Long-term outcomes of the pentaspline pulsed field ablation catheter for the treatment of paroxysmal atrial fibrillation: Results of the prospective, multicenter FARA-Freedom Study.

Abstract

INTRODUCTION/OBJECTIVES

Pulmonary vein isolation (PVI) is well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing the promise of pulsed-field ablation (PFA) for this treatment, long term efficacy and safety data demonstrating single procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate long-term efficacy and safety of PFA using the pentaspline catheter for PAF.

METHODS

FARA-Freedom, a prospective, non-randomized, multicenter study, enrolled patients with PAF undergoing de novo PVI with PFA, which were followed for 12 months with weekly transtelephonic monitoring (TTMs) and 72-hr Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success; which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time.

RESULTS

The study enrolled 179 PAF patients (62 ± 10 yr, 39% female) at 13 centers. At index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20 min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high with 88.4% and 90.3% with weekly event and 72-hour Holter monitors, respectively. Freedom from composite primary effectiveness endpoint was 66.6%, 41 patients had atrial tachyarrhythmia recurrence: mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in 2 patients (1.1%), 1 tamponade and 1 TIA. There was no coronary spasm, PV stenosis, or AE fistula. There were 4 cases of transient phrenic nerve palsy, but all resolved during index procedure.

CONCLUSIONS

In this prospective, non-randomized, multicenter study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigorous endpoint definitions and high monitoring compliance and demonstrated favorable safety.