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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
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DOI：10.1093/ehjopen/oeaf146.png)
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Abstract
En 中文
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%; P < 0.001). When analysing only the patients exhibiting OF, the mortality was 71.0% among the RF patients, 86.7% among the CB patients, and 100% among those receiving laser ablations (P = 0.427). Among patients exhibiting OF only, the mortality was 80% for those treated surgically, 80% for those treated exclusively endoscopically, and 100% for those treated conservatively. 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.
Keywords:
Catheter ablation
Atrial fibrillation
Radiofrequency energy
Oesophageal fistula
Cryoenergy
Oesophageal injury
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