Efficacy and safety of pulsed field ablation versus conventional thermal techniques for patients with atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials

Abstract

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia and a leading cause of stroke. Pulsed field ablation (PFA) emerges as a novel, non-thermal energy source offering myocardial-selective ablation with a potentially improved safety and efficacy profile. Objectives: To compare the safety and efficacy of PFA versus RFA/CBA ablation in patients with AF. Methods: Multiple databases were systematically searched from inception to May 2025. Randomized Controlled Trials (RCTs) comparing PFA versus thermal ablation (TA) were analyzed using risk ratio (RR) and mean difference (MD) with 95% Confidence Intervals (CI). Random-effects model was employed to account for heterogeneity, as measured by I2 and quantified using leave-one-out analysis. Results: We included 1,294 patients, of whom 653 (50.4%) underwent PFA from four RCTs. Among the included patients, 62.4% have hypertension and a CHA2DS2-VASc mean score of 2.0 ± 1.4. In the pooled analysis, no significant differences were found between PFA group when compared to TA regarding treatment success (RR = 1.11; 95% CI 0.87–1.42; ρ = 0.20), serious adverse events (RR = 1.24; 95% CI 0.38–4.09; ρ = 0.51), recurrent atrial arrhythmias (RR = 0.86; 95% CI 0.54–1.38; ρ = 0.31), and repeat ablation (RR = 0.89; 95% CI 0.18–4.38; ρ = 0.78). However, the procedural time (MD = -38.80 min; 95% CI -75.52–2.08; ρ = 0.04) was significantly reduced in patients who underwent PFA. Conclusion: PFA appears comparable to radiofrequency and cryoballoon ablation for atrial fibrillation, with shorter procedure times but similar efficacy and complication rates. Given that most outcomes were graded as low or very low certainty, further large, long-term randomized trials are needed to confirm these findings.