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Endoscopic bariatric therapy consists of devices or procedures for primary weight loss or weight regain after Roux-en-Y gastric bypass that are placed or done endoscopically. In most cases, they result in less weight loss, but fewer complications than bariatric surgery; and more weight loss than lifestyle therapy or weight loss medications. These therapies are important advances to treat patients with obesity. This article focuses on therapies or devices with US Food and Drug Administration approval or those with current or planned US pivotal trials., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Obesity remains a tremendous public health, clinical, and scientific challenge globally. Conventional approaches in the management of obesity offer limited potential for sustained weight loss. Bariatric surgery, although it represents the most effective weight loss treatment, has its own risks and is associated with substantial costs and limited patient applicability. Endoscopic weight loss procedures are considered as the major breakthrough in the management of obesity. Endoluminal interventions performed entirely through the gastrointestinal tract have evolved as a result of an attempt to replicate some of the anatomical features and the physiological effects of the traditional weight loss surgery while being reversible, less invasive, and more cost-effective. Restrictive procedures act to decrease gastric volume by space-occupying devices and/or by suturing or stapling techniques that alter gastric anatomy, whereas malabsorptive procedures tend to create malabsorption by preventing food contact with the duodenum and proximal jejunum. Other procedures act by influencing gastric function (gastric botulinum injections, gastric pacing, and vagal nerve blocking) or by gastric aspiration. It is important to underline that the majority of endoscopic weight loss procedures are still being evaluated and are not yet available routinely. Even though some of the techniques and devices that have recently emerged have demonstrated promising short-term results, evidence on their safety and long-term efficacy from well-designed and well-conducted research should be given before they can become an inherent part of everyday clinical practice. Given the rapid development of endoscopic weight loss procedures, this review considers the current state and recent trends in endoscopic management of obesity., (© The Author(s) 2016.)

Older models of intragastric balloons (IGBs) had unacceptably high complication rates and inconsequential weight loss. With FDA approval of newer models, we aimed to systematically examine the literature regarding the efficacy of IGB therapy for obesity. A comprehensive electronic database search was completed. Title searching was restricted to the following keywords: bariatric, gastric, gastric bypass, gastric band, sleeve gastrectomy, and intragastric balloon. Twenty-six primary studies (n = 6101) were included. At balloon removal, mean change in weight and BMI were 15.7 ± 5.3 kg and 5.9 ± 1.0 kg/m(2). The most common complications were nausea/vomiting (23.3 %) and abdominal pain (19.9 %). Serious complications were rare: mortality (0.05 %) and gastric perforation (0.1 %). IGBs are associated with marked short-term weight loss with limited serious complications.

Background: Intragastric balloons (IGBs) are safe and effective in inducing weight loss in obese patients. The objective of this study was to review and analyze the available data of the effect of IGB on markers of nonalcoholic fatty liver disease (NAFLD) and liver enzymes., Methods: Searches were performed of MEDLINE and Embase databases from inception through January 2016. Study inclusion criteria were the following: ≥5 overweight or obese adult patients undergoing intragastric balloon placement, with liver tests [alanine aminotransferase (ALT) or gamma-glutamyl transpeptidase (GGT)] or markers of NAFLD (e.g., imaging, biopsy) reported before balloon insertion and after balloon removal at 6 months., Results: Nine observational studies and one randomized trial were identified. ALT decreased by -10.02 U/l (95 % CI, -13.2, -6.8), GGT decreased by -9.82 U/l (95 % CI, -12.9, -6.8), and BMI decreased by -4.98 kg/m(2) (-5.6, -4.4) with IGB therapy. Hepatic steatosis improved from baseline after 6 months of balloon therapy by magnetic resonance imaging (fat fraction, 16.7 ± 10.9-7.6 ± 9.8, p = 0.003), ultrasound (severe liver steatosis, 52-4 %, p < 0.0001). Histological NAFLD activity score was lower after 6 months of IGB versus control with sham endoscopy and diet (2 ± 0.75 vs. 4 ± 2.25, p = 0.03)., Conclusion: The use of intragastric balloon decreases liver enzymes and is potentially an effective short-term treatment for NAFLD as part of a multidisciplinary approach. Larger, more rigorous trials are needed to confirm the effect of IGBs on NAFLD.

Obesity and its comorbidities - including diabetes and obstructive sleep apnea - have taken a large and increasing toll on the United States and the rest of the world. The availability of commercial, clinical, and operative therapies for weight management have not been effective at a societal level. Endoscopic bariatric therapy is gaining acceptance as more effective than diet and lifestyle measures, and less invasive than bariatric surgery. Various endoscopic therapies are analogues of the restrictive or bypass components of bariatric surgery, utilizing gastric remodeling or intestinal anastomosis to achieve proven weight loss and metabolic benefits. Others, such as aspiration therapy, employ novel mechanisms of action. Intragastric balloons have recently been approved by the United States Food and Drug Administration, and a number of other technologies have completed large multicenter trials (such as AspireAssist aspiration therapy and Primary Obesity Surgery Endolumenal). Endoscopic sleeve gastroplasty and transoral outlet reduction for endoscopic revision of gastric bypass have proven safe and effective in a number of studies. As devices are approved for use, data will continue to accumulate for safety, effectiveness, and cost effectiveness. Bariatric endoscopists should be prepared to appropriately target and apply various endoscopic bariatric therapies in the context of a comprehensive long-term weight management program.

Endoscopic bariatric therapy may be a useful alternative to pharmacological treatment for obesity, and it provides greater efficacy with lower risks than do conventional surgical procedures. Among the various endoscopic treatments for obesity, the intragastric balloon is associated with significant efficacy in body weight reduction and relief of comorbid disease symptoms. Anatomically, this treatment is based on gastric space-occupying effects that increase the feeling of satiety and may also affect gut neuroendocrine signaling. The simplicity of the intragastric balloon procedure may account for its widespread role in obesity treatment and its applicability to various degrees of obesity. However, advances in device properties and procedural techniques are still needed in order to improve its safety and cost-effectiveness. Furthermore, verification of the physiological outcomes of intragastric balloon treatment and the clinical predictive factors for treatment responses should be considered. In this article, we discuss the types, efficacy, safety, and future directions of intragastric balloon treatment.

Obesity and its associated cardio-metabolic comorbidities have emerged as a global pandemic. The efficacy of various hypo-caloric diets and prescription drugs has been poor with respect to sustained weight loss. Recent advancements in endoscopic technology and techniques have opened a new field of minimally invasive endoscopic treatment options for combatting obesity both as a first line and adjunctive therapy. Presently, two endoscopic space-occupying devices in the form of intragastric balloons have received FDA approval for 6-month implantation in patients within a BMI range of 30-40 kg/m(2). Furthermore, full-thickness suturing has led to the development of primary endoscopic sleeve gastroplasty and Roux-en-Y gastric bypass revision as viable endoscopic alternatives to surgical approaches. These techniques have the potential to reduce adverse events, cost, and recovery times. Looking forward, a variety of promising and novel medical devices and endoscopic platforms that target obesity and diabetes are in various phases of development and investigation. The present review aims to discuss the current and forthcoming endoscopic bariatric therapies with emphasis on relevant procedural technique and review of available evidence.

Treatment of obesity and concomitant diseases have a significant burden on the health care system. Due to the lack of efficacy of conservative treatment methods, attention has shifted towards invasive methods. Surgical and endoscopic treatments of obesity are based on two different methods: restrictive and malabsorptive procedures or their combination. The author reviews the most effective surgical and endoscopic procedures in the treatment of obesity.

Intragastric balloon (IGB) has been introduced in the 1980's for weight reduction. It can be classified into nonadjustable IGB, such as the BioEnterics Intragastric Balloon (BIB), or newer generation Spatz adjustable balloon system. Late IGB-induced gastric perforation is a rare major complication, presenting as acute abdominal pain weeks to months after its insertion. We herein present a 20-year-old patient, with gastric perforation occurring 10 months after Spatz IGB deployment. The patient underwent a successful endoscopic IGB retrieval and laparoscopic exploration with abdominal lavage. We also review the literature of late IGB-induced gastric perforation.

Obesity represents a global hazard that predisposes to many serious health problems. Various solutions have been proposed to overcome obesity ranging from dietary balance to bariatric surgery. Intragastric balloons are a widely used measure to decrease weight, although they are advocated as safe devices, some major complications have been reported. We report a case of acute pancreatitis after insertion of a gastric balloon for weight reduction. Abdominal pain associated with nausea and vomiting maybe due to acute pancreatitis caused by compression of the pancreas by the balloon. It is advisable that physicians recognise these complications early to avoid serious and severe end-results., (Copyright © 2015 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.)

The prevalence of obesity has steadily increased throughout recent decades, and along with it, the costs of caring for the associated comorbid conditions has increased as well. Traditional bariatric surgical procedures generally are safe and effective, but patient acceptance, the risk of minor and sometimes serious complications, costs, and insurance coverage have limited the application of these techniques to the treatment of a minority of patients. Endoluminal techniques represent newer approaches to weight loss that can be used independently or in concert with traditional medical and surgical treatments for obesity, with varying degrees of success. It is anticipated that less invasiveness will increase the appeal across a broader representation of patients, perhaps increasing the number of obese patients who choose an intervention over medical management and possibly resulting in a greater total loss of excess body weight across a population; this may reduce costs involved in treating the complications of weight-related comorbidities. Acceptance of endoluminal bariatric procedures and devices will hinge on proving safety, efficacy, and value., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse™, a procedureless gastric balloon., Methods: Eight patients (mean BMI = 31.0 kg/m(2)) participated in this study. Each patient swallowed one Elipse™ balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed., Results: All eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities., Conclusions: This pilot study demonstrates the safety and performance of Elipse™, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks.

Background: Obesity has become a worldwide epidemic, and many methods are currently used to reduce obesity. This systematic review shows the effectiveness of the intragastric balloon (IGB) method compared to the sham/diet (s/d) method., Objective: To demonstrate the effectiveness of the IGB method compared to the s/d method., Setting: Hospital das Clinicas da Universidade de São Paulo, Brazil, Public Hospital., Methods: After searching MEDLINE, Embase, Cochrane, Lilacs, Scopus, and CINAHL, only enrolled randomized control trials comparing IGB/diet with s/d were analyzed. For qualitative analysis, 12 studies were selected, and 9 of these were acceptable for quantitative analysis., Results: The IGB/diet is more effective than s/d when comparing body mass index (BMI) loss with a mean difference of 1.1 kg/m(2) by the Student's t test and 1.41 kg/m(2) by the meta-analysis, with significant differences in both. It is also more effective in weight loss (WL), with a mean difference of 2 kg by the Student's t test and 3.55 kg by the meta-analysis. In the qualitative analysis of % excess WL (%EWL), the mean %EWL is 14.0% in favor of the IGB group compared to the s/d group by the Student's t test; however, no significant difference was found between these groups by quantitative analysis., Conclusion: Based on randomized control trial data alone, IGB>400 mL is more effective than sham/diet in achieving BMI loss, WL, and %EWL., (Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Intragastric balloons (IGBs) have been successfully used to treat obesity for the last 18 years. These balloons are made of different materials and filled with either air or saline. It seems that balloons filled with saline result in more effective weight loss, but are associated with worse tolerance after implantation. In contrast, balloons filled with air are associated with excellent tolerance, but result in less effective weight loss., Aim: To report the early safety and effectiveness results of the End-Ball ® balloon and to encourage discussions on how to best use this new-generation IGB for endoscopic weight loss management., Material and Methods: Twenty obese patients (mean age: 40.5 years; mean body mass index: 34.8 kg/m 2 ) were included in a 6-month study. Balloons were inflated with 300 ml of saline containing 5 ml of methylene blue and 300 cm 3 of air., Results: No serious adverse events occurred during treatment. Patients experienced varying degrees of nausea, vomiting (mean: 3.7 times the first day), and abdominal pain after implantation. Six months (23-29 weeks) after End-Ball ® balloon insertion, we observed a significant decrease in body weight (13.9 ±5.1 kg) and percent excess weight loss (37.9 ±12.9%). We also found a significant decrease in the levels of glycated hemoglobin (p < 0.001), C-peptide (p < 0.002), and triacylglycerols (p < 0.001) and an increase in the concentration of high-density lipoprotein cholesterol (p < 0.025)., Conclusions: The End-Ball ® IGB is a safe and effective treatment for morbid obesity, with positive effects on weight loss and saccharide metabolism., Competing Interests: The authors declare no conflict of interest.

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.

Introduction: Treating concomitant diseases in obese patients generates costs which are twice as high as the costs of the therapies in individuals with a normal weight. The conservative management of obesity involving lifestyle and dietary modifications and medical treatment shows only short-term efficacy and carries a 90% risk of recurrence. The intragastric balloon causes a permanent feeling of satiety, thus reducing the amount of food consumed by the patient., Aim: To assess the early and long-term effect of intragastric balloon treatment in obese patients., Material and Methods: In 2012, we performed 75 intragastric balloon procedures in obese patients. A total of 70 patients were enrolled in the study. The balloon was removed at 6 months. The patients were interviewed 2 years after removal., Results: Upon balloon removal, mean total weight loss (TWL) was 15.9 kg, and excess weight loss (EWL) was 41 ±19.6% (p < 0.001). Only one patient was classified as a non-respondent. Satisfactory results (> 10% TWL) were achieved in all other patients. The mean body mass index (BMI) reduction was 5.8 kg/m(2) (15.5%) (p < 0.001). Two years later 45 patients still maintained reduced weight, 7 returned to baseline body weight, whereas 18 subjects experienced a full yo-yo effect (mean gain of 2.7 kg). During 2 years following the balloon removal, mean total weight increased by 10.9 kg, and mean BMI increased by 3.9 kg/m(2) (12.5%). A satisfactory effect (> 10% TWL) was achieved in only 19 patients., Conclusions: Obesity management with the intragastric balloon is a safe treatment method, which effectively induces weight loss. Poor tolerance and lack of response occurring in some individuals should be taken into consideration. The best results are achieved in women with class 1 obesity.

Introduction: Intragastric balloons are a non-surgical treatment method for obesity., Presentation of Case: We report a 28year old Kuwaiti women presented with vomiting and epigastric pain two years following insertion of a intra gastric balloon. The women was diagnosed as a case of intestinal obstruction secondary to intragastric balloon migration., Discussion: Most intragastric balloons, should be removed in 6 months, to prevent complications. In our case, failure to follow up and remove the intragastric balloons in time led to bowel obstruction secondary to balloon migration., Conclusion: We report a rare complication of the BioEnterics intragastric balloon. Adherence to manufacturer and physician recommendations may prevent serious complications of intra gastric balloon insertion., (Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background Today a variety of bariatric surgical procedures is available and, currently, it is difficult to identify the most effective option based on patient characteristics and comorbidities. Aim of this retrospective study is to evaluate the efficacy of four different techniques; Intragastric Balloon (IB), Laparoscopic Adjustable Gastric Banding (LAGB), Laparoscopic Sleeve Gastrectomy (LSG) and Laparoscopic Mini Gastric Bypass (LMGB), performed in our unit along ten years. Patients and methods Starting from January 2005, 520 patients, 206 men (39.6%) and 314 women (60.4%) were treated at our institution. Among patients candidate to bariatric surgery 145 underwent IB, 120 underwent LAGB, 175 underwent LSG and 80 underwent LMGB. Follow up rate was 93.1% for IB at 6 months; 74.1% and 48% for LAGB at 36 and 60 months respectively; 72.8% and 58.1% for LSG at 36 and 60 months respectively; and 84.2% for LMGB at 36 months. Results The period 2005–2014 has been considered. Mortality was 1/520 patients (0.19%). The excess weight loss rate (EWL%) has been 32.8 for IB at six months, 53.7 for LAGB and 68.1 for LSG, at 60 months respectively and 79.5 for LMGB at 36 months. Early major postoperative complications requiring surgery were 0.6% for IB and 1.1% for LSG whereas late major postoperative complications were 1.2% for IB, 4.1% for LAGB and 0.5% for LSG. Diabetes resolution rate was 0 for LAGB, 76.9% for LSG and 80% for LMGB at 36 months. Conclusions If more invasive procedures as LSG or LMGB may entail higher operative and peroperative risks, conversely, in skilled hands their efficacy remains undisputed, especially in the long term, presenting a very low rate of major complications. In general, the efficacy of a bariatric surgery unit seems improved by the capability to offer both different primary procedures and re-do surgery. [ABSTRACT FROM AUTHOR]

Abstract: Background: Obesity has become a worldwide epidemic and is associated with significant morbidity and mortality. Many strategies to promote weight loss, including medications and surgical techniques, have been developed; however, few have proven effective. As the rates of obesity and associated complications continue to climb, there is growing pressure on the medical community to develop less invasive procedures that can provide lasting weight loss results. Objectives: One surgical treatment for obesity, available in several countries but not yet approved for use in the United States, is the intragastric balloon (IGB). The IGB is a temporary, space-occupying device placed endoscopically into the stomach to decrease gastric volume and provide a sense of early satiety. Our objective is to highlight potential complications of this device that emergency physicians should be familiar with, in particular, gastric outlet obstruction. Case Report: We report the case of a morbidly obese 63-year-old Middle Eastern man who presented to an emergency department in Texas with mechanical gastric outlet obstruction 2 months after IGB placement. After three endoscopic attempts, the balloon was successfully removed and the obstruction relieved. Conclusion: With an increasingly mobile and obese global population, emergency physicians should be aware of weight loss procedures such as the IGB and appropriate time-sensitive management of high-risk complications. [Copyright &y& Elsevier]

The problem of obesity is increasing worldwide in epidemic proportions; the situation is similarly becoming more common in patients with cirrhosis which negatively affect the prognosis of disease and also makes liver transplantation difficult especially in the living donor liver transplantation setting where low graft to recipient weight ratio negatively affects survival. Treatment of obesity is difficult in cirrhosis due to difficulty in implementation of lifestyle measures, limited data on safety of anti-obesity drugs and high risk of surgery. Currently approved anti-obesity drugs have limited data in patients with cirrhosis. Bariatric surgery remains an option in selected compensated cirrhotic patients. Endoscopic interventions for obesity are emerging and are quite promising in patients with cirrhosis as these are minimally invasive. In present review, we briefly discuss various modalities of weight reduction in obese patients and their applicability in patients with cirrhosis.

Background: Lifestyle interventions are often ineffective in the treatment of pediatric obesity. Weight loss devices have been introduced for the temporary nonsurgical treatment of morbid obesity., Objective: The aim of the study is to evaluate the efficacy of Obalon Intragastric Balloon on weight loss and on metabolic and cardiovascular parameters in a pediatric population with severe obesity., Methods: We enrolled 10 children with severe obesity. In all patients anthropometric parameters, biochemical tests, ultrasound liver examination and blood pressure monitoring were evaluated at the time of insertion and after removal of device., Results: The Obalon had a positive effect on decrease of weight, body mass index and percentage of excess body weight within 3 months from placement. Moreover, this safe minimally invasive device improves the cardio-metabolic profiles of obese children., Conclusions: The Obalon could be a useful tool in the difficult management of pediatric patients with morbid obesity, inducing in short-term a meaningful weight loss., (© 2014 World Obesity.)

Introduction: The dietary management of obesity is associated with a high failure rate. Methods which enable the long-term reduction of food intake have been developed. Patients treated with an intragastric balloon may experience some unwanted symptoms during therapy. The severity of these symptoms may result in poor tolerance of treatment, while patients who do not experience these symptoms may refuse to follow dietary modifications. In these cases, weight reduction at the end of treatment may be below expectations., Aim: To assess the tolerance of intragastric balloon treatment in obese patients as well as their satisfaction with this treatment., Material and Methods: Fifty-seven gastric balloon procedures were performed in 51 females and 6 males aged 17 to 65 years (39.5 ±10.7 years). Baseline weight was 104 ±14.5 kg (78-140 kg), body mass index 37.2 ±4.1 kg/m(2) (29.8-48.1 kg/m(2)), mean excess body weight 41.2 ±11.5 kg (20.4-63.1 kg). The balloon was filled with 669 ±25.8 ml of saline solution (550-700 ml). Upon balloon removal 6 months later, the patients completed a 12-question survey., Results: We obtained 57 surveys. The most common symptoms included vomiting, heartburn, abdominal pain and others. Twenty-two patients reported > 2 symptoms. Two patients were symptom-free. The mean duration of symptoms was 24.8 days. Patients reported better control of hypertension, diabetes and resolution of obstructive sleep apnoea and joint symptoms. Only 14 patients did not observe any significant improvement in their bodily function. Fifty-four patients expressed satisfaction after treatment, 6 patients were dissatisfied with the weight loss, and 5 patients would not opt for balloon re-treatment., Conclusions: The balloon treatment is a safe and well-tolerated therapy with a low complication rate.

Background: Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake., Objective: 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., Setting: Academic and community practice, United States., Methods: 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., Results: 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%)., Conclusion: 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 and Objectives: This project is a continuation of a larger project entitled "Treatment with intragastric balloon (IGB) in patients with overweight and obesity in Recife" developed by Professor Dr. Gustavo Lopes de Carvalho. It is a project studying the effectiveness of treatment with IGB evaluating the loss of weight and body mass index and its impact on blood pressure, blood glucose, triglycerides, total cholesterol and fractions. It also assesses the lifestyle of patients studying whether treatment with IGB interferes in smoking, alcohol consumption, eating habits and physical exercises performed by patients. The present study added a larger project, the separate evaluation of the different types of abdominal fat-visceral fat and subcutaneous cell tissue fat - and was conducted to discover which of the 2 types of fat undergoes the greater reduction after IGB treatment. To measure these 2 types of fat, we used the ultrasonography technique, because it has been shown to be accurate and noninvasive., Methods: Twenty-five patients were evaluated before and after 6 months of IGB treatment., Results: The patients' ages ranged from 20 to 61 years, with 60% being 40 years of age or older. The majority (72%) were women. All variables (weight, body mass index [BMI], VF, and SCTF) showed a significant reduction (P < .05) in mean values after treatment. The difference was highest in the SCTF (17.5%) and ranged from an 11.4% to an 11.6% reduction in all other variables. The average loss of SCTF was highest among the patients who had lost up to 10.0% of their initial weight (19.2% for the ≤10.0% group vs 15.9% for the >10.0% group); however, the difference was not significant (P = .66). The average loss of VF was higher in the subgroup of patients who had lost >10.0% of their initial weight (16.2% vs 6.3%; P = .003). The Pearson correlation between the reductions in SCTF vs VF was negative, low, and nonsignificant (-0.17; P = .41)., Conclusions: After 6 months of IGB treatment, there was no significant difference between the reduction in abdominal SCTF and VF, but the results signify a possible correlation between the percentage of body weight loss and the type of abdominal fat reduced, as the impact on the VF was higher when the patients lost >10.0% of their initial weight.

Abstract: Obesity in Prader–Willi syndrome (PWS) is progressive, severe and resistant to dietary, pharmacological and behavioural treatment. A reduction in body weight is mandatory to reduce the risk of cardiorespiratory and metabolic complications. The aim of the present study was to assess the risks and benefits of the BioEnterics Intragastric Balloon (BIB) for the treatment of morbid obesity in patients with PWS. Twenty-one BIBs were positioned in 12 patients with PWS (4 male and 8 female) aged from 8.1 to 30.1 years, and were removed after 8 ± (SD) 1.4 (range 5–10) months. Auxological, clinical and nutritional evaluations were performed every 2 months. Variations in body composition were analysed by dual-energy X-ray absorptiometry (DEXA). One patient (aged 28.5 years and with a body mass index [BMI] of 59.3 kg/m2) died 22 days after BIB positioning because of gastric perforation. In another individual (26.2 years, BMI 57.6 kg/m2), the BIB was surgically removed after 25 days because of symptoms suggesting gastric perforation (which was not confirmed). The remaining 10 patients showed a significant decrease of BMI (p = 0.005) and of fat tissue as measured by DEXA (p = 0.012). No significant modifications in bone mineral density occurred, but a slight loss in lean body mass (p = 0.036) was documented. In five patients, BIB treatment was repeated more than once. This study shows that when non-invasive pharmacological therapies fail, BIB may be effective to control body weight in PWS patients with morbid obesity, particularly when treatment is started in early childhood. However, careful clinical follow-up and close collaboration with parents are crucial to avoid severe complications, which can be caused by persisting unrestrained food intake. [Copyright &y& Elsevier]

Background and Aims: Obesity is a chronic disease with considerable morbidity and mortality. The intragastric balloon appears attractive for a group of patients who do not respond to medical therapy and who are not surgical candidates. Postoperative nausea and vomiting (PONV) are distressing adverse effects for these patients. Midazolam has been used as an antiemetic, both as a preventive or rescue medication. The study aims at studying effect of combined use of ondansetron and midazolam to decrease the PONV following intragastric balloon insertion., Materials and Methods: The study was conducted on 54 patients presented for intragastric balloon insertion during the period between 1(st) of January 2012 and 31 December 2012. Patients were randomly allocated into two groups; Ondansetron group and ondansetron/midazolam group. Patients were assessed for the incidence of nausea and vomiting, nausea and vomiting score, degree of sedation and occurrence of adverse effects during the first 24 h after the operation., Results: Incidence of nausea and/or vomiting during the first 24 h postoperatively was 66% in the ondansetron group, while 34.5% among the ondansetron-midazolam group. There was significant reduction of nausea and/or vomiting in the second group. Degree of postoperative sedation was also significantly different between the two groups in the immediate postoperative period and 30min postoperatively., Conclusion: Use of midazolam combined with ondansetron provides significant reduction and therefore better outcome regarding nausea and vomiting following intragastric balloon insertion.

Background: The intragastric balloon has been reported to be a safe and effective tool for temporary weight loss. The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding., Methods: A longitudinal multicenter study was conducted in patients with body mass index (BMI)>35 kg/m(2) who underwent gastric banding with the BioEnterics Intragastric Balloon (BIB). After balloon removal (6 mo), patients were allocated into 2 group according to their percentage of excess weight loss (%EWL): group>25 (%EWL>25%) and group<25 (%EWL<25%). Patients from both group underwent laparoscopic adjustable gastric banding (LAGB) 1-3 months after BIB removal. The LAP-BAND AP band was placed in all patients via pars flaccida. Weight loss parameters were considered in both groups., Results: From January 2005 to December 2009, 1357 patients were enrolled in this study. Mean BMI at time of BIB positioning was 44.9±8.4 (range 29-82.5). After 6 months, at time of removal, mean BMI was 39.4±7.3. According to the cutoff, patients were allocated into group A (n = 699) and group B (n = 658). At this time the mean BMI was 36.4±6.4 and 42.7±6.9 (P = .001) in groups A and B, respectively. At 1-year follow-up from LAGB, mean BMI was 35.8±6.5 and 40.0±7.4 (P<.001) in groups A and B, respectively. This significant difference was confirmed at 3- and 5-year follow-ups. A similar pattern was observed with the %EWL., Conclusion: Satisfactory results with BIB are predictive of a positive outcome of LASB at 1, 3, and 5 years after the procedure, and poor results do not inevitably indicate a negative outcome for gastric banding., (Copyright © 2014 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Morbid obesity is an increasing health problem. Dietary intervention often fails in the medium to long term, and surgery is the gold standard. Intragastric balloon is a valuable treatment in the short-term, and multiple balloon treatment has been shown to be effective in the medium term. The aim of this study was to investigate the efficacy of multiple balloon treatment in the long-term (6 years) in terms of weight loss, influence on co-morbidities, and quality of life in patients refusing surgery., Methods: Eighty-three patients with body mass index (BMI)>40, good candidates for surgery but refusing it, were enrolled in a clinical treatment protocol involving multiple intragastric balloon placement. After removing the first balloon, a second balloon was placed when the patients had regained ≥ 50% of the weight loss achieved with previous balloon. Weight, co-morbidities parameters, and quality of life test were recorded during a follow-up of 72 months., Results: All patients experienced a second balloon placement; 22.2% had a third device placed and 1 patient had a fourth device placed. At 76 months follow-up, mean BMI was 37.6 kg/m(2) (P < .001); weight cycling periods were observed. Significant difference was recorded in the presence of co-morbidities at baseline (80% of the patients) and follow-up (30%) (P = .02). Quality of life test in the follow-up indicated better scores than those at baseline (P < . .001)., Conclusion: Despite the weight cycling, in patients refusing surgery, multiple intragastric balloon is the recommended treatment, allowing the patients to achieve a good weight loss, better control of co-morbidities, and better quality of life than at baseline., (Crown Copyright © 2013 Published by American Society for Metabolic and Bariatric Surgery on behalf of American Society for Bariatric Surgery All rights reserved.)

Several neuroimaging studies are presented, which derive from prior work on gastric distension. Using a nonsurgical approach, we inserted gastric balloons into rats, which led to a marked decrease in food intake that normalized at 8 weeks. Body weight, however, remained below controls, which encouraged pursuit of studies in humans. A gastric balloon was inserted in obese and lean subjects, and filled through a tube that led behind the subject with water to 0, 200, 400, 600, 800 mL, on different days prior to ingestion of a liquid meal. As gastric volume increased, intake decreased by about 40%. Stomach capacity was then investigated using a gastric balloon, by assessing subjective (maximal tolerance) and objective measures (gastric compliance). Obese individuals had a much larger stomach capacity than lean by both measures. Next, in a 2-month study, an indwelling gastric balloon was inflated to 400 mL for 1 month and deflated for 1 month in counterbalanced order. Body weight was reduced during the month when the balloon was inflated within the 2nd and 3rd week. The subsequent study involved fMRI in response to gastric distension of 0, 250, and 500 mL while the subject was in a scanner. Ratings of fullness, but not discomfort, increased at 500 mL. Amygdala and insula activation were associated with gastric distension. The amygdala, as part of the limbic system, is involved in emotion and reward, and the insula in interoception. The right amygdala activation was inversely related to BMI, consistent with greater gastric capacity at a higher BMI. The next fMRI study in obese and lean subjects used visual and auditory stimuli of high energy dense (ED) and low ED foods. Increased activation was observed in the midbrain, putamen, posterior cingulate gyrus, hippocampus, and superior temporal gyrus in the obese vs. lean group in response to high vs. low ED food cues. Several of these areas lie within the mesolimbic reward pathway, and greater activation to high ED foods in the obese, suggests they have increased reward-driven eating behavior. Lastly, an fMRI study using the same stimuli was conducted pre and post-gastric bypass surgery. There were postsurgical reductions in neural activity in mesolimbic areas including the prefrontal cortex, and to a greater degree for high ED than low ED cues, reflecting more normalized responses. Through the use of various methodologies, the stomach's influence on food intake, sensations of fullness, and brain activation is presented with suggestions for future research., (Copyright © 2013 Elsevier Ltd. All rights reserved.)