Multielectrode Catheter-Based Pulsed Electric Field Versus Cryoballoon For Atrial Fibrillation Ablation: A Systematic Review And Meta-Analysis.

Abstract

Background: 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.

Objective: We performed a meta-analysis to compare the efficacy and safety of PFA with the single-shot pentaspline system versus currently available 2nd/3rd/4th generation Cryoballoon technologies (CRYO).

Methods: We systematically searched electronic databases for studies focusing on AF ablation employing the PFA single-shot pentaspline system or 2nd/3rd/4th 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).

Results: Twenty and 70 studies were included for PFA and CRYO, respectively. PFA 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). PFA 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 to 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).

Conclusions: PFA contributed to higher acute procedural success, and safety compared to CRYO. No statistically significant differences in AT recurrence at 1-year follow-up were observed.