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(Download PDF) Difficult Decisions in Bariatric Surgery John Alverdy Online Ebook All Chapter PDF
(Download PDF) Difficult Decisions in Bariatric Surgery John Alverdy Online Ebook All Chapter PDF
John Alverdy
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Difficult Decisions in Surgery:
An Evidence-Based Approach
John Alverdy
Yalini Vigneswaran Editors
Difficult
Decisions
in Bariatric
Surgery
Difficult Decisions in Surgery:
An Evidence-Based Approach
Series Editor
Mark K. Ferguson
Department of Surgery
University of Chicago
Chicago, IL, USA
The complexity of decision making in any kind of surgery is growing exponentially.
As new technology is introduced, physicians from nonsurgical specialties offer
alternative and competing therapies for what was once the exclusive province of the
surgeon. In addition, there is increasing knowledge regarding the efficacy of
traditional surgical therapies. How to select among these varied and complex
approaches is becoming increasingly difficult. These multi-authored books will
contain brief chapters, each of which will be devoted to one or two specific questions
or decisions that are difficult or controversial. They are intended as current and
timely reference sources for practicing surgeons, surgeons in training, and educators
that describe the recommended ideal approach, rather than customary care, in
selected clinical situations.
Difficult Decisions
in Bariatric Surgery
Editors
John Alverdy Yalini Vigneswaran
Department of Surgery Department of Surgery
University of Chicago University of Chicago
Chicago, IL Chicago, IL
USA USA
This Springer imprint is published by the registered company Springer Nature Switzerland AG
The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Contents
v
vi Contents
Part VI Complications
24 Stenting for Leaks After Sleeve Gastrectomy������������������������������������������ 257
Betty Li and Uzma D. Siddiqui
25 Reoperation for Repair of Anastomotic Leaks and Staple Line
Disruptions������������������������������������������������������������������������������������������������� 273
Andres Felipe Sanchez, Emanuele Lo Menzo, Samuel Szomstein,
and Raul J. Rosenthal
26 Gastric Sleeve Stricture, Twist or Kink, Now What? ���������������������������� 287
Laurel L. Tangalakis and Jonathan A. Myers
27 Hiatal Hernia Complicating Bariatric Surgery�������������������������������������� 295
Priya Rajdev, Phylicia Dupree, and Farah Husain
28 Management of GERD in Duodenal Switch�������������������������������������������� 307
Michelle Campbell and Mustafa Hussain
For a patient to make the difficult decision to undergo bariatric surgery, they need to
be fully convinced of the following: (1) that they will not, and cannot lose the weight
needed to become healthy unless they undergo bariatric surgery (2) that their health
is in jeopardy specifically due to their present weight and the co-morbidities that
exist because of it and (3) that they trust that the surgery is safe because their sur-
geon is experienced and works in a high performance environment. For a surgeon to
embark on the practice of bariatric surgery, he or she needs to be committed to the
following: (1) to be willing, above all, to properly evaluate and offer the right opera-
tion to a given candidate patient (2) to be himself/herself convinced that the patient’s
health is in jeopardy and that the surgery proposed is indicated and safe (3) to be
confident that their skills, judgment and team are of the highest standard and that
their environment is properly equipped to offer state-of-the art bariatric care for the
patient both in the short and long term process of care. Finally, for an insurance
company to offer and support the finances of bariatric surgery, they need to: (1)
ensure their customers do not fall prey to unscrupulous practices (2) make sure that
the patients are not making rushed decisions to undergo bariatric surgery (3) that
resources within their insurance pool are sufficient to support the entire process of
bariatric surgery.
Yet if a patient, a surgeon and an insurance agent were to walk into a bar and tell
their individual stories over drinks, the discussion could become heated and con-
frontational. Much angst develops when each participant has to constantly reconcile
the wishes of the patient with the judgement of the surgeon and the prerequisites
and approval criteria of the insurance company. For many bariatric practices, this
reconciliation dance is riddled with unreasonable demands by the insurance com-
pany, capitulation of the surgeon’s recommendations for one operation versus the
J. Alverdy (*)
Department of Surgery, University of Chicago, Chicago, IL, USA
e-mail: jalverdy@surgery.bsd.uchicago.edu
Surgeons daily make difficult decisions. These decisions can range from how to
counsel an individual patient to how to weigh in on national policy changes.
Additionally, these decisions involve multiple stakeholders—patients, families,
members of the medical team, policymakers, payors, and communities. Our role as
surgeons in these deliberations often requires us to synthesize information that can
be complex and incomplete. Bariatric surgery in particular has the added challenge
of technology that is constantly evolving. The questions we have to answer have
serious implications for patients. Does laparoscopic sleeve gastrectomy or Roux-
en-Y gastric bypass offer better safety, healthcare utilization, or clinical outcomes?
Do buttressed staple loads prevent bleeding more that staple loads without rein-
forcement? When is pregnancy safe for mothers and babies after bariatric surgery?
When is too young or too old for bariatric surgery?
For us to answer these questions rigorously requires an understanding of
evidence-based medicine approaches. This chapter will examine evidence-based
medicine in the context of bariatric surgery. The rest of this book will explore a
number of important and emerging questions in our field. The authors have put
together the best supporting evidence available and made recommendations using
principles of evidence-based medicine.
G. F. Chao (*)
National Clinician Scholars Program, Veterans Affairs, Ann Arbor, MI, USA
Department of Surgery, Yale School of Medicine, New Haven, CT, USA
e-mail: grace.f.chao@yale.edu
J. B. Dimick
Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, USA
Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, USA
Rigorously evaluating evidence can mean the difference between helping patients
and harming them, as the cautionary tale of laparoscopic gastric banding has taught
us. The medical field has seen medical reversals throughout history because of stud-
ies with design weaknesses recognized after practice patterns had changed—hor-
mone replacement therapy in post-menopausal women, tight glycemic control in
the ICU, and routine PSA screening. In bariatric surgery, we have recently seen this
in laparoscopic gastric banding.
Banding held great theoretical promise to help patients improve their health.
As the most minimally invasive, restrictive procedure at the time, it was thought
to be a safe option for bariatric surgery. However, studies published varied
widely in their outcomes. Studies reported rates of reoperation ranging any-
where from 4% up to 60% [1–8]. These studies lacked adequate sample size,
long-term follow-up, or geographic representation to be able to give a true pop-
ulation estimate.
In order to address this uncertainty over outcomes, researchers used Medicare
administrative data with a sample size of 25,042, an average follow-up time of
4.5 years, and national scope [9]. This study revealed high reoperation rates due
to failure of weight loss and complications. On average, patients had 3.8 proce-
dures in addition to their index operation. Hospital referral regions had reopera-
tion rates ranging from 5.1% to 95.5%. Additionally, from 2006 to 2013, the
proportion of annual spending on the gastric band device due to reoperations rose
from 16.4% to 77.3%. Five years prior to this study, the FDA had concluded the
existing evidence supported safety and effectiveness of gastric banding [1]. Of
note, at that time, the FDA relied heavily on a single-group trial of 149 patients to
reach its conclusion. A chapter of this text will delve more into the story of the
Lap-Band. However, what we can see for now is that a lack of robust evidence led
to many more devices being placed that not only were ineffective, but also exposed
patients to the risks of multiple operations and complications, took away valuable
time spent on more effective therapy, and increased financial burden on the sys-
tem. And it was evidence-based medicine that was crucial in eventually identify-
ing these issues.
The goal of research is to produce evidence that accurately describes causal rela-
tionships or true phenomena. Evidence-based medicine is the approach to deter-
mine how well a study accomplishes this goal. We will next delve into the
components that strengthen and weaken the ability of studies to do this. In order to
appropriately appraise the evidence available, we must clearly define our question,
look for appropriate evidence available, and then critically evaluate this evidence.
We will first discuss three key threats to validity that we must always consider in
evaluation. We will also introduce Levels of Evidence and the GRADE system.
Authors will use the GRADE system throughout this textbook as a strategy for
evaluating evidence and subsequent recommendations.
2 Evidence-Based Medicine and Decision Making 7
The PICO format defines our search question (Table 2.1). For “Patients,” we iden-
tify the disease and characteristics of interest. The “Intervention” can be in the form
of a procedure or medication. We compare the intervention’s outcomes to those of
specific “Comparators.” Comparators can be no intervention, usual care, or another
treatment. Lastly, examples of “Outcomes” of interest are mortality, complication
rate, time to event, and costs.
Looking within the bounds of the study, internal validity is how well the results of a
study represent the truth in the study sample. For the remainder of this chapter, we will
refer to internal validity as “validity.” The three major threats to validity are chance,
bias, and confounding. Robust study designs should account for each of these threats.
2.3.3 Chance
This first threat to validity is when findings are due to random error. Chance can
distort results in either direction; it can increase the estimated effect or decrease the
2.3.4 Bias
Bias occurs due to systematic error. Two major sources of error are sample selection
bias and systematic measurement error. The major source of sample selection bias
in bariatric surgery is in the operation chosen. A patient who undergoes laparo-
scopic sleeve gastrectomy and a patient who gets a gastric bypass may differ.
Patients who undergo gastric bypass may have a higher burden of diabetes than
those who elect to have or who are counseled towards sleeve gastrectomy. Another
important source of sample selection bias is loss to follow-up. This may happen
when examining outcomes in claims data due to patients changing insurance plans.
Systematic errors are sources of incorrect measurement that distort study findings in
one direction. Systematic measurement error may occur if a study asks diabetic
patients after surgery how many days per week they had well-controlled glucose
levels. Patients with good post-operative glycemic control may systematically
report more days than patients with poor control because they of higher compliance
of checking glucose levels. This specific form of systematic bias is recall bias.
2.3.5 Confounding
Finally, confounding is when other variables are associated with both the exposure
and outcome. These confounding variables, rather than the one studied, are what
truly drive the results. For example, a comparative effectiveness study may show
there is a higher risk of myocardial infarction after sleeve gastrectomy compared to
gastric bypass. However, this would be an erroneous finding if there was no adjust-
ment in the analysis for significant cardiac history. Surgeons may have counseled
patients with a higher risk for myocardial infarction to undergo sleeve gastrectomy
rather than gastric bypass. Thus, the findings are confounded by a history of severe
cardiac disease.
2 Evidence-Based Medicine and Decision Making 9
Building upon the major threats to validity and Levels of Evidence, the GRADE
system provides further principles for evaluation of evidence and in many ways is a
more extensive list of threats to validity. The GRADE system is a commonly used
framework to evaluate data within systematic reviews and meta-analyses. Beyond
systematic reviews, it provides principles valuable in broadly evaluating studies and
the conclusions drawn from them.
Systematic reviews first pose a specific clinical question with the PICO guide-
lines. Researchers next identify studies that answer this question. They then pool
data from these studies to generate a best estimate of the effect on the outcome of
interest. A scoring system lastly classifies recommendations from systematic
reviews into four categories as detailed in Table 2.3—High Quality, Moderate
Quality, Low Quality, or Very Low Quality.
Initially, randomized control trials begin with a “High Quality” rating and obser-
vational studies with a “Low Quality” rating. As noted earlier, the authors believe
that observational studies can be even more rigorous than randomized trials depend-
ing on features of study design. However, for purposes of the GRADE system, we
22 K. Lak and J. Gould
The treatment of hypertension can become more complex in the setting of not only
obesity but also diabetes. The Look AHEAD trial evaluated patients with type II
diabetes and assessed cardiovascular outcomes based on the amount of weight loss
achieved by lifestyle interventions [17]. Patients who achieved a 10% total body
weight loss were found to have a 20% lower risk of composite death from cardio-
vascular causes. Likewise, Sjöström et al. demonstrated an overall mortality benefit
in the Swedish Obese Subjects study of obese patients who underwent bariatric
surgery compared to those receiving conventional medical treatment at an average
of 10 years follow-up [18]. In this study, the most common causes of death were
myocardial infarction and cancer. The mortality benefit described in this study was
achieved in patients matched for diabetes. At 10-year follow-up patients in the sur-
gical group achieved a significantly greater weight loss than those in the conven-
tional medical treatment group.
The STAMPEDE trial, a RCT which aimed to describe the effects of bariatric
surgery on the glycemic control and cardiovascular risk factors in diabetic patients
also demonstrated a decrease in medications needed to control hypertension [16].
At 5-year follow-up in the surgical group there was a 40.8% decrease in the number
of patients who needed ≥3 medications for hypertension control compared to a
13.1% decrease in the intensive medical therapy group. Mingrone et al. also aimed
to determine the effects of bariatric surgery on glycemic control in diabetic patients
[19]. In their study the rates of hypertension improvement or resolution were sig-
nificantly increased in the RYGB or BPD groups compared to the intensive medical
management group.
The long-term impact on cardiovascular morbidity and mortality after bariatric
surgery has yet to be studied in a multi-center controlled trial; however, several
systematic reviews have collected data which describes the impact on cardiovascu-
lar risk factors such as hypertension, diabetes mellitus, hyperlipidemia, and novel
markers such as CRP, albuminuria or proinflammatory markers. In the systematic
review by Heneghan et al. a 40% relative risk reduction of 10-year coronary artery
heart disease risk based on the Framingham risk score was demonstrated [20].
Across 52 studies, an average 68% resolution rate of hypertension was found. This
was in addition to 75% reduction or resolution of diabetes mellitus and 71% rate of
resolution or reduction in dyslipidemia. The Framingham heart study found that
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