Pulsed-field ablation for atrial fibrillation with a novel simplified protocol: the Swiss PFA dose multicenter study

Abstract Introduction Pulsed-field ablation (PFA) has emerged as a novel treatment technology for patients with atrial fibrillation (AF). So far, little is known about the optimal number of PFA applications per pulmonary vein (PV). The standard protocol for PFA, as per manufacturer’s recommendation, entails 8 applications per PV. Purpose To assess the optimal pulsed-field ablation dosing (simplified versus standard protocol vs. extended protocol). Method We prospectively enrolled patients undergoing their first PVI using PFA in three tertiary referral centers. The following PFA dose protocols were applied: In the simple PFA group, a novel simplified protocol for PFA was performed with only 4 applications per PV (2x in basket and 2x in flower configuration). In the standard PFA group, a standard protocol with 8 applications per PV (4x basket and 4x flower configuration) was applied and in the extended PFA protocol, an extended protocol with 12 applications per PV (4x basket and 8x flower configuration) was applied. Results 364 patients were included (32% female, median age 66 [IQR 58 – 73] years). Among these, 100 patients (36%) were in the simple PFA group, 180 patients (50%) in the standard PFA group and 84 (24%) patients in the extended PFA group. The median procedure duration, left atrial dwell time and the fluoroscopic time for the simple PFA, standard PFA and extended PFA group were 45 [interquartile range (IQR) 28 – 57] min vs. 54 [IQR 41 – 67] min vs. 63 [55 – 76] min (p < 0.001), 25 [IQR 12 – 38] min vs. 37 [IQR 27 – 50] min vs. 39 [29 – 55] min (p < 0.001), 9 [IQR 8 – 12] min vs. 11 [IQR 9 – 14] min vs. 9 [8 – 10] min (p < 0.001), respectively. A total of four procedural complications (two tamponades, one stroke, one temporary ST elevation) were observed for the standard PFA group and none for the simple or extended PFA group (p = 0.382). The recurrence rate of atrial arrythmias was 41 (23%) for the standard protocol, 11 (11%) for the simple protocol and 12 (14) % for the extended protocol over a median follow-up of 285 [IQR 173 – 478] days (p = 0.065). Conclusion A novel simplified PFA protocol resulted in significantly shorter procedure duration, left atrial dwell time and fluoroscopic time, without compromising procedural efficacy compared to the standard or extended protocol.Figure 1