ArticleEuropean heart journal open2025
Impact of ablation energy on mortality after oesophageal fistula and injury complicating atrial fibrillation ablation procedures: results from a worldwide FDA database, the POTTER-AF 2 study.
Article in European heart journal open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Adverse events and device malfunctions in robotic thyroidectomy: a decade-long analysis of the MAUDE database.Journal of robotic surgery · 2026Article
- Association between the sedation type and the risk of major oesophageal injury following increased intraoesophageal temperature during radiofrequency ablation for the treatment of atrial fibrillation.Journal of thoracic disease · 2026Article
- Impact of age on the management and prognosis of esophageal fistula after atrial fibrillation ablation-a subanalysis of the worldwide POTTER-AF study.Frontiers in cardiovascular medicine · 2025Article
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Authors and funding
13 authors.
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Abstract
Aims: Oesophageal fistulas (OF) and injuries (OI) are rare, but life-threatening complications following catheter ablation for atrial fibrillation (AF). Data about their incidence, management, and outcome are scarce. This study investigates the clinical characteristics and outcomes of OF and OI following AF ablation. Methods and results: All OF and OI reported between August 2009 and August 2019 in the Manufacturer and User Facility Device Experience (MAUDE) database of the Food and Drug Administration were analysed. A total of 1274 device adverse events following AF/atrial flutter (AFL) ablation were reported in the MAUDE database. Of them, 60 (4.7%) represented patients with OF or OI. A total of 47 patients exhibited OF, while 13 OI without perforation. A total of 35 (58.3%) patients underwent radiofrequency (RF)-based ablation, 20 (33.3%) cryoballoon (CB)-based PVI, and 5 (8.3%) a laser-based PVI. The mortality was 63.3%, but significantly higher in the OF group as compared to the OI group (76.6% vs. 15.4%; Conclusion: Almost one-third of the patients developing OF underwent CB-based ablation. More than three-fourths of the patients died, without significant difference between the ablation energy used. All patients with OF treated conservatively died. OF may occur despite oesophageal temperature monitoring.
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