Comparison of acute efficacy, safety, and feasibility of pulmonary vein isolation and left atrial roof ablation in patients with atrial fibrillation using two pulsed field ablation single-shot devices

Introduction
The aim of this study was to compare the feasibility, safety, and acute efficacy of pulmonary vein isolation (PVI) and left atrial roof ablation (LARA) using two pulsed field ablation (PFA) catheters – a pentaspline catheter and a circular PFA catheter – in patients with symptomatic atrial fibrillation (AF).

 

We enrolled consecutive AF patients who underwent either PVI alone or PVI combined with LARA using the pentaspline catheter (Farapulse™) or the circular array PFA catheter (PulseSelect™ PFA System) between November 2023 and September 2024. LARA was performed only in patients with persistent AF and left atrial enlargement (LA > 20 cm²). Patients with concomitant typical atrial flutter also underwent cavo-tricuspid isthmus (CTI) ablation.

 

A total of 175 AF patients were included and divided into two groups: group 1 (N = 96) treated with the pentaspline PFA catheter and group 2 (N = 79) treated with the circular PFA catheter.

Acute PVI was achieved in 100% of pulmonary veins in both groups. The total number of PFA applications for pulmonary veins (PVs) in group 1 was slightly higher than in group 2 (35 ± 3 vs. 34 ± 3, p < 0.01). In group 1, 29 patients (30.2%) received additional LARA, and 25 patients (31.6%) underwent LARA in group 2 (p = 0.97). LARA was performed with more PFA applications in group 1 than in group 2 (10.8 ± 5.5 vs. 8.5 ± 3.6, p < 0.01). In group 1, three patients received CTI ablation compared to five patients in group 2 (p = 0.47). CTI ablation was achieved with more PFA applications in group 1 (15 ± 6) than in group 2 (6 ± 4, p < 0.01). Conduction block across the left atrial roof and CTI was confirmed in all patients.

Procedural times were longer in group 2, including total skin-to-skin time (61.6 ± 16.1 min vs. 67 ± 13.8 min, p < 0.01) and PFA catheter time in the left atrium (41.9 ± 14.0 min vs. 44.6 ± 10.6 min, p < 0.01). However, fluoroscopy time was shorter in group 2 (13.9 ± 5.7 min vs. 13.4 ± 4.7 min, p < 0.01).

No significant differences in complication rates were observed between the groups (p = 0.69). Four procedural complications occurred in the pentaspline catheter group (two vascular access complications, one tamponade, and one transient ST elevation), and two vascular complications were noted in group 2.

 

This study demonstrates comparable effectiveness between the two PFA systems for PVI and LARA. Although more PFA applications were performed by pentaspline catheter, the overall procedural time was shorter, while the circular catheter was associated with reduced fluoroscopy time. Both systems showed a similar safety profile. Further studies are needed to evaluate the long-term clinical outcomes of these PFA technologies.