When combined with longitudinal nutritional support, endoscopic sleeve gastroplasty (ESG) is a safe and effective tool for adults with class III obesity (body mass index (BMI) ≥40kg/m2), with clinically-meaningfully weight loss at one year that was sustained in the subsequent two years, as well as improvement in weight-related comorbidities, according to a study by US and Brazilian researchers. The authors stated that this is one of the first studies - and the largest to date - that examines the novel application of ESG in patients with class III obesity, a demographic traditionally relegated to surgery for weight loss.
This retrospective cohort study assessed 404 adults with BMI≥40kg/m2 who underwent ESG, without concomitant weight loss medications, and with longitudinal lifestyle counselling at two centres with expertise in endobariatric therapies from May 2018 to March 2022. The primary outcome was total body weight loss (TBWL) at 12 months. Secondary outcomes included changes in TBWL, excess weight loss (EWL) and BMI at various time points up to 36 months, clinical responder rates at 12 and 24 months, and comorbidity improvement.
All subjects underwent self-financed ESGs at True You Weight Loss (Cary, NC) and Clinica Angioskope (Sao Paulo, Brazil). All ESGs were performed by two experts in endoscopic bariatric therapies, each having performed over five hundred ESG procedures by the start of the study. Procedures were performed using the OverStitch Endoscopic Suturing System (Apollo Endosurgery) under general anaesthesia with endotracheal intubation.
Patients were discharged the same day and were enrolled in a comprehensive lifestyle programme with long-term nutritional support and monitoring at monthly virtual or in-person visits with registered dieticians who provided counselling on dietary and exercise behaviors to reinforce weight loss. Follow up with a physician or nurse practitioner was also offered as needed during the first year after ESG to provide further support and address symptoms. Patient weights were collected at each visit, either in person or virtually by standardised Bluetooth-enabled digital scale, while safety outcomes were monitored longitudinally.
Outcomes
Four hundred and four patients (mean age 42.9 years, 78.5% female, mean pre-procedural weight 127.3 ± 20.1 kg, mean pre-procedural BMI 44.8 ± 4.7 kg/m2) underwent ESG with a 100% technical success rate. Mean procedure duration was 42 ± 9 min and used a median of seven sutures, with a range of four to 12 sutures. Prior to ESG, the cohort had the following obesity-associated comorbidities: hypertension (35.4%), type II diabetes (17.8%), and hyperlipidaemia (16.8%).
Total body weight loss was 12.5±3.7% at three months, 16.5 ± 4.8% at six months, 20.9 ± 6.2% at 12 months, 21.6 ± 7.2% at 15 months, 20.5 ± 6.9% at 24 months, and 20.3 ± 9.5% at 36 months (Figure 1A). EWL was 29.5 ± 9.6% at three months, 39.2 ± 12.7% at six months, 49.6 ± 15.1% at 12 months, 51.6 ± 16.8% at 15 months, 49.4 ± 16.7% at 24 months, and 47.1 ± 23.5% at 36 months. BMI decreased from 44.8 ± 4.7 kg/m2 at baseline to 38.8 ± 3.1 kg/m2 at three months, 37.0 ± 4.0 kg/m2 at six months, 35.0 ± 4.0 kg/m2 at 12 months, 34.5 ± 4.7 kg/m2 at 15 months, 34.0 ± 4.7 kg/m2 at 24 months, and 35.6 ± 5.5 kg/m2 at 36 months.
For BMI, there were statistically significant differences in values between preceding and subsequent time points through month six, with no statistical differences noted from time points spanning six to 36 months. While less than 10% of subjects were cured of obesity during study duration, most subjects (85.4%) exited class III obesity by six months, without notable increase in the proportion of class III obesity in the study duration. A plurality of the cohort had class I obesity by 12 and 24 months. Twelve months clinical response rates showed 96.7% achieved at least 10% TBWL, 87.4% achieved at least 15% TBWL, and 55.6% achieved at least 20% TBWL, with similar proportions of clinical responders observed at 24 months (Figure 1).
Of the cohort with the respective comorbidity at the 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. No patient underwent an additional endoscopic procedure for repeat suturing. One subject (starting BMI 50.5 kg/m2) converted to a Roux-en-Y gastric bypass at 22 months after achieving 22% TBWL.
There were no instances of death, gastrointestinal perforation, abscess/sepsis, gastrointestinal bleeding, intensive care unit admission, or need for endoscopic or surgical intervention for management of procedural complications. There were two instances of dehydration requiring emergency room presentation day two and day eight after the ESG, one of which required three-day hospitalisation for acute kidney injury, which resolved with intravenous fluids. This yielded an overall adverse event rate of 0.5% and a 0.2% serious adverse event rate.
“Based on the promising results presented in this study, ESG in combination with a prescribed nutritional program should be offered to patients with class III obesity. Given the global burden of obesity, compounded by limited therapeutic options that are both accessible and appealing to patients, ESG can be a useful tool for reducing the substantial management gap in this disease when performed by experienced endobariatric physicians with reliable, long-term aftercare,” the authors concluded. “Further study of ESG in class III obesity should assess improvement in associated medical problems, the effects of combination ESG-pharmacotherapy, and directly compare ESG to traditional bariatric surgeries.”
The findings were featured in the paper, ‘Endoscopic sleeve gastroplasty in class III obesity: Efficacy, safety, and durability outcomes in 404 consecutive patients’, published in the World Journal Gastrointestinal Endoscopy. To access this paper, please click here