Dual Intragastric Balloon: Single

Ambulatory Center Spanish Experience

with 60 Patients in Endoscopic Weight Loss
Management

G. Lopez-Nava, I. Bautista-Castaño,
A. Jimenez-Baños & J. P. Fernandez-
Corbelle

Obesity Surgery
The Journal of Metabolic Surgery and
Allied Care

ISSN 0960-8923

OBES SURG
DOI 10.1007/s11695-015-1715-6

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 Author's personal copy
OBES SURG
DOI 10.1007/s11695-015-1715-6
ORIGINAL CONTRIBUTIONS
Dual Intragastric Balloon: Single Ambulatory Center Spanish
Experience with 60 Patients in Endoscopic Weight Loss
Management
G. Lopez-Nava 1 & I. Bautista-Castaño 1 & A. Jimenez-Baños 1 & J. P. Fernandez-Corbelle 1
# Springer Science+Business Media New York 2015
Abstract
Background Many obese patients fail conventional medical
management and decline bariatric surgery. Less invasive
weight loss options such as intragastric balloons may provide
an opportunity to reach this large number of untreated pa-
tients. The aim of this study was to investigate the safety
and effectiveness of the Dual Intragastric Balloon (DIGB) in
the treatment of obese patients, as well as the impact of degree
of obesity, age, and gender.
Methods The study was conducted at the Bariatric Endoscopy
Unit of the Madrid Sanchinarro University Hospital. Sixty
patients (11 men, 49 women) underwent endoscopic place-
ment of a DIGB filled with a total of 900 cc of saline
(450 cc in each balloon) for at least 6 months, along with
regular counseling from a multidisciplinary team. Study out-
comes included: change in body weight (TBWL), % of loss of
initial body weight (%TBWL), % of excess body weight loss
(%EWL), and adverse events.
Results Initial BMI 38.8 kg/m2 decreased 6.1 units, with
mean TBWL, %TBWL, and %EWL of 16.6 kg, 15.4 %,
and 47.1 %, respectively. We found no difference in %TBWL
between grade of obesity, age or sex, but morbidly obese
patients demonstrated greater TBWL, and women and less
obese subjects obtained higher %EWL. The DIGB was gen-
erally well tolerated, with one early removal for patient intol-
erance, one early deflation without migration, and one gastric
perforation. Fourteen patients had small, clinically insignifi-
cant ulcers or erosions noted at the time of removal.
* G. Lopez-Nava
gontrandlopeznava@gmail.com
1
Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital,
C/Oña n° 10, 28050 Madrid, Spain
Conclusions The present study shows that the DIGB was easy
to use, resulted in significant weight loss, safe, and well
tolerated.
Keywords Dual intragastric balloon . Bariatric endoscopy .
Obesity treatment
Introduction
It is well known that obesity has adverse health consequences
with multiple metabolic, structural, degenerative, neoplastic,
and psychological effects. These effects reduce quality of life
and increase morbidity and mortality. Given the epidemic of
obesity worldwide, treatment of obesity has emerged as a
significant unmet medical need [1].
The rate of successful treatment for obesity remains low
[2]. Many obese cannot lose sufficient weight to improve
health with conventional medical management which includes
diet, physical activity, and behavioral modifications. In this
population, failure is primarily due to a high rate of drop-
outs and weight gain post diet [3]. Although drugs for obesity
treatment provide additional options for weight management,
no obesity medication has been shown to reduce cardiovascu-
lar morbidity or mortality [4].
Bariatric surgery does provide substantial and sustained
effects on weight loss and ameliorates obesity-attributable co-
morbidities, although risks of complication, reoperation, and
death exist. Meeting appropriate indications for bariatric sur-
gery as well as cost currently limit its application as a viable
treatment option. In fact, only a small percentage of morbidly
obese patients actually undergo the surgery [5].
For these reasons, less invasive weight loss procedures are
appealing and provide an opportunity to reach a greater
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number of patients who currently have no viable treatment

alternative.
Intragastric balloons (IGB) are designed to fill the space
within the stomach and induce satiety, and have been used
successfully for over 15 years. Recently, Ponce et al. [6] re-
ported the first results in 30 obese patients randomized to the
endoscopic placement of a dual intragastric balloon (DIGB) as
an adjunct to diet and exercise (n=21) or to a control group
(n=9) with diet and exercise alone [6]. After 24 weeks, the
DIGB group demonstrated a 31.9 %EWL compared to the
control group (18.4 %EWL). There were no deflations or early
retrievals, and retrieval endoscopies demonstrated two sub-
jects with gastritis and 19 with normal stomachs. Fig. 2 Radiograph image of Reshape Duo balloon inserted and inflated
The aim of this study was to investigate the safety and in the stomach
effectiveness of the DIGB in a larger population and deter-
mine whether the degree of obesity, age, and gender impacted At balloon retrieval, the patient was placed into a left lateral
treatment response. decubitus position and sedated using standard procedures. A
special catheter (ReShape Duo Removal Catheter) was
inserted through the instrument channel of the endoscope,
Materials and Methods the distal coring needle was advanced using a Bcorkscrew-like
facility^ to puncture each balloon, and the balloon fluid is
Insertion and Retrieval of the Dual Intragastric Balloon drained, under suction, through the removal catheter. A stan-
dard endoscopic snare or grasper was then used to remove the
The DIGB (ReShape Medical) is comprised of two indepen- fully deflated dual balloon from the stomach.
dent silicone balloons bonded to a common, flexible silicone
shaft that is attached to a delivery catheter for endoscopic
Patient Follow-up
insertion (Fig. 1). The DIGB was inserted under sedation fol-
lowing standard diagnostic endoscopy to exclude gastric pa-
Post procedure care included weekly or bi-weekly follow-up
thology. With the patient placed into a left lateral decubitus
by a nutritionist and a psychologist, with an additional empha-
position, a 0.035-in. guidewire was positioned through the
sis on initiating an exercise program. A follow-up program
endoscope in the stomach with the tip advanced through the
was organized by the team in relation to diets, psychological
pylorus. The balloon delivery catheter was then advanced over
support, physical activity counseling, and visit schedule.
the guidewire and the DIGB positioned along the greater cur-
A liquid diet was started 1 day prior to the procedure and is
vature of the stomach. Under endoscopic visualization, the
continued for at least 1 week post procedure. The patient is
proximal and then the distal balloon were filled with 450 cc
then progressively advanced from hypo-caloric liquids to
of a sterile saline/methylene blue solution using an automated
small semi-solid meals over the second week. Hypo-caloric
pump. The delivery catheter was detached from the balloon
solid meals were started in the third week and continued for 6
and removed (Fig. 2).
to 7 months. Individual energy requirements and taste prefer-
ences were taken into account in designing all diets.
Following the diet progression an exercise plan was strong-
ly recommended during follow-up. The exercise plan initially
began with walking and progressively increased in intensity.

Outcome Assessment

At each assessment, the patient’s weight and height were mea-

Fig. 1 DIGB from ReShape: two independent silicone balloons bonded
to a common, flexible silicone shaft that is attached to a delivery catheter
for endoscopic insertion
sured with calibrated scales and wall mounted stadiometer;
patients wore indoor clothing and no shoes. BMI was calcu-
lated as weight in kilograms divided by the square of height in
meters. At the time of retrieval, outcomes were measured as
change in body weight (TBWL), percentage loss of initial
body weight (%TBWL), and percentage of excess weight loss
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(%EWL) defined as current weight minus the weight corre-
sponding to BMI 25 kg/m2. All adverse events were recorded.
Statistical Analysis
Descriptive analyses of the variables were performed using
the test of proportions for qualitative variables and measure-
ments of central tendency (mean) and measures of dispersion
(standard deviation: s.d.) for quantitative variables. We ana-
lyzed the association between changes in the initial and final
values of weight parameters using Student’s t test for related
pairs. Data analysis was performed using SPSS 17.0 (SPSS
Inc., Chicago, IL, USA). Statistical significance was set at a
two-tailed probability level of <0.05.
Results
A total of 60 patients (11 men, 49 women) were enrolled
between September 2012 and June 2013 in the Madrid Bar-
iatric Endoscopic Unit of the Sanchinarro University Hospital.
Prior to implant, BMI was 38.84+5.28 kg/m2 and initial
weight was 107.43+ 19.11 kg in the 42 women and 11 men
with an average age of 39.25+9.59 years. Implantation time
varied from 8 to 25 min, with a mean implantation time of
12 min. Mean duration of treatment was 6.9 months.
Weight loss results are displayed in Table 1. BMI for the
group decreased from 38.8 to 32.7 kg/m2 for a total decrease
of 6.1 units. Thirty percent of the total population (18 pts.)
decreased their BMI below 30 kg/m2. Of the 21 morbidly
obese patients, 15 (71.4 %) decreased their BMI below
40 kg/m2. After 6 months of follow-up, total body weight loss
was 16.6+9.33 kg. Morbidly obese subjects lost significantly
more weight than non-morbidly obese subjects (20.5 vs
14.4 kg). No significant differences for TBWL were observed
for either age or gender. Although all subjects averaged a
%TBWL of 15.4+7.95 %, there were no statistical differences
between obesity grade, gender, or age. Finally, mean %EWL
was 47.1+4.26 % with women having a slight but statistically
Table 1 Weight changes after Dual balloon procedure (n=60)
Total weight loss (kg) (mean+SD)
Total (n=60) 16.60+9.33
Obesity grade BMI<40 kg/m2 (n=39) 14.49+8.07*
BMI>40 kg/m2 (n=21) 20.52+10.39*
Gender Male (n=11) 15.79+9.66
Female (n=49) 16.78+9.34
Age <40 years (n=34) 16.94 + 9.75
>40 years (n=26) 16.15+8.90
Comparisons of absolute means between groups were with T of Student: *p<0.05
higher %EWL as compared to men (50.7 vs 30.9 %). Non-
morbidly obese subjects had higher %EWL than morbidly
obese ones (52.2 vs 37.4 %). No significant differences in
%EWL were observed between age groups.
Adverse Events
The dual balloon was generally well tolerated, with only one
early removal for patient intolerance, one early deflation with-
out migration, and one gastric perforation (diagnosed in other
hospital without available data). Fourteen (14) patients had
gastric ulcers or erosions noted at the time of removal; none
were clinically significant; this study was performed with the
original design device which has now been modified to sig-
nificantly reduce such findings.
Discussion
The primary aim of this study was to determine if the DIGB is
an effective, safe, and well-tolerated treatment for obesity.
Secondarily, we sought to determine if effectiveness was re-
lated to sex, age, and/or level of obesity. In the sixty patients
implanted with a DIGB for at least 6 months, all achieved
clinically significant weight loss with a low complication rate.
To our knowledge, Ponce et al. [6] are the only other investi-
gators to publish results in subjects using the DIGB. In their
randomized control trial in 21 subjects, those implanted with a
DIGB had a %EWL of 31.8 %. In contrast, in our patients, we
observed a %EWL of a 47.1 %. This difference could have
arisen from the use of a highly experienced multidisciplinary
team in our trial. In our experience, the multidisciplinary team
tends to increase patient commitment through a combination
of more frequent follow-up nutritional and psychological and
support as well as continual guidance regarding physical ac-
tivity. That said, differences between these studies should be
viewed with caution due to sample size and patient population
differences. In relation to trials that investigated the effective-
ness of single intragastric balloons, our results of a mean
% of weight loss (%) % of excess weight loss (%)
15.45+7.95 47.1+4 26.72
14.90+7.71 52.27+28.72*
16.46+8.47 37.48+19.72*
12.09+7.63 30.92+21.03*
16.20+7.89 50.73+26.68*
15.56+8.01 48.49+26.72
15.31+8.02 45.28+27.13
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TBWL of 16.6 kg is similar to other published trials which
demonstrated an average weight loss of 12 to 15 kg over a 6-
month period [7, 8]. It should be noted that our results and
other trials using gastric balloons demonstrate a greater
%EWL than those obtained by behavioral and/or pharmaco-
logical treatments alone [2, 4].
In conventional non-endoscopic treatment of obese pa-
tients, the co-factors of male gender and older age were pre-
dictive of higher success rate [9]. In contrast, in our trial using
a DIGB, there was no significant difference in total weight
loss with regard to gender, age, or obesity grade. We did find
that women achieved a higher %EWL which could be due to
the lower number of men in the study and/or higher excess
weight at baseline in our male subjects.
In our trial, morbidly obese subjects lost significantly more
total body weight than the non-morbidly obese. There was no
significant difference between these groups with regard to
%TBWL although the non-morbidly obese subjects did have
a greater %EWL than the morbidly obese subjects.
Bariatric surgery trials have documented substantial and
sustained weight loss in obese patients in addition to a reduc-
tion in comorbidities in a majority of the subjects. However,
bariatric surgery has a high rate of refusal, with worldwide
estimates suggesting <1 % of the population has access to
surgery. DIGBs could prove to be a bridge to a safer laparo-
scopic gastric bypass in surgery in morbidly obese patients
due to the significant reduction in BMI. Of the 21 morbidly
obese patients in our trial, 15 (71.4 %) decreased their BMI
below 40 kg/m2. Zerrweck et al. demonstrated that IGB usage
prior to bypass surgery in superobese subjects was associated
with a shorter operative time and a lower overall risk of sig-
nificant adverse outcomes [10].
The dual balloon was designed to hypothetically have less
risk of migration and impaction, and therefore be more toler-
able. The hypothesis are as follows [1]: The design of the dual
balloon reduces the risk of migration, because if one balloon
deflates the other inflated balloon may prevent migration [2];
The shape of the dual balloon may be better adapted to the
gastric silhouette avoiding impaction and improving tolerabil-
ity. In our study, we did not observe migration through the
6 month rated life of the balloon. There was one early removal
for patient intolerance, one early deflation without migration,
and one gastric perforation. In order to conclude whether or
not migration risk or tolerability decreases or increase with the
dual balloon, more extensive and specific studies are needed.
As mentioned above, monitoring of patients in this study
was carried out by a multidisciplinary team with extensive
experience in the treatment of obesity with IGB. We agree
with other investigators who have stated that IGB is an effec-
tive therapy to aid patients in achieving a short-term weight
loss. Nevertheless, we believe that significant and long lasting
results will depend on the modification of lifestyle best
achieved using a multidisciplinary approach [11, 12].
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Conclusions
While surgery is safe and effective treatment for the severely
obese, the DIGB treatment offers nonsurgical patients a safe,
reversible option which is much more effective than medically
supervised diet and exercise regimens.
In investigating the long-term safety and effectiveness of
DIGBs in a large cohort of patients, the present study demon-
strated that the DIGB was easy to use and safely produced
substantial weight loss. Long-term results will depend on the
modification of lifestyle obtained by a multidisciplinary
approach
Ethical Approval All procedures were conducted in accordance
with good clinical practice and within the guidelines of the Decla-
ration of Helsinki for studies using human subjects. The study was
registered with the institutional review board of the Sanchinarro
University Hospital of Madrid. Written informed consent was ob-
tained from all patients. Data were collected prospectively for
analysis.
Conflict of Interest The study was fully funded by ReShape Medical.
All the authors declare that they have no conflict of interest.
References
1. Hiatt WR, Thomas A, Goldfine AB. What cost weight loss?
Circulatio n. 2012;125(9):1171 –7 . doi:10.1161/
CIRCULATIONAHA.111.023499.
2. Kushner RF, Ryan DH. Assessment and lifestyle management of
patients with obesity: clinical recommendations from systematic
reviews. JAMA. 2014;312(9):943–52. doi:10.1001/jama.2014.
10432.
3. Middleton KM, Patidar SM, Perri MG. The impact of extended care
on the long-term maintenance of weight loss: a systematic review
and meta-analysis. Obes Rev. 2012;13(6):509–17. doi:10.1111/j.
1467-789X.2011.00972.x.
4. Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a
systematic and clinical review. JAMA. 2014;311(1):74–86. doi:10.
1001/jama.2013.281361.
5. Chang SH, Stoll CR, Song J, et al. The effectiveness and risks of
bariatric surgery: an updated systematic review and meta-analysis,
2003-2012. JAMA Surg. 2014;149(3):275–87. doi:10.1001/
jamasurg.2013.3654.
6. Ponce J, Quebbemann BB, Patterson EJ. Prospective, randomized,
multicenter study evaluating safety and efficacy of intragastric dual-
balloon in obesity. Surg Obes Relat Dis. 2013;9(2):290–5. doi:10.
1016/j.soard.2012.07.007.
7. Genco A, Balducci S, Bacci V, et al. Intragastric balloon or
diet alone? A retrospective evaluation. Obes Surg. 2008;18(8):
989–92. doi:10.1007/s11695-007-9383-9.
8. Lopez-Nava G, Rubio MA, Prados S, et al. BioEnterics®
intragastric balloon (BIB®). Single ambulatory center Spanish ex-
perience with 714 consecutive patients treated with one or two
consecutive balloons. Obes Surg. 2011;21(1):5–9. doi:10.1007/
s11695-010-0093-3.
9. Bautista-Castaño I, Molina-Cabrillana J, Montoya-Alonso JA,
et al. Variables predictive of adherence to diet and physical
activity recommendations in the treatment of obesity and
 Author's personal copy
OBES SURG
overweight, in a group of Spanish subjects. Int J Obes Relat
Metab Disord. 2004;28(5):697–705.
10. Zerrweck C, Maunoury V, Caiazzo R, et al. Preoperative weight
loss with intragastric balloon decreases the risk of significant ad-
verse outcomes of laparoscopic gastric bypass in super-super obese
patients. Obes Surg. 2012;22(5):777–82. doi:10.1007/s11695-011-
0571-2. PubMed.
11. Genco A, López-Nava G, Wahlen C, et al. Multi-centre European
experience with intragastric balloon in overweight populations:
13 years of experience. Obes Surg. 2013;23(4):515–21. doi:10.
1007/s11695-012-0829-3. PubMed.
12. Machytka E, Klvana P, Kornbluth A, et al. Adjustable intragastric
balloons: a 12-month pilot trial in endoscopic weight loss manage-
ment. Obes Surg. 2011;21(10):1499–507. doi:10.1007/s11695-
011-0424-z.