Key result
FARAPULSE pulsed field ablation linked to ~12-fold higher acute kidney injury signal in MAUDE reports.
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Why the study?
Pulsed field ablation for AF showed a favorable safety profile in pivotal trials, but real-world post-market adverse event signals across FDA-approved systems remained incompletely characterized.
What are the real-world adverse events and brand-specific safety signals associated with four FDA-approved pulsed field ablation systems for atrial fibrillation in the MAUDE database?
Observational (n=7,177)
Yes
What are the real-world adverse events and brand-specific safety signals associated with four FDA-approved pulsed field ablation systems for atrial fibrillation in the MAUDE database?
Post-market MAUDE surveillance of 7,177 reports reveals distinct, clinically meaningful brand-specific adverse event profiles across four FDA-approved pulsed field ablation systems, including hemolysis/acute kidney injury with FARAPULSE, cerebrovascular events with VARIPULSE, and ventricular/bradyarrhythmic events with Affera Sphere-9.
MAUDE signals warrant device-specific vigilance in pulsed field ablation; leaves open true risks and causality pending prospective studies.
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 We analyzed adverse events associated with four FDA-approved PFA systems using the 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 by Event-Type and NLP analysis. Proportional Reporting Ratio (PRR), corroborated by the reporting odds ratio (ROR), with Evans criteria. RESULTS After de-duplication, 7,177 unique reports were identified: FARAPULSE (4,541), PulseSelect (1,687), Affera Sphere-9 (630), 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/CVA (10.9%), and cardiac tamponade (9.0%). The most frequent device problem was FARAWAVE basket-catheter entrapment (1,026 FARAPULSE reports). Brand-specific signals included: FARAPULSE for acute kidney injury (PRR 11.70), hemolysis (PRR 6.59), and coronary occlusion/MI (PRR 4.25); VARIPULSE for stroke/CVA (PRR 8.72), TIA (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.
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Hammadeh et al. (2026) conducted an observational in Atrial fibrillation (n=7,177). Pulsed field ablation (PulseSelect, FARAPULSE, VARIPULSE, Affera Sphere-9) vs. Cross-brand comparison across four FDA-approved PFA systems was evaluated on Adverse events, deaths, and brand-specific disproportionality signals (PRR 11.70 (FARAPULSE for acute kidney injury)). Pulsed field ablation showed brand-specific safety signals across 7,177 MAUDE reports, including FARAPULSE for AKI (PRR 11.70), VARIPULSE for stroke (PRR 8.72), and 191 NLP-adjudicated deaths.
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