Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation
Abstract:
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 AEF rate with active esophageal cooling has not previously been performed.
Objectives: Compare AEF rates before and after the adoption of active esophageal cooling.
Methods: This IRB approved study was a prospective analysis of retrospective data, designed prior to 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 pre-specified 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 prior to adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In the pre-adoption 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 post-adoption cohort, no AEFs were found in the pre-specified 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.
Editor-in-Chief
Kalyanam Shivkumar, MD, PhD, FACC
CME Editor
Kenneth A. Ellenbogen, MD, FACC
Author
Mahmoud Houmsse, MD, FACC
Important Dates
Date of Release: December 25, 2023
Term of Approval/Date of CME/MOC Expiration: December 24, 2024