Multicenter comparative study of pulsed field ablation vs. radiofrequency balloon ablation for paroxysmal atrial fibrillation: a propensity score matched analysis

Abstract Introduction Pulsed Field Ablation (PFA) has emerged as a novel, non-thermal energy source to selectively ablate cardiac tissue. We performed a multicentre comparative study on Pulmonary Vein Isolation (PVI) with PFA or Radiofrequency Balloon (RFB) ablation for Paroxysmal Atrial Fibrillation (PAF). Methods This prospective multicenter study included all consecutive patients with symptomatic drug-resistant paroxysmal AF undergoing PVI with PFA or RFB between July 2022 and May 2024. The primary efficacy endpoint included PVI rate with the single-shot device only and arrhythmia-free survival at 1-year follow-up. The primary safety endpoint was a composite of device-related major adverse events within 7 days. A propensity score matching technique was adopted to attenuate the imbalance of covariates among the two groups (PFA:RFB ratio = 1:1). Results Among 764 PAF patients undergoing first time PVI with either PFA (n = 316) and RFB (n = 448), propensity score matching yielded 173 PFA and 173 RFB patients. The PVI rate using the single-shot device only was higher in the PFA group than in the RFB group on PV basis (100% vs 98.8%; p=0.005) and patient basis (100% vs 96.5%; p=0.013). At 1-year follow up no differences were reported for any atrial tachyarrhythmia (86.9% vs 87.8%; p= 0.87) and atrial fibrillation recurrence (88.8% vs 89.2%; p= 0.73) between PFA and RFB. No difference was found for major complications (0% vs 1.2%; p=0.16) and overall complications (1.7% vs 2.9%; p=0.47) between PFA and RFB. No differences were found for left atrium dwelling time (29 vs 25 min; p=0.42) and Fluoroscopy time (15 vs 14.5 min; p=0.54) between PFA and RFB. Conclusions While PFA may offer procedural advantages, both techniques are comparably effective in maintaining sinus rhythm after one year of follow-up with good safety profiles.