Endoscopic sleeve gastroplasty in class III obesity: Efficacy, safety, and durability outcomes in 404 consecutive patients.

Background: Endoscopic sleeve gastroplasty (ESG) is an effective therapy for class I-II obesity, but there are knowledge gaps in the published literature about its implementation in patients with class III obesity [body mass index (BMI) ≥ 40 kg/m].

Aim: To evaluate the safety, clinical efficacy, and durability of ESG in adults with class III obesity.

Methods: This was a retrospective cohort study that used prospectively collected data on adults with BMI ≥ 40 kg/m who underwent ESG and longitudinal lifestyle counseling at two centers with expertise in endobariatric therapies from May 2018-March 2022. The primary outcome was total body weight loss (TBWL) at 12 mo. Secondary outcomes included changes in TBWL, excess weight loss (EWL) and BMI at various time points up to 36 mo, clinical responder rates at 12 and 24 mo, and comorbidity improvement. Safety outcomes were reported through the study duration. One-way ANOVA test was performed with multiple Tukey pairwise comparisons for TBWL, EWL, and BMI over the study duration.

Results: 404 consecutive patients (78.5% female, mean age 42.9 years, mean BMI 44.8 ± 4.7 kg/m) were enrolled. ESGs were performed using an average of 7 sutures, over 42 ± 9 min, and with 100% technical success. TBWL was 20.9 ± 6.2% at 12 mo, 20.5 ± 6.9% at 24 mo, and 20.3 ± 9.5% at 36 mo. EWL was 49.6 ± 15.1% at 12 mo, 49.4 ± 16.7% at 24 mo, and 47.1 ± 23.5% at 36 mo. There was no difference in TBWL at 12, 15, 24, and 36 mo from ESG. TBWL exceeding 10%, 15%, and 20% was achieved by 96.7%, 87.4%, and 55.6% of the cohort at 12 mo, respectively. Of the cohort with the relevant comorbidity at time of ESG, 66.1% had improvement in hypertension, 61.7% had improvement in type II diabetes, and 45.1% had improvement in hyperlipidemia over study duration. There was one instance of dehydration requiring hospitalization (0.2% serious adverse event rate).

Conclusion: When combined with longitudinal nutritional support, ESG induces effective and durable weight loss in adults with class III obesity, with improvement in comorbidities and an acceptable safety profile.