Endoscopic sleeve gastroplasty in the management of overweight and obesity: an international multicenter study.

BACKGROUND AND AIMS: Obesity is a pandemic affecting approximately 700 million adults worldwide, with an additional 2 billion overweight. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric therapy that involves remodeling of the greater curvature in an effort to reduce gastric capacity and delay gastric emptying. A variety of ESG suture patterns has been reported. This study is the first to use a uniform "U" stitch pattern across all centers to simplify technical aspects of the procedure and limit cost. This also uniquely assessed outcomes in all body mass index (BMI) categories and changes in metabolic rate, lean body mass, and adipose tissue composition. METHODS: This is a multicenter analysis of prospectively collected data from 7 centers including patients with overweight and obesity who underwent ESG. Primary outcomes included absolute weight loss, percent total body weight loss (%TWL), change in BMI, and percent excess weight loss (%EWL) at 6 and 12 months in overweight and obese classes I, II, and III. Secondary outcomes included adipose tissue, lean body mass reduction, and metabolic rate analyzed by bioimpedance. Additionally, immediate or delayed adverse events (AEs) were analyzed. Clinical success was defined as achieving ≥25% EWL at 1 year with ≤5% serious AE (SAE) rate following the American Society for Gastrointestinal Endoscopy (ASGE)/American Society for Metabolic and Bariatric Surgery (ASMBS) threshold. RESULTS: A total of 193 patients underwent ESG during the study period. All groups had >10% TWL and >25% EWL at 6 months of follow-up. On average, %TWL was 14.25% ± 5.26% and 15.06% ± 5.22% and the %EWL 56.15% ± 22.93% and 59.41% ± 25.69% at 6 months and 1 year of follow-up, respectively. %TWL was 8.91% ± .3%, 13.92% ± 5.76%, 16.22% ± 7.69%, and 19.01% ± .95% and %EWL 56.21% ± 2.0%, 62.03% ± 27.63%, 54.13% ± 23.46%, and 46.78% ± 2.43% for overweight and obesity classes I, II, and III, respectively, at 1 year. Male sex, age <41 years, and higher BMI were predictors of achieving a TWL ≥10% at 1-year follow-up. There was a significant reduction in adipose tissue from baseline. SAEs occurred in 1.03%, including 2 perigastric collections needing surgery. CONCLUSIONS: ESG appears to be feasible, safe, and effective in the treatment of patients with overweight and obesity according to ASGE/ASMBS thresholds.

ASSESSMENT OF WEIGHT LOSS AFTER NON-ADJUSTABLE AND ADJUSTABLE INTRAGASTRIC BALLOON USE.

BACKGROUND: Intragastric balloon (IGB) use is indicated for patients whose BMI precludes the option of bariatric surgery or who need to lose weight prior to undergoing surgery. It is a minimally invasive procedure and currently there are two main models of IGBs in use, the non-adjustable intragastric balloon (NIB), implanted for six months, and the adjustable intragastric balloon (AIB), implanted for up to 12 months. OBJECTIVE: Analyze clinical characteristics between patients receiving non-adjustable gastric balloon and the adjustable (prolonged implantation) intragastric balloon. METHODS: This was a cross-sectional study of 470 patients diagnosed as obese or overweight who had balloon implantation from October 2011 to July 2018. The associations between percentage excess weight loss versus clinical and demographic variables were calculated using the chi-squared test. Independent samples were submitted to the Student's t test to determine the quantitative variables, with a confidence interval of 95%. Calculation of excess weight was based on an estimated ideal weight that would correspond to a BMI of 24.99 kg/m2. RESULTS: A total of 414 patients completed the treatment achieving an average total body weight loss (%TBWL) of 15.4±7 with the NIB and 15.5±9.6 with the AIB. Overweight patients achieved higher excess weight loss (%EWL) values using AIBs (157.2±82.5) and obese patients did so with NIB use (56±29.7). Women achieved higher %EWL values (65.6±62.2) than men (48±27.1). Individuals who attended >4 consultations with a nutritionist (60.8%) achieved TBWL >18%. All of those P-values were <0.001. CONCLUSION: Obese individuals and women registered the greatest weight losses. Overweight patients achieved greater losses using AIB and obese patients did so using NIBs. NIB use was associated with higher EWL percentages. Nutritional accompaniment had a positive impact on the %TBWL.