Retrospective Cohort Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jun 16, 2023; 15(6): 469-479
Published online Jun 16, 2023. doi: 10.4253/wjge.v15.i6.469
Endoscopic sleeve gastroplasty in class III obesity: Efficacy, safety, and durability outcomes in 404 consecutive patients
Daniel Barry Maselli, Anna Carolina Hoff, Ashley Kucera, Emily Weaver, Laura Sebring, Lori Gooch, Kathleen Walton, Daniel Lee, Taylor Cratty, Selena Beal, Srikar Nanduri, Kendall Rease, Christina S Gainey, Laura Eaton, Brian Coan, Christopher E McGowan
Daniel Barry Maselli, Ashley Kucera, Emily Weaver, Laura Sebring, Lori Gooch, Kathleen Walton, Daniel Lee, Taylor Cratty, Selena Beal, Srikar Nanduri, Kendall Rease, Brian Coan, Christopher E McGowan, Department of Endobariatrics, True You Weight Loss, Cary, NC 27513, United States
Anna Carolina Hoff, Bariatric Endoscopy, Angioskope Clinic, São José dos Campos 12243-680, São Paulo, Brazil
Christina S Gainey, Gastroenterology and Hepatology, University of North Carolina System, Chapel Hill, NC 27599, United States
Laura Eaton, UltaMed Corporation, UltaMed Corporation, Fort Lauderdale, FL 33308, United States
Author contributions: Maselli DB prepared and edited the manuscript; Hoff AC, Weaver E, Sebring L, Gooch L, Walton K, collected data and critically revised the manuscript; Kucera A, critically revised the manuscript and authored the study protocol; Lee D critically revised the manuscript and managed the study database; Cratty T, Beal S, Nanduri S, Rease K, Gainey C, and Coan B critically revised the manuscript; McGowan CE conceptualized and designed the study and critically revised the manuscript.
Institutional review board statement: The study was reviewed and approved for publication by our Institutional Reviewer (WCG IRB, Puyallup, WA).
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrollment as part of undergoing the ESG at the institutions participating in this study.
Conflict-of-interest statement: All the Authors have no conflict of interest related to the manuscript except as specified below: Christopher E. McGowan: consultant for Apollo Endosurgery. Anna C. Hoff: consultant for Apollo Endosurgery. Daniel B. Maselli: consultant for Apollo Endosurgery. No author has a proprietary relationship in Apollo Endosurgery.
Data sharing statement: The original anonymous dataset is available on request from the corresponding author at drmcgowan@trueyouweightloss.com.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Christopher E McGowan, AGAF, FASGE, MD, Director, Department of Endobariatrics, True You Weight Loss, 2001 Weston Pkwy, Cary, NC 27513, United States. drmcgowan@trueyouweightloss.com
Received: March 6, 2023
Peer-review started: March 6, 2023
First decision: April 28, 2023
Revised: May 8, 2023
Accepted: May 22, 2023
Article in press: May 22, 2023
Published online: June 16, 2023
Processing time: 99 Days and 18.4 Hours
ARTICLE HIGHLIGHTS
Research background

Endoscopic sleeve gastroplasty (ESG) is a minimally invasive weight loss tool that narrows and shortens the stomach into a tubular construct through full-thickness suturing. The majority of published data on the ESG focus on patients with class I [(Body mass index (BMI) 30.0-34.9 kg/m2] or class II (BMI 35.0-39.9 kg/m2) obesity.

Research motivation

Patients with class III obesity (BMI ≥ 40 kg/m2) face greater mortality risk and increased emergence of weight-related comorbidities compared those of lower obesity classes; however, the vast majority of patients with class III obesity do not pursue bariatric and metabolic surgery, leading to a substantial therapeutic gap in this patient population, which ESG may help address.

Research objectives

To address knowledge gaps in the clinical adoption of ESG as a weight loss tool in adults at higher ranges of body mass index, we sought to evaluate the clinical efficacy of ESG in patients with class III obesity based on weight loss and resolution of comorbidities, as well as safety outcomes, over the course of three years.

Research methods

This was a retrospective evaluation of prospective collected data of adult patients undergoing ESG from May 2018-March 2022 at two centers with expertise in endobariatric therapies.

Research results

404 adult patients with class III obesity underwent ESG and achieved 20.9 ± 6.2% total body weight loss and 49.6 ± 15.1% excess weight loss at one year, which was maintained at two and three years. 87.4% of patients achieved > 15% total body weight loss by one year. Of the cohort, 66.1% had improvement in hypertension, 61.7% had improvement in type II diabetes, and 45.1% had improvement in hyperlipidemia over the study duration. There was a 0.2% serious adverse event rate.

Research conclusions

When combined with longitudinal nutritional support, ESG facilitates safe and effective weight loss at one year in adults with class III obesity, which is maintained at years two and three. ESG should be considered for patients with class III obesity wishing to avoid metabolic and bariatric surgery.

Research perspectives

While safe and effective in the treatment of class III obesity, ESG did not cure patients of obesity within the confines of this study, and future research should evaluate practices that enhance weight loss from ESG in this population, including procedural modifications or combination therapy with pharmacologic agents.