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Letter to the Editor| Volume 97, ISSUE 1, P151-152, January 2023

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Limitations in endoscopic sleeve gastroplasty outcomes data derived from surgery-based repositories

      To the Editor:
      We read the article by Gudur et al.
      • Gudur A.R.
      • Geng C.
      • Kshatri S.
      • et al.
      Comparison of endoscopic sleeve gastroplasty versus surgical sleeve gastrectomy: a metabolic and bariatric surgery accreditation and quality improvement program database analysis.
      We have concerns regarding critical, but understandably inherent, limitations that portend significant implications regarding their interpretation and subsequent perception among clinicans and patients alike.
      Endoscopic sleeve gastroplasty (ESG) is a novel procedure 10 years in evolution. The MERIT study reported ESG-related serious adverse events occurring in 2% of patients,
      • Abu Dayyeh B.K.
      • Bazerbachi F.
      • Vargas E.J.
      • et al.
      Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, andomized trial.
      congruent with retrospective series estimating them to be between 0.5% and 2.2%.
      • Abu Dayyeh B.K.
      • Rajan E.
      • Gostout C.J.
      Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity.
      • Storm A.C.
      • Abu Dayyeh B.K.
      Endoscopic sleeve gastroplasty for obesity: defining the risk and reward after more than 1600 procedures.
      • Alqahtani A.
      • Al-Darwish A.
      • Mahmoud A.E.
      • et al.
      Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
      • Storm A.C.
      • Abu Dayyeh B.K.
      Endoscopic sleeve gastroplasty for obesity: defining the risk and reward after more than 1600 procedures.
      • Sarkar A.
      • Tawadros A.
      • Andalib I.
      • et al.
      Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study.
      • Brunaldi V.O.
      • Neto M.G.
      Endoscopic sleeve gastroplasty: a narrative review on historical evolution, physiology, outcomes, and future standpoints.
      In both studies, these adverse events were managed conservatively without intensive care or surgery.
      • Abu Dayyeh B.K.
      • Bazerbachi F.
      • Vargas E.J.
      • et al.
      Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, andomized trial.
      • Abu Dayyeh B.K.
      • Rajan E.
      • Gostout C.J.
      Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity.
      • Storm A.C.
      • Abu Dayyeh B.K.
      Endoscopic sleeve gastroplasty for obesity: defining the risk and reward after more than 1600 procedures.
      • Alqahtani A.
      • Al-Darwish A.
      • Mahmoud A.E.
      • et al.
      Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
      • Storm A.C.
      • Abu Dayyeh B.K.
      Endoscopic sleeve gastroplasty for obesity: defining the risk and reward after more than 1600 procedures.
      • Sarkar A.
      • Tawadros A.
      • Andalib I.
      • et al.
      Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study.
      • Brunaldi V.O.
      • Neto M.G.
      Endoscopic sleeve gastroplasty: a narrative review on historical evolution, physiology, outcomes, and future standpoints.
      Expected accommodative GI symptoms occur, whereas bleeding, perforations, neighboring visceral injury, and abscess formation are rare, and none were reported in MERIT.
      • Abu Dayyeh B.K.
      • Bazerbachi F.
      • Vargas E.J.
      • et al.
      Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, andomized trial.
      Gudur et al
      • Gudur A.R.
      • Geng C.
      • Kshatri S.
      • et al.
      Comparison of endoscopic sleeve gastroplasty versus surgical sleeve gastrectomy: a metabolic and bariatric surgery accreditation and quality improvement program database analysis.
      analyzed a surgical database reporting what was described as 6000 ESG cases. The lack of granularity did not allow important ancillary details, such as adequate center volume meeting competency thresholds. This is critical, given the reportedly 6 early mortalities, which has not, to the best of our knowledge, been reported in the literature or conference proceedings. However, the most important, historically identified in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), relates to Current Procedural Terminology coding inaccuracies.
      • Noyes K.
      • Myneni A.A.
      • Schwaitzberg S.D.
      • et al.
      Quality of MBSAQIP data: bad luck, or lack of QA plan?.
      As such, surgical procedures may have been erroneously indexed as ESG.
      This is suggested by a very unusual serious adverse event profile ascribed to ESG, such as “GI leaks.” Leaks can complicate bariatric surgeries but not ESG. Similarly, stricturing necessitating balloon dilation has not been described with ESG, to the best of our knowledge. Last, we are unable to explain reported pneumonia cases after a procedure that does not result in GI reflux disease.
      • Bazerbachi F.
      • Abu Dayyeh B.K.
      The pressure is on! Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: toward better patient allocation beyond pygmalionism.
      Whereas burgeoning bariatric endoscopy research is critical to advancing the field, we are concerned that these data pose inaccuracies stemming from possible incorrect Current Procedural Terminology coding, which is critical to the perception of ESG as a novel, safe, and effective weight loss option in the fight against obesity.

      Disclosure

      Dr Abu Dayyeh is a consultant for Endogenex, Endo-TAGS, Metamodix, BFKW, USGI, Spatz Medical, and Boston Scientific and the recipient of grants or research support from USGI, Spatz Medical, Boston Scientific, Apollo Endosurgery, Cairn Diagnostics, and Aspire Bariatrics. Dr Neto is a consultant for Apollo Endosurgery, GI Dyamics, Keyron, and USGI. Dr Boškoski is a consultant for Apollo Endosurgery, Cook Medical, Boston Scientific, and Nitinotes, the recipient of a research grant from Apollo Endosurgery, and a board member of Endo Tools. Dr Bove is a consultant for Apollo Endosurgery. The other author disclosed no financil relationships.

      References

        • Gudur A.R.
        • Geng C.
        • Kshatri S.
        • et al.
        Comparison of endoscopic sleeve gastroplasty versus surgical sleeve gastrectomy: a metabolic and bariatric surgery accreditation and quality improvement program database analysis.
        Gastrointest Endosc. Epub 2022 Jul 20;
        • Abu Dayyeh B.K.
        • Bazerbachi F.
        • Vargas E.J.
        • et al.
        Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, andomized trial.
        Lancet. 2022; 400: 441-451
        • Abu Dayyeh B.K.
        • Rajan E.
        • Gostout C.J.
        Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity.
        Gastrointest Endosc. 2013; 78: 530-535
        • Storm A.C.
        • Abu Dayyeh B.K.
        Endoscopic sleeve gastroplasty for obesity: defining the risk and reward after more than 1600 procedures.
        Gastrointest Endosc. 2019; 89: 1139-1140
        • Alqahtani A.
        • Al-Darwish A.
        • Mahmoud A.E.
        • et al.
        Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients.
        Gastrointest Endosc. 2019; 89: 1132-1138
        • Storm A.C.
        • Abu Dayyeh B.K.
        Endoscopic sleeve gastroplasty for obesity: defining the risk and reward after more than 1600 procedures.
        Gastrointest Endosc. 2019; 89: 1139-1140
        • Sarkar A.
        • Tawadros A.
        • Andalib I.
        • et al.
        Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study.
        Ther Adv Gastrointest Endosc. 2022; 15 (26317745221093883)
        • Brunaldi V.O.
        • Neto M.G.
        Endoscopic sleeve gastroplasty: a narrative review on historical evolution, physiology, outcomes, and future standpoints.
        Chin Med J (Engl). 2022; 135: 774-778
        • Noyes K.
        • Myneni A.A.
        • Schwaitzberg S.D.
        • et al.
        Quality of MBSAQIP data: bad luck, or lack of QA plan?.
        Surg Endosc. 2020; 34: 973-980
        • Bazerbachi F.
        • Abu Dayyeh B.K.
        The pressure is on! Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: toward better patient allocation beyond pygmalionism.
        Gastrointest Endosc. 2019; 89: 789-791