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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Article info
Publication history
Published online: April 14, 2017
Footnotes
Dr Pokorney receives research support from Boston Scientific, Gilead, Bristol-Myers Squibb, and the Food and Drug Administration as well as advisory board/consulting support from Boston Scientific, Medtronic, and Bristol-Myers Squibb. Dr Bahnson receives research funding from St. Jude Medical. Dr Daubert receives honoraria and/or research support from Boston Scientific, Biosense Webster, and St. Jude Medical. Dr Piccini receives research funding from Boston Scientific, Johnson & Johnson, and St. Jude Medical and provides consulting to Johnson & Johnson and Medtronic.
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Copyright
© 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- To the Editor— Contact force–sensing catheters and increased risk of atrioesophageal fistula: Is the tool to blame or the workmen?Heart RhythmVol. 15Issue 1
- PreviewWe read with great interest the article by Black-Maier et al1 suggesting a significant increase in the risk of atrioesophageal fistula formation with the use of contact force (CF)–sensing catheters. While the authors allude to the possibility that operators using CF catheters “may ablate longer and with greater force than those using traditional catheters,” we would go further by suggesting that widespread use of a force-time integral (FTI) target value of 400 gs may have contributed to this issue.
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