Abstract 15366: Quantification of Recent Reporting Rates of Atrioesophageal Fistula After Left Atrial Ablation for the Treatment of Atrial Fibrillation

Abstract

Introduction: Atrio-esophageal fistulas (AEF) are a feared and fatal complication of left atrial ablation for the treatment of atrial fibrillation (AF). The recent POTTER-AF survey suggests that AEFs continue to occur despite best efforts to prevent them. A quantification of recent incidence rates and outcomes of AEF reported to the Manufacturer and User Facility Device Experience (MAUDE) database of the U.S. FDA may further elucidate trends in this complication. Research Question(s): What are the recent trends in reporting rates of AEF, and what are the outcomes? Purpose: To quantify the number of AEF reports as well as any reported outcomes of atrioesophageal fistulas and determine any trends over the last 4 years. Methods: We reviewed data from the Manufacturer and User Facility Device Experience (MAUDE) database for complications under the category of fistula that occurred over the last 4 years (2019 to 2022 inclusive). Reports were reviewed for any descriptions of outcome, and narratives were compared in an attempt to identify and exclude any duplicate reporting. Results: In total, three product codes resulted in 121 reported AEFs. Of these, 50 (41%) were listed as fatal. When provided, the time frame of death ranged from 12 days to several weeks after the index procedure. Product codes reporting AEFs included LPB (88 cases), OAE (22 cases), and OAD (11 cases), with codes representing cardiac ablation catheters and radiofrequency generators. Incidence by year showed a generally increasing trend (21 in 2019, 22 in 2020, 41 in 2021, and 37 in 2022, Figure 1). Conclusion: The annual rate of reported AEFs has not decreased over the last 4 years, and instead shows a generally increasing trend. Reported fatality rates remain high at 41%.