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.
Authors
- Muhammad Khuzzaim Khan (ORCID: https://orcid.org/0000-0003-4586-8607)
- Marco Schiavone (ORCID: https://orcid.org/0000-0003-0720-3380)
- Majd Al Deen Alhuarrat (ORCID: https://orcid.org/0000-0003-2016-1496)
- Mohamad Anas Oudih (ORCID: https://orcid.org/0000-0003-2276-0476)
- Hussam Al Hennawi (ORCID: https://orcid.org/0000-0002-1968-4962)
- Mouaz Oudih
- Fengwei Zou (ORCID: https://orcid.org/0000-0001-6355-8843)
- Nils Guttenplan
- L Di Biase
- other members of the PFA Meta‐Analysis Study Group
- Daniel Pugliese
Institutions
- Albert Einstein College of Medicine (US)
- UMass Memorial Health Care (US)
- Montefiore Medical Center (US)
- University of Massachusetts Chan Medical School (US)
- Ball Memorial Hospital (US)
- Dow University of Health Sciences (PK)
- Centro Cardiologico Monzino (IT)
- Saint Joseph Hospital (US)
- Geisinger Wyoming Valley Medical Center (US)
Publication Details
- Journal
- Pacing and Clinical Electrophysiology
- Published
- 2026-07-25
- DOI
- https://doi.org/10.1111/pace.70375
- Primary Topic
- Atrial Fibrillation Management and Outcomes
- Type
- article
- Field-Weighted Citation Impact
- 0.00