Direct comparison of two commercially available pulsed field ablation systems for atrial fibrillation; procedure characteristics and acute outcomes

Limited data is available about everyday clinical outcomes of the currently commercially available pulsed field ablation (PFA) systems for atrial fibrillation (AF).

In this study we evaluated the acute procedural and safety outcomes of two currently available PFA-systems: the FARAPULSE pentaspline catheter system (FP) and the PulseSelect circular catheter system (PS) beyond their market release.

This is an international, multicenter, observational registry study. Patients with paroxysmal or persistent atrial fibrillation (AF) undergoing a first ablation with either ablation system between January 29th, 2024 and September 1st, 2024 were included. The planning department was responsible for scheduling patients and systems with no influence of the operators to select patients. Ablation procedures were performed per local institutional standards. Primary efficacy endpoint was the electrical isolation of ablation targets, primary safety endpoint was freedom from major adverse peri-procedural events up to 30 days.

A total of 402 patients were enrolled at the 6 participating centers; 56.5% in the FP cohort and 44% in the PS cohort. While acute procedural efficacy, after a median number of 8 applications per vein, was 100% for both the FP and PS cohorts, there were significant differences in other procedural characteristics. Ultrasound guided femoral access was used more often in the FP cohort (81.1% vs. 90.7%, p = 0.008), while use of periprocedural echocardiography (TEE or ICE) and electroanatomic mapping systems was higher in the circular catheter group. The median procedure duration was significantly longer in the PS compared to the FP cohort (49.0 min [IQR 41.5;76.0] versus 36.0 min [IQR 31.0; 44.0], p<0.001), mainly driven by electroanatomic mapping time. Major adverse events during follow-up were scarce and not different between cohorts: of note two patients (0.5%) experienced a CVA and one patient (0.2%) had a serious vascular access site complication requiring surgical intervention. Minor vascular access site complications were predominantly affecting patients in the FP cohort (FP cohort: 11.9% vs. PS cohort: 1.1%, p < 0.001). One patient in the FP cohort had a TIA during follow-up.

This multicenter study shows excellent efficacy and safety of both PulseSelect and FARAPULSE PFA-systems in an everyday clinical setting. Our findings reveal several relevant procedural differences between the ablation systems, often driven by operator choice. However, both procedures demonstrated high procedural efficiency, great efficacy and a low incidence of serious adverse events.

Table procedural characteristics