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.

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Journal
Pacing and Clinical Electrophysiology
Published
2026-07-25
DOI
https://doi.org/10.1111/pace.70375
Primary Topic
Atrial Fibrillation Management and Outcomes
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article
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article

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

Muhammad Khuzzaim Khan, Marco Schiavone, Majd Al Deen Alhuarrat, Mohamad Anas Oudih et al.
Pacing and Clinical Electrophysiology
Atrial Fibrillation Management and Outcomes
article

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

Muhammad Khuzzaim Khan, Marco Schiavone, Majd Al Deen Alhuarrat, Mohamad Anas Oudih, Hussam Al Hennawi, Mouaz Oudih, Fengwei Zou, Nils Guttenplan, L Di Biase, other members of the PFA Meta‐Analysis Study Group, Daniel Pugliese
article en

Abstract

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.

Pacing and Clinical Electrophysiology
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)
Openalex Percentile: Top 8%
Atrial Fibrillation Management and Outcomes
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