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©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
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/m2].
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/m2 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/m2) 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.
Core Tip: Patients with obesity wishing to avoid bariatric surgery can benefit from endoscopic sleeve gastroplasty (ESG), but little has been published about the safety and efficacy of ESG in those with class III obesity (body mass index ≥ 40 kg/m2). Based on this appraisal of a large, international cohort, ESG can be safely performed in adults with class III obesity, with clinically meaningful weight loss at one year that can be maintained over the subsequent two years, as well as improvement in weight-related comorbidities. Patients and medical providers should be made aware that ESG combined with longitudinal nutritional support is a promising weight loss tool for those with class III obesity.
