Atrioesophageal fistulas (AEFs), a rare but often fatal complication of left atrial ablation procedures, continue to pose a significant risk to patients despite advancements in ablation technology and protective strategies. Given the serious nature of AEFs and their continued occurrence, we sought to quantify their prevalence across the United States to better understand the scope of the issue and identify potential gaps in current protective strategies.
As presented at #AHA24, we queried the FDA’s publicly available MAUDE database, which allows for post-market monitoring of medical devices, to identify all AEF reports from 2019 to 2023. In total, there were 202 AEFs reported. Of these, 30% of cases used luminal esophageal temperature (LET) monitoring as a protective measure, 2% used esophageal deviation, 5% did not use a protection method, and 63% did not report whether a protection method was used. Over the study period, both the absolute number of AEFs and the proportion of fatal cases have risen. Notably, 37% of the 202 reported AEFs were fatal.