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Meta-Analysis
. 2024 Dec 3;26(12):euae293.
doi: 10.1093/europace/euae293.

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

Affiliations
Meta-Analysis

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

Giampaolo Vetta et al. Europace. .

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.

Keywords: Ablation; Atrial fibrillation; Catheter ablation; Cryoballoon ablation; Pulmonary vein isolation; Pulsed field ablation.

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Conflict of interest statement

Conflict of interest: The authors of this manuscript have the following competing interests. A.N. received speaker honoraria from Boston Scientific, Biosense Webster, Abbott, Biotronik, and Medtronic and is a consultant for Biosense Webster, Abbott, and Janssen. G.-B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. C.d.A. receives research grants on behalf of the centre from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus. The other authors have declared that no competing interests exist.

Figures

Graphical Abstract
Graphical Abstract
Efficacy and safety of pulse field ablation and cryoballoon ablation for atrial fibrillation ablation. CRYO, cryoballoon ablation; PFA, pulsed field ablation.
Figure 1
Figure 1
Acute procedural success per vein. Forest plot comparing acute procedural success per vein between PFA and CRYO. References in brackets are reported in Supplementary material. CI, confidence interval; CRYO, cryoballoon ablation; PFA, pulsed field ablation.
Figure 2
Figure 2
Acute procedural success per patient. Forest plot comparing acute procedural success per patient between PFA and CRYO. References in brackets are reported in Supplementary material. CI, confidence interval; CRYO, cryoballoon ablation; PFA, pulsed field ablation.
Figure 3
Figure 3
Overall periprocedural complications. Forest plot comparing overall periprocedural complications between PFA and CRYO. References in brackets are reported in Supplementary material.
Figure 4
Figure 4
Major periprocedural complications. Forest plot comparing major periprocedural complications between PFA and CRYO. References in brackets are reported in Supplementary material. CI, confidence interval; CRYO, cryoballoon ablation; PFA, pulsed field ablation.
Figure 5
Figure 5
Procedural time. Forest plot comparing procedural time between PFA and CRYO. References in brackets are reported in Supplementary material. CI, confidence interval; CRYO, cryoballoon ablation; PFA, pulsed field ablation.
Figure 6
Figure 6
Fluoroscopy time. Forest plot comparing fluoroscopy time between PFA and CRYO. References in brackets are reported in Supplementary material. CI, confidence interval; CRYO, cryoballoon ablation; PFA, pulsed field ablation.
Figure 7
Figure 7
Kaplan–Meier survival estimates for atrial tachycardia recurrences comparing PFA and CRYO. CRYO, cryoballoon ablation; PFA, pulsed field ablation.

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