Multielectrode catheter-based pulsed electric field vs. cryoballoon for atrial fibrillation ablation: a systematic review and meta-analysis

Aims: Pulsed field ablation (PFA) is an innovative technology recently adopted for the treatment of atrial fibrillation (AF). Preclinical and clinical studies have reported a remarkable safety profile, as a result of its tissue-specific effect targeting cardiomyocytes and sparing adjacent tissues. Single-shot pentaspline system was the first PFA device to receive regulatory approval. We performed a meta-analysis to compare the efficacy and safety of PFA with the single-shot pentaspline system vs. currently available second-/third-/fourth-generation cryoballoon ablation (CRYO) technologies.

Methods and results: We systematically searched electronic databases for studies focusing on AF ablation employing the PFA single-shot pentaspline system or second-/third-/fourth-generation CRYO technologies. The primary endpoints were acute procedural success assessed on a vein and patient basis. Safety endpoints included overall periprocedural complications and major periprocedural complications. We also compared procedural, fluoroscopy times, and freedom from atrial tachyarrhythmias (ATs) at follow-up (secondary endpoints). Twenty and 70 studies were included for PFA and CRYO, respectively. Pulsed field ablation demonstrated greater acute procedural success on a vein basis (99.9% vs. 99.1%; P < 0.001), as well as per patient (99.5% vs. 98.4%; P < 0.001). Pulsed field ablation yielded lower overall periprocedural complications (3.1% vs. 5.6%; P < 0.001), shorter procedural time (75.9 min vs. 105.6 min; P < 0.001), and fluoroscopy time (14.2 min vs. 18.9 min; P < 0.001) compared with CRYO. No differences were found for major periprocedural complications (1.2% vs. 1.0%; P = 0.46) and freedom from ATs at 1 year (82.3% vs. 80.3%; log-rank P = 0.61).

Conclusion: Pulsed field ablation contributed to higher acute procedural success and safety compared with CRYO. No statistically significant differences in AT recurrence at 1-year follow-up were observed.