Sanchez J, Woods C, Zagrodzky J, Nazari J, Singleton MJ, Schricker A, Ruppert A, Brumback B, Jenny B, Athill C, Joseph C, Shah D, Upadhyay G, Kulstad E, Cogan J, Leyton-Mange J, Cooper J, Tamirisa K, Omotoye S, Timilsina S, Perez-Verdia A, Kaplan A, Patel A, Ro A, Corsello A, Kolli A, Greet B, Willms D, Burkland D, Castillo D, Zahwe F, Nayak H, Daniels J, MacGregor J, Sackett M, Kutayli WM, Barakat M, Percell R, Akrivakis S, Hao SC, Liu T, Panico A, Ramireddy A, Dewland T, Gerstenfeld EP, Lanes DB, Sze E, Francisco G, Silva J, McHugh J, Sung K, Feldman L, Serafini N, Kawasaki R, Hongo R, Kuk R, Hayward R, Park S, Vu A, Henry C, Bailey S, Mickelsen S, Taneja T, Fisher W, and Metzl M
Background: Active esophageal cooling reduces the incidence of endoscopically identified severe esophageal lesions during radiofrequency (RF) catheter ablation of the left atrium for the treatment of atrial fibrillation. A formal analysis of the atrioesophageal fistula (AEF) rate with active esophageal cooling has not previously been performed., Objectives: The authors aimed to compare AEF rates before and after the adoption of active esophageal cooling., Methods: This institutional review board (IRB)-approved study was a prospective analysis of retrospective data, designed before collecting and analyzing the real-world data. The number of AEFs occurring in equivalent time frames before and after adoption of cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were quantified across 25 prespecified hospital systems. AEF rates were then compared using generalized estimating equations robust to cluster correlation., Results: A total of 14,224 patients received active esophageal cooling during RF ablation across the 25 hospital systems, which included a total of 30 separate hospitals. In the time frames before adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In the preadoption cohort, a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates for procedures using LET monitoring. In the postadoption cohort, no AEFs were found in the prespecified sites, yielding an AEF rate of 0% (P < 0.0001)., Conclusions: Adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate., Competing Interests: Funding Support and Author Disclosures No specific funding for this research was provided. Some authors are supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health, under Award Number R44HL158375 for the evaluation of esophageal cooling (the content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health). Academic advisors to—and representatives of—Attune Medical participated in the study design, data collection, analysis, and interpretation and participated in the preparation, review, and approval of the manuscript. Dr Woods has received consulting fees from Abbott and research funding from Biosense Webster; and has equity in Inheart Medical and intellectual property with Attune Medical. Dr Zagrodzky has received consulting fees from Biosense Webster and Attune Medical. Dr Singleton has received consulting fees from Biosense Webster. Dr Brumback has received consulting fees from Attune Medical. Dr Athill has received consultant fees from Abbott, Boston Scientific, Biosense Webster, and Acutus; and speaker fees from Zoll Medical. Dr Joseph has served an internship with Attune Medical. Dr Shah has received consulting fees from Abbott and Janssen Pharmaceuticals. Dr Kulstad holds equity in and has had employment in Attune Medical. Dr Upadhyay has received consulting fees from Abbott, Biotronik, Boston Scientific, Medtronic, Philips BioTel, and Zoll Medical. Dr Cogan has received consulting fees from Abbott and Biosense Webster. Dr Cooper has received support for data acquisition from Attune Medical. Dr Tamirisa has received speaking fees from Abbott and Medtronic; and consultant fees from Sanofi. Dr Patel has received consulting fees from Biosense Webster. Dr Greet has received consulting fees from Medtronic. Dr MacGregor has received research fees from Boston Scientific. Dr Percell has served on Speaker Bureau for Abbott and Janssen. Dr Hao has received consultant fees from Rampart IC. Dr Dewland has received consulting fees from Adagio Medical. Dr Gerstenfeld has received lecture honoraria from Medtronic, Boston Scientific, and Abbott; research funding, scientific advisory board, and compensation from Biosense Webster; has served on a scientific advisory board for Farapulse; and Data and Safety Monitoring Board for trials sponsored by Thermedical Inc and Abbott. Dr Panico has received consulting fees from Abbott and Impulse Dynamics. Dr Mickelsen has received consulting fees from Field Medical, Atraverse Medical, and Attune Medical. Dr Metzl has received consulting fees from Abbott, Biosense Webster, Attune Medical, Medtronic, Sanofi Aventis, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)