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9 Per-oral Endoscopic Pyloromyotomy 119
10
Endoluminal Bariatric Procedures
Jonah Cohen and Ram Chuttani
Abstract
Obesity is a disease that is growing in burden. It is estimated that over 1.4 billion
people worldwide suffer from obesity, and 68% of Americans are considered
overweight or obese. While bariatric surgery has also increased in popularity
over the last two decades, the morbidity of these procedures has led investigators
to develop less invasive therapies that may cause weight loss and resolution of
comorbid conditions associated with obesity. There are two intragastric
balloons on the market in the USA, which have been widely available in Europe
and other countries, and three more remain under investigation but should be
available soon. These balloons are typically placed endoscopically and are
removed after a duration of months. Other novel technologies to treat obesity
that are under investigation include endoscopic suturing devices to create
anatomic simulations of bariatric procedures, endoluminal sleeves that create
malabsorptive states, aspiration therapy to reduce caloric intake, duodenal
mucosal resurfacing to induce malabsorption, and endoscopic magnetic
anastomotic devices to create intestinal bypasses. These new devices may
eventually become part of a growing toolbox for surgeons and endoscopists to
offer therapy to morbidly obese patients in a much less invasive manner than
bariatric surgery, although more data are needed.
Keywords
Obesity
Bariatric surgery
Intragastric balloons
Endoluminal surgery
Endoluminal suturing
Aspiration therapy
Duodenal mucosal resurfacing
J. Cohen R. Chuttani (&)
Department of Medicine and Division of
Gastroenterology, Center for Advanced Endoscopy,
Beth Israel Deaconess Medical Center,
Harvard Medical School, 330 Brookline Avenue,
Stoneman 458, Boston, MA, USA
e-mail: rchuttan@bidmc.harvard.edu
J. Cohen
e-mail: jmcohen@bidmc.harvard.edu
© Springer International Publishing AG 2017
J.R. Romanelli et al. (eds.), NOTES and Endoluminal Surgery,
Clinical Gastroenterology, DOI 10.1007/978-3-319-50610-4_10
121
Abbreviations
ASGE/ASMBS American Society of Gastrointestinal Endoscopy/
American Society for Metabolic and Bariatric Surgery
BIB Bioenterics Intragastric Balloon, now known as
Orbera™
BMI Body mass index
CC Completed cases
CVD Cardiovascular disease
DJBS Duodenojejunal bypass sleeve
DMR Duodenal mucosal resurfacing
EBT Endoscopic bariatric therapy
EBW Excess BMI weight loss
ESG Endoscopic sleeve gastroplasty
EWL Excess weight loss
FDA Food and Drug Administration
HDL High-density lipoprotein
IGB Intragastric balloon
IOP Incisionless operating platform
POSE Primary obesity surgery endoluminal
ITT Intent to treat
LDL Low-density lipoprotein
NHANES National Health and Nutrition Examination Survey
NIH National Institutes of Health
PEG Percutaneous endoscopic gastrostomy
TWL Total weight loss
WHO World Health Organization
Obesity: Growing Burden of Disease
Obesity is a chronic disease increasing in
prevalence in adults and children on a global
scale. Worldwide, more than 1.4 billion adults
are overweight or obese, and in the USA, 68% of
adults are overweight or obese [1–4]. Further-
more, the morbidity and mortality associated
with being overweight (body mass index
(BMI) defined as the weight in kilograms
(kg) divided by height in meters squared of 25–
29.9 kg/m
2
) or obese (BMI of ≥30 kg/m
2
) have
been known for many years, and mounting evi-
dence increasingly implic ates obesity as an
independent risk factor for various medical con-
ditions, with enormous economic costs as well
[5]. The USA spent $190 billion on obesity-
related healthcare expenses in 2005, and
obesity-attributable medical problems accounted
for 21% of healthcare expenditures [4, 6]. Based
upon data collected for the National Health and
Nutrition Education Survey (NHANES) between
2011 and 2012, the measured prevalence of
obesity in adults in the USA is 34.9% [7 ].
Notably, BMI classifications of obesity as per the
National Institutes of Health (NIH) and World
Health Organization (WHO) for Caucasian,
Hispanic, and Black individuals refer to Class I
122 J. Cohen and R. Chuttani
as BMI of 30.0–34.9 kg/m
2
, Class II as BMI of
35.0–39.9 kg/m
2
, and Class III (or severe) as
BMI ≥ 40 kg/m
2
[8]. Morbid obesity is defined
as a BMI > 40, or ≥35 in the presence of
comorbidities. The age-adjusted prevalence of
class III obesity (BMI ≥ 40) in the USA has
been estimated to be around 6% [3]. BMI is
increasing worldwide, with 36.9% of men and
38% of women estimated to have a
BMI ≥ 25 kg/m
2
[9, 10]. It is important to note
that obesity is ultimately a complex,
multi-factorial, metabolic, and psychoneuroen-
docrine disease, and not simply an imbalance
between energy intake and energy expenditure.
While many elements have contributed to this
increase in obesity, sedentary lifestyle and diet
are among the most important etiologies.
Obesity is associated with myriad complica-
tions including increased rate of death from all
causes and from cardiovascular disease
(CVD) [11]. Obesity and central adiposity are
also associated with increased morbidity in
addition to mortality [1]. Compared with normal
weight individuals, overweight and obese indi-
viduals have a higher relative risk of diabetes
mellitus, hypertension, hypercholesterolemia,
nonalcoholic fatty liver disease, gout, stroke,
venous thrombosis, cholelithiasis, depression,
symptomatic osteoarthritis, gastroesophageal
reflux disease, infertility, and obstructive sleep
apnea, as well as CVD including heart failure,
atrial fibrillation, and coronary disease [12].
Obesity is also an independent risk factor for
many different cancers including breast, pancre-
atic, endometrial, gallbladder, kidney, liver,
colon, and cervical cancer as well as leukemia
[13]. Additionally, multiple studies have showed
impaired quality of life among obese individuals
including negative social and economic conse-
quences [14].
Endoscopic Bariatric Therapies:
A New Paradigm
Decreasing total body weight by only 5–10% has
been shown to slow and even prevent the onset
of obesi ty-related comorbidities, and has
historically been recommended as the initial goal
for weight-loss therapy [15, 16]. A reasonable
time period for a 10% reduction in total body
weight is 6 months [17]. While this amount of
weight loss may appear modest, it is associated
with a decrease in systolic blood pressure of
10 mmHg and in diastolic blood pressure of
20 mmHg; a reduction in total cholesterol by
10% and low-density lipoprotein (LDL) by 15%;
and an increase of 7% in high-density lipoprotein
(HDL) [18]. Interestingly, ovarian function is
improved by only 5% weight loss. Furthermore,
weight loss of 10–20% has been shown to
improve glycemic control, while 15–20% of
weight loss may reverse the elevated mortality
risk of diabetes mellitus [18]. While to date
first-line therapy, behavioral modification,
including physical activity and dietary programs,
thus far has yielded only modest long-term out-
comes for treating obesity and metabolic disease
[19–23]. Current pharmacologic therapies for
obesity, including orlistat and lorcaserin, increase
weight loss by 3–9% compared with lifestyle
modification therapy alone, but are associated
with significant side effects [24]. Unfortunately,
both lifestyle and pharmacologic therapies are
subject to significant rates of weight-loss recidi-
vism [25]. While bariatric surgery has shown to
be the most effective alternative for achieving
durable weight loss as well as remission of dia-
betes in many obese patients, it is limit ed for use
only in patients with a BMI > 40 or ≥35 with
comorbidities. In addition, it is expensive, diffi-
cult to reverse, and associated with significant
short- and long-term complications and even risk
of death [26–32]. Some of the complications of
bariatric surgery include cardiopulmonary
events, anastomotic leak, stomal stenosis, mar-
ginal ulceration, incisional hernias, internal her-
nias, and formation of fistulae, as well as
nutritional deficiencies, risk of reoperation, and
chronic abdominal pain [30 ]. Current bariatric
surgical procedures include open and laparo-
scopic Roux-en-Y gastric bypass, laparoscopic
adjustable gastric banding, laparoscopic sleeve
gastrectomy, and open or laparoscopic biliopan-
creatic diversion with duodenal switch. Evidence
indicates that less than 1% of morbidly obese
10 Endoluminal Bariatric Procedures 123
patients who qualify for bariatric surgery actually
undergo operative management which has been
attributed to cost, access, and patient concerns
regarding morbidity and mortality of surgery
[33]. Thus, the majority of overweight and obese
patients are left without significant options aside
from surgery once diet, lifestyle modifications,
and weight-loss medications are unsuccessful.
This provides a significant opportunity for novel
therapeutic alternatives [17]. Indeed, as previ-
ously mentioned, the relatively low reduction in
total body weight leading to significant
improvements in comorbidities creates an excit-
ing opportunity for these novel therapeutic
options.
Recent technological advances have led to the
emergence of endoscopic bariatric therapies
(EBTs) for obesity and metabolic disease.
Endoscopic procedures in development and in
clinical trials, as well as those already used in
practice, have the opportunity to bridge a sig-
nificant gap between medical therapies and bar-
iatric surgery and may serve as an alternative or
an adjunct to medical treatment [34, 35]. Nota-
bly, endoscopic therapies for weight loss are
potentially less invasive, lower cost, and rever-
sible, with the option for repeat procedures as
necessary [17, 36]. These include a variety of
devices that work via different mechanisms of
action including intragastric balloons, implan-
table sleeves, neuromodulatory, and gastric
restriction devices, as well as endoscopic sutur-
ing and stapling platforms [34, 35]. Endoluminal
bariatric procedures can be also organized into
six main categories defined by their potential role
as follows: (1) early-intervention procedures to
treat patients that are overweight and obese but
whom do not meet criteria for conventional
weight-loss surgery; (2) primary obesity or
metabolic procedures that may provide durable
weight-loss similar to traditional bariatric surg-
eries or focus on obesity-related comorbid
metabolic conditions such as diabetes; (3) bridge
procedures that offer short-term weight reduction
to decrease the operative risks associated with
morbid obesity; (4) revisional procedures that
repair failed traditional bariatric operations where
patients have not lost or re-gained weight;
(5) postsurgical complication procedures that
endoscopically manage entities such as anasto-
motic leaks, bleeding, strictures, and fistulae; and
(6) routine endoscopy in p ostsurgical patients
which includes procedures to access the bil-
iopancreatic limb and endoscopic retrograde
cholangiopancreatography (ERCP) in patients
who have previously underwent bariatric surgery
(Table 10.1)[37, 38]. Finally, current primary
obesity or metabolic endoscopic therapies can be
classified as follows: (1) space-occupying;
(2) restrictive; (3) bypass; (4) aspiration; or
(5) other novel therapies. This chapter will focus
on recent advances in the field of EBTs as pri-
mary management to treat obesity or metabolic
Table 10.1 Endoluminal bariatric procedures
Categories of
endoluminal bariatric
procedures
Examples
1. Early-intervention
procedures
Treat patients that are
overweight and obese but
whom do not meet criteria
for conventional
weight-loss surgery
2. Primary obesity or
metabolic
procedures
Provide durable
weight-loss similar to
traditional bariatric
surgeries or focus on
obesity-related comorbid
metabolic conditions such
as diabetes
3. Bridge procedures Offer short-term weight
reduction to decrease the
operative risks associated
with morbid obesity prior
to bariatric surgery
4. Revisional
procedures
Repair failed traditional
bariatric operations
5. Postsurgical
complication
procedures
Manage entities such as
anastomotic leaks,
bleeding, strictures, and
fistulae
6. Routine endoscopy
in postsurgical
patients
Includes procedures to
access the biliopancreatic
limb and endoscopic
retrograde
cholangiopancreatography
(ERCP) in patients who
have previously underwent
bariatric surgery
124 J. Cohen and R. Chuttani
disease via devices or procedures in clinical
practice or in advanced stages of development;
however, many of these interventions may
overlap as early-intervention or bridge
procedures.
Challenge of Weight-Loss Reporting
and Goals of Endobariatric Therapy
Of note, challenges exist in interpreting the
available clinical data on primary endoscopic
therapies for weight loss given that studies often
differ in endpoints and have variable follow-up.
Additionally, many factors other than weight loss
play an important role in post-procedural quality
of life, and such data are often not clearly
reported [39]. Finally, central adiposity data vis a
vis the metabolic syndrome are measured by
waist circumference, and these data are not cap-
tured by relative weight-loss measures com-
monly used and may not be reported.
Weight-loss results are expressed in absolute
terms such as kg or BMI, as well as relative terms
such as percentage excess weight loss (%EWL),
percentage excess BMI loss (%EBL), or per-
centage total weight loss (%TWL). The %EWL
and %EBL are compared to reference points of
ideal body weight and BMI of 25, respectively.
Interestingly, one of the strongest links between
obesity and health risks including mortality has
been reported via BMI specifically in an almost
1-million-subject study [40]. Furthermore, there
are limitations of relative measures such as
%EWL and %TWL as they depend on a patient’s
initial status, and thus, percentage change may
correspond with a variety of possible BMI results
in different patients. Thus, %EWL and %TWL
are unable to express health risk reduction
unequivocally among different patients [41]. As
lighter patients show higher %EWL and %TWL,
studies and physicians may improve “their
power” paradoxically by enrolling patients on the
safer and lower end of the scale. Therefore,
absolute terms are often favored by investigators
in nonsurgical studies on weight loss, while rel-
ative measures tend to be used by proceduralists
[42, 43].
Given this bias, it has been advocated by
some that weight and BMI at all time points
should be provided as a minimum by all journals
reporting on intentional weight loss [42]. How-
ever, one recent report carefully showed that
%TWL is less affected by the variation caused by
initial BMI than %EWL, and thus, %TWL may
be better suited for comparing weight loss among
different patients or studies than %EWL if only
relative measures are used [41]. Nevertheless, in
most endobariatric studies, %EWL is the most
commonly used endpoint.
Finally, other confounding variables such as
dietary compliance, as well as nutritional and
exercise interventions, affect the outcomes of
weight-loss studies, introducing heterogeneity
and limiting comparisons between studies. Such
limitations are relevant and should be considered
when interpreting data in the field of bariatric
surgery and endobariatric procedures. A recent
white paper by the ASGE/ASMBS Task Force
on Endoscopic Bariatric Therapy delineated
requirements of EBTs with respect to targets of
safety, weight-loss efficacy, durability,
reversibility, repeatability, costs, and the alter-
ation of anatomy [44]. Therein, they advocate
defining successful weight loss in primary inter-
ventions as %EWL
> 25% at 12 months or 15%
greater %EWL compa red to a control
group. They also recommended a minimum
threshold of total weight loss of 5% for early,
bridge-to-surgery, and metabolic interventions,
based on the aforementioned health benefits of
5% weight loss. The threshold for incidence of
serious adverse events associated with a partic-
ular EBT was set at 5% or less. Hence, the
expected lower complication rates with EBTs
allow the efficacy bar to be lower compared to
surgical therapies.
Importance of Patient Selection,
Follow-Up, and Multidisciplinary
Teams
Like any medical intervention, contraindications
exist and correct patient selection is essential.
Aside from the aforementioned indication
10 Endoluminal Bariatric Procedures 125
categories for EBT patient selection (i.e., early
intervention, primary intervention, bridge, meta-
bolic), other factors also play a role in successful
management. For example, extensive preproce-
dural counseling and prophylactic symptom
management is important in the case of intra-
gastric balloons. These help minimize early
device removal by managing expectations and
reducing nausea and vomiting. This deters
patients with a high likelihood of attrition from
proceeding [45]. Contraindications for primary
EBTs include the following: endocrine cause for
obesity, alcoholism or drug abuse, desire of
pregnancy or lactation, lack of patient compli-
ance with previous lifestyle or medical therapies,
inadequately treated psychiatric disease or eating
disorders, malignancy in previous 5 years, and
previous gastric surgery [44, 46]. Other
procedure-specific contraindications also exist
and will be discussed when applicable. One of
the most critical aspects of creating a successful
EBT program is the formation of a team of
providers that can assist with patient selection as
well as frequent and durable follow-up [47].
Recent work has highlighted that the number of
nutritional and psychological contacts predicted
successful weight loss [48]. Internists, endocri-
nologists, gastroenterologists, bariatric surgeons,
dietitians, psychologists/psychiatrists, and exer-
cise physiologists each play an important role
and ideally are integrated via weight-loss centers
or programs [49].
Space-Occupying Devices
Space-occupying devices most often take the
form of temporarily placed prostheses such as
endoscopically placed intragastric balloons
(IGBs). However, space-occupying devices other
than balloons are also in clinical trials. Such
space-occupying devices induce gastric disten-
tion and displace volume but likely also work via
alterations in gastrointestinal motility such as
delaying gastric emptying, as well as neurohor-
monal shifts [50]. IGBs were first described in
1982 and approved for use in the USA in 1985
with the air-filled Garren-Edwards Gastric
Bubble [51]. These balloons unfortunately had
limited efficacy and were associated with multi-
ple adverse events including gastric ulceration
and small-bowel obstructions related to sponta-
neous balloon deflation and migration [52, 53].
Since that time, IGBs have demonstrated decades
of improved safety and efficacy internationally.
As of 2015 two devices, the Orbera™ and
ReShape Duo
®
intragastric balloons were
approved for use by the US Food and Drug
Administration (FDA) [54, 55]. Other
space-occupying devices in development which
will not be discussed in this chapter include IGBs
such as the Heliosphere BAG, satiety-inducing
devices such as Full Sense™, and transpyloric
devices designed to impair gastric emptying such
as Transpyloric Shuttle
®
and SatiSphere™.
Orbera™ Intragastric Balloon
The Orbera™ (formerly Bioenterics) intragastric
balloon (Apollo Endosurgery, Austin, Texas) is
an elastic spherical balloon made of silicone
(Fig. 10.1). It is placed blindly into the stomach
and then under endoscopic visualization is filled
with approximately 500–700 mL of saline solu-
tion and often 10 mL of methylene blue which
acts as an indicator of inadvertent balloon
deflation via urine discoloration. It is indicated
for intragastric residence up to 6 months at
which time it is punctured and retrieved endo-
scopically. The Orbera™ balloon has been used
worldwide for severa l decades with extensive
experience and data supporting its efficacy and
safety. While a Cochrane Systematic Review in
2007 lacked sufficient evidence to clearly rec-
ommend benefit on weight loss via the Orbera™
balloon, a subsequent meta-analysis from 2008
showed clear safety and efficacy data for
short-term weight loss [53, 56]. This 2008
meta-analysis evaluated 3608 patients and 15
studies with estimates for weight lost at time of
balloon removal after 6 months of implantation
was 14.7 kg in total weight, 12.2% TWL,
5.7 kg/m
2
BMI, and 32.1% EWL.
However, it is important to note that there
were limited data following patients post balloon
126 J. Cohen and R. Chuttani
removal. Regarding safety, the majorit y of
complications were mild, and the early removal
rate was 4.2%. The largest study from the
meta-analysis evaluating 2515 patients from Italy
included dietary counseling recommending
approximately 1000 kcal/day. The reported
overall complication rate was 2.8% [49]. They
reported gastric perforation occurring in 5
patients (0.19%), 4 of whom had undergone
previous gastric surgery. Two died and 2 were
successfully treated by laparoscopic repair after
balloon removal. Thus, the authors of this study
concluded that the previous gastric surgery is a
contraindication to BIB placement.
Of note, 19 gastric obstructions (0.76%) pre-
sented in the first week after positioning and
were successfully treated by balloon removal.
Balloon rupture occurred in 9 patients (0.36%)
and was treated by removal. Finally, esophagitis
(n = 32; 1.27%) and gastric ulcer (n = 5; 0.2%)
presented in patients without a history of peptic
disease and wer e treated conservatively with
medical therapy. After 6 months, %EWL was
33.9 and BMI loss was 4.9 kg/m
2
. Of note, there
was statistically significant improvement in
fasting glucose, blood pressure, and lipid mark-
ers, while hemoglobin A1c decrease or normal-
ization was reported in 87.2% of the 488 patients
with diabetes in the study.
A recent ASGE Technology Review aggre-
gated much of the available evidence on
Orbera™ in over 18 studies and cited a median
%TWL of 12% at 6 months when the device was
removed [57]. With respect to longer-term
weight loss, they reported %EWL ranging from
11 to 51% at 12 months (6 months after balloon
removal) based on 10 prospective trials with
1161 patients. Two trials reported long-term data
with approximately 6% TWL maintained
36 months after implantation, and mean %EWL
was 55.6% at 6 months and 29.1% at 3 years
[58, 59]. One study followed patients out to
5 years after balloon placement and found that
about 40% of patients presented weight loss of
7 kg, BMI reduction of 2.5 kg/m
2
, and %EWL
of 13 [60]. In another meta-analysis of 17 studies
including 1638 patients, Abu Dayyeh et al. [46]
reported that %EWL with the Orbera™ IGB at
12 months was 25.44 (95% CI, 21.47–29.4).
Three RCTs compared %EWL in patients who
Fig. 10.1 Orbera™
intragastric balloon
10 Endoluminal Bariatric Procedures 127
received the Orbera™ IGB with a control group,
with the mean difference in %EWL in patients
who received the Orbera™ IGB over controls
being 26.9% (95% CI, 15.6–38.2; P
< 0.001)
[47–49]. Finally, a recent systematic review
evaluating weight loss in 547 patients and 9 trials
after Orbera™ removal showed that at removal
patients lost on average 16.7 kg, 6 months
post-removal, had a net loss of 15.9 kg (sus-
taining 95% weight loss), and 12 months
post-removal had a net loss of 8.7 kg (sustaining
52% of the initial weight lost) [50].
Importantly, sequential placement of IGBs
after an IGB-free time interval has been sug-
gested a s a mechanism for resetting the stom-
ach’s normal motility prior to repeating therapy
to provide additional weight loss. Lopez-Nava
et al. [61] and Genco et al. [62] reported that a
second Orbera™ IGB after a 1-month
balloon-free period led to an additional average
decrease in BMI of 2.6 and 4.2 kg/m
2
, respec-
tively, and to an increase in the percentage of
EWL from 25.1 to 51.9% compared to patients
who underwent a single 6-month Orbera™ bal-
loon placement followed by 7 months of dietary
counseling [62]. Finally, Dumonceau et al. [63]
found that obese patients who repeat Orbera™
IGB therapy after a balloon-free period lost
approximately 9.0 kg during their second
Orbera™ balloon placement in addition to the
14.6 kg lost from the first balloon.
In a meta-analysis evaluating Orbera™ safety
in 68 studies [ 46 ], the most frequent side effects
were pain and nausea occurring in over one-third
of subjects. The pooled early removal rate was
approximately 7%, and serious adverse events
from Orbera™ were uncommon with an inci-
dence of migration and gastric perforation of 1.4
and 0.1%, respectively. Notably 4 of 8 gastric
perforations occurred in patients with previous
gastric surgeries, and the four reported deaths
were related to gastric perforation or aspiration
events. While delayed gastric emptying is felt to
be induced by the IGB, once removed, it is felt
the there is no long-term risk of gastr oparesis
based on current available evidence.
Reshape Duo® Intragastric Balloon
The ReShape Duo
®
(ReShape Medical, San
Clemente, California) is an endoscopically
inserted and retrieved, saline-filled, dual intra-
gastric balloon system with 2 balloons attached
to each other by a flexible tube which helps
prevents migration if one ball oon inadvertently
deflates (Fig. 10.2). Filling volume is recom-
mended at 900 mL of saline solution with
methylene blue via a power pump delivering
450 mL to each balloon. The device is recom-
mended for removal after 6 months similar to
Orbera™. Again similar to Orbera™, ReShape
Duo
®
was officially FDA-approved in 2015 for
adult obese patients who have a BMI of 30–
40 kg/m
2
and who have been unable to lose
weight through diet and exercise. Furthermore,
patients must also have one or more
obesity-related conditions such as diabetes, high
blood pressure, or high cholesterol, and they
must also participate in a supervised diet and
exercise plan. FDA approval was based on of the
REDUCE Pivotal Trial which was a prospective,
sham-controlled, double-blinded, randomized,
Multicenter, clinical study that enrolled 326
subjects [55]. The results showed that ReShape
Duo
®
patients lost over twice the amount of
weight of those patients who underwent sham
endoscopy with diet and exercise alone. Duo
patients had significantly greater %EWL at
24 weeks (25.1% intent to treat (ITT), 27.9%
completed cases (CC, n = 167) compared with
control group patients (11.3% ITT, P = 0.004,
12.3% CC, n = 126). Notably, the secondary
endpoint evaluating weight maintenance was not
met as more than 50% of treatment subjects who
lost weight wi th the device did not maintain
greater than 40% of their %EWL for the
24 weeks after the device was removed.
Regarding total weight loss, the average number
of pounds in the ReShape
®
group was 14.4
(6.8% TWL) versus 7.2 (3.3% TWL) in the
control group at 24 weeks via ITT analysis, and
9.9 lb in ReShape
®
group at 48 weeks. Balloon
deflation occurred in 6% but without migrations,
128 J. Cohen and R. Chuttani
and early retrieval for nonulcer intolerance
occurred in 9% of subjects. Gastric ulcers were
observed, and a minor device change led to sig-
nificantly reduced ulcer size and frequency
(10%). Based on these data, the FDA felt the
risk–benefit profile was favorable enough to
grant approval.
Obalon Intragastric Balloon
The Obalon Gastric Balloon (Obalon Therapeu-
tics Inc., Carlsbad, California) is a 250-mL
gas-filled balloon that is packaged within a
large dissolvable gelatin capsule. It is swallowed
under fluoroscopic visualization but does not
require endoscopic placement. A cathet er, which
extends through the esophagus and outside the
mouth, is used to fill the balloon by using a
gas-filled canister. The Obalon balloon requires
endoscopic removal via puncture and forceps
extraction. Up to 3 balloons can be swallowed
during the same or sequential sessions, and bal-
loons are removed endoscopically after 12–
24 weeks. The target population is patients with
BMI 27 or greater who have failed previous
conservative measures for weight loss. Initial
feasibility data demonstrated proof of concept for
preliminary safety and efficacy in 17 patients
[64]. Based on data from the European Union
Limited Market Release (unpublished data from
Obalon) from eleven cen ters throughout Bel-
gium, Germany, Italy, and Spain studying 119
subjects in the absence of a contr ol group, they
found a 50.2% EWL, 8.3% %TWL, 2.8-point
reduction in BMI, and mean weight loss of
8.0 ± 5.8 kg over the 3-month period. In this
study, most commonly reported adverse events
were nausea (10.1%), vomiting (6.7%), and 9
patients (7.6%) requested early removal of bal-
loons mainly due to a lack of commitment to the
full 3-month therapy period. One (0.8%) small
Fig. 10.2 Reshape Duo™
intragastric balloon
10 Endoluminal Bariatric Procedures 129