Background: Atrioesophageal fistula formation is a rare but life-threatening complication of atrial fibrillation ablation. Contact force (CF)-sensing catheters improve procedural effectiveness. However, the impact of the implementation of CF-sensing technology on the risk of atrioesophageal fistula formation has not been explored.
Objective: The purpose of this study was to determine the association between the use of CF-sensing catheters and atrioesophageal fistula development.
Methods: We searched the Manufacturer and User Facility Device Experience database for adverse event reports involving Food and Drug Administration-approved ablation catheters.
Results: Among 2689 device reports, we identified 78 atrioesophageal fistula cases, 65 of which involved CF-sensing catheters and 13 non-CF-sensing catheters. The percentage of total reports involving atrioeosphageal fistula was 5.4% for CF-sensing catheters (65 of 1202) and 0.9% for non-CF-sensing catheters (13 of 1487) (P < .0001). Procedural details (CF and power settings) were not consistently reported. Esophageal temperature increases were detected in only 2.5% of cases (2 of 78). The mean time to presentation was 16 ± 9 days. Overall mortality was at least 56%, with patients who underwent surgical repair more likely to survive than those treated with stenting or no intervention.
Conclusion: Atrioesophageal fistula formation accounted for a much higher proportion of reported adverse events with CF-sensing catheters compared with non-CF-sensing catheters. Improved understanding of the relationship between power/force delivery and esophageal damage is needed to minimize the risk of atrioesophageal fistula formation.
Keywords: Atrial fibrillation; Atrioesophageal fistula; Catheter ablation; Contact force; Pulmonary vein isolation; Radiofrequency ablation.
Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.