Multielectrode catheter-based pulsed electric field vs. cryoballoon for atrial fibrillation ablation: a systematic review and meta-analysis
Giampaolo Vetta, Domenico G. Della Rocca, Antonio Parlavecchio, Michele Magnocavallo, Antonio Sorgente, Luigi Pannone, Alvise Del Monte, Alexandre Almorad, Juan Sieira, Lorenzo Marcon, Ioannis Doundoulakis, Sanghamitra Mohanty, Charles Audiat, Kazutaka Nakasone, Gezim Bala, Erwin Ströker, Stéphane Combes, Ingrid Overeinder, Stefano Bianchi, Pietro Palmisano, Pietro Rossi, Serge Bovéda, Marc La Meir, Andrea Natale, Andrea Sarkozy, Carlo de Asmundis, Gian‐Battista Chierchia
Abstract
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.