Heart rhythm · 2026
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.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Hammadeh Bara M, Aldib Layan, Challa Abhiram, Gerlt Deitrich, Al Mubaid Ahmed, Kohli Utkarsh
Аннотация
BACKGROUND: Pulsed field ablation (PFA) for atrial fibrillation (AF) has entered practice with a favorable safety profile from pivotal trials, but real-world post-market signals remain incompletely characterized.
OBJECTIVE: To analyze adverse events associated with 4 Food and Drug Administration-approved PFA systems using the Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS: We queried MAUDE for reports involving PulseSelect, FARAPULSE, VARIPULSE, and Affera Sphere-9 from each device's approval date through May 29, 2026. 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.
RESULTS: After de-duplication, 7177 unique reports were identified: FARAPULSE (4541), PulseSelect (1687), Affera Sphere-9 (630), and VARIPULSE (319). Event-Type recorded 180 deaths; NLP adjudication identified 191 (κ = 0.96). Leading clinical events were pericardial effusion (14.8%), hypotension (14.1%), stroke or cerebrovascular accident (10.9%), and cardiac tamponade (9.0%). The most frequent device problem was FARAWAVE basket-catheter entrapment (1026 FARAPULSE reports). Brand-specific signals included FARAPULSE for acute kidney injury (PRR, 11.70), hemolysis (PRR, 6.59), and coronary occlusion or myocardial infarction (PRR, 4.25); VARIPULSE for stroke or cerebrovascular accident (PRR, 8.72), transient ischemic attack (PRR, 6.45), and cardiac tamponade (PRR, 3.06); Affera Sphere-9 for ventricular arrhythmia (PRR, 8.10), vascular-access complication (PRR, 7.89), and bradyarrhythmia (PRR, 3.03). PulseSelect generated no signal.
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.
OBJECTIVE: To analyze adverse events associated with 4 Food and Drug Administration-approved PFA systems using the Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS: We queried MAUDE for reports involving PulseSelect, FARAPULSE, VARIPULSE, and Affera Sphere-9 from each device's approval date through May 29, 2026. 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.
RESULTS: After de-duplication, 7177 unique reports were identified: FARAPULSE (4541), PulseSelect (1687), Affera Sphere-9 (630), and VARIPULSE (319). Event-Type recorded 180 deaths; NLP adjudication identified 191 (κ = 0.96). Leading clinical events were pericardial effusion (14.8%), hypotension (14.1%), stroke or cerebrovascular accident (10.9%), and cardiac tamponade (9.0%). The most frequent device problem was FARAWAVE basket-catheter entrapment (1026 FARAPULSE reports). Brand-specific signals included FARAPULSE for acute kidney injury (PRR, 11.70), hemolysis (PRR, 6.59), and coronary occlusion or myocardial infarction (PRR, 4.25); VARIPULSE for stroke or cerebrovascular accident (PRR, 8.72), transient ischemic attack (PRR, 6.45), and cardiac tamponade (PRR, 3.06); Affera Sphere-9 for ventricular arrhythmia (PRR, 8.10), vascular-access complication (PRR, 7.89), and bradyarrhythmia (PRR, 3.03). PulseSelect generated no signal.
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.