Arrhythmias & electrophysiology
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
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
Methodological detailsProportional 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
- 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
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 | PulseSelect, Affera Sphere-9, VARIPULSE: 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 | PulseSelect, Affera Sphere-9, VARIPULSE: not reported in the abstract |
| Hemolysis | 6.59 | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | PulseSelect, Affera Sphere-9, VARIPULSE: 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 | PulseSelect, Affera Sphere-9, VARIPULSE: 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 | FARAPULSE, PulseSelect, Affera Sphere-9: not reported in the abstract |
| Transient ischemic attack | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 6.45 | FARAPULSE, PulseSelect, Affera Sphere-9: not reported in the abstract |
| Cardiac tamponade | Not reported in the abstract | Not reported in the abstract | Not reported in the abstract | 3.06 | FARAPULSE, PulseSelect, Affera Sphere-9: not reported in the abstract |
| Ventricular arrhythmia | Not reported in the abstract | Not reported in the abstract | 8.10 | Not reported in the abstract | FARAPULSE, PulseSelect, VARIPULSE: 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 | FARAPULSE, PulseSelect, VARIPULSE: not reported in the abstract |
| Bradyarrhythmia | Not reported in the abstract | Not reported in the abstract | 3.03 | Not reported in the abstract | FARAPULSE, PulseSelect, VARIPULSE: 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.
Summarised from the published abstract; every number is checked against it