
reported successfully treating three patients with leaks endo- role of endoscopy to treat postoperative anastomotic leaks.
scopically and concluded that endoscopy may be a feasible, Chronic fistulas may be found in the presence of marginal
less invasive alternative to surgical repair [77]. A study at the ulcers or as a result of staple line disruption. Staple line
Cleveland Clinic, which used three different types of stents dehiscence after SG has been reported at rates ranging from
for the management of anastomotic complications after bar- 0.3 to 5 % [80]. Patients with a chronic fistula may present
iatric surgery (a prototype salivary stent, a partially or fully with nausea, emesis, epigastric pain, and weight gain.
covered self-expanding metal stent, and a silicone-coated However, many fistulas may remain subclinical, and the true
392 A. Zelisko and M. Kroh
Band Erosion and Slippage—Band erosion into the gastric Weight Regain or Inadequate Weight Loss—Initial weight
lumen can occur after AGB and VBG. Band slippage is loss failures after bariatric surgery or weight regain after an
another complication that can occur after AGB. The incidence initial postoperative weight loss may be the result of a tech-
of band erosion after VBG and AGB is uncommon and has nical failure. These may include gastrogastric fistula from a
been reported at 1–3 % after VBG and 0.9–3.8 % after AGB staple line dehiscence, a large patulous gastrojejunal anasto-
[88–90]. Band erosion can be asymptomatic or can cause mosis that fails to restrict food intake, dilatation of the gas-
abdominal pain, nausea, emesis, access port site infection, fis- tric pouch, or band slippage. However, often the cause is
tula, increased food intake, and GI bleeding. Band slippage related to dietary noncompliance, and thus, preoperative
may present with weight gain, worsening reflux symptoms, or counseling is needed to establish realistic weight loss goals.
obstruction. Erosion is best diagnosed endoscopically. Endoscopy remains the best way to assess postoperative
Endoscopy can allow for direct visualization of a band erod- anatomy [30], and it can also provide a method for manage-
ing through gastric mucosa (Fig. 7), and endoscopic removal ment. Endoscopic therapies for weight regain are evolving.
techniques for near completely eroded bands have been Large gastrojejunal anastomoses can be treated with four-
described [89, 91]. However, surgical repair is usually recom- quadrant endoscopic injection of sodium morrhuate into the
mended with excision and replacement or conversion. While stoma to cause scarring and reduction in stomal size [109].
band slippage can be demonstrated with endoscopy, it may be Novel techniques utilizing endoscopic suturing devices can
best diagnosed with contrast radiography, since findings on allow for nonoperative revision of the gastrojejunal anasto-
41. Role of Flexible Endoscopy in the Practice of Bariatric Surgery 393
FIG. 7. (a) Illustration and (b) endoscopic views of band erosion. Reprinted with permission, Cleveland Clinic Center for Medical Art &
Photography © 2010–2013. All Rights Reserved.
mosis and reduction of pouch size after RYGB. The long- other hand, exclusion of the ampulla after RYGB makes
term durability of these endoscopic techniques remains to be access technically more difficult. Successful biliary cannula-
demonstrated [110]. tion after RYGB depends on factors including the skill of the
endoscopist and the lengths of the biliopancreatic and/or
Bezoars—Food bezoars can occur in patients after bariatric Roux limbs. Using varying techniques, both side-viewing and
surgery and are most common after AGB [111, 112]. They forward-viewing endoscopes have been used successfully.
form within the first postoperative month, and patients typi- Wright et al. reported on a series of 15 patients in which the
cally present with nausea, emesis, and dysphagia. Bezoars papilla was reached and successfully cannulated in 66 %; this
can be diagnosed and effectively treated with upper endos- was accomplished through the use of various techniques
copy by fragmentation and removal [113]. If an anastomotic including advancing a duodenoscope over a stiff guide wire
stricture or stenosis is discovered with the bezoar, then it that was previously placed with a forward-viewing scope and
should be treated with endoscopic dilation. pulling up a duodenoscope with a wire-guided biliary balloon
anchored at the pylorus. Therapeutic maneuvers including
sphincterotomy, sphincter of Oddi manometry, stone extrac-
Special Considerations—Endoscopic tion, and stent placement were also successfully accom-
plished in this study [116]. Other techniques that may be used
Retrograde Cholangiopancreatography to cannulate the biliary system include single- and double-
(ERCP) and Transgastric Endoscopy balloon-assisted enteroscopy. These enteroscopes more effec-
tively pleat the small bowel and improve the advancement of
Pancreaticobiliary disease and specifically gallstone disease the scope through the small intestine. Medical centers with
are common after bariatric surgery. Studies showed postop- experience in balloon-assisted enteroscopy report an 80 %
erative rates of gallstone detection from 22 to 71 % and cho- success rate [117]. The double-balloon enteroscope may also
lecystectomy rates from 7 to 41 % in patients who had a prior be used to place a retrograde percutaneous endoscopic gas-
gastric bypass [114, 115]. The occurrence of choledocholi- trostomy (PEG) tube in the remnant stomach and then per-
thiasis has not been determined for this patient group. ERCP form an ERCP through the PEG tube [118, 119]. Similar to
after AGB, VBG, and SG is relatively straightforward. On the the factors associated with successful biliary cannulation
394 A. Zelisko and M. Kroh
mentioned above, the success of reaching the gastric remnant tissue within a metal cap and thereby places a stitch. Stoma
is largely dependent on the length of the Roux limb. Schreiner reduction using the EndoCinch was investigated using a ran-
and associates reviewed the records of post-RYGB bariatric domized sham control trial; using an average of four sutures
patients who underwent an ERCP and reported that patients per patient, the results of this study demonstrated a 4.7 %
with a Roux limb less than 150 cm have a significantly higher weight loss compared to 1.9 % in the sham group [128]. The
rate of therapeutic success. For patients with a Roux limb invention of Incisionless Operating Platform (IOP) allowed
greater than 150 cm, a laparoscopically assisted ERCP was a the ability to perform serosal tissue plications under direct
better initial option [120]. visualization to adjust dilated pouches and gastric outlets.
Although the previously mentioned techniques to access Plications were made using specialized jaws and nitinol tis-
the biliary system and gastric remnant after bariatric surgery sue anchors that were deployed through a curved hollow
have been shown to be effective, they may not be widely needle. Only initial feasibility studies have been performed
replicated due to lack of equipment or expertise. Further, for this device [129, 130].
methods such as balloon and overtube endoscopy require the There is significant interest in the development of suc-
use of front-viewing endoscopes instead of the side-viewing cessful and effective endoscopic techniques and alternatives
endoscopes typically used for ERCP. Transgastric endos- to surgery for primary weight loss. No such method has been
copy can access the gastric remnant or duodenum through a perfected, but three different approaches stand out in the lit-
laparoscopic approach or by placement of a percutaneous erature—endoscopic gastroplasty, intragastric balloons, and
gastrostomy tube with radiologic guidance [121–123]. These endoluminal sleeves. Endoscopic gastroplasty has been per-
techniques have been associated with high success rates and formed using stapling and suturing devices. Suturing devices
low postoperative morbidity [124]. Laparoscopic-assisted achieve volume reduction by anterior and posterior gastric
transgastric ERCP has been demonstrated to be an effective wall approximation. Devices that have been used and
technique in the treatment of biliary pathology including described in the literature include the EndoCinch, the Endo
stone disease, sphincter of Oddi dysfunction, ampullary ste- Stitch, and the OverStitch. Alternatively, with the TOGA
nosis, and the diagnosis of and treatment of both benign and system (Satiety Inc.), staples are used to form a gastric sleeve
malignant strictures [125, 126]. An additional benefit of the similar to an unsupported VBG [131]. Well-designed studies
laparoscopic transgastric approach is the ability to perform with long-term follow-up will be needed to determine the
an abdominal exploration to evaluate for any other causes of outcomes of these techniques. Since the 1980s, intragastric
abdominal pain, such as an internal hernia. The use of lapa- balloons have been used as space-occupying devices for
roscopic transgastric endoscopy through the gastric remnant weight loss. They may have value in select high-risk patient
is safe, reliable, and associated with a high success rate and groups as a bridge to surgery in those individuals who may
low complication rate. have otherwise been nonoperative candidates [132]. There
are two available models of the intragastric balloon, the
BioEnterics balloon and the Heliosphere BAG, both of which
Future Considerations were used in a prospective randomized study that resulted in
27–30 % excess weight loss at 6 months [133]. Long-term
Flexible upper endoscopy in bariatric patients currently also studies are lacking, and complications including esophagitis,
includes revisional procedures as well as primary weight loss nausea, emesis, abdominal pain, rupture, and obstruction
therapies, in both experimental models and in patients. Such have been associated with placement of these devices.
endoscopic interventions require advanced skill sets with Placement of these devices is relatively uncomplicated, but
novel equipment and methods. knowledge of proper removal is important to minimize the
Obesity is a multifactorial disease and the changes that occur risk to the patient [131]. Currently, these devices remain
after bariatric surgery are numerous. Specifically, mechani- unapproved by the Food and Drug Administration for use in
cal changes in the postbariatric anatomy, such as dilation of the United States [134]. Similar to the surgical interventions
an anastomosis or pouch, are thought to contribute to weight that alter anatomy and exclude the proximal small bowel,
regain. Several endoscopic revisional procedures have pre- endoscopic insertion of a barrier in the small bowel may rep-
sented potential solutions. Sclerotherapy is a procedure that licate this intestinal bypass. Two unique, novel devices are
uses a traditional endoscope with an injection needle to inject currently under study: the ValenTx endoluminal bypass and
sodium morrhuate around the gastric outlet. About 2 cm3 per the EndoBarrier (GI Dynamics) (Fig. 8). The ValenTx endo-
injection (a total of 20 cm3 per procedure) and about 2–3 ses- luminal bypass is anchored at the esophagogastric junction
sions are needed to achieve a desired outlet size. Initial stud- with a specialized device, and the sleeve extends 120 cm
ies reported a 75 % weight loss in patients over 6 months through the stomach and into the mid-jejunum. The imper-
compared to 50 % in matched controls [127]. The EndoCinch meable sleeve allows nutrients to bypass the proximal bowel
is another endoscopic technique that was originally devel- and entice metabolic effects through stimulation of the distal
oped for fistula repair and gastric pouch reduction. This small bowel [131]. The EndoBarrier is similar in concept to
device guides a needle through a piece of vacuum-acquired the ValenTx endoluminal bypass, but it is a duodenojejunal
41. Role of Flexible Endoscopy in the Practice of Bariatric Surgery 395
FIG. 8. (a) ValenTx endoluminal bypass (courtesy of ValenTx, with permission). (b) GI Dynamics EndoBarrier (courtesy of GI Dynamics,
with permission).
bypass sleeve that anchors in the duodenal bulb by a self- endoscopy is well documented in the medical literature. In
expanding cuff and extends a polyethylene sleeve 60 cm into addition, the use of flexible upper endoscopy has been vali-
the small bowel. It does not need additional equipment for dated throughout medical literature for the evaluation of
anchoring at the proximal end and is easily removable with a postoperative patients and has both diagnostic and therapeu-
removal loop. A short-term study by Schouten et al. evaluated tic potential. Such widespread advantages of flexible endos-
26 patients after the placement of the EndoBarrier and dem- copy should encourage bariatric surgeons to develop and
onstrated a 19 % excess weight loss in 3 months along with a refine their endoscopic skills and proficiencies (Video 1).
reduction in hemoglobin A1C and glucose control medica-
tions [135]. However, complications of migration, stent
obstruction, and upper GI bleeding have been reported with References
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42
Bariatric Surgery in Adolescents
Sean J. Barnett, Marc P. Michalsky, and Thomas H. Inge
Paralleling the epidemic of adult obesity are the increasing make accurate predictions about adiposity. Instead, for the
trends in prevalence and incidence of childhood obesity. vast majority of children and adolescents, growth charts are
Recent data from the National Health and Nutrition used to assign cutoffs for obesity that are actually age, race,
Examination Survey (NHANES) reports that approximately and sex specific [8]. In this context, some authors have
69 % of adults in the United States are overweight and 36 % defined pediatric obesity as BMI greater than the 95th per-
obese [1], while 17 % of children and adolescents are over- centile for age and sex. Overweight, or at risk for over-
weight or obese [2]. Furthermore, approximately 4 % (over weight, has been defined as a BMI > 85th percentile [9–11].
two million children and adolescents) may be considered It is important to first recognize that these percentile defini-
extremely obese (body mass index (BMI) > 99th percentile) tions of obesity and overweight become unreliable at the
[3]. The immediate and long-term health consequences of extreme categories of obesity. In essence, for the very severe
childhood obesity as well as the psychosocial and economic categories of obesity, which might prompt consideration for
effects continue to provide compelling arguments to perform bariatric surgery in adolescence, there are currently no
bariatric surgery on adolescents to achieve aggressive weight strong, reliable population-based data by which one can cal-
loss. Clinical trials show that behavioral weight management culate percentile boundaries. This is due to children and
may have long-lasting effects in younger children compared adolescents with BMI values in the >40 kg/m2 range being
with adults, but durable weight loss is rare. Furthermore, very poorly represented in the National Health and Nutrition
such conventional treatment approaches are not effective for Examination Survey (NHANES)—the dataset that provides
those who suffer from severe obesity [4–7], leading to the the weight and height information used to create the com-
consideration of weight loss surgical options for select ado- monly used pediatric growth charts. Alternatively, most
lescents. In order to provide a framework for considering have used BMI ≥ 40 kg/m2 as a conservative threshold for
and/ or performing adolescent bariatric surgery, this section defining morbid obesity in youth, which is congruent with
discusses the basic concepts of severe pediatric obesity, the World Health Organization definition for adults.
including definitions, risk factors, and consequences of obe- Adopting a BMI threshold as a general guideline for con-
sity unique to the adolescent population. In addition, we sidering adolescent bariatric surgery is done with the under-
review the available evidence for the efficacy of bariatric standing that an obese adolescent with an advanced, severe,
procedures in the adolescent population and provide sug- and incontrovertibly weight-related comorbidity also should
gested guidelines and pathways for the application of bariat- be considered for weight loss surgery without strictest regard
ric surgery among adolescents. to level of BMI.
adolescence [13, 14]. In neonates, lower birth weight has been cerebri, and psychosocial impairment [39–42]. These diseases
linked to higher BMI in childhood and adulthood [15–19]. have an onset at a younger age and carry an increased risk for
Childhood obesity risks are also higher for offspring of moth- adult morbidity and mortality [43–45]. This serves to heighten
ers with diabetes mellitus [20, 21]. Through a recent critical awareness about the significance of medical consequences of
review of the literature, it seems that the most critical early obesity among adolescents.
markers for obesity during the neonatal period are related
most to maternal BMI, smoking, and weight gain during preg-
nancy [22]. Extended duration of breast-feeding in the postna- Cardiovascular Disease
tal period reduces the risk of adolescent overweight [23–27].
In fact, early bottle-feeding accelerates the age of obesity There is a relative paucity of data focusing on the cardiac
rebound, which predicts obesity in later life [23]. It should also health of severely obese adolescents, likely due to the gen-
be noted that those infants who grow more rapidly during the eral belief that associated sequelae (i.e., atherosclerosis,
first 3 months to 2 years of life are more likely to be obese as peripheral vascular disease, etc.) become more clinically rel-
adults [28]. evant later in life. However, a mounting body of evidence has
Due in part to the rapid hormonal changes, puberty is also demonstrated that the pathogenesis of various cardiovascular
considered to be a critical period for the development of both disease states can find their development and subsequent
insulin resistance [29] and obesity [30]. Interestingly, earlier progression in early childhood and adolescence. Recent evi-
menarche is seen in obese children, suggesting that the obese dence demonstrates the presence of these cardiovascular risk
experience an earlier onset of physiologic maturation com- factors, namely, hypertension, hypertriglyceridemia, ele-
pared with children of normal weight [31]. vated fasting serum glucose, and cholesterol abnormalities,
Obesity in family members is an additional and important as well as cardiac structural and functional abnormalities in
risk factor for adolescent obesity. As an example, recent evi- the obese adolescent population [41, 42, 46, 47]. Almost
dence demonstrates that the risk for persistence of childhood 60 % of obese children in the Bogalusa Heart Study had one
obesity into adulthood is elevated threefold and tenfold if risk factor for cardiovascular disease, with 20 % having two
one or both parents are obese, respectively [32–35]. The risk or more risk factors [48]. Of note, following gastric bypass
of obesity persisting into adulthood is far higher among and significant weight loss in obese adolescents, recent data
obese adolescents than among overweight younger children demonstrates significant improvement in left ventricular
[36]. Finally, there is a preexisting racial-ethnic disparity in hypertrophy and overall cardiac function [41]. Gastric bypass
the risk of obesity, with lower socioeconomic groups being in adolescents has also been shown to significantly improve
especially vulnerable because of poor diet and limited oppor- the major cardiovascular risk, hypertension, and hyperlipid-
tunity for physical activity [37, 38]. emia in those patients at 1-year follow-up [46, 49]. Large,
In summary, important risk factors for childhood and ado- prospective trials are currently ongoing to better investigate
lescent obesity include (1) low birth weight; (2) bottle- the cardiac health of this patient population.
feeding; (3) maternal factors including weight, smoking
habits, and diabetes; (4) rapid growth at a young age; and (5)
parental obesity. Knowledge of these important risk factors Glucose Impairment
for adolescent obesity and its persistence into adulthood
gives some insight into the phenotypes of those individuals Given the current increases in childhood diabetes and obesity
who may be least likely to succeed with nonsurgical man- prevalence, epidemiologists at the Centers for Disease Control
agement of obesity and, by inference, those who may benefit and Prevention (CDC) have made a sobering prediction: type
most from early application of surgical therapy. 2 diabetes is expected to develop in 33–50 % of all Americans
born in the year 2000 [50]. There have also been recent reports
linking the development of abnormalities related to normal
Consequences of Obesity glucose regulation, including hyperinsulinemia (60–80 %),
impaired glucose tolerance (12–15 %), and type 2 diabetes
in Adolescence mellitus (1–6 %) to childhood obesity [40]. The prevailing
thought is that the generalized state of low-grade chronic
In association with the remarkable increase in the prevalence inflammation could be a significant factor leading to insulin
of pediatric obesity is a parallel increase in the severity of resistance and subsequent dysregulation (i.e., metabolic syn-
obesity and in obesity-related chronic diseases. Important drome). Of note, there is not only a relationship between
complications of obesity commonly encountered in adoles- severely obese adolescent patients and insulin resistance (ele-
cents include increased risk of cardiovascular disease (espe- vated hemoglobin A1c and C-reactive protein (CRP) levels),
cially hypertension and left ventricular hypertrophy), but there is significant improvement seen in most markers of
nonalcoholic fatty liver disease (NAFLD), type 2 diabetes metabolic dysfunction within the first year following gastric
mellitus and insulin resistance, sleep apnea, pseudotumor bypass and significant weight loss [46, 49].
42. Bariatric Surgery in Adolescents 403
Obstructive Sleep Apnea identify themselves as overweight [60]. Data does suggest
that following significant weight loss after gastric bypass,
Sleep deprivation and excessive daytime sleepiness are more adolescents experience significant improvement in psycho-
common in obese children, and poor school performance has social and health-related quality of life scores [61].
been associated with disordered sleep patterns in these children
[51, 52]. Alarmingly, recently studies have documented obstruc-
tive sleep apnea (OSA) rates as high as 46 % in obese children Best Practice Guidelines for Adolescent
[53]. Of particular concern is the fact that children with chronic Bariatric Surgery
OSA also exhibit the development and progression of early car-
diac abnormalities such as right and left ventricular hypertrophy The application of surgical weight loss procedures in the
and dysfunction associated with cardiac remodeling [42]. severely obese adolescent population has been an ongoing and
Despite the prevalence of this chronic disease, reversal of car- evolutionary process over the past decade and continues to
diovascular abnormalities [42] as well as improvement in school gain attention within the medical community as an effective
performance has been documented among affected adolescents treatment strategy. The increased interest in the use of surgical
following surgical weight loss [52]. weight loss surgery in the adolescent population comes on the
heels of a significant body of literature demonstrating the
safety and efficacy of bariatric intervention for the treatment
Polycystic Ovarian Syndrome (PCOS) of severely obese adults [62, 63], as well as the disappointing
results associated with attempts to lower pediatric and adoles-
A consequence of the epidemic of adolescent obesity is the cent BMI through diet, exercise, and behavior modification
increasing incidence of polycystic ovarian syndrome (PCOS) [64, 65]. The increasing use of this treatment modality is fur-
and hyperandrogenism related to insulin resistance and ther supported by an increasing body of literature reporting
hyperinsulinism, which affect ovarian function [54]. Obesity encouraging longitudinal outcomes for adolescents undergo-
is present in over 50 % of adolescents with PCOS; thus sus- ing surgical weight reduction. As a result of these factors, the
tained weight loss can ameliorate the clinical manifestations reported volume of adolescent bariatric procedures in the
of acne and hirsutism as well as favorably impact insulin United States has risen three to fivefold between the late 1990s
resistance [55]. to 2005 [66, 67] with more recent reports demonstrating a sur-
prisingly high number of adolescent cases being performed
supporting the consensus that the rising trend continues into
Nonalcoholic Fatty Liver Disease the current decade [68, 69]. Although an accurate accounting
(NAFLD) of the number of adolescent bariatric procedures being per-
formed in the United States annually is uncertain at the present
NAFLD and steatohepatitis occur more frequently in obese time, several trends have emerged with regard to the general
children and adolescents, present in up to 83 % of liver biop- environment in which adolescent bariatric procedures have
sies obtained from severely obese adolescents undergoing been undertaken during the previous decade that lend support
gastric bypass [56]. The most serious consequence of liver for the need to establish specific guidelines and standardiza-
injury associated with obesity is fibrosis and accelerated cir- tion of adolescent bariatric care [67]. Schilling et al. reported
rhosis, which can lead to end-stage liver disease. Studies in that 87 % of hospitals performing adolescent bariatric surgical
the adult population demonstrate improvement or complete operations from 1997 to 2003 performed four or fewer on an
resolution of steatosis, steatohepatitis, and subsequent fibro- annual basis and that the majority (85 %) were carried out
sis following bariatric surgery [57] with similar studies in within an adult facility. A similar pattern of adolescent bariat-
adolescents ongoing. ric care within adult facilities is seen in a more recent review
of 890 adolescent bariatric procedures performed between
2004 and 2010 at 360 adult facilities in the United States [69].
Psychological and Quality of Life Issues Although no specific inferences can be drawn regarding the
associated level of adolescent-specific resources from these
Psychosocial and quality of life issues are among the most reports, including whether or not an adolescent-specific multi-
prevalent in obese adolescents. The patterns of discrimina- disciplinary team was involved in the patient management
tion against obese children are established early in life and process, the recent rise in the number of centers focusing
become ingrained in a culture in which thinness is admired strictly on the surgical weight reduction for severely obese
[58]. Recent evidence has demonstrated a link between obe- adolescents underscores the need for standardized patient
sity in adolescents and an increased risk for the development selection criteria as well as recommendations for the develop-
of depression [59]. Further studies have predicted a signifi- ment of bariatric surgical centers that take into account the
cant increased risk for adult depression in those children that specific needs of this emerging population.
404 S.J. Barnett et al.
Early guidelines addressing the specific use of bariatric direction of an adult bariatric surgeon, a pediatric surgeon
surgery in the adolescent population, first presented in 2004 specializing in bariatric care, or a combination of the two).
[70], have been updated several times and should be referred The following key items are presented for consideration
to for in-depth consideration [71–73]. Since no national con- herein as a general overview and do not take into consider-
sensus conference pertaining to the surgical treatment of ation institutional-specific logistics and available clinical
severe adolescent obesity has been convened as yet, the pre- resources at the local level:
vious and more current recommendations for adolescent bar-
1. Surgical specialist: A surgeon performing adolescent bar-
iatric care have been based on modification of the 1991
iatric surgery must demonstrate certification by the
National Institutes of Health (NIH) consensus guidelines for
American Board of Surgery, American Osteopathic Board
adult bariatric surgery, which offer little to no substantive
of Surgery, and/or the Royal College of Physicians and
recommendations for the surgical care of the severely obese
Surgeons of Canada. In addition, he or she must have
pediatric population. In contrast to the initial report by Inge
appropriate training and experience performing bariatric
et al. [70], current recommendations have undergone a shift
procedures and be institutionally credentialed to perform
toward a less conservative approach that has become more
such procedures.
consistent with the widely accepted adult eligibility criteria
2. Medical specialist: A physician with specialty training in
and appear to reflect a general consensus among centers pro-
pediatrics (including possible subspecialty training in
viding adolescent bariatric surgery at this time. Although
endocrinology, gastroenterology, cardiology, nutrition,
several of the initial recommendations have been modified
etc.), adolescent medicine, or family practice experience.
based on nearly a decade’s worth of experience since the
The medical specialist should have or obtain experience
original publication, the most significant departure relates to
screening adolescents for bariatric surgery and be willing
the assessment of preoperative BMI with regard to surgical
to assume responsibility for the management of obesity-
eligibility (i.e., originally recommended to be BMI ≥ 40 kg/
related comorbid conditions in coordination with the
m2 with serious comorbid conditions and BMI ≥ 50 kg/m2
patient’s primary care provided (i.e., medical home).
with less severe comorbid conditions). In addition to an
3. Behavioral health specialist: A behavioral health special-
expanding body of literature demonstrating safe and effica-
ist may include a psychologist, psychiatrist, or other qual-
cious outcomes that support the shift toward a lower than
ified and independently licensed mental health provider
previously recommended BMI range, recent observations
with specific experience treating children, adolescents,
demonstrating a potentially fixed “ceiling” effect (i.e., maxi-
and families. In addition, the individual should have
mal expected reduction in BMI) among adolescent bariatric
experience treating obesity and eating disorders as well as
patients suggest that the earlier timing of bariatric interven-
specific experience regarding pre-bariatric evaluation.
tion (i.e., at a lower BMI) may result in a high propensity to
4. Bariatric program coordinator: A bariatric surgical coor-
achieve an optimal postoperative result (i.e., BMI ≤ 35 kg/
dinator may consist of a registered nurse or social worker
m2) [49]. As the number of healthcare institutions providing
or any other member of the bariatric team who has the
bariatric surgical care for the severely obese adolescent pop-
responsibility of coordinating the care of the adolescent
ulation has increased, a parallel consensus has developed
patient and helping to facilitate patient compliance and
regarding a number of key elements that serve as the founda-
clinical follow-up.
tion for an adolescent-specific multidisciplinary team
5. Registered dietician: A dietician with experience treating
approach, which are briefly reviewed herein.
children and families with obesity. Experience with bariat-
In a recent effort to establish a more uniform approach to
ric surgical patients is ideal but not mandatory. Nutritional
adolescent bariatric surgical care in the United States,
recommendations and structured educational content
national accreditation guidelines for adolescent bariatric care
should be provided to the patient and associated caregivers
are presently under development and are expected to be fully
(e.g., parents, grandparents, siblings) in an effort to estab-
incorporated within the newly developed Metabolic and
lish an understanding of age-appropriate healthy nutri-
Bariatric Surgery Accreditation and Quality Improvement
tional guidelines by multiple family members in the home
Program (MBSAQIP) which is expected to replace the previ-
prior to undergoing a bariatric procedure.
ous independent bariatric standards and accreditation pro-
6. Exercise physiologist/physical therapist: An exercise phys-
grams separately administered by the American College of
iologist, physical therapist, or other licensed provider with
Surgeons (ACS) and the American Society for Metabolic and
specialty training to provide safe physical activity educa-
Bariatric Surgery (ASMBS) in the near future. The funda-
tion for the severely obese adolescent population.
mental components representing previously published best
7. Social worker: A dedicated social worker is not manda-
practice recommendations will be included and are presented
tory but highly recommended and may serve to assist in
below [72–74]. The effort to provide widely accepted stan-
the evaluation of the patient’s psychosocial needs as well
dards for the treatment of the severely obese adolescent pop-
as perioperative logistics including transportation, access
ulation will most likely occur in one of several programmatic
to community resources, insurance coverage, etc.
models (i.e., an adult facility vs. a pediatric facility under the
42. Bariatric Surgery in Adolescents 405
In addition to the recommended adolescent-specific (8–9 cm/year) and boys (9–10 cm/year), girls should achieve
resources outlined above and in keeping with the multidisci- >95 % linear growth by 13 years of age and boys by 15 years
plinary care model, the development of an adolescent bariat- of age [75]. The onset of menarche is also a marker for phys-
ric surgery program should include the establishment of a iologic maturity in girls, and growth is generally completed
formal multidisciplinary adolescent bariatric committee within 2 years after menarche. Bone age can also be assessed
designed to review individual cases that are being considered by plain radiography of the hand and wrist if there is uncer-
for surgical intervention. The committee, consisting of core tainty about status of physiologic maturation. Nomograms
members (i.e., surgical and medical director, dietician, are used by radiologists to accurately predict the percentile
behavioral specialist, and program coordinator), should meet of adult stature that a child has attained.
on a regular basis to review patient-specific information. In While overall physiological assessment is an important
addition, ad hoc members of the review committee may foundation during the patient selection process leading up a
include subspecialists such as experts in adolescent pulmo- weight reduction surgery, additional factors are equally
nary medicine, hematology, cardiology, endocrinology, and important and include several that distinguish themselves
medical ethics (including formal involvement of the institu- from the routine preoperative evaluation process in the cor-
tional ethics committee when considered necessary). responding adult bariatric population. In addition to individ-
As mentioned earlier, the development of criteria for ado- ual BMI and comorbid disease status, as the basis of
lescent bariatric patient selection has been an ongoing and eligibility criteria, assessment of the adolescent patient’s
evolutionary process which, since its earliest recommenda- psychosocial maturity level, including the ability to demon-
tion, has been based on a modification of the adult surgical strate a general understanding of the benefits and risks of
patient selection guidelines defined by the 1991 National bariatric surgery, has been shown to be an important factor in
Institutes of Health (NIH) consensus panel on bariatric sur- determining eligibility. Although the factors related to matu-
gery [70–72, 74]. Because all adolescent boys and most ado- rity and general comprehension regarding bariatric surgery
lescent girls <18 years of age with a BMI of 35 kg/m2 among adolescents are only now beginning to emerge, pre-
correspond to BMI percentile of 99th percentile for age, the operative evaluation should attempt to determine an adoles-
application of adult selection criterion based on BMI appears cents patient’s ability to demonstrate the ability to comply
to be appropriate [40], with a more conservative approach with nutritional guidelines prior to surgical intervention.
regarding the incorporation of associated comorbid disease Despite the paucity of data regarding the advisability of
thresholds [72, 73]. Currently, recommendations for selec- mandatory preoperative weight loss and its ability to offer
tion criteria for adolescent bariatric surgery based on preop- predictive value regarding postoperative dietary compliance,
erative BMI and examples of associated obesity-related it is currently recommended that the adolescent be able to
comorbid diseases are seen below: successfully demonstrate stabilization of preoperative weight
(i.e., avoid significant weight gain) prior to surgical interven-
• BMI ≥ 35 kg/m2 with major comorbid disease
tion. In addition, it is considered extremely important to
Type 2 diabetes mellitus assess the quality of the patient’s “support mechanisms”
Pseudotumor cerebri (i.e., home environment, parental/caregiver status, etc.) in an
Severe NASH effort to determine the likelihood of postoperative nutritional
Moderate to severe obstructive sleep apnea [apnea-hypopnea and behavioral compliance as well as the ability to comply
index >15] with required postoperative follow-up. Finally, adolescent
• BMI ≥ 40 kg/m2 with less severe comorbid disease bariatric surgical intervention should take into consideration
the overall risk-benefit ratio related to the progression of
Glucose intolerance untreated or poorly treated comorbid diseases (i.e., type 2
Hypertension diabetes, hyperlipidemia, hypertension, etc.) if left untreated.
Dyslipidemia As mentioned earlier, this may include the decision to seek
Impaired weight-related quality of life input from an institutional medical ethics committee in
Mild to moderate obstructive sleep apnea [apnea-hypopnea certain cases when needed.
index >5]
Since adolescence represents an extensive period of sub-
stantial growth and maturation, both physically and emotion- Outcomes of Bariatric Surgery
ally, special attention to developmental issues in adolescents in Adolescents
is critical when considering bariatric procedures that will
have marked impact on future growth and development. For Currently, the most commonly performed bariatric proce-
adolescents who have attained the vast majority (>95 %) of dures in the adolescent population are the Roux-en-Y gastric
linear growth, there is clearly little reason to believe that bypass (RYGB), the adjustable gastric band (AGB), and the
growth would be impaired by a bariatric procedure. Based on more recently introduced vertical sleeve gastrectomy (VSG).
peak height velocity measurements in normal-weight girls The successful use of the duodenal switch has been reported
406 S.J. Barnett et al.
in this population [76], but is generally considered more com- loss among two groups of severely obese adolescents has
plex and with its associated significant malabsorption and demonstrated a significant amount of weight loss at 2 years
nutritional complications is not commonly performed. In when compared to lifestyle intervention alone (BMI reduc-
general, published literature suggests that overall weight loss, tion of 28 % vs. 3 %) but noted a significantly high reopera-
resolution of comorbidities, and safety are comparable to or tion rate (33 %) [91]. Finally, the results of a nearly completed
better in adolescents when compared to adults [49, 77, 78]. multi-institutional industry-sponsored FDA trial designed to
investigate longitudinal outcomes among a cohort of 200
severely obese adolescent (less than 18 years of age) are still
Roux-en-Y Gastric Bypass (RYGB) pending.
The use of RYGB for weight loss in the United States can
trace its origins back to the 1960s for adults and the 1970s Vertical Sleeve Gastrectomy (VSG)
for adolescents [79]. Multiple small studies have been pub-
lished looking at long-term outcomes following RYGB in The VSG, historically utilized as a key anatomic compo-
adolescents [42, 49, 80–85] with a recent meta-analysis nent of the highly complex duodenal switch operation, has
reporting the outcomes of adolescents undergoing RYGB recently gained popularity as a primary weight loss proce-
demonstrating sustained reduction in excess body weight dure in the United States and abroad. Given the propensity
and improvement in associated comorbidities [86]. Multiple for less complications, particularly metabolic and vitamin
studies demonstrate improvements or complete resolution deficiency when compared to RYGB, it has quickly gained
of comorbidities related to obesity including type 2 diabe- acceptance in the treatment of obesity in adolescents.
tes mellitus [46], obstructive sleep apnea [87], depression Although initial reports have been encouraging, only a few
and psychosocial function [61], and hypertension [46]. A long-term and large-scale reports are currently available
recent publication from Cincinnati Children’s Hospital examining the use of the sleeve gastrectomy in the adoles-
demonstrated significant weight loss (decrease in BMI by cent population. The largest study to date, consisting of 108
37 % at 1 year) in patients following gastric bypass. patients from Saudi Arabia, has demonstrated a significant
Interestingly, the study demonstrated a “fixed ceiling” with weight loss (excess weight loss of 61.8 %) at 1 year with no
regard to expected reduction in BMI regardless of preop- serious postoperative complications and significant resolu-
erative BMI. Specifically, such results highlight the poten- tion of the expected comorbidities [92]. When compared to
tial timeliness of bariatric surgical intervention within the adult counterparts, VSG in the pediatric patient was noted
spectrum of preoperative BMI in that subjects noted to have to be similar in its effectiveness and safety with fewer
the highest BMI values (i.e., >50 kg/m2) have a lower prob- major complications [93]. Given the paucity of long-term
ability of achieving a nonobese nadir weight despite sig- data coupled with the durability of weight loss and the
nificant reduction in excess body weight and in comparison potential for significant gastroesophageal reflux induced by
to subjects who were noted to have a lower initial BMI (i.e., VSG, there remains cautious optimism for its widespread
<50 kg/m2) [49]. Given the concern over long-term meta- use in adolescents.
bolic and nutritional deficiencies as a result of RYGB in
this young population, adequate nutritional and vitamin
supplementation is of the utmost importance. Reasonable Summary
protocols have been established to meet the needs of this
growing patient population [88]. Surgical approaches for clinically severely obese adolescents
may be reasonable for individuals who have obesity-related
comorbidities and have been unsuccessful in achieving sus-
Adjustable Gastric Band (AGB) tained weight loss following organized attempts. Suggested
indications and contraindications for operative intervention
Though not approved in the United States for patients under should not be inflexibly applied to every patient but rather
the age of 18 years of age by the Food and Drug Administration should be considered guidelines for use of bariatric surgery in
(FDA), there have been a number of short-term studies pub- adolescents. Individuals should be considered based on the
lished for the use of AGB in adolescents. These studies do degree of obesity, the severity of comorbid conditions, physi-
show a modest amount of weight loss at 1 year, but long-term cal and emotional maturity level, and the stability of family
follow-up is lacking [82, 89, 90]. Over a period of 2 years support. The benefits of a multidisciplinary approach in ado-
(2007 to 2009), their use had dramatically increased in the lescent weight management and bariatric surgery cannot be
state of California [68], but their current usage is unclear overemphasized. Families and patients alike must participate
across the country. In addition, a recent randomized control fully in all aspects of preoperative decision making given the
trial comparing the use of the AGB versus medical weight level of comprehension about potential complications that
42. Bariatric Surgery in Adolescents 407
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43
Bariatric Surgery in the Elderly
Elizabeth A. Hooper, Bamdad Farhad, and Julie J. Kim
body mass index (BMI) than the ideal weight currently Patient Selection and Preoperative
defined in federal guidelines for all individuals as a BMI
between 18.7 and 24.9 [6]. Longitudinal studies looking at Assessment of Surgical Risk
the effects of aging on body composition suggest that aging in the Elderly
is associated with a decrease in lean muscle mass and
increase in fat mass regardless of changes in overall body Due to the lack of any uniform consensus, the onus of patient
weight [7, 8]. This loss of muscle mass that occurs with selection falls on the bariatric surgeon. Chronologic age
aging is a process called sarcopenia, which may not be as alone is a poor predictor of the outcome as the elderly patient
clearly identified by BMI alone [9]. In addition, the natural may have limited ability for recovery. Preoperative evalua-
loss of height seen with increases in age is more significant tion necessitates further investigations compared to the gen-
in females and may also arbitrarily elevate BMI [10]. eral population [17]. Emphasis should be placed on the
Several studies have shown that the excess mortality asso- evaluation of the functional status of the individual. The
ciated with obesity actually declines with age [11]. In addi- impact of age on surgical risk arises from a decrease in vital
tion, there have been conflicting data from observational organ function. This is attributable to the normal aging pro-
studies associating weight loss with increased mortality in cess in conjunction with any preexisting disease, resulting in
the elderly [12–14]; however, the far majority of studies do a decreased ability to respond optimally to operative stress
not make the distinction between intentional and uninten- [18]. The decline in physiologic capacity to respond to surgi-
tional weight loss, the latter of which may be a reflection of cal stress, independent of specific individual organ system
other confounding conditions such as cancer, failure to dysfunction, is referred to as frailty [17].
thrive, or worsening of chronic comorbid conditions, which Frailty takes into account multiple factors that may place
would increase mortality risk and may explain some of the the geriatric patient at a distinct physiologic disadvantage. It
discrepancy. A recent RCT, however, found no significant is important to note that a patient does not simply fall into one
difference in all-cause mortality between older (mean age of the two categories: for an elderly with or without frailty
65.5 ± 4.5 years) overweight and obese (mean BMI rather, one needs to carry out a quantitative analysis for mea-
31.1 ± 2.3) adults who were randomized to intentional surement of frailty index [19]. There are multiple tools that
dietary weight loss (mean weight loss of 4.4 kg) over a can be used for preoperative frailty assessment, one of which
12-year period [15]. Given the increased incidence of sar- is the Katz ADL score which examines the patients’ level of
copenic obesity in the elderly population, future prospec- independence on daily activities. The patient is given a point
tive studies will need to continue to separate and make the for each of six activities: grooming, bathing, feeding, dress-
clear distinction between intentional and unintentional ing, toiletry, and dressing [20]. In addition to independence in
weight loss when determining the risk of mortality. daily life and medical comorbidites, an assessment for mobil-
Therefore, until age-specific recommendations are made, ity, nutritional, and cognitive status (the mini-mental test) has
elderly patients who are being considered for weight reduc- been recommended for preoperative evaluation of patients in
tion surgery should continue to meet whatever the currently general surgery literature [21].
accepted weight criteria or other criteria for defining morbid In addition to age, one should consider other independent
obesity and clinically severe obesity exist, whether this be patient risk characteristics associated with increased morbid-
the NIH consensus guidelines or other new emerging guide- ity and mortality, which include male gender [22]. Patients
lines. There are also very few studies involving medical should be stratified into a high- or low-risk category based on
weight loss in the elderly. Most studies on supervised diets the number of associated diseases. The literature suggests
or medications have been performed in younger patients. that the preoperative condition of the patient is more impor-
Thus, it is recommended that elderly patients have attempted tant than intraoperative events in predicting adverse out-
a serious effort at documented medical weight loss before comes after surgery. A dramatic increase in perioperative
undergoing surgical treatment, particularly since moderate deaths has been seen in elderly patients with multisystem
dietary reduction and exercise have been shown to be safe in disease. Premorbid conditions that may increase periopera-
preserving lean muscle mass. Studies looking at physical tive risk include congestive heart failure (CHF) and coronary
activity in the elderly have shown that increased physical artery disease [23]. Nguyen et al. published data from the
activity is associated with decreased mortality. In an obser- National Inpatient Sample which reviewed >300,000 inpa-
vational study by Lee et al., it was shown that there was a tients undergoing lap and open gastric bypass over a 3-year
higher all-cause and cardiovascular mortality in lean unfit period (2006–2008) and identified peripheral vascular dis-
subject than in obese fit subjects, once again emphasizing ease and chronic renal failure as comorbid conditions associ-
the importance of physical activity and muscle mass preser- ated with increased risk of inpatient mortality. The goal of
vation over the amount of body fat alone, in predicting the any bariatric operation should be to improve the quality of
risk of mortality [16]. postoperative life, or at minimum, not impair it. Therefore,
43. Bariatric Surgery in the Elderly 413
preoperative optimization of the elderly patient’s overall many obese elderly patients may be denied corrective joint
condition, without undue delay in surgery, is advocated. repair due to their excess weight. Their immobility, however,
There are several normal age-related physiologic changes may limit their ability to lose weight through more conserva-
that may or may not have any overt clinical findings. These tive measures such as diet and exercise, leaving surgery as
age-related changes result in altered end organ function, one of the few options for effective treatment. Immobility
most importantly cardiac, pulmonary, and renal function. can also result in wound care issues, with the formation of
Cardiac output can be decreased from a blunted response to decubitus ulcers. Elderly bariatric patients requiring long-
catecholamines, which can lead to increased ectopy that may term intensive care are at high risk for the development of
not be seen in the resting state. Hypertrophy of the left ven- such ulcers. For the uncomplicated postoperative patient,
tricular mass can add to any underlying diastolic dysfunction early ambulation is essential, which in the elderly may
already present. It may be prudent in elderly patients to eval- require assistance from physiotherapists or the nursing staff.
uate the functional cardiac status under stressed conditions In addition, consideration for extended DVT chemoprophy-
(using a treadmill stress test or a Persantine thallium scan), laxis and/or placement in acute rehab postoperatively should
even in the presence of a normal electrocardiogram. A trans- be discussed as part of informed consent and preoperative
thoracic echocardiogram should also be considered in any planning for patients with poor mobility.
patient with history of CHF.
The changes in the respiratory system include decreased
chest wall compliance, decreased lung volumes, and
decreased strength of the respiratory musculature, resulting Outcomes of Bariatric Surgery
in an overall decline of pulmonary function. Elderly patients, in the Elderly
therefore, may be more susceptible to postoperative respira-
tory complications. Pulmonary function tests are not nor- There are several studies in the literature that suggest an
mally required in the workup of a routine bariatric candidate increased risk of mortality in the elderly after surgery. In
but may be informative, particularly if there is a question general, most of these studies, however, have small sample
regarding pulmonary reserve in a patient with baseline size, include patients in their eighth and ninth decades of life,
chronic lung disease (previous episodes of pneumonia, long as well as those undergoing cancer operations, cardiac pro-
smoking history, pulmonary embolus, asthma) or obesity cedures, or semi-emergent operations [27–30]. It is on the
hypoventilation syndrome. basis of such a wide range of operations that much of our
Normal renal changes include decreased renal blood flow early outcomes data on the elderly had been gathered.
with resultant decreased glomerular filtration rate and Although we are still gaining insight on the safest way to
decreased creatinine clearance. Patients who present with manage elderly patients, certain trends have been estab-
marginal renal function should have close attention to their lished. Emergency surgery is associated with higher morbid-
perioperative fluid status. Gentle hydration without large vol- ity and mortality in all age groups, but particularly in the
ume shifts is generally better tolerated. Any potentially neph- elderly. Elderly patients often present with more advanced
rotoxic drugs should be discontinued prior to surgery [18]. disease, forcing surgical therapy once complications have
One postoperative complication that is relatively unique to already occurred. Elderly patients have a higher percentage
the elderly population is delirium. Delirium is defined as a of preexisting comorbid conditions, making them less likely
“clinical syndrome in which there is an acute disruption of to tolerate complications, if they occur; therefore, prevention
attention and cognition” [24]. Delirium has been associated remains essential [23].
most commonly with cardiac and orthopedic procedures but Historically, many bariatric centers refused surgery to
has been reported in all types of surgery. When delirium occurs patients over 50. In 1977, Printen et al. [31] reported a greater
postoperatively, it has been associated with increased morbid- than twofold increase in mortality after gastric bypass in
ity and mortality [25]. Preoperative risk factors include age, patients older than 50 compared with those younger than 50
history of or current alcohol abuse, history of depression, (8 % vs. 2.8 %). This, however, was an evaluation of only 36
dementia, and the presence of any metabolic derangements patients during a time when the overall mortality for gastric
[25]. Recent studies have suggested preoperative variables bypass was significantly higher than what is seen today. In
associated with an increased risk of postoperative delirium to contrast, MacGregor and Rand [32] in 1993 did not find a
include: age, low serum albumin, impaired functional status, statistical difference in mortality (1.1 % vs. 0.6 %) in those
medical comorbidities, and presence of dementia. The stron- patients aged 50 or older as compared with younger patients
gest single risk factor for the development of delirium was undergoing a variety of obesity operations. Similar findings
preexisting dementia [26]. Screening for these risk factors and were shown by Murr et al. [33] in 1995. A later study by
correction preoperatively as necessary should be attempted. Livingston et al. [34] suggested that increasing age was not
Immobility is a problem associated with morbid obesity associated with increased morbidity after gastric bypass.
that can become aggravated in elderly patients. The inci- However, if a complication were to occur in this population,
dence of degenerative joint disease increases with age, and the incidence of mortality associated with an adverse event
414 E.A. Hooper et al.
was threefold in older patients, reinforcing the concept that comorbid conditions, however, showed dramatic resolution:
elderly patients may have less physiologic reserve than 75 % DM, 88 % HTN, and 94 % sleep apnea [39]. Similar
younger patients to overcome an adverse event [35]. findings have also been reported by Hallowell et al., compar-
National databases have been utilized to examine morbid- ing patients undergoing gastric bypass looking at Medicare
ity trends in older populations with some variability. In 2005, and non-Medicare cohorts as well as age less than 60 versus
Flum et al. reported on a large retrospective database of over 60 with no difference in morbidity or mortality [10].
Medicare recipients undergoing bariatric surgery from 1998 In 2011, Leivonen et al. found equivalent safety profile
to 2002. This study found higher 30-day, 90-day, and 1-year for laparoscopic sleeve gastrectomy in >55 compared to
mortality for those greater than 65 with low-volume sur- under 55 populations. Excess weight loss in the two age
geons and/or hospitals. It also showed that those over age 75 groups was equivalent with 0 % mortality rates They did find
had the most significant increase in mortality risks, when a higher incidence of vitamin irregularities in the elderly
compared to the under 65 population. Notably, in those 65 or group highlighting the continued importance of routine fol-
older undergoing surgery with high-volume surgeons, there low-up care [40].
was no significant increase in mortality 1.8 % vs. 1.1 %. In 2009, utilizing the ACS NSQIP database, Dorman et al.
Despite a sample size of over 16,000 patients, only 10 % of analyzed a data set that included laparoscopic procedures
those included were over age 65. At the time of the study, and pooled data from a wide range of care settings. Patients
there were no formal CPT codes for laparoscopic bariatric were separated into age groups and evaluated for significant
procedures. This led to inclusion of all open operations but morbidity or mortality differences. The overall 30-day mor-
possible undersampling of laparoscopic bariatric procedures tality was 0.15 % with the 65–69 subset = 0.4 % and >70 year
[35]. Livingston and Langert reviewed data from 2001 to age = 0.5 %. Although there was an increasing trend with
2002 NIS database which also included open procedures and age, statistical significance was not determined. Major
found a threefold increase in mortality when compared to adverse events were also reported and were less than 5 % in
under 55 group [34]. all age groups. Predicted length of stay more than 3 days
In the last 10 years, there have been significant advances was, however, significantly higher in the 65–69 and >70 sub-
in patient selection, preoperative preparation of patients, set group [41].
perioperative care, ICU care when required, and long-term In 2012, Lynch et al. published a meta-analysis of the
follow-up of patients in multidisciplinary settings. Although available literature and found 18 studies which included
there is no longer a paucity of literature about obesity sur- 1,200 patients over the age of 55 who underwent bariatric
gery in the 60 and older population, the quality of the data surgery. 30-day mortality was 0.25 % for the population
remains variable. Many studies continue to include patient again in line with the longitudinal Assessment of Bariatric
cohorts from the pre-laparoscopic era or retrospective evalu- Consortium mortality rate of 0.30 % for a younger patient
ations of single institution experiences. population. There continued to be significant improvement
The 2006 CMS National Coverage Determination (NCD) in comorbidity resolution [42].
for bariatric surgery has allowed increasing numbers of Several other studies of nonbariatric laparoscopic proce-
patients 65 and older access to bariatric surgery and better dures have been shown to be safe and effective in the elderly,
data collection. The post-NCD addition of the LAGB, including laparoscopic cholecystectomies, laparoscopic
increasing utilization of laparoscopic over open techniques Nissen fundoplications, and laparoscopic colectomies [43–46].
particularly for the gastric bypass, and mandating centers of In 2012, the ACS NSQIP group collaborated with the
excellence have all resulted in significant decrease in the risk American Geriatrics Society (AGS) to review the literature
of death, complications, readmissions, and per patient pay- on the presurgical assessment in patients. After an exhaustive
ments. In 2011 a study by Flum et al., utilizing pre- and post- search of the literature, 117 articles were reviewed to create
NCD Medicare data from 2004 to 2008, found the 90-day a consensus approved checklist for preoperative assessment.
mortality pre-NCD was 1.5 % (1.8 % ORYGB, 1.1 % Interestingly, this article did not suggest that more testing is
LRYGB) and post-NCD was 0.7 % (1.7 % ORYGB, 0.8 % better for all patients. It instead suggests thorough screening
LRYGB, 0.3 % LAGB; P < 0.001) [36] consistent with other for all patients with a detailed history and physical and lab
comparisons [37]. tests only as warranted. The exceptions to that would be that
The current literature for bariatric surgery reports mortal- measurement of hemoglobin, renal function, and albumin
ity rates of 0.5 % or less for all comers [38] with emerging should be obtained for all geriatric patients, but other tests
data supporting a much lower mortality risk for patients 60 may be obtained for higher-risk patients based on the pres-
years and above [39]. Wittgrove reported a single institution ence of comorbid conditions [47].
experience of 120 patients over age 60 with a 0 % mortality One argument against performing bariatric surgery on the
rate and 19 % morbidity for laparoscopic Roux-en-Y gastric elderly is that it may offer limited benefits with respect to
bypass. Ten percent of the morbidity was attributed to steno- prolongation of life and provision of quality-of-life years
sis at the GJ anastomosis, which is more likely a function of compared to the younger severely obese population. At a
technical considerations than the age of the patient. Associated time when fewer than 1 % of individuals eligible to undergo
43. Bariatric Surgery in the Elderly 415
bariatric surgery with its expected benefits are actually independently, his mobility (transferring) is somewhat
receiving surgical treatment, one could pose an argument in restricted as he has to use a walker so would receive
favor of continuing to target these procedures to younger 5 points. Patient C and D both require assistance with mul-
patients or to elderly patients who by physiologic assessment tiple daily activities and received 3 and 4 points respec-
are low risk for surgery. tively, giving each a higher frailty score than patient A.
2. Unintentional weight loss in the elderly is:
A. Associated with decreased risk of mortality
Conclusion B. May represent confounding conditions such as can-
cer, failure to thrive or worsening of underlying
The elderly comprise the fastest-growing segment of the
comorbid conditions
population in the United States. The proportion of elderly
C. Associated with decreased fat mass
patients who will consider weight reduction surgery is likely
D. Has a similar benefit as intentional weight loss
to increase over the next several decades. Performing bariat-
The answer is B.
ric surgery in the elderly today is less controversial and is
Unintentional weight loss in the elderly may represent con-
supported by retrospective publications as being safe and
founding conditions such as cancer, failure to thrive or
feasible, in patients over the age of 65 and even 70. Given the
worsening of underlying comorbid conditions and can be
limitations found in current studies looking at the effect of
associated with a higher risk of mortality.
obesity on mortality outcomes in the elderly, the decision to
offer bariatric surgery should still be made with consider-
ation of current weight guidelines and failure of conservative
efforts. Careful preoperative screening is advocated in References
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44
The High-Risk Bariatric Patient
Eric Ahnfeldt, Monica Dua, and Derrick Cetin
Over the past decade, the number of patients undergoing This chapter evaluates the evidence behind each of these
weight loss surgery has increased exponentially with risk factors and suggests strategies for perioperative plan-
approximately 13,000 patients undergoing weight loss sur- ning and risk reduction to aid in the identification and surgi-
gery in 1998 to 200,000 patients in 2009 [1]. During that cal care of the high-risk bariatric patient.
time, advances in technique and approach to bariatric sur-
gery have decreased the morbidity of these procedures,
thus allowing patients that were previously at unaccept- Estimating Risk
ably high risk to now be candidates for weight loss sur-
gery. Oftentimes the very comorbidities that placed these Who is the high-risk patient? Every patient undergoing a
patients at high risk (namely, cardiopulmonary disease) procedure requiring anesthesia is given an American Society
are the same comorbidities that effective long-term weight of Anesthesiologist’s (ASA) classification category. This cat-
loss could improve. egory system was developed in 1941 and revised in 1963.
Careful identification and perioperative management of Since that time, the ASA classification has been extensively
these higher-risk patients is crucial in decreasing morbidity evaluated and correlates well as a predictor of postoperative
after weight loss surgery. Recognizing that these patients morbidity and mortality [5]. However, the majority of
needed to be specifically identified, the American Heart patients undergoing weight loss surgery have an ASA clas-
Association issued “A Science Advisory” in 2009 concern- sification of three or higher based on the BOLD database,
ing the evaluation and management of severely obese patients making them all high risk by conventional standards [3].
undergoing surgery [1]. Obesity is associated with many This created a need to further define risk categories within
comorbidities either known or unknown. Overall risk of the bariatric population that would guide the perioperative
developing anyone of a number of comorbidities rises with work-up and management.
an increasing BMI. It has been noted that the number of indi- In 2007 DeMaria and colleagues evaluated 2,075 patients
viduals with a BMI > 50 kg/m2 has quintupled between 1986 undergoing gastric bypass surgery seeking to define which
and 2000. For this reason, the scientific advisory was devel- variables could be used to predict postoperative mortality
oped to provide recommendations concerning preoperative [2]. They found that BMI, male gender, hypertension, history
cardiopulmonary evaluation of severely obese patients of venous thromboembolic event, and age greater than 45
undergoing surgery [1]. These recommendations included were significant independent predictors of mortality. They
risk factors such as age, BMI, gender, hypertension, and his- further developed the Obesity Surgery Mortality Risk Score
tory of venous thromboembolic events. These risk factors (OS-MRS). This scoring system is divided into three classes
were drawn from the Obesity Surgery Mortality Risk Scoring A, B, and C, where each of the five variables is assigned one
system developed by DeMaria in 2007 and validated by sev- point. Patients with 0–1 point are included in category A, 2–3
eral other studies since that time [2–4]. points category B, and 4–5 points category C. Categories A,
However, in addition to these risk factors, there are other B, and C were associated with a 0.3 %, 1.90 %, and 7.56 %
factors that place certain patients at higher risk when under- mortality risk, respectively (Table 1).
going weight loss surgery. When considering weight loss That same year, Buchwald and colleagues conducted a
surgery on these patients, careful preoperative preparation meta-analysis to evaluate a 30-day mortality based on type
and perioperative multidisciplinary management can lead to (gastric banding, gastroplasty, gastric bypass, or BPD/DS, or
successful outcomes and durable comorbidity resolution or revisional surgery) and approach (laparoscopic vs open) of
reduction. weight loss surgery [4]. They found significant differences in
TABLE 1. Obesity surgery mortality risk score found several factors that increased mortality with bariatric
Class No. of points Mortality rate (%) surgery: increasing age, male gender, electrolyte abnormali-
A 0–1 0.31 ties, and congestive heart failure. He also found that the
B 2–3 1.90 patients that had Medicare had greater disease burden and
C 4–5 7.56 thus had higher morbidity.
One point assigned for each of the following: BMI > 50 kg/m2, male gender, Finally in 2011, Nguyen proposed a revised bariatric mor-
HTN, PE risk, Age >45 years tality risk classification system for patients undergoing bar-
iatric surgery [7]. This updated, but more complicated,
TABLE 2. Thirty-day mortality for bariatric surgery by procedure classification system encompassed those factors in DeMaria’s
classification system and added other risk factors such as
Surgery type Death ≤30 days, mean (95 % CI)
presence of diabetes, Medicare status, and type of operation
Gastric banding and approach. The significance of this system is the acknowl-
Open 0.18 (0.00–0.49)
Laparoscopic 0.06 (0.01–0.11)
edgement of the differences in the risk profiles of the differ-
Gastroplasty ent types and approaches (open vs laparoscopic) to weight
Open 0.33 (0.15–0.51) loss surgery.
Laparoscopic 021 (0.00–0.48) By using these classification systems and the consider-
Gastric bypass ations presented by the American Heart Association, patients
Open 0.44 (0.25–0.64)
Laparoscopic 0.16 (0.09–0.23)
that have multiple risk factors can be identified early in the
Biliopancreatic diversion/duodenal switch preparation period. They can then be medically optimized
Open 0.76 (0.29–1.23) for a risk-appropriate weight loss surgery. These patients can
Laparoscopic 1.11 (0.00–2.70) more appropriately be counseled as to their increased risk for
Revisional surgery complications after surgery. However, using a multidisci-
Open 0.96 (0.09–1.82)
Laparoscopic 0.00 (0.00–1.47)
plinary approach, the perioperative management can help
Adapted from Buchwald et al.
effectively decrease overall morbidity and mortality.
Score, his evaluation of the >2,000 gastric bypass patients effect on platelets. It also increases the synthesis of C-reactive
demonstrated that male gender was an independent risk factor protein contributing to the chronic inflammatory state of
for mortality [2]. Livingston came to similar conclusions in obesity. Tissue factor, also secreted from adipose tissue, ini-
his study in 2006 [6]. However, more recently (2011), Nguyen tiates the coagulation cascade when exposed to blood and
et al. suggested that even more than advanced age, male gen- bound to factor VIIa. Obese individuals demonstrate higher
der was associated with greater mortality after bariatric sur- levels of TF-mediated coagulation. Finally IL-6, a proin-
gery [7]. Because of this, he gave male gender a greater flammatory cytokine, secreted from adipose tissue has direct
contribution to his bariatric mortality risk classification. effect on inflammation in the human body. IL-6 overproduc-
tion has been implicated in the pathogenesis for inflamma-
tory conditions such as rheumatoid arthritis, Crohn’s disease,
Body Mass Index and juvenile idiopathic arthritis. Approximately one third of
circulating IL-6 is produced from adipose tissue, and patients
Elevated weight or body mass index has been evaluated in that are morbidly obese have higher circulating levels of
many studies [8–10]. It seems intuitive that there would be a IL-6. IL-6 inhibits gene expression and secretion of adipo-
direct relationship between increasing BMI and risk of peri- nectin, a powerful anti-inflammatory mediator. This may
operative morbidity. Frequently as BMI increases, the physi- contribute to increased platelet aggregation and endothelial
ology of the patient deteriorates. Patients with elevated BMIs adhesion.
typically have a higher incidence of cardiopulmonary insuf- Furthermore, obese individuals have chronically elevated
ficiency including right heart failure, pulmonary hyperten- intra-abdominal pressure and decreased blood velocity in the
sion, obstructive sleep apnea, and obesity-related common femoral vein resulting in venous stasis and ulti-
hypoventilation syndrome [8–10]. In addition to the physio- mately contributing to increased risk for deep venous throm-
logic consequences of morbid obesity, there are also mechan- bus formation.
ical challenges that these patients present. Their thickened DeMaria recognized the elevated risk of these patients
abdominal wall, large liver, increased intraperitoneal fat, and and included “PE risk” in his mortality risk score [2]. He
limited working space after insufflation add to the technical found that the combination or presence of any of the follow-
difficulty of the procedure and may lengthen the duration of ing findings—previous VTE event, previous IVC filter place-
surgery [11, 12]. Acute presurgical weight loss may help ment, a history of right heart failure or pulmonary
ameliorate some of these technical difficulties and possibly hypertension, history of physical findings of venous stasis
decrease overall complications [13, 14]. All of these factors including brawny edema or typical ulcerations—was highly
probably contribute to the fact that elevated BMI has been statistically significant as a predictor of postoperative mor-
found in multiple studies, such as DeMaria’s evaluation of tality. As such, he included “PE risk” in his mortality risk
2,075 gastric bypass patients, to be an independent risk fac- score system, underscoring the fact that pulmonary embo-
tor for perioperative mortality especially in BMI >50 [2]. lism is the leading cause of mortality in bariatric surgery cen-
ters, where the incidence of pulmonary embolism in patients
who have undergone surgical procedures has been reported
Thromboembolic Disease as high as 2 % [16].
Risk reduction strategies for decreasing thromboembolic
Darvall et al. did an extensive review of the relationship events in patients that are at high risk include preoperative
between obesity and venous thrombosis [15]. Within this placement of vena cava filters, heparin windows, preoperative
review which included a medline review and Cochrane data subcutaneous heparin administration, postoperative home
base search from 1966 to 2005, a number of mechanisms administration of Lovenox, etc. In an analysis of the BOLD
were identified which connected obesity and venous throm- data base by Li, it was found that surgeons more typically put
botic events. vena cava filters in patients with higher BMIs, that are
In fact, the adipose tissue itself acts as an endocrine, para- African-American, who have had previous surgeries, who
crine, and autocrine organ, regulating among other pro- have prior history of venous thromboembolism, impaired
cesses, vascular homeostasis. The substances that are functional status, lower extremity edema, obstructive sleep
secreted by the adipose tissue that are potentially involved apnea, and pulmonary hypertension [17]. Interestingly, the
with venous thrombosis include leptin, adiponectin, resistin, patients that had the vena cava filters placed also had a higher
plasminogen activator inhibitor-1 (PAI-1), tissue factor, incidence of DVTs and higher mortality rate. It is presumed
angiotensin II, and other substances of the renin-angiotensin that selection bias is responsible for the association between
system, non-esterified free fatty acids (NEFAs), tumor necro- the filters and higher DVT/mortality rate. However, any deci-
sis factor-a (TNF-a), transforming growth factor-b (TGF-b), sion to place a filter should consider the technical difficulty in
and interleukin-6 (IL-6) [15]. placement and retrieval in the super-obese.
Leptin has been found to potentiate the aggregation of At our institution, Lovenox is typically given the day of
platelets by enhancing ADP’s and thrombin’s pro-aggretory surgery and a prophylaxis dose is given based on BMI.
420 E. Ahnfeldt et al.
(BMI > 60 = 60 mg Lovenox BID; BMI <60 = Lovenox 40 mg cardiac performance. In fact there are many case reports of
BID). Also patients with a BMI >55 are given a prescription patients undergoing weight loss surgery in order to meet cri-
for home Lovenox for 2 weeks after hospital discharge for teria for heart transplantation [23, 24]. Oftentimes these
extended prophylaxis. Patients with previous DVT/PE, patients have left ventricular ejection fractions as low as
known hypercoagulable state, or other risk factors (immobil- 15 %. Ramani et al. demonstrated safety and efficacy of bar-
ity) are also given 2–4 weeks of extended prophylaxis after iatric surgery in morbidly obese patients with severe systolic
hospital discharge. However, the optimal strategy for preven- heart failure, improving their New York Heart Association
tion of venous thromboembolism in the setting of bariatric score and left ventricular ejection fraction some of whom
surgery is uncertain [18]. then became candidates for transplantation after lowering
their BMI while others improved to the point of not requiring
transplantation [25]. These types of patients are all cared for
Obstructive Sleep Apnea by a multidisciplinary team including experienced bariatric
surgeons, cardiologists with fellowship training in heart fail-
Obstructive sleep apnea is discussed in detail in Chap. 51. ure, and cardiac anesthesia teams. The conduct in the OR is
However, in relationship to risk assessment in the high-risk to minimize operative time while ensuring integrity of the
patient, many studies have demonstrated the association with anastomoses. Oftentimes these heart failure patients or heart
obstructive sleep apnea and perioperative complications. transplant patients have either internal cardiac defibrillators
Memtsoudis et al. performed a case control study that evalu- or pacemakers. Prior to surgery, it is important to identify the
ated 58,358 orthopedic patients and 45,547 general surgery type and model of the patient’s device, who controls it, what
patients in the journal Anesthesia and Analgesia in 2011. the patient’s underlying rhythm is, what the “magnet mode”
They found that patients undergoing orthopedic and general default is, and if the institution has a programmer on site.
surgeries were at statistically significant higher risk for aspi- Knowing these details will prevent any delay of care if
ration pneumonia, reintubation, ARDS, and mechanical ven- patients should have device malfunctions.
tilation [19]. That same year in the journal CHEST, Kaw
et al. performed a cohort study evaluating 471 patients
undergoing noncardiac surgery within 3 years of polysom- Surgical Factors
nography and found that these patients had higher risks of
hypoxemia, transfer to the ICU, and an increased length of Prior Upper Abdominal Surgery
hospital stay [20].
Vasu et al. included these two studies as well as nine oth- Prior upper abdominal surgery can cause adhesions that can
ers in their review of the association between obstructive make exposure difficult. Often the stomach and the liver can
sleep apnea syndrome and perioperative complications in the be fused via adhesions making formation of the pouch very
Journal of Clinical Sleep Medicine in 2012. They pointed out difficult. If the patient has had a midline laparotomy or even
that beyond the risk association between OSA and periopera- lower abdominal surgery, adhesional disease may require
tive complications, many people that have OSA are undiag- tedious and often lengthy lysis of adhesions before enough
nosed at the time of surgery. This makes them at higher risk small bowel is released to measure and create the jejunojeju-
for these complications since they are not being treated for nostomy. When performing weight loss surgery in a patient
their OSA in the perioperative period [21]. that has had multiple prior abdominal surgeries, obtaining
previous operative notes can help prepare the surgeon for the
environment that he is about to discover. Furthermore, hav-
Cardiovascular Disease ing the requisite skill set to laparoscopically repair any surgi-
cal misadventures that may be encountered will spare the
In Livingston’s population-based study of patients undergo- patient of the short and long-term complications of having to
ing bariatric surgery, he found the event rate for cardiac com- convert to an open procedure.
plications to be as high as 15.3 per 1,000 patients. And the Occasionally weight loss surgery is required in patients that
Women’s Health Initiative Observational Study [22] found have received transplanted organs. Obesity with its associ-
that the prevalence of myocardial infarction, angina pectoris, ated comorbid conditions may lead to early graft failure and
percutaneous coronary intervention, and coronary artery poor outcome including death after transplantation [26].
bypass graft to be as high as 11.5 % in morbidly obese There are several studies that demonstrate that bariatric sur-
women (BMI > 40). Thus, it is easy to understand that gery can be a safe and effective means of weight loss after
patients with higher BMIs are at a higher risk for periopera- organ transplantation [27, 28]. In this patient population,
tive events. active comanagement with the transplant team is essential
However, with minimally invasive techniques and shorter for good patient outcomes. Immunosuppressive medication
operative times, skilled bariatric surgeons are able to safely levels need to be followed closely in the perioperative period.
perform weight loss surgery on patients that have very poor And to ensure consistent immunosuppressive medication
44. The High-Risk Bariatric Patient 421
dosing despite variable oral intake, a gastrostomy tube the surgeon to more comprehensively and realistically esti-
should strongly be considered at the time of the bariatric mate the amount of risk that each patient is incurring. In
surgery. addition, the surgical team can be better prepared for compli-
cations, should they arise, and have the appropriate consul-
tants involved with the perioperative care of the patient.
Revisional Surgery True risk seems to be a dynamic interaction between the
Revisional bariatric surgery is discussed in depth in previous patient’s physical health, medical history, surgeon’s skill,
chapters. However, in analyzing revisional surgery with type of surgery, operative team’s experience, and medical
regard to risk, Sarr et al. from Mayo Clinic performed the assets available at the medical institution that the surgery is
largest analysis of revisional bariatric surgery outcomes [29]. being performed. The very high-risk patients should not nec-
They evaluated 218 patients that underwent revisional bariat- essarily be denied surgery, as long as they can have their sur-
ric surgery (open revisions) and they reported a 0.9 % mor- gery at institutions with the capabilities to address the
tality rate and a 26 % serious operative morbidity rate. As specific factors that make the patient high risk. Further inno-
expected, this is much higher than the traditionally quoted vations in the surgical treatment for obesity will continue to
rates for primary (non-revisional) bariatric surgery [3]. These focus on procedures that decrease risk to patients, while pro-
rates are consistent with other similar studies [30]. In the viding excellent long-term weight loss.
series presented by Mayo Clinic, it is important to note that
all the revisional surgery was performed by experienced bar-
iatric surgeons. Because of the distorted anatomy and exten- Review Questions and Answer
sive scarring that is present in revisional surgery, the risk
factor is indirectly related to surgeons’ experience perform-
1. Which of the following is not included in the Obesity
ing such complicated surgeries.
Mortality Risk Scoring System:
(a) BMI
Psychiatric Disorders (b) Age
One of the contraindications for bariatric surgery is uncon- (c) HTN
trolled psychiatric disorders that would preclude the patient (d) Gender
from having coping skills necessary or support structures in (e) PE risk
place to handle the psychologic stressors of bariatric surgery (f) Serum creatinine
(ASMBS position statement on presurgical psychologic test-
ing 2004). However, for patients that have psychologic disor- Answer: f
ders that are controlled, there are some studies that suggest 2. True or False: In published studies, gender has not been
that even these patients have suboptimal weight loss when found to contribute to increased risk for adverse
compared to patients that do not have an Axis I or II diagno- outcomes
sis (according to the Diagnostic and Statistical Manual of Answer: false
Mental Disorders). When offering surgery to these patients, 3. Obstructive sleep apnea has been found to be associated
it is important to have active engagement with the patient’s with all of the following, except:
psychiatric team for smooth transition and medication moni- (a) Reintubation
toring during the perioperative period. (b) Need for mechanical ventilation
(c) Hypoxemia
(d) Transfer to ICU
Life Style Risk Factors
(e) Prolonged hospital stay
There are many modifiable lifestyle factors that can increase (f) Death
a patients risk for perioperative events. Smoking and seden- Answer: h
tary lifestyle have been found to be the most directly related
to adverse outcomes after surgery [31]. Preoperative educa-
tion and postoperative follow-up targeted toward addressing
these risk factors can mitigate these risks.
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45
Long-Term Mortality After Bariatric Surgery
Aaron D. Carr and Mohamed R. Ali
According to the 2009 US Centers for Disease Control of HTN in 61.7 %, DYS in 83.6 %, DM in 76.8 %, and
and Prevention vital data report, a total of 2,437,163 deaths obstructive sleep apnea in 61.7 % of patients [22]. In the spe-
occurred in the United States. Of those deaths, 24.6 % were cific context of patients with metabolic syndrome, Roux-
related to heart disease, 23.3 % to malignant neoplasm, en-Y gastric bypass (RYGB) has been shown to reduce the
5.6 % to respiratory disease, 4.8 % to accidents, 2.8 % to severity of DM in 75 % of patients, HTN in 69.4 %, and DYS
diabetes, 1.5 % to suicide, 1.3 % to liver disease, and 1.1 % in 76.4 % of patients as early as 2 months postoperatively
to hypertension [12]. As indicated, a number of these leading [23]. Complete remission, among these patients, was
causes of mortality are associated with severe obesity and are observed in 65.3 % with DM, 51.4 % with HTN, and 73.6 %
more prevalent among obese individuals than among non- with DYS up to 1 year postoperatively [23]. Bariatric surgery
obese individuals. It is inherently difficult to ascertain a sin- has also been shown to reduce the prevalence of metabolic
gular risk of mortality for a given comorbidity, because syndrome from 87 to 29 % compared to medical manage-
all-cause mortality is multifactorial and likely results from ment, which can only achieve a minor reduction from 85 to
the interaction of various comorbidities. Furthermore, mor- 75 % [14]. The dramatic improvement in obesity-related
tality is not only a function of the incidence and prevalence comorbidities is the primary driving force behind the
of disease, but of the severity of illness at diagnosis and the decrease in disease-related mortality experienced by patients
effectiveness of treatment. who undergo bariatric surgery.
Therefore, the relationship between body mass and mor-
tality is not always readily discernable. This is well-illustrated
by CVD, the primary disease-related cause of death in the Mortality After Bariatric Surgery
United States. The major risk factors for CVD are DM, HTN,
DYS, and renal impairment. DM is one of the more signifi- The case for mortality benefit following bariatric surgery has
cant risk factors for CVD and, alone, increases the morbidity been historically based on the hypothesis that significant
and mortality of CVD as much as 29 times compared to non- improvement in obesity-related comorbidities would trans-
diabetics with CVD [13]. In addition, metabolic syndrome late into reduced end-organ injury and, ultimately, improved
marks the “perfect storm” of comorbidities for CVD and is health and increased survival. Despite widespread accep-
defined by increased serum triglycerides (TG), low serum tance, the premise that weight loss and associated comorbid-
high-density lipoprotein cholesterol (HDL-C), elevated blood ity improvements following bariatric surgery would decrease
pressure, increased fasting plasma glucose, and increased long-term mortality (5 or more years after surgery) in obese
waist circumference [14]. Clearly, the obese patient is at sig- individuals had, until recently, been subjected to surprisingly
nificant risk for metabolic syndrome and CVD. little specific scientific evaluation. Long-term mortality can
Furthermore, body mass, as an individual factor, can sig- be viewed within the context of specific procedures, namely,
nificantly impact mortality. According to recent estimates, adjustable gastric banding (AGB), vertical sleeve gastrec-
life expectancy may be reduced by 7.1 years in nonsmoking tomy (VSG), biliopancreatic diversion (BPD) with or with-
obese women and by 5.8 years in nonsmoking obese men as out duodenal switch (DS), and RYGB, or in terms of the
compared to their normal-weight counterparts [4]. Individuals effects of bariatric surgery overall.
with BMI ≥ 30 kg/m2 have a 20–179 % increase in premature
death compared to a healthy-weight cohort [15, 16]. Obesity
accounts for a 40 % increase in mortality attributable to Adjustable Gastric Banding
CVD, a 60 % increase in mortality from DM, and a 10 %
increase in cancer-related deaths [17]. Thus, obesity increases AGB is a safe and effective weight loss operation with very
the incidence of most major causes of death [12]. low perioperative mortality [24]. While the long-term out-
comes of AGB can be confounded by a number of variables,
several of these issues deserve specific mention. First, there
Comorbidity Response to Bariatric are a variety of bands made by a number of manufacturers.
Surgery Second, the technology of AGB has changed, such that cur-
rent bands are technologically quite different than previous
Currently bariatric surgery is the only effective treatment for generations. Third, the technical aspects of AGB placement
obesity class II or greater. The annual number of bariatric have evolved over the years, most notably illustrated by the
operations increased exponentially from 12,775 cases in change from perigastric to pars flaccida technique and more
1998 to over 220,000 cases in 2008 [18, 19]. During this time deliberate diagnosis and treatment of concurrent hiatal her-
period, the proportion of operations performed laparoscopi- nia [25, 26]. Finally, the weight loss success and health
cally has increased, and overall morbidity and mortality have improvement following AGB is highly dependent on postop-
decreased [20]. Patients who undergo bariatric surgery can erative management [27]. Although these limitations increase
experience resolution of the major comorbidities related to the heterogeneity of study conditions in this literature, there
obesity [21]. Bariatric surgery results in individual remission is strong evidence that AGB is safe and can lead to a survival
45. Long-Term Mortality After Bariatric Surgery 425
benefit in morbidly obese patients. The Australian experi- 0.5 % of cases and only one patient had to be converted to
ence of O’Brien et al. has contributed significantly to the cur- RYGB for stenosis. VSG patients were also able to achieve
rent literature regarding AGB. In an early report contrasting sustained excess weight loss of 86.8 % ± 27.1 % at 3 years
996 AGB patients to 2,119 obese individuals, AGB reduced and had significant improvement in metabolic biochemical
mortality risk by 72 % (10.6–0.4 %) at 4 years [28]. A recent parameters. This profile of safety and efficacy of LVSG
update to this experience revealed that the survival benefit resulted in 0 % mortality during adequate postoperative fol-
with AGB continued to 10 years [29]. The authors affirmed low-up at 1 (81.8 %), 2 (74.7 %), and 3 (71.7 %) years [36].
the safety of AGB by reporting 0 % perioperative mortality A much smaller study followed only 20 patients who under-
among 3,227 cases. This chapter also provided longer fol- went LVSG but was able to achieve 100 % follow-up at 3
low-up on the original cohort of 996 AGB patients and years with 0 % mortality [37]. The low power of this study
reported the same 0.4 % mortality at 10 years with 98 % clearly compromises its generalizability to the general popu-
follow-up for deaths. The four deaths in 10 years occurred lation of bariatric surgery patients [37].
from cancer (n = 2), suicide (n = 1), and CVD (n = 1) [29]. The excellent mortality results for VSG have also been
Similar low mortality rates following AGB have been shown in high-risk patients. In a recent study, VSG was
reported. At 5 years post-surgery, a significantly lower mor- designed as a first-stage therapy in class V obese patients
tality rate was identified in AGB patients (0.97 %) than (mean BMI = 66 kg/m2) [38]. Although the original intention
matched nonoperative controls (4.38 %) [30]. At the same was to proceed with second-stage conversion to RYGB, 75
5-year follow-up interval, another group identified a mortal- patients (60 %) were able to achieve 48 % excess weight loss
ity risk of 0 % among surgical patients and 2.5 % among with VSG as a single procedure [38]. With 93 % follow-up at
matched controls [31]. The same study also reported a non- a mean of 6 years postoperatively, this study also demon-
controlled mortality rate of 0 % in 1,791 AGB patients up to strated 0 % mortality [38].
12 years after surgery [31]. Additional data without control
groups revealed long-term mortality at a mean of 7 years
post-AGB to range from 0.2 to 2 % [32, 33]. Biliopancreatic Diversion
Even studies which report a high reoperation rate corrob-
orate the low long-term mortality risk associated with No case-controlled studies of long-term mortality following
AGB. At 13 years of follow-up (54.3 % of eligible patients), BPD with or without DS have been performed. In a case
a significant proportion of patients (59.8 %) required reop- series of 74 patients undergoing BPD, with excellent follow-
eration following AGB while the mortality was only 3.7 %. up of 93.7 % between 4 and 8 years postoperatively, data
Furthermore, the three deaths were not directly related to were collected for weight loss, changes in comorbidities,
health risks of obesity or operative factors (melanoma, lung nutritional deficiencies, morbidity, and mortality [39]. This
cancer, and suicide) [34]. As a consensus statistic, a review study demonstrated 0 % perioperative deaths and 1.35 %
of seven studies, with adequate long-term follow-up after long-term mortality. The single death during the study period
AGB, revealed only one death in 6,177 patients (mortality of was unrelated to bariatric surgery and occurred as a
0.02 %) over 10 years [29]. consequence of breast cancer [39].
A large series of 1,423 patients evaluated the outcomes of
BPD-DS in terms of change in body mass, improvement in
Vertical Sleeve Gastrectomy medical conditions, nutritional issues, complications, and
mortality [40]. BPD-DS was performed via the open tech-
VSG has only recently gained significant traction as a pri- nique early in the study and subsequently switched to lapa-
mary bariatric procedure. The original case for VSG was roscopy. The authors were able to achieve follow-up on 93 %
made as the first stage of two-stage RYGB in high-risk bar- of patients at a mean of 7.3 years and reported specific causes
iatric patients [35]. In the relatively short period since the of mortality. The patient population, which had a mean age
original reports, data have been amassed to support the safety of 40.1 ± 10.5 years and mean BMI of 51.5 ± 9.9 kg/m2, expe-
and efficacy of VSG. However, there are currently no long- rienced a mortality rate of 8 % [40]. However, the authors
term case-controlled mortality data on VSG. only attributed 20 % of the deaths to surgery (malnourish-
Existing studies which evaluate long-term outcomes fol- ment, delayed operative death, reoperation, intestinal
lowing VSG are largely retrospective. The largest study com- obstruction, and gastrointestinal hemorrhage). Long-term
pared 811 VSG patients to 786 RYGB patients for mortality unrelated to surgery resulted from cancer, trauma,
complications and mortality at 1, 2, and 3 years [36]. suicide, pulmonary insufficiency, pulmonary embolus, and
Although patients who underwent VSG had a relatively low sudden death [40].
mean BMI (37.9 ± 4.6 kg/m2), VSG was associated with low Several other non-case-controlled studies have examined
operative time (76.6 ± 28 min), short hospital stay the mortality after BPD-DS at several years follow-up. The
(2.8 ± 0.8 days), and low complication rates (early = 2.9 % largest study had a group of 1,300 BPD-DS patients that
and late = 3.3 %) [36]. Specifically, leaks occurred in only were followed from 1 to 15 years and reported mortality of
426 A.D. Carr and M.R. Ali
0.57 % [41]. A similarly low mortality rate of 0.74 % was number of control patients (matched for age, gender, and
identified in 540 patients, half of whom underwent BPD BMI) were evaluated over 7 years. While the reduction in
while the other half underwent BPD-DS, followed for a mortality following RYGB was significantly lower, mortality
mean of 7.4 years [42]. Large surgical experiences seem to in both groups was lower than other studies (2.7 % in the
corroborate these low mortality rates. A study of 1,000 surgery group vs. 4.1 % in the control group) [50]. Another
patients with BPD-DS reported mortality of 0.2 % with a recent report identified a 5-year mortality of 1.8 % following
90 % follow-up at a mean of 2 years [43]. Another multi- LRYGB [51].
center report of 874 patients found a mortality rate of 0.8 % These overall mortality data are most notable in that the
at a mean follow-up of 11.9 years [44]. Smaller series have reduced rates for surgical patients also inherently contain
reported higher rates of mortality, such as 3.9 % in 51 patients all mortality-associated surgery and related complications.
who underwent BPD-DS with 92 % follow-up for 5 years When specifically investigated, mortality within the first
[45]. Although somewhat larger with 190 patients, another year following surgery was essentially identical between
investigation reported 2.8 % mortality at 3.7 years with RYGB patients (0.53 %) and matched obese individuals
93.7 % follow-up [46]. (0.52 %), underscoring the safety of current bariatric surgi-
cal practice [50]. In this vein, the transition from open
RYGB to laparoscopic RYGB has fundamentally changed
Roux-en-Y Gastric Bypass the safety profile of this operation. In a review of nine stud-
ies which reported a mortality rate of 0.8 % at 10 years
RYGB enjoys a robust body of literature that has examined among 2,684 RYGB patient, all deaths occurred during the
the outcomes of this procedure over five decades. Numerous open bypass era [29].
studies have elucidated the efficacy of RYGB in achieving The positive impact of RYGB on mortality is most promi-
and maintaining meaningful weight loss. Additionally, the nent in patients with significant comorbidities related to obe-
beneficial effects of RYGB on obesity-related medical con- sity. Death attributable to CVD is reduced by 56 % in patients
ditions have become well established. Mortality following who undergo RYGB [50]. Similarly, mortality related to DM
RYGB has been primarily studied from the perspective of decreases by 92 %, and mortality related to cancer dimin-
surgical safety and has focused heavily on early postopera- ishes by 60 % [50]. Men also seem to derive a greater mortal-
tive results. Thus, sufficiently powered randomized con- ity benefit than women (56 % reduction vs. 32 % reduction)
trolled data that address long-term mortality and are specific [50]. It is hypothesized that this difference may be due to a
to RYGB are virtually nonexistent. Furthermore, studies higher prevalence of medical conditions responsive to
with case-matched controls involve primarily open RYGB, RYGB, such as CVD, in morbidly obese male patients.
while one case series with exclusively laparoscopic RYGB However, the rate of death from accidents and suicide has
comments on long-term mortality. been reported to be 58 % higher in RYGB patients [50].
One of the earlier studies followed 154 patients who under- These affirmative data certainly seem to point to a distinct
went RYGB and found a mortality rate of 9 % up to 9 years survival advantage as a response to RYGB in morbidly obese
postoperatively. This represented a significant improve- patients. However, a number of potential confounding issues
ment when compared with the control group of 78 mor- exist. Most prominent among these is the lack of data on
bidly obese patients who did not have surgery and exhibited comorbidity severity among RYGB patients or among the
a mortality rate of 28 % up to 6.2 years of follow-up [47]. control groups of obese individuals. Similarly, there are no
An identical mortality rate of 9 % was reported by another indications as to whether or not surgical patients may have
study of 233 patients who underwent RYGB and were fol- received more aggressive treatment of comorbidities.
lowed for 10 years postoperatively [48]. This investigation Additionally, patients who undergo surgery may be more
benchmarked surgery patients against a large group of predisposed to seeking and adhering to medical care. Finally,
11,132 morbidly obese individuals in the general popula- the demonstrable increase in deaths not related to disease
tion followed for the same 10-year interval and determined among RYGB patients has not been fully evaluated. While it
a significant reduction in long-term mortality as compared is unclear whether such factors would appreciably impact the
to the approximately 12 % mortality rate observed in the survival benefit observed following RYGB, they certainly
control group [48]. Similar results have been identified by warrant consideration and further study. Variability in mor-
noncomparative descriptive data, illustrated by a report of tality reduction has been reported in high-risk patients under-
8 % all-cause mortality among 1,025 RYGB patients fol- going RYGB. Advanced age, high BMI, and male gender
lowed for 2–12 years [49]. have been identified as risk factors for poor surgical out-
More recent data corroborate the significant reduction in comes, including complications and perioperative mortality
long-term mortality (40 %) for morbidly obese individuals [52, 53]. High-risk patients who undergo RYGB experience
who undergo RYGB [50]. These data are based on a large a 36 % reduction in mortality over 7 years [54]. After adjust-
experience with RYGB in 7,925 patients operated during an ment for covariates, this benefit drops to 20 % but remains
18-year experience. Surgical patients and an identical statistically significant. However, the mortality improvement
45. Long-Term Mortality After Bariatric Surgery 427
loses statistical significance when compared to a matched 0.68 % for the surgical cohort compared to 6.17 % for the
cohort (17 %) and when corrected for follow-up interval control group at 5 years [57].
(6 %) [54]. It should be noted that within these data lie a rela- Perhaps the most robust data set regarding bariatric sur-
tively high perioperative mortality rate of 1.5 %. This gery comes from the Swedish Obese Subjects (SOS) study.
accounts for 86.6 % of deaths at 1 year, 59 % of deaths at 2 The SOS has addressed mortality in a long-term prospective
years, and 19.4 % of deaths at 6 years. Furthermore, while case-controlled fashion. In a report that contrasted 2,010
the hazard ratios may not have been significant, RYGB patients who underwent bariatric surgery (RYGB 13 %,
patients exhibited decreased mortality rates at 1 year (1.5 % VBG 68 %, and AGB 19 %) to 2,037 patients who received
vs. 2.2 %), 2 years (2.2 % vs. 4.6 %), and 6 years (6.8 % vs. conventional treatment for obesity and related comorbidities,
15.2 %) when compared to unmatched obese patients [54]. the overall mortality was 5.0 % in the surgery group and
Although early survival was not statistically different when 6.3 % in the control group [58]. The corresponding 24 %
benchmarked against matched obese individuals at 1 and 2 reduction in mortality was observed at a mean follow-up of
years, a significant reduction was identified at 6 years (6.7 % 10.9 years [58].
vs. 12.8 %) [54]. Thus, the interpretation of survival benefit In addition to its breadth, the SOS data collection was
following RYGB in high-risk patients must include three also specific and detailed. The patients in both groups were
critical variables: optimization of physiologic status to well-matched for anthropomorphic and demographic char-
reduce higher than average perioperative mortality risk, acteristics. All patients were evaluated at regular intervals,
potential quality of life gains associated with weight loss, up to 15 years, indexed to the timing of operation of patients
and comorbidity improvement and evidence that a signifi- in the surgery group. Evaluation consisted of anthropomor-
cant survival advantage may not be realized until a long post- phic, physiologic, comorbidity, and biochemical assess-
operative interval. ments. The investigators were able to achieve excellent
As further illustration, 908 patients underwent RYGB and follow-up at 2, 10, and 15 years of 94, 84, and 66 % for the
were followed for a mean of 4.4 years [55]. When contrasted surgical arm and 83, 75, and 87 % for the control group [58].
to a control group of 112 obese individuals followed for a Although the 90-day mortality following bariatric surgery
mean of 3.6 years, surgical patients exhibited significantly was low (0.25 %), it was higher than mortality in the control
reduced overall mortality rate of 2.9 % as compared with group (0.10 %) [58]. However, surgical patients gained sur-
14.3 % in the control group. These investigators reported that vival benefit as the duration of follow-up increased. In terms
the mortality curves diverged more greatly with increasing of cause-specific mortality, surgical patients had less death
length of follow-up [55]. due to CVD (2.14 % vs. 2.6 %) and noncardiovascular causes
Another notable obstacle to determining long-term mor- (2.88 % vs. 3.7 %) [58]. Cancer-related mortality dropped
tality following RYGB (and bariatric surgery in general) is from 2.36 % in control patients to 1.44 % in surgical patients
the inconsistent and often low rate of long-term patient fol- [58]. The greatest predictor of overall mortality was history
low-up. Few studies can document excellent patient follow- of myocardial infarction or stroke, which corresponded to
up at many years postoperatively. Furthermore, many studies mortality risk of 19.6 % in the surgical group and 24.5 % in
of bariatric surgical outcomes do not specifically address the the control group [58]. Other factors shown to increase risk
adequacy of patient follow-up. When patient follow-up has of death among all patients included advanced age, smoking,
been reported, it has frequently been quite low in the long increased plasma triglycerides, and increased blood glucose.
term as exemplified by a study which found an overall mor- Body mass also affected mortality in that more severely
tality rate of 3.3 % but only had follow-up of 33 % at 2 years obese patients (BMI ≥ 40 kg/m2) realized a greater reduction
and 26 % at 10 years [56]. in mortality (30 %) in response to bariatric surgery than
patients with BMI below 40 kg/m2 (20 %) [58].
Taken together, AGB and RYGB are quite effective at
reducing mortality associated with obesity. A recent meta-
Overall Effect of Bariatric Surgery analysis identified eight case-controlled clinical trials that
on Mortality compared 44,022 bariatric surgery (RYGB or AGB) patients
to a control cohort of 29,970 obese individuals to an average
It is undeniable that bariatric operations have varying mecha- follow-up of 7 years [59]. The type of operation (RYGB or
nisms of achieving weight loss and effects on obesity-related AGB) did not statistically affect global mortality or all-cause
comorbidities. Yet, bariatric surgery has been repeatedly mortality. Surgical patients exhibited reduced global mortal-
shown to improve overall health in morbidly obese patients ity (50 %), cardiovascular mortality (42 %), and all-cause
regardless of the specific operation [57, 58]. Within this con- mortality (30 %) [59]. RYGB more significantly reduced
text, the generalized effects of bariatric surgery on overall CVD mortality than AGB (52 % vs. 29 %), presumably
and disease-specific mortality have been evaluated. In a large related to its metabolic effects on DM [59]. In terms of abso-
series of RYGB and vertical banded gastroplasty (VBG) lute rates, overall mortality was 2.84 % in the surgical group
with case-matched controls, the reported mortality was and 9.73 % in the control group [59].
428 A.D. Carr and M.R. Ali
TABLE 1. Mortality following restrictive procedures TABLE 2. Mortality following biliopancreatic diversion
Follow-up Follow-up
Study N Mortality (%) (years) Procedure Study N Mortality (%) (years) Procedure
Busetto et al. (2004) Guedea et al. (2004) 74 1.4 4–8 BPD
Surgery 821 0.97 5 AGB Hess et al. (2005) 1,300 0.6 1–15 BPD-DS
Control 821 4.4 5 Marceau et al. (2007) 1,423 8 7.3 BPD-DS
Peeters et al. (2007) Crea et al. (2011) 540 0.7 7.4 BPD/BPD-DS
Surgery 996 0.4 4 AGB Biertho et al. (2011) 1,000 0.2 2 BPD-DS
Control 2,119 10.6 4 Topart et al. (2011) 51 3.9 5 BPD-DS
Pata et al. (2012) 874 0.8 11.9 BPD-DS
Miller et al. (2007)
Dorman et al. (2012) 190 2.8 3.7 BPD-DS
Surgery 554 0.2 7.6 AGB
Control N/A BPD biliopancreatic diversion, DS duodenal switch
Favretti et al. (2007)
Surgery 821 0 5 AGB
Control 821 2.5 5 TABLE 3. Mortality following Roux-en-Y gastric bypass
Stroh et al. (2011) Study N Mortality (%) Follow-up (years)
Surgery 200 2 7.8 AGB
McDonald et al. (1997)
Control N/A
Surgery 154 9 9
Himpens, et al. (2011) Control 78 28 6.2
Surgery 82 3.7 13 AGB
Sugerman et al. (2003)
Control N/A
Surgery 1,025 8 2–12
Boza et al. (2012) Control N/A
Surgery 811 0 3 VSG
Flum et al. (2004)
Control N/A
Surgery 233 9 10
Sarela et al. (2012) Control 1,131 16 15
Surgery 20 0 3 VSG
Sowemimo et al. (2006)
Control N/A
Surgery 908 2.9 4.4
Eid et al. (2012) Control 112 14.3 3.6
Surgery 75 0 6 VSG
Adams et al. (2007)
Control N/A
Surgery 7,925 2.7 7
AGB adjustable gastric band, VSG vertical sleeve gastrectomy Control 7,925 4.1 7
Maciejewski et al. (2011)
Surgery 847 6.8 6
Summary Control 847 15.2 6
Suter et al. (2011)
Obese individuals often suffer from associated comorbidi- Surgery 379 1.8 5
ties. Left untreated, these medical consequences of obesity Control N/A
can cause end-organ injury and resultant mortality. Bariatric Higa et al. (2011)
surgery is the best current means of achieving and maintain- Surgery 242 3.3 10
Control N/A
ing significant weight loss [18, 19]. Surgery also effectively
treats many of the medical conditions associated with obe-
sity as a consequence of weight loss and by weight-loss- 10-year mortality of 5 % compared to 6.3 % in the control
independent mechanisms. Thus, bariatric surgery is group [58].
hypothesized to significantly reduce mortality, in large part, The procedures that include intestinal bypass (BPD and
by improving comorbidities of obesity. The mortality benefit RYGB) have metabolic effects that act synergistically with
derived from the various bariatric operations is likely related weight loss to improve medical comorbidities. The mortality
to the comorbidity severity of the individual patients as well reduction data for these operations are summarized in
as the metabolic effects of each procedure. Tables 2 and Table 3. BPD with or without DS has a reported
The restrictive procedures (AGB and VSG) exert their a mortality of 0.2–8 % at mean follow-up of 2–12 years
comorbidity effects primarily as a function of weight loss, (Table 2) [36–43]. RYBG had the most data available. The
and their mortality reduction data are summarized in Table 1. long-term mortality ranged from 1.8 to 9 % at a mean follow-
The long-term mortality for AGB ranged from 0 to 3.7 % up of 4.4–10 years compared to a control mortality rate of
with a range of mean follow-up of 5–13 years, while the 4.1–28 % during a similar follow-up period (Table 3) [29,
respective controls had mortality of 2.5–10.6 % [28–34]. 46–51, 54].
VSG also demonstrated a low long-term mortality at mean Studies that reviewed aggregated mortality of bariatric
follow-up of 3–6 years, although the data were much less surgery across multiple procedures are summarized in
established, not case controlled, and relatively shorter term Table 4. The overall long-term mortality rate for bariatric
[36–38]. As observed in the SOS, VBG is associated with surgery ranged from 0.68 to 5 % and was significantly lower
45. Long-Term Mortality After Bariatric Surgery 429
TABLE 4. Mortality In mixed studies 3. What is the proposed mechanism by which bariatric sur-
Follow-up gery reduces long-term mortality?
Study N Mortality (%) (years) Procedure (%)
A. Weight loss
Christou et al. (2004)
B. Improvement in comorbidities
Surgery 1,035 0.68 5 RYGB (81.3)
Control 5,746 6.17 5 VBG (18.7) C. Decrease in cancer incidence
Sjostrom et al. (2007) D. Multifactorial
Surgery 2,010 5.00 10.9 AGB (19) E. All of the above
Control 2,037 6.30 10.9 VBG (68)
RYGB (13)
Answer: E
4. Which of the following is the greatest predictor of overall
RYGB Roux-en-Y gastric bypass, VBG vertical banded gastroplasty, AGB mortality following bariatric surgery?
adjustable gastric band
A. Previous surgery
B. History of myocardial infarction
than control mortality of 6.17–6.3 % at 5–11 years after sur- C. BMI > 50 kg/m2
gery [57, 58]. D. Type II diabetes mellitus
Accurate determination of long-term mortality following Answer: B
bariatric surgery can be hindered by several limitations that
pervade the current body of literature. First, most of the stud-
ies are not case controlled, while randomized trials are even
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46
Gastroesophageal Reflux Disease
in the Bariatric Surgery Patient
Maria Altieri and Aurora Pryor
Gastroesophageal Reflux Disease The position is also important, since this determines what
length is exposed to the positive intra-abdominal pressure.
Gastroesophageal reflux disease, GERD, is a chronic condition If the intra-abdominal length of the esophagus is decreased,
that is defined as “a condition that develops when the reflux of as in cases such as the presence of a hiatal hernia, then
stomach contents causes troublesome symptoms and/or com- there will be less pressure exerted on the LES, which can
plications.” It is the most common gastrointestinal diagnosis lead to reflux.
recorded during visits to outpatient clinics in the United States
and affects approximately 19 million Americans (1). Symptoms
include heartburn, regurgitation, dysphagia, and chest pain and Association Between GERD
can range from mild to severe. Those patients with severe and Obesity
symptoms usually seek medical attention.
GERD-related complications include erosive esophagitis, Obesity is a serious health problem in the United States.
aspiration, Barrett’s esophagus, and esophageal adenocarci- Two-thirds of adults are overweight (BMI > 25 kg/m2) or
noma. In the United States, these conditions have been increas- obese (BMI > 30 kg/m2) (6). While obesity has been impli-
ing, as the incidence of esophageal adenocarcinoma has cated as a cause for a lot of serious diseases, it is strongly
increased fourfold over the past several years (2, 3). The exact associated with the development of GERD. Studies looking
reason for the increase in GERD and these conditions is not at the prevalence of GERD in the obese population have
fully understood, but changes in diet, smoking, alcohol use, found a combined incidence of between 39 % in a large
and prescription medications have been implicated. study at the Houston VA Medical Center and 53 or 61 % in
Interestingly, with a recently observed increase in obesity, there two smaller studies (7–9).
is a parallel increase in the development of esophageal adeno- Other studies have looked into the odds ratio (OR) for the
carcinoma, and a relationship has been hypothesized (4). development of GERD in the obese population, which has a
GERD is a multifactorial disease in which both functional range between 2.6 and 6.3 (10–12). Nocon et al. studied
and anatomical factors play a role. The main mechanism 7,124 subjects in Germany and confirmed the relationship
implicated is attributed to transient lower esophageal sphincter between reflux symptoms and being overweight or obese
relaxation (TLESR) (5). The lower esophageal sphincter (odds ratio 1.8, 95 % confidence interval; odds ratio 2.6,
(LES) provides the barrier between the esophagus and the 95 % confidence interval, respectively) (10). The Bristol
stomach, and it prevents gastric contents from entering the helicobacter project similarly showed that patients with
esophagus. Three characteristics of the LES are attributed to BMI > 30 kg/m2 have an adjusted odds ratio of 1.8 of experi-
keep its function: pressure, overall length, and position. The encing weekly symptoms of reflux. The group studied 10,537
LES is associated with a high-pressure zone to prevent the subjects, age 20–59 in Southwest England (11).
regurgitation of gastric contents, except in two cases: after A variety of pathophysiological mechanisms have been
swallowing to allow the passage of food and when the fundus proposed to explain the association between GERD and obe-
is distended with gas, to allow the elimination of gas. The sity. These can be divided into abnormalities associated with
pathology of GERD is associated with abnormal relaxation of the esophagus, gastroesophageal (GE) junction, or stomach,
the LES, thus allowing contents to enter the esophagus. The and they include esophageal and gastric motility disorders
resistance of the LES is a combination of both its pressure and (13–16), increased abdominal pressure, diminished LES
the length over which the pressure is exerted, and in GERD pressure (13, 17), increased frequency of TLESRs (18), and
both of these mechanisms of protection will be impaired. the presence of hiatal hernia (9, 17).
Roux-en-Y Gastric Bypass and GERD 1997 to 2003, mean BMI of 46.5 kg/m2. Upper endoscopy was
performed in 18 patients after 30 months showing a high
The underlying mechanism for RYGB has been used as a prevalence of esophagitis. Postoperative esophageal pH-
stand-alone reflux procedure: gastric volume reduction and manometry was performed in 16 patients and was pathologic
rapid emptying into the small bowel. Several studies have in 43.8 % of the cases. The group concluded that the inci-
shown that GERD either improves or completely disappears dence of gastroesophageal reflux and esophagitis remains
after RYGB. Frezza et al., in a study of 435 patients undergo- increased after laparoscopic gastric banding (34). These
ing laparoscopic Roux-en-Y gastric bypass (LRYGB), in results were similar to those by Ovrebo et al., Westling et al.,
which 55 % had evidence of chronic GERD, showed that and Suter et al. Overall, the mechanism by which this proce-
there was a significant decrease in GERD-related symptoms, dure may lead to poorer outcomes in reducing the incidence
including heartburn (from 87 to 22 %, P < 0.001), water of GERD is not well understood. However, it is thought that
brash (from 18 to 7 %, P < 0.05), wheezing (from 40 to 5 %, postoperative reflux may be attributed to an unrecognized
P < 0.001), laryngitis (from 17 to 7 %, P < 0.05), and aspira- hernia at the time of procedure or inappropriate (overly tight)
tion (from 14 to 2 %m P < 0.01). The researchers concluded adjustment regimens.
that this procedure provides a very good control of GERD in Other studies have shown that laparoscopic adjustable
morbidly obese patients during the 3-year study. The authors gastric banding improves pH and symptoms. De Jong et al.
proposed that in addition to volume reduction and rapid studied 26 patients who underwent gastric banding. The
egress, the mechanism of how LRYGB affects symptoms of patients were assessed by 24-h pH monitoring, endoscopy,
GERD is through weight loss and elimination of acid pro- and barium swallow, preoperatively, at 6 weeks, and at 6
duction in the gastric pouch. The gastric pouch lacks parietal months. The group concluded that this procedure generally
cells; thus, there is no acid production, and also, due to its decreases GERD symptoms, as they claimed that the antire-
small size, it minimizes any reservoir capacity to promote flux effect of a proximally placed gastric band is due to creat-
regurgitation (24). ing a longer intra-abdominal pressure zone or by pulling the
Similar results have been reported in other studies. Smith stomach more in the abdomen in the presence of a hiatal her-
et al. found a significant reduction in reflux symptoms after nia. They also hypothesized that the pouch formation is a
RYGB with or without distal gastrectomy and gastropexy. In crucial determining factor in the occurrence of symptoms
their study of 188 patients who were followed up to 4 years, after the procedure, as newer techniques advocate for a
there was a significant decrease in symptoms, as only 14 “virtually-no-pouch” procedure with placement of the band
patients reported the need for medication postoperatively (31). at or near the gastroesophageal junction. This high place-
Jones compared Nissen fundoplication to RYGB in reflux ment can still lead to pouch formation and possible dilatation
patients with BMI under 35. RYGB was done primarily as an of the esophagus, which can lead to concomitant esophageal
antireflux procedure in 332 patients from 1987 to 1996. motility disorders. They showed that the presence of a pouch
Postoperatively only one patient was symptomatic (32). leads to esophagitis (35).
Varela et al. compared laparoscopic fundoplication with lap- Tolonen et al. also studied the relationship between gas-
aroscopic gastric bypass in morbidly obese patients in terms tric banding and GERD. The study included 31 patients who
of mean length of stay, observed mortality, risk-adjusted underwent gastric banding. The patients were monitored
mortality, and hospital costs and concluded that LRYGB is using 24-h pH tests, symptom assessment, and upper GI
as safe as laparoscopic fundoplication in the treatment of endoscopy. The number of reflux episodes significantly
GERD in this group of patients (33) and it may provide addi- decreased postoperatively (44.6 ± 23.7 SD to 22.9 ± 17.1 SD,
tional health-related benefits. P = 0.0006) after 19 months, symptoms decreased from 48.3
to 16.1 % (P = 0.01), and the diagnosis of GERD on 24-h pH
recordings decreased from 77.4 to 37.4 % (P = 0.01). No
Gastric Banding and GERD
pouch enlargement was noted on upper GI endoscopy. The
Since its FDA approval in 2001, the gastric band has rapidly researchers concluded that a gastric band that is correctly
become a popular bariatric procedure for obese patients due placed is associated with the effective treatment of GERD
to its simplicity, lack of reconstruction, and perceived safety symptoms. They also hypothesized that these results were
profile. However, conflicting results have been published due to incomplete relaxation of the LES. No correlation
about the effect of gastric banding on GERD. A few studies between gastric band and esophageal motility was discov-
have shown that the incidence of GERD is still increased ered. The group also felt that the antireflux effect may be
after gastric banding; however, the majority of the literature mechanical, as the band may provide a narrowing at the
suggests that in fact symptoms and pH improve after the pro- region of the gastroesophageal junction similar to the histori-
cedure. In fact an overly tightened band can induce reflux. cal Angelchik prosthesis (36).
One study, done by Gutschow et al., reported worsening of Due to the conflicting results of studies looking into lapa-
reflux symptoms. In the study, 31 patients were followed from roscopic adjustable gastric banding and GERD, many surgeons
46. Gastroesophageal Reflux Disease in the Bariatric Surgery Patient 437
would not recommend this procedure for the treatment of Patterson et al. presented one of the few studies that
GERD in bariatric patients. directly compared standard treatment versus bariatric sur-
gery. The group studied 12 patients, 6 undergoing LRYGB
(mean BMI 55) and 6 laparoscopic Nissen fundoplication
Sleeve Gastrectomy and GERD (mean BMI 29.8). The patients underwent preoperative and
Laparoscopic sleeve gastrectomy has become a new option for postoperative esophageal physiologic testing. Both groups
the surgical treatment of morbid obesity. It is a gastric-specific experienced a significant improvement in heartburn symp-
operation, but unlike the gastric band, it does not require adjust- toms postoperatively, as the mean preoperative symptom
ments nor does it carry the complications of having a foreign score improved from 3.5 to 0.5 in the laparoscopic Nissen
object in the body. When compared to laparoscopic Roux-en-Y, group (P = 0.01) and from 2.2 to 0.2 in the gastric bypass
it does not have any of the complications such as malnutrition, group (P = 0.003). The group concluded that the two proce-
dumping syndrome, or marginal ulcers. It has been argued that dures are both effective in treating heartburn symptoms and
laparoscopic sleeve gastrectomy is a superior procedure in objective acid reflux in the morbidly obese population (43).
terms of weight loss compared to the gastric band and it has Similar results were reported by Varela et al. The group
similar low complications and mortality rates compared to the looked into all patients who underwent either laparoscopic
RYGB (37). Although sleeve gastrectomy is emerging as a fundoplication or laparoscopic gastric bypass from October
favorable procedure, there have been conflicting results, as 2004 to December 2007 (n = 27,264). The authors compared
some have hypothesized that this procedure can promote the safety between the two procedures in terms of length of stay,
development of or exacerbate GERD symptoms. in-hospital overall complications, mortality, risk-adjusted
A study by Himpens et al. showed that the de novo appear- mortality radio, and hospital costs. They concluded that the
ance of GERD occurred in 21.8 % of patients a year after two procedures were comparably safe in terms of treatment
sleeve gastrectomy. However, the group also noted that after of GERD and recommended that in patients with morbid
3 years, GERD symptoms were present in only 3.1 % of the obesity, laparoscopic gastric bypass should be the preferred
study population. They hypothesized that these results were procedure of choice due to the favorable effect on other
most likely due to restoration of the angle of His. Also, comorbid conditions (44).
symptoms in 75 % of patients who were affected before sur- Other groups looked into the outcomes of conversion of a
gery disappeared by 3 years after surgery (38). Another failed fundoplication procedure to a gastric bypass. Ibele
group with similar results contributed the de novo symptoms et al. looked into the impact of takedown of previous fundo-
to too-radical resection of the gastric antrum (39). plication and conversion to laparoscopic gastric bypass. In
A study done by Soricelli et al. showed that sleeve gas- their study population, 36 % of patients had recurrent GERD
trectomy and crural repair in the obese patients are safe tech- at the time of revision, due to anatomic failure of the original
niques. The group studied 378 patients; 60 patients (15.8 %) fundoplication, and another 36 %, although with intact fun-
had symptomatic GERD, and hiatal hernia alone was diag- doplication, had recurrent GERD symptoms. After surgery,
nosed in 42 patients (11.1 %). 73.3 % of these patients had all of the patients in this group reported complete resolution
complete remission of GERD symptoms following sleeve of symptoms following surgery (45). Similar results were
gastrectomy, whereas the rest of the patients had decreased also reported in a study of 7 patients who originally had a
use of antireflux medications. In addition, GERD symptoms laparoscopic Nissen fundoplication that was converted to a
developed in 22.9 % of patients undergoing sleeve gastrec- LRYGB, as the study showed significant reduction in symp-
tomy, but none if hiatal hernia repair was performed (40). toms postoperatively (16.7 % vs. 4.4 %) (46).
Kellogg et al. looked into the anatomic findings and out-
comes in patients with failed Nissen fundoplication and sub-
Bariatric Surgery Versus Fundoplication sequent conversion to RYGB. The group retrospectively
in the Treatment of GERD reviewed a database of 1,435 patients who underwent RYGB
between 2001 and 2006 and identified 11 patients who had
As previously mentioned there are conflicting data about the previously undergone fundoplication. The mean BMI prior
surgical approach for the treatment of GERD in cases of to gastric bypass procedure was 44 kg/m2. Nine of these
obese patients. Interestingly, there are very few studies that patients had GERD preoperatively. All patients had 100 %
have compared traditional GERD surgeries in this popula- improvement in symptoms, with complete resolution in
tion to bariatric surgery techniques. As laparoscopic gastric 78 %. Wrap disruption was present in 45 % of the patients,
bypass is successful in treating both obesity and related dis- whereas herniation of an intact wrap occurred in 1 patient
ease plus GERD, some surgeons are advocating this surgical (47). Based on these results, many surgeons advocate pri-
procedure as the procedure of choice for morbidly obese mary bariatric surgery to avoid the risk of revision to RYGB
patients who also have GERD (41, 42). in the event of wrap failure.
438 M. Altieri and A. Pryor
(a) Vertical band gastroplasty 20. Jones MP, et al. Hiatal hernia size is the dominant determinant of
(b) Laparoscopic gastric band esophagitis presence and severity in gastroesophageal reflux
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47
Gallbladder and Biliary Disease
in Bariatric Surgery Patients
Mohammad H. Jamal and Manish Singh
examined gallbladder emptying before and after LRYGB, [17] found that adding cholecystectomy to LRYGB increased
by determining the volume of gallbladder pre- and post- the procedure by an average of 20 min.
liquid meal, as well as measuring the fasting volume, the In programs where cholecystectomy was not combined
maximum ejection fraction, and the residual gallbladder with bariatric surgery, the rate of gallbladder symptomatol-
volume. Postoperatively, the meal was administered via a ogy requiring surgery varies. D’Hondt et al. studied 625
gastrostomy tube. Biliary sludge was detected in 65 % of patients who had LRYGB and found that 43 (6.9 %) of the
subjects at 1 month post LRYGB, and gallstones were patients developed symptoms related to gallbladder disease
detected in 30 % of subjects subsequently. The study also and required cholecystectomy [3]. A study from Duke
showed significant reduction in gallbladder motility post- University Medical Center examined 1,391 patients who had
operatively which was independent of duodenal exclusion. an LRYGB, and 334 (24 %) of this cohort had a cholecystec-
Given the reported incidence of symptomatic gallstone tomy prior to the LRYGB. Of the remaining 1,057 patients,
disease requiring cholecystectomy post-bariatric surgery 73 6.9 % underwent a simultaneous cholecystectomy at the
(6–15 %), three different strategies have been suggested and time of gastric bypass. Of the remaining cohort of 984 patients
developed. One approach is to perform a simultaneous cho- who did not undergo a cholecystectomy at the time of gastric
lecystectomy at the time of bariatric surgery. This was espe- bypass, only 80 patients (8.1 %) needed a cholecystectomy
cially popular in the era prior to the use of laparoscopy, as it for symptomatic gallstone disease. All their patients were fol-
did not require modifications in the access incision. This lowed for more than 6 months, and none received prophylaxis
would also prevent complications such as gallstone pancre- with bile salts. Some of their patients underwent an ORYGB,
atitis and common bile duct stones that will become more but the majority had an LRYGB [18].
challenging to treat after bypassing the duodenum in some Benarroch-Gampel et al. [19] studied the cost of the dif-
bariatric procedures including RYGB. A second approach is ferent strategies of gallbladder management in patients
to perform simultaneous cholecystectomy only in those with undergoing bariatric surgery by developing a decision model.
abnormal pre-bariatric surgery ultrasound or in those who The strategies examined were LRYGB without cholecystec-
have biliary symptoms. A third approach is a wait-and-see tomy with ursodiol therapy and without, routine simultane-
approach in which cholecystectomy is performed in those ous cholecystectomy, and selective cholecystectomy based
who develop symptoms post-bariatric surgery. The last on the presence of gallstones on a preoperative ultrasound.
approach, which is utilized by most centers currently, is to That study found that the most cost-effective strategy is to
wait and see and prophylax with bile salts. perform an LRYGB without preoperative ultrasound and
Fobi et al. [14] reviewed 761 patients who underwent an without simultaneous cholecystectomy. They concluded that
open RYGB (ORYGB) and simultaneous cholecystectomy. a simultaneous cholecystectomy should not be performed at
23 % of their patient cohort had a prior cholecystectomy. Of the time of LRYGB and that ursodiol use postoperatively
the 76 % who had a simultaneous cholecystectomy at the increases cost without much justification.
time of ORYGB, they found that 86.2 % of patients had gall- A metanalysis by Warschow et al. [6] examined 13 stud-
bladder pathological findings. Gallbladder ultrasound was ies that included 6,048 patients who did not have a cholecys-
done preoperatively in all patients, but gallstones were found tectomy at the time of gastric bypass and had more than 3
in only 20 % of patients. Only 14 % of their cohort had nor- months of follow-up post-bariatric surgery. In six of those
mal gallbladder at cholecystectomy. The performance of studies, bile salts were not used postoperatively as prophy-
cholecystectomy added only 15 min to the ORYGB without laxis. The rate of subsequent cholecystectomy was 6.8 %
added morbidity. Therefore the authors recommended rou- (398 patients from the total cohort of 6,048). The cholecys-
tine simultaneous cholecystectomy at the time of ORYGB tectomy rate correlated with years of follow-up in the ran-
given the high incidence of gallbladder pathology. Dittrick dom effect model, whereby the rate increased by 3.1 % for
et al. [15] in a similar study examined 478 obese patients every year of follow-up. The reasons for the subsequent cho-
who underwent simultaneous bariatric surgery and cholecys- lecystectomies were biliary colic or dyskinesia in 5.3 % of
tectomy and found that only 30 % of these patients had nor- cases, cholecystitis in 1 % of cases, biliary pancreatitis in
mal gallbladder pathology and that in patients with a BMI 0.2 % of cases, and choledocholithiasis in 0.2 % of cases. No
above 50, only 14 % had a normal gallbladder pathology. mortality was reported in any of the studies. The complica-
Hamad et al. [16] studied all patients who had a prophy- tion rate of the subsequent cholecystectomy was 1.8 %, and
lactic cholecystectomy at the time of LRYGB. At their insti- 95.6 % of the procedures were performed laparoscopically.
tution a prophylactic cholecystectomy was only offered to They concluded that cholecystectomy is not necessary at the
those who had gallstone disease prior to the LRYGB. Ninety- time of LRYGB.
four patients underwent a simultaneous cholecystectomy and Worni et al. [20] used the Nationwide Inpatient Sample
LRYGB from 556 patients who underwent LARYGB. They (NIS) data to identify trends in patients undergoing simulta-
found that adding a secondary procedure lengthened the neous cholecystectomy at the time of gastric bypass surgery
LRYGB significantly but did not require altered port place- between 2001 and 2008. They found that out of 70,287
ment, and it nearly doubled patients’ hospital stay. Kim et al. patients, simultaneous cholecystectomy was performed in
47. Gallbladder and Biliary Disease in Bariatric Surgery Patients 443
6,402 (9.1 %) of the patients. This decreased from 26.3 % in measure was the number of patients who experienced symp-
2001 to 3.7 % in 2008. From this study we observe a decline tomatic and complicated gallstones disease. They found no
in simultaneous cholecystectomies performed in the United significant difference in symptomatic or complicated gall-
States in favor of the wait-and-see approach. Not all the cen- stones between the two groups, despite patients in group A
ters favoring the wait-and-see approach are using prophy- having a significantly higher preoperative BMI than group B
laxis with ursodiol, a bile salt which is shown to reduce the and more patients in group A having more than a BMI of 45
formation of gallstones by increasing cholesterol solubility preoperatively and more than 25 % weight loss after bariatric
in a period of rapid weight loss. surgery [24].
In a multicenter randomized trial by Sugerman et al. [21], At the Cleveland Clinic, our approach is to perform a
233 patients who had a negative preoperative gallbladder combined cholecystectomy and bariatric procedure only if
ultrasound and an RYGB were randomized to a placebo the patient has symptomatic cholelithiasis. Ursodiol is given
group, a group receiving 300 mg of ursodiol, a group receiv- to all other patients for 6 months after bariatric surgery.
ing 600 mg of ursodiol, and the fourth group receiving
1,200 mg of ursodiol. All patients received treatment for 6
months or until formation of gallstones, and a gallbladder Biliary Disease in Bariatric Patients
ultrasound was performed at 2, 4, and 6 months. The rate of
gallstones formation was 2 % in those receiving 600 mg of With the rise in bariatric surgery, in particular RYGB, the
daily ursodiol and 6 % in those receiving 1,200 mg. The pla- management of bariatric patients with choledocholithiasis or
cebo group had a rate of 32 % of gallstone formation, while other causes of obstructions at the ampulla of Vater is com-
the group receiving 300 mg of daily ursodiol had a 13 % rate. plicated in those who have undergone a procedure that
The study concluded that prophylaxis with a daily dose of bypasses the duodenum (Roux-en-Y gastric bypass and duo-
600 mg of ursodiol for 6 months is sufficient to reduce gall- denal switch). Minimally invasive methods of access to the
stone formation in a period of rapid weight loss following ampulla involve either the use of laparoscopy, enteroscopy,
RYGB, and hence this will reduce gallbladder disease requir- or interventional radiology to gain entrance to the excluded
ing surgery post RYGB. stomach or the biliopancreatic limb. In most elective cases at
Another randomized single-center study by Wudel et al. our institution, the preferred approach is laparoscopic-
[22] randomized patients into 3 groups, one receiving 600 mg assisted transgastric ERCP.
of ursodiol daily, one receiving 600 mg of ibuprofen daily, The indications for accessing the biliary tree post-bariatric
and one group receiving a placebo. All patients had a nega- surgery include sphincter of Oddi dysfunction, biliary pan-
tive gallbladder ultrasound prior to an open RYGB. Ultrasound creatitis, common bile duct stones, pancreatic mass evalua-
to check for stone formation was done in subjects enrolled in tion, and treatment of bile leak postcholecystectomy as
the study at 3, 6, 9, and 12 months, and gallbladder emptying reported by Gutierrez et al. [25], who performed surgical
was assessed at 3 and 6 months. Of the 60 patients enrolled gastrostomy to facilitate ERCP in patients post RYGB. Their
at the beginning of the study, 41 patients completed the study included 30 RYGB patients, and the most common
study. The investigators found no difference in gallstone for- indication for biliary access was sphincter of Oddi dysfunc-
mation between the different groups; however, the comple- tion. Surgical gastrostomy was performed laparoscopically
tion rate for the study was only 28 % (17/60). Therefore, the in 28 patients and was planned as an open procedure in two
compliance of patients with this treatment is an issue that patients. The success rate of biliary cannulation and treat-
needs to be considered. ment was 100 % in their study.
A single-center randomized trial by Miller et al. [23] Sphincter of Oddi dysfunction (SOD) is also discussed in
examined the role of ursodiol in preventing gallstone forma- several other reports as a major indication for biliary tree
tion in patients post-bariatric restrictive procedures vertical access after RYGB. Without the use of endoscopic transam-
banded gastroplasty (VBG) and gastric banding (GB). 152 pullary manometry, the diagnosis of SOD is challenging,
patients were enrolled in the study that randomized 76 however. A study by Morgan et al. [26] identified 16 patients
patients to a placebo group and 76 to a group receiving a who had SOD requiring therapeutic ERCP after RYGB. The
daily dose of 500 mg of ursodiol. Only 3 % of the ursodiol median presentation after RYGB was 2 years, and all of
group had gallstones at 1 year compared to 22 % of the pla- these patients had a previous cholecystectomy. The diagnosis
cebo group. of SOD was supported by magnetic resonance cholangio-
A similar rate of gallstone formation and disease is found pancreatography with secretin stimulation (ssMRCP) in 11
following gastric restrictive procedures, and therefore, the patients; 7 had a dilated common bile duct, 2 had main pan-
management is similar to that following RYGB. Li and creatic duct dilation, and 3 had evidence of chronic pancre-
Rosenthal compared 496 patients who had an RYGB (group atitis. Of the 16 patients, 2 did not undergo MRCP, and 3 had
A) to 52 patients who had a sleeve gastrectomy (group B) normal findings.
after excluding revision cases, patients with previous chole- All patients underwent open transduodenal sphincteroplasty
cystectomy, and patients with gallstones. The main outcome with biliary sphincteroplasty and pancreatic ductal septoplasty.
444 M.H. Jamal and M. Singh
FIG. 1. A gastrostomy is created and a 15 mm trocar is then inserted in the left upper quadrant and advanced into the gastrostomy. The
enteroscope is advanced through the gastrostomy and used as in standard ERCP procedures.
In all patients ampullary stenosis was confirmed by intraopera- accessed, dilated, and a repeat ERCP performed without
tive examination. At follow-up (median 25 months), 11 patients laparoscopic assistance.
(85 %) reported improvement of pain with 9 patients reporting
discontinuing narcotic pain medications.
Retrograde Endoscopy
Laparoscopic-Assisted ERCP Technique In order to reach the ampulla of Vater in patients who under-
went a Roux-en-Y gastric bypass, the endoscope must travel
With the patient supine in the operating table, we use three the length of the alimentary limb which is 100–150 cm and
trocars between 5 and 10 mm in size to perform diagnostic then travels retrograde through the biliopancreatic (BP) limb.
laparoscopy and lysis of adhesions if needed. After identi- The angulation between the BP limb and the anastomosis
fying the remnant stomach, a purse-string suture is placed can be difficult to negotiate. The technical challenges of this
at the suitable site in the anterior greater curvature of the procedure are mainly related to the length of the bypassed
remnant stomach. Cautery is then used to create the gas- segment and the angulation at the Roux-en-Y anastomosis.
trostomy in the stomach. A 15 mm trocar is then inserted The use of side-viewing scopes that are utilized for ERCP is
in the left upper quadrant and advanced into the gastros- difficult due to their short lengths. Therefore, a traditional
tomy (Fig. 1). The purse-string suture is then tied around push enteroscopy is used, and more recently single- and
the trocar to maintain insufflation. After the surgical field double-balloon enteroscopy has been reported. This comes
is appropriately draped off, the enteroscope is passed at the cost of losing the side view which makes cannulation
through the 15 mm trocar, and a standard ERCP procedure of the ampulla more difficult. Choi et al. [27] summarize the
is completed (Fig. 2). We typically close the gastrostomy limitations of double-balloon enteroscopy which has the
and all fascial defects equal or larger than 10 mm. If a stent potential to be the most successful endoscopic technique
is placed or there is an expected need to repeat the ERCP, due to the length of the scope. These limitations are (1) the
a gastrostomy tube (24Fr or larger) is placed in the gastric lack of an elevator, (2) the absence of the side view, (3) the
remnant, and gastropexy sutures are placed to bring the long time of the procedure and the fact that it is time-con-
stomach to the anterior abdominal wall. After the gastros- suming (40–180 min), (4) the limited accessories for thera-
tomy tube tract has matured (3–4 weeks), the site can be peutic maneuvers, and (5) the presence of a learning curve.
47. Gallbladder and Biliary Disease in Bariatric Surgery Patients 445
Questions
has been shown to persist at 6 months and 1 year postopera- (HOMA-IR) were also shown to decrease to a greater extent
tively [12]. Restrictive procedures, such as vertical banded gas- after RYGB. The degree of suppression of ghrelin levels
troplasty (VBG) and LAGB, have not shown to be associated post-meal did not differ significantly presurgery to week
with any changes in the levels of GLP-1 postoperatively [13]. 52 in either the LAGB or RYGB and did not differ between
Ghrelin is an orexigenic hormone produced primarily groups. Laferrère et al. [8] suggested that the markedly
bVBy the stomach, and administration of ghrelin and its ana- increased incretin levels and effect observed after the RYGB
logs stimulates food intake. Ghrelin levels have an inverse may well be one of the mediators of the antidiabetic effects
relationship with body weight, and consequently obese indi- of the surgery, and they set out to determine whether the
viduals have lower ghrelin levels. Weight loss induced by magnitude of change of the incretin levels is greater after the
caloric restriction results in an increase in the levels of ghre- RYGB compared to a hypocaloric diet at an equivalent
lin, which subsequently may contribute to the resistance to weight loss. Their results showed a markedly increased
lifestyle interventions for obesity. Ghrelin may play a role in GLP-1 response to oral glucose after the RYGB, but GLP-1
glucose homeostasis and has been shown to inhibit insulin levels tended to decrease after diet intervention, although
secretion and suppress the insulin-sensitizing hormone adi- this decrease was not significant. The incretin effect mark-
ponectin [14]. Ghrelin deletion in diabetic obese mice mod- edly increased after an RYGB, but not with diet, and sug-
els has shown to reduce fasting glucose and insulin and thus gests that this effect was not likely to be weight loss related.
improve glucose tolerance [15]. Several groups have reported Therefore, this could play a key role in the remission and
a decrease in the levels of ghrelin after RYGB, which may resolution of T2DM after an RYGB. Data from various stud-
partly account for the improved glycemia [12, 16]. This has ies has shown that beneficial changes of incretin levels occur
not been consistently reported with other studies showing rapidly after the RYGB, which is secondary to the bypass
either unchanged or increased ghrelin levels [9, 17]. As procedure, thus resulting in an improved insulin secretion
expected, ghrelin levels are markedly suppressed following profile and decreased postprandial glucose [21].
resection of the ghrelin-rich gastric fundus as with a sleeve Another mechanism proposed in recent years is the effect
gastrectomy. However, ghrelin levels show the normal physi- of bariatric surgery on the alteration of taste. This novel
ological rise with weight loss after LAGB and VBG. weight loss mechanism involves alterations in food prefer-
PYY is an anorexigenic hormone co-secreted with GLP-1 ences, which may be secondary to changes in taste detection
from intestinal L cells in response to food intake. PYY has and reward. Miras et al. [22] have shown that after RYGB,
been shown to decrease food intake in humans when injected. patients’ eating behavior changes, and they start to adopt
Experimental studies in rodents suggest that PYY may healthier food preferences by avoiding high-calorie and
directly ameliorate insulin resistance [18]. Several studies high-fat foods. Patients find sweet and fatty meals less pleas-
have reported elevated PYY levels after RYGB. In a prospec- ant than preoperatively, and this may be attributed to changes
tive, nonrandomized controlled study comparing the effects in the sense of taste. A putative mechanism to explain this is
of medical and surgical treatment on PYY levels after similar that RYGB may reverse the higher activation of brain taste
weight loss, it was observed that PYY’s area under the curve reward and addiction centers in response to high calorie and
increased following RYGB and sleeve gastrectomy, but fat tasting.
remained unchanged in the medical arm [19]. Two hypotheses have been proposed to explain improved
Korner et al. [7] conducted a prospective study of gut hor- glycemia following gastrointestinal surgery. The “hindgut
mone and metabolic changes after LAGB and RYGB and hypothesis” posits that the expedited delivery of ingested
suggested that the changes in hormone secretion may con- nutrients to the lower bowel, due to an intestinal bypass,
tribute to the efficacy of the particular procedure in improv- stimulates L cells, which results in an increased secretion of
ing obesity-related comorbidities. It is established that PYY incretin hormones and an improved glucose homeostasis [5].
and GLP-1 are secreted shortly after food intake from L cells Consistent with the hindgut hypothesis, the bariatric opera-
in the distal small bowel and colon. Both decrease appetite, tions most noted for rapid T2DM remission, RYGB and
increase satiety, slow gut motility, and improve insulin sensi- BPD, create GI shortcuts for food to access the distal bowel.
tivity. GLP-1 also functions as an incretin to potentiate However, a significant improvement in glycemia and remis-
glucose-stimulated insulin release. In contrast, ghrelin stim- sion of diabetes with elevated incretin levels is also noted to
ulates appetite, profoundly promotes food intake and gut occur after a sleeve gastrectomy, which does not involve an
motility, and decreases insulin sensitivity [20]. Korner et al. intestinal bypass. It must be noted that GLP-1 secretion is
[7] found that in LAGB patients, the postprandial rise of stimulated not only by direct nutrient contact with distal
GLP-1 measured at 30 min did not change after surgery, intestinal L cells but also by proximal nutrient-related sig-
whereas in contrast, postprandial GLP-1 levels after RYGB nals that are transmitted from the duodenum to the distal
were significantly greater compared with 30-min values bowel by neural pathways and other unknown mechanisms
before surgery and threefold higher compared with the same [9]. The alternative hypothesis is the “foregut hypothesis,”
time points after LAGB. Fasting glucose, insulin, and which depends on the exclusion of the duodenum and proxi-
homeostasis model assessment of insulin resistance mal jejunum from the transit of nutrients, possibly preventing
48. Effects of Bariatric Surgery on Diabetes 449
secretion of a putative signal that promotes insulin resistance end point was 12 % for the medical group, 42 % in the RYGB
and T2DM [6]. Rubino et al. conducted a study to investigate group, and 37 % in the SG group. Glycemic control was dem-
these mechanisms by testing both hypotheses and found that onstrated to improve in all three groups with a mean HbA1c
the exclusion of the proximal small intestine from contact level of 7.5 ± 1.8 % in the medical therapy group, 6.4 ± 0.9 %
with ingested nutrients is a critical component in the mecha- in the gastric bypass group, and 6.6 ± 1.0 % in the sleeve gas-
nism improving glucose tolerance after the DJB in GK rats, trectomy group. It was demonstrated that many patients in the
thus supporting the foregut hypothesis [6]. surgical groups, particularly in the RYGB group, achieved
Other hypothesized antidiabetic mechanisms after bariat- glycemic control without the use of diabetes medications
ric surgery include changes in intestinal nutrient-sensing after 1-year follow-up. Secondary end points, including BMI,
mechanisms regulating insulin sensitivity, disruption of body weight, waist circumference, and the HOMA-IR,
vagal afferent and efferent innervations, bile acid perturba- improved more significantly in the surgical groups than the
tions, changes in gut microbiota, and alterations in undiscov- medical therapy group. It was also shown that the reduction in
ered gut factors. the use of glycemic pharmacotherapy occurred before
achievement of maximal weight loss, thus supporting the
weight-independent mechanisms of surgery. This trial also
The Effects and Outcomes of Bariatric supported the notion that bariatric surgery represents a useful
Surgery on Diabetes in Patients management strategy for uncontrolled T2DM.
Mingrone et al. [26] published results from an RCT con-
with a BMI > 35 kg/m2 ducted including 60 patients (BMI ≥ 35 kg/m2) with a history
of at least 5 years of T2DM, and an HbAlc level of 7.0 % or
The outcomes of bariatric surgery on diabetes and the meta- more. They compared conventional medical therapy to the
bolic profile in patients with a BMI of >35 kg/m2 have been RYGB or BPD. The primary end point was the rate of diabe-
well documented over many years. tes remission at 2 years (defined as a fasting glucose level of
Buchwald et al. [23] conducted a meta-analysis including <100 mg/dL and an HbA1c level of <6.5 % in the absence of
22,094 patients with T2DM reported an overall 77 % remis- pharmacological therapy). At 2 years follow-up, diabetes
sion rate of T2DM (defined as persistent normoglycemia remission had occurred in no patients in the medical therapy
without diabetes medication after bariatric surgery). The group versus 75 % in the RYGB group, and 95 % in the BPD
mean procedure-specific resolution of T2DM was 48 % for group. All patients in the surgical groups had discontinued
LAGB, 68 % for VBG, 84 % for RYGB, and 98 % for their pharmacotherapy (oral hypoglycemic agents and insu-
BPD. The drawback of this study is that the majority of these lin) within 15 days after the operation. At 2 years, the aver-
studies included was retrospective and had a short follow-up age baseline HbA1c level (8.65 ± 1.45 %) had decreased in
duration of 1–3 years. The multicenter Swedish Obese all groups, but patients in the two surgical groups had the
Subjects (SOS) study, a large prospective observational greatest degree of improvement (average HbA1c levels,
study [24], compared bariatric surgery (LAGB n = 156, VBG 7.69 ± 0.57 % in the medical therapy group, 6.35 ± 1.42 % in
n = 451, RYGB n = 34) with conservative medical manage- the RYGB group, and 4.95 ± 0.49 % in the BPD group). The
ment in a group of well-matched obese patients. At 2 years, findings support the conclusion that bariatric surgery may be
72 % of diabetic subjects in the surgical group achieved more effective than conventional medical therapy in control-
remission of T2DM compared to 21 % in the medically ling hyperglycemia in severely obese patients with T2DM.
treated arm. At 10 years, the relative risk of incident T2DM
was three times lower, and the rates of recovery from T2DM
were three times greater, for patients who underwent surgery The Effects and Outcomes of Bariatric
than for individuals in the control group. The proportion of
subjects in whom the remission was sustained at 10 years Surgery on Diabetes in Patients
declined to 36 % in the surgical group and 13 % in the medi- with a BMI > 35 kg/m2
cal group. It must be noted, however, that approximately
95 % of patients in the SOS study underwent gastric restric- The effects of bariatric surgery in the morbidly obese popu-
tive procedures rather than RYGB. lation (>35 kg/m2) are well documented. The field of meta-
Recently, Schauer et al. [25] published results from their bolic surgery has become increasingly researched in recent
randomized, non-blinded, single-center trial and compared years, investigating the effects and benefits of operating on
intensive medical therapy alone versus medical therapy plus those patients with a BMI of less than 35 kg/m2. The aims of
RYGB or sleeve gastrectomy (SG) in 150 obese patients metabolic surgery differ slightly from bariatric surgery; in
(BMI 27–43 kg/m2) with uncontrolled T2DM. The primary that, there is a shift in goals of surgery from weight reduction
end point was the proportion of patients with a glycated to the control of metabolic disease, with the aim of “curing”
hemoglobin (HbA1c) level of 6.0 % or less 12 months after T2DM or putting this prevalent condition into remission.
treatment. The proportion of patients who reached the primary Recently, prospective RCTs have been conducted in lower
450 A. Soni et al.
BMI patients (<35 kg/m2) in order to compare various gas- any postoperative time point. There was also no association
trointestinal surgical procedures versus intensive medical between the amount of weight lost and magnitude of
management, to identify the differences between conven- improvement in β-cell sensitivity to glucose.
tional treatment and metabolic surgery. Despite these prospective RCTs being conducted at vari-
Dixon et al. [27] conducted an RCT comparing the LAGB ous institutions, it is clear that longer-term follow-up of these
versus conventional therapy in 60 obese patients (BMI > 30 patients is required. Larger and perhaps multicenter trials are
and <40 kg/m2) with recently diagnosed (<2 years) necessary to evaluate the potential benefits of bariatric sur-
T2DM. The primary outcome measure was the remission of gery for the treatment of T2DM in less obese patients.
T2DM (defined as fasting plasma glucose < 126 mg/dL and Studies are consistent in showing the efficacy of surgery with
an HbA1c level of <6.2 % while taking no glycemic ther- regard to the improvement in glycemic indexes as well as
apy). After a 2-year follow-up, remission of T2DM was improving other aspects of the metabolic syndrome. The
achieved in 73 % in the surgical group and 13 % in the con- impact of surgery on microvascular and macrovascular com-
ventional therapy group, and it was found to be related to plications of diabetes needs to be assessed with long-term
weight loss. Mean levels of fasting plasma glucose and follow-up.
HbA1c were significantly lower in the LAGB group at 2
years. There was also a significant reduction in the use of
pharmacotherapy for glycemic control in the LAGB group at Improvement in Cardiovascular
2 years. Secondary outcome measures, such as insulin sensi- Outcomes and Mortality in Type 2
tivity and levels of triglycerides and HDL, were also
improved in the surgical group. It was concluded that this Diabetic Patients
trial presents evidence to support the early consideration of
surgery in the treatment of obese patients with T2DM. It is now evident that apart from its glycemic effects, bariatric
Lee et al. designed a randomized, double-blind trial [28] surgery confers non-glycemic benefits including improve-
in order to compare the RYGB versus SG on T2DM resolu- ment of cardiovascular risk factors such as dyslipidemia and
tion (remission defined as fasting plasma glucose < 126 mg/ hypertension. More importantly, it has been established that
dL, HbA1c < 6.5 % without the use of oral hypoglycemics or there is a reduction in mortality. The meta-analysis by
insulin) in non-morbidly obese patients (BMI < 35 kg/m2) Buchwald et al. [23] showed a marked decrease in levels of
who had T2DM that was inadequately controlled. The reso- total cholesterol, LDL cholesterol, and triglycerides after gas-
lution rate was 93 % in the RYGB group compared with trointestinal surgery. An improvement in hyperlipidemia was
47 % in the SG group. These results are consistent with the shown in approximately 70 % of patients, and hypertension
RYGB being more effective than restrictive-type procedures. was shown to improve or resolve in 79 % of patients. Lee
The RYGB group also achieved a lower waist circumference, et al. have demonstrated these beneficial effects of gastroin-
fasting plasma glucose level, HbA1c level, and blood lipid testinal surgery in patients with a BMI < 35 kg/m2 [30].
level. Therefore, the RYGB group had a higher remission Follow-up of participants in the SOS study after an average of
rate for the metabolic syndrome than the SG group. This 11 years found that bariatric surgery was associated with a
study concluded that RYGB is more effective than SG for 29 % reduction in all-cause mortality after adjusting for age,
surgical treatment of inadequately controlled T2DM, sug- sex, and risk factors in this severely obese group [31].
gesting that duodenal exclusion plays a role in the mecha- In a recent study, Cohen et al. [29] prospectively followed
nism behind the remission of T2DM. up type 2 diabetic patients who had an RYGB, and it was
Cohen et al. published results from a prospective study demonstrated that the predicted 10-year risk of cardiovascu-
[29] following 66 diabetic patients (BMI 30–35 kg/m2) up to lar disease, calculated by the UKPDS risk engine, fell sub-
6 years who elected to have the RYGB. The percentage of stantially after surgery. There was a decrease in the risk of
patients experiencing diabetes remission (defined as an events: 71 % decrease in coronary heart disease, 84 %
HbA1c < 6.5 % without the use of hypoglycemic medication) decrease in fatal, 50 % decrease in stroke, and 57 % decrease
was identified. The mean HbA1c fell progressively through- in fatal stroke.
out the duration of the study from 9.7 ± 1.5 to 5.9 ± 0.1 %, Romeo et al. recently published on the prospective, con-
and fasting plasma glucose fell from 156 ± 11 to 97 ± 5 mg/ trolled SOS study, looking at the effects of bariatric surgery
dL. HOMA-IR also fell dramatically within the first 6 on cardiovascular events on participants with T2DM [32].
months. Remission of diabetes occurred in 88 % of patients, The mean follow-up was 13.3 years for all cardiovascular
whose diabetes medications were discontinued 3–26 weeks events. Bariatric surgery was associated with a reduction in
after surgery. Improvement of diabetes without full remis- the incidence of fatal and nonfatal cardiovascular events, and
sion was seen in 11 % of patients, which lead to a decrease in importantly, the benefit of surgery was present after adjust-
the usage of pharmacotherapy and withdrawal of insulin ing for baseline parameters. Bariatric surgery was associated
when previous used. There was found to be no correlation with a lower incidence of myocardial infarction. A total of 38
between the change in body weight and change in HbA1c at of the 345 individuals in the surgery group compared with 43
48. Effects of Bariatric Surgery on Diabetes 451
of the 262 individuals in the control group had myocardial LAGB. Other factors that have been positively correlated
infarction during follow-up. Interestingly, no significant dif- with diabetes remission are percentage of excess weight loss
ferences in the incidence of myocardial infarction were (% EWL), younger age, lower preop HbA1c, and shorter
found between the different surgical procedures (RYGB, duration of diabetes (less than 5 years) [35]. Severity of dia-
LAGB, vertical gastroplasty). However, bariatric surgery betes, as judged by preop treatment modality, has also been
was not found to be associated with changes in the incidence noted to be a significant factor. Schauer et al. [36] have
of cerebral stroke in these type 2 diabetic patients. reported in their series of 191 obese diabetic patients (the
Adams et al. conducted a retrospective cohort study majority of whom were on oral agents or insulin) a diabetes
including 7,925 severely obese patients and 7,925 similarly remission rate of 97 % in diet-controlled, 87 % in oral agent-
obese matched controls [33]. After a mean follow-up of treated, and 62 % in insulin-treated subjects. This was also
8.4 years, it was demonstrated that surgery reduced overall confirmed by a recent retrospective analysis of 505 morbidly
mortality by 40 %, cardiovascular mortality by 56 %, cancer obese diabetic patients who underwent RYGB [37]. In this
mortality by 60 %, and diabetes-related mortality by 92 %. study, a more recent diagnosis of T2DM and the absence of
preoperative insulin therapy were significant predictors of
remission, independent of the percentage of EWL. Dixon
Comparative Efficacy of Different et al. [38] have recently identified diabetes duration < 4 years,
BMI > 35 kg/m2, and fasting c-peptide concentration > 2.9 ng/
Bariatric Procedures to Treat Diabetes mL as three clinically useful cutoffs and independent preop-
erative predictors of remission after analyzing the outcomes
Bariatric procedures differ in their ability to ameliorate
of 154 ethnic Chinese subjects after gastric bypass.
T2DM, with intestinal bypass procedures (i.e., RYGB, BPD)
C-peptide > 3 ng/mL has also previously been shown to be an
generally associated with greater glycemic control and
important predictor of diabetes resolution after sleeve gas-
remission rates than purely restrictive procedures (i.e.,
trectomy in non-morbidly obese diabetic subjects by Lee
LAGB). As indicated in the meta-analysis by Buchwald et al.
et al. [39].
[23], BPD appears to be the most efficacious closely fol-
lowed by RYGB and then LAGB. A systematic review by
Tice et al. [34] of 14 comparative studies, albeit of low qual-
ity (mostly retrospective and unmatched), testified to the
The Future of Metabolic Surgery
superior efficacy of RYGB over LAGB in treating
In recent years, there has been an increasing amount of
T2DM. There has been until now a paucity of data from
research conducted to look at minimally invasive methods
RCTs comparing the efficacy of various bariatric procedures
with the aim of mimicking the effects of gastrointestinal sur-
to treat diabetes. There are currently several ongoing small-
gery but providing a safer and reversible alternative to con-
to medium-sized RCTs comparing the efficacy of medical
ventional surgery. Endoluminal and transgastric procedures
versus surgical treatment of type 2 diabetes including some
are evolving concepts that combine the skills and techniques
that have more than one bariatric procedure as the surgical
of flexible endoscopy with minimally invasive surgery. This
comparator. The results of some of these have recently been
is the future of bariatric and metabolic surgery in order to
published. Lee et al. [28] have reported the results of their
develop less morbid and less costly treatment options [40].
RCT comparing gastric bypass to sleeve gastrectomy in
The endoluminal sleeve (ELS) was an idea, which
patients with BMI 25–35 kg/m2; the remission rate for T2DM
stemmed from an experimental model in rats performed by
was 93 % for patients who underwent RYGB compared to
Rubino et al. They developed an (ELS) to prevent contact
47 % for those who underwent sleeve gastrectomy. The
between nutrients and the duodenal mucosa in rats [2], there-
recently published RCT by Schauer et al. [25] also indicates
fore producing a functional duodenal bypass without creat-
superior efficacy of RYGB over sleeve gastrectomy in the
ing a rapid delivery of nutrient to the distal bowel. Rats
treatment of diabetes in obese individuals. On the other hand,
undergoing the ELS demonstrated a dramatic improvement
BPD produced greater remission of diabetes in morbidly
of glucose tolerance compared to matched controls in which
obese patients compared to RYGB (95 % versus 75 %) in the
the ELS had been fenestrated to allow nutrients to come into
RCT reported by Mingrone et al. [26].
contact with the duodenal mucosa. The antidiabetic effect of
ELS was also shown by Aguirre et al. [41] in a diet-induced
rat model of insulin resistance. A prospective randomized
Predictors of Remission of Type 2 trial comparing ELS to sham endoscopy plus a low-fat diet
Diabetes Following Bariatric Surgery and exercise showed a dramatic decrease in HbA1c of 2.9 %
in the ELS group compared to the conventional therapy
As discussed above, the choice of procedure is an important group [42].
determinant of outcome with a decreasing gradient of effi- Gut hormones and the enteric nervous system are involved
cacy predicted from BPD, RYGB to SG and then in the regulation of satiety signals, GI motility, and insulin
452 A. Soni et al.
sensitivity. Electrophysiologic devices interfere with vagal safer and less risky procedure to treat their diabetes. Further
signals between the brain and gastrointestinal tract, through research and prospective studies offer the potential to
a variety of mechanisms including gastric stimulation or pac- advance pharmacotherapy in order to develop and uncover
ing, neuromodulation, vagal resection, and intermittent vagal new therapeutic targets in order to manage type 2 diabetes
nerve blockage as a means of controlling satiety [42]. The more effectively.
TANTALUS system is a laparoscopically implantable sys-
tem, which is a gastric electrical stimulator. Bohdjalian et al. Financial Support/Conflict of Interest None.
[43] conducted a multicenter open-label European feasibility
trial involving 24 obese diabetic patients treated with insulin
and/or oral hyperglycemic agents with a BMI between 33.3 Review Questions and Answers
and 49.7 kg/m2. In those subjects that reached the 1-year
visit, weight was reduced by 4.5 ± 2.7 kg (p < 0.05) and
1. Factors that are positively correlated with the remission
HbA1c by 0.5 ± 0.3 % (p < 0.05). In a subgroup of patients on
of T2DM after surgery include all except:
oral medications, weight was reduced by 6.3 ± 3.4 kg
A. Increasing age
(p < 0.05), and HbA1c was reduced by 0.9 ± 0.4 % (p < 0.05).
B. Lower preoperative HbA1c
The group on insulin had no significant changes in either
C. Shorter duration of diabetes
weight or the HbA1c. The study concluded that the
D. Percentage of excess weight loss
TANTALUS system and gastric electrical stimulation can
potentially lead to improvement in glucose metabolism and Answer is A. Patients who have a lower preoperative
the lipid profile, as well as inducing weight loss and favor- HbA1c and a shorter duration of T2DM, and those who
able changes in eating behavior, in obese diabetic individu- have a higher percentage of excess weight loss, have a
als. Consistent results were published by Sanmiguel et al. greater chance of remission of T2DM after surgery.
[44] in a study involving 14 obese type 2 diabetic patients.
2. Improvement in insulin sensitivity following bariatric sur-
They demonstrated that short-term therapy with the
gery is accompanied by all of the following mechanisms
TANTALUS system improves glucose control, induces
except:
weight loss, and improves blood pressure and the lipid pro-
A. Decrease in the lipid content of the liver and muscle
file in these subjects on oral antidiabetes therapy and found
B. Reduction in the levels of adiponectin
that the improvement in glucose control did not correlate
C. Increase in the concentration of insulin receptors
with weight loss.
D. Increase in the markers of insulin signaling
These endoluminal procedures and other novel minimally
invasive procedures offer a lot of potential for the future of Answer is B. There is an elevation in the levels of adipo-
bariatric and metabolic surgery. However, an extensive amount nectin following bariatric surgery, as adiponectin is an
of research is required in order to take it from the experimental insulin-sensitizing hormone.
trial settings and actually incorporate it into standard practice.
3. The Swedish Obese Subjects (SOS) study demonstrated
Prospective randomized trials are necessary in order to inves-
the following effects of bariatric surgery on cardiovascu-
tigate these procedures further, but it certainly offers a lot of
lar events on participants with T2DM except:
scope for the future of interventional diabetology, potentially
A. Reduction in the incidence of fatal and nonfatal
revolutionizing this newly emerging field.
cardiovascular events
B. Lower incidence of myocardial infarction
C. Lower incidence of cerebral stroke
Conclusion D. Similar incidence of myocardial infarction following
different surgical procedures
The incorporation of bariatric surgery into the treatment
options for type 2 diabetes is currently being researched Answer is C. Bariatric surgery was not found to be asso-
quite extensively. Type 2 diabetes is a worldwide epidemic, ciated with changes in the incidence of cerebral stroke in
and current conventional methods of treatment have their type 2 diabetic patients in the SOS study.
limitations. Despite advancements in medical therapy,
many patients still fail to achieve optimal glycemic control,
and thus surgery may provide a suitable alternative for References
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49
Cardiovascular Disease in the Bariatric
Surgery Patient
Amanda R. Vest and James B. Young
combined supine/prone protocols are now more widely subjects demonstrated a rate of progression that was more
available and have the potential to minimize the frequency of similar to lean controls than the threefold higher progression
false-positive SPECTs in obese patients. Therefore, SPECT, of patients who continued to be obese [22]. The findings
or the related nuclear technique of cardiac position emission from these two subclinical atherosclerosis assessment
tomography (PET) which has the added benefit of superior modalities generate the hypothesis that bariatric surgery may
spatial resolution [14], is usually the preferable modality. slow the progression of CAD. Although this is a novel propo-
Alternate strategies are stress transesophageal echocardio- sition in the cardiology field, there are several lines of basic
grams [15] or proceeding directly to cardiac catheterization science and experimental evidence that support potential
in high-risk individuals, such as those with multiple risk anti-atherosclerotic and anti-inflammatory actions of bariatric
factors. procedures.
Coronary revascularization prior to noncardiac surgery
has not been shown to enhance survival, and due to the
requirement for dual antiplatelet medications for a minimum Metabolic Effects of Adiposity
of 6–8 weeks after percutaneous coronary intervention (the
exact time interval is dependent on the stent type and loca- and Bariatric Surgery on the Heart
tion), revascularization will necessitate postponement of bar- and Vasculature
iatric surgery. Due to these management considerations,
preoperative cardiac stress test testing should be restricted to The proposed mechanisms linking obesity to adverse cardio-
patients in whom the results will actually change outcomes vascular outcomes largely center on the signaling proteins
[11]. There remains an absence of consensus among cardi- known as adipokines and gut hormones. It has been observed
ologists as to how an asymptomatic obese patient presenting that although BMI is an important epidemiological predictor
for bariatric surgery with a positive stress test should be of CVD [23], the location of the excess adipose tissue and its
managed [16]. Perioperative beta-blockade is commonly degree of metabolic dysfunction may be the more relevant
prescribed for patients with a known CAD history or a posi- cardiac risk factor. The degree of “central” or “visceral” adi-
tive stress, although the risk-benefit ratio has never been posity more closely correlates with insulin resistance than
studied in the bariatric population [12]. Blood pressure overall BMI, and visceral—but not peripheral—adiposity is
should be kept to target preoperatively, statin therapy should a significant contributor to asymptomatic atherosclerosis as
be resumed as soon as possible postoperatively, and any detected by coronary CT [24]. Similarly the presence of the
period of time off baseline antiplatelet medications periop- metabolic syndrome (of which insulin resistance and central
eratively should be kept to the minimum duration that is adiposity is a central feature) has been independently associ-
acceptable to the bariatric surgeon. As further discussed ated with an increased risk of incident heart failure in cohort
below, limited data suggest that patients with compensated, without diabetes or baseline CAD, whereas overall adiposity
stable heart failure can reasonably be considered for bariatric was not an independent predictor [25]. The recognition of
surgery candidacy [11]. this subgroup of overweight and obese patients with the most
Cardiologists are increasingly considering bariatric sur- insulin-resistant state and highest CVD risk has led to a
gery as a useful component of comprehensive cardiac man- deeper appreciation of dysfunctional adipose tissue and the
agement for severely obese patients with established new concept of “adiposopathy” [26]. Adipokines are pro-
CAD. There is some data, albeit limited, that patients with a teins that are synthesized and released by adipose tissue,
diagnosis of CAD show improvements in vascular function which is now acknowledged as an active endocrine and para-
and symptoms after surgical weight loss [17–19]. Bariatric crine organ and not just a passive lipid repository.
procedures with a malabsorptive component may be superior Adiponectin, resistin, leptin, tumor necrosis factor-α (TNF-
in their impact on coronary atherosclerosis, as there is evi- α), and interleukin-6 (IL-6) are of particular relevance to car-
dence for a reduction in angina symptoms after gastric diovascular health.
bypass but not with gastric volume reduction procedures Adiponectin, a 244-amino-acid protein, is markedly
(HR for angina from 3.8 to 2.04 in men, 3.9 to 0.98 in reduced in obesity. This hormone promotes insulin sensitiv-
women) [20]. The pathological process of atherosclerosis ity and fatty acid catabolism and exerts anti-inflammatory
within arteries may also be favorably influenced by bariatric and antiatherogenic effects [27]. Adiponectin inhibits TNF-
surgery. In 136 consecutive subjects returning for 5-year α-induced expression of adhesion molecules on the endothe-
follow-up after gastric bypass, coronary computed tomogra- lium [28] and suppresses the generation of foam cells [29].
phy (CT) calcium scores were lower in postsurgical subjects Endothelial dysfunction and transmigration of lipid-laden
than in a nonsurgical obese control cohort, independent of macrophages into the intima are key inflammatory compo-
traditional CVD risk factors [21]. Another marker for cardio- nents of atherosclerotic plaque formation. Lower adiponec-
vascular atherosclerosis burden is carotid intima-media tin concentrations are associated with an increased risk of
thickness. One group measured intima-media thickness at coronary events [28], although it is suggested that adiponec-
baseline and 3–4 years post-gastroplasty. The surgical tin levels do not contribute to cardiac risk prediction once
49. Cardiovascular Disease in the Bariatric Surgery Patient 457
other CVD risk factors have been considered [30]. The inflammatory milieu probably has a role in the relationship
Framingham Study group recently demonstrated an inverse between obesity, insulin resistance, and CVD.
relationship between adiponectin and left ventricular mass, Dramatic changes in these inflammatory markers, adipo-
adjusted for key covariates including BMI [31]. Levels are kines, and gut hormones are seen in the weeks and months
reported to be elevated in established heart failure [32–34]. after bariatric surgery. CRP and IL-6 levels fall by as much
In contrast, resistin, a cysteine-rich protein secreted pri- as 81 % and 23 % respectively postoperatively, paralleling
marily by adipose tissue, reduces insulin sensitivity and the improvement in insulin sensitivity that emerges almost
stimulates glycogenolysis and gluconeogenesis [35] and is immediately after procedures with a malabsorptive function
pro-inflammatory. Circulating levels are increased in obesity. [58]. These inflammatory and glycemic changes long pre-
There is a strong association between elevated levels of resis- cede the nadir of weight loss. Both Roux-en-Y gastric bypass
tin, obesity, and type 2 diabetes (T2DM) and in vitro evi- (RYGB) and sleeve gastrectomy are also associated with
dence of a role in promoting smooth muscle cell proliferation reductions in circulating leptin concentrations by almost half
[36]. Increasing serum resistin levels correlate with the as early as 1 week postoperatively, with ongoing decreases
degree of heart failure decompensation and are also predic- until 12 months postoperatively. Adiponectin progressively
tive of rehospitalization or cardiac mortality in individuals rises over this time frame [59]. Circulating resistin levels
with advanced heart failure [37]. decrease after gastric bypass or sleeve gastrectomy [60].
Leptin is a pleiotropic adipokine with structural and func- Additional contributors to the relationship between obe-
tional similarities to pro-inflammatory cytokines. It is a sity and CVD may be the gut hormones. Key gut molecules
167-amino-acid protein and is a principal stimulant of satiety that are dysregulated in obesity and appear to have cardiac
through its actions on the hypothalamus. It is also an insulin- effects are ghrelin, peptide YY (PYY), glucose-dependent
sensitizing hormone and deficiency due to rare leptin gene insulinotropic peptide (GIP), and glucagon-like peptide 1
mutations causes insulin resistance and obesity. However, in (GLP-1). Ghrelin is produced preprandially by the stomach
obese states other than that due to leptin gene mutation, and stimulates appetite via increased expression of neuro-
leptin levels are markedly increased but the protein’s action peptide Y (NPY) in the hypothalamus; conversely PYY is
is reduced due to leptin resistance, thereby abolishing their released postprandially from the distal gastrointestinal tract
satiety signal [38, 39]. Leptin is widely expressed in mono- and inhibits NPY release, which promotes satiety. In obese
cytes and atherosclerotic plaques and has been suggested to individuals, total circulating ghrelin levels are lower and not
stimulate macrophage foam cells and platelet aggregation suppressed by food intake, in comparison to normal-weight-
[40, 41]. Leptin is increased in patients with heart failure and matched controls. Peripheral administration of ghrelin
is predictive of incident heart failure [42, 43]. The reduction induces weight gain in rodents by increasing carbohydrate
in left ventricular mass with bariatric weight loss has been utilization [61]. Circulating levels of PYY also tend to be
correlated with reduced circulating leptin concentrations in reduced in obesity with a blunted postprandial PYY rise.
both animal models and humans [44–46]. Additionally, There are potential mechanisms by which reduced circulat-
leptin receptor isoforms are expressed in myocardium, and ing levels of ghrelin in obesity could contribute to myocar-
leptin induces myocyte hypertrophy in culture [47, 48]. dial dysfunction, because effects of this peptide include
TNF-α and IL-6 are also secreted by adipose tissue and anti-inflammatory activity, peripheral vasodilation, enhanced
hence show higher concentrations in obese individuals. cardiomyocyte contractility, and inhibition of myocyte apop-
C-reactive protein (CRP), the acute-phase reactant released tosis. In a rat model of HF, ghrelin administration improves
in response to circulating IL-6, IL-1, and TNF-α, is elevated left ventricular dysfunction and deters development of car-
in obesity. The liver is the predominant site of CRP release, diac cachexia, possibly due to its promotion of growth hor-
although adipose tissue also appears to be a direct source of mone secretion [62].
CRP [49]. CRP is an independent predictor of coronary The incretins, including GLP-1 and GIP, are a family of
events and is also chronically elevated in heart failure [50, 51]. gut hormones that stimulate postprandial insulin release,
It stimulates endothelial dysfunction by multiple pathways inhibit glucagon, slow gastric empting, and promote weight
including increasing the expression of circulating adhesion loss. They are found at subnormal levels in patients with
molecules and endothelial PAI-1 [52], upregulating angio- T2DM, and obese subjects show a blunted postprandial
tensin type 1 receptors on cell surfaces, and attenuating GLP-1 response compared to lean subjects. GLP-1 analogs
endothelial nitric oxide release [53, 54]. Adipocytes have such as exenatide and liraglutide and sitagliptin, a dipepti-
also been observed to directly produce PAI-1 and monocyte dyl-peptidase-4 inhibitor that deters the degradation of
chemoattractant protein-1 (MCP-1) [55, 56], a substance that GLP-1 and GIP, are new pharmacological agents for T2DM
is instrumental in leukocyte transmigration into the intima. that have attracted attention regarding potentially favorable
Adipocytes also release angiotensinogen, a precursor of the cardiovascular effects. GLP-1 receptors are found on cardio-
pro-atherogenic vasoconstrictor angiotensin, which has roles myocytes, and animal models of heart failure have shown
in promoting both endothelial dysfunction and insulin resis- positive responses to GLP-1. GLP-1 agonists appear to have
tance [57]. The contribution of visceral adipose tissue to the a host of favorable cardiovascular effects, including choles-
458 A.R. Vest and J.B. Young
terol lowering [63], protection from post-myocardial infarc- Half of the cohort has a hypertension diagnosis preopera-
tion complications in a mouse model [64], and improvements tively. The initial mean systolic blood pressure in the hyper-
in endothelial dysfunction in stable CAD patients [65]. tensive group was 145 mmHg; among these subjects, systolic
RYGB patients demonstrate a brisk three- to fivefold blood pressure declined by approximately 16 mmHg in the
increase in postprandial GLP-1 and PYY levels postopera- first 6–9 months postoperatively. The initial mean diastolic
tively, which precedes significant weight loss and is indepen- blood pressure in the hypertensive group was 87 mmHg; this
dent of caloric restriction [66]. The sharp increases in declined by approximately 9 mmHg in the first 6–9 months
postprandial GLP-1 and PYY levels that occur post-RYBG after surgery. A patient’s blood pressure was considered to
also precede significant weight loss and are independent of have returned into the normal range if, on 2 of the last 3
caloric restriction [67]. Restored GLP-1 levels may be a clinic visits, systolic blood pressure was less than 140 mmHg
mechanism for the recovery of early-phase insulin secretion and diastolic pressure was less than 90 mmHg. The blood
in response to oral carbohydrates. Ghrelin responses after pressures of 65 (73 %) of the 89 unmediated hypertensive
RYGB are more heterogeneous and are therefore less likely patients had decreased into the normal range by the end of
to explain reduced appetite and improved glucose homeosta- the follow-up period. Thirty-four percent of the cohort
sis postoperatively [60]. ceased antihypertensive medication during the follow-up
period. The blood pressure of medication cessation group at
their final visit was 137 ± 15 mmHg systolic and 80 ± 1 mmHg
The Impact of Bariatric Surgery diastolic.
on Cardiovascular Risk Factors Approximately three-quarters of patients with diabetes
also experience resolution of this CVD risk factor. Two-year
The impact of bariatric procedures on the key “traditional” data from SOS demonstrated 72 % resolution of preexisting
cardiovascular risk factors of hypertension, diabetes, and diabetes in the surgical group, compared to 21 % of controls
hyperlipidemia is not a new observation—in fact, the first (p < 0.001) [8]. At 10 years, diabetes remained in remission in
jejunoileal bypass in 1953 was specifically performed to 36 % of the surgical group and 13 % of controls (p = 0.001).
induce weight loss from malabsorption and improve the lipid These findings were mirrored in Buchwald’s 135,246-patient
profiles of severely hyperlipidemic obese patients [68]. meta-analysis that demonstrated complete resolution of dia-
Among 114 patients who underwent RYGB (74 % females), betes (defined as cessation of diabetes therapy with fasting
total cholesterol change was −23.6 %, −22.3 %, and −18.4 % blood glucose < 100 mg/dL or HgA1c < 6 %) for 74.6 % with
at 6, 12, and 18 months, respectively [69]. The nadir for total more than 2 years’ follow-up [71]. Adams et al. recently
cholesterol was reached at 6 months postoperatively and described 75 % diabetes remission at 2 years and 62 % remis-
then remained constant. LDL dropped by −24.1 %, −29.8 %, sion at 6 years among 418 RYGB patients, with an odds ratio
and −26.7 % at 6, 12, and 18 months, respectively. The nadir for remission of 16.5 (95 % CI, 4.7–57.6; p < 0.001) [72].
for LDL was achieved at 12 months postoperatively, with a The overall impact of bariatric surgery on hypertension,
small nonsignificant rise 6 months later. HDL, for which diabetes, and hyperlipidemia prevalence is summarized in
higher levels confer cardiovascular risk benefits, initially Table 1. In a systematic review of 73 cardiovascular risk fac-
dropped by 13.0 % at 6 months and then steadily increasing tor studies involving 19,543 bariatric surgery subjects (mean
by 3.8 % at 12 months and 19.3 % at 18 months. Triglycerides, age 42 years, 76 % female), baseline prevalence of hyperten-
a prominent component of the metabolic syndrome, progres- sion, diabetes, and hyperlipidemia were 44 %, 24 %, and
sively fell by −27.4 %, −37.8 %, and −47.3 % at 6, 12, and 44 %, respectively. Postoperative resolution or improvement
18 months, respectively. of hypertension occurred in 63 % of subjects, of diabetes in
Bariatric surgery also has a significant impact on hyper- 73 %, and of hyperlipidemia in 65 % at a mean follow-up of
tension. In one study of 347 RYGB and vertical banded gas- 57.8 months and an average excess weight loss of 54 % [73].
troplasty patients, systolic blood pressure declined modestly Biomarkers of cardiovascular risk also improve post-bariatric
by 5–6 mmHg (mean change to nadir value) and diastolic surgery, including a 73 % CRP reduction from 9.1 mg/L
blood pressure by 4–5 mmHg (mean change to nadir value) [70]. preoperatively to 2.5 mg/L across 8 studies (1,157 subjects)
in this systematic review. Five studies (938 subjects) gave a 11.5 % adjusted HR, 0.67; 95 % CI, 0.54–0.83; p < 0.001),
pooled reduction in Framingham 10-year global coronary fatal myocardial infarctions, and total myocardial infarctions
heart risk score from 5.9 to 3.3 %. than controls. Cardiovascular deaths were also reduced, with
1.4 % cardiovascular mortality in subjects vs. 2.4 % in con-
trols, adjusted hazard ratio 0.47 (95 % CI, 0.29–0.76,
The Impact of Bariatric Surgery p = 0.002). The baseline degree of insulin resistance was far
on Cardiovascular Outcomes more predictive of cardiovascular benefit than baseline BMI
in this study, supporting the hypothesis of the importance of
To date, the majority of trials seeking to evaluate the cardio- metabolic dysfunction in the relationship between adipose
vascular impact of bariatric surgery have only presented the tissue and cardiac outcomes. Cardiovascular outcomes have
cardiovascular risk endpoints of hypertension, diabetes, also been investigated specific to patients with diabetes. An
hyperlipidemia, inflammatory markers, and risk prediction adjusted hazard ratio of 0.56 (95 % CI, 0.34–0.93, p = 0.025)
scores, with far fewer reporting actual cardiovascular events for myocardial infarction was seen at 2 years for 345 SOS
or mortality. Among cardiologists, reliance on cardiovascu- surgical subjects compared to 262 nonsurgical controls, all
lar risk markers as indicators of reduced clinical risk after with diabetes [76].
bariatric surgery is regarded with suspicion, because of prior Mortality outcomes after bariatric surgery are considered
instances where CVD risk surrogates have not translated into in greater detail in Chap. 45, but as cardiovascular mortality
an actual survival benefit. Hence, there is now interest in findings are relevant to the consideration of cardiac benefit
designing bariatric surgery trials focused on the collection of from surgical weight loss, they are also outlined here. The
longer-term data on actual cardiovascular events, cardiovas- favorable mortality rate over 9 years in 154 RYGB patients
cular mortality, and all-cause mortality. Ideally, such studies vs. 78 controls (who were referred for surgery but did not
should randomize subjects to surgical vs. nonsurgical man- undergo the procedure) was primarily due to a lower rate of
agement of obesity. As all the existing cardiovascular out- CV death [77]. An observational study of 1,035 predomi-
comes data is from nonrandomized, matched cohorts, it nantly open RYGB patients and 5,746 matched controls dem-
remains possible that features specific to obese patients who onstrated that the surgical subjects had 50 % fewer
pursue a surgical intervention, as compared to those who do hospitalizations during the 5-year follow-up and developed
not opt for surgery, are currently confounding the relation- significantly fewer cardiovascular diagnoses (4.73 % vs.
ship between bariatric surgery and CV outcomes. 26.79 %, RR 0.18, 95 % CI, 0.12–0.22) [78]. At 5 years, the
There is limited data examining the outcomes of bariatric same cohort also showed significantly decreased incidences
surgery in cohorts of obese patients with preexisting cardiac of new pulmonary edema (RR 0.42, 95 % CI, 0.18–0.96),
disease. The safety of RYGB with preexisting CAD was angina (RR 0.53, 95 % CI, 0.40–0.70), coronary artery bypass
assessed in a cohort of 52 patients (with prior coronary grafting (RR 0.28, 95 % CI, 0.14–0.61), and coronary angio-
revascularization, >30 % angiographic coronary stenosis, plasty (RR 0.36, 95 % CI, 0.19–0.66) in the postsurgical sub-
prior myocardial infarction, or a positive stress test). There jects compared to controls, although the decrease in
were no in-hospital deaths among the 52 CAD patients or myocardial infarctions (RR 0.71, 95 % CI, 0.50–1.00) did not
507 surgical patients without CAD. Three CAD patients reach significance (p = 0.05) [79]. There was favorable all-
(5.8 %, 95 % CI, 0–12.2 %) and 7 without CAD (1.4 %, cause mortality, and also a specific reduction in death from
95 % CI, 0.4–2.4 %) had perioperative cardiac complications CAD (59 % risk reduction, p = 0.006), observed among 7,925
(p = 0.06). Postoperative cardiovascular event data is more RYGB patients vs. 7,925 severely obese matched control sub-
abundant for the full population of patients undergoing bar- jects [10]. Further details of the patient characteristics and
iatric surgery. One study of 575 high-risk VA bariatric sur- major results from the 14 largest studies reporting cardiovas-
gery patients, 42 % with BMI ≥50 kg/m2, revealed 1.6 % and cular outcomes after bariatric surgery are presented in Table 2.
0.5 % rates for perioperative cardiac arrest and myocardial
infarction, respectively. The overall mortality in this group Effects of Adiposity and Bariatric
was 1.4 %, slightly exceeding the national published rates
which are under 1 % [74]. Torquati et al. reported a rate of Surgery on Myocardial Structure
1 % for CV events in the 5 years after bariatric surgery within and Function
a cohort of 500 RYGB patients [75]. SOS investigators have
reported cardiovascular outcomes for their 2010 surgical The cardiac effects of excess weight and surgical weight loss
patients and matched nonoperative controls, up to a median have been predominantly considered in terms of the impact
follow-up of 14.7 years [3]. Despite an excess of smoking on atherosclerotic CAD progression and rates of myocardial
and higher baseline weights and blood pressures in the surgi- infarction or other cardiovascular events. However, the direct
cal cohort, bariatric surgery was associated with a lower impact of obesity on the structure and function of the myo-
number of total first-time cardiovascular events (9.9 % vs. cardium is also becoming increasingly evident. Obesity is
ABLE
T 2. Major studies of bariatric surgery with cardiovascular event or mortality endpoints
460
Follow-up
First author Year, country Surgical subjects, N Nonsurgical controls, N period Outcomes Comments
MacDonald [77] 1997, USA 154 obese patients with 78 obese patients with 9 years mean 9 % mortality in subjects (including Lower CV mortality in the
non-insulin-dependent non-insulin-dependent for subjects, perioperative) vs. 28 % in controls, surgical group was the primary
diabetes who diabetes who were 6.2 years for p < 0.0003; annualized mortality rate of 1.0 % driver of the overall survival
underwent RYGB referred for, but did in subjects vs. 4.5 % in controls benefit
(referred 1979–1994) not receive, surgery
(patient choice/
insurance)
Christou [78] 2004, 1035 predominantly open 5,746 age-/gender- 5 years 0.68 % mortality in surgical group (including 50 % fewer hospitalizations in
Canada RYGB patients matched controls 0.4 % perioperative mortality) vs. 6.17 % for surgical subjects and
extracted from a controls (relative risk, 0.11, 95 % CI, significantly fewer CV
health insurance 0.04–0.27) diagnoses (4.73 % vs.
database, baseline 26.79 %, relative risk)
BMIs unknown
Flum and 2004, USA 3,328 gastric bypass 62,781 nonsurgical 4.4 years At 15 years 11.8 % mortality in subjects vs. 30-day surgical mortality 1.9 %;
Dellinger patients obese subjects median; 16.3 % in controls; after propensity matching, postoperative mortality
[123] matched for age, 15.5 years odds of survival at 5 years 59 % higher in associated with surgeon
gender, and maximum surgical group (OR 1.59, 95 % CI, 1.49–1.72) inexperience
comorbidities
Sampalis [79] 2006, 1,035 predominantly open 5,746 age-/gender- 5 years Decreased incidences of new pulmonary edema The decrease in myocardial
Canada RYGB patients— matched controls (RR 0.42, 95 % CI, 0.18–0.96), angina (RR infarctions (RR 0.71, 95 % CI,
morbidity outcomes for extracted from a 0.53, 95 % CI, 0.40–0.70), coronary artery 0.50–1.00) did not reach
the same cohort as health insurance bypass grafting (RR 0.28, 95 % CI, significance (p = 0.05)
Christiou et al. database, baseline 0.14–0.61), and coronary angioplasty (RR
BMIs unknown 0.36, 95 % CI, 0.19–0.66)
Livingston [74] 2006, USA 575 veterans affairs None Maximum 2 30-day cardiac arrest rate 1.6 % and 30-day Adverse postoperative event risk
patients, 42 % with years myocardial infarction rate 0.5 %; overall increased in patients >350 lb
BMI ≥ 50 kg/m2, 87 % 30-day mortality 1.4 % and 2-year mortality and smokers
open bariatric 3.1 %
procedures
Adams [10] 2007, USA 7,925 RYGB patients 7,925 age-/gender-/ Mean 7.1 years All-cause mortality 40 % lower in surgical Rates of death not caused by
(1984–2002) BMI-matched obese group (adjusted HR 0.60, 95 % CI, 0.45–0.67, disease, such as accidents and
controls drawn from p < 0.001); lower surgical mortality for all suicide, were 58 % higher in
driver’s license diseases combined (52 %, p < 0.001), CAD the surgery group (p = 0.04)
applicants (59 %, p = 0.006), diabetes (92 %, p = 0.005),
and cancer (60 %, p = 0.001)
Torquati [75] 2007, USA 500 RYGB patients, mean None 5 years 1 % for CV event rate at 5 years Study primarily reported
45 years, 81 % female improvement in Framingham
risk scores postoperatively
Sowemimo 2007, USA 908, majority open RYGB 112 evaluated for 9 years 2.9 % mortality in subjects vs. 14.3 % in Greatest surgical benefit seen in
[124] (mean age 43.2 vs. surgery but did not controls; adjusted mortality 82 % lower in patients <55 years and with a
47.9 years in controls; proceed for a variety surgical subjects (HR 0.18, 95 % CI, BMI >50 kg/m2
BMI 54 kg/m2 vs. of reasons 0.09–0.35, p < 0.0001)
51 kg/m2 in controls,
both p < 0.0001)
A.R. Vest and J.B. Young
Busetto [125] 2007, Italy 821 LAGB patients with 821 gender-, age-, and 5 years Survival was 60 % higher in surgical group, Other factors correlating with
BMI > 40 kg/m2 BMI-matched p = 0.0004; on multivariate Cox, adjusted death on univariate analysis
controls mortality risk 0.36 (95 % CI, 0.16–0.80) in included male gender, greater
surgical group age, and higher BMI
Peeters [126] 2007, 966 LAGB patients, mean 2,119 matched Median 4 years Surgical patients had a 72 % lower risk of No perioperative deaths. Gender,
Australia age 47 years, mean community controls, for surgical mortality, adjusted for gender/age/BMI than age, and degree of obesity did
BMI 45 kg/m2 mean age 55 years, subjects, controls (HR 0.28, 95 % CI, 0.10–0.85) not significantly affect
mean BMI 38 kg/m2 mean 12 mortality risk
months for
controls
Maciejewski 2011, USA 850 veterans who 41,244 matched controls Mean 6.7 years 2-year and 6-year crude mortality significantly Comprehensive claims data
[127] underwent bariatric (mean age 54.7 years, lower for surgical patients (2.2 % vs. 4.6 %, permitted adjustment for
surgery, mean age mean BMI 42.0 kg/ p < 0.001, and 6.8 % vs. 15.3 %, p < 0.001, factors including ethnicity,
49.5 years, mean BMI m2) from the same 12 respectively); significance of mortality benefit BMI, comorbidity burden, and
47.4 kg/m2 veterans integrated lost with propensity matching of 1,694 marital status
service networks patients (HR 0.83, 95 % CI, 0.61–1.14)
untreated for obesity
Adams [72] 2012, USA 418 RYGB (2000–2011) 418 obese patients who 6 years 2.9 % mortality (12/418) in the surgical cohort All 4 suicides occurred in the
sought but did not vs. 3.3 % mortality in control group 1 and surgical cohort (4 of 12
undergo surgery 0.9 % mortality in control group 2 mortalities)
49. Cardiovascular Disease in the Bariatric Surgery Patient
strongly associated with left ventricular hypertrophy (thick- The Impact of Bariatric Surgery
ening of the walls of the main pumping chamber) and dia-
stolic dysfunction (abnormal relaxation of the left ventricle on Patients with Heart Failure
during chamber filling) [80–82]. It has been established, in
cohort sizes of 16–60 patients, that obese individuals without Several cross-sectional and prospective studies have demon-
overt cardiac disease can show improvements in left ventric- strated that increasing BMI or waist circumference is inde-
ular mass and the echocardiographic markers of diastolic pendently associated with development of incident heart
function in the 3 months to 3.6 years after bariatric surgery failure (HF) [95–97]. A prospective Framingham study of
[83–87]. Furthermore, there is evidence that the regression 5,881 participants, stratified by BMI at enrollment, found
of left ventricular mass is independent of changes in blood that the risk of clinically symptomatic HF increased by 5 %
pressure post-bariatric surgery [83]. Prolongation of the iso- for men and 7 % for women per unit BMI increase, despite
volumic relaxation time is probably the most consistent dia- adjustments for demographics and known CAD risk factors
stolic abnormality seen in obesity, with left atrial volume, [98]. In a prospective study of 4,080 men age 60–79 years
tissue Doppler velocities, and mitral inflow patterns also without baseline HF followed for a mean period of 9 years,
showing derangement in obese subjects [88, 89]. the adjusted hazard ratios associated with a 1-standard devia-
Most of the current data is from echocardiography stud- tion (SD) increase in BMI were 1.37 (95 % CI, 1.09–1.72)
ies, but cardiac magnetic resonance imaging (MRI) also has and 1.18 (95 % CI, 1.00–1.39) in men with and without
a developing role in defining structural and functional CHD, respectively. Increased leptin was significantly associ-
changes after bariatric surgery and can provide superior vol- ated with an increased risk of HF in men without preexisting
umetric assessments. Thirty obese subjects without cardiac CHD, independent of BMI and potential mediators (adjusted
risk factors underwent MRIs at baseline and 1-year post- HR for a 1-SD increase in log leptin 1.30, 95 % CI, 1.06–
weight loss (bariatric surgery or diet) [90]. There was a 10 % 1.61, p = 0.01) [43].
mean reduction in left ventricular mass and a 40 % reduction The evidence suggesting improvements in obesity-
in right ventricular mass. Left ventricular end-systolic vol- associated diastolic and systolic dysfunction after bariatric
ume, stroke volume, and cardiac output also fell with weight surgery raises the possibility of echocardiographic and clini-
loss. An early echocardiographic study of left ventricular cal improvements in obese patients who have a preoperative
systolic, as well as diastolic, function was published with 38 clinical diagnosis of heart failure. Indeed, there are a handful
SOS surgical subjects who underwent echocardiography of early case reports describing HF recovery after surgical
pre- and post-gastroplasty. An improvement in left ventricu- weight loss [99–101]. Such reports do, however, feature very
lar ejection fraction (LVEF) was reported at 1 year postop- obese individuals who were young and predominantly
eratively, but the mean baseline and follow-up LVEFs in both affected by systolic HF, and so the results may not be
groups were >50 %, so any statistical differences after sur- generalizable.
gery were not clinically meaningful. Similarly, there was a Beyond case reports, the published evidence in favor of
statistically significant improvement in LVEF at 3 years improvements in HF after bariatric surgery is limited to three
post-bariatric surgery in another 23-patient cohort, but the small studies. The first is a prospective analysis of fractional
baseline LVEF mean was already supranormal at 71 % [88]. shortening performed pre- and post-vertical band gastro-
More sensitive echocardiographic techniques than LVEF plasty that incorporated 13 subjects with low preoperative
are now available for detecting subtle changes in systolic systolic function [102]. There were modest improvements in
function, particularly in the setting of left ventricular hyper- fractional shortening (22 ± 2 % to 31 ± 2 % p < 0.01) at a
trophy [91]. Two-dimensional speckle tracking-derived mean of 4.3 months after weight loss plateaued, accompa-
strain and strain rate imaging have highlighted the subclini- nied by reductions in left ventricular end-diastolic diameter
cal systolic dysfunction that can be associated with obesity and mean arterial blood pressure. The same group published
[92, 93]. Barbosa and colleagues demonstrated slight differ- a study of fractional shortening pre- and post-vertical band
ences in left ventricular global strain (22.5 % ± 3.5 vs. gastroplasty in 14 subjects with clinical diagnoses of HF and
24.4 % ± 2.5, p < 0.005) between 92 patients with class III an average fractional shorting that lies just below the lower
obesity and 31 healthy controls, despite no differences in limit of normal [103]. This cohort showed improvements in
LVEF between subjects and controls, suggesting incipient New York Heart Association functional class from III to II in
systolic dysfunction with obesity. Of note, these authors four patients, III to I in three patients, and II to I in five
reported that only 9 patients (9 % of the cohort) had a techni- patients but no statistically significant improvements in sys-
cally inadequate echocardiogram that was not amendable to tolic function. However, these postoperative echocardio-
strain analysis. Thirteen obese patients with LVEFs above grams occurred at only 4.5 ± 1.2 months postoperatively, and
40 % demonstrated regression of these subclinical abnor- the older procedure of vertical band gastroplasty is not asso-
malities of myocardial deformability in the 6–24 months ciated with the same degree of metabolic recovery as malab-
after bariatric surgery [94]. sorptive bariatric surgery.
49. Cardiovascular Disease in the Bariatric Surgery Patient 463
An overlapping cohort of HF patients that underwent bar- ence (WC) [113]. Both high WC and the combination of
iatric surgery generated two publications [104, 105]. The high WC/high BMI were associated with improved mortal-
Ramani study utilized an independent echocardiogram ity, or freedom from urgent heart transplant, in this cohort.
reader. Twelve patients with a mean age of 41 years, BMI of Analysis of chronic systolic HF subjects in the SOLVD and
53 kg/m2, and LVEF of 22 ± 7 % were retrospectively V-HeFT II trials revealed that the loss of more than 6 % of
reviewed. Nine underwent RYGB, two received sleeve gas- body weight during the study duration was an independent
trectomies, and one underwent gastric banding. Subjects predictor of mortality [114]. Lower BMIs may simply be a
were matched to ten controls who received diet and exercise marker of cardiac cachexia and more advanced HF, but the
counseling only. At 1 year, hospital readmission in bariatric possibility remains that weight loss may be detrimental to sur-
patients was significantly lower than controls (0.4 ± 0.8 vs. vival in obese patients with HF. Heart failure with preserved
2.5 ± 2.6, p = 0.04). There was a significant improvement in ejection fraction is also more frequently seen in obese patients
mean LVEF for the bariatric group (35 ± 15 %, p = 0.005) but than their lean counterparts and is also associated with a sur-
not for controls, and the NYHA class improved in bariatric vival paradox with increasing BMI (hazard ratio for mortality
patients (2.3 ± 0.5, p = 0.02) but deteriorated in controls. The 0.67, 95 % CI, 0.56–0.81) [115]. These survival observations
third cohort was a subset of 9 patients with LVEF ≤ 50 %, have sparked interest in a hypothesis that although some of the
within a 57-patient cohort of obese subjects with mean BMI adipokine and gut hormone changes associated with obesity
of 49 kg/m2, who underwent RYGB. Although there did may promote cardiac dysfunction, others may potentially
appear to be a trend towards increased LVEF in these 9 become protective once HF is established.
patients (preoperative LVEF 44.8 ± 7 to postoperative LVEF
59.5 ± 10.1, no p value presented), there was a similar rise in
mean LVEF in the nonsurgical controls with initial The Impact of Bariatric Surgery
LVEF ≤ 50 % (44.9 ± 7.9 to 58.6 ± 14.1) [83]. on Arrhythmias
Atherosclerosis and myocardial dysfunction are not the only
The Obesity Survival Paradox cardiac effect of obesity; obese individuals also have an
increased risk of arrhythmias and sudden death. It is postu-
Despite the suggestions of improvements in symptoms and lated that the myocardial of obese patients is vulnerable to
systolic function after bariatric surgery for patients with HF, ventricular repolarization abnormalities. Russo et al. reported
HF patients with higher BMIs actually show more favorable a significant postoperative decrease in the heterogeneity of
survival rates than their leaner counterparts [106–108]. Each ventricular repolarization among 100 bariatric surgery
incremental 5 kg/m2 BMI increase was associated with 10 % patients with pre- and postoperative electrocardiograms
lower in-hospital mortality among 108,927 decompensated [116]. Decreased QT interval and QT dispersion have also
HF patients [109]. A cohort of 2,271 chronic systolic heart been observed in 85 patients post-biliopancreatic diversion
failure patients (mean age 71.9 ± 11.3 years, 74.6 % male) [117]. Such electrophysiological modulation may reduce the
was followed for a median of 1,785 days, during which time substrate for ventricular arrhythmias in this high-risk patient
912 patients died. Measures of body mass were strong uni- population. Obesity also increases the risk for atrial arrhyth-
variable predictors of outcome, and body surface area mias such as atrial fibrillation. Significant regression of
(χ2 = 71.3) was the strongest predictor followed by height P-wave dispersion, a marker of atrial refractoriness heteroge-
(χ2 = 68.6), weight (χ2 = 57.4), then BMI (χ2 = 15.2). The neity and a risk factor for atrial fibrillation, has been reported
greater the patient’s overall size, the greater the likelihood of after bariatric surgery [118]. This suggests that surgical
survival. Body surface area was the single strongest predic- weight loss may hold potential for reducing incident atrial
tor of outcome in a multivariable model including 14 vari- fibrillation, or the incidence of new atrial fibrillation, after
ables [110]. However, the survival advantage of obesity may bariatric surgery.
be lost in individuals with diabetes. Of 2,153 chronic mild to
moderate systolic HF patients with diabetes, of whom 798
(37 %) were obese, all-cause mortality occurred in 38 % of
obese patients and 39 % of nonobese patients (hazard ratio, Conclusion
0.99; 95 % CI, 0.80–1.22; p = 0.915) [111].
The paradoxical survival relationship noted in HF popula- Although bariatric surgery was initially conceived as a
tions has also been observed in patients with CAD but may weight loss procedure, the impact of these operations on car-
disappear when survival is correlated to waist circumference, diovascular risk factors and CAD outcomes has now been
rather than the cruder parameter of BMI [112]. Conversely, demonstrated to be substantial. The procedures that incorpo-
the paradox persists with anthropometric measurements of rate a malabsorptive function appear to have the most signifi-
obesity in HF and was recently demonstrated in advanced cant cardiovascular impact, in line with the known effects of
systolic HF patients stratified by BMI and waist circumfer- malabsorptive procedures on adipokines and gut hormones,
464 A.R. Vest and J.B. Young
which may even directly mediate the cardiovascular benefits an independent predictor of coronary artery disease
of bariatric surgery. This has elevated bariatric surgery to the development, although it is a weaker association than the
spectrum of interventions that may prove useful in minimiz- six major risk factors. The strongest predictor of cardio-
ing future cardiac morbidity, and perhaps also mortality, in vascular risk in any risk equation, including the
patients who are obese. There is also data to suggest improved Framingham Risk Score, is patient age. Serum HDL, for
biventricular hypertrophy and diastolic dysfunction after which higher levels confer cardiovascular risk benefits,
bariatric surgery and a possible role in improving symptoms was observed by Garcia-Marirrodriga et al. [69] to
and systolic function in obese heart failure patients. There decrease by 13.0 % at 6 months and then steadily increase
has been a consequent recent surge in interest in bariatric by 3.8 % at 12 months and 19.3 % at 18 months.
surgery in the cardiology literature.
2. Which of the following statements regarding adipokines
The next step for outcomes investigators is to study long-
and gut hormones is correct?
term cardiovascular events for obese patients who undergo
bariatric surgery, especially among patients with preexisting (a) Circulating leptin levels are consistently low in obese
cardiac diagnoses. Large randomized controlled trials would individuals, compared to normal-weight controls.
yield the most robust data, but large sample sizes would be (b) Resistin, a cysteine-rich protein secreted primarily by
required to provide adequate power within this population of adipose tissue, promotes insulin sensitivity and is
relatively young and predominantly female subjects who anti-inflammatory.
seek bariatric surgery, as their actual cardiovascular and (c) CRP is an independent predictor of future cardiovascu-
mortality event rates are low. Ongoing refinement of patient lar risk in asymptomatic women and has been observed
selection criteria to select out the cohort of patients who to fall significantly in the months after bariatric surgery.
derive the most benefit from surgical weight loss remain a (d) GLP-1 agonists are a group of new diabetes medica-
challenge and will require ongoing input from cardiologists tions that show significant reductions in glycemic
and internists. However, the available literature already pro- parameters but with the adverse effect of weight gain
vides a solid platform from which physicians can initiate dis- in many patients.
cussions with their obese patients regarding the role of (e) Ghrelin is the gut hormone with the strongest evi-
bariatric surgery in promoting future cardiovascular health. dence for mediation of the post-RYGB effects on
glycemia.
Correct answer: (c) Ridker et al. [51] described the rela-
tionships between CRP, the metabolic syndrome, and
Review Questions and Answers incident cardiovascular events among 14,719 apparently
healthy women who were followed up for an 8-year
1. Which of the following statements regarding coronary period for myocardial infarction, stroke, coronary revas-
artery disease epidemiological risk factors is correct? cularization, or cardiovascular death. At all levels of
severity of the metabolic syndrome, CRP added prognos-
(a) LDL serum concentration is inversely associated with
tic information on subsequent risk. Circulating leptin lev-
cardiovascular mortality.
els are elevated in obese states other than that due to leptin
(b) Systolic blood pressure is an independent coronary
gene mutation, due to leptin resistance. Resistin is an adi-
artery disease risk factor.
pokine that promotes insulin resistance, gluconeogenesis,
(c) The strongest predictor of cardiovascular risk in the
and a pro-inflammatory state. The GLP-1 agonists are
Framingham equation is body mass index (BMI).
subcutaneously injected diabetes medications that also
(d) Obesity is not an independent predictor of coronary
promote small but significant decreases in body weight
artery disease risk.
during treatment duration. Ghrelin responses after RYGB
(e) HDL serum concentration has been observed to rise
are quite heterogeneous and are therefore less likely to
significantly within the first postoperative week of
explain reduced appetite and improved glucose homeo-
Roux-en-Y gastric bypass (RYGB).
stasis postoperatively than some of the other gut hor-
Correct answer: (b) Systolic blood pressure is one of the mones and adipokines.
six major epidemiological risk factors for coronary artery
3. An asymptomatic 50-year-old patient with a BMI of
disease development and cardiovascular events. The other
45 kg/m2 and diagnoses of coronary artery disease and
major risk factors are advancing age, smoking, family
diabetes presents for bariatric surgery evaluation. Which
history, elevated serum LDL or total cholesterol, low
of the following statements are incorrect?
serum HDL, and diabetes. Diabetes is usually considered
as a “coronary artery disease equivalent” in terms of risk (a) Compensated systolic heart failure is not a contrain-
prevention, because patients with diabetes and no known dication to bariatric surgery.
coronary artery disease have a similar risk of cardiovas- (b) Markers of inflammation and endothelial function
cular events as patients without diabetes who have a improve in the weeks and months after bariatric
known coronary artery disease diagnosis. Obesity is also surgery.
49. Cardiovascular Disease in the Bariatric Surgery Patient 465
(c) He must undergo cardiac catheterization, with angio- heart failure may experience a postoperative improve-
plasty of any significant coronary stenosis, before ment in their left ventricular ejection faction. The ejection
proceeding to the surgery. fraction is a relatively crude assessment of systolic func-
(d) Existing data suggests a lower rate of future cardio- tion, and echocardiographic techniques such as strain and
vascular events for patients who undergo bariatric strain rate measurement offer much more sensitive assess-
surgery, compared to obese matched controls. ments of subclinical abnormalities of systolic function.
(e) Large trials have demonstrated decreases in long-
term cardiovascular events in patients who undergo
bariatric surgery, compared to patients who receive
optimal medical therapy, but none of these studies to References
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50
Obesity and Cancer with Emphasis on Bariatric
Surgery
Ted D. Adams, Steven C. Hunt, Lance E. Davidson, and Mia Hashibe
p < 0.0001) and renal (RR 1.34, 95 % CI 1.25–1.43; and progesterone; and tumor growth promotion, a result of
p < 0.0001), endometrial (RR 1.59, 95 % CI 1.50–1.68; hyperinsulinemia (associated with insulin resistance subse-
p < 0.0001), and gallbladder (RR 1.59, 95 % CI 1.02–2.47; quent to increased body fatness, in particular, abdominal or
p = 0.04) cancers [17]. Further, Renehan et al. found “weaker central obesity) [8, 30, 33]. A perspective/opinion paper of
positive associations (RR < 1.20)” for increased BMI and the molecular mechanisms or links of how obesity might
rectal and malignant melanoma cancer for men and, for cause an increased risk for cancer has recently been pub-
women, postmenopausal breast, pancreatic, thyroid, and lished by Khandekar et al. [31].
colon cancers [17]. For both sexes, an increasing BMI was Efforts have been undertaken to further identify bioener-
associated with a greater risk for leukemia, multiple getics (i.e., food, nutrition, and physical activity) associated
myeloma, and non-Hodgkin lymphoma [17]. with overweight and obesity risk and subsequent risk of can-
Nonsurgical change in weight status and subsequent can- cer as well as “tumor behavior.” [8] These findings have
cer mortality has also been reported in large population stud- illustrated the potential protective or promoting influences
ies [13, 28, 29]. The most recent of these studies examined that food, nutrition, physical activity, and obesity can have
cancer mortality of 1.2 million UK women (Million Women upon cancer development [8]. Noting that the timeline for
Study), recruited between 1996 and 2001 and then followed these influences begin with and incorporates the fetal expo-
7.0 years for cancer mortality [13]. The primary predictor sure period and subsequent developmental years, careful
measure was BMI, adjusted for a number of factors such as consideration should be given to the prevention and screen-
alcohol intake, physical activity, menopausal status, and hor- ing of overweight and obesity among children and adoles-
mone replacement status. During the follow-up period, a cents [34–36] in relation to their lifetime cancer risk.
total of 17,203 cancer deaths were reported. The trend of Estimates are that obesity among children and adolescents
increasing BMI beyond the reference group (BMI = 22.5– (defined as BMI ≥95th percentile, age and gender specific)
24.9 kg/m2) was significantly correlated with an increased in the United States have increased three- to sixfold [37] and
mortality for the following cancers: adenocarcinoma of the suggest that 12–18 % of children and adolescents are obese
esophagus (RR 2.24, 95 % CI 1.40–3.58), pancreas (RR [36, 38, 39]. Further, children and adolescents who are obese
1.21, 95 % CI 1.04–1.41), postmenopausal breast (RR 1.36, have a greater risk of type 2 diabetes, asthma, and nonalco-
95 % CI 1.12–1.66), endometrium (RR 2,46, 95 % CI 1.78– holic fatty liver disease [36, 40, 41] and are much more likely
3.39), kidney (RR 1.65, 95 % CI 1.28–2.13), and ovary (RR to have adult obesity, hypertension, hyperlipidemia, and
1.17, 95 % CI 1.03–1.33); multiple myeloma (RR 1.56, 95 % metabolic syndrome [42, 43]. These data may suggest that
CI 1.15–2.10); leukemia (RR 1.34, 95 % CI 1.05–1.71); obese children and adolescents have a greater lifetime cancer
brain cancer (RR 1.17, 95 % 0.95–1.43); and all cancers (RR risk. For example, overweight and obesity have been associ-
1.06, 95 % CI 1.02–1.10) [13]. Although not significant, ated with an earlier age onset of puberty [43], and as a result
Reeves et al. reported a decreased premenopausal cancer- of earlier menarche, breast cancer risk may be significantly
related mortality associated with a trend for increasing BMI greater in adulthood [43–46]. Editors of the World Cancer
(RR 0.68, 95 % CI 0.37–1.24) [13]. Research Fund and American Institute for Cancer Research
review document (2007) summarize the importance of tak-
ing the “whole life course approach” with regard to preven-
Potential Mechanisms: Obesity tion of overweight and obesity [8]. They state: “Some of the
and Cancer Risk most persuasive evidence in the whole field of food, nutri-
tion, and physical activity indicates that the basis for preven-
Considerable research effort regarding how obesity influ- tion of cancer should be a whole life course approach,
ences cancer has generated several published studies and starting at the beginning of life, or even in maternal prepara-
review articles that have postulated biological mechanisms tion for pregnancy.” [8]
[8, 9, 30, 31]. A recently published book details possible
molecular mechanisms relating adipose tissue and cancer,
with specific reference to mechanistic links between obe- Lifestyle-Based Guidelines
sity and specific cancer types [32]. These scientific reports for Cancer Prevention
all point to the presence of multiple mechanisms, suggest-
ing “a web of interacting hormones, growth factors, cyto- In view of the multiple studies linking obesity with increased
kines, and inflammation mediators that promote tumor cancer risk, one would naturally reason that individuals who
initiation and growth.” [9] In brief, these mechanisms have are overweight or obese should be advised to reduce their
been classified into three general areas which focus on: body weight in order to lessen their risk for developing can-
chronic inflammation associated with increased release of cer. Following this reasoning, two specific national and inter-
inflammatory promoters in obese individuals; over-release national documents have provided lifestyle-related
of steroid-related hormones such as estrogens, androgens recommendations for the prevention of cancer: the American
50. Obesity and Cancer with Emphasis on Bariatric Surgery 473
Cancer Society Guidelines on Nutrition and Physical Activity in population-based studies attempting to demonstrate an
for Cancer Prevention (American Cancer Society) [47] and association of nonsurgical weight loss and subsequent cancer
Food, Nutrition, Physical Activity and the Prevention of risk have included the inability to maintain sustained weight
Cancer: A Global Perspective (World Cancer Fund and loss and the limited amount of weight lost [53, 54, 56].
American Institute for Cancer Research) [8]. These two doc- Although multiple studies have demonstrated short-term
uments focus on the relevance of following a healthy diet weight loss success when subjects engage in traditional ther-
and participating in consistent physical activity for the pur- apy (i.e., dietary, physical activity, and behavioral interven-
pose of both preventing and treating overweight and obesity. tions), the proportion of participants who achieve long-term
These recommendations are in concert with prevention- weight loss maintenance is estimated to be as minimal as
oriented guidelines published by other international organi- 5–10 % [56, 57]. Additional limitations of weight loss and
zations (the European Code Against Cancer for cancer cancer risk association studies are the failure to identify
prevention [48], the American Heart Association for coro- weight loss intentionality (i.e., was weight loss voluntary or
nary heart disease prevention [49], and the American not) within the reported research methods, and the absence
Diabetes Association for diabetes prevention) [50] and of studies whose initial primary outcome is identified as
guidelines aimed at promoting overall good health (the 2010 weight loss intention [56]. For these reasons, in meaningful
Dietary Guidelines for Americans [51] and the 2008 Physical sized weight loss population studies with lifestyle-focused
Activity Guidelines for Americans) [47, 52]. intervention (i.e., physical activity, diet and behavioral modi-
Of particular interest, the World Cancer Research Fund fication), successful long-term weight loss outcomes have
and the American Institute for Cancer Research has recom- been difficult to attain [53, 56, 57].
mended that for cancer prevention, individuals should “be as There are, however, a limited number of large population
lean as possible within the normal range of body weight.” In multicenter randomized clinical trials that have demonstrated
addition, the guidelines identified for people who have successful weight loss through intensive lifestyle therapy and
gained weight, but remain within the normal weight range, inclusion of medication. Examples of such studies are the
are that they work toward returning to their original weight, Diabetes Prevention Program (DPP) study in which all
and that individuals lose enough weight to approach the nor- recruited participants were prediabetic [58] and the Action
mal weight range if they are above the normal weight range for Health in Diabetes (Look AHEAD) study, where all sub-
[8]. Following an approach similar to the World Cancer jects were overweight and diagnosed with type 2 diabetes
Research Fund and the American Institute for Cancer [59]. Participants of the DPP who were randomized to the
Research regarding the recommendation for body weight intensive lifestyle therapy had a 1-year reported weight loss
and cancer prevention, the American Cancer Society’s (ACS) of 7 kg (approximately 7.5 % loss from their initial weight)
guidelines encourage individuals: “Achieve and maintain and gradual regain of 5 kg over the approximately next 4
weight throughout life; be as lean as possible throughout life years, resulting in 5-year maintenance of about 2 kg less than
without being underweight; and avoid excess weight gain at their initial weight [60]. Results of the Look AHEAD study,
all ages.” [47] Finally, the recommendation of the ACS for the first randomized control trial to explore whether or not
individuals who are currently overweight or obese is that weight loss, in combination with physical activity, results in a
they reduce body weight and keep in mind that losing even a reduction of cardiovascular morbidity and mortality [61, 62],
small amount of weight is associated with health benefits. showed that participants randomized to the intensive lifestyle
The ACS guidelines do not specifically include in their group had lost on average 8.6 % of their initial weight at the
“health benefits” a reduced cancer risk, but this positive end of year one. At 4 years, this group had an average weight
health outcome could certainly be implied. In summary, loss of 6.2 %. The intense lifestyle group also demonstrated a
these national and international documents which contain significant improvement in diabetes status (hemoglobin A1c
recommendations for lifestyle intervention to prevent cancer level (−0.36 % versus −0.09 %; p < 0.001)) [25].
include strong implication that individuals who participate in Based upon the results of these two large population tri-
voluntary weight loss can reduce their risk for subsequent als, the opportunity to achieve both meaningful and sus-
cancer development. tained nonsurgical weight loss appears to require intensive
lifestyle intervention. Even with this in-depth therapeutic
approach, the expected achieved weight loss at 1 year is
7–9 %, with weight regain after year 1. One might hypothe-
Nonsurgical Weight Loss, Cancer size that in order to sufficiently evaluate the outcome of vol-
Prevention, and Cancer Recurrence untary weight loss upon subsequent cancer risk, a meaningful
follow-up period (i.e., perhaps many years) coupled with a
Although convincing evidence has linked obesity and certain substantial degree of sustained weight loss (i.e., perhaps at
cancer types, whether or not intentional weight loss reduces least 7–10 % of initial weight) may be required. However,
the risk of cancer incidence and cancer recurrence is uncer- whether or not these weight loss criteria are essential for
tain [30, 47, 53–56]. Identified research limitations inherent reducing cancer incidence and/or cancer recurrence is not
474 T.D. Adams et al.
known. For example, research has demonstrated that even in weight in relation to pre- and postmenopausal time peri-
modest weight loss can result in improvements in insulin ods, the general conclusion of the results suggested that
sensitivity, sex- and metabolic-related hormones, and inflam- “weight loss and maintenance during these years (between
matory markers, all of which have been proposed to be asso- age 18 years and menopause) reduces the risk of postmeno-
ciated with mechanisms linking obesity and cancer risk [47, pausal breast cancer.” [68] Other examples of weight loss
55, 63]. associated with subsequent cancer risk include two
Keeping in mind the potential limitations of intentional population-based case-control studies [67, 73]. Trentham-
weight loss and subsequent cancer risk (i.e., limited degree Dietz et al. analyzed weight change and risk of endometrial
of weight loss, resistance to long-term weight loss mainte- cancer in 790 newly diagnosed endometrial cases and 2,342
nance, and unknown intentionality), several large population controls free of cancer [67]. Participants were interviewed
studies have explored the question of whether or not weight regarding whether or not they had ever lost at least 20 lb and
loss results in reduced cancer risk, cancer recurrence, and then gained at least half of the weight back within a 6-month
cancer mortality [20, 21, 28, 29, 64–72]. Rodriguez et al. period. Following adjustment for variables such as tobacco
examined BMI change (BMI self-reported in 1982 and again use, menopause status, and diabetes, the authors reported
measured in 1992 at study enrollment) and incident prostate that women reporting a “sustained weight loss” had a reduced
cancer in 69,991 men participating in the Cancer Prevention endometrial cancer risk (OR, 0.7; 95 % CI 0.6–0.9) [67]. As
Study II Nutrition Cohort [21]. A total of 5,252 incident part of the Long Island Breast Cancer Study Project, Eng
prostate cancers were detected through the follow-up period et al. studied 990 cases of women diagnosed with postmeno-
(from enrollment through mid-2003) [21]. Results suggested pausal breast cancer compared with 1,006 controls and found
obesity increased the risk of “more aggressive prostate can- that in contrast to increased postmenopausal breast cancer
cer” and “may decrease” incidence of less aggressive tumors risk with weight gain, “weight loss over the lifetime was
[21]. With reference to the men who lost weight (weight loss associated with decreased risk of postmenopausal breast
categories were 6–10, 11–20, or ≥21 lb), the authors reported cancer” (OR, 0.55; 95 % CI 0.32–0.96) [73].
a reduction in risk of the more aggressive prostate cancer More recently, review articles not specifically focused on
(RR 0.58, 95 % CI 0.42–0.79) [21]. In a study examining weight loss through bariatric surgery have focused on weight
weight change (weight gain and weight loss) and cancer risk loss and subsequent risk for cancer incidence and cancer
among a cohort of 64,649 Austrian adults (28,711 men; 96, recurrence risk [9, 53, 55, 56]. Wolin and Colditz reviewed
938 women), Rapp et al. reported that although the incidence the relationship between weight loss and weight gain to can-
of all cancers combined was not “clearly associated” with cer incidence, with a specific focus on colon, breast, prostate,
weight loss or weight gain, weight loss (>0.10 kg/m2/year) esophageal, pancreatic, endometrial, and kidney and renal
was inversely associated with colon cancer in men (HR 0.50, cell cancers [53]. While their review identified multiple stud-
95 % CI 0.29–0.87) [64]. In a prospective study (National ies demonstrating a positive association between weight gain
Institutes of Health-AARP Diet and Health Study) of adult and some cancers, the research linking weight loss to a
weight change and breast cancer risk of 99,039 postmeno- reduction in cancer risk was limited. With reference to weight
pausal women, Ahn et al. reported that weight gain during loss and subsequent cancer risk, the authors cited studies that
adulthood was associated with increased breast cancer risk, demonstrated reduced risk in postmenopausal breast cancer
but adult weight loss was “unrelated to breast cancer com- following weight loss and limited evidence linking reduced
pared with stable weight.” [65] In contrast to the study of prostate cancer risk to weight loss. Further, the authors spec-
Ahn et al., Parker and Folsom reported the results of ques- ulated that weight loss may reduce cancer adenocarcinoma
tionnaire data regarding intentional and unintentional weight of the esophagus because weight loss has been shown to
loss activity of ≥20 lb during adulthood [66]. Of the 21,707 lower the risk for gastroesophageal reflux, a potential partner
postmenopausal women who participated, those women who in the mechanistic development of this cancer [53]. Wolin
“ever experienced” an intentional weight loss of ≥20 lb with- and Colditz emphasize that there are limited data on weight
out a reported unintentional weight loss had an 11 % lower loss linked to cancer risk, likely due to “small numbers of
incidence rate for any cancer type (RR 0.89, 95 % CI 0.79– individuals able to achieve sustained weight loss,” but do
1.00) and 19 % lower for breast cancer (RR 0.81, 95 % CI conclude:If individuals achieve and maintain weight loss, we
0.66–1.00), when compared with women who reported no could prevent substantial cancer burden. This is most evident
≥20 lb weight loss episodes [66]. for postmenopausal breast cancer. The time frame for the
The association of weight gain and weight loss (in excess benefits of reduced cancer risk after successful weight loss
of 5 % of body weight) both before and after menopause in remains unclear for most cancers [53].
relation to postmenopausal breast cancer risk was studied as In a review of intentional weight loss and subsequent can-
part of the Iowa Women’s Health Study [68]. A total of cer risk, Byers and Sedjo identified three cohort studies and
33,660 postmenopausal women were followed for over 15 three dietary randomized trials where intentional weight loss
years, in which 1,987 incident cases of breast cancer were was linked to a reduction in cancer risk [55]. The three cohort
reported. Although study analyses were stratified by changes studies highlighted in this review have been previously dis-
50. Obesity and Cancer with Emphasis on Bariatric Surgery 475
cussed in this report [66, 68, 71]. While the primary design loss may well lead to meaningful reductions in cancer risk
of the three dietary randomized control trial studies focused with a short latency time [55].
on breast cancer risk reduction (new incidence or recurrence) An extensive and systematic review by Birks et al.,
following dietary intervention and not on intentional weight published in 2012, examines the influence of weight loss
loss [74–76], Byers and Sedjo theorized that because the upon cancer incidence and mortality [56]. Using PubMed
dietary interventions had the potential to achieve differences and EMBASE, a systematic literature search was conducted
in weight loss between the randomized groups, the studies for manuscripts that contained key terms such as “weight
could “be taken as indirect evidence about the potential loss,” “weight change,” and “obesity” and were published
impact of intentional weight loss on cancer risk.” [55] In the between 1978 and April of 2011. From a total of 4,748 arti-
Women’s Healthy Eating and Living (WHEL) randomized cles, 34 studies met that search criteria and were further ana-
trial, Pierce et al. explored the influence of a diet high in veg- lyzed. Of the 34 articles, the following categories were
etables and fruit and low in fat on women who previously identified: surgical weight loss and cancer (n = 3), intentional
had been treated from early-stage breast cancer [74]. The nonsurgical weight loss and cancer (n = 3), any weight loss
intervention group (n = 1,537) received telephone-based (i.e., intentionality not identified in the manuscript) and post-
dietary counseling and cooking classes, and the comparison menopausal breast cancer (n = 10), and any weight loss (i.e.,
group (n = 1,551) was given print material describing the intentionality not identified in the manuscript) and any can-
5-A-Day program. Over a mean follow-up period of cer other than postmenopausal breast cancer (n = 6 exploring
7.3 years, there were no significant differences in invasive all cancers and n = 12 exploring other specific cancers) [56].
breast cancer events or mortality between the intervention Studies identified by Birks et al. that were related to weight
and the comparison groups. There were also no significant loss surgery will be discussed in the next section of this
differences in change in body weight between groups with chapter. Of the nonsurgical weight loss surgical studies
each group losing less than 1 kg compared with baseline where weight loss intention was known (n = 3), one of these
[74]. The Women’s Intervention Nutrition Study (WINS) studies [66] has been previously discussed. The other two
included the randomization of 2,437 women with a history of reported articles were published by Williamson et al. and
breast cancer to a low-fat diet versus a control diet [76]. After examined intentional weight loss and mortality in white
a median follow-up of 60 months, the intervention group had women [77] and white men [29]. The white women-only
a significantly lower dietary fat intake (p < 0.0001) and lower study involved 43,457 overweight, never-smoking US par-
body weight of approximately 6 lb compared with the con- ticipants (age range, 40–64 years) who self-reported weight,
trol group (p = 0.005). There was a reported 9.6 and 12.4 % weight change information (i.e., how much weight (gain or
decrease in breast cancer relapse events in the dietary and loss), time interval and intentionality), and preexisting ill-
control groups, respectively, representing a hazard ratio in nesses with specific reference to obesity-related illnesses.
the intervention versus the control group of 0.76 (95 % CI The vital status of participants was determined 12 years later
0.60–0.98; p = 0.077 for stratified log rank and p = 0.34 for [77]. For women who reported intentional weight losses of
adjusted Cox model analysis) [76]. From 1993 to 2005, 40 1–19 lb and ≥20 lb and preexisting obesity-related illnesses,
US clinical centers participated in a randomized, controlled, there was a significant reduction in cancer mortality risk,
primary prevention study in which 48,835 postmenopausal with an adjusted HR of 0.63 (95 % CI 0.43–0.93) and HR of
women without prior breast cancer history were randomly 0.71 (95 % CI 0.52–0.97), respectively. Among women with
assigned to a dietary intervention promoting low fat (20 %) intentional weight loss reported in these two weight loss
and increased fruits and vegetables (at least five servings ranges but without any preexisting illnesses, the cancer mor-
daily) and increased grains (at least six servings daily) or to tality risk varied from HR of 1.27 (95 % CI 0.98–1.65) for
a comparison group that were asked not to alter their dietary weight loss of 1–19 lb to HR of 0.84 (95 % CI 0.62–1.15) for
intake [75]. Over an 8.1-year follow-up period, 0.42 % of weight loss ≥19 lb; neither was significant [77]. The men-
the intervention group and 0.45 % women of the compari- only study of Williamson et al. reported no significant differ-
son group were diagnosed with breast cancer (7 % differ- ences in cancer mortality risk associated with intentional
ence), representing a hazard ratio of 0.91 (95 % CI weight loss [29]. Of the remaining studies reviewed by Birks
0.83–1.01). At 6-year follow-up, the mean difference in et al. where weight loss intentionality was not known (n = 28),
body weight between the intervention and comparison the link between weight loss and cancer risk varied from
groups was −0.8 kg (p < 0.001) [75]. In addition to these inverse to null to positive associations [56]. As part of the
reported cohort and randomized control trial studies, the discussion, Birks et al. reported:Although the literature
review by Byers and Sedjo also identified several studies reviewed compared cancer incidence between two equiva-
designed to examine changes in cancer-related hormonal lent groups of people (one of which achieved weight loss),
biomarkers and proinflammatory agents following inten- only six studies (including the three [weight loss] surgery
tional weight loss [55]. The authors conclude:Because both studies) investigated the effect of weight loss among specifi-
cancer incidence and levels of circulating cancer biomarkers cally overweight or obese individuals. [Further] when inten-
drop fairly rapidly following weight loss, intentional weight tional weight loss is achieved in those with excess weight,
476 T.D. Adams et al.
there is consistent evidence that the incidence of cancer is geries performed globally in 2008 [84, 85]. Because bariatric
reduced. When intentionality is not known, results are less surgery is now recognized as the only successful treatment
clear, although more than half of such studies analyzed here for substantial, long-term weight loss for most severely obese
still demonstrate a significant inverse association between patients [86–88], and due to the fact that the prevalence of
weight loss and cancer incidence [56]. extreme obesity in the United States has increased at a greater
Limited research has been conducted on the use of weight rate than moderate obesity [2, 3], the popularity of weight
loss-specific pharmacological agents and subsequent cancer loss surgery is likely to continue. These trends and the result-
risk. Given the relationship between obesity and diabetes ing increase in post-bariatric surgery patients provide an ideal
incidence and the associated pharmacological treatment of patient population to study the association of meaningful and
these disorders, additional studies are likely to provide addi- sustained weight loss on subsequent cancer incidence and, in
tional insight related to cancer risk following the use of drug some cases, cancer recurrence.
therapy that might “target the factors thought to play a role in The longest ongoing prospective bariatric surgery study is
the cancer risk-increasing mechanisms of obesity” such as the Swedish Obesity Subjects (SOS) study, with reported
metformin [9]. In a review/meta-analysis of metformin and significant and sustained weight loss among surgical patients
cancer risk in diabetic patients (11 total studies), a 31 % for a period of greater than 10 years when compared with
reduction “in overall summary relative risk” was reported to matched severely obese control participants [89]. Further
be 0.69 (95 % CI 0.61–0.79) for patients who were reported demonstration of significant, long-term weight loss (out to 6
to be taking metformin compared with other antidiabetic years) following Roux-en-Y gastric bypass surgery has been
medications [78]. reported in the prospective Utah Obesity Study [90]. To date,
Studies have suggested that increased risk of cancer recur- three randomized clinical trials have been published compar-
rence may be attributed to obesity [9, 79–82]. For example, ing diabetic patients with bariatric surgical procedures or
for patients who were diagnosed with cancer, a BMI in the intensive medical therapy [91–93]. Although the primary
normal range was shown to be associated with more favor- outcome for each of these trials related to improved diabetes
able outcomes for pre- and postmenopausal women [80]. A status following bariatric surgery, these studies demonstrated
study by Joshu et al. reported that weight gain in the period the successful attainment of major weight loss. Dixon et al.
of 5 years prior to and 1 year following a prostatectomy randomized severely obese diabetic patients to an adjustable
increased the risk of prostate cancer recurrence [9, 83]. As a gastric banding group or to nonsurgical medical interven-
result of these and other similar findings, whether or not to tion, and after two years of intervention, the surgical patients
advise overweight or obese patients recently diagnosed with had reduced their initial body weight by 20.7 % compared
cancer to voluntarily lose weight or to avoid weight gain for with a loss of 1.7 % in the nonsurgical group [93]. Schauer
reasons related to reducing risk for cancer progression or et al. reported a reduction in baseline weight at 1-year inter-
recurrence is an important consideration. Unfortunately, lim- vention of 27.5 % for gastric bypass patients, 24.7 % for
ited data exists regarding the influence of weight loss on can- sleeve patients, and 5.2 % for patients receiving an intensive
cer progression or recurrence. lifestyle-based program only [92]. At 2 years post-
intervention, patients participating in the study by Mingrone
et al. achieved weight loss from baseline of 33.3 %, 33.8 %,
and 4.7 % for gastric bypass, biliopancreatic diversion, and
Bariatric Surgery, Weight Loss, the intensive lifestyle therapy program, respectively [91]. To
and Cancer Risk date, associations with weight loss and subsequent cancer
incidence risk have not been reported for these three trials.
While most of the large population cancer and weight loss Results from prospective and randomized control trial stud-
studies previously cited in this report have included partici- ies have clearly demonstrated that significant and sustained
pants who are not necessarily overweight or obese, with little weight loss can be achieved through bariatric surgery. The
exception post-bariatric surgery patients are severely obese question of whether or not this intentional weight loss can
prior to their weight loss surgery. Most insurance companies impact future cancer risk can now (and has recently been) be
require patients seeking bariatric surgery to have first engaged explored using the bariatric surgery model in a manner not
in nonsurgical weight reduction activity and have a BMI of previously undertaken in non-weight loss population groups
≥35 kg/m2 but <40 kg/m2 and at least two obesity-related risk due to weight loss sustainability limitations of interventions
factors or a BMI ≥ 40 kg/m2 [10]. The adjustable gastric previously identified in this chapter.
banding system (Allergan©) has also been approved as a sur- Likely the first study demonstrating a possible link
gical treatment option for patients whose BMI is ≥30 kg/m2 between post-bariatric surgery weight loss and cancer mor-
and who have at least one preexisting obesity-related risk fac- tality risk was by MacDonald et al. who prospectively fol-
tor. Following these guidelines, treatment of severe obesity lowed 154 type 2 diabetic patients who underwent gastric
through bariatric surgery has gained greater favor over the bypass surgery and 78 severely obese type 2 diabetic patients
past few decades, with an estimated 344,000 weight loss sur- who did not have weight loss surgery and who were matched
50. Obesity and Cancer with Emphasis on Bariatric Surgery 477
to the surgical patients by age, sex, and BMI [94]. The mean showed the surgical group had a reported 79 cancers com-
follow-up time was 9 years and 6.2 years for the surgical and pared with 130 cancers in the control females, giving an HR
nonsurgical groups, respectively. Although not significantly value of 0.58 (95 % CI 0.44–0.77; p = 0.0001). Unlike the
different between groups, the cancer mortality for the gastric cancer results of female-only participants, SOS reported that
bypass group was 0 % compared with 0.6 % cancer mortality there were no effects related to bariatric surgery and subse-
for the nonsurgical group [94]. Since this initial paper, a quent cancer incidence in males (38 cancer cases among men
number of studies have been published on the association of in both the surgical and control groups) [100]. The lack of
cancer mortality and cancer incidence risk with bariatric sur- significant differences in cancer incidence between the male
gery, including review papers [25, 54–56, 84, 95–98] and post-bariatric surgery patients and nonoperated comparison
prospective and retrospective studies [33, 89, 99–105]. participants may have been influenced by the fewer numbers
As previously indicated, the Swedish Obesity Subjects of male subjects. Exploration of possible variables associ-
study (SOS study) is a long-term study that has followed ated with cancer incidence showed that the degree of weight
2,010 patients who underwent bariatric surgery (71 % loss or changes in energy intake among the SOS subjects
females) and 2037 severely obese participants who did not participating in the bariatric surgery group were not signifi-
undergo weight loss surgery. Both groups were matched cantly related to the reduction in cancer incidence [98].
using multiple parameters. The study participants were fol- However, sagittal trunk diameter (a substitute measure for
lowed at 25 surgical departments and 480 primary health intra-abdominal adiposity [100, 107]) was shown to contrib-
care centers in Sweden and of the surgical group, 376 ute significantly to cancer incidence [100].
(18.7 %) underwent nonadjustable or adjustable gastric Christou et al. conducted an observational study (mean
banding, 1,396 (68.1 %) had vertical banded gastroplasty, follow-up approximately 2.5 years; maximum of 5 years) of
and 265 (13.2 %) Roux-en-Y gastric bypass procedures weight loss following bariatric surgery of 1,035 patients
[106]. Study inclusion criteria included age between 37 and (65.6 % female; operated on between 1986 and 2002) in
60 years and a BMI of 34 kg/m2 or more for men and 38 kg/ which bariatric surgical patients were compared with a com-
m2 for women. The initial SOS mortality study followed par- parison group of 5,746 age- and gender-matched severely
ticipants in both groups for an average of 10.9 years, and obese patients. The comparison group was obtained from a
vital status was determined for all but three of the partici- large health care claims database (which included hospital-
pants (follow-up rate of 99.9 %) [89]. izations) using ICD codes that are commonly related to obe-
As the SOS study is the only prospective investigation to sity [101]. The types of bariatric surgery included open
report long-term changes in clinical variables and cancer Roux-en-Y gastric bypass (79.2 %), vertical banded gastro-
incidence, a significant strength of this mortality study was plasty (18.7 %) and laparoscopic Roux-en-Y gastric bypass
the prospective tracking of weight. Maximum weight loss (8 %) procedures. The mortality rate was reported as 0.68 %
from baseline that occurred over the period of up to 15 years for the surgical group and 6.17 % for the control group [101].
was 25 %, 16 %, and 14 %, respectively, for gastric bypass, As a follow-up to this initial cancer-focused study,
vertical banded gastroplasty, and gastric banding, with an Christou et al. published a study in which first-time physi-
approximate ±2 % weight change among the control group cian/hospital visits were linked to eventual “all cancer diag-
[89]. The unadjusted overall total mortality HR in the sur- nosis.” The study population included 1,035 post-bariatric
gery group when compared with the control group was 0.76 surgical patients (surgery performed between 1986 and
(95 % CI 0.59–0.99; p = 0.04), and when adjusted for sex, 2002). Similar to Christou’s earlier study, the age- and
age, and risk factors, the HR was similar at 0.71 (p = 0.01). gender-matched morbidly obese group (n = 5,746) of partici-
The SOS study reported a total of 129 deaths (6.3 %) among pants were identified using ICD codes for morbid obesity,
the control group and 101 deaths (5.0 %) in the surgical who had not undergone bariatric surgery and whose data
group. Interestingly, cancer was the most common cause of were part of a single-payer administrative database [102].
death over this mean 10-year period (48 deaths in the control Any surgical or control participant found to have visited a
groups compared with 29 deaths in the surgical groups), and physician or hospital for purposes that were related to cancer
myocardial infarction was the second leading cause of death (diagnosis or treatment) within 6 months before their inclu-
(25 deaths among the control group and 13 deaths in the sur- sion into the study was excluded from the analysis [54].
gical group) [89]. Analysis of the data after a maximum of 5 years follow-up
As a follow-up study (mean follow-up of 10.9 years; showed the number of visits to the physician/hospital that led
range from 0 to 18.1 years) among SOS study participants, to a cancer-related diagnosis for the weight loss surgical
Sjöström et al., reported on the incidence of cancer [100]. group was 21 visits (2.0 %) compared with 487 visits (8.5 %)
The number of reported cancers among the post-bariatric among the comparison group, with a relative risk of 0.22
surgery group was 117 compared with 169 cancers among (95 % CI 0.14–0.35; p = 0.001) [102]. Reported relative risk
the control group, representing an HR of 0.67 (95 % CI for breast cancer was 0.17 (95 % CI 0.01–0.31; p = 0.001),
0.53–0.85; p = 0.0009). Because the SOS study consisted of but menopausal status in relation to these cancers was not
primarily female participants, the female-only analysis noted. The risk ratio for colorectal cancer between the two
478 T.D. Adams et al.
groups was 0.32 (95 % CI 0.08–1.31; p = 0.63). This study combined, the gastric bypass surgery group demonstrated a
did not report all-cause mortality between study groups [54]. 24 % reduction in cancer incidence when compared with
Drawing upon post-gastric bypass patient data collected the comparison group (HR 0.76, 95 % CI 0.65–0.89;
by surgeons of the Rocky Mountain Associated Physicians p = 0.0006). Similar to other reported studies where women
(Salt Lake City, UT) over two decades, Adams et al. con- represent the greater percentage of bariatric surgical
ducted a retrospective cohort study of long-term mortality patients, in this study only 14 % and 17 % of the surgical
(from 1984 to 2002) [99]. The study included 7,925 post- and comparison participants, respectively, were men. The
Roux-en-Y gastric bypass patients matched to 7,925 severely small number of male subjects may have influenced the
obese comparison subjects who had applied for a Utah driv- finding of no significant group differences in incidence of
er’s license. Matching included age, sex, BMI, and the date all cancers when only males were compared. However, all
of bariatric surgery with the year the comparison participant incident cancers were significantly lower for females of the
applied for their driver’s license. The self-reported BMI of surgical group compared with comparison female-only
all driver’s license applicants was corrected using gender- group (HR 0.73, CI 0.62–0.87; p = 0.0004). When cancers
specific regression equations derived from a subset of 592 identified as “likely” to be obesity-related were grouped
subjects using weight that had been clinically measured (esophageal adenocarcinomas, colorectal, pancreas, post-
before bariatric surgery. To assure that none of the compari- menopausal breast, corpus and uterus, kidney, non-Hodgkin
son group participants had previously undergone weight loss lymphoma, leukemia, multiple myeloma, liver and gallblad-
surgery, they were linked to the state hospitalization registry. der), incident risk for these obesity-related cancers was sig-
If a comparison participant had ICD codes for bariatric sur- nificantly lower in the surgery group compared with the
gery, they were excluded from the study analyses [99]. comparison group (HR 0.62, 95 % CI 0.49–0.78), whereas
Names, date of birth, Social Security numbers, and state of the grouped “nonobesity”-related incident cancers were not
birth of all patients and comparison group participants were significantly different between groups. Results from this
submitted to the National Death Index for the purpose of study estimated that approximately 71 gastric bypass surger-
obtaining mortality status and cause of death. ies would be necessary to prevent one incident cancer [33].
Total study follow-up was 18 years with a mean follow-up When specific stratification of cancer by stage [108] at
of 7.1 years. For all-cause deaths, there were 213 deaths first diagnosed was performed, there were no stage differ-
among the surgical group and 321 deaths among the group ences between groups in the in situ (stage 0) and local (stage
(hazard ratio of 0.60, 95 % CI 0.45–0.67; p < 0.001, after 1). However, the regional cancers (stages 2–5) were signifi-
covariate adjustment). Prevalent cancers for the surgical and cantly lower in the surgical group compared with the com-
comparison groups were 1.67 % and 1.59 %, respectively, parison group (HR 0.61, 95 % CI 0.43–0.89; p = 0.009). The
not significantly different (p = 0.71). With specific reference distant cancers (stage 7) were also significantly lower in the
to cancer deaths, the gastric bypass surgery group (31 deaths; surgical patients compared with comparison participants
5.5 cancer deaths per 10,000 person years) was 60 % lower (HR 0.61, 95 % CI 0.39–0.96; p = 0.03). Finally, the cancer
than the comparison group (73 deaths; 13.3 cancer deaths case fatality rates were not significantly different between
per 10,000 person years) (P = 0.001). Any cancer deaths groups nor were the mean times to cancer detection [33]. As
occurring within 5 years of baseline were eliminated from has been previously indicated, unlike the SOS study, this
the analysis [99]. Unlike the SOS study, weight and other study only had baseline weight available, and no follow-up
associated clinical data at the time of death were not obtain- clinical data for surgical patients and comparison groups
able, and as indicated, only self-reported baseline weight (other than incident cancer information) were obtained.
was available for the comparison group participants. Further discussion related to strengths and weaknesses of
Adams et al. extended the mortality follow-up study to this study have been previously reviewed [33]. This study
24 years (mean, 12.5 years) and added cancer incidence further surmised that:…regional and distant cancers that
data by linking all participant data to the Utah Cancer would have resulted without the surgery [gastric bypass]
Registry (UCR) [33]. Cancer site (type), stage, date of were detected in the in situ and local stages and in situ and
diagnosis, vital status, and date of death were also obtained. local stage cancers that would have occurred without surgery
Subjects included gastric bypass patients who were Utah were prevented or delayed beyond the end of the follow-up
residents (6,596 of a total 9,949 post-gastric bypass period [33].
patients) and severely obese comparison participants A study by Östlund et al. addresses whether or not bariat-
(n = 9,442) as identified through Utah driver’s license appli- ric surgery reduces the postsurgical cancer risk to the risk of
cations. There were no differences between groups for the general population [103]. Östlund et al. analyzed the
baseline cancer prevalence. Results showed that 254 incidence of obesity-related cancers among 13,123 post-
(3.1/1,000 person years) and 477 (4.3/1,000 person years) bariatric surgical patients operated on in Sweden over a 26
incident cancers were detected in the post-gastric bypass years period (1980–2006). Cancers were identified through
and comparison groups, respectively [33]. For all cancers the Swedish Cancer Registry, and follow-up after surgery
50. Obesity and Cancer with Emphasis on Bariatric Surgery 479
included three different intervals: 1–4, 5–9, and ≥10 years, nosed well before their participation in bariatric surgery makes
and the mean follow-up time was 9 years. Of the total post- this study design rather unique, sorting out the long-term
bariatric surgery cohort, there were 296 obesity-related can- impact of bariatric surgery-related weight loss on cancer
cers identified. The number of obesity-related cancers were (or cancer recurrence) may be problematic.
divided by the expected number of cancers (representing the Gagne et al. reported on a large case series (n = 1,566;
risk at baseline and derived using the “entire background 1999–2008) of bariatric surgery patients with reference to
population in Sweden”) to determine a standardized inci- cancer diagnosed prior to, during, or following their bariatric
dence ratio (SIR). The primary outcome for this study was surgery [105]. They reported that of these patients, 36
the time trends for SIR. (2.3 %), 4 (0.26 %), and 16 (0.9 %) of patients had diagnosed
There were no significant differences in the SIR for all cancers before undergoing bariatric surgery evaluation, pre-
obesity-related cancers combined (SIR 1.04, 95 % CI 0.93– operatively, and postoperatively, respectively. In addition to
1.17) with a p for trend of 0.40 for follow-up time [103]. this study by Gagne et al., there are multiple small case stud-
However, when individual obesity-related cancers were ies in the literature that report on malignancies discovered
reported, breast cancer did show a significant decrease in risk during workup for bariatric surgery, at the time of bariatric
following bariatric surgery (SIR 0.55, 95 % CI 0.44–0.68) surgery, when bariatric revisional surgery is performed, and
[103]. When analyzed individually, colorectal, endometrial, among bariatric surgical patients who at a later point in time
and kidney cancers demonstrated increased risks, with SIR after their bariatric surgery undergo surgery for an unrelated
values of 2.14 (95 % CI 1.33–3.22), 2.15 (95 % CI 1.62– reason. The extent to which weight loss is related to these
2.81), and 2.68 (95 % CI 1.71–3.98), respectively [103]. The findings is not certain.
difference in comparison group selection between the Östlund Concluding this section, mention is made of the increas-
et al. study and studies previously reviewed (i.e., using the ing interest in measuring specific biomarkers in patients
general population versus severely obese-only subjects) pres- before and following bariatric surgery. For example,
ents the possibility that bariatric surgery may be associated Sainsbury et al. collected mucosal biomarkers in bariatric
with a reduction in obesity-related cancers when compared to patients (n = 26) before and 6 months after surgery and com-
nonoperated severely obese individuals, but this reduction in pared with mucosal biomarkers of 21 age- and sex-matched
cancer risk, except possibly for breast cancer, may not drop to normal weight participants [109]. They reported that the
the cancer rates of the general population (whose average mucosal biomarkers, “accepted as indictors of future colorec-
BMI is considerably lower than that of the severely obese and tal cancer risk,” were found to be increased in the bariatric
usually lower than post-bariatric surgery patients). surgical patients at 6 months after surgery when compared
Reporting on the relationship of female cancers related to with the normal weight comparison group [109]. As indi-
bariatric surgery, McCawley et al. identified women whose cated, this study was only 6 months in duration. No doubt,
cancer had been diagnosed prior to their having bariatric longer follow-up studies with greater numbers of post-
surgery as well as women free of cancer before surgery but bariatric surgical patients will be conducted with the intent to
diagnosed with cancer following bariatric surgery [104]. Of follow cancer-related biomarkers. Currently, however, there
a total of 1,482 women who underwent bariatric surgery, 34 are a limited number of cancer biomarkers that can be
(64.1 %) had been diagnosed prior to their surgery, with a included in such studies.
mean interval between their cancer diagnosis and subse-
quent bariatric surgery of 9.9 years [104]. A total of 17
(32 %) of surgical women were diagnosed with cancer, on Exploring Potential Mechanisms
average, 4.2 years postsurgery [104]. Finally, one patient
(1.9 %) had cancer discovered during the perioperative eval- Associated with Bariatric Surgery
uation, and in one patient (1.9 %) the time of diagnosis was and Subsequent Cancer Risk
not known. McCawley et al. also included a control popula-
tion of women (n = 3,495) who were severely obese. Their Highlighted in Fig. 1 is a schematic by Ashrafian et al. that
study results indicated that the bariatric surgical group had presents probable physiologic mechanisms that occur fol-
fewer cancers (3.6 % versus 5.8 %; p = 0.002) when com- lowing bariatric surgery and that may result in a decrease in
pared with the severely obese comparison group [104]. future cancer incidence [84].
However, the bariatric surgery women were significantly These authors suggest that bariatric (or metabolic) sur-
younger (41.7 versus 46.9 years; p < 0.001) and had cancer gery “interrupts” the postulated mechanistic pathways that
diagnosed as a younger age (45.0 versus 56.8 years; are thought to promote both obesity and subsequent cancer.
p < 0.001) when compared with the nonoperated group As review authors, we predict that during the next few years,
[104]. The most commonly diagnosed cancers in the bariat- there will be a significant escalation in research related to the
ric surgical women were breast (n = 15, 28.3 %), endome- potential mechanisms postulated by Ashrafian et al., leading
trial (n = 9, 17 %), and cervical (n = 6, 11.3 %) cancers [104]. to a clearer understanding of the relationship of voluntary
Although the inclusion of women whose cancer was diag- weight loss and cancer risk.
480 T.D. Adams et al.
FIG. 1. Mechanisms of decreased cancer risk by metabolic surgery. IGF-1 = Insulin-like Growth Factor 1, AMPK = 5′ adenosine mono-
phosphate-activated protein kinase. (Figure adapted from Ashrafian, et al. [84] and reprinted by permission).
Conclusion have shown a lower risk for cancer incidence among patients
who have undergone bariatric surgery compared with nonop-
The link between increased adiposity (i.e., obesity) and erated, severely obese comparison groups. One study has sug-
greater risk for cancer has been well established. However, gested that the risk for obesity-related cancers following
due to the difficulty in achieving meaningful and sustained bariatric surgery is not reduced below cancer rates of the
weight loss in large population studies, whether or not volun- background population. Further, reported reductions in obe-
tary weight loss reduced the risk of cancer incidence and can- sity-related cancer risk have been limited to females, perhaps
cer recurrence is not entirely clear. The opportunity to study due to the greater percentage of women who undergo weight
cancer risk following voluntary weight loss is possible when loss surgery when compared with men. With reference to the
bariatric surgical patients are followed over time. Although various types of bariatric surgical procedures, there is limited
limited in number, studies have demonstrated a reduction in evidence of how these procedures might differ in relation to
cancer mortality among post-bariatric patients compared with their potential for reducing subsequent cancer risk. There is
severely obese, nonoperated controls. In addition, one pro- an increasing consensus that intentional weight loss may lead
spective study (SOS study) and a few observational studies to lower cancer incidence [56]. Finally, recent national and
50. Obesity and Cancer with Emphasis on Bariatric Surgery 481
international guidelines that have recommended weight loss Answer 4: Because patients who have undergone bariatric
for individuals (if clinically indicated), for the purpose of surgery generally lose a large amount of weight (i.e.
reducing cancer incidence risk, appear to be supported by the greater than 20% of initial weight) and maintain signifi-
few weight loss and cancer studies that have been published, cant weight loss for an extended period of time (i.e.
including those related to bariatric surgery. years), these patients are ideal to study weight loss and
subsequent cancer risk. There are multiple studies that
Acknowledgments We wish to thank Maureen Rice of the McMaster have shown when bariatric cancer patients are compared
University Evidence-based Practice Center (MU-EPC), McMaster to severely obese non-surgical subjects, the bariatric sur-
University, Hamilton, Ontario, for conducting a medical literature gical patients demonstrate lower cancer mortality and
review. We also express appreciation to Kenneth Adams, Ph.D.; the late
cancer incidence when compared to severely obese non-
Eugenia Calle, Ph.D.; Paul Hopkins, M.D.; Richard Gress, M.S.; Nan
Stroup, Ph.D.; Sherman Smith, M.D.; Steven Simper, M.D.; and operated controls.
Rodrick McKinlay, M.D.
T.D.A. receives partial funding through the Huntsman Fellowship—
Advancing Community Cancer Prevention, Intermountain Research References
and Medical Foundation, Intermountain Healthcare Corporation, SLC,
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51
Obstructive Sleep Apnea in Bariatric
Surgery Patients
Christopher R. Daigle and Stacy A. Brethauer
surge in sympathetic autonomic tone, which leads to tachy- diagnosis can be achieved by PSG [24]. For a PSG study, the
cardia and hypertension and can predispose to cardiac patient is admitted overnight to a sleep study lab, and the
arrhythmias [19]. Some subjects with OSA also demonstrate number of apneic and hypopneic events per hour is quanti-
hypercapnia and chronic respiratory acidosis during wake- fied. To be defined as apnea during the study, there must be a
fulness, known as the obesity hypoventilation syndrome. complete cessation of upper airway flow; to be defined as a
These patients usually also suffer from chronic obstructive hypopneic event, there must be a 50–90 % decrease in flow
pulmonary disease (COPD) and are thought to be at even and at least a 4 % decrease in oxygen saturation for over 10 s.
higher risk than those with OSA alone [20]. From this data, an apnea-hypopnea index (AHI) is calculated
The constellation of effects that OSA imparts on obese indi- and used to not only diagnose OSA but also to characterize
viduals is significant and certainly raises concerns when con- the severity of disease [25].
sidering bariatric surgery on patients who suffer from it. The
importance of thorough preoperative assessment and testing by
a multidisciplinary team cannot be overstated as it can drasti- Treatment
cally affect outcomes in an already high-risk population.
While surgical procedures aimed at increasing airway
patency do exist, their efficacies vary and many are not vali-
Clinical Features dated in morbidly obese patients [26, 27]. For the purpose of
this review, we will focus on the medical treatment of OSA.
Unfortunately, many of the clinical symptoms of OSA are Continuous positive airway pressure (CPAP) is currently
nonspecific, and this may lead to delayed diagnosis. Patients the mainstay in treatment of both obese and nonobese OSA
may be asymptomatic or experience symptoms at night, dur- patients (Fig. 51.1). It delivers continuous airway pressure
ing wakefulness, or both. The classic presentation is loud that keeps the upper airway open during sleep, and studies
snoring with periods of “snorting” that are usually witnessed have shown that it improves OSA-related desaturation
by a partner, and this is typically accompanied by excessive events, hypertension, and “sleepiness” in those with an
daytime sleepiness and the need for naps. While less com- established diagnosis of OSA. Conventional nasal CPAP
mon, patients may give a history of conscious “gasping” or masks can be difficult to tolerate for some patients, and com-
“choking” episodes while abruptly waking from sleep [21, pliance is a constant concern, but numerous types of masks
22]. Over a prolonged period of time, these symptoms can exist, and some may be better tolerated than others. For
lead to frequent headaches, irritability, and depressed mood, patients with significant nasal dryness or obstruction, a
all of which can negatively affect quality of life for the CPAP facemask can be utilized to improve therapy [28–30].
patient and those around them [23]. While no clear consensus exists on the duration of CPAP
therapy before considering surgery, the patient should be
given ample time to adjust to the system before moving
Diagnosis ahead with surgery [10].
Previously, there have been concerns regarding the postop-
The diagnosis of OSA is made by clinical history, physical erative use of CPAP and the risk of anastomotic leak after
examination, validated screening tools, and polysomnogra- Roux-en-Y gastric bypass based on studies that reported
phy (PSG). While the numerous screening tools available increased complication rates in those using postoperative
can be useful in establishing a diagnosis (Table 51.1) CPAP [31, 32]. Because of these concerns, some have sug-
(Maintenance of Wakefulness Test, the Epworth Sleepiness gested omitting positive airway pressure therapy in the imme-
Scale, the Berlin 60 questionnaire, and the STOP-BANG diate postoperative period to avoid adverse surgical events.
questionnaire), their sensitivities vary, and a more reliable The American Society for Metabolic and Bariatric Surgery
(ASMBS) released their position statement in 2012 addressing
TABLE 1. STOP-BANG scoring tool this issue and concluded that there was no evidence that post-
operative CPAP increased the risk of anastomotic leak and that
Do you Snore loudly? Yes/no
the usage of CPAP immediately after bariatric surgery was
Do you often feel Tired, sleepy, or fatigued during the day? Yes/no appropriate if indicated for pulmonary concerns [10].
Has anyone Observed you stop breathing? Yes/no
Have you been diagnosed with high blood Pressure? Yes/no
BMI > 35? Yes/no
Age > 50? Yes/no Postoperative Care of the Bariatric
Neck circumference > 17″ (male), 16″ (female)?
Gender = male?
Yes/no
Yes/no
Patient with Sleep Apnea
Three “Yes” responses place the patient in the category
of suspected high risk of having OSA The level of postoperative monitoring and care required will
Modified from Frances Chung et al. A tool to screen patients for obstructive ultimately depend on numerous patient- (OSA severity, other
sleep apnea. Anesthesiology 2008; 108:812–21 comorbidities) and procedure-specific factors (type of surgery,
51. Obstructive Sleep Apnea in Bariatric Surgery Patients 487
FIG. 1. (a) Continuous positive airway pressure (CPAP) device, with face mask (b). (GE Breas iSleep™ 20i self-adjusting CPAP; courtesy
of GE Healthcare).
laparoscopic vs. open). Our patients are placed on continuous diabetes and metabolic syndrome [35–37]. Many studies
telemetry including pulse oximetry monitoring while on the have also shown that bariatric surgery is capable of improv-
surgical ward. Higher-risk patients such as those with severe ing or resolving OSA, which is not surprising given the fact
OSA, numerous other comorbidities, superobesity, or that even modest weight loss can achieve some degree of
advanced age may be better served with a brief ICU stay improvement. Interestingly, many patients develop clinical
depending on the facility and airway expertise available at improvement or resolution of symptoms of OSA after bariat-
night. There are numerous published guidelines on the postop- ric surgery, regardless of whether a normal BMI is achieved.
erative care of bariatric patients, and institutions vary regard- In fact, 10–20 % weight loss has been associated with
ing the protocols they incorporate into practice [33, 34]. The improvement of symptoms and a significant reduction in
level of monitoring should be at the discretion of the surgeon AHI [38]. It is important to note that not all causes of OSA
in consultation with the medical consultants managing the are obesity related, and bariatric surgery may not improve
patient. For instance, Grover et al. omitted intensive monitor- symptoms of sleep apnea in all patients [39].
ing for their bariatric patients undergoing laparoscopic Marti-Valeri et al. reported prospective outcomes in 30
RYGB. Their cohort included over 200 patients with OSA, subjects who required CPAP (or BiPAP) therapy before
and they reported no increase in overall or pulmonary compli- RYGB surgery. At 1 year after RYGB, patients experienced
cations despite non-routine use of intensive monitoring [34]. significant weight loss and achieved a decrease in mean RDI
There is consensus, however, that patients should continue assessed by PSG (63.6 ± 38.4 preoperatively, 17.4 ± 16.6
their CPAP therapy postoperatively to avoid potential cardio- postoperatively; p = 0.004) [40]. Dixon and colleagues pub-
pulmonary events in a patient already under considerable lished their prospective randomized control trial assessing
physiologic stress. Patients are encouraged to bring their own surgical (LAGB, n = 30) vs. conventional weight loss (n = 30)
masks from home to ensure they have a properly fitting mask therapy for the treatment of OSA. At 2 years follow-up, the
during their admission. It is also helpful to have experienced surgical cohort lost significantly more weight and achieved
respiratory therapists who are comfortable with positive pres- greater AHI reductions (reduction of 25.5 events/h vs. 14
sure therapy in morbidly obese patients. The surgeon and the events/h) than the conventional weight loss cohort [41].
multidisciplinary team should discuss the perioperative usage Greenberg et al. performed a meta-analysis in 2009 looking
of CPAP at length with the patient prior to surgery. at the effects of surgical weight loss on objective measures of
OSA. Their analysis included 12 studies (n = 342 patients)
that had polysomnography performed before and at least 3
months after bariatric surgery. The cohort achieved a 17.9 kg/
Effect of Bariatric Surgery m2 reduction in BMI, which corresponded to a pooled cohort
on Obstructive Sleep Apnea reduction of 38.2 hypopneic/apneic events per hour [2].
While many patients subjectively notice improvement in
Bariatric surgery is now considered to be the most effective their sleep apnea after bariatric surgery and stop using their
way to achieve durable weight loss and has been shown to CPAP at home several months after surgery, we recommend
improve many obesity-related comorbidities like type 2 that they continue to follow up with their pulmonologist to
488 C.R. Daigle and S.A. Brethauer
have their CPAP titrated down during the rapid weight loss 15. Schwab RJ, Pasirstein M, Pierson R, Mackley A, Hachadoorian R,
phase. Patients should also undergo a repeat PSG 6–12 Arens R, et al. Identification of upper airway anatomic risk factors
for obstructive sleep apnea with volumetric magnetic resonance
months after surgery to determine the need for further CPAP imaging. Am J Respir Crit Care Med. 2003;168(5):522–30.
therapy. 16. Kryger MH, Roth T, Dement WC. Principles and practices of sleep
medicine. 3rd ed. Philadelphia: WB Saunders; 2000.
17. Vgontzas AN, Papanicolaou DA, Bixler EO, Hopper K, Lotsikas A,
Conclusion Lin HM, Kales A, Chrousos GP. Sleep apnea and daytime sleepi-
ness and fatigue: relation to visceral obesity, insulin resistance, and
hypercytokinemia. J Clin Endocrinol Metab. 2000;85(3):1151–8.
Obstructive sleep apnea is prevalent in the morbidly obese, 18. Sharma S, Malur A, Marshall I, Huizar I, Barna BP, Pories W,
and bariatric surgeons must be aware of the history and Dohm L, Kavuru MS, Thomassen MJ. Alveolar macrophage activa-
symptoms suggestive of OSA, as well as the evaluation and tion in obese patients with obstructive sleep apnea. Surgery.
management of these patients. A multidisciplinary approach 2012;151(1):107–12.
19. Salah HA. Obstructive sleep apnea and cardiac arrhythmias. Ann
involving the patient, surgeon, anesthetist, medical special- Thorac Med. 2010;5(1):10–7.
ists, respiratory therapists, and support staff is paramount if 20. Kessler R, Chaouat A, Schinkewitch P, et al. The obesity-
these patients are to achieve therapeutic success. Metabolic hypoventilation syndrome revisited: a prospective study of 34 con-
surgery can offer these patients durable weight loss and secutive cases. Chest. 2001;120:369–76.
improvement or remission of OSA. 21. Sleep-related breathing disorders in adults: recommendations for
syndrome definition and measurement techniques in clinical
research. The Report of an American Academy of Sleep Medicine
Task Force. Sleep. 1999;22:667–89.
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52
Ventral Hernias in the Bariatric Patient
Krzysztof J. Wikiel and George M. Eid
need for concomitant repair at the time of a bariatric proce- of the hernia repair. Patients with a thinner abdominal wall
dure as opposed to a delayed treatment following weight loss were considered to have favorable anatomy. Hernia reducibil-
to the appropriate approach to use in cases that violate the ity is considered a favorable feature, as incarcerated contents
intestinal tract to appropriate mesh and procedure selection. may be more difficult to reduce intraoperatively. Hernias of
With the understanding that the literature provides little 8 cm or less in greatest diameter were also considered favor-
guidance regarding the ideal method to address hernias in able, because they allow the surgeon to approximate the edges
obese patients or in conjunction with bariatric surgery, we of the defect with primary sutures under reduced pneumo-
present the approach we utilize at our institution. peritoneum. Finally, a BMI of 50 kg/m2 or greater was con-
The question that needs to be immediately answered is sidered unfavorable due to the elevated operative risks
whether the patient is symptomatic or asymptomatic. This associated with super-obese patients [14].
could aid in the selection of method as well as timing of ven- Our algorithm divides the patients into four treatment
tral hernia repair in this patient population. As a good propor- subgroups (Fig. 1):
tion of these defects are noted during bariatric procedures, an
1. Symptomatic patients with favorable anatomy: Here we
important consideration is whether to place mesh into a clean-
recommend that these patients undergo ventral hernia
contaminated field encountered during bariatric procedures
repair as an initial and separate procedure. This repair
that violate the gastrointestinal tract, such as laparoscopic
may be followed by bariatric procedure of choice at a
Roux-en-Y gastric bypass or laparoscopic sleeve gastrec-
later date. Generally this group qualifies for laparoscopic
tomy, as opposed to performing a primary hernia repair. On
hernia repair which is described later in this text.
the other hand deferring surgical repair may result in signifi-
2. Asymptomatic patients with favorable anatomy: These
cant morbidity. In our experience, 36 % of patients whose
patients are good candidates to undergo concomitant bar-
hernia repair was deferred at the time of gastric bypass devel-
iatric surgery and ventral hernia repair. We recommend
oped small bowel obstruction due to incarceration in the post-
that after performing laparoscopic bariatric procedure,
operative period. The time interval for this complication is an
the surgeon addresses the hernia defect. If possible
average of 63 days (range 10–150 days) from the bariatric
abdominal wall is repaired primarily with the placement
procedure [8]. The risk of infecting a prosthetic mesh by con-
of nonabsorbable sutures using a suture-passing device
tamination with enteric contents is also well documented, and
through the abdominal wall and fascia to decrease rate of
the authors of this text do not recommend using these meshes
recurrence (Fig. 2, photo 1). The approximated defect
if the defect repair is concomitant with a bariatric procedure
was then reinforced using biologic mesh (Fig. 2, photo 2).
which violates the gastrointestinal system.
The mesh was introduced through the abdomen via one of
The basis of our approach is the notion that all hernias are
the port sites and secured in place with both sutures and
not created equal, and that every bariatric patient with an
circumferential tacks.
abdominal wall defect should be approached individually.
3. Symptomatic patients with unfavorable anatomy present
Certain factors, such as the patient’s past medical history,
the biggest challenge from surgical standpoint. In this popu-
body mass index (BMI), body habitus, defect size and loca-
lation we recommend a medically supervised very low calo-
tion, level of operative field contamination, and the presence
rie diet for up to 12 weeks. Dietary supplements, including
or absence of symptoms, should always be taken into consid-
daily multivitamins as well as ursodiol treatment to prevent
eration while developing a surgical plan.
gallstone formation during rapid weight loss, should be
In our opinion, the most important factors to consider
given to these patients. This group requires careful monitor-
when planning a hernia repair are body habitus based on fat
ing with qualified medical staff to ensure no adverse health
distribution (android versus gynecoid), BMI, hernia location,
changes. Once appropriate weight loss is achieved these
and reducibility. During the work-up, computer tomography
patients are candidates to undergo a hernia repair either with
is used for a precise evaluation of the defect size, contents,
concomitant or deferred bariatric procedure.
and abdominal wall thickness. The above criteria are then
4. Asymptomatic patients with unfavorable anatomy are
used to divide patients into favorable and unfavorable anat-
best treated with bariatric surgery first, followed by a ven-
omy groups. If the defect is located centrally or in the upper
tral hernia repair at a later date, only after significant
half of the abdomen, it allows for easier accessibility and
weight loss had occurred. At our institution laparoscopic
laparoscopic port placement; it is considered favorable.
gastric bypass and sleeve gastrectomy are the preferred
Lower abdominal defects are considered unfavorable.
options, given the more likely early rapid weight loss.
Android body habitus is considered unfavorable due to less
This would allow a timely repair of the abdominal wall
compliant abdominal wall and intra-abdominal fat distribu-
hernia. Nevertheless, the decision for which procedure to
tion causing increased technical difficulty, as opposed to
perform should be made jointly by the patient and the sur-
favorable gynecoid fat distribution. Patients with abdominal
geon after thorough discussion and counseling.
wall thicker than 4 cm are placed in the unfavorable group, as
thicker abdominal wall tends to cause greater torque on lapa- Next consideration is the choice of surgical modality.
roscopic instruments, leading to increased surgical difficulty Ventral hernia repairs have evolved considerably over the
52. Ventral Hernias in the Bariatric Patient 493
Favorable Unfavorable
Anatomy Anatomy
Concomitant
Medically
LVHR* first LVHR* and Bariatric surgery
supervised diet
bariatric surgery
Bariatric Surgery
FIG. 2. Ventral hernia repair at time of bariatric surgery with follow-up laparoscopy 1 year later. (a) Suture repair of the hernia defect at
the time of a laparoscopic Roux-en-Y gastric bypass (step #1). (b) Subsequent placement of biologic mesh as a reinforcement of the pri-
mary suture repair during a laparoscopic Roux-en-Y gastric bypass (step #2). (c) Anterior abdominal wall of the patient above who was
undergoing an elective laparoscopic cholecystectomy at the 24-month time mark. Note the absence of the hernia defect and visible partially
peritonized surgical tacks.
years. Traditional open primary suture repairs are falling out result in a fairly high incidence of postoperative morbidity
of favor especially in the obese population, as the reported and wound complications [15]. Nevertheless the latter still
recurrence rates have been over 50 % [15]. Open tension-free remains a good option in some patient groups and is still
mesh repairs, including separation of components procedure, widely used.
have considerably lower recurrence estimated at 20–30 %. Laparoscopic ventral hernia repair was first reported
Unfortunately, large abdominal incisions in the morbidly about 20 years ago. Application of this method in certain
obese patients with wide tissue dissection and flap creation situations might be advantageous, as it is associated with
494 K.J. Wikiel and G.M. Eid
fewer complications and faster recovery [15–17]. It appears routinely use the above technique as a temporary fix with the
that this advance in hernia repair might benefit the bariatric main goal of avoiding bowel strangulation, clearly it cannot be
patient as well, just as recent studies have demonstrated an considered a permanent repair. The reasoning behind this is
advantage of the laparoscopic approach over open bariatric that deferring repair of the defect carries a significant risk of
surgery [18]. Similarly, shorter hospital stays, decreased bowel incarceration and possibly even strangulation, espe-
pain, lower wound complications, lower recurrence rates, cially when the surgeon reduces an omental incarceration
and quicker return to work are reported for laparoscopic ven- without addressing the underlying hernia [8]. Based on our
tral hernia repair patients [15–19]. experience, we believe that the use of bio-absorbable mesh
The technique we have chosen to use in our patient popu- with concomitant laparoscopic gastric bypass can only be
lation is based on the modified Rives-Stoppa technique. This effectively utilized as reinforcement for suture repair. On the
involves reduction of the hernia and, under laparoscopic other hand, concomitant bariatric surgery and hernia repair in
vision, outlining the hernia defect on anterior abdominal patients with unfavorable hernia and body habitus characteris-
wall skin using a marker pen. A further outline adds an extra tics as described above can be challenging and time consum-
4-cm overlay margin. An appropriate mesh, depending on ing. Performing a bariatric procedure at the time of the hernia
the level of contamination during the case, is placed and then repair not only adds considerable operation time and risk, but
tailored to size using the outline on the abdominal wall. also introduces contamination with subsequent risk for mesh
Nonabsorbable sutures are placed onto the corners of the infection as previously mentioned.
mesh, which is then rolled up and introduced into the abdo- As mentioned above, it is not unusual to find incidental
men through a trocar. Using a Carter-Thomason device, the hernias during laparoscopy which have remained asymp-
mesh is anchored into the desired position using the previ- tomatic while performing bariatric surgery. Most of these
ously placed sutures. The mesh is further anchored with sev- defects, missed during preoperative work-up, are small
eral rows of titanium helical tacks placed circumferentially and have greatest diameter less than 2 cm. These defects
at about 1-cm intervals. Through several small stab incisions, should be repaired primarily with the use of permanent
the mesh is secured in place using nonabsorbable sutures at sutures using a Carter-Thomason suture-passing device
3-cm intervals along its circumference. This is also done with simple or figure-of-eight stitches (Fig. 3). It is also
with the Carter-Thomason device. important to mention that these small hernias need to be
Weight loss surgery may be an important adjunct treat- addressed as they are more likely to lead to potential bowel
ment in the management of ventral hernia. Unfortunately, strangulation requiring emergent surgery with potential
laparoscopic gastric bypass as well as sleeve gastrectomy poor outcomes [5, 8].
both require division of the gastrointestinal tract, which
results in at least some contamination of the surgical field. In
such cases, there is a general lack of acceptance within the Clinical Pearls
surgical community of concomitant bariatric surgery and
hernia repair with permanent mesh, due to risk of mesh Hernias still present a therapeutic challenge in the morbidly
infection. However, limited data has been reported demon- obese and as the prevalence of obesity increases, so does the
strating the feasibility of such an approach. A small trial in incidence of ventral hernias in the obese population. Those
which ventral hernias were repaired with prosthetic dual patients require a complex and thought-out approach, devised
meshes in conjunction with laparoscopic gastric bypass has on a case-by-case basis. It is also important to make the mor-
been reported. No mesh infections and two recurrences were bidly obese patient aware of the potential intraoperative dis-
seen in this study [20]. While such data does exist, it is by no covery of incidental hernias and the high risk of recurrence
means considered a standard of care, as it only involves small associated with their repair. It is also strongly encouraged to
series with lack of long-term follow-up. Mesh infection, repair all incarcerated incisional hernias in the morbidly
necessitating subsequent mesh removal, is a very morbid and obese population, that required reduction to complete the
costly problem in an already high risk bariatric patient popu- bariatric procedure, because of the high risk of strangulating
lation, not to mention the high recurrence rates associated bowel obstruction in the postoperative period [8].
with mesh infections and the potential medical-legal impli- Concomitant hernia repair with bariatric procedure versus
cations. For those reasons, we do not favor this approach. a staged approach should be based on patients’ symptoms
High recurrence rates have been encountered when bio- and the hernia characteristics. Our suggested algorithm has
absorbable mesh is used as a bridge to close the hernia defect been helpful in our practice with the selection of timing,
in a similar fashion to permanent mesh. Although initial data mesh, and type of repair. All decisions are made on individ-
reported zero recurrence rates at short-term follow-up using ual case basis. In cases of concomitant repair, reinforcing
this technique concomitantly with laparoscopic gastric bypass, defects that are >2 cm in diameter with biomaterial mesh as
unfortunately, majority of patients will present with a recur- an underlay following primary repair may help reduce the
rence when followed for over 2 years. While some surgeons incidence of hernia recurrences [5].
52. Ventral Hernias in the Bariatric Patient 495
FIG. 3. (a) Sutures are placed across the fascial defect (arrow) with a Carter-Thomason device. (b) All sutures are tied once the pneumo-
peritoneum has been released.
Question 2 References
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the bariatric population is: 2. Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity
(a) Better cosmetic outcome. and trends in distribution of body mass index among US adults
(b) Better visualization of the defect. 1999–2010. JAMA. 2012;307(5):491–7.
3. Sugerman HJ, Kellum Jr JM, Reines HD, DeMaria EJ, Newsome
(c) Decreased risk of postoperative wound complications. HH, Lowry JW. Greater risk of incisional hernia with morbidly
(d) All of the above. obese than steroid-dependent patients and low recurrence with pre-
fascial polypropylene mesh. Am J Surg. 1996;171:80–4.
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considered one of the major advantages of laparoscopic over physiological impact of smoking, smoking cessation and nicotine
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5. Eid GM, et al. Laparoscopic repair of umbilical hernias in conjunc- 14. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gas-
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53
Plastic Surgery Following Weight Loss
Dennis Hurwitz
Minimally invasive gastrointestinal bypass surgery for morbid for breast and buttock augmentation and suspension. These
obesity was successfully pioneered at the University of are extensive and complex operations over large portions of
Pittsburgh Medical Center [1]. Soon dozens of women the body, requiring a team of operators, working in consort
demanded a solution to their hanging skin and ptotic breasts from 6 to 12 h under general anesthesia. Minor wound heal-
and buttocks. I accepted the request by the surgeon director, ing complications were common, but major morbidity was
Philip Schauer, to focus my plastic surgery skills on body fortunately rare.
contouring after massive weight loss. Speaking in lecture By diligent assessment of outcomes, feedback from
halls full of these patients, I learned of the disheartening numerous presentations and the work of others, I have tai-
changes in body contour with repulsive hanging skin and lored body contouring surgery to adequately treat the defor-
bizarre rolls of skin and fat. In the course of achieving mities and needs of the patient. A complete medical and
extraordinary weight loss and alleviation of comorbidities, nutritional evaluation with comprehensive consideration of
successful bariatric surgery creates these problems that the total body deformity is essential. The plan is based on the
diminish patients’ quality of life. The Bariatric Center clini- application of plastic surgical principles that incorporate art-
cal staff in Pittsburgh and then throughout the country antici- istry, efficiency, and tight closures, with minimal trauma to
pate these issues and encourage completion of rehabilitation tissues (Table 1).
through skilled body contouring surgery. This chapter presents the patient profile, preoperative
In the late 1990s, many plastic surgeons agreed that skin preparation, and operative planning. There is a summary of
redundancy of the trunk and thigh is best treated by a circum- the operative technique, as well as selected case presenta-
ferential abdominoplasty and a lower body lift [2–8]. tions. Advances since the first edition of this text will be
However, results vary, and there is no consensus on approach. highlighted. The principles of treatment are detailed, fol-
The magnitude of the challenge for each patient was just lowed by an evaluation of the surgical outcomes. Over
being appreciated. The concept of multiple operations during the past 12 years, this author has performed over 1,600
a single operative session was introduced but by no means procedures on more than 500 patients after massive weight
accepted. There are few reports that include body contouring loss, pregnancy, or aging. These include singly or in combi-
surgery after massive weight loss. Those patients of the nation abdominoplasty, lower body lift, upper body lift,
1970s usually underwent the physiologically disruptive medial thighplasty, brachioplasty, mastopexy, breast reduc-
jejunal-ileal bypass and were poor candidates for prolonged tion, facelift, gynecomastia correction liposuction, and
body contouring surgery. Minimally invasive surgery with lipoaugmentation. The body mass index (BMI) ranged from
the Roux-en-Y gastrointestinal bypass delivered a much less 24 to 42. Due to the potential of a high rate of complications,
traumatized and healthier patient. Consistent patterns of we have treated few patients with morbid obesity [9].
deformity were discovered, necessitating individualization
and new combination of procedures. Hence, I was in a posi-
tion to explore a variety of approaches, procedures, and Patient Profile
patient intraoperative positioning. An innovative approach
evolved that featured comprehensive and coordinated plan- Obesity is a stigmatizing disorder, especially among women,
ning in one to three stages, termed the total body lift. Not which may explain why women predominate in seeking
only was loose skin to be removed but the body was to be weight loss treatment [2]. The increased demand is due to
sculptured by what was left behind and by autogenous flaps word-of-mouth comments on the improved results and lower
TABLE 1. Plastic surgical principles plateau, waiting beyond 18 months before initiating body
1. Analyze deformity and patient contouring surgery is counterproductive. Commonly, over
2. Be efficient in design and execution the next year patients gain much of the weight removed dur-
3. Excise excess as much as possible transversely ing body contouring surgery. On the other hand, in some
4. Position incisions favorably, and respect scars patients unanticipated further weight loss occurs, from 20 to
5. Focus on the ultimate contour and tissue tension 60 lb, because of partial gastrointestinal mechanical obstruc-
6. Preserve healthy dermis and subcutaneous fascia tion. This causes malnutrition reflected in low serum preal-
7. Remove fat from flaps gently and effectively bumin fraction, anemia, and measurably low trace elements
8. Make closure tight and secure [13]. The nutritional deficiency may prolong what would
9. Minimize swelling, infection, phlebitis, and seroma otherwise be minor wound healing problems [14]. Additional
10. Analyze your experience weight loss results in new skin laxity, which will detract
from what could have been an optimal outcome.
The patients who struggle with their layers of hanging
morbidity, supported by reports in scientific journals, the skin and fat and have the courage to consider surgery present
Internet, and the media [10]. Over 80 % of the patients in this to plastic surgeons. When obese, their massive size presented
series seeking body contouring after weight loss are women. an unappealing but recognizable shape. Hanging skin dis-
Most patients report to me that their laparoscopic bypass torts the body shape and patient age and appearance, and it
operation was brief, followed by easily controlled pain. flaps around during vigorous activity. Skin beneath folds
Through four to six small incisions, their peritoneal cavity becomes moist, malodorous, and inflamed. Clothes fit poorly.
has been inflated to expose intestines for rerouting and/or Embarrassment of their hanging pannus, mons pubis, and
partition over what has routinely become a 2-h session. They inner thighs thwarts sexual intimacy. While many compre-
are discharged within days to return to work within a week. hend that plastic surgery is an anticipated part of their reha-
Those who are converted to open procedures due to technical bilitation, they still may resent and even regret the bypass
considerations tend to have a slightly more prolonged post- operation. The plastic surgeon’s empathy is important, espe-
operative course. Delayed wound healing and incisional her- cially when asking the patient to accept the new risks and
nia are common in the open group. Extensive scars and self-pay costs of body contouring surgery. If the patient has
abdominal hernias are important considerations in abdomi- limited financial means, we offer national cosmetic surgery
noplasty planning. finance plans at reasonable rates for those with good credit.
With small gastric pouches and a moderately long Roux- With the ease of convalescence, effective weight loss,
en-Y jejunal bypass (the length varies directly with the improved exercise habits, and encouragement from others
degree of obesity [11]), the patients shed pounds rapidly due who have gone before them, patients are accepting of the
to limited intake, reduced absorption, and early satiety. Many arduous body contouring procedures yet ahead. The oppor-
experience mild gastrointestinal dumping after minimal tune time to perform body contouring is when the patient has
sugar or fat intake. Most become uninterested in food, which completed the catabolism and has reduced comorbidities.
may be a hormonally mediated change. All are encouraged These include sleep apnea, hypertension, gastroesophageal
to maintain a small caloric multiple-meal diet and an active reflux disease (GERD), cardiomyopathy, diabetes, leg edema,
exercise program, in anticipation of increased gastrointesti- osteoarthritis, and mental depression. Because of their
nal capacity over time. In general, patients lose weight diseases and prolonged postoperative negative nitrogen bal-
because of reduced food intake and increased physical activ- ance (starvation), we avoid panniculectomy coincidental to
ity and not intestinal malabsorption. Many become champi- the intestinal bypass. Moreover, the panniculectomy scar
ons of bariatric surgery and encourage others at a variety of may preclude optimal subsequent surgical planning for
organized support group meetings. Most have been intro- definitive contour correction.
duced to the results of plastic surgery at these group meet- We find most patients understand the goals and limita-
ings and individually through the bariatric nurse coordinators, tions and the need for multiple stages and possible revisions.
who have personal experience. A referral program called We impress upon them that optimal contour improvement
Life after Bypass has been instituted at the University of entails a very tight closure with risk of suture line dehis-
Pittsburgh. Patients receive automatic appointments and an cence. If that complication is unacceptable, then less pull
informative brochure about body contouring surgery, shortly will be made. While the scars are generally thin, they may be
after their bypass. Patients find their way to the Hurwitz thickened and uneven. After revealing the common and seri-
Center for Plastic Surgery through Internet searches, word- ous risks of their operations, we offer a detailed consent form
of-mouth referrals, and national television programs featur- for each procedure. We have established a Web site (www.
ing the total body lift (the author’s signature procedure). hurwitzcenter.com) that patients may visit before the first
After a steady weight loss to about 70 % of their excess office appointment. They learn about the surgery, see results
weight over 18 months, most regain about 20 % over the next of operations on a variety of patients, and are cautioned
few years [12]. Therefore, if a patient’s weight loss reaches a about the risks. There is a detailed intake form, which is
53. Plastic Surgery Following Weight Loss 499
instructive to the patient and gathers important information Both anteriorly and posteriorly, there is medial to lateral
for the surgeon. The Hurwitz Center for Plastic Surgery staggered sweep of redundant tissue. Thigh skin is adherent
sends each patient who seeks a consultation a complimen- below the anterior superior iliac spine, along the midlateral
tary copy of a consumer directed book, Total Body Lift: and midmedial regions and to a lesser extent along the entire
Reshaping the Breasts, Chest, Arms, Thighs, Hips, Back, posterior thigh. By the time the weight loss plateaus, the
Waist, Abdomen, and Knees After Weight Loss, Aging, and amount of fat within this redundant skin varies considerably.
Pregnancies, published by MDPublish, New York, New York, With massive weight loss, there are extensive layered folds
2005. We attempt to exclude candidates suffering from or wrinkling. The skin is like an oversized suit and in no
chronic medical and psychiatric illnesses and those with dimension, vertical or horizontal, is there normal skin ten-
unrealistic expectations. sion. Unlike posttraumatic or congenital deformity surgery,
Digital imaging is used during the second visit several there is no displaced normal tissue to relocate. All the skin is
weeks before the scheduled surgery. The patient’s preopera- disordered and is treated accordingly.
tive photographs are displayed. Electronic pens allow for
drawing anticipated incision lines, indicating the direction of
tissue tensions and final scar placement on multiple views of Etiology of Skin Laxity
their images. Their new silhouette can be drawn, but no prom-
ises are made. Technique and outcomes vary according to the The etiology of skin laxity after rapid weight loss is inade-
patient’s basic body habitus. Oversized people, endomorphs, quately understood. The subdermal to aponeurosis fibroelas-
cannot be transformed into ectomorphs. During office follow- tic spans, overflowing with adipocytes in the obese, have
up, impatient and disappointed patients, as well as pleased fractured elastin fibers on microscopic study. The damaged
patients, are graphically reminded of the extent of their origi- elastin and collagen allow for no skin retraction after weight
nal deformity by having a monitor with all possible images loss. With rapid weight loss, there is no way to prevent sag-
available within view of the examination room. ging of the abdominal skin, skin of the breasts and buttocks,
The surgeon considers the body shape (endomorph, and the inner portions of the arms and thighs. It is important
mesomorph, or ectomorph), extent of deformity, size, sex, to repair the abdomen with the best quality of skin, usually
patient priorities, lifestyle, and tolerance for risk. Before from the upper portions. Unfortunately, in massive and rapid
embarking on such lengthy procedures, the surgeon and the weight loss patients, there is usually no quality skin. The
support team and hospital should have experience working problem is compounded in individuals over 55, who lose
together on less extensive procedures. Three days of hospital considerable skin elasticity without weight loss. Until we are
care are essential. The larger the patient and the longer the able to reverse this complex disorder of subcutaneous dis-
procedure, the more likely are complications. ease, we are forced to excise the widest possible areas of skin
and then close the skin flaps as tightly as possible.
Three factors contribute to postoperative skin laxity. First
The Deformity is the diseased skin collagen and elastin. Second, the farther
the skin is from the line of closure, the less effective is the
The massive weight loss patient has a deflated shape based pull. I refer to this as the law of skin laxity. Otherwise stated,
on familial and gender-specific fat deposition and skin to fas- skin laxity is corrected closest to the line of closure and is
cia adherence. The most susceptible regions are the anterior progressively increased farther away. Third, the adherence of
neck, upper arms, breasts, lower back, flanks, abdomen, the skin to underlying fascia prevents tightening beyond the
mons pubis, and thighs. In men there is a tendency to accu- adherence. Surgical disruption of these customary and
mulate fat around the flanks, intra-abdominally, and the unique adherences mobilizes the flaps, but since perforating
breasts. In women the fullness lies in the subcutaneous fat of blood supply usually occurs there, flap vitality may be
the abdomen, hips, and thighs. Patterns of deformity are compromised.
emerging that seem to be affected by the magnitude of initial As yet there are no proven means to improve skin and
BMI and change in BMI. subcutaneous tissue elasticity. I am pleased with the applica-
Redundant skin hangs over regions of fibrous adherence bility of Endermologie (LPG, Montreal, Canada), a
to deep fascia (Fig. 1). The skin of the trunk is densely adher- computer-modulated differential vigorous massage and
ent along the inframammary fold, down the upper midline to suction machine, to treat these patients. LPG claims that sig-
the linea alba, and in the groin. Adherence is variably dense nificant skin laxity can be reduced with about 20 twice-
across the rectus abdominis transverse tendinous inscriptions weekly treatment sessions. We have initiated treatments to
(more so in the male) and along one or two transverse levels improve our surgical results and substantiate this claim. We
across the anterolateral ribs, flanks, and back. Skin flaps are convinced that if expertly performed, Endermologie has-
undermined beyond adherences will readhere after the oper- tens resolution of postoperative performed, Lipomassage®
ation and have less tension on the skin, which explains why reduces swelling and induration. It softens most hypertro-
the epigastrium usually maintains an unwanted roll after an phic scars and reduces scar-related neuralgia. It is Food
abdominoplasty. and Drug Administration (FDA) approved to temporarily
500 D. Hurwitz
FIG. 1. Massive weight loss deformity varies according to the original fat distribution and pattern of skin adherence. (a) This 33-year-old,
203-lb woman lost 300 lb 2 years after Roux-en-Y gastrointestinal bypass. She has a large hanging pannus and considerable skin laxity in
the mid-torso, hips, and medial thighs. The redundant skin and fat torso rolls cascade from midline to lateral. There is an anterior midline
adherence along the linea alba and umbilicus, which is somewhat accentuated in the epigastrium by her vertical surgical scar. There are
paramedian vertical folds reflective of the semilunar lines along the lateral rectus margins extending from the costal margins to the end of
the hanging pannus. Beginning with the inframammary folds, there is an asymmetrical stairstep array of transverse skin adherences.
Immediately superior to the costal margin, the skin is broadly adherent, more on the left than on the right side. Inferiorly, two transverse
lines reflecting the tendinous inscriptions cross from lateral rectus border to the midline in the epigastrium and at the umbilicus. (b) On
lifting the pannus, one sees the broad adherence along the iliac crests, across the suprapubic region, and diverting along each labial thigh
junction. There is a progressive lateral flowing of rippled skin from upper medial thigh to the suprapatellar region. (c) Back folds begin
inferior to the scapula. The left back has two oblique lines of back fascia adherence, while the right has a series of three. The last rolls
overlap the pelvic rim. The firmly adherent central buttock fullness is framed laterally and inferiorly by numerous thin folds of lax skin.
The posterior and lower lateral thigh skin below the lateral trochanter is broadly adherent to the fascia lata. The markings for a circumfer-
ential abdominoplasty, lower body lift, and medial thighplasty are drawn. Surgical lines for the first stage have been drawn while the
patient reclines, pulls her pannus out of the way, and stands. The vertical lines ensure proper alignment for closure. The markings begin
with the patient reclined and pulling up on her pannus. A 14-cm transverse line is centered about 8 cm above the labial commissure. With
firm oblique upward pull on the pannus to the opposite costal margin, the incision line is continued across each groin and over the anterior
superior iliac crests. The inferior incision continues across the hip with the patient in lateral decubitus and abducting the thigh. With all
excisable skin drawn cephalad, the transverse line extends posteriorly to end immediately superior to the intergluteal fold. When the
patient is standing, as seen here, the line dips inferiorly to the extent there is lateral thigh skin laxity. The anterior superior incision is along
the umbilicus and is planned by pulling down the superior flap to the bikini line, because unraveling upper redundancy will be limited by
costal margin skin adherences. The medial thighplasty has an inner line along the labial thigh groove extending to border the lateral mons
pubis. The outer line is an estimate of skin removal, aided by the patient raising her leg while in the supine position. The posterior exten-
sion of the medial thighplasty overlies the ischial tuberosities and ends along the inferior gluteal folds.
There is no undermining of the superior flap or alteration or Experienced anesthesiologists will be prepared for the
reconstruction of the umbilicus. It is often complemented position change and protection of the face and weight-
with liposuction of surrounding, nonundermined bulging bearing surfaces. A foam rubber mask with a cutout for the
skin. It satisfies the medical indications by correcting the endotracheal tube has been our preferred approach (Gentle
inflammatory sequelae of an overhanging pannus. This lim- Touch™ 5” headrest pillow by Orthopedic Systems Inc.,
ited abdominoplasty is aesthetically adequate in the rare Union City, CA). Intravenous fluids are scaled down in con-
patient who has most of the deformity between the umbilicus sideration of the use of several liters of saline tumescent sub-
and pubis. After an ill-advised panniculectomy, a subsequent cutaneous injections for liposuction. Intraoperative fluid and
abdominoplasty results in a much higher and less aesthetic medical management are controlled by the anesthesia team.
lower abdominal scar. The need for colloid and blood replacement is discussed dur-
ing the procedure. All patients are continuously monitored,
which includes urine output. Hemoglobin concentration is
Operative Planning and Care optimized with iron and vitamin supplements, resorting to
iron infusions if necessary. Erythropoietin may be taken a
Operative planning and sequencing is based on the deformity month before surgery, accepting an increased risk for throm-
and patient priorities. The majority of patients are prepared boembolism. Larger patients pre-donate 1–3 units of blood
for removal of excess tissue of the lower torso and thighs for later transfusion. Or preferably, our anesthesiologist
through a circumferential abdominoplasty and lower body removes about 500 cm3 at the beginning of the case, replen-
lift. Unwanted redundancy distal to the mid-thighs requires ishes the volume with saline and then administers the donated
long vertical medial excision of skin. Most patients accept blood at the end of the case. In that way patients do not
this long scar, which usually heals favorably and is concealed receive thrombogenic old banked blood. A liter of Hespan
by the thighs, in exchange for the distasteful skin redundancy. colloids helps resort both volume and oncotic pressure.
Many want the midback rolls and sagging breasts also cor- Intermittent leg pressure pumps are activated and
rected, which is usually performed more than 3 months later. intravenous antibiotics are given before the induction of gen-
eral anesthesia. Additional risk factors for thrombophlebitis,
a history of phlebitis, thromboembolism, lower extremity
Upper and Total Body Lift swelling, over 50, prolonged surgery, and obesity prompt the
use of low-molecular-weight heparin.
An upper body lift treats epigastric skin and midback folds Patients are hospitalized for about 3 days for fluids, elec-
and flattened, distorted breasts. Similarly, upper body lifts trolytes, and pain management. Also their movements are
treat ptotic gynecomastia in continuity with back rolls. In assisted to reduce excessive tension on tight suture lines.
women the upper body lift focuses on establishing a higher In my patients, there have been rare medical complica-
and firm inframammary fold. In men the fold should be oblit- tions or documented thrombophlebitis. Minor wound dehis-
erated. Abdomens that have defined midlevel skin adherence cence, requiring bedside suture line closure, was allowed to
resulting in a two-tiered pannus (Fig. 43.1) will not have heal in 52 patients. Minor skin necrosis occurred in ten
adequate correction of the epigastrium without an upper patients. Skin loss requiring debridement and grafting
body lift. Due to abdominal flap blood supply concerns and occurred in one cigarette-smoking woman after an upper
the magnitude of the complex operation, a total body lift is body lift. Multiple seroma aspiration was required in eight
usually staged with the lower body preceding the upper. The patients.
ideal scenario for a single-stage total body lift lasting up to
10 h are the correction of difficult gynecomastia back and
abdomen, and taller female patients who want as much Summary of Operative Technique
accomplished as possible in a single operative session. The
single-staged TBL is controversial and is uncommonly per- Our basic operative technique has been reported elsewhere
formed. When it is, it should be limited to the most experi- [18]. In essence, a circumferential abdominoplasty with a
enced operative teams, including a second experienced lower body lift removes a wide swath of skin and fat along
plastic surgeon, a physician assistant, and talented residents the bikini line (Figs. 1, 2, 3, 4 and 5). The panniculectomy is
in plastic surgery training. a small portion of the procedure. This approach requires at
Each of the body contouring procedures takes 2–3 h. least one turn of the patient. This procedure varies according
Unless medically contraindicated, cosmetic procedures were to patterns of truncal skin adherence and the patient’s BMI.
added to a medically necessary (insurance reimbursed) pro- The full abdominoplasty features removal of all the
cedure. At Magee Women’s Hospital, which is part of the redundant skin of the lower abdomen, central undermining
University of Pittsburgh Medical Center, facility and to the xiphoid, and minimal lateral undermining of the supe-
anesthesia-related costs and hospital convalescence costs are rior flap. A running #2 PDO Quill® barbed suture (Angiotech,
considerably reduced this way. Vancouver, Canada) has replaced large braided permanent
502 D. Hurwitz
FIG. 2. The operation was started with the patient in the prone position. A scalpel cut was made for the inferior incision. (a) After direct
undermining to just beyond the lateral trochanter, a long blunt underminer designed by Dr. Ted Lockwood is used. (b) Pushing against the
fascia lata, the surgeon repeatedly thrusts the underminer down the lateral, posterior, and anterior thigh. When skin mobilization is com-
plete, the thigh flap is pulled up to the proposed superior incision. If appropriate, the superior transverse incision is made. (c) Then the
intervening island of skin and fat is excised, leaving behind the appropriate amount of large globular fat along the flank. The wound is very
large. (d) To avoid persistent thigh skin laxity, the incision should be closed as tightly as possible. Several maneuvers assist in obtaining a
secure closure. The thigh is fully abducted onto a padded utility table placed next to the operating room table. The wound margins are
approximated with towel clips. Closely placed large braided permanent sutures are used to approximate the subcutaneous fascial system
as the clips are replaced. Before the patient is turned for the abdominoplasty, the lateral triangular shape extensions of the medial thighplas-
ties are excised and closed
suture to imbricate the central fascia from xiphoid to pubis. onto arm boards that swing the legs out from the operating
The operating table is flexed as the superior flap is approxi- room table. Liposuction is liberally used except through the
mated to the incision over the pubis and groins with lateral distal central flap. A medial thighplasty frequently accompa-
oblique tension. That tension narrows the waist and raises nies the lower body lift in massive weight loss patients.
the anterolateral thighs. High central skin tension is created Smaller patients may have additional coincidental major pro-
through the umbilicoplasty by deepithelializing three small cedures, such as mastopexies and brachioplasties.
flaps in the abdominal flap umbilical cutout and suturing Proper preoperative marking of the incisions plans for the
them around the base of the isolated umbilicus. The lower removal of excess skin and estimates the closure tension,
body lift, performed with the patient in the prone position, which affects the contour for the surrounding tissues and
incorporates extensive undermining distally along the hips final location of the scars. Long abdominal scars must be
and thighs followed by a very tight subcutaneous fascial clo- respected, to avoid a narrow ischemic segment of skin
sure with #2 PDO Quill, aided by full abduction of the leg between the incision and scar. The surgeon can either include
53. Plastic Surgery Following Weight Loss 503
FIG. 3. (a, b) The result 4 months after the first stage is seen as well as the surgical markings for the upper body lift, mastopexy, and vertical
thighplasty. (a) The wide vertical resect. of medial thigh skin was performed because of an inadequate correction from the high transverse
medial thighplasty. A broad rim of skin is resected from the lower thorax to the inframammary fold. (b) The excision is continued around
the back. Because of the severe skin redundancy, a broad oblique excision of skin crosses the transverse band. The operation was begun
with the patient in the prone position. After the reverse abdominoplasty is done, a Wise pattern mastopexy completed the upper body lift.
Then the medial thighplasty was performed.
the scar in the incision or leave enough space between the abdominal binding, several days of purging, and avoiding
incision and scar to ensure adequate blood supply to the nitrous oxide anesthesia (gaseous distention) during abdomi-
intervening skin. Because of the physical difficulties of nal wall plication. If obesity is the cause, then further weight
marking the heavy hanging tissue while the patient is stand- loss is indicated.
ing, many of the surgical lines are made with the patient Efficiency is the second principle. Inefficiency lengthens
reclined, and then reevaluated with the patient standing. an already long operation, thereby increasing bleeding, med-
Others have advocated a similar approach [4, 6]. ical and wound healing complications, surgeon fatigue, and
costs. The surgeon should develop a consistent procedure so
that the surgical assistants can anticipate the surgeon’s needs.
Principles of Treatment Unusual equipment or sutures should be requested ahead of
time. With experience, preoperative assessment of the width
These multiple operations are lengthy, envelop large portions of the resection becomes accurate (especially for the thinner
of a big body, and require position changes and high-tension patients) but does require nearly an hour of vigorous skin
closure of undermined and thinned flaps. Accordingly, we displacement while the patient lies, sits, and stands for the
have listed the relevant plastic surgery principles for success- markings.
ful results with a low complication rate. The precise tech- The most effective and efficient positioning and turning
nique varies according to the deformity and surgeon of the patient starts in the prone and ends in the supine posi-
preferences, but the principles are inviolate (Table 1). tions, which includes the recent modification of placing the
The first principle is to analyze the patient and the defor- leg in abduction [19].
mity, which has been discussed. We need to emphasize that Prone followed by supine requires only one position
the farther from the suture line, the less effective is the pull. change. The flap with the greatest movement is elevated first.
Therefore, following a bikini line closure, residual laxity is The operation starts with the patient in the prone position,
seen in the epigastrium, midlateral trunk, and distal thighs. with the inferior incision of the lower body lift. Once suc-
This upper laxity can be treated secondarily through a reverse tioned and mobilized, the buttock and thigh flap is pulled
abdominoplasty, which we have developed into the upper superiorly and the anticipated superior incision line is con-
body lift. The lower laxity is corrected by direct excisions firmed and incised. The intervening low back and flank skin
along the medial and posterior thighs. Excessive intra- is removed as an island of skin and fat from side to side.
abdominal girth limits the aesthetic contour of even tight Appropriate traction and countertraction permit rapid resection
skin closures. This may be reduced by a month of preoperative through a potentially bloody and vague plane of dissection.
504 D. Hurwitz
FIG. 4. (a, b) The result 6 months later than that shown in Fig. 3 is seen and immediately after bilateral brachioplasties [24]. The patient
had a staged total body lift. Prior to her body contouring surgery, she weighed 210 lb and now she weighs 170 lb. (a) Her breasts are well
shaped and symmetrical [25]. All redundant skin is removed and a natural hip and waist contour is established. (b) The thighs have a natu-
ral tapered contour. Most of her extensive back scars can be covered by underwear.
Care is taken to leave behind the ideal and symmetrical Proper incision planning, the fourth principle, as dis-
amount of fat along the flanks and hips. The central back cussed previously, leaves level scars along the bikini line.
closure is not tight; hence, it better tolerates the marked flex- Most excisions are made with the patient reclining, but
ion needed for the abdominal closure later in the operation. checked standing. Mid- and upper abdominal transverse
Before the patient is turned, the posterior portion of the scars are included in the excision, to avoid possible skin
medial thighplasty is performed superficially along the infe- necrosis, whenever possible.
rior gluteal fold. Later the patient is turned and placed in the The fifth principle is to focus on the contour and tension
supine position onto a second operating room table and ster- of the tissue left behind, much as in a breast reduction. When
ile sheets for the abdominoplasty. Experienced residents great closure tension is present, some late thinning of the
assist or perform portions of the procedure with both the subcutaneous tissues can be anticipated, particularly in the
attending and the residents suctioning fat or suturing lateral buttock region. Nevertheless, the central buttock
simultaneously. assumes a more spherical shape over time. The inclusion of
The third principle is to excise skin transversely. Skin a deepithelialized upper buttock flap often fills out the flat-
redundancy is predominantly vertical, and crisscrossing with tened buttocks.
vertical excisions leaves compromised flap tips. Transverse We follow the sixth principle, preservation of dermis and
scars are easily placed within underwear areas and are less subcutaneous fascia, by preliminary infiltration along the
likely to hypertrophy. Plan the trunk scar along the bikini anticipated incision of 100 of milliliters of lactated Ringer’s
line, which is easily covered and represents the greatest cir- solution with 1 mg of epinephrine and 40 cm3 of 1 %
cumference of the female torso (Fig. 5). When the relatively Xylocaine per liter. This preparation minimizes bleeding and
narrow waist level excess skin is advanced over the iliac limits the use of electrocautery. The incision is slightly bev-
crests, much of the transverse excess is taken in. eled along the dermis and perpendicularly through the fat
Inverted superior anterior midline V excision is reserved and subcutaneous fascia, as the flaps are retracted from each
for removal of widened and depressed surgical scars. A pos- other. The use of a vasoconstrictor follows the second prin-
terior V-shaped excision is limited to the midline buttock ciple, efficiency, requiring interruption to coagulate bleeders
flap, to help rotate in excessively redundant lateral thigh only after considerable tissue is incised.
skin. A broad vertical segment of midline back skin is invari- The seventh principle is gentle fat removal, which is pos-
ably adherent, and therefore it is only excised as the end of a sible by liposuction with prior infiltration of Xylocaine and
transversely oriented ellipse. Further exceptions to the rule epinephrine. A brief run with an ultrasound probe reduces
of transverse excisions are the correction of severe gyneco- the vigor of the liposuction cannula stokes. Both the LySonix
mastia and midback rolls, where obliquely and vertically ori- (Mentor Corporation, Santa Barbara California) and the
ented ellipses have been used. VASER (Sound Surgical Technologies, Louisville, CO)
53. Plastic Surgery Following Weight Loss 505
ultrasound systems are satisfactory. Bleeding rarely occurs, PDO Quill large subcutaneous tissue bites followed by intra-
and if some blood is seen in the cannula, significant vessel dermal 3-0 Monoderm®. The reverse abdominoplasty, the
damage of the flap is presumed and the liposuction is stopped. central aspect of the upper body lift, is successful after estab-
Flap edge direct resection of excess sub-Scarpal fat does not lishing the new inframammary fold with high-tension
diminish overlying skin blood supply. advancement of the upper abdominal skin flap fixed about
The eighth principle dictates a high-tension skin flap clo- the ribs with running #2 PDO.
sure. After massive weight loss the trunk skin flaps are rela- The ninth principle is that swelling, infection rate, phle-
tively inelastic. The flap vessels are large, a remnant of the bitis, and seroma are reduced by closing wounds as expedi-
prior obesity, which appears to increase blood flow, permit- tiously as possible over long dwelling suction catheters.
ting greater undermining and tension on the flaps than one Elasticized garments with minimal pressure over the lower
would generally consider safe. Correction of the lateral thigh abdomen are comfortable and reassuring to the patient.
saddlebag deformity has been improved by fully abducting Aside from some flap tacking sutures in the groins, we have
the leg onto a side utility table while closing with the patient not closed the dead space. Lower abdominal sub-Scarpa
in the prone position (Fig. 2) [21]. Preliminary approxima- fascia lymphatics are preserved as much as possible.
tion with towel clips keeps the tension during closure of the Seromas are a rare experience. Preoperative adipose prepa-
wound minimal. Optimal abdominoplasty closure is achieved ration and postoperative Lipomassage™ speed recovery
by flexing the trunk, approximating the wound edges with #2 and improve results.
506 D. Hurwitz
The tenth principle is that analyzing the aesthetic results 7. Van Geertruyden JP, Vandeweyer E, de Fontanie S, et al.
and the patient outcomes a year or more postoperative is very Circumferential torsoplasty. Br J Plast Surg. 1999;52:623–30.
8. Hunstad JP. Addressing difficult areas in body contouring with
instructive. Persistent heavy tissues, particularly of the emphasis on combined tumescent and syringe techniques. Clin
thighs, lower the transverse scars and depress the contours. Plast Surg. 1996;23:57–80.
Review of standard photography is the best gauge of our 9. Matory Jr WE, O’Sullivan J, Fudem G, et al. Abdominal surgery in
efforts. We have developed a deformity and outcome grading patients with severe morbid obesity. Plast Reconstr Surg.
scale, which we have applied to our results [19, 20]. 1994;94:976–80.
10. Mitka M. Surgery for obesity, demand soars amid scientific, ethical
Correction of deformity may not always equate with optimal questions. JAMA. 2003;289(14):1761.
aesthetic results, but it is an improvement. The best aesthet- 11. Schauer PR, Ikramuddin I. Laparoscopic surgery for morbid obe-
ics leave the most unobtrusive symmetrical scars and gender- sity. Surg Clin North Am. 2001;81:1145–51.
specific contours. 12. Buchwald H. Overview of bariatric surgery. J Am Coll Surg.
2002;194:367–75.
13. Agha-Mohammadi S, Hurwitz DJ. Nutritional deficiency of post-
bariatric body contouring patients: what every plastic surgeon
The Surgical Challenge should know. Plast Reconstr Surg. 2008;122(2):604–13.
14. Agha-Mohammadi S, Hurwitz DJ. Potential impacts of nutritional
The ongoing presentation of many reasonably healthy, body- deficiency of post-bariatric patients on body contouring. Plast
conscious weight loss patients has offered me a rare surgical Reconstr Surg. 2008;122(6):1901–14.
15. Adcock D, Paulsen S, Davis S, Nanney L, Shack RB. Analysis of
opportunity and challenge. Complex planning based on clin- the cutaneous and systemic effects of Endermologie in the Porcine
ical experience and artistic skills, followed by a physically model. Aesthet Surg J. 1998;18:414–20.
demanding and tedious procedure, is rewarded by incredible 16. Latrenta GS. Endermologie versus liposuction with external ultra-
body transformations. The metamorphosis is greeted with sound assist. Aesthet Surg J. 1999;19:1110–4.
patient elation and gratitude. This is plastic surgery that 17. Ersek RA, Mann II GE, Salisbury S, Salisbury AV. Noninvasive
mechanical body contouring: a preliminary clinical outcome study.
melds reconstructive and cosmetic procedures for eagerly Aesthetic Plast Surg. 1997;21:61–7.
anticipating patients. Effective, reliable, and reduced risk 18. Latrenta GS, Mick S. Endermologie after external ultrasound-
procedures are evolving so that future contributions are assisted lipoplasty (EUAL) versus EUAL alone. Aesthet Surg
available to the legion of surgeons who want to commit their J. 2001;21:128–36.
talents to this needy population [21–23]. 19. Dabb RW. A combined program of small-volume liposuction,
Endermologie, and nutrition: a logical alternative. Aesthet Surg
J. 1999;19:388–93.
20. Hurwitz DJ, Zewert TE. Body contouring after bariatric surgery.
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54
The Female Patient: Pregnancy and Gynecologic
Issues in the Bariatric Surgery Patient
Karina A. McArthur, Giselle G. Hamad, and George M. Eid
Polycystic Ovary Syndrome and Morbid The prevalence of obesity in women with PCOS ranges
from 30 to 80 % [6, 9]. The role that obesity plays in the
Obesity pathophysiology of PCOS is controversial. Nevertheless,
obesity undoubtedly exacerbates some of the features of
Polycystic ovary syndrome (PCOS) was initially named PCOS, including insulin resistance [9]. The prevalence of
Stein-Leventhal syndrome for the physicians who recog- obesity in US women aged 20 and older is 35.8 % in 2009–
nized in 1935 a clinical triad of hirsutism, amenorrhea, and 2010 [10]. Obesity is clearly associated with a number of
obesity. Since then, the National Institutes of Health (NIH) comorbidities including cardiovascular disease, hyperten-
has updated this definition to the Rotterdam consensus crite- sion, diabetes mellitus, sleep apnea, osteoarthritis, dysfunc-
ria requiring two of the three following clinical manifesta- tional uterine bleeding, and endometrial carcinoma. When
tions: menstrual irregularity, hyperandrogenism (clinical or compared to their nonobese PCOS counterparts or to obese
biochemical), and polycystic ovaries on ultrasound [1]. women without PCOS, women with PCOS and obesity have
Estimates of the prevalence of polycystic ovary syndrome an even higher risk of developing the comorbidities that
(PCOS) have ranged between 4 and 18 % [2]. overlap between the two conditions. In other words, the risks
The etiology of PCOS remains largely unclear. It is cur- are additive [11].
rently thought to represent a complex interaction of genetics PCOS treatment focuses on the clinical manifestation of
and environmental factors, including intrauterine factors that the syndrome such as hyperandrogenemia and insulin resis-
predispose an individual to having endocrine abnormalities tance. Insulin-sensitizing agents are one of the mainstays of
including insulin resistance, hyperandrogenemia, and infer- treatment of PCOS. Advocates of their use believe that high
tility. Recently several studies have been published implicat- insulin levels trigger the cascade of endocrinopathies that
ing candidate genes from genome-wide association studies lead to anovulation and hyperandrogenism. While some
[3, 4]. This represents an exciting avenue for further elucida- studies have shown an improvement in ovulation and preg-
tion of the etiology of PCOS. Obesity is also thought to influ- nancy rates with the use of insulin-sensitizing agents, a
ence the phenotype of PCOS strongly [5], potentially recent meta-analysis did not show any improvement in live
forming a part of a “vicious” cycle further contributing to birth rates with the use of insulin-sensitizing agents in PCOS
androgen excess [6]. [12]. A potential explanation for the heterogeneity of the
PCOS is primarily a disorder of ovary function, resulting results of insulin-sensitizing agents in studies looking at
in menstrual irregularities, infertility, and hyperandrogen- PCOS and improvement of metabolic dysfunction is the
ism. Hyperandrogenism is manifested in a number of ways, broader Rotterdam consensus criteria, including many
including hirsutism and acne. There is also a strong preva- patients without metabolic dysfunction in the definition of
lence of insulin resistance in the PCOS population, in both PCOS [13]. Treatment with antiandrogens is generally
obese and lean women [7]. The relationship between hyper- effective for the amelioration of hirsutism and acne but does
androgenism and insulin resistance is not clearly defined. not produce an insulin-sensitizing effect. Similarly, oral
However, hyperandrogenism predisposes to central obesity, contraceptives may improve menstrual cycle regularity and
which itself correlates with insulin resistance [8]. As a acne [14].
result of these endocrinopathies, women with PCOS may be Currently, there is no ideal treatment for PCOS, as none
at risk for cardiovascular events and other end organ compli- of the treatments described can remedy all of the biochemi-
cations [9]. cal aberrations, signs, and symptoms of the disease. Instead,
most treatments tend to target only one or a few components Another population-based study over a 20-year period
of PCOS. Weight loss is the only treatment that improves compared pregnancy outcomes after different types of
many of the endocrine aspects of the disease in the obese bariatric surgeries, including laparoscopic adjustable gas-
PCOS patient. A recent Cochrane review [15] showed that tric band (LAGB), vertical banded gastroplasty, silastic ring
lifestyle intervention reduces adiposity and improves hyper- gastroplasty, and Roux-en-y gastric bypass (RYGB).
androgenism and insulin resistance in women with Among the groups, there was no significant difference in low
PCOS. However, weight loss achieved by lifestyle interven- birth weight, macrosomia, low Apgar scores, or perinatal
tion is generally modest (5–10 %) and is followed by a regain mortality [26].
in weight in the majority of cases [16]. Gestational diabetes confers an increased risk of cesarean
Surgical management of weight is, therefore, an attractive delivery and macrosomia [27]. Following bariatric surgery,
option for improving the symptomatology of PCOS. Although the rate of gestational diabetes decreases [28]. In a retrospec-
studies on this subject are limited, they appear to show a tive study of a private insurance claims database, women
significant benefit of bariatric surgery in treating PCOS [6]. who underwent bariatric surgery were less likely to have ges-
One retrospective study evaluated 24 patients with an estab- tational diabetes and cesarean section compared to those
lished diagnosis of PCOS [17]. All patients were oligomen- who delivered before having bariatric surgery [29].
orrheic, 96 % had hirsutism, 20 % had acne, and 50 % had
ovary cysts on ultrasound. All of the patients had resolution
of their menstrual abnormalities and the five patients who Pregnancy Following Gastric Bypass
wished to conceive postoperatively were able to do so with-
out clomiphene. A common question among women of reproductive age who
Similarly, in another retrospective study of 20 patients are potential candidates for bariatric surgery concerns the
with PCOS who underwent Roux-en-Y gastric bypass, 82 % safety and optimal timing of subsequent childbearing. The
of patients had improvement in menstrual cycle irregularity, period of rapid weight loss following RYGB was initially
and all six patients who desired pregnancy were able to thought to be a vulnerable time period for a pregnancy.
achieve it, five without any additional intervention [18]. In Traditionally, bariatric surgeons have counseled patients to
regard to the effect of restrictive bariatric procedures on avoid pregnancy for up to 24 months following RYGB
PCOS, a study of the Swedish adjustable gastric band showed because of the concern that rapid weight loss leads to adverse
improvement of symptoms in 48 % of the patients with fetal outcomes. However, recent studies have challenged the
PCOS [19]. While several small studies have shown promis- notion that pregnancy should be avoided in the first 2 years
ing results in PCOS treatment with bariatric surgery, further after bariatric surgery. In a retrospective review comparing
research is necessary to establish bariatric surgery as a stan- RYGB patients who became pregnant within 1 year of sur-
dard therapy for PCOS. gery with those who became pregnant after 1 year, there was
no increase in malnutrition, adverse fetal outcomes, or com-
plications in pregnancy in the women who became pregnant
Pregnancy After Bariatric Surgery within 1 year after surgery [31]. These data suggest that
recommending a delay in conceiving beyond 1 year after
Because preoperative menstrual irregularities and infertility bariatric surgery is unnecessary.
frequently improve following bariatric surgery, female One theoretical challenge in the management of this pop-
patients of reproductive age may become more fertile [17, ulation is the possibility that the anatomy of the RYGB
20]. Patients should be advised that they are at increased risk impairs absorption of oral contraceptives, which might lead
of becoming pregnant following bariatric surgery. Given that to unintended pregnancy [31]. There are few pharmacoki-
micronutrient deficiencies can result in deleterious effects on netic studies in the literature to guide clinical practice and
the fetus, it is critical to discuss the importance of compli- more clinical trials are needed.
ance with micronutrient supplementation. Gastric bypass has been shown to reduce the rate of
Bariatric surgery is associated with improved perinatal pregnancy-related complications. In an analysis of insurance
outcomes. Obese pregnant women are at higher risk of a claims data from bariatric surgery patients who had at least
number of perinatal complications, including preeclampsia, one pregnancy [32], mothers having prior bariatric surgery
gestational diabetes, hypertension, post-datism, meconium had lower rates of preeclampsia, eclampsia, and gestational
staining, and prolongation of labor [21–23]. In a review of 75 hypertension compared to deliveries prior to bariatric surgery.
published articles, post-bariatric surgery mothers had lower The majority (81.5 %) had undergone RYGB surgery.
rates of pregnancy-related complications than obese women A small bowel obstruction is a potentially catastrophic
without bariatric surgery [24]. A population-based study complication following RYGB that may result in major mor-
demonstrated a lower risk of macrosomia following bariatric bidity and mortality for both mother and fetus [33–35]. The
surgery, but these patients were more likely to be anemic, gravid uterus displaces the intestines cephalad and a closed-
hypertensive, and deliver small for gestational age infants [25]. loop obstruction through an internal hernia defect may occur.
54. The Female Patient: Pregnancy and Gynecologic Issues in the Bariatric Surgery Patient 509
This may progress to infarction or perforation if not recognized Pregnancy Following Biliopancreatic
promptly. A small bowel intussusception is another possible
etiology of small bowel obstruction that can lead to bowel Diversion
necrosis [35]. A pregnant post-RYGB patient who complains
of abdominal pain may present with vague clinical com- There are few studies in the literature evaluating pregnancy
plaints which make diagnosis difficult. Clinicians may be outcomes in BPD patients. One study with 18-year follow-up
reluctant to submit pregnant patients for CT scanning has addressed pregnancy following biliopancreatic diversion
because of the radiation exposure. In addition, imaging stud- (BPD) [41]; 239 pregnancies occurred in 1,136 women who
ies may fail to diagnose an internal hernia or even intestinal had previously undergone BPD. Thirty-five women experi-
volvulus [36]. Therefore, in a pregnant post-GBP patient enced improvement in fertility following BPD. Eighty-five
with unexplained abdominal pain, serious consideration percent delivered at term and 28 % were small for gestational
should be given to exploratory laparotomy or diagnostic lap- age. Total parenteral nutrition was required in 21 %. Two birth
aroscopy, as early surgical intervention is needed to avoid a malformations were observed and three fetal deaths occurred.
delay in diagnosis [37]. In another study of pregnancy in BPD patients, a survey
of 783 women showed an improvement in fertility in 47 % of
patients who were unable to conceive preoperatively [28].
Pregnancy Following Restrictive Although fetal macrosomia improved after the BPD, the
Procedures miscarriage rate remained elevated at 26 %. The authors sup-
ported delaying pregnancy until weight stabilization.
A low rate of pregnancy-related complications has been The most recent study of pregnancy outcomes after BPD
noted among patients having restrictive procedures. retrospectively evaluated ten BPD patients who previously
Following LAGB, there is a lower risk of gestational diabe- had type 2 diabetes mellitus which resolved after BPD [42].
tes, pregnancy-induced hypertension, preeclampsia, cesar- None of the mothers developed gestational diabetes and
ean section, macrosomia, and low birth weight babies none of the infants had macrosomia.
compared to pregnancies in obese mothers who did not
undergo bariatric surgery [38].
An advantage of LAGB is that the restriction may be Nutritional Issues
adjusted during pregnancy to decelerate weight loss or to
relieve hyperemesis. Dixon and colleagues cite the adjust- Several essential micronutrients are malabsorbed in GBP
ability of the gastric restriction of the LAGB as an ideal patients [43]. Therefore, compliance with vitamin and min-
method to control the weight of pregnant bariatric patients eral supplementation is of utmost importance in pregnant
[39]. Of 1,382 gastric band patients, 79 pregnancies were patients following gastric bypass surgery. Deficiencies in
compared with the patients’ previous pregnancies and with vitamin A, iron, calcium, vitamin D, vitamin B12, thiamine,
matched obese subjects and community outcomes data. Birth and folate have all been described. Thiamine deficiency may
weights were comparable to the community birth weights. lead to Wernicke’s encephalopathy, which may have
Gestational diabetes and pregnancy-induced hypertension devastating neurologic consequences.
were comparable to the community incidence and were less The post-GBP reduction in calcium absorption may lead
frequent compared to the obese cohort. Stillbirths, preterm to a decrease in bone density which potentially places a
deliveries, and abnormal birth weights were concordant with female patient at risk for osteoporotic fractures [44]. Longer-
the community data. term follow-up of 3 years reveals that the reduction in bone
Conceiving within a year after LAGB appears to be safe density continues [45].
according to a retrospective study which demonstrated that Premenopausal women are at risk of iron deficiency ane-
bariatric surgery patients who became pregnant during the first mia because of menstrual losses. Following GBP, these
postoperative year did not have a higher rate of perinatal com- women are even more predisposed to iron deficiency. Gastric
plications compared to those who became pregnant more than acid is required for release of iron and cobalamin from food.
12 months postoperatively [26]. In this study, the majority of Iron is maximally absorbed in the duodenum, while cobala-
patients had undergone LAGB (61.5 %). These data suggest min is absorbed in the terminal ileum. Following gastric
that it is safe to conceive within 1 year of bariatric surgery. bypass, the parietal cells in the distal stomach are bypassed,
The timing of pregnancy after LAGB is related to the rate thereby reducing gastric acidity and subsequent absorption
of revisional surgery [40]. Among LAGB patients who of iron and cobalamin. Therefore, daily iron supplementa-
became pregnant following LAGB, excess weight loss was tion is mandatory in GBP patients. Prenatal vitamins or mul-
equivalent at 3 years compared to nonpregnant controls. The tivitamin supplements containing iron are generally
rates of revisions of the band, port, and tubing were equivalent inadequate to meet the needs of the GBP patient; a separate
between the two groups. However, the women who became iron supplement is required.
pregnant sooner after LAGB and pregnancy had a higher rate In the setting of folate deficiency, neural tube defects
of band revisions. may occur after GBP and may result in devastating fetal
510 K.A. McArthur et al.
abnormalities [46]. Therefore, patients must be counseled Review Questions and Answers
about the importance of folic acid supplementation, espe-
cially as an increasing number of adolescent and childbear-
ing-aged females undergo bariatric surgery. Question 1
What combination of characteristics does not meet the
Urinary Stress Incontinence and Obesity requirement for the diagnosis of PCOS according to the
Rotterdam criteria?
Obesity is a risk factor for urinary stress incontinence [47]. It (a) Obesity and polycystic ovaries on ultrasound
has been postulated that the increased intra-abdominal pres- (b) Hyperandrogenism and menstrual irregularity
sure due to obesity increases the intravesical pressure until it (c) Menstrual irregularity and polycystic ovaries on
overcomes the maximal urethral closing pressure [48]. ultrasound
Neurogenic mechanisms for urinary stress incontinence in (d) Hyperandrogenism and polycystic ovaries on ultrasound
the obese have also been proposed [49].
Weight loss appears to be an essential element in sus-
tained improvement in stress incontinence. The effect of
nonsurgical weight reduction resulting in weight loss of Answer: A
≥5 % had a ≥50 % reduction in incontinence frequency
compared to only 25 % of women with <5 % weight loss The Rotterdam consensus criteria requires two of the three
(p < .03) [50]. Similarly, a recent randomized controlled trial following clinical manifestations: menstrual irregularity,
demonstrated that a weight loss of 8.0 % resulted in a self- hyperandrogenism (clinical or biochemical), and polycystic
reported decrease in incontinence episodes in 47 % of ovaries on ultrasound. Although obesity exacerbates many of
patients in the intervention group, compared to 28 % in the the clinical abnormalities of PCOS, it is not a required com-
control group that had 1.6 % of weight loss (p = 0.01) [51]. ponent of the diagnosis.
There has been increasing support in the literature citing
the improvement of stress incontinence after bariatric sur-
gery. One prospective study demonstrated that urinary Question 2
incontinence resolved in 64 % and improved in 92 % at 1
year after gastric bypass [52]. Whitcomb et al. found that A 24-year-old G2P1 woman is 32 weeks pregnant and pres-
the overall prevalence of stress urinary incontinence ents with dehydration, nausea, vomiting, and left upper quad-
decreased from 32 % at baseline to 15 % at 6 months rant abdominal pain. She underwent a gastric bypass 2 years
(p = 0.006) [53]. ago and has lost 150 lb. Physical exam reveals tachycardia of
The impact of obesity on the surgical treatment of urinary 110, blood pressure of 90/50, and a gravid abdomen with left
stress incontinence has been investigated in a modest number upper quadrant tenderness without peritonitis. White blood
of studies. The literature looking at results of traditional sur- cell count is 11.0. CT scan reveals distended bowel loops and
gical treatment such a Burch colposuspension in obese swirling of the small bowel mesentery. What is the next step
patients is mixed. However, there is an increasing consensus in diagnosis and treatment?
that cure rates and complication rates after tension-free vagi- (a) Insertion of nasogastric tube
nal tape repair are similar between obese and nonobese (b) Upper endoscopy
patients [49]. (c) Serial abdominal exams
(d) Surgical exploration
Conclusion
Obesity and PCOS are closely related; surgically-induced Answer: D
weight loss improves menstrual irregularities, hirsutism, and
infertility. Postoperative bariatric patients are at increased risk Internal hernia is a devastating complication in a gastric bypass
of becoming pregnant. During pregnancy, compliance with patient, possibly resulting in necrosis of the bowel, perfora-
vitamin supplementation is of utmost importance. Pregnancy tion, peritonitis, and short gut. Pregnancy complicates the
outcomes are improved following bariatric surgery. If possi- diagnosis of internal hernia due to a gravid uterus displacing
ble, close prenatal surveillance should be established with an intra-abdominal contents. Clinicians may be reluctant to sub-
obstetrician with experience in high-risk pregnancies. Elevated ject the fetus to ionizing radiation, making diagnosis challeng-
BMI is a risk factor for urinary stress incontinence, which ing. In a patient with high suspicion of internal hernia, there
improves with surgically-induced weight loss. should be no delay in intervening surgically.
54. The Female Patient: Pregnancy and Gynecologic Issues in the Bariatric Surgery Patient 511
pregnancy: retrospective analysis of insurance claims data. BMJ. 43. Bal BS, Finelli FC, Koch TR. Origins of and recognition of
2010;340:c1662. micronutrient deficiencies after gastric bypass surgery. Curr Diab
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34. Loar 3rd PV, Sanchez-Ramos L, Kaunitz AM, Kerwin AJ, Diaz bypass surgery is associated with extent of weight loss. J Clin
J. Maternal death caused by midgut volvulus after bariatric surgery. Endocrinol Metab. 2008;93(10):3735–40.
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35. Tohamy AE, Eid GM. Laparoscopic reduction of small bowel Gordejuela AG, et al. Evaluation of bone mineral density loss in
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Andrade RS, Slusarek B, et al. Small bowel obstruction and internal 48. Kolbl H, Riss P. Obesity and stress urinary incontinence: signifi-
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55
Medicolegal Issues: The Pitfalls and Pratfalls
of the Bariatric Surgery Practice
Kathleen M. McCauley
Historical Perspective profession expanded to include those who were trained and
untrained, alternative, and traditional, with little quality
There was an explosion in the number of medical malpractice control. At the same time, lawyers found themselves in an
lawsuits filed in the early part of this century, and general equally hostile culture of competition, and medical malprac-
surgeons experienced the effects of this boom in and out of tice became an area of growth for the legal profession [11].
the operating room. While medical negligence lawsuits have The result of this fight for professional survival was an
been recognized for over two centuries, the modern-day unprecedented increase in the number of medical malpractice
impact of this type of litigation in the United States has been suits filed in the United States. Between 1840 and 1860, the
simmering for decades. With litigation reaching crisis pro- number of lawsuits alleging medical negligence grew by
portions in the mid-1980s and again in the last decade, medi- 950 % [11]. Although medical malpractice litigation exploded
cal risk management has become an integral part of every onto the scene in the middle of the nineteenth century as a
surgical practice [8]. result of a cultural shift, the phenomenon has perpetuated in
The legal theory behind medical malpractice claims origi- response to both scientific innovation and the call for profes-
nates in English jurisprudence dating back to the eighteenth sional regulation. Historically, with every new era of medical
century; however, lawsuits alleging medical malpractice innovation or expansion came an increase in claims for
were filed sparingly in the United States until the middle of negligence. Once the innovation became passé, the wave of
the nineteenth century [9]. By 1850, medical malpractice litigation abated but it never fell back to zero [12].
litigation as we know it today was entrenched in the American Despite the recognition that medicine is not perfection
legal landscape. Historians have attributed the precipitous and physicians are fallible, our culture demanded a standard
increase in professional negligence actions in the United by which mistakes could be measured. Accordingly, the mid-
States to the cultural decline in fatalist philosophical thought nineteenth century saw the advent of various professional
and the marked increase in religious perfectionism, both organizations, including the American Medical Association.
concepts having grown out of the Christian revivals of the As a result of this self-regulation, unqualified physicians
1820s and 1830s [10]. The increase in the number of suits were identified and driven from the profession. However, the
filed in later decades of the nineteenth century has been impact on those who remained was the creation of uniform
attributed to the birth of what has been called “marketplace standards by which medical professionals would be judged.
professionalism” [11]. The concept of marketplace profes- In the wake of these new licensing requirements and stan-
sionalism, unique to the United States during this stage in the dards of care, the profession was exposed to more litigation
country’s development, illustrates the most dramatic as lawyers now judged physicians by the profession’s own
American divergence from traditional European models of standards [12].
professional evolution [11]. Historically, the learned profes- Finally, the introduction of professional liability insur-
sions of Western Europe were granted authority by the ruling ance in the late nineteenth century proved to be both a cham-
class. In the United States, however, this sanction was not pion and an enemy of the physician. Insurance virtually
embraced by American society and became most evident in erased risk to the financial survival of the individual practi-
the 1830s when concepts of social status, economic class, tioner, but at the same time it guaranteed resources to the
monopoly, and elitism garnered great public criticism [11]. malpractice plaintiff [13]. As a result, the introduction of
The professions, including law and medicine, were thrust insurance to the profession effectively guaranteed the sur-
into the marketplace to fend for themselves in an environ- vival of medical malpractice litigation into the twentieth
ment of Darwinian competition. Consequently, the medical century and beyond [13]. Today, medical malpractice litigation
is pervasive. One economic study by the Joint Economic physician? What is the impact of a medical malpractice
Committee of the US Congress suggests that the current state lawsuit on the physician’s career? What is the impact on the
of the medical malpractice litigation system has had a nega- physician’s job satisfaction and personal happiness? These
tive impact on the access to and the cost of professional are the questions that cause the medical profession angst,
liability insurance, the quality of health care, and the cost of despair, and insomnia. For some, the topic inspires only ire
and access to health care in this country [14]. While the and frustration.
future of the current medical liability system in the United The word malpractice has been defined as “any professional
States is unknown, the prudent bariatric surgeon must be misconduct, unreasonable lack of skill or fidelity in the pro-
able to identify potential risks associated with litigation and fession or fiduciary duties, evil practice or illegal or immoral
how best to avoid it. conduct” [20]. The term medical malpractice is derived from
the Latin mala praxis—bad practice—and was first applied to
the profession of medicine by Sir William Blackstone in 1768
Medical Negligence Litigation [21]. To prevail in a medical negligence suit, the plaintiff
and Recent Trends must prove by the greater weight of the evidence all four ele-
ments of the cause of action. That is, to prove a prima facie
Despite having preconceived ideas of how they will be per- case of medical negligence, the plaintiff must establish:
ceived, physicians should be reassured to learn that juries 1. A duty to the patient
usually “get it right.” Over 30 years of data show us that out- 2. A breach of that duty or standard of care
comes in medical malpractice litigation are remarkably con- 3. A compensable injury
sistent with the quality of care provided to a patient as 4. Proximate causation to the injury or damages [22, 23]
critiqued by physician peers [15]. In general, physicians win
80–90 % of those cases where other physicians conclude Once the physician–patient relationship is established, the
there is weak evidence of medical negligence, 70 % of the physician owes his or her patient the duty of due care. “Due
borderline cases, and 50 % of cases where other physicians care” is defined as the care required of a reasonably prudent
believe that the plaintiff should prevail [15]. In fact, one physician in the same field of practice under the same or
study suggested that favorable physician outcomes in the similar circumstances [24]. In most cases, the duty of due
face of no documented evidence of negligence have improved care—or the standard of care—must be proved through
and that the perception of a broken American tort system is expert testimony. Likewise, any alleged breach of the stan-
misplaced [16]. dard of care and proximate causation must be proved through
After the litigation crises of the mid-1980s and early the introduction of expert testimony. The plaintiff often uses
2000s, a 2006 study by Aon, a global provider of risk man- documents such as medical records, medical literature, and
agement and insurance and reinsurance brokerage, revealed demonstrative aids such as models, charts, medical chronol-
that claims against hospitals and physicians began to stabi- ogies, and diagrams at trial as well.
lize. In its seventh annual Hospital Professional Liability and Physicians are sued for myriad reasons, from the sublime
Physician Liability Benchmark Analysis, Aon attributed the to the ridiculous. That said, most suits for malpractice allege
decrease in frequency and increase in severity to claims man- the following:
agement, tort reform, and patient safety and quality assur- • Failure to communicate or miscommunication
ance efforts [17]. This stabilization in frequency of claims • Failure to diagnose
remained true for several years until the economy took a turn • Failure to treat
for the worse [18]. A new study suggests that by the end of • Failure to document appropriately
2012, claim severity for hospitals and physicians nationwide • Failure to perform a procedure appropriately
had increased by 2.5 % with claim frequency increasing by • Failure to get appropriate consultations
1 %. In its 2012 Benchmark study, Aon and the American • Inappropriate orders or delegation of duties
Society for Healthcare Risk Management concluded that we • Breach of confidentiality
should expect to see a sharp increase in medical malpractice • Failure to admit a patient to the hospital or premature
claims and warn that loss rates for both hospitals and physi- discharge
cians are projected to grow by 3.5 % by 2013 [19]. • Failure to order appropriate diagnostic tests or studies
• Misinterpreted diagnostic tests or studies
• Bad outcomes and unreasonable expectations
Medical Negligence Litigation • Complications and failure to timely address recognized
complications
and the Bariatric Surgeon • Inadequate informed consent or no informed consent
• Failure to follow up or patient abandonment
What is medical malpractice? How does a plaintiff prove
medical malpractice? Why the surge in medical malpractice In recent years, there has been a focus on finding data to
claims involving bariatric surgery? Why do people sue their support why plaintiffs choose to sue healthcare practitioners.
55. Medicolegal Issues: The Pitfalls and Pratfalls of the Bariatric Surgery Practice 515
One recent survey reveals that the number of years in recognized complications of the procedure are the most
practice dictates the likelihood of being named in litigation. common cause for a subsequent medical negligence claim [30].
A 2011 survey sent out by the ASMBS Patient Safety Regardless of the theory of liability against the bariatric sur-
Committee determined that the probability of reporting at geon, the suits continue to be filed across the nation.
least one lawsuit independently increased with the number of
years a surgeon was in practice [25]. Another study revealed
that only about 5 % of physicians are sued annually but that Informed Consent
42.2 % of physicians have had medical malpractice claims
filed against them during their career [26]. Pediatricians and Informed consent is a process, not a piece of paper. It is a
psychiatrists were sued least often with their colleagues in common misconception that one proves informed consent
surgery and obstetrics/gynecology having higher frequency with a signed “consent for treatment” form. To the contrary,
data [26]. That said, a subsequent American Medical the signed consent form is merely one piece of evidence that
Association study revealed that 55 % of all cases filed against the attending physician completed the informed consent pro-
physicians are dismissed, with less than 5 % of cases making cess. The doctrine of informed consent is based on the prem-
it to trial [27]. Of those cases tried to a judge or jury, 79.6 % ise that people have a right to decide what happens to their
of cases resulted in verdicts in favor of the physician [27]. own bodies and minds. It is based on the concept of auton-
The study involved claims closed between 2002 and 2005 omy—a concept firmly grounded in philosophy, not law.
and outcomes varied across specialties, with medicine-based Autonomy—or self-determination—embraces the notion
specialties enjoying the highest rate of dismissal (61.5 %) that people have the right to choose the course of their own
and pathologists suffering the lowest (36.5 %) [27]. medical treatment in accordance with their own values,
So why do surgeons get sued? Anecdotally, we know that mores, religious beliefs, and life goals. The principle is also
bad clinical outcomes are at the heart of most litigation. grounded on the premise that no other person, institution, or
The data shows that those bad clinical outcomes can be tied other entity should be permitted to intervene to overrule an
to injury to adjacent organ or anatomic structure. In a 2008 individual’s wishes, whether or not those wishes are “right,”
survey of 91 lawsuits against general surgeons, 30 % of those as long as the decision does not negatively affect another
suits involved iatrogenic injury to adjacent structures, 37 % individual [31]. That choice, however, must be based on
of which involved nerve injury [28]. However, patients and information regarding diagnosis, prognosis, risks, and bene-
their families also sue because they are angry, offended, or fits of the procedure or course of therapy, as well as the con-
grieving. As well, experience tells us that plaintiffs often use sequences of refusing treatment.
the litigation process to apportion blame, shift accountability, The doctrine of informed consent is composed of two dis-
manage guilt or grief, and seek closure. crete components: permission and knowledge. A patient is
Bariatric surgeons see claims of malpractice for similar entitled to give express permission for any touching by
reasons, although weight-loss procedures and morbidly another and that permission is to be based on information
obese patients are unique in the medical litigation mise-en- that is deemed to be important by the patient’s physician.
scéne. Cases against bariatric surgeons include many of That is, it is incumbent on the medical practitioner to impart
those claims delineated above but also may include the fol- all information necessary for the patient to make a well-
lowing allegations: reasoned, educated choice regarding treatment. Informed
consent is of paramount importance when dealing with
• Inexperience of the operator
elective procedures, as consent is implied in the case of an
• Inadequate facilities or equipment for the bariatric patient
emergency. As bariatric surgery is a high-risk elective proce-
• Failure to monitor or inadequate postoperative monitoring
dure by its very nature, the informed consent process must be
• Failure to diagnose or to timely diagnose a lethal
well planned and well executed.
complication
Causes of action involving issues of informed consent fall
• Inadequate preoperative workup or substandard patient
into two categories: the tort of battery (no consent) or negli-
selection
gence (inadequate consent). Battery—or unauthorized
• Contraindications to surgery, including history of gall-
touching—occurs when the physician fails to obtain informed
stones or cholecystitis
consent or if the touching exceeds the scope of the informed
• Poor follow-up support after surgery
consent. Negligent informed consent is consent that is based
• Unrecognized or unaddressed psychiatric issues
on inadequate information. In most jurisdictions, informed
• Misguided motivation for surgery
consent is based on the “reasonable” man standard; that is, con-
Today, the lion’s share of litigation involving weight-loss sent is informed when it is based on the information that a
procedures concentrates on allegations of negligence during reasonably prudent surgeon would convey to his or her
the postoperative period, immediate postoperative inpatient patient during the informed consent process. Suits alleging
care, and follow-up once the patient is discharged to home [29]. negligent informed consent usually require expert testimony
Specifically, postoperative leaks and delayed diagnosis of on the subject; cases alleging battery do not.
516 K.M. McCauley
Generally, the informed consent process should include recommendations for treatment, actual ongoing care and
the following: treatment, and follow-up. It is important to include the most
current information available, which will ensure that the
1. A discussion in laymen terms regarding the description of
patient’s chart will be the most reliable resource for ongoing
the surgical procedure to be performed
patient care and the best evidence that appropriate and timely
2. A discussion of the significant risks and benefits of the
care was provided. As the medical record is the primary
procedure to be performed
conduit for continuing care and communication among a
3. A discussion of the alternatives to the proposed surgical
patient’s care providers, it should include all pertinent clini-
procedure
cal information, including the physician’s assessment and
4. A discussion of the consequences of the procedure being
reaction to laboratory reports, radiology, and other studies.
declined by the patient
Surgeons often fail to include their rationale for clinical deci-
5. Documentation of the informed consent process and the
sions, including data to support the differential diagnosis;
actual consent, including a signed consent form, a note in
however, this information is critical. Physicians should be
the physician’s progress notes, in the patient’s clinic
sure to document a differential diagnosis when the facts
chart, and in the operative report
permit a reasonable inference that something other than the
It is important to be sensitive to false or unrealistic expec- primary diagnosis may be valid. It is far more difficult to
tations in the patient population and to dispel any miscon- allege that a surgeon failed to consider all of the options
ceptions about the procedures of anticipated outcome. It is when faced with clinically pertinent data if it is documented
reasonable to assume that any representation about obesity in the medical record, especially in an area of medicine
surgery made on a Web site, in promotional materials, or in where potential complications are many, are potentially
informational pamphlets or videotapes will be relied upon by lethal, and often occur quickly.
patients and their families. Surgeons should be wary of mak- Regardless of the procedure, the operative note should be
ing promises and predictions. dictated expeditiously—ideally on the same day—and
should include all findings and complications encountered
and the related management of those findings. Operative
Documentation notes dictated weeks or months after the procedure are a “red
flag” in litigation, particularly in situations where complica-
The most credible piece of evidence in litigation is medical tions were encountered by the surgical team. Despite the rou-
record documentation. Accordingly, the medical record must tine nature of some surgical procedures, the prudent surgeon
be complete, concise, accurate, legible, timely, and authen- should avoid using “boilerplate” language, rather endeavor-
tic. While this may seem a daunting task, physicians may be ing to personalize the operative note to the individual patient.
asked to interpret or rely upon a medical record several years Furthermore, all dictation should be reviewed, corrected, and
after the provided care and treatment to a patient. In the busy signed promptly and include the results of the sponge and
practice, particularly one in the academic milieu, it is of par- instrument counts. Likewise, postoperative orders should be
amount importance to maintain an accurate and comprehen- legible and signed by the operating surgeon, and follow-up
sive medical record. and discharge instructions should be signed by the patient or
Why document in the medical record? Is the documenta- his or her responsible party.
tion strictly used to defend the surgeon who finds himself In the bariatric clinic setting, it is important to document
embroiled in litigation? No. The medical record memorial- all preoperative patient encounters, referrals, and consulta-
izes care and treatment contemporaneously in an effort to tions. Preoperative screening should be comprehensive and
promote continuity of care, accurate communication among noted in the patient’s chart, as well as all relevant discussions
the care team members, and data for retrospective review with the patient and family and any consultants. All consulta-
and analysis and to defend surgeons who find themselves tion reports should be contained in the record, as well as pre-
embroiled in litigation. operative laboratory results, radiology, and other screening
Accurate and complete documentation may prove to be exams pertinent to the bariatric patient headed for surgery.
the most important tool in the management of the bariatric When documenting the informed consent process, include
patient. In this highly specialized practice of surgery, both the risks, benefits, and alternatives discussed, as well as
the pre- and postsurgical phases of treatment require effec- whether additional information was provided to the patient
tive communication among various disciplines (i.e., medi- and family (e.g., videotape, brochure, pamphlets, referral to
cine, surgery, nutrition, psychology, and occupational and support groups, or other forms of patient education). In most
physical therapy) and adequate data to provide comprehen- cases, the informed consent process for bariatric procedures
sive, timely, and safe treatment to this unique patient popu- is lengthy, is candid, and may be included in the patient
lation. In general, effective inpatient documentation screening mechanism. That being said, it should be well doc-
describes in an objective manner all noteworthy data umented to protect the care team from claims alleging inad-
regarding a patient’s presentation, history and physical, equate consent after a bad outcome.
55. Medicolegal Issues: The Pitfalls and Pratfalls of the Bariatric Surgery Practice 517
Postoperative follow-up is arguably the most important • Do not use phrases that imply a risk.
phase in caring for the bariatric patient. Accordingly, the sur- • Do not include incident reports, quality assurance infor-
geon or professional staff should document clearly all fol- mation, or documents involving the legal process in the
low-up instructions, appointments, referrals, prescriptions patient chart… ever.
and refills, and the plan of care going forward. As the medi-
While the patient chart is first and foremost a medical
cal record is used as a communication tool and for documen-
document, it is also a legal document. It is the best defense to
tation of continuing care, it is critical that all telephone
any claim of medical malpractice and should reflect the
communications are entered in the chart, as well as missed,
attention to detail required of the prudent bariatric surgeon.
canceled, and rescheduled appointments. Above all, docu-
ment and include all correspondence related to the physi-
cian’s decision to terminate the physician–patient relationship
or when the patient informs the physician that the physician’s
Confidentiality
services are no longer necessary.
Since the Clinton Administration, patient privacy and medical
Do’s of Effective Charting
record confidentiality have garnered much public and political
• Do use precise, concise, specific language. attention. Congress passed the Health Insurance Portability
• Do use objective, factual statements. and Accountability Act (HIPAA), historically known as the
• Do document a patient’s verbatim statements. Kassebaum-Kennedy Law, in 1996 [32]. Its primary purpose
• Do date and time each entry in the medical record. was to improve continuity and portability in the delivery of
• Do make sure the patient’s name appears on the page health care while preserving the privacy of certain sensitive
before writing. health information [32]. Furthermore, it seeks to “combat
• Do draw diagonal lines through all blank space after an waste, fraud and abuse in health insurance and health care
entry. delivery… [and] simplify the administration of health insur-
• Do document adverse reactions to medications or ance” [32]. In an effort to carry out these purposes in the age
therapy. of technology, HIPAA targets three areas of the healthcare
• Do “red flag” all allergies. industry: (1) insurance portability, (2) fraud enforcement,
• Do ensure that all procedure notes and chart entries are and (3) administrative simplification [33]. It is the adminis-
timely and accurate. trative simplification section of HIPAA that concentrates
• Do be sure to read a medical record entry before on patient privacy and that is of most interest to healthcare
cosigning. professionals and their staff [34].
• Do include time and specific action in all discharge The privacy regulations (Privacy Rule) of HIPAA are
instructions. designed to provide patients a process by which to maintain
• Do include all pertinent communications with residents, the confidential nature of certain protected health infor-
attending physicians, nursing staff, and consults. mation (PHI). The final Privacy Rule was published in
• Do include an addendum or late entry if necessary. December 2000, to be effective in April 2001 [35]. It applies
• Do include the words “addendum” or “late entry”; time to specific “covered” entities including health plans, health-
and date the note. care clearinghouses, and healthcare providers who transmit
health information in electronic form related to a transaction
Don’ts of Effective Charting
covered by the federal regulations [36]. The final modifica-
• Do not alter the medical record… ever. This is a criminal tions to the Privacy Rule were published in August 2002 [37],
act. and the previously specified entities were required to comply
• Do not obliterate errors or remove pages from the chart. with the Privacy Rule by April 14, 2003 [38].
• Do not use personal abbreviations, initials, or ditto marks. The Privacy Rule protects individually identifiable health
• Do not include derogatory or discriminatory remarks. information (the PHI) that is maintained or transmitted by a
• Do not document conflicts with other physicians or nurs- covered entity, whether oral or written [39]. Individually
ing staff. identifiable health information includes even the most basic
• Do not use subjective statements about prior treatment or demographic information collected from an individual
poor outcomes. patient [39]. It also includes any information created by or
• Do not include a late entry after an adverse event. received by a health plan, a patient’s employer, a healthcare
• Do not include non-patient care information. clearinghouse, or a healthcare provider that relates to past,
• Do not perpetuate incorrect information. present, or future physical or mental health condition of an
• Do not write any finger-pointing or self-serving statements. individual [39]. Further, the Privacy Rule relates to informa-
• Do not alter existing documentation or withhold portions tion regarding the past, present, or future payment for health
of the chart once a claim has been made or after the record care by the individual, if the information identifies the indi-
has been copied. vidual patient [39].
518 K.M. McCauley
The Privacy Rule does not prohibit disclosure of PHI; As one would expect, patients are granted rights to their
rather, it requires that the information be disclosed only in own PHI under HIPAA’s Privacy Rule. Specifically, patients
accordance with the provisions of HIPAA [40]. That is, when may request certain restrictions be placed on the disclosure
a covered entity discloses PHI or when it is requesting pro- of their PHI [45], the right to review and copy their PHI [46],
tected information from another covered entity, it must make the right to amend their PHI [47], the right to receive a copy
reasonable efforts to limit the transmission of protected of the HIPAA notice from the covered entity [48], and the
information to the minimum disclosure necessary to meet right to receive an accounting of disclosures of PHI [49].
the requirements of the request [40]. However, the Privacy It is important to note that any provision of the HIPAA
Rule requirement does not apply to the release of PHI in the Privacy Rule that is contrary to individual state law preempts
following scenarios: that provision of state law [50]. That being said, federal law
will not preempt state law if the state law is promulgated to
1. Requests from or disclosure to a healthcare provider for
prevent fraud and abuse related to payment for medical ser-
the purpose of medical treatment
vices; to ensure state regulation of the insurance industry and
2. Release of PHI to the patient himself
healthcare plans; to report on the delivery of health care and
3. Disclosure of PHI to the US Department of Health and
related costs; to serve a compelling need related to public
Human Services
health, safety, or welfare; or to regulate controlled substances
4. Disclosures or requests required by law
[51]. Furthermore, HIPAA will not preempt the state law if
5. Release of or request for information in accordance with
the state law is more restrictive than the federal statute [51].
the Privacy Rule [41]
It is extremely important for physicians to be aware of their
The Privacy Rule requires that a covered entity not dis- state’s confidentiality statutes that control when and how pri-
close or use PHI without an authorization, unless the dis- vate health information may be disclosed.
closure is contemplated by the regulations [42]. For an Under the American Recovery and Reinvestment Act of
authorization to be valid under HIPAA, it must include the 2009, the federal government included a set of provisions
following: titled the Health Information Technology for Economic and
Clinical Health Act (HITECH) that advance the use of tech-
1. A description of the information to be disclosed
nology in health care. The Act encourages physicians and
2. Identification of the persons or class of persons autho-
hospitals to purchase and incorporate electronic medical
rized to use or disclose the PHI
record systems (the Act calls them electronic health records
3. Identification of the persons or class of persons to whom
(EHR)) into their practice before the end of 2015. The goal
disclosure will be made
of the Act is to improve quality of care and to control esca-
4. A description of the purpose of the use of disclosure
lating costs associated with the delivery of health care in
5. An expiration date certain or precipitating event
the United States. In an effort to facilitate and ease the tran-
6. The individual’s signature and date
sition from paper-based medical records to EMR, the Act
7. A description of the authority of the signatory to act on
includes incentive payments to qualifying professionals
behalf of the individual, if signed by a personal represen-
and hospitals.
tative [43]
The Centers for Medicare & Medicaid Services (CMS)
The authorization for disclosure under HIPAA must also administers the Medicare and Medicaid EHR incentive pay-
include the following: ments to eligible physicians, hospitals, and critical access
hospitals [52] as they “adopt, implement, upgrade, or dem-
1. A statement that the individual may revoke authorization
onstrate meaningful use” of EMR technology. An estimate of
and instructions regarding how to do so.
$27 billion has been set aside to accomplish the Act’s goals
2. A statement that medical treatment, payment, enrollment
and specifically to assist in the implementation of the EMR,
in a plan, or eligibility for benefits may not be predicated
with roughly $17 billion going toward incentives. The incen-
on obtaining the authorization from the individual if such
tive payments are available to hospitals and physicians when
a condition is prohibited by the Privacy Rule. To the
they adopt certified EMR and the numbers are significant. In
degree it is not prohibited, the authorization must include
recent years—and in large part due to these incentives—
a statement about the consequences of not authorizing use
EMRs are being adopted, implemented, and used by hospi-
and/or disclosure.
tals and surgeons in increasing numbers. The process has not
3. A statement about the likelihood that the recipient will
been seamless for most and the transition has been, and will
disclose the PHI [43].
continue to be, fraught with complications and unintended
Patient authorization is not required for disclosure in accor- consequences. Nevertheless, the EMR is here to stay.
dance with public health activities; reporting victims of abuse, Along with the implementation of this technology in the
neglect, or domestic violence; health oversight activities; office, clinic, and hospital setting comes new requirements
judicial and administrative proceedings; or law enforcement for maintaining confidentiality. The HIPAA/HITECH Final
purposes (i.e., pursuant to court order or subpoena) [44]. Rule was published by the Department of Health and Human
55. Medicolegal Issues: The Pitfalls and Pratfalls of the Bariatric Surgery Practice 519
Services, Office for Civil Rights (OCR) on January 25, 2013 fees for complying with a request for PHI. This fee may
[53]. The effective date is March 26, 2013, and compliance is include actual labor costs for copying PHI in paper or elec-
required by September 23, 2013. The HITECH Act required tronic form, actual costs for technical staff to create and copy
that certain aspects of HIPAA be modified, including the electronic files, and costs for postage and supplies.
August 24, 2009, interim final rule on Breach Notification There is no requirement that a provider use portable devices
for Unsecured Protected Health Information; the October 7, brought by patients or other individuals (i.e., flash drives), as
2009, proposed rule modifying the HIPAA Privacy Rule as these pose a security risk. A provider may send PHI in an
required by the Genetic Information Nondiscrimination Act encrypted email; however, they must first advise the individual
(GINA); the October 30, 2009, interim final rule adopting that there is some level of risk associated with email and that
changes to the HIPAA Enforcement Rule; and the July 14, the PHI may be accessed and read by a third party [55].
2010, proposed modifications to the HIPAA Privacy, With continued attention to patient privacy, surgeons and
Security, and Enforcement Rules [54]. their professional staff have become increasingly more sen-
It is important to be aware that the new rules include (1) sitive to the requirements of HIPAA and the HITECH Act;
the redefinition of “business associate” under HIPAA; (2) the however, the principles behind the law have been part and
broader liability application to business associates and their parcel of good medicine for centuries. The concept of patient
agents and subcontractors; (3) changes to the breach stan- privacy is based on the principles of fidelity and confidential-
dards; (4) prohibitions regarding the sale of PHI without ity; two ideals articulated in the Oath of Hippocrates and the
authorization; (5) new rules related to fundraising, market- Prayer of Maimonides. Accordingly, the ethics of HIPAA
ing, immunization information to schools, and the disclosure and the requirements to keep private that information
of deceased patients’ PHI; (6) broader individual access to imparted to the surgeon for purposes of treatment shall
electronic PHI; and (7) penalties associated with violations remain tantamount to the prudent practice of medicine.
of these and other provisions of HIPAA. For purposes of this
chapter, we will only discuss the changes to patient access to
electronic PHI. Risk Management and Prevention
As with the original Privacy Rule, patients have the right
to access their own health information. Under the HITECH Physicians in modern American society cannot control
Act, Congress gave patients the right to electronic copies of whether or not they are sued; they can, however, control how
PHI in EHR; however, in the new rule, OCR expanded this they defend themselves. The best defense in litigation
right to include all electronic designated record sets (DRS). amounts to the best practices of the profession.
Accordingly, if an individual requests an electronic copy of
PHI that is maintained electronically in more than one DRS,
the provider must produce it in the electronic form and for- The Physician
mat requested, if it is readily reproducible. If it is not readily
reproducible in the requested form or format, it must be pro- While an excellent education is imperative to the practice of
duced in a readable electronic form and format as agreed surgery, experience is the keystone to a successful bariatric
upon by the parties. If the individual declines to accept any surgery practice. Because obesity surgery has been in the
format that is readily reproducible by the provider, then the media spotlight in recent years, dozens of surgeons have
provider may produce a hard copy. There is no requirement broadened their practices by adding weight-loss procedures.
that the provider scans paper copies. Finally, providers must By the surgical community’s own admission, the procedures
comply with individuals’ requests that their PHI be sent generate revenue and the practice area has proven to be
directly to another person if that request is in writing, is lucrative. It has also provided hope and recovery to a large
signed by the individual, and clearly identifies the designated portion of the population for whom other weight-loss
person to whom the PHI should be sent. programs have proven to be a miserable failure. It saves
The provider, at his or her discretion, may accept verbal lives. However, a fact that must not be ignored is that bariat-
requests for PHI or require written, signed authorizations. ric surgery is extraordinarily dangerous at the hand of the
You have 30 days to provide access to a patient’s PHI, and a inexperienced or under-experienced surgeon. Obesity sur-
30-day extension may apply in situations where a hard copy gery was not included in the general surgery residency train-
or electronic PHI must be retrieved from off-site storage or ing as a matter of course until recent years and is not widely
where other time constraints make the extension necessary. available even today. Accordingly, many surgeons learn the
Nonetheless, the provider must apprise the individual of any procedures in weekend classes and mini-fellowships. This
delay in making the PHI available if not within the 30-day training, while provided by the professional community’s
period and provide a date when the information may be rea- finest bariatric surgeons, is inadequate to arm the general
sonably expected. If not otherwise provided by state law, the practitioner with the skills and experience necessary to main-
final rule permits providers to charge reasonable cost-based tain a safe surgical weight-loss practice.
520 K.M. McCauley
Continued Assessment of Outcomes While bad outcomes are not always preventable, it has
been suggested that physicians who apologize for bad out-
It is recommended that the local facility review the surgeon’s comes are less likely to be the subject of a malpractice claim.
outcome data within 6 months of initiation of a new program Because anger is often the driving force in a lawsuit, contri-
and after the surgeon’s first 50 procedures (performed inde- tion and honesty have been shown to dispel anger long before
pendently) as well as at regular intervals thereafter, to con- litigation is ever contemplated [57]. Good communication
firm patient safety. In addition, the surgeon should continue between physician and patient has been linked to a decrease
to meet Global Credentialing Requirements for bariatric in physician shopping, noncompliance, and malpractice
surgery at the time of reappointment. Documentation of claims as well [58]. Not only have communication and hon-
continuing medical education related to bariatric surgery is esty been shown to positively impact the physician–patient
also strongly recommended. relationship, but the manner in which the information is
In addition to the ASMBS, the American College of Surgeons communicated may dictate the likelihood of a lawsuit result-
(ACS) and the Society of American Gastrointestinal and ing from a bad outcome [59].
Endoscopic Surgeons (SAGES) have crafted guidelines and
resources for credentialing bariatric surgeons. Further, the
Metabolic and Bariatric Accreditation and Quality The Facility
Improvement Program (MBSAQIP) is a national program
that maintains a data registry and provides guidance and With the unprecedented growth in obesity surgery programs
standards for quality improvement for bariatric surgery. It is nationwide, more and more hospitals are providing the surgi-
important for physicians to be aware of these recommenda- cal venue, but without the appropriate facilities and equip-
tions even if the hospital at which they seek privileges has ment for the bariatric patient population. The key to a
not adopted the ASMBS or other guidelines, as the recom- successful and safe surgical weight-loss program is strategic
mendations were crafted and endorsed by the leaders in bar- planning for this unique population, adequate spending to
iatric surgery. It is noteworthy that literature published in retrofit or build the appropriate facilities, and appropriate
2010 suggests that these credentialing initiatives for training staffing and staff education.
and practice are justified in light of improved clinical out- While bariatric procedures are elective, they are not cos-
comes for bariatric patients [56]. In the current litigation cli- metic surgery. Because bariatric patients are often very ill
mate where the experience of the operator increasingly has and require complex care, hospitals and staff must be pre-
been called into question, expertise may be the best defense pared and equipped to manage their preoperative, periopera-
to such allegations at trial. tive, and postoperative courses. Accordingly, facilities should
As discussed earlier in the chapter, the physician’s best be equipped with appropriately sized surgical instruments,
line of defense in litigation is documentation. The physician blood pressure cuffs, endotracheal and nasogastric tubes, and
should be concise, clear, and complete, as malpractice litiga- adequate imaging equipment including computed tomogra-
tion is often won or lost on the content and quality of the phy and magnetic resonance imaging. Further, surgical
medical record. The documentation the physician creates weight-loss patients require specialty beds, chairs, and inten-
today may be used years later in litigation; therefore, good sive care unit facilities.
record keeping should be an integral part of the bariatric sur- Outpatient facilities should include large examination
geon’s daily routine. Because meticulous medical records tables and enough chairs to accommodate patients and their
constitute the very best evidence at trial, this aspect of mal- families. It is important to be aware of the needs of this
practice litigation remains in the exclusive control of the patient population and to respect their unique perspective.
practitioner: Document, document, document… and docu- Every detail should be taken into consideration down to the
ment well. magazines available in the waiting room.
Patients and their families sue for a variety of reasons, In 2000, the American College of Surgeons published rec-
some that are within the control of the surgeon and some that ommendations for facilities caring for the morbidly obese
are not. The most important human relationship in bariatric [60]. These comprehensive guidelines provide facilities with
surgery exists between the patient and the surgeon, not recommendations for equipping and managing a safe and
between the surgeon and his or her attorney. Accordingly, appropriate venue for weight-loss surgery and for the even
surgeons should treat the physician–patient relationship with more important follow-up period.
as much care as they treat the actual patient. This interper- Staff education is as important as having the appropriate
sonal relationship is becoming more important in the increas- equipment. As the bariatric surgeon cannot be at the bedside
ingly more hostile healthcare environment. Patients who are 24 h a day, well-trained staff must be the eyes and ears of the
treated with compassion and respect are less likely to resolve surgical team. Precious time is lost when postoperative
their feelings or disagreements in court. Physicians must complications manifest if the condition is not diagnosed
give the patient their time and their undivided attention. and treated immediately. Accordingly, nursing staff must be
55. Medicolegal Issues: The Pitfalls and Pratfalls of the Bariatric Surgery Practice 521
attuned to the special needs of the bariatric population and the surgical professional from allegations involving poor
must be quick to recognize and react to pertinent clinical infor- planning, inadequate facilities, inappropriate equipment, and
mation. The best solution is to have a devoted bariatric service inadequately trained staff.
and floor of the facility. When such a solution is unavailable,
specialized training and education of hospital medical-surgi-
cal staff is the best defense to allegations of missed postopera- Conclusion
tive complications and negligent nursing care.
It is safe to expect that the bariatric surgical community will
continue to thrive as the demand for weight-loss surgery con-
The Program tinues. As we move toward the future of bariatric medicine,
it is important to recognize the risks of practicing in this
Bariatric surgeons treat the most complex patient population exciting and rewarding field. With education, conscientious
in the general surgery community—the morbidly obese. bariatric surgeons can avoid many of the legal pitfalls,
Bariatric surgical candidates often have multiple and varied despite the fact that it is impossible to insulate your practice
comorbidities, which make the care and treatment of these from lawsuits. Nevertheless, prudent practices, complete
special patients challenging. Patients who meet the criteria medical record documentation, appropriate informed con-
for weight-loss surgery present with myriad health problems, sent, and a healthy physician–patient relationship will pro-
including asthma and sleep apnea, gout, heart disease, stroke, vide the best defense for surgeons who find themselves
diabetes, gallbladder disease, hypertension, hypercholester- exposed to the litigation process.
olemia, osteoarthritis, and a higher incidence of cancer. As a
result, many of these patients have low reserves and a pro-
foundly compromised ability to recover from the many com- Review Questions and Answers
plications associated with surgical weight-loss procedures.
A comprehensive preoperative screening process, detailed
informed consent discussions, and an appropriate and a well- 1. What must the plaintiff prove in order to prevail in a med-
supported long-term follow-up program are of paramount ical malpractice lawsuit?
importance to the successful bariatric practice. A. Duty
The safest and most successful bariatric surgery programs B. Breach
are built on an interdisciplinary approach to health care. This C. Proximate causation/damages
interdisciplinary approach contemplates the special needs of D. All of the above
the morbidly obese and the health concerns with which they Answer: D
present. A successful program includes a comprehensive
introduction to weight-loss surgery, patient/family educa- 2. What organizations do not provide guidance for creden-
tion, and sensitivity to the patients served. tialing bariatric surgeons?
The program should include a thorough preoperative A. ASMBS
workup and a well-documented informed consent process B. ACS
based on the interdisciplinary approach. Morbidly obese C. SSAT
patients come with myriad diagnoses, which require attention D. SAGES
and management throughout the patient’s journey from sur- Answer: C
gery to follow-up. Therefore, preoperative and postoperative
care should include consultations with various subspecialties 3. Q: True or false: After an increase in litigation in the early
of internal medicine (including cardiology, endocrinology, 2000s, there was a decrease in frequency of filing medical
pulmonology, etc.), psychiatry, nutrition, and physical and malpractice lawsuits until 2012.
occupational therapy. The program should include a process Answer: True
for choosing the appropriate weight-loss procedure for the
individual patient, based on the patient’s diagnoses, risk fac-
tors, and other needs. This decision should be well docu-
mented, including the thought process employed by the References
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17. Aon Seventh Annual Hospital Professional Liability and Physician impossible to comport with both state and federal law or that the
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18. See Aon Hospital Professional Liability and Physician Professional Rule. 45 C.F.R. § 160.203 (2001).
Liability Benchmark Analysis 2007–2010. www.aon.com/hpl_ 51. 45 C.F.R. § 160.203(a) (2001).
study; Zurich 2010 Claims Benchmarking Perspective. 2010;16(3). 52. Critical access hospitals (CAH) are small facilities (25 beds or less)
www.zurichna.com/internet/zna/Site CollectionDocuments/en/ located in geographically remote areas that provide acute care ser-
Products/healthcare/HC_Perspectives_newsletter_Fall.pdf. vices to the community. To be designated as a CAH by CMS, a
19. Aon 2012 Hospital Professional Liability and Physician Liability hospital must be located in a rural area, provide 24-hour emergency
Benchmark Analysis. 2012. www.aon.com/hpl_study. services; have an average length of stay for its patients of 96 hours
20. Black’s Law Dictionary, citing Mathews v. Walker, 34 Ohio App.2d or less; be located more than 35 miles (or more than 15 miles in
128,296 N.E.ed 569, 571. areas with mountainous terrain) from the nearest hospital or be des-
21. Mohr JC. American medical malpractice litigation in historical per- ignated by its state as a “necessary provider.”
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Commentaries on the Laws of England, vol. 3. Oxford, England: 54. HIPAA Administrative Simplification Regulations are found at 45
Clarendon Press, 1768:122. C.F.R. Parts 160, 162, and 164. To learn about the Rulemaking
22. See, generally, Fiscina S et al. Medical liability. Eagan, MN: West History of the HIPAA Enforcement Rule, see 42 C.F.R. Part 160,
Group; 2004:209. West Publishing; 1991. subparts C, D, and E.
23. It is important to note that the law of torts is customarily controlled 55. 42 CFR §164.524.
by the individual states. Accordingly, medical negligence case law 56. Kohn GP, Galanko JA, Overby DW, Farrell TM. High case volumes
may vary from jurisdiction to jurisdiction, although it is based on and surgical fellowships are associated with improved outcomes for
the more general common law. bariatric surgery patients: a justification of current credentialing initia-
24. Pike v. Honsinger, 155 N.Y. 201, 49 N.E. 760 (1898). tives for practice and training. J Am Coll Surg. 2010;210(6):909–18.
25. Dallal R. Survey: long surgical career raises likelihood of lawsuit. 57. Zimmerman R. Doctors’ new tool to fight lawsuits: saying “I’m
Clinical Endocrinology News Digital Network 2012 Jul 12. sorry.” The Wall Street Journal 2004 May 18.
26. American Medical Association Policy Research Perspectives. 58. Levinson W, Roter DL, Mullooly JP, Dull VT, Frankel
Carol K. Kane, Medical Liability Claim Frequency: A 2007–2008 RM. Physician–patient communication: the relationship with mal-
Snapshot of Physicians. AMA Economic and Health Policy practice claims among primary care physicians and surgeons.
Research, 2010 Aug. JAMA. 1997;277:553–9.
27. Outcomes of medical malpractice litigation against US physicians. 59. Ambady N, LaPlante D, Nguyen T, Rosenthal R, Chaumeton N,
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28. van Heerden JA, Farley DR. Why do surgeons get sued? Common Surgery. 2002;132:5–9.
causes revealed. Contemp Surg. 2008;64(6):284–5. 60. Bariatric surgery: American College of Surgeons recommendations
29. Misreading Obesity Surgery Risk. www.rmf.harvard.edu. Accessed for facilities performing bariatric surgery. Bull Am Coll Surg.
7 Aug 2004. 2000;85(9).
Index
A Adjustments
Aarts, E.O., 168 band, 193, 200–201
Abdelbaki, T.N., 182 in-office adjustment algorithm, 203
Abdominoplasty NYU, 202
aesthetic lower abdominal scar, 501 radiographic criteria, 203–204
circumferential, 501, 505 Adolescent
extensive scars and abdominal hernias, 497–498 bariatric surgery practice guidelines, 403–405
optimal closure, 505 cardiovascular disease, 402
plastic surgeons, 497 glucose impairment
reverse, 503, 505 CDC, 402
Abou-Nukta, F., 377 life issues, 403
ABS. See American Board of Surgery (ABS) NAFLD, 403
Acceleromyography, 110–111 OSA, 403
Accreditation PCOS, 403
ACS, 127 type 2 diabetes, 402
MBSAQIP, 50 NHANES reports, 401
patient safety and quality improvement, 121–122 obesity
perioperative phase, 86 consequences, 402
ACSM. See American College of Sports Medicine (ACSM) risk factors, 401–402
Adams, T.D., 46, 89, 428, 450, 458, 460, 461, 471–481 outcomes, bariatric surgery, 405–406
Adiposity pediatric obesity, 401
adipokines, 456 Adverse outcomes, 49, 418, 421
adiponectin, 456 Afaneh, C., 137–141
“adiposopathy”, 456 Agarwal, R., 376, 378
angiotensinogen, 457 AGB. See Adjustable gastric band (AGB)
BMI, 456 Aguirre, V., 451
CAD, 456 Ahnfeldt, E., 417–421
cardiovascular outcomes, 456 Ahnfeldt, E.P., 75–80
Cochrane review, 508 Ahn, J., 474
CRP, 457 Airway equipment
CVD risk, 456 induction of anesthesia, 111
cysteine-rich protein, 457 physical examination, 109
endothelial dysfunction and transmigration, 456 and video laryngoscopes, 113
ghrelin induces weight gain, 457 Alaedeen, D., 385
GLP-1 receptors, 457 AlAwashez, A., 227–233
incretins, 457 Albanopoulos, K., 148
inflammatory markers, 457 Alcohol use disorders (AUD), 89
intra-abdominal, 477 Ali, M.R., 423–429
leptin, 457 Almogy, G., 151
liver, 457 Altieri, M., 433–438
myocardial structure and function, 459, 462 Amaral, J.F., 441
obesity and CVD, 457 American Board of Surgery (ABS), 50, 127
PYY and NPY release, 457 American College of Sports Medicine (ACSM), 285
RYGB patients, 458 American College of Surgeons (ACS)-BSCN, 127–128
TNF-α and IL-6, 457 American Society for Bariatric Surgery (ASBS), 43, 45
in vitro evidence, 457 American Society for Metabolic and Bariatric Surgery (ASMBS)
Adjustability, 206, 509 and ASBS, 43
Adjustable gastric band (AGB) ASMBS-SRC and BOLD, 128
endoscopic findings, postsurgical anatomy, 386 credentialing and training, 49–50
mortality, 424–425 nurse coordinator and bariatric, 54
outcomes, adolescents, 406 qualifications, behavioral health professional, 84
American Society for Metabolic and Bariatric Surgery Apollo Endosurgery, 343, 344, 346, 360
(ASMBS)-SRC, 128 Ardestani, A., 273
American Society of Anesthesiologist’s (ASA), 109, 110, 144, 347, 417 Aretxabala, X., 155
Anastomosis Armstrong, P.A., 152
anterior suture lines, 244 ASA. See American Society of Anesthesiologist’s (ASA)
early complications, 244–246 ASBS. See American Society for Bariatric Surgery (ASBS)
gastrojejunostomy, 244 Ashrafian, H., 479
late complications, 246 ASMBS. See American Society for Metabolic and Bariatric Surgery
long-term data, gastric bypass, 244 (ASMBS)
postoperative management, 244 Astrup, A., 30
and proximal staple lines, 244 Atherosclerosis, 256, 257, 463
Roux limb, 244 Atraumatic bowel clamps, 100, 101
Andraos, D., 180 AUD. See Alcohol use disorders (AUD)
Anemia Azagury, D.E., 121–125
copper, 327
folate, 326–327
iron, 326 B
vitamin B12, 326 Baker, R.S., 153
vitamin B1 (thiamine) deficiency, 327–328 Balanced hypocaloric diet, 15–16
zinc, 327 Band revision
Anesthesia incidence, 222
airway, 107 LAGB, 224
airway equipment, 111 long-term patient satisfaction, 219, 221
cardiovascular morbidity, 108 Barba, C.A., 372
communication, operating room personnel, 111–112 Barbosa, M.M., 462
endocrine comorbidities, 108 Bariatric. See Endoluminal bariatric procedures
and endotracheal intubation, 94 Bariatric costs
fluid status, 108 malpractice insurance, 57–58
induction, 138 program expenses, 58
intraoperative concerns and adaptations, 110–112 Bariatric credentialing, 49–50
monitoring, 110–111 Bariatric equipment
oxygenation, 107–108 caregivers, 62
PACU, 63, 115, 140 decreasing morbidity, 62
positioning, 111, 112 definition, 61
postoperative pain management, 108, 112–113 diagnostic testing, 62
preoperative evaluation, 108–110 efficiency of care, 62
renal function, 108 essential and optional recommendations, 62
vascular access, 110 information listing, 63, 64
ventilation, 107–108 investigation and planning, 62–63
Angrisani, L., 194, 271–274 large size and often-limited mobility, 61
Anterior prolapse, 211, 212 morbid and super morbid obesity, 61
Anthone, G., 303 periodic reevaluation, 72
Anti-obesity medications postoperative, 70–72
GLP-1 analogues, 29–31 preoperative, 63–70
late phase of development safety, 62
cetilistat, 32–33 “therapeutic patient environment”, 61
naltrexone-bupropion extended release, 31–32 Bariatric history and metabolic surgery. See Metabolic and bariatric
Anvil surgery
advantages, 237 Bariatric outcome longitudinal database (BOLD)
anastomosis, 237 and ASMBS-SRC, 128
complications, 235 MBSAQIP, 129
cricopharyngeus muscle, 235 standardized, 43
distal esophagus, 235 Bariatric program
EEA, 235–237 AUD, 89
endotracheal tube, 229 electronic resources, 57
gastrojejunal anastomosis, 227 MBSAQIP, 50
gastrotomy, 229 NSQIP, 49
laparoscopic/endoscopic, 239 patient education materials, 50
oral passage, 229 psychiatric interviews and objective psychological test, 76
orogastric tube, 230 support group meetings, 56
pharyngeal/esophageal injury, 232 Bariatric surgery
Roux limb, 236 adolescents, 401–407
transabdominal technique, 232 advantages and disadvantages, 140, 141
transgastric techniques, 235 anesthesiologist, 55
transoral and transgastric, 233 behavioral health (see Behavioral health)
transoral placement, 228 body mass index (BMI), 49
transoral technique, 232 bowel obstruction, 315
Index 525
Laparoscopic adjustable gastric band (LAGB), 436, 438 American Society for Metabolic and Bariatric Surgery, 184
adequate band adjustment, 224 anti-Trendelenburg position, 180
adhesion, 271, 272 BMI, 181
band adjustments, 200–201 calibration of gastric tube, 180
band revision vs. Roux-en-Y gastric bypass conversion, 273 complications, 182–183
band’s strength, 224 description, 179
bariatric surgery, 209, 219 EndoFLIP®, 180
cardioesophageal junction, 272 energy sources, 180
challenges, 209 EWL, 181
comorbidity and quality of life outcomes, 194–195 LSG, 179
complaints and symptoms, 204–206 mean HbA1c, 179
complications, 273 mean percentage, total and excess weight loss, 181–182
controversy, 219–221 methylene blue leak test, 180
cost-effectiveness outcomes, 195 mobilization, 180
counseling, 206 morbid obesity, 179, 181
diabetics, 223–224 neuroendocrine mechanisms, 179
esophageal motility disorders, 273 nonabsorbable suture, 180, 181
fibrous tissue, 272 operation, 180
follow-up, 221–222 restrictive procedure, 182
gastroenteroanastomosis and enteroenteroanastomosis, 273 revisional surgery, 184
gastroesophageal reflux symptoms, 273 serosa-to-serosa plication, 180
gastrogastric stitches, 271, 272 trocar placement, 180
harmonic scalpel, 272 and type 2 diabetes outcomes, 182
immediate postoperative management, 199 ULQ, 180
jejunotomy, 272 upper GI series, 180, 181
long-term mortality outcomes, 195 URQ, 180
and LRYGBP, 273, 274 volume reduction, 179
mechanism of action, 193 Laparoscopic malabsorptive procedures
nutritional evaluation, 206 duodenal switch (see Duodenal switch)
O’Brien review, 219 patient and team, 289, 290
office-based adjustment, 201–203 sleeve gastrectomy, 289, 290
outcomes, bariatric operations, 256 trocars, 289, 291
perigastric dissection, 196 Laparoscopic RYGB (LRYGB)
perioperative mortality (see Perioperative mortality) BMI categories, 257
physiological competence, 209 complications, 258
placement and postoperative management, 193 flexible endoscope, 102–103
postoperative dietary guidelines, 199–200 gastrojejunostomy anastomosis, 231, 233
proximal gastric enlargements (see Proximal gastric enlargements, ghrelin levels, 148
LAGB) GLP-1 and PYY3-36, 148–149
radiographically guided adjustment, 203–204 vs. IMT plus, 146
redo timing, 273 Kaiser Permanente system, 257
revisional surgery, 195–196 and LAGB, 45, 144, 145, 273, 274
revisions, 222–223 and LSG, 144, 145, 147
Roux limb, 272 MBSAQIP database, 257, 258
single incision band surgery, 189–190 minimally invasive surgery, 44
standard technique, 187–189 obesity-related medical diseases, 258
treatment, morbid obesity, 219 operative mortality and morbidity, 257
vertical banded gastroplasty, 273 OSA, patients, 255
weight loss outcomes, 193–194 outcomes, laparoscopic vs. open RYGB, 257
without gastro-gastric plication, 196 patient, 258
Laparoscopic approach, 209, 210, 259 postoperative nutritional complications, 258
Laparoscopic bariatric surgery quality of life, 256
equipment (see Equipment) radiological evaluation, 117
instrumentation, 99–101 vs. RYGB, 256–257
LGCP, 179–184 surgeons’ practices, 258
operating room (see Operating room) type II diabetes, 273
Laparoscopic gastric bypass See also Gastric bypass ultrasonic dissection, 102
circular vs. linear technique, gastrojejunostomy, 253 urinary and serum inflammatory markers, 256
gastrojejunal stenosis rate, 231 Laparoscopic sleeve gastrectomy (LSG)
incidence, 253 comorbidity (see Comorbidity)
stricture rate, 231 complications (see Complications)
weight loss, 253 crohn’s disease, 143
Laparoscopic greater curvature gastric plication (LGCP) durability, 144–146
adjuvant of AGB, 183 effectiveness, 175–176
advantages, 179, 184 failed bariatric surgeries, 173
AGP, 179 failed GB, 173, 176–177
Index 535
Obstruction Outcomes
fluoroscopy, 204 adolescents, bariatric surgery
post-LSG, 165 AGB, 406
proximal/distal leaks, 157 RYGB, 406
small bowel VSG, 406
functional, 205 bariatric and metabolic surgery, 299
mechanical, 204–205 biliopancreatic limb, 306
and strictures, 162–164 BOLD, 128, 129
Obstructive sleep apnea (OSA), 255, 257 cardiovascular, 32
cardiovascular disease, 420 distal gastric bypass, 299
case study, 420 Duodenal switch, 303–304
clinical features, 486 elderly bariatric surgery
CPAP therapy, 108, 109 ACS NSQIP database, 414
description, 485 2006 CMS National Coverage Determination (NCD), 414
diagnosis, 486 emergency surgery, 413
effects, 487–488 mortality, 413–414
epidemiology and pathophysiology, 485–486 National databases, 414
glucose impairment, adolescent, 403 nonbariatric laparoscopic procedures, 414
independent risk factor, 107 gastric bypass, 301
life style risk factors, 421 ghrelin, 305
medical history, 109 health, 84
multidisciplinary approach, 488 internal database, 129
and neck circumference, 107 jejunoileal bypass, 299
obese patients, 107 JIB and bariatric procedures, 301–302
and obesity hypoventilation syndrome, 107 LAGB (see Laparoscopic adjustable gastric band (LAGB))
patients, 485 long-term high-quality patient outcomes, 54
postoperative care, 486–487 LSG (see Laparoscopic sleeve gastrectomy (LSG))
postoperative management, 112 MBSC, 129
practice advisory for preanesthesia evaluation, 109 medical and emotional health, 299
prior upper abdominal surgery, 420–421 nutritional deficiency, 301
psychiatric disorders, 421 obesity, 299
revisional surgery, 421 patient instructions, 305
risk assessment, 420 perioperative, 86
sleep studies, 109 postoperative, 86
treatment, 486 Roux limb, 299, 301
Office equipment, 51 RYGB, 304–305
Olasky, J., 235–237 Scopinaro procedure, 302–303
O’Leary, J.P., 45 SCOUT, 26
Operating room short bowel syndrome, 299–300
communication, 111–112 short-term postsurgical, 86
layout, 52, 103 sleeve gastrectomy, 305
organization, 52 suicide, 4
patient positioning volume, 123
anesthesia and endotracheal intubation, 94 weight loss, 87, 88, 306
heating blankets, 94 Overby, D.W., 375
lateral transfer devices, 93, 94 Ovrebo, K.K., 436
morbidly obese, 93
prepping and draping, 94
rhabdomyolysis, 94 P
sequential compression device, 94 PACU. See Post-anesthesia care unit (PACU)
stationary retractor-holding device, 94 PAI-1. See Plasminogen activator inhibitor-1 (PAI-1)
supine position, 93 Pain management
Trendelenburg, 93–94 postoperative, anesthesia, 108, 113
working field, 94–95 postoperative pathways, 116–117
staff, 111 Pandemic
Operating tables, 93, 94, 98–99, 103, 111, 180 Pandolfino, J.E., 434
Orlistat (Xenical®), 25–26 Papalazarou, A., 286
OSA. See Obstructive sleep apnea (OSA) Parikh, M., 147, 223
Östlund, M.P., 478, 479 Parsimonious models, 124
Outcome measurement Pasini, D., 115–119
patient safety and quality improvement Pata, G., 428
composite measures, 124 Pathophysiology, obesity comorbidity, 7–11
mortality, 124 Patient-controlled analgesia (PCA), 112, 113, 140
quality improvement, 124–125 Patient safety and quality improvement
risk adjustment, 124 information, 121
volume, 123 outcomes, 124–125
Index 539
Post-operative phase (cont.) IVC filters (see inferior vena cava (IVC) filters)
weight loss outcomes, 88 patient population, 372
weight regain, 88 pharmacologic anticoagulation agents, 372
PRA. See Plasma renin activity (PRA) SCDs, 372
Practice guidelines, adolescent bariatric surgery, 403–405 systematic reviews, 376–378
Prathanvanich, P., 151–169 thrombotic complications, 372
Praveen Raj, P., 367 Protein malnutrition
Pregnancy albumin and prealbumin, 324
after bariatric surgery, 508 bariatric surgery, 324
after LAGB, 509 liver failure, 325
biliopancreatic diversion, 509 Proteins
gastric bypass, 508–509 and energy deficiency
nutritional issues, 509–510 albumin and prealbumin, 324
PCOS and morbid obesity, 507–508 biliopancreatic limb, 325
postoperative bariatric patients, 510 carbohydrates, 325
urinary stress incontinence and obesity, 510 gastric restriction, 324
Preoperative assessment, 75, 79, 89 hypoalbuminemia/anemia, 324
Preoperative, bariatric equipment hypoproteinemia, 325
abdominal CT scans, 69 protein-calorie malnutrition, 324
blood pressure monitoring, 67–68 “sleeve” gastrectomy, 324
cardiac risk stratification, 68–70 steatosis and nonalcoholic steatohepatitis, 325
chairs, 66–67 stomach and anastomosis, 325
commodes, 67 GBP
examination tables, 68 clear liquids, 279
MRI, 69–70 Dietary Reference Intake, 279
scales and height-measuring devices, 67, 68 fat/carbohydrate, 278
Siemens Luminos Agile Fluoroscopy System, 69 high-quality protein sources, 278
SOMATOM Sensation Open scan, 69 IAA and BCAA, 280
standard radiographic studies, 68 liquid protein supplements, 279
transportation equipment, 63–66 Proximal gastric enlargements, LAGB
ultrasonography, 68–69 access port/tubing problems, 215–216
x-rays, 68–70 classification
Preoperative evaluation anterior slip, 212
anesthesia focal, 213
ASA, 109 posterior slip, 212
CPAP, OSA, 109 symmetrical, 212–213
laboratory data and studies, 109–110 clinical presentation, 215
medical history, 109 diagnosis, 213, 215
patients scheduled, 108–109 erosions, 214
physical examination, 109 etiology, 211, 215
cardiopulmonary, 417 incidence, 214–215
CCBRS, 76–77 management, 215
description, 76 physiology and pathophysiology, 211–212
domains, 76–77 prevention, 214
eating behaviors and habits, 76 treatment
esophagogastroduodenoscopy (EGD), 77 nonsurgical, 213
morbid obesity, 76 surgical, 213–214
patient safety and quality improvement, 122 Pryor, A., 433–438
population studies, 76 Prystowsky, J.B., 377
UGI, 77 Pseudotumor cerebri, 7–11
Preoperative protocol Psychosocial
Cleveland Clinic Bariatric and Metabolic Institute (BMI), 77 behavioral health, 83–84
consultation with bariatric surgeon, 78 body image, 90
CPAP device, 78–79 development of eating pathology, 90
epidemiology and prevention, 78 eating disorders, 90
follow-up schedule, 79, 80 elements, evaluation
nutritional sessions, 79 assessment, 85
pathway assignment, 78 description, 85
poor functional capacity, 78 diagnostic interview, 85
specialized psychology groups, 79 drugs, 85
standard investigations, 78 DSM-5 diagnosis, 86
treatment, 78 eating and weight history, 85
ultrasonography, 78 medications, 85
Printen, K.J., 42, 413 patient’s adjustment and success, 85
Prophylaxis and sedentary activity, 86
chemoprophylaxis (see Chemoprophylaxis) perioperative stage, 86
inferior vena cava (IVC) filters, 372 postoperative phase, 86–88
Index 541
Technique. See also Duodenal switch Upper gastrointestinal (UGI), 62, 77, 79, 117, 164, 166
adjunctive airway, 138 Upper left quadrant (ULQ), 180
pneumoperitoneum, 138 Upper right quadrant (URQ), 180
TERIS. See Trans-oral endoscopic restrictive implant system (TERIS) Urinary bladder pressures (UBPs), 7, 9–11
Thompson, C.C., 353–361 Urinary incontinence, 7, 9–11
Tice, J.A., 451 Urinary stress incontinence, 510
Tinoco, A., 366 Ursodiol, 442, 443, 492
TLESR. See Transient lower esophageal sphincter relaxation (TLESR)
TOGA system. See TransOral GAstroplasty (TOGA) system
Toh, S.Y., 258 V
Tolonen, P., 436 Vagal blockade, 337, 340
Topart, P., 428 Vagal nerve
TORe. See Transoral outlet reduction (TORe) gastroesophageal junction, 340
Torquati, A., 459, 460 weight loss, 340
Total body lift surgery, 497, 499, 501, 504 Varela, J.E., 436, 437
Transfer devices, 93, 94 Vasu, T.S., 420
Transgastric circular stapler technique Vaziri, K., 375
anastomotic strictures, 237 VBG. See Vertical banded gastroplasty (VBG)
anvil (see Anvil) Venous stasis disease, 7, 9, 10
EEA (see End-to-end anastomosis (EEA)) Venous thromboembolic (VTE) disease
Endo GIA Ultra Universal Stapler, 236 Antithrombotic Therapy and Prevention of Thrombosis, 376
gastric division, 236 bleeding complication, 376
gastrojejunostomy, 235 blood flow and vascular endothelial injury, 371
gastrotomy, 236 description, 371
intended gastric pouch, 235 diagnosis
laparoscopic Roux-en-Y gastric bypass, 235 anticoagulation, 380
pouch and the intragastric balloon, 236 compression ultrasonography, 379
Roux limb, 236 CTPA, 379–380
surgeons use, 235, 237 hypotension, 379
transgastric techniques, 235 hypoxia, 380
upper gastrointestinal, 237 indications, 380
Transgastric endoscopy, 393–394 popliteal artery and vein, 379
Transient lower esophageal sphincter relaxation (TLESR), 433, 434 signs and symptoms, 379
Transoral circular. See Gastrojejunostomy technique treatment, 380
Trans-oral endoscopic restrictive implant system (TERIS), 354, 355 evidence-based guidelines, 376
TransOral GAstroplasty (TOGA) system, 354, 355 femoral veins, 371
Transoral outlet reduction (TORe), 359, 360 fibrinogen, 371
Transportation equipment fibrinolysis and hemostasis, 371
stretchers, 64–66 intrinsic risk obesity, 371
temporary transfer PAI-1, 371
HoverJack™ Air Patient Lift, 64, 65 prophylaxis, 115–117 (see also Prophylaxis)
HoverMatt™ Air Transfer System, 64, 65 risk factor, 371
safely, 63 thrombotic complications, 371–372
transfer-flat, 64, 65 Ventral hernia repair, 492–494
wheelchairs, 64, 65 Veress needle approach, 95
Tremblay, L.J, 239 Vertical banded gastroplasty (VBG), 41, 42, 44, 173, 176
Trendelenberg, 70, 93, 99, 111, 117, 138, 187, 227, 272, 293, 295, 371 complications, 273
Tretbar, L.L., 179 endoscopic findings, postsurgical anatomy, 386
Trigilio-Black, C.M., 375, 378 esophageal bougie, 271
Trocars fibrosis and scarring, 271
description, 95 gastrojejunostomy, 272
5-mm optical viewing, 96 lesser curve neurovascular bundle, 271
100-mm shafts, 96 LRYGBP, 273
site closure, suturing devices, 101 redo surgery, 273
spinal needle, 96 stomach, 272
Tsang, A., 183 Vertical sleeve gastrectomy, 305, 406, 425, 428
Tubing damage, 215–216 Very-low-calorie diets (VLCD), 17
Tur, J., 15–34 Vest, A.R., 455–465
Type 2 diabetes mellitus (T2DM), 7, 19, 20, 27, 29, 31, 32, 108, Vidal, J., 147
146–147, 182, 364, 367, 447, 449–451, 451, 457 Video monitor, 98, 99
Vilsboll, T., 31
Visualization
U copious adipose tissue, 97
UBPs. See Urinary bladder pressures (UBPs) laparoscope, 97, 98
Uglioni, B., 176 light source and cable, 98
Ulcer prophylaxis, 123 operating tables, 98–99
Umscheid, C.A., 378 safely and effective performance, 96–97
544 Index