Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity.

BACKGROUND & AIMS: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. METHODS: Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. RESULTS: 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. CONCLUSION: POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. CLINICALTRIALS: gov Identifier: NCT03721731.

The Efficacy and Safety of Endoscopic Sleeve Gastroplasty as an Alternative to Laparoscopic Sleeve Gastrectomy.

Endoscopic sleeve gastroplasty (ESG) is a therapeutic endoscopic technique for reducing the size of the gastric reservoir in obese patients, using a full-thickness endoscopic suturing device. The effectiveness of ESG in weight loss is significantly greater than that of high-intensity diet and lifestyle therapy and lower than that of laparoscopic sleeve gastrectomy (LSG). The efficacy at 12 months after ESG in terms of percentage of total body weight loss and excess body weight loss was approximately 16% and 60%, respectively. The well-known predictive factors for increased weight loss by ESG are good compliance with regular monitoring and post-procedure care involving a multidisciplinary team approach. Although the underlying mechanism of weight loss induced by ESG is debatable, delayed gastric emptying and early satiation are some of the proposed mechanisms. The pooled rate of adverse events after ESG reported in several meta-analysis studies ranged from 1.5% to 2.3% and the incidence of new-onset gastroesophageal reflux disease after ESG was negligible, indicating that ESG has a superior safety profile to LSG. Moreover, ESG reduced the risk of obesity-related metabolic comorbidities, evidenced by the reduction in HbA1c level, systolic blood pressure, triglyceride level, and risk of hepatic steatosis and fibrosis; it even improved the quality of life. ESG could be considered safe and qualify as an alternative treatment to LSG.