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BioEnterics® Intragastric Balloon (BIB®). Single Ambulatory Center Spanish Experience with 714 Consecutive Patients Treated with One or Two Consecutive Balloons

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The BioEnterics® Intragastric Balloon (BIB®) is a well-established device for temporary treatment in morbidly obese patients. The aim of this study is the evaluation, in a population of 714 consecutive outpatient setting cases, BIB® results in terms of weight loss and comorbidity change. BIB® was positioned in all cases after diagnostic endoscopy. The device was inflated under direct endoscopic vision with saline solution (600-700 ml) and methylene blue (10 ml). Intubation was carried out in patients with body mass index (BMI) > 40 kg/m(2) affected by sleep apnea or chronic obstructive pulmonary disease. After 6 months, balloon removal was carried out, and patients were discharged with drug therapy and 1,000 kcal diet. More than 100 patients underwent a second consecutive balloon positioning. One month from the removal of the first BIB, patients were given a second BIB. Patients were followed up weekly. Mortality, complications and their treatment, postplacement symptoms, comorbidities, BMI, percentage of excess BMI loss (%EBL), and percentage of excess weight loss (%EWL) were considered. Data are expressed as mean ± standard deviation. From June 1, 2005, to May 31, 2007, 714 patients underwent BIB® placement (143 males/571 females; mean age, 38.4 ± 16.1; mean BMI, 37.6 ± 5.7 kg/m(2); mean EW, 56.3 ± 27.1 kg). After 6 months, mean BMI was 31.1 ± 7.2, mean %EWL was 41.6 ± 21.8, mean BMI loss was 6.5 ± 12.7, and mean %EBL was 44.5 ± 22.6. Of 714 patients, 112 underwent a second BIB placement. At the time of the second balloon placement, mean BMI was 32.9 ± 6.7 kg/m(2); range was 31-51. After the second balloon removal, mean BMI was 30.3 ± 7.2. BIB® treatment is a safe and effective procedure for weight reduction, without mortality and with very low morbidity rates even in nonhospitalized patients. A second balloon can also be positioned without difficulties, achieving good results after 12 months of treatment.
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CLINICAL RESEARCH
BioEnterics® Intragastric Balloon (BIB®). Single
Ambulatory Center Spanish Experience with 714
Consecutive Patients Treated with One or Two
Consecutive Balloons
Gontrand Lopez-Nava &Miguel Angel Rubio &
Susana Prados &Gabriela Pastor &
Mar Rodriguez Cruz &Ena Companioni &Andres Lopez
Received: 28 January 2009 /Accepted: 28 January 2010
#Springer Science+Business Media, LLC 2010
Abstract
Background The BioEnterics® Intragastric Balloon (BIB®)
is a well-established device for temporary treatment in
morbidly obese patients. The aim of this study is the
evaluation, in a population of 714 consecutive outpatient
setting cases, BIB® results in terms of weight loss and
comorbidity change.
Methods BIB® was positioned in all cases after diagnostic
endoscopy. The device was inflated under direct endoscopic
vision with saline solution (600700 ml) and methylene
blue (10 ml). Intubation was carried out in patients with
body mass index (BMI)>40 kg/m
2
affected by sleep apnea
or chronic obstructive pulmonary disease. After 6 months,
balloon removal was carried out, and patients were
discharged with drug therapy and 1,000 kcal diet. More
than 100 patients underwent a second consecutive balloon
positioning. One month from the removal of the first BIB,
patients were given a second BIB. Patients were followed
up weekly. Mortality, complications and their treatment,
postplacement symptoms, comorbidities, BMI, percentage
of excess BMI loss (%EBL), and percentage of excess
weight loss (%EWL) were considered. Data are expressed
as mean±standard deviation.
Results From June 1, 2005, to May 31, 2007, 714 patients
underwent BIB® placement (143 males/571 females; mean
age, 38.4±16.1; mean BMI, 37.6± 5.7 kg/m
2
; mean EW,
56.3± 27.1 kg). After 6 months, mean BMI was 31.1±7.2,
mean %EWL was 41.6±21.8, mean BMI loss was 6.5±12.7,
and mean %EBL was 44.5±22.6. Of 714 patients, 112
underwent a second BIB placement. At the time of the second
balloon placement, mean BMI was 32.9±6.7 kg/m
2
;range
was 3151. After the second balloon removal, mean BMI
was 30.3±7.2.
Conclusions BIB® treatment is a safe and effective
procedure for weight reduction, without mortality and with
very low morbidity rates even in nonhospitalized patients.
A second balloon can also be positioned without difficulties,
achieving good results after 12 months of treatment.
Keywords Obesity .BIB® .Weight loss .Complications .
Comorbidity
Introduction
The BioEnterics® Intragastric Balloon (BIB®) is a well-
established device for temporary treatment in morbidly
obese patients [13]. The BIB® is potentially attractive to
health care practitioners who have experienced poor results
with dietary programs, drug treatment, and behavioral
therapy [4]. Moreover, it has been recommended as a
weight reduction adjuvant therapy before bariatric surgery
and before all kinds of planned surgery in the morbidly
G. Lopez-Nava (*):S. Prados :G. Pastor :M. R. Cruz
Department of Digestive and Endoscopy,
Madrid Sanchinarro University Hospital,
C/Padre Arrupe 89, Chalet,
28050 Madrid, Spain
e-mail: clinicalwriter@ymail.com
M. A. Rubio
Department of Endocrinology,
Madrid Sanchinarro University Hospital,
Madrid, Spain
E. Companioni :A. Lopez
Department of Anesthesiology,
Madrid Sanchinarro University Hospital,
Madrid, Spain
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DOI 10.1007/s11695-010-0093-3
obese to reduce life-threatening comorbidities and lessen
surgical risk [14]. The aim of this study is the evaluation, in
a population of 714 consecutive outpatient setting cases,
BIB® results in terms of weight loss and comorbidity change.
Patients and Methods
The BIB® (Allergan, Irvine, CA, USA) was positioned in
all cases. Patients were selected according to National
Institutes of Health criteria and guidelines for obesity surgery
[5] and were independently evaluated by members of the
bariatric staff: internists, dieticians, and psychologists. More
in detail indications for BIB use may be summarized as the
following: (1) preoperatory weight loss in a patient candidate
to bariatric surgery with high anesthesiological risk, (2)
temporary weight loss treatment in a patient with body mass
index (BMI) in the range of bariatric surgery (>35) who
refuse surgery or has possible low compliance to surgery or
in case of very long waiting list, and (3) temporary weight
loss treatment for a patient with no indications to surgery in
the context of an integrate medical approach to obesity
(BMI< 35). Exclusion criteria were all conditions precluding
safe endoscopy, esophagitis, large hiatal hernia (>5 cm),
chronic therapy with steroids or nonsteroidal drugs, active
peptic ulcer or its previous complications, previous gastric
surgery, lesions considered at risk for bleeding or anticoagu-
lant therapy, pregnancy, and physical inability to maintain
regular follow-up. The patient was positioned in a lateral
decubitus position, and diagnostic endoscopy was performed.
BIB® placement was performed under unconscious sedation
(propofol, 2 mg/kg) and was inflated under direct endoscopic
vision with saline solution (600700 ml) and methylene blue
(10 ml). Intubation was carried out in patients with BMI>
40 kg/m
2
affected by sleep apnea or chronic obstructive
pulmonary disease (COPD), as a preanesthesia protocol.
After 6 months of placement, endoscopy was performed, and
balloon removal was carried out using a dedicated instru-
ment following complete deflation of the device. All patients
were discharged after 3 h. On the first postoperative day,
isotonic liquids with rabeprazole (20 mg/day), ondansetron
(8 mg/day), and butylscopolamine bromide (20 mg× 3/day)
were given to all patients. After the fifth postoperative day,
they began a progressive solid 1,000 kcal diet. More than 100
patients underwent a second consecutive balloon positioning.
In these cases, after the removal of the first BIB, patients were
given 1 month of medical therapy, followed by a second BIB
positioned according to the same protocol as the first
positioning and removed after 6 months. Patients were
followed up weekly. Mortality, complications and their
treatment, postplacement symptoms, comorbidities, BMI,
percentage of excess BMI loss (%EBL), and percentage of
excess weight loss (%EWL) were considered (EW was
calculated according to Lorenz formula). Data are expressed
as mean± standard deviation, except as otherwise indicated.
Statistical analysis was done by means of Studentsttest for
numerical variables and χ
2
test or Fishers exact test for
categorical variables. p<0.05 was considered significant.
Results
From June 1, 2005 to May 31, 2007, 714 patients
underwent BIB® placement (143 males/571 females; mean
age, 38.4± 16.1; range, 1566; mean weight, 106.3±
21.5 kg; range, 68190; mean BMI, 37.6 ± 5.7 kg/m
2
;
range, 3157; mean EW, 56.3±27.1; range, 16205 kg).
Mortality, Complications, and Early Removal
Endoscopic and postpositioning mortality was absent.
Balloon positioning was uncomplicated in all cases. Of 714
patients, 31 (4.3%) underwent BIB® removal at between 24 h
and 6 weeks after positioning, mainly due to psychological
intolerance or gastroparesis (n=6/31; 19.3%). In patients with
balloon positioning under general anesthesia (27/714; 3.8%),
complications were absent. Overall complication rate was
29/714 (4.1%). Gastroduodenal ulcer, gastric perforation,
and gastric and intestinal obstructions were absent. Balloon
rupture was absent, while partial balloon deflation was
observed in three cases (0.4%). In one patient, the balloon
was not found at the time of removal and probably was lost
with stools after deflation. Esophagitis (n=7; 0.9%) and
acute mucosal gastroduodenal lesions (n=22, 3.1%) were
Symptoms and complications Patient (n, %) Symptoms duration
mean±SD (range)
Therapy
Vomiting 140 (19.6) 4.7±3.7 (128) Medical
Epigastric pain 137 (19.1) 5.4±6.3 (151) Medical
Gastroparesis 6 (0.8%) 3±3.1 (121) Balloon removal
Gastroduodenitis 22 (3.1) Medical
Esophagitis 7 (0.9) Medical
Psychological intolerance 25 (3.5) Balloon removal
Table 1 Postpositioning
symptoms and complications
in 714 patients underwent
BioEnterics® Intragastric
Balloon
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treated conservatively by doubling drug doses for all the
remaining treatment time.
Of 714 patients, 32 were readmitted in ambulatory after
4.7±3.1 (range, 112) days from BIB positioning for
untreatable vomiting. They represent the 32/140 (26.6%)
patients affected by this complication. Postpositioning
symptoms or complications and their treatment are reported
in Tables 1and 2.
Comorbidities
One or more preoperative comorbidities were diagnosed in
162/714 (22.7%) patients: hypertension (22/162; 13.6%),
type II diabetes (16/162; 9.8%), respiratory disorders (31/162;
19.1%), osteoarthropathy (14/162; 8.6%), and others (79/162;
46.9%). Comorbidities were resolved in 64/162 (39.5%) and
improved (lower pharmacological dosage or shift to other
therapy) in 76/162 (46.9%) patients. In 22/162 (13.6%)
patients, the weight loss has not been associated with changes
in comorbidities. In the subgroup of patients treated with a
second BIB, 25/112 (12.3%) comorbidities were diagnosed.
After the first intragastric balloon, comorbidities were
resolved, improved, or unchanged in 10/112 (8.9%), 11/112
(9.8%), and 4/112 (3.4%) patients, respectively (Table 3).
After the second BIB, these results were without significant
change (p=NS; Table 4).
Weight Loss
In all treated patients, after 6 months, mean weight was
94.7±22 (range, 52160 kg); mean BMI was 31.1± 7.2
(range, 2448 kg/m
2
), mean %EWL was 41.6±21.8 (range,
077), mean weight loss was 18.8±9 (range, 045 kg);
mean BMI loss was 6.5±12.7 (range, 021 kg/m
2
); and
mean %EBL was 44.5±22.6 (range, 081). Results according
the initial BMI are reported in Table 5. Of 714 patients, 112
underwent a second BIB placement. At the time of the
second balloon placement, mean weight was 98±25.1
(range, 58160 kg); mean BMI was 32.9±6.7 kg/m
2
(range,
3151); and mean EW was 41.7±21.1 (range, 6127 kg).
After the second balloon removal, mean BMI was 30.3±7.2
(range, 2440 kg/m
2
;Fig.1); mean %EWL was 31.5 ± 23.2
(range, 0100); mean BMI loss was 2.5±18.2 (range,
020 kg/m
2
); and mean %EBL was 59.9±24.6 (range,
0100). In 148 patients, the balloon was not followed by any
bariatric or other surgical procedure. Their initial mean BMI
was 35.1±8.3 kg/m
2
. After BIB removal, their mean BMI
was 28.7± 5.1 kg/m
2
. After 24 months of follow-up, 22 (%)
patients regained the pre-BIB weight, 61 (%) regained the
4550% of their pre-BIB weight, and 45 remain at the
weight level after BIB removal ±2 kg.
Discussion
The use of intragastric devices to promote weight reduction
is not novel [6,7]. Several authors, over the years, have
tried different types of balloon devices as they were thought
to be promising and less invasive than surgery for the
treatment of morbid obesity [712]. By the end of the
1990s, several prospective and controlled studies reported
that devices, such as Ballobes and GarrenEdwards gastric
bubbles, had no significant adjuvant effects for weight
reduction in morbidly obese patients [712]. Reasons for
this were considered to be the small volume of the balloon
(220 ml for GarrenEdwards and 400 ml for Ballobes); the
air filling having no weight effect on stomach walls, and the
cylinder shape of these devices. In addition, these devices
had high rates of complications (gastric erosion, 26%;
gastric ulcer, 14%; MalloryWeiss tears, 11%; complete
deflations, migrations, and intestinal obstructions) [712].
The latest version of the BIB®, according to Tarpon
Springs meeting suggestions, has a spherical shape, high
Table 2 Postpositioning symptoms and complications in 112 patients
underwent a second BioEnterics® Intragastric Balloon
Symptoms and
complications
Patient
(n,%)
Symptoms duration
mean± SD (range)
Therapy
Vomiting 20 (17.8) 4.3± 2.1 (118) Medical
Epigastric pain 20 (17.8) 4.7± 3.1 (325) Medical
Table 3 Comorbidities and their outcome according to resolution criteria
Comorbidity Incidence (n, %) Resolution criteria Resolution (n, %) Improvement (n, %) No change (n,%)
Respiratory disorders 31 (19.1) Absence of symptoms 17 (54.8) 13 (41.9) 1 (3.2)
Hypertension 22 (13.6) Systolic, <120130 mmHg 7 (31.8) 11 (50) 4 (18.1)
Diabetes mellitus type II 16 (9.8) Fasting glycemia, <110 mg/dl 4 (25) 10 (62.5) 2 (12.5)
HbA1c, <6%
Osteoarthropathy 14 (8.6) Pain absence without drugs 3 (21.4) 7 (50) 4 (28.5)
Others 79 (46.9) 33 (41.7) 35 (44.3) 11 (13.9)
Total 162 64 (39.5) 76 (46.9) 22 (13.6)
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volume capacity (400700 ml), and uses saline solution as
filling [13]. Prospective studies and extensive clinical
experience have shown that complication rates are very
low [1419]. In the present study, BIB placement was also
safe and feasible in an outpatient setting (no hospital
admission) settlement. Related hospital mortality and major
complications were absent.
Intragastric balloon placement was usually performed
under conscious or unconscious sedation and local
anesthesia to avoid all the life-threatening complications
related to general anesthesia in morbidly obese patients
with one or more vascular or respiratory comorbidity.
Moreover, at the beginning of our experience, we
preferred performing intragastric balloon positioning
under general anesthesia and intubation in those patients
(27/714; 3.8%) with sleep apnea or COPD. In all these
patients, the BIB placement was without complication.
Despite almost all BIBs having been inflated with more
than 600 ml of saline, gastric or intestinal obstruction was
not observed. Only gastroparesis without obstruction was
diagnosed in 6/714 (0.8%) patients and presented with
abdominal pain and untreatable vomiting. Because of these
symptoms, the balloon was removed in all these patients.
The reasons for this complication are still unclear.
History of peptic ulcer or inflammatory disease of the
gastrointestinal tract was not considered a contraindication
for BIB® positioning, but duodenal ulcer, gastric ulcer, or
esophagitis can complicate the treatment with BIB®. Genco
observed that these patientsconservative treatment, such as
doubling H
2
proton pump inhibitor dosage, was easily
accomplished without causing particular discomfort [15]. In
the present experience, esophagitis and gastroduodenal
acute mucosal lesions were diagnosed in seven (0.9%)
and 22 (3.1%) patients, respectively, and were treated
conservatively by doubling drug doses with symptom relief
and without any kind of complication. No gastroduodenal
ulcers have been found due to rabeprazole compliance
treatment.
Large hiatal hernia was considered a contraindication for
intragastric balloon positioning, but very little is known
about small size hiatal hernia with gastroesophageal reflux
(GERD). In the present experience, 11/714 (1.5%) had
preoperative diagnosis of large hiatal hernia with GERD.
All patients were symptom-free and under drug therapy. In
all patients, the intragastric balloon was positioned and
followed without difference from the described protocol
and, during the 6-month treatment period, remained
symptom-free.
Weight loss has traditionally been the main outcome
measure in bariatric procedures. The mean BMI loss in the
presented series is 4.9±12.7 kg/m
2
and is comparable with
other results reported in the literature in patients with
different BMI at baseline (Table 6). In cases with a
Table 4 Comorbidities outcome after second intragastric balloon
Comorbidity Baseline
Incidence
(n,%)
Incidence after first
balloon (improved
+no changed)
Incidence
after second
balloon
Respiratory
disorders
7 (28) 3/7 (42.8) 2/3 (66.6)
Hypertension 5 (20) 3/5 (60) 2/3 (66.6)
Diabetes
mellitus type II
4 (16) 2/4 (50) 2/2 (100)
Osteoarthropathy 4 (16) 4/4 (100) 4/4 (100)
Others 5 (20) 3/5 (60) 3/3 (100)
Total 25 15/25 (60) 13/15 (86.6)
Table 5 Mean body mass index (BMI) at time of intragastric balloon
removal according to BMI initial range
BMI range Patients number Mean BMI at removal
<35 286 27±5.1
35< 40 223 29± 7.2
40< 45 145 37± 8.9
45< 50 39 43± 9.1
50< 21 41 ±10.9
25
30
35
40
baseline 4 months 2nd BIB 4 months
BMI
Fig. 1 Mean body mass index in 112 patients who underwent
sequential treatment with a second intragastric balloon
Table 6 Body mass index pre- and post-BioEnterics® Intragastric
Balloon placementliterature report with >50 patients
Author Patients
number
BMI at
baseline
BMI at
removal
Loffredo [3] 77 46.6 41.2
Sallet [19] 483 38.2 32.9
Melissas [25] 140 42.3 33.1
Genco [15] 2,515 44.4 35.4
Lopez-Nava 714 37.6 31.1/30.3
a
a
All patients/patients with second balloon
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consecutive treatment with a second BIB, the patients also
continue to lose weight, if not at the same rate of the first
balloon. The second BIB was usually inserted after 1 month
from the first balloon removal. This procedure was proposed
in a patient who hesitates for a definitive surgical treatment
and in cases of a long waiting list for the definitive bariatric
operation. This experience support this sequential approach in
which the patients had a continuous weight loss, also if not
significant, to avoid the patients weight regain waiting for
definitive bariatric surgery. Obviously, this outcome is not
comparable with results observed from bariatric surgery, but it
has obtained satisfactory basic results in terms of resolution of
comorbidities, since the risk of death from cardiovascular
disease, cancer, or other diseases increases throughout the
range of moderate and severe overweight [20,21]. Most
morbidly obese patients have several comorbidities that can
be life-threatening and/or have a negative influence on other
surgical treatments (i.e., orthopedic prosthesis). In the
present series, the improvement or resolution of preoperative
comorbidities has been obtained in 140/162 (86.4%)
patients. The importance of these results has also been
confirmed in a study that demonstrated the benefit of 10 kg
weight loss in terms of comorbidities (diabetes, blood
pressure, lipids, etc.) and related mortality [2224].
This study shows that BIB® treatment is a safe and
effective procedure for weight reduction, without mortality
and with very low morbidity rates even in nonhospitalized
patients. BIB® does not represent adequate and definite
treatment of morbid obesity, but in several experiences, it
has been demonstrated to be helpful in the preoperative
treatment of morbidly obese patients undergoing bariatric
or other elective surgeries by helping to lower mortality and
morbidity risk. A second balloon can also be positioned
without difficulties, achieving good results after 12 months
of treatment. In conclusion, according to other experiences,
we believe that patient motivation and compliance are
essential, and respect for dietary and behavioral rules is
mandatory.
Acknowledgments We thank Dr. Michele Lorenzo for his precious
help.
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... IGB treatment is a well-recognized therapy for overweight/ obesity [2,3,18,19] and has been successfully used to generate weight loss for the last 20 years [11]. The mechanism of action of an IGB is multifactorial and incompletely understood [20,21]. ...
... However, there are conflicting reports regarding these. [20,21] The best results with IGB occur when treatment is combined with behavioral changes [2,3,18,19]. However, it is not possible to establish the ideal balloon size for a specific patient, since the threshold for nausea, vomiting, and abdominal pain are not measurable or predictable [8]. ...
... Moreover, some studies have demonstrated a decrease in IGB efficacy in promoting weight loss due to a reduction in the satiety effect after 3 months [22][23][24]. However, the traditional IGB has some limitations: a decrease in the efficacy of promoting weight loss after 2 to 3 months, a maximum length of treatment of 6 months, and a significant rate of complications during the early implantation period (nausea, vomiting, and discomfort), leading to balloon extraction in 4-5% of patients [5,18,[22][23][24] [8]. The introduction of the Spatz3® Adjustable Balloon system provides features that address these limitations. ...
Article
Full-text available
Background: To analyze the results regarding weight loss and complications related to the Spatz3® adjustable intragastric balloon (IGB) in Brazil. Methods: This randomized prospective study covered patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil. The patients had a minimum body mass index (BMI) of 27 kg/m2. The study examined complications of Spatz3® treatment and BMI reduction, percentage of total weight loss (%TWL), and % of excess weight loss (%EWL). Results: One hundred eighty patients underwent a Spatz3® balloon implant in the period. The patients were randomly divided into one group in which the Spatz balloon was kept at the same volume (600 mL) throughout treatment (Control Group), and another adjustment group with 250 mL greater volume. The complication rate was 16.14%. No death or major complication occurred during the study. Mean BMI decreased from 39.51 to 32.84 kg/m2 (p < 0.0001), bodyweight from 111.87 to 90.28 kg (p < 0.0001), and excess weight from 41.55 to 22.99 kg (p < 0.0001). The adjustment resulted in greater mean weight loss of 4.35 kg (- 8 to 17.6 kg), and the average time of the procedure was 7.12 ± 1.63 months. The upward adjustment group did not present greater %TWL, %EWL, or BMI reduction when compared with the control group (p = 0.4413, p = 0,9245, p = 0.2729, respectively). Conclusion: This study shows that Spatz3® IGB treatment is an effective procedure for weight reduction, with no mortality but higher morbidity compared with traditional IGBs. This procedure also enabled the balloon to stay in place for longer. The efficacy of upward adjustment still requires further confirmation.
... The authors comment that those obese patients who lost 80% of their total weight loss during the first 3 mo of the 6-mo treatment, succeeded in maintaining a percent EWL of > 20 long-term after BIB removal: more precisely, this cutoff point was achieved in 83% at the time of removal and in 53%, 27%, and 23% at 12-, 24-, and 60-mo follow-up [13]. Quite similar were the results of a meta-analysis of 7 studies (409 patients) reporting a mean weight loss of 12.9 ± 0.8 kg at 3 mo and 16 ± 0.9 at 6 mo, meaning that 80% of the weight loss was achieved within the first 3 mo of treatment [66]. ...
... Based on this, some argue that a long-lasting balloon such as one with 12 mo lifespan in the stomach (the Orbera365 and the Spatz3) may be more useful since it allows more time for life-style re-education to become habituated [87,88]. On the other hand, it is well known that the greatest weight loss, even up to 80% of the total %EWL, is achieved within the first 3 mo of balloon-life in the stomach; weight loss then continues, but at a reduced percent monthly[13, 66,89]. Thus, a 12-mo lifespan balloon probably offers questionable benefits. ...
Article
Endoscopically placed intragastric balloons (IGBs) have played a significant role in obesity treatment over the last 30 years, successfully bridging the gap between lifestyle modification/pharmacotherapy and bariatric surgery. Since they provide a continuous sensation of satiety that helps the ingestion of smaller portions of food, facilitating maintenance of a low-calorie diet, they have generally been considered an effective and reversible, less invasive, non-surgical procedure for weight loss. However, some studies indicate that balloons have limited sustainable effectiveness for the vast majority attempting such therapy, resulting in a return to the previous weight after balloon removal. In this review we try to summarize the pros and cons of various balloon types, to guide decision making for both the physician and the obese individual looking for effective treatment. We analyzed the six most commonly used IGBs, namely the liquid-filled balloons Orbera, Spatz3, ReShape Duo and Elipse, and the gas-filled Heliosphere and Obalon - also including comments on the adjustable Spatz3, and the swallowable Obalon and Elipse - to optimize the choice for maximum efficacy and safety.
... Most IGBs are oval or round and have a volume of 400-700 ml. IGBs may be filled with a fluid, a gas or a combination of both [25][26][27][28]. The Reshape Duo™ (ReShape Lifesciences™, USA) uses two balloons in order to decrease the risk of balloon migration [29]. ...
Article
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Obesity is a significant problem worldwide. Several serious diseases that decrease patient quality of life and increase mortality (high blood pressure, dyslipidaemia, type 2 diabetes etc.) are associated with obesity. Obesity treatment is a multidisciplinary and complex process that requires maximum patient compliance. Change of lifestyle is fundamental in the treatment of obesity. While pharmacotherapeutic options are available, their efficacy is limited. Surgical treatment though highly effective, carries the risk of complications and is thus indicated mostly in advanced stages of obesity. Endoscopic treatments of obesity are less invasive than surgical options, and are associated with fewer complications and nutritional deficits. Currently, there is a large spectrum of endoscopic methods based on the principles of gastric volume reduction, size restriction and gastric or small bowel bypass being explored with only few available in routine practice. The aim of this publication is to present an up-to-date summary of available endoscopic methods for the treatment of obesity focusing on their efficacy, safety and nutritional aspects.
... The IGB positioning and retrieval were safe, and mortality was absent. Early removal occurred in 6.10% of the patients, mainly due to intolerance, similar to what was observed by Lopez-Nava et al. [10]. Balloon leakage was observed in 32 patients (0.54%), and production of gas enlarging the balloon was observed in 12 (0.20%); both complications were rapidly diagnosed, and IGBs were substituted, allowing the patients to continue the treatment. ...
Article
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Background: Endoscopic methods, especially the intragastric balloon (IGB), have been shown to be effective for the treatment of excess weight. This study aimed to assess the tolerance, complications, and efficacy of excess weight treatment with a non-adjustable IGB during 6 months. Methods: A total of 5874 patients treated with a liquid-filled IGB (600-700 mL) and followed up by a multidisciplinary team were evaluated. Participants presented an initial body mass index (BMI) ≥ 25 kg/m2 and were stratified according to sex and degree of overweight (overweight and obesity grades I, II, and III). Results: The incidence of complications was 7.32% (n = 430): 6.10% (n = 357) early IGB removal, 0.20% (n = 12) gas production inside the balloon, 0.54% (n = 32) leakage, 0.32% (n = 19) pregnancy, 0.07% (n = 4) gastric perforation, 0.05% (n = 3) upper digestive bleeding, 0.01% (n = 1) Wernicke-Korsakoff syndrome due to excessive vomiting, and 0.02% each (n = 1) pancreatitis and esophagus perforation. The 5444 remaining patients (4081 women, 38 ± 38 years) presented a weight loss of 19.13 ± 8.86 kg and a BMI decreased significantly (p < 0.0001) (36.94 ± 5.67 vs. 30.08 ± 5.06 kg/m2). The % total weight loss (%TWL) was 18.42 ± 7.25%, and the % excess weight loss (%EWL) was 65.66 ± 36.24%. The treatment success rate (%TWL ≥ 10%) was 85%. The %EWL was higher in the pre-obese group (122.19%), followed by obesity grades I (76.67%), II (56.01%), and III (45.45%), with p < 0.0001 for each group. %EWL was higher in women (69.71%) than in men (53.39), with p < 0.0001 for each group. There was also a statistical difference between the TWL and EWL groups, with p < 0.001 for all analyses. Conclusion: Endoscopic IGB treatment for excess weight is an excellent therapeutic option for patients with different degrees of overweight.
... In 2015-2016, the prevalence of obesity among the US adults was nearly 40% [2]. The efficacy of intragastric balloons (IGBs) at promoting weight loss has been widely documented in multiple global clinical studies in the past 20 years [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. There is also evidence in the literature to support improvement in obesity-related comorbidities with IGB [11,13,17,[23][24][25][26]. ...
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Background and Objectives Obesity and its related comorbidities are associated with serious health risks. This trial evaluated the safety and effectiveness of the ORBERA® Intragastric Balloon System (IGB) as an adjunct to lifestyle intervention in a post-marketing clinical setting.Methods and MaterialsIn this multicenter study, 258 adults with a body mass index of 30–40 kg/m2 were treated with the IGB as an adjunct to weight reduction and followed for up to 12 months. The primary objective was to demonstrate in a post-marketing clinical setting that the incidence of device and procedure-related serious adverse events (SAEs) after 26 weeks of IGB treatment is no greater than 15%.ResultsThe incidence of device and procedure-related SAEs was 8.9% with a 1-sided upper limit confidence interval of 12.4%, compared with the 9.6% overall SAE rate seen in the US pivotal study; therefore, the primary safety endpoint was met. The key secondary effectiveness endpoint was also met with a mean maximum %TBWL of 12.5 being achieved at the time of IGB removal (26 weeks).Conclusions The post-marketing safety and effectiveness profile of the IGB are consistent with what was observed in the US pivotal study. No new risks were identified.Clinical trial registration: Clinical Trials.gov NCT02828657
... The procedures were standardized, and there was no technical variation between the patients. We have presented our procedure technique in detail in our previous publications [20,22,23]. Post-procedure the patients were followed up at regular intervals by nutritionist, psychologist, and physiotherapist. ...
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Introduction: Endoscopic bariatric therapies (EBT) have demonstrated to induce weight loss and improve comorbidities in obese patients. However, little is known about its impact on health-related quality of life (HRQOL) outcomes and physical activity status. This study aimed to evaluate the change in HRQOL and physical activity following EBT induced weight loss in obese patients. Methods: We approached 181 patients who underwent EBT in a standardized multidisciplinary follow-up program to participate in the study. We provided them two questionnaires-a) Short Form-36 health survey with the physical (PSC) and mental (MSC) summary component scores to capture generic HRQOL, and b) international physical activity questionnaire (IPAQ) for physical activity (PA). We administered the survey at baseline and at 9 months post-procedure. We expressed the procedure outcome as percentage total body weight loss (%TBWL). We expressed continuous variables as mean (SD) or median and categorical variables as percentages. We used non-parametric tests for comparison and performed multivariable linear regression analysis to identify factors associated with improvement in HRQOL. Results: The mean age was 42.2 (11.3) years, and the mean BMI was 38 (5.9)kg/m2. A majority of them were female (n-132, 73%). The EBT included intragastric balloons (n-136, 75%) and endoscopic sleeve gastroplasty (n-24, 25%). The mean %TBWL achieved after the intervention was 16.9 (9.7)%. We noticed a significant improvement in the median PSC (77.8 vs. 90.4, p < 0.001) and MSC (67 vs. 80.2, p < 0.001) scores after EBT. Similarly, we observed a significant positive change in physical activity compared to baseline (1606.2 vs. 2749 MET-minutes/week, p = < 0.001). Linear regression analysis showed an increase in %TBWL was associated with significant improvement in PSC (β = 0.193, p = 0.003) and MSC (β = 0.166, p = 0.02) scores of HRQOL, and likewise, increase in PA was independently associated with improvement in MSC (β = 0.192, p = 0.01). We did not find any difference in outcome based on gender or the type of intervention. Conclusion: EBT improves HRQOL in obese patients regardless of the type of intervention. The weight loss induced by EBT and the improvement in PA positively influence the health outcomes and quality of life.
Article
Current figures from the Robert Koch Institute (RKI) show that in Germany two thirds of men (67 %) and half of women (53 %) are overweight (body mass index >25 kg/m2). Bariatric or metabolic interventions (surgical/endoscopic) for the treatment of obesity and its secondary diseases are currently being performed in increasing numbers. Especially sleeve gastrectomy and bypass surgery play significant roles and are supported by a high level of evidence. With bariatric surgery, effective and permanent weight loss can be achieved. The effects on the metabolically active hormone balance and, thus, on manifest type 2 diabetes mellitus are also favorably influenced. In this paper, current aspects of the above-mentioned procedures are presented.
Thesis
Die Adipositas mit ihren Begleiterkrankungen stellt weltweit ein progredientes Problem dar, für das es bis zum jetzigen Zeitpunkt keine langfristig effektive konservative Therapie gibt. Die einzige nachhaltig erfolgreiche Therapie besteht derzeit in der bariatrischen/metabolischen Chirurgie. Der Roux-Y-Magenbypass ist momentan eines der am häufigsten angewendeten chirurgischen Verfahren zur Therapie der Adipositas, welches zu einem dauerhaften Gewichtsverlust sowie simultaner Therapie der Begleiterkrankungen führt. Trotz der überzeugenden Therapieerfolge kommt es immer wieder zu Komplikationen bzw. einem mangelhaften Ansprechen (Non Responding) auf die Operation. Ziel der Studie war es, mithilfe eines Score-Systems schon präoperativ anhand von bestimmten Variablen das Risiko für ein schlechtes postoperatives Ergebnis bzw. ein Non Responding abzuschätzen. Auf diese Weise sollen in Zukunft mangelhafte Therapieergebnisse und postoperative Komplikationen vermieden bzw. die Nachsorge dementsprechend individuell angepasst werden.
Article
Bariatric and metabolic surgery is the most dynamically developing branch of visceral surgery. This is due to the pandemically increasing number of patients with morbid obesity and the associated subsequent diseases within the metabolic syndrome. These are counteracted by the high effectiveness and safety of surgical procedures for overcoming these diseases including the regression of subsequent diseases. This results in new applications for gastrointestinal endoscopy, which range from the perioperative and procedure-determining diagnostics to overcoming early and late postoperative complications. The altered anatomy makes biliary duct access difficult. Ultimately, endoscopic procedures are in development, which can alleviate metabolic diseases by utilizing experiences from surgery. They can be implemented as a supplement to irreversible surgical procedures in terms of bridging or as an alternative for less severe cases. This review article gives an overview of the current state of the procedures for physicians active in gastrointestinal endoscopy.
Article
Background: Body-mass index (the weight in kilograms divided by the square of the height in meters) is known to be associated with overall mortality. We investigated the effects of age, race, sex, smoking status, and history of disease on the relation between body-mass index and mortality. Methods: In a prospective study of more than 1 million adults in the United States (457,785 men and 588,369 women), 201,622 deaths occurred during 14 years of follow-up. We examined the relation between body-mass index and the risk of death from all causes in four subgroups categorized according to smoking status and history of disease. In healthy people who had never smoked, we further examined whether the relation varied according to race, cause of death, or age. The relative risk was used to assess the relation between mortality and body-mass index. Results: The association between body-mass index and the risk of death was substantially modified by smoking status and the presence of disease. In healthy people who had never smoked, the nadir of the curve for body-mass index and mortality was found at a body-mass index of 23.5 to 24.9 in men and 22.0 to 23.4 in women. Among subjects with the highest body-mass indexes, white men and women had a relative risk of death of 2.58 and 2.00, respectively, as compared with those with a body-mass index of 23.5 to 24.9. Black men and women with the highest body-mass indexes had much lower risks of death (1.35 and 1.21), which did not differ significantly from 1.00. A high body-mass index was most predictive of death from cardiovascular disease, especially in men (relative risk, 2.90; 95 percent confidence interval, 2.37 to 3.56). Heavier men and women in all age groups had an increased risk of death. Conclusions: The risk of death from all causes, cardiovascular disease, cancer or others disease increases throughout the range of moderate and severe overweight for both men and women in all age groups. The risk associated with a high body-mass index is greater for whites than for blacks. (N Engl J Med 341:1097–1105, 1999)
Article
Sixty morbidly obese patients were treated with 88 intragastric balloons. An air-filled intragastric balloon was used, which was permanently connected to an inflation catheter exiting through the nose. Patients were evaluated for loss of body weight and tolerance of the balloon; the balloon was inspected for efficacy and safety. A mean total loss of body weight of 21 kg was obtained after a mean of 39 weeks in 15 men (mean age 37.7 years) and 45 women (mean age 36.2 years), with a mean initial weight of 127.9 kg. The maximum rate of weight loss occurred in the first 6 months, with a steady decrease of 1 kg per week; thereafter the rate declined. Subjective complaints were infrequent and consisted of nasal discomfort or abdominal symptoms. Intolerance in 12 per cent of patients was due to enhanced hunger (one patient), nasal pulling sensation (four patients) and symptomatic ulcer (two patients). Fifteen patients asked for removal of the well functioning balloon after a mean of 169 days; 14 of the 15 balloons were still airtight. Forty balloons failed prematurely. Nine were retrieved orally and 31 were passed per anum, of which 28 passed with mild abdominal cramping, two patients required transabdominal puncture and one needed laparotomy. Even the 40 prematurely removed balloons remained in situ for a mean of 108 days; only one-third showed leakage. As yet, 33 well functioning balloons have been in situ for a mean of 167 days. Well functioning balloons deflated at a rate of 2.3 ml per day. Malfunctioning of the balloon was due to leakage in 12 cases and to clogging of the inflation catheter in three cases. Major complications (8 per cent) included two gastric ulcers and three cases of mild ileus. One ileus patient required surgery (2 per cent). The reported intragastric balloon model is effective and safe. We recommended this type of balloon as a weight reducing adjuvant therapy before bariatric surgery.
Article
The mechanism by which intragastric balloons induce weight loss is not known, although they may act simply by reducing the amount of food needed to induce satiety. The knowledge that a balloon is present may influence the patients' eating patterns and reduce caloric intake and weight. In order to test whether the balloon or the secondary psychological effect caused weight loss, a double blind balloon versus sham procedure was devised with both groups receiving identical outpatient dietary advice (800 kcal/day). Twenty four obese women with body mass index greater than 30 kg/m2 from an obesity clinic were studied. Twelve had the balloon and 12 the sham procedure. The balloon was removed after three months and the patients were followed for a further three months. There was significantly greater weight loss in the balloon group, mean weight loss (SD) of 7.33 (6.12) kg compared with the sham group, mean weight loss (SD) of 3.33 (3.9) kg (p less than 0.05). Weight loss was not maintained in all patients after balloon removal. Side effects were more common in the balloon group (abdominal pain, nausea, and vomiting) but resolved by the second week. We conclude that the intragastric balloon is a safe and effective method of inducing weight loss in well motivated obese patients.
Article
We investigated the effect of an endoscopically placed gastric balloon, the Garren-Edwards gastric bubble (GEGB), on weight loss in obese patients. Fifty-nine obese patients were entered into a prospective double-blind study and randomized into two groups. In one group (34 patients) the GEGB was inserted, and in the other group (25 patients) a sham insertion was done. All patients participated in a standard weight loss program consisting of dietary therapy, behavior modification, and physical exercise. The bubble was removed endoscopically after 3 months from both groups. Patients were followed for an additional 9 months after bubble removal and weight loss was monitored. Weight loss was the same in both groups at 3 months (18.7 lb vs. 17.2 lb). This was true whether determined by change in pounds, percentage of body weight, or body mass index. We concluded that the GEGB was of no added benefit as compared with sham insertion, when combined with a standard weight loss program. Because of the lack of proven efficacy and the relatively high cost, we recommend that such devices be restricted to controlled studies until significant benefits are proven.
Article
In spite of the widespread use of the Garren-Edwards gastric bubble as an adjuvant device in weight reduction, its efficacy has not been established. Therefore, our purpose was to conduct a randomized, double-blind, crossover study of this device in the management of exogenous obesity. The study group consisted of 23 patients, 21 women and 2 men, ranging in age from 21 to 53 yr. Patients were 25%-111% above their ideal body weight. They were studied for 24 wk, consisting of two separate 12-wk evaluation periods. Patients were randomly assigned either to receive the gastric bubble or to have a sham procedure. After the first 12-wk evaluation period, the gastric bubble and sham were administered in crossover fashion, so that those who had received the gastric bubble initially received the sham later and vice versa. The study coordinator remained blind to the kind of treatment, weighed each patient biweekly, enforced dietary counseling, and provided behavior modification. Those who had passed or were found to have a deflated bubble at the end of the treatment period were excluded from the study. Mean weight reduction in the two evaluation periods did not differ significantly. Patients lost 5.4 +/- 1.7 kg (mean +/- SE) during the gastric bubble period and 5.20 +/- 0.8 kg during the sham period. The order of administration of the gastric bubble and sham did not significantly affect the result. The time-course of mean biweekly values, however, revealed that with the gastric bubble, weight loss was significantly greater only during first (p less than 0.005) and second (p less than 0.025) 2-wk evaluation periods. This difference, however, disappeared after the initial 4 wk of treatment. These observations suggest that although gastric bubble implantation reduced weight significantly more than the sham procedure initially, the mean weight loss during 12 wk of evaluation was not different between the two periods. In our opinion, the gastric bubble is of no value as an adjuvant device in weight reduction.
Article
Since its approval by the Food and Drug Administration in September 1985, the Garren-Edwards gastric bubble has been extensively used as an adjunct to diet and behavioral modification in the treatment of exogenous obesity. In an attempt to evaluate the efficacy of the Garren-Edwards gastric bubble, a double-blind crossover study was undertaken. Ninety patients were randomized into three groups: bubble-sham, sham-bubble, and bubble-bubble in two successive 12-wk periods. Sixty-one patients completed the entire 24-wk study. All groups participated in ongoing diet and behavioral modification therapy in a free-standing obesity program, the members of which were blinded to randomization arms. All patient groups lost weight during this study. The mean cumulative weight loss in pounds at 12 wk was as follows: bubble-sham = 19, sham-bubble = 12, and bubble-bubble = 8; and at 24 wk: bubble-sham = 23, sham-bubble = 16, and bubble-bubble = 18. The mean cumulative change in body mass index (kg/m2) at 12 wk was as follows: bubble-sham = -3.1, sham-bubble = -2.3, and bubble-bubble = -2.9; and at 24 wk: bubble-sham = -3.1, sham-bubble = -3.0, and bubble-bubble = -3.3. Although weight loss occurred more consistently in patients with a Garren-Edwards gastric bubble, there were no significant differences between any of the three groups at 12 or 24 wk with respect to weight loss or change in body mass index. The major part of the weight loss noted during this study occurred during the first 12-wk period, irrespective of therapy (bubble or sham). Side effects observed during this study included gastric erosions (26%), gastric ulcers (14%), small bowel obstruction (2%), Mallory-Weiss tears (11%), and esophageal laceration (1%). We conclude that, in this study, the use of a Garren-Edwards gastric bubble did not result in significantly more weight loss than diet and behavioral modification alone in the management of exogenous obesity, and it may result in significant morbidity.