Abstract
BACKGROUND: Pulsed field ablation (PFA) is a novel, non-thermal ablation modality to achieve pulmonary vein isolation (PVI) for the treatment of atrial fibrillation (AF). For the pentaspline catheter, eight applications per pulmonary vein (PV) are considered standard, with four in basket configuration and four in flower configuration. The objective of the study is to investigate whether pentaspline PFA using 16 applications per PV is associated with an improved outcome compared with the standard procedure. METHODS: The prospective study included a total of 292 patients with AF. According to the number of applications per PV, patients were assigned to group PFA-8 (8 applications per PV; 4x basket configuration, 4x flower configuration; n = 130) or group PFA-16 (16 applications per PV; 6x basket, 10x flower; n = 162). The primary endpoint was freedom from atrial arrhythmia (AA), i.e. AF, atrial flutter, and atrial tachycardia, after a follow-up period of 1 year, as assessed by Holter monitoring after 3 and 12 months, respectively. RESULTS: Freedom from AA was significantly higher in group PFA-16 than in group PFA-8 (73.9% vs. 62.3%; p < 0.05). Subgroup analysis showed greater effectiveness in the PFA-16 group than in the PFA-8 group (66.1% vs. 45.3%; p < 0.05) in patients with persistent AF, while freedom from AA was similar in both groups in patients with paroxysmal AF (78.8% in PFA-16 vs. 75.7% in PFA-8; p = ns). Serious adverse events were observed in 8 (2.7%) patients, with no differences between the two groups. CONCLUSION: PVI using 16 PFA applications per PV may improve clinical outcome in patients with persistent AF.