Arrhythmias & electrophysiologyCohort study
Real-world adverse events of pulsed field ablation for atrial fibrillation: A comprehensive analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database
- comprehensive analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database
- Proportional reporting ratio (PRR), corroborated by the reporting odds ratio, was used with Evans criteria
- Duplicates were removed by report number and narrative fingerprint
- Deaths were counted using Event-Type and natural language processing (NLP) analysis
Authors' conclusion
Real-world MAUDE reports identify clinically meaningful, brand-specific signals despite PFA's favorable overall safety profile: VARIPULSE with cerebrovascular predominance, FARAPULSE with hemolysis-acute kidney injury and basket entrapment, Affera Sphere-9 with ventricular and bradyarrhythmic events, and PulseSelect with device-integrity issues. NLP narrative review identified additional under-coded deaths, warranting continued vigilance and prospective registry confirmation.
Study context
- Population
- MAUDE reports involving 4 Food and Drug Administration-approved pulsed field ablation (PFA) systems for atrial fibrillation (AF), from each device's approval date through May 29, 2026unique reports after de-duplication · FARAPULSE 4,541 · PulseSelect 1,687 · Affera Sphere-9 630 · VARIPULSE 319
- Participants
- 7,177 reports
- Exposure
- Brand-specific signals by proportional reporting ratio (PRR) across 4 PFA systems
- FARAPULSEn = 4,541
- PulseSelectn = 1,687
- Affera Sphere-9n = 630
- VARIPULSEn = 319
Further findings
Deaths
- Deaths recorded by Event-Type
- 180
- Deaths identified by NLP adjudication
- 191
- Agreement
- κ = 0.96
Safety
| Outcome | FARAPULSE | PulseSelect | Affera Sphere-9 | VARIPULSE |
|---|---|---|---|---|
| Most frequent device problem: FARAWAVE basket-catheter entrapment | 1026 events | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract |
| Brand-specific signals (PRR) | no signal | |||
| acute kidney injury | 11.70 | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract |
| hemolysis | 6.59 | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract |
| coronary occlusion or myocardial infarction | 4.25 | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract |
| stroke or cerebrovascular accident | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 8.72 |
| transient ischemic attack | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 6.45 |
| cardiac tamponade | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 3.06 |
| ventricular arrhythmia | Not reported in the abstract | Not reported in the abstract | 8.10 | Not reported in the abstract |
| vascular-access complication | Not reported in the abstract | Not reported in the abstract | 7.89 | Not reported in the abstract |
| bradyarrhythmia | Not reported in the abstract | Not reported in the abstract | 3.03 | Not reported in the abstract |
Leading clinical events
- pericardial effusion
- 14.8%
- hypotension
- 14.1%
- stroke or cerebrovascular accident
- 10.9%
- cardiac tamponade
- 9.0%
Original publication
Real-world adverse events of pulsed field ablation for atrial fibrillation: A comprehensive analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database. Heart Rhythm. Published 31 July 2026. doi:10.1016/j.hrthm.2026.07.032
Summarised from the published abstract; every number is checked against it