Pulsed field ablation for atrial fibrillation with a novel simplified protocol: The PFA dose study

BACKGROUND: Pulsed field ablation (PFA) with use of a pentaspline catheter for the treatment of atrial fibrillation is performed in a standardized fashion. Whether a reduced number of applications results in similar clinical outcomes has not been fully investigated. OBJECTIVE: This study aimed to assess a simplified PFA dosing protocol for pulmonary vein isolation (PVI) compared with a standard protocol. METHODS: Consecutive patients undergoing their first PVI by PFA were enrolled. In the simple PFA group, patients received 4 applications per pulmonary vein (2× basket and 2× flower configuration), whereas 8 applications per pulmonary vein (4× basket and 4× flower configuration) were used in the standard PFA group. RESULTS: We included 245 patients (32% female; median age, 66 years), 96 (39%) in the simple PFA group and 149 (61%) in the standard PFA group. Median procedure duration, left atrial dwell time, and fluoroscopy time were significantly shorter in the simple PFA group compared with the standard PFA group at 40 (25-55) minutes vs 53 (41-67) minutes (P .999). Overall, 4 procedural complications were observed, all in the standard PFA group (P = .303). During a median follow-up of 373 days, freedom from atrial arrhythmias was 79% in the simple PFA group and 77% in the standard PFA group (P = .767). Findings were confirmed in comparing only patients who received PVI with or without electroanatomic mapping. CONCLUSION: The novel simplified PFA protocol was associated with increased procedural efficiency while maintaining noninferior efficacy and safety compared with the standard PFA protocol.