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. The FarapulseTM 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 FarapulseTM system versus currently available 2nd generation Cryoballoon technologies (CRYO). Methods We systematically searched electronic databases for studies focusing on AF ablation employing the FarapulseTM PFA or 2nd 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 Fifteen and 69 studies were included for PFA and CRYO, respectively. PFA demonstrated greater acute procedural success on a vein basis (99.9% vs 99%;p<0.001), as well as per patient (99.5% vs 98.4%;p<0.001). PFA yielded lower overall periprocedural complications (3.0% vs 5.7%;p<0.001) and shorter fluoroscopy time (14.0 min vs 18.9 min;p=0.02) compared to CRYO (Figure 1). No differences were found for major periprocedural complications (1.2% vs 1.0%;p=0.37), procedural time (84.4 min vs 106.2 min;p=0.07) (Figure1) and freedom from ATs at 1 year (81.8% vs 80.3%; Log-rank p =0.98) (Figure 2). 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.Figure 1Figure 2