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Risk of atrioesophageal fistula formation with contact force–sensing catheters

      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

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