Efficacy, Safety, and Procedural Outcomes of Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation: A Meta-Analysis.

INTRODUCTION

Pulsed-field ablation (PFA) is a novel, nonthermal modality for the treatment of atrial fibrillation (AF) that may reduce procedural complications compared with conventional thermal ablation methods.

METHODS AND

RESULTS

A systematic literature review was conducted to identify studies comparing PFA with second-generation cryoballoon ablation (2G-CBA) and contact force-sensing radiofrequency ablation (CF-RFA) for paroxysmal AF (pAF) from the inception of PFA to January 2026. A single-arm meta-analysis was performed using random-effects models, reporting the arcsine of the square root transformation (PAS) or mean (95% CI) for each intervention. Overall, 29 studies (9 randomized controlled trials and 20 observational studies) were included. Arrhythmia recurrence rates were comparable across all three interventions [PFA: 23.90% (PAS 0.24, 95% CI 0.19-0.29, p < 0.0001); CF-RFA: 23.72% (PAS 0.24, 95% CI 0.19-0.29, p < 0.0001); 2G-CBA: 25.56% (PAS 0.26, 95% CI 0.20-0.31, p < 0.001)]. Overall procedure time was significantly shorter with PFA than with CF-RFA and comparable to 2G-CBA [PFA: mean 87.66 min (95% CI 74.29-101.04, p < 0.001); CF-RFA: mean 137.54 min (95% CI 123.65-151.43, p < 0.001); 2G-CBA: mean 105.56 min (95% CI 89.93-121.18, p < 0.001)]. Fluoroscopy time was shorter with PFA than with 2G-CBA but comparable to CF-RFA [PFA: mean 16.12 min (95% CI 12.36-19.88); CF-RFA: mean 17.28 min (95% CI 13.59-20.98); 2G-CBA: mean 22.08 min (95% CI 18.23-25.94)]. Overall complication rates did not differ significantly among the three interventions [PFA: 2.93% (95% CI 1.87-4.22%); CF-RFA: 3.66% (95% CI 1.84-6.07%); 2G-CBA: 6.52% (95% CI 4.41-9.00%)]. The incidence of phrenic nerve palsy was significantly higher with 2G-CBA than with PFA or CF-RFA.

CONCLUSION

PFA demonstrated comparable efficacy and safety to CF-RFA and 2G-CBA, with a numerically shorter procedure time than CF-RFA and a lower incidence of phrenic nerve palsy than 2G-CBA, supporting PFA as a viable alternative to established ablation techniques for pAF.