McGowan, Christopher

Abstract Endoscopic sleeve gastroplasty (ESG) facilitates 13.6%–16.2% total body weight loss (TBWL) at 12 months, but falls short of that seen with surgical vertical sleeve gastrectomy, in part owing to the retention of the gastric fundus. In adults with obesity, gastric fundal mucosal ablation (GFMA) reduces fasting plasma ghrelin (FPG), hunger, cravings, and accommodation. Combined GFMA-ESG could improve TBWL. This study aimed to evaluate the effectiveness and safety of sequential GFMA followed by ESG in adults with obesity, building on previously published 6-month results of GFMA alone. This was a prospective, first-in-human, two-phase clinical trial. Ten participants underwent GFMA, followed by ESG at month 6, and were followed for 12 months post-ESG (18 months total). GFMA was performed using hybrid argon plasma coagulation to lift and ablate the entire gastric fundal mucosa. ESG was performed using standard full-thickness endoscopic suturing of the gastric body. The primary end point was TBWL; secondary end points were safety and changes in FPG, maximum tolerated volume (MTV), and validated appetite questionnaires. Mean TBWL was 22.5% (SD 8.3%) at month 18. Hunger-related behaviors and eating self-efficacy showed sustained improvements. FPG was decreased at month 6 and returned toward baseline by month 18, while MTV remained suppressed. No serious adverse events occurred. Sequential GFMA-ESG is safe and induces substantial weight loss, reduced MTV of ingested nutrients, and improved behavioral measures. This combination approach builds on prior traditional ESG and GFMA-only results and may represent a promising advancement of endoscopic therapeutic options for weight loss.

Abstract Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons (P<0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases (P<0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists (P<0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists (P>0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) has gained popularity over the past decade and has been adopted in both academic and private institutions globally. We present outcomes of the largest cohort of patients from the United States undergoing ESG and evaluate these according to obesity class. METHODS: We performed a retrospective analysis of adult patients who underwent ESG. Medical information was abstracted from the electronic record with weight records up to 2 years after ESG. Percent total body weight loss (%TBWL) at 6, 12, 18, and 24 months was calculated based on baseline weight at the procedure. SPSS (version 29.0) was used for all statistical analyses. RESULTS: A total of 1,506 patients from 7 sites were included (501 Class I obesity, 546 Class II, and 459 Class III). Baseline demographics differed according to obesity class due to differences in age, body mass index (BMI), height, sex distribution, and race. As early as 6 months post-ESG, mean BMI for each class dropped to the next lower class and remained there through 2 years. %TWBL achieved in the Class III group was significantly greater when compared with other classes at all time points. At 12 months, 83.2% and 60.9% of patients had ≥10% and ≥15% TBWL for all classes. There were no differences in adverse events between classes. DISCUSSION: Real-world data from a large cohort of patients of all BMI classes across the United States shows significant and sustained weight loss with ESG. ESG is safe to perform in a higher obesity class with acceptable midterm efficacy.