Direct Comparison of Two Commercially Available Pulsed Field Ablation Systems for Atrial Fibrillation; Procedure Characteristics and Acute Outcomes.

Abstract

Background: There are few comparative studies on the everyday clinical outcomes of commercially available pulsed field ablation (PFA) systems for atrial fibrillation (AF).

Objective: This study evaluates the acute efficacy and safety outcomes of the FARAPULSE™ (pentaspline catheter) and PulseSelect™ (circular catheter) system.

Methods: International, multicenter, registry on patients with paroxysmal or persistent AF, undergoing a first ablation using either PFA system between January 29th, 2024 and September 1st, 2024. Primary endpoints were electrical isolation of ablation targets, procedural characteristics and freedom from major adverse events within 30 days postprocedure.

Results: A total of 402 patients were enrolled at the six participating centers, of whom 56.5% were treated with the pentaspline ablation-catheter. Acute procedural efficacy was 100% for both groups. Use of the pentaspline ablation-catheter was associated with significantly shorter procedural times (36.0 min [IQR 31.0; 44.0] vs. 49.0 min [IQR 41.5;76.0]) compared to the circular ablation-catheter (p < 0.001). Major adverse events were scarce and not different between cohorts. Two patients (0.5%) experienced a stroke and one patient (0.2%) had a serious vascular access site complication. One patient had a transient ischemic attack (0.2%). Minor vascular access site complications were more common in the pentaspline catheter group (11.9% vs. 1.1%, p < 0.001).

Conclusions: This study showed excellent acute efficacy and safety for both PFA-systems. Our findings reveal shorter procedural times with the pentaspline catheter, less minor access site complications with the circular catheter, and several procedural differences between the ablation systems, often driven by operator choice.