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Patients undergoing intragastric balloon achieve approximately 50% of their target weight loss in the first month postoperatively: a MBSAQIP® analysis
Abstract
Background:
Intragastric balloon (IGB) placement can provide a mean percent total weight loss (%TWL) of 10.2% at 6-month follow-up.
Objectives:
We aimed to evaluate 30-day outcomes and safety of patients undergoing IGB placement.
Setting:
Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.
Methods:
The 2016 to 2017 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program was queried for adult patients who underwent primary IGB placement. Demographic characteristics and preoperative risk factors were collected. Postoperative outcomes included %TWL, percent excess weight loss, and complications rates and causes. Subset analysis was done for outcomes comparison between surgeons or gastroenterologists performing the procedure. Statistical analysis was performed using SPSS 25.0.
Results:
A total of 1221 patients were included. The majority was female (81.9%), Caucasian (81.2%), with a mean age of 48 ± 11.3 years and a mean preoperative body mass index of 34.9 ± 11.2 kg/m2. Of patients, 98.8% were discharged within 24 hours of the procedure. Two patients were admitted to the intensive care unit, and 7.2% received postoperative treatment for dehydration. Reoperation and readmission rates were 1.1% and 7.2%, respectively, mainly due to nausea, vomiting, and poor nutritional status (n = 22). The intervention rate was 6.2%. Patients in this cohort achieved a mean %TWL of 6.2% (standard deviation, 5.52%) and mean TWL of 6.8 kg within 30 days postoperatively (n = 147; 24-30 d).
Conclusions:
Our data show patients met approximately 50% of their target weight loss 30 days after IGB placement. Nausea, vomiting, and poor nutrition status were the most common complications within 30 days of the procedure. Long-term follow-up is necessary to determine if these patients are able to sustain their weight loss and for how long.
... Mild complications can include abdominal pain, dyspepsia, nausea, vomiting, dehydration, and acid reflux. More severe complications, while rare, may involve electrolyte disturbances, small bowel obstruction (SBO), perforation, bleeding, and even death [5][6][7][8]. Meta-analyses of the efficacy and safety of IGBs have reported the incidence of intestinal obstruction associated with IGBs to range from 0.17% to 0.8% [5,9]. Notably, air-filled IGBs carry a higher migration risk and SBO than fluid-filled ones [10,11]. ...
... Small intestinal foreign body obstruction is relatively rare, as most swallowed foreign bodies tend to become lodged in the narrowest segments of the gastrointestinal tract, specifically the oropharynx and esophagus [14,15]. However, cases of small intestinal foreign body obstruction have been documented, particularly involving a partially deflated gastric balloon that migrates distally and becomes lodged in various locations within the small intestine and rarely in the colon [5][6][7][8][9][10][11][12][13]. The clinical presentation generally resembles other bowel obstruction etiologies; however, a history of non-retrieval of an inserted IGB may be indicative, and imaging studies can reveal the presence of a migrated gastric balloon [5][6][7][8][9][10][11][12][13]. ...
... However, cases of small intestinal foreign body obstruction have been documented, particularly involving a partially deflated gastric balloon that migrates distally and becomes lodged in various locations within the small intestine and rarely in the colon [5][6][7][8][9][10][11][12][13]. The clinical presentation generally resembles other bowel obstruction etiologies; however, a history of non-retrieval of an inserted IGB may be indicative, and imaging studies can reveal the presence of a migrated gastric balloon [5][6][7][8][9][10][11][12][13]. Migration can occur anytime post-insertion, although the risk is heightened after six months [5][6][7][8][9][10][11][12]. ...
... Various endoscopic therapies for treatment of overweight and obesity have been developed. These procedures are capable of producing clinically meaningful weight loss, whilst being less invasive with comparable/lower peri-procedural risks as compared to MBS [6]. These procedures are therefore able to fulfil the treatment gap between MBS and conservative measures or pharmacotherapy for treatment of obesity and related co-morbidities. ...
Intra-gastric balloons (IGB) are a mainstay of endoscopic treatment of overweight and obesity. In recent years, an IGB which can remain in situ for 12 months has been developed. The current study aimed to analyse the safety and efficacy of this 12-month IGB.
Consecutive patients receiving the Orbera 365TM IGB (Apollo Endosurgery, TX, USA) between September 2017 and August 2021 were included in a prospective database. Patients received regular follow-up consultations followed by endoscopic removal at 12 months. Demographic data along with weight loss data were collected. All adverse events were recorded.
In total, 1149 patients were included in the study. A majority of the patients were female (87.13%). Median body mass index (BMI) prior to insertion was 36.30 kg/m2 (IQR 32.60–40.00 kg/m2). Median absolute weight loss for all patients was 11.36 kg (IQR 6.70–16.82 kg). There was ongoing sustained weight loss until device removal at week 52. For patients with a weight recording at point of IGB removal, median weight loss was greater (15.88 kg, IQR 10.43–21.72) with percentage total body weight loss of 15.38% (IQR 10.99–21.77) and excess weight loss of 53.99% (IQR 32.44–76.30). Increased patient engagement with post-procedural follow-up was associated with increased weight loss (p<0.001). There were 60 total complications (5.22%). Fifty patients required balloon removal due to intolerance. There were eight cases of balloon rupture. There were only two severe complications (0.17%).
The current study has confirmed safety of this IGB at 12 months with adverse events comparable to published literature. Weight loss increased up until the point of removal at 12 months.
... In a retrospective analysis on 1221 patients by Armijo et al., patients reached 50% of their target weight loss within 30 days of intra-gastric balloon insertion (6.2% TBWL). However, it was also noted that weight loss in the first 30-days after the procedure was most likely due to dehydration [38]. A meta-analysis published by the American society for Gastrointestinal Endoscopy and Bariatric Endoscopy (ASGE) suggested that the Orbera Intra-gastric balloon leads to an overall %TBWL of 13.16% after 6 months [6]. ...
Obesity is a complex metabolic illness that is interrelated to a plethora of complications that predispose to avoidable morbidity and mortality. The considerable impact of obesity has invited various therapies ranging from lifestyle advice, pharmacotherapy, endoscopic bariatric therapy and ultimately surgery. Intragastric balloons are space-occupying therapies that aim to increase satiety through mechanical and neuroendocrine mechanisms. Their prevalence is owed to their ease of administration and general safety. However, long term data concerning safety and efficacy is scarce when considering the various types of balloons in use. In this review, we discuss the intragastric balloon comprehensively in terms of efficacy, safety, limitations and future direction.
... This represents approximately 50% of target weight loss within 30 days of balloon placement. 12 In the authors' experience, balloons result in 30-50 pound weight loss in most patients. Intragastric balloons discussed in this section can be found in Table 2. ...
Obesity poses a significant health care concern in the United States, with 39.8% of adults being classified as obese. Several different methods have been introduced to combat obesity, from medical therapy to surgical options. Bariatric surgery has been demonstrated to be superior to medical therapy alone for weight loss in obese patients. Despite this information, only about 1% of eligible patients undergo bariatric surgery per year. The reason for this treatment gap is multifactorial, but patient apprehension to undergo surgery is a major driving force. Many patients perceive bariatric surgery as dangerous, and believe that living with their current weight is safer than undergoing surgery. To combat this treatment gap, endoscopic therapies have been developed to reach more patients in a less invasive way. This article will review endoscopic treatment options currently available and approved by the Food and Drug Administration, as well as other treatment modalities that are currently in development.
Background:
The efficacy and safety of a fluid-filled intragastric balloon (IGB) for weight loss in cirrhotic patients on the liver-transplant waitlist is unknown.
Methods:
We enrolled stable compensated waitlisted patients with BMI >35 for IGB placement endoscopically for a maximum of 6 months.
Results:
8 patients (7 male), 56 ± 4.6 years with MELDNa 14.1 ± 3.4 experienced weight reduction (146 ± 22.2kg vs.127 ± 21.6kg, p=0.005 with IGB in place and 130±24.6kg, p=0.014 at 6months), with TWBL12.2% ± 8.8% with IGB in place and 10.9± 8.9% ITT at 6 months. Body fat decreased from 48.6% ± 5.8% to 40.6% ± 6.4% (p=0.001) and lean mass increased from 51.3% ± 6% to 59.4% ± 6.4% (p=0.001). No change in MELDNa occurred (p=0.77). Early balloon retrieval was due to accommodative symptoms (n=2) and liver decompensation (n=1). Mallory-Weiss tears (n=3) but no portal hypertensive bleeding occurred. Liver decompensation and/or HCC developed in 3 patients. 4 with liver transplantation ±sleeve gastrectomy maintained overall weight loss. 2/4 without transplant experienced weight regain.
Conclusion:
IGB results in short-term weight loss in cirrhotic patients awaiting liver-transplantation, with body fat loss without lean mass loss. Side effects were common. Decompensation and HCC did occur, with uncertainty of the relation to weight loss, thus careful patient selection and close followup is required.
Background
Obesity is an important risk factor for several chronic diseases and also is associated with worse quality of life. Intragastric balloon (IGB) is an effective method for weight loss. Although changes in lifestyle are critical to weight loss during and after IGB therapy, only a few studies evaluated dietary intake and none evaluated changes in physical activity with a validated questionnaire during the treatment. The aim of this study was to evaluate changes in total and central body adiposity, dietary intake, physical activity, and quality of life of patients with obesity submitted to IGB treatment for 6 months.
Methods
Prospective observational study involving 42 patients with obesity using IGB for 6 months. The patients were evaluated, on the day of insertion and withdrawal or adjustment of IGB for total and central body adiposity (anthropometry and bioelectrical impedance), dietary intake, physical activity (Baecke questionnaire), and quality of life (SF-36 questionnaire).
Results
There was a significant decrease in total and central body adiposity. The mean % total weight loss and % excess weight loss were 15.88 ± 1.42 and 56.04 ± 4.90, respectively and waist circumference decreased 13.33 ± 1.39 cm. There was a reduction in energy intake, an increase in physical activity, and an improvement of quality of life during IGB treatment.
Conclusion
The present study suggests that IGB treatment during 6 months in individuals with obesity is effective for decreasing total and central body adiposity being associated with reduction in energy intake, increase in physical activity, and improvement in quality of life.
Background:
Laparoscopic bariatric surgery (LBS) is effective for severe obesity but is invasive and costly. Intragastric balloons (IGBs) are increasingly popular as an alternative to LBS with modest short-term weight loss. However, IGBs are associated with complications and a comparison of the safety of IGB to LBS is warranted.
Objectives:
The objective of this study was to compare the safety profile of IGB with LBS through analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database.
Setting:
The MBSAQIP collects data from 791 bariatric surgery centers in the United States and Canada.
Methods:
A propensity-matched analysis was performed between IGB and LBS. Multivariable logistic regression analysis was performed to determine if IGBs were independently associated with adverse outcomes.
Results:
A total of 145,408 patients were included, of which 144,627 (99.5%) underwent LBS and 781 (0.5%) underwent IGB therapy. With one-to-one propensity score matching, 684 pairs of IGB and LBS patients were selected. Multivariable logistic regression found that IGB (odds ratio 1.97, confidence interval 1.10-3.52, P = .023) was independently predictive of 30-day adverse outcomes. This was due to a significantly higher nonoperative reintervention rate in the IGB cohort (4.2% versus 1.0%, P < .001) from early balloon removal (2.8%).
Conclusions:
In this propensity-matched analysis, IGBs were associated with a higher adverse event rate than LBS, due to a 4-times higher nonoperative reintervention rate. The utility of IGB as a primary weight loss intervention should be reconsidered due to its poor safety profile compared with LBS.
Purpose of review:
In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data.
Recent findings:
Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.
Background
Intragastric balloons (IGBs) are a minimally invasive option for obesity treatment, acting as a space-occupying device and leading to weight loss through increased satiety. This device has been growing in popularity owing to its safety profile and good weight loss results. However, there are no published guidelines that standardize the technical aspects of the procedure.
Objectives
To create a practical guideline for intragastric balloon usage.
Setting
Private and Academic Settings, Brazil.
Methods
A consensus meeting was held in São Paulo, Brazil, in June 2016, bringing together 39 Brazilian endoscopists with extensive experience in IGBs from all regions of the country. Topics on patient selection, indications, contraindications, multidisciplinary follow-up, technique, and adverse events were discussed in the form of questions. After electronic voting, a consensus was defined when there was ≥70% agreement. Experts were also requested to provide data on their experience with IGBs.
Results
The selected experts discussed and reached a consensus on 76 questions, mainly concerning specific indications and contraindications for the procedure; technical details, such as patient preparation, minimum balloon-filling volume, techniques for implant and explant; patient follow-up and recommended medication for the adaptation period; and adverse event management. The overall Brazilian expert data encompassed 41,863 IGBs, with a mean percentage total weight loss of 18.4% ± 2.9%. The adverse event rate after the adaptation period was 2.5%, the most common being hyperinflation (.9%) and spontaneous deflation (.8%) of the device. The early removal rate due to intolerance was 2.2%.
Conclusions
The present consensus represents practical recommendations for performing IGB procedures and reflects Brazil’s significant experience with this device. The experience of over 40,000 cases shows that the device leads to satisfactory weight loss with a low rate of adverse events.
Background:
Gastric balloons for weight loss have historically been placed after a screening endoscopy. However, the utility and yield of these endoscopies has not been studied. Therefore, we wanted to evaluate the utility of screening endoscopy and to assess patients who had balloons placed without endoscopy.
Methods:
Data was collected on two cohorts. Cohort 1 consisted of patients who had a screening endoscopy prior to or upon balloon placement. Cohort 2 consisted of patients who were followed after having a balloon placed under fluoroscopic guidance without endoscopy. Balloon intolerance and findings on removal endoscopy were assessed in both cohorts.
Results:
In cohort 1 (n = 253), two patients had severe symptoms on history; balloon placement was contraindicated based on screening endoscopy findings. Eleven patients with a history of hiatal hernia and the presence of severe belching demonstrated an insignificant hiatal hernia on endoscopy. In cohort 2 (n = 50), all patients had an unremarkable history. Three previously asymptomatic patients had balloon intolerance and one was found to have a 4-cm hiatal hernia and oesophagitis upon balloon removal. Out of 194 patients, 25 were either intolerant to the balloon or had relevant findings on removal endoscopy. Findings on screening endoscopy did not correlate with balloon intolerance or findings on removal endoscopy.
Conclusion:
These results demonstrate that a careful history can identify patients who may have contraindications for balloon therapy and that balloons can be placed safely after taking a careful history without screening endoscopy. Screening endoscopy may not be useful in predicting balloon intolerance or potential complications.
Introduction:
There are only few reports regarding the use of intragastric-balloons (IGB®) to achieve weight loss and subsequently decrease surgical complications. In this study, we try to assess whether presurgery weight loss using IGB decreases the postsurgical mortality after bariatric surgery.
Methods:
This is a prospective case-control study. We matched 1:1 by gender, age (± 10 y-o) and type of surgery (sleeve resection [LSG] or gastric bypass [LGBP]), matching cases (A) and controls (H, from a historic cohort). Morbidly obese patients with an indication for bariatric surgery were included in the study. Cases (A) were recruited from an ongoing clinical trial, and the controls (H) came from a historic cohort prior to the start of the clinic trial. The presurgical weight loss in group A was reached by IGB combined with diet, versus only diet in group H.
Results:
We included 58 patients, 65.5% women, 69% LGBP/31% LSG. The mean age of group A was 42 and 43.4 years old for group H. ASA III of 24.1% group A vs 58.6% group H, p = 0.012. The mean total weight loss (TWL) before surgery was greater in group A (16.2 kg, SD 9.75) than in group H (1.2 kg, SD 6.4), p < 0.0001. The % of EWL before surgery was 23.5 (SD 11.6) in group A vs 2.4 (SD 8) in group H, p < 0.001. Hospital stay was seven days for group A, and eight days for group H, p = 0.285. The rate of unsuccessful IGB treatment to accomplish the scheduled weight loss was 34.5%. The balloon morbidity was 17.2% (6.9% severe). All in all, morbidity (due to bariatric surgery and IGB) was 41% in both groups. Postsurgical morbidity moderate-severe was 20.3% in group A (6.9% severe) and 27.3% in group H (17.2% severe) without statistical significance. One patient died in group H (mortality rate, 3.44%).
Conclusion:
Preoperative IGB treatment in morbid obesity has not been found to be effective at decreasing postsurgical morbidity LSG and LGBP, despite the fact that it acheives a greater weight loss than diet and exercise.
Obesity and its associated metabolic diseases including diabetes mellitus are severe medical problems that are increasing in prevalence worldwide and result in significant healthcare expenses. While behavioral and pharmacological treatment approaches are partly effective in the short term, their effects are not long-lasting. Although previous studies have described bariatric surgery as the most effective treatment for obesity, it is associated with morbidity, mortality, and economic burden. Endoluminal interventions performed entirely using gastrointestinal flexible endoscopy offer alternative approaches to the treatment of obesity that are safer and more cost-effective than current surgical approaches. The use of endoluminal techniques in the field of metabolic obesity disease has diverse promising applications including endoscopic gastroplasty, intragastric balloon, endoluminal malabsorptive bariatric procedures, and gastric electrical stimulation (GES) for the modulation of gastric emptying. This review discusses recent trends and roles in endoscopic bariatric therapies using the currently available endoluminal and transgastric technologies.
Significant uncertainty remains regarding the effects of obesity on the mortality levels of individuals and of populations. In this article, we describe some of the analytic sources of that uncertainty. We illustrate the effects of major biases and threats to generalizability that are commonly encountered in observational studies of the mortality risks of obesity. Our preferred model requires no sample exclusions and uses lifetime maximum body mass index to address several biases. Compared to people of normal weight, this model produces excess mortality levels associated with overweight, obese class I, and obese class II individuals of 5, 23, and 59 percent. We estimate that 16.2 percent of US adult deaths are attributable to overweight and obesity. Among the alternative models examined, the association between excess weight and mortality was most significantly underestimatedwhen body mass index at the time of survey was used. Using this model, only 5.5 percent of deaths were attributed to overweight/ obesity. The highest relative risks of death associated with obesity were estimated when the sample was restricted to never-smokers: 35.6 percent of deaths among never-smokers were attributed to overweight/ obesity. While these estimated risks are too high for the current population as a whole, they prefigure a growing role for obesity in the national mortality profile as smoking continues to decline.
Background:
Super obese patients are recommended to lose weight before bariatric surgery. The effect of intragastric balloon (IGB)-induced weight loss before laparoscopic gastric bypass (LGBP) has not been reported. The aim of this prospective randomized multicenter study was to compare the impact of preoperative 6-month IGB with standard medical care (SMC) in LGBP patients.
Methods:
Patients with BMI >45 kg/m(2) selected for LGBP were included and randomized to receive either SMC or IGB. After 6 months (M6), the IGB was removed and LGBP was performed in both groups. Postoperative follow-up period was 6 months (M12). The primary endpoint was the proportion of patients requiring ICU stay >24 h; secondary criteria were weight changes, operative time, hospitalization stay, and perioperative complications.
Results:
Only 115 patients were included (BMI 54.3 ± 8.7 kg/m(2)), of which 55 underwent IGB insertion. The proportion of patients who stayed in ICU >24 h was similar in both groups (P = 0.87). At M6, weight loss was significantly greater in the IGB group than in the SMC group (P < 0.0001). Three severe complications occurred during IGB removal. Mean operative time for LGBP was similar in both groups (P = 0.49). Five patients had 1 or more surgical complications, all in the IGB group (P = 0.02). Both groups had similar hospitalization stay (P = 0.59) and weight loss at M12 (P = 0.31).
Conclusion:
IGB insertion before LGBP induced weight loss but did not improve the perioperative outcomes or affect postoperative weight loss.
Background and Objectives:
Current treatments for overweight adults include reduced-calorie diet, exercise, behavior modification, and selective use of medications. Many achieve suboptimal results with these measures and progress to obesity. Whether the intragastric balloon (IGB), a reversible device approved for treatment of obesity, is a safe and effective option in overweight adults is less well studied. We conducted a study to prospectively analyze the safety and effectiveness of IGB in overweight adults, to compare the results to a simultaneously studied cohort of obese patients, and to share procedural tips for safe IGB placement and removal.
Methods:
One hundred thirty-nine patients were evaluated in this prospective, nonrandomized study. Twenty-six overweight [body mass index (BMI), 26–30)] and 113 obese (BMI > 30) patients underwent outpatient, endoscopic IGB placement under intravenous sedation. The IGB was filled with a 550–900 mL (average, 640 mL) solution of saline, radiological contrast, and methylene blue, with an approximate final proportion of 65:2:1. The patients were followed up at 1–2 weeks and then monthly for 6 months. At 6 months, they underwent IGB removal via an esophageal overtube to optimize safety, and then they were observed for 6 more months.
Results:
IGB time was 190 ± 36 d in the overweight patients and 192 ± 43 d in the obese patients. Symptoms of IGB intolerance included nausea and pain, which were transiently present in 50–95% of patients for several days, and necessitated early IGB removal in 6% of patients. There were no procedure-related complications and no IGB-related esophagitis, erosion, perforation, or obstruction. The percentage of excess weight loss (EWL%) was 96 ± 54% in the overweight group and 41 ± 26% in the obese group (P < 0.001).
Conclusion:
In overweight adults failing standard treatments, IGB placement for 6 months had an acceptable safety profile and excellent weight loss.
The aim of the present study was to compare differential impacts of bariatric surgery and exercise-induced weight loss on excessive abdominal and cardiac fat deposition.
Excessive fat accumulation around the heart may play an important role in the pathogenesis of cardiovascular disease. Recent evidences have suggested that bariatric surgery results in relatively less decrease in epicardial fat compared with abdominal visceral fat and paracardial fat.
Sixty-four consecutive overweight or obese subjects were enrolled in the study. Clinical characteristics and metabolic profiles were recorded. The volumes of abdominal visceral adipose tissue (AVAT), abdominal subcutaneous adipose tissue (ASAT), epicardial (EAT), and paracardial adipose tissue (PAT) were measured by computed tomography in the bariatric surgery group (N = 25) and the exercise group (N = 39) at baseline and 3 months after intervention. Subjects in both the surgery and exercise groups showed significant reduction in body mass index (15.97%, 7.47%), AVAT (40.52%, 15.24%), ASAT (31.40, 17.34%), PAT (34.40%, 12.05%), and PAT + EAT (22.31%, 17.72%) (all P < 0.001) after intervention compared with baseline. In both the groups, the decrease in EAT was small compared with the other compartments (P < 0.01 in both groups). Compared with the exercise group, the surgery group had greater loss in abdominal and cardiac visceral adipose tissue (AVAT, ASAT, PAT, EAT+PAT) (P < 0.001), but lesser loss in EAT (P = 0.037).
Compared with the exercise group, bariatric surgery results in significantly greater percentage loss of excessive fat deposits except for EAT. EAT, but not PAT, was relatively preserved despite weight reduction in both the groups. The physiological impact of persistent EAT deserves further investigation.
Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake.
To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone.
Academic and community practice, United States.
Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment.
Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%).
The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.
Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Background:
Weight regain after weight loss is a common problem for all those obese or overweight who have had a recent weight loss. Different cures such as diet therapy, behavioral therapy, exercise or a mixture of them have been advised as solutions. The purpose of this review is to find the best diet or eating pattern to maintain a recent weight loss.
Materials and Methods:
We searched in PubMed and SCOPUS by using the following key words: Overweight, obesity, weight maintenance, weight regain, and diet therapy. Finally, we assessed 26 articles in the present article.
Results:
Meal replacement, low carbohydrate-low glycemic index (GI) diet, high protein intake, and moderate fat consumption have shown some positive effects on weight maintenance. However, the results are controversial. A Dietary Approach to Stop Hypertension (DASH)-type diet seems helpful for weight maintenance although the need for more study has remained. Some special behaviors were associated with less weight regain, such as, not being awake late at night, drinking lower amount of sugar-sweetened beverages, and following a healthy pattern. Some special foods have been suggested for weight maintenance. However, the roles of specific foods are not confirmed.
Conclusion:
Healthy diets recommend low carbohydrate, low GI, and moderate fat foods, but it is not clear whether they are useful in preventing weight gain. It seems that consuming fewer calories helps people to keep weight loss. Further research to find strategies in obesity management focusing on successful maintenance of weight loss is needed.
Aim of this study is to compare the efficacy of BioEnterics Intragastric Balloon (BIB®) followed by diet with BIB followed by another BIB. A prospective study was designed: a homogeneous group of 100 obese patients (age range 25-35, BMI range 40.0-44.9, M/F ratio 1/4) was allocated into two groups according to procedure: BIB (6 months) followed by diet therapy (7 months; group A = 50 pts), BIB positioning followed by another BIB after 1 month (group B = 50 pts). Baseline demographics were similar in both groups (Group A 10M/40F; mean age 31.4 ± 2.6; range 25-35; mean weight 106.3 ± 12.5 Kg; range 88-150; mean BMI 42.6±2.7 Kg/m(2); range 40.2-43.8; Group B 10M/40F; mean age 32.1 ± 2.1; range 25-35; mean weight 107.1 ± 11.9 Kg; range 90-150; mean BMI 42.9 ± 2.3; range 40.2-43.9). In both groups, weight loss parameters (Kg, BMI, and % EBL) were considered. Statistics were by Fisher's exact test (p < 0.05 was considered significant). At the time of 1st BIB removal, weight loss parameters in both groups were not significantly different: Group A: mean weight was 83.7±19.1 (range 52-151); mean BMI 34.2 ± 3.9 (range 32.4-43.8); and mean %EBL 43.5 ± 21.1 (range 0-68). Group B: mean weight was 84.9 ± 18.3 (range 50-148); mean BMI 34.8 ± 3.3 (range 32.4-43.8); and mean % EBL 45.2 ± 22.5% (range 0-68). At the study end, weight loss parameters were significantly lower in patients who underwent consecutive BIB (p < 0.05): mean BMI was 30.9 ± 7.2 Kg/m(2) (range 24-40), and 35.9 ± 9.7 Kg/m(2) (range 34-42); mean % EBL was 51.9 ± 24.6% (range 0-100) and 25.1 ± 26.2% (range 0-100) in group B and A, respectively. As compared with diet, a second intragastric balloon can be positioned without difficulties, achieving good results with continuous weight loss.
The intragastric balloon is a temporary treatment for obese patients. Fluid-filled devices have shown efficacy and safety, and are widely used. Recently, although there are no comparative studies between them, an air-filled balloon, Heliosphere® bag, has been proposed. Prospective, double-blind study in 33 patients with morbid and type 2 obesity: 23 female, 43.9±10 years, 120.3±17 kg, and body mass index (BMI) of 44.2±5 kg/m2, placing 18 gastric balloons filled with 960 cm3 of air (Heliosphere® bag) or 15 balloons filled with 700 ml of saline (Bioenterics-BIB®). Both balloons were placed with conscious sedation and removed under general anesthesia 6 months later. Intravenous drugs were given to control symptoms for 48 h. Patients were sent home on a 1000-kcal diet, multivitamin supplements, and oral proton pump inhibitors, and were followed monthly. Complications, symptoms, weight, and quality of life evaluated by the Gastrointestinal Quality of Life Index (GIQLI) scale were recorded. At 6 months, mean weight loss (12.8±8 vs 14.1±8 kg), BMI loss (4.6±3 vs 5.5±3 kg/m2) and percent excess weight loss (27±16 vs.30.2±17) showed no significant differences between both groups. At removal, two Heliosphere® bags were not found in the stomach, and four patients required extraction of the balloon by rigid esophagoscopy or surgery (p=0.02). Tolerance was good in both groups, but early removal occurred in three BIB® (20%) due to vomits and dehydration. The GIQLI total scores remained unchanged. Both balloons achieve a significant weight loss with good tolerance in obese patients. Nevertheless, Heliosphere® bag has severe technical problems that need to be solved before recommending it.
Saline-filled intragastric balloons (IB) may be inserted for 6 months to promote weight loss. We aimed to assess potential benefits of repeating IB therapy.
One hundred eighteen consecutive subjects (median body mass index, 34.0 kg/m(2); interquartile range [IQR], 31.2-36.9) treated with IB were included in a prospective non-randomized multicenter study.
Nineteen (16%) subjects had repeat IB therapy at their own request, either to prolong first treatment (n = 8) or after a IB-free interval (n = 11). Higher weight loss 3 months after first IB insertion independently predicted repeat therapy (P = 0.008). Median weight loss in subjects who had repeat therapy was lower with second vs first IB (9.0 vs 14.6 kg; 30.4% vs 49.3% excess weight [EW]; P = 0.003). Compared to subjects with single treatment (n = 99), those with repeat treatment (n = 19) had greater weight loss at first IB extraction (14.6 vs 11.0 kg; 49.3% vs 30.7% EW; P = 0.026) and 1 year later (12.0 vs 6.0 kg; 40.9% vs 20.8% EW; P = 0.008) but the difference became less than 2 kg starting at 3 years. At final follow-up (4.9 years; IQR, 3.4-6.7), the whole subject population had lost a median of 2.0 kg (IQR, -3.0 to 10.3) or 6.2% EW (IQR, -8.1 to 31.6) and identical proportions of subjects with single/repeat treatment had >or=10% baseline weight loss (26%) or bariatric surgery (32%).
Higher weight loss at 3 months independently predicted repeat IB therapy; weight loss with the second IB was lower compared to first IB. Repeat treatment had no effect on proportions of subjects with >or=10% baseline weight loss or bariatric surgery at final follow-up.
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.
The authors investigated the usefulness of preoperative treatment with the BIB intragastric balloon in super-obese patients before undergoing laparoscopic adjustable gastric banding (LAGB).
The case-control study involved 43 case patients treated with the intragastric balloon followed by LAGB ("Case" group) and 43 sex-, age- and BMI-matched historical controls treated with LAGB alone.
Mean length of the intragastric balloon treatment was 164.4+/-39.7 days, with a fill volume of 609+/-95 ml. Total complication rate with balloon was 7.0% and percent excess weight loss (%EWL) was 26.1 +/- SD 9.3 %. At the time of gastric band placement, both operative time and hospital stay were shorter in patients treated previously with the balloon (Case group) than in the Control group patients. No Case patients required conversion to open surgery or had intraoperative complications. In the Control group, the rate of conversion was 16.3% (P<0.05) and the rate of intraoperative complications was 7.0%. Postoperative follow-up length was 1.1+/-1.0 years in Case patients and 4.4+/-1.8 years in Control patients (P<0.001). The %EWL produced by the intragastric balloon in the Case patients was identical to the %EWL observed in the first 6 months after LAGB in the Control group (26.1+/-9.3 vs 25.3+/-12.4%). %EWL 6 months after banding was higher in the Case patients than in Controls (33.6+/-12.5 vs 25.3+/-12.4%, P<0.01). However, no significant difference in %EWL between the two groups was observed at the subsequent postoperative evaluations.
Preoperative treatment with the intragastric balloon reduced the risk of conversion to open surgery and the risk of intraoperative complications in super-obese patients treated with LAGB. Preoperative treatment with the intragastric balloon did not change the total weight loss after LAGB.
Objectives:
This systematic review and meta-analysis was performed to examine the rates of nausea and vomiting along with other common side effects reported from different subtypes of intragastric balloons (IGBs) placed in obese adults.
Methods:
The online databases of Pubmed, Cochrane Database, and Web of Science were searched to include studies conducted from 09/31/2012 to 09/31/2017 in English using keywords to identify articles relevant to this study. Two independent reviewers performed a full text review to ensure quality of studies and report rates of primary end point of interest: nausea and vomiting post IGB placement.
Results:
Ten studies fulfilled the inclusion criteria. The treatment group's sample size comprised of 688 patients and adverse events' sample size comprised of 938 patients. We evaluated rates of nausea and vomiting of four subtypes of IGB systems: Elipse, Obalon, ORBERA, and ReShape and calculated meta-analytic rates based on adverse events' sample size. Total 564 patients reported experiencing nausea which provided a meta-analytic rate of 63.33% (95% CI 61.49% - 65.16%), and 507 patients reported experiencing vomiting which resulted in a meta-analytic rate of 55.29% (95% CI 53.59% - 56.99%). The ORBERA balloon system had the highest rates of nausea and vomiting compared to other balloon systems.
Conclusions:
Based on the findings from previous studies scrutinizing side effects of different types of IGB offered on the market, it has been concluded that nausea and vomiting are very common side effects post gastric balloon placement.
Background/objectives:
This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.
Subjects/methods:
In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30–40 kg m⁻² were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.
Results:
At 6 months, weight loss was −3.3% of total body weight (−3.2 kg) in the lifestyle arm vs −10.2% (−9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was −3.4% (−3.2 kg) vs −9.1% (−8.8 kg, P⩽0.001); and at 12 months, −3.1% (−2.9 kg) vs −7.6% (−7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.
Conclusions and relevance:
Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.
The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in % EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%16.73%), 13.16% (95% CI, 12.37%13.95%), and 11.27% (95% CI, 8.17%14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.
Extreme obesity increases morbi-mortality in bariatric surgery. We previously showed that significant weight loss can be obtained within 3 months in super-super obese patients (BMI > 60 kg/m(2)) with an intragastric balloon (IGB). Here, we explored the potential benefit of preoperative IGB on the outcome of laparoscopic gastric bypass (LGBP) in super-super obese patients.
In this case-control study, we compared the records of 60 consecutive super-super obese patients (66.5 ± 3.4 kg/m(2)) submitted to a LGBP between 2004 and 2009, with preoperative IGB (n = 23, cases) or without (n = 37, controls). We analyzed the clinical outcome of surgery and a composite end point of significant adverse events defined as the presence of at least one of the following conditions: conversion to laparotomy, intensive care unit stay for more than 2 days, and overall hospital stay superior to 2 weeks.
All baseline clinical and biological characteristics were homogenous between both groups. IGB was maintained during 155 ± 62 days and induced a loss of 5.5 ± 1.3 kg/m(2) (11.2 ± 3.2% of excess body mass index) at the time of LGBP, associated with a decrease in systolic blood pressure and gamma-glutamyl transpeptidase level (p < 0.05 vs. baseline). Operative time was lower in the IGB group (146 ± 47 vs. 201 ± 81 min in controls; p < 0.01). Significant adverse events occurred less frequently after LGBP in the IGB group (2 vs. 13 in controls; p < 0.05). All patients were alive at 1 year and overall weight loss was similar in both groups (52.4 ± 17.3 vs. 50.3 ± 12.7 percent of excess BMI loss in controls; NS).
IGB prior to LGBP in super-super obese patients significantly reduced excess BMI. It was associated with a shorter operative time and a lower overall risk of significant adverse outcomes.
The BioEnterics Intragastric Balloon (BIB) has been considered an effective, less invasive method for weight loss, as it provides a permanent sensation of satiety. However, various non-randomized studies suggest BIB is a temporary anti-obesity treatment, which induces only a short-term weight loss. The purpose of this study was to present data of 500 obese who, after BIB-induced weight reduction, were followed up for up to 5 years.
The BioEnterics BIB was used, and remained for 6 months. At 6, 12, and 24 months post-removal (and yearly thereafter), all subjects were contacted for follow-up.
From 500 patients enrolled, 26 were excluded (treatment protocol interruption); 474 thus remained, having initial body weight of 126.16 ± 28.32 kg, BMI of 43.73 ± 8.39 kg/m2, and excess weight (EW) of 61.35 ± 25.41. At time of removal, 79 (17%) were excluded as having percent excessive weight loss (EWL) of <20%; the remaining 395 had weight loss of 23.91 ± 9.08 kg (18.73%), BMI reduction of 8.34 ± 3.14 kg/m2 (18.82%), and percent EWL of 42.34 ± 19.07. At 6 and 12 months, 387 (98%) and 352 (89%) presented with weight loss of 24.14 ± 8.93 and 16.31 ± 7.41 kg, BMI reduction of 8.41 ± 3.10 and 5.67 ± 2.55 kg/m2, and percent EWL of 42.73 ± 18.87 and 27.71 ± 13.40, respectively. At 12 and 24 months, 187 (53%) and 96 (27%) of 352 continued to have percent EWL of >20. Finally, 195 of 474 who completed the 60-month follow-up presented weight loss of 7.26 ± 5.41 kg, BMI reduction of 2.53 ± 1.85 kg/m2, and percent EWL of 12.97 ± 8.54. At this time, 46 (23%) retained the percent EWL at >20. In general, those who lost 80% of the total weight lost during the first 3 months of 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-month follow-up.
BIB seems to be effective for significant weight loss and maintenance for a long period thereafter, under the absolute prerequisite of patient compliance and behavior change from the very early stages of treatment.
Obesity threatens to become the foremost cause of chronic disease in the world. Being obese can induce multiple metabolic abnormalities that contribute to cardiovascular disease, diabetes mellitus, and other chronic disorders. Unfortunately, prevalence of obesity is increasing both in the United States and worldwide. Reasons for the rising prevalence include urbanization of the world's population, increased availability of food supplies, and reduction of physical activity. Although severe obesity has received much attention in the clinical setting, most obesity in the general public is only moderate. Even so, moderate obesity can elicit several metabolic abnormalities that are precursors to chronic disease. Therefore, for the population as a whole, moderate obesity is responsible for most obesity-related disorders. Moderate obesity is undoubtedly multifactorial in origin, and acquired influences probably exceed genetic factors in its causation. These acquired causes thus deserve greater attention in the development of a public health strategy for the control of overweight in the general population. A major public health effort is urgently needed to counter the increasing frequency of moderate obesity in the United States and throughout the world.
Obesity is recognized as a serious, chronic illness affecting all ages. The cause for obesity is multi-factorial, which makes successful management complex and challenging. Meaningful weight loss is frequently difficult to achieve, particularly when the goal is not merely to lose weight but to maintain this loss. The efficacy of future endoscopic approaches needs to be validated through well-designed controlled studies, and verification of safety is essential. Endoluminal therapies must have a sound physiologic basis for their development. The availability of specialized radionuclide imaging of gastric capacity and accommodation provide a useful tool in constructing interventions. Endotherapy is likely best suited for nonmorbid obese individuals with BMI ranging from 30 to 39 or as a budge to bariatric surgery. This specific BMI range has been targeted by the National Institutes of Health for emerging technologies. Presurgical weight loss to reduce surgical risk is another potential target group. Regardless of which endoscopic methods prevail, patients will continue to require a comprehensive, multi-modality management approach to this complex disease.
Differential effects of bariatric surgery versus exercise on excessive visceral fat deposits.
- Wu F.Z.
- Huang Y.L.
- Wu C.C.
ORBERA™ Intragastric Balloon System (ORBERA™)
- Apollo Endosurgery