Comparative evaluation of 2 pulsed field ablation systems for atrial fibrillation: Insights from real-world clinical implementation and short-term outcomes
- PMID: 39515496
- DOI: 10.1016/j.hrthm.2024.10.068
Comparative evaluation of 2 pulsed field ablation systems for atrial fibrillation: Insights from real-world clinical implementation and short-term outcomes
Abstract
Background: Pulsed field ablation (PFA) is a safe and effective technology for catheter ablation of atrial fibrillation (AF). Multiple PFA-platforms for AF ablation have been developed. However, evidence comparing the real-world implementation and performance of different PFA systems is still limited.
Objective: This study compares procedural and acute outcome parameters during implementation of the PFA system employing a pentaspline PFA catheter (FARAPULSE, Boston Scientific, Marlborough, MA) and a platform using a circular PFA-catheter (PulseSelect, Medtronic, Minneapolis, MN).
Methods: The first consecutive 40 patients treated with each PFA system were included. Baseline characteristics, procedural parameters, and short-term outcome regarding periprocedural safety and efficacy were evaluated.
Results: The majority of patients showed paroxysmal AF, nearly one-third of patients in both groups suffered from persistent AF. Overall procedural complication rates were not different among subgroups (circular catheter: 12.5%; pentaspline catheter: 7.5%, P = .71), mainly minor (circular catheter: 10.0%; pentaspline catheter: 7.5%, P =1.00). There was no significant difference in median procedure duration (circular catheter: 42.0 minutes; pentaspline catheter: 43.0 minutes, P = .292), left atrial (LA) dwell time (circular catheter: 29.0 minutes; pentaspline catheter: 31.0 minutes, P = .623), and fluoroscopy duration (circular catheter: 13.2 min; pentaspline catheter: 11.9 minutes, P = .132). With the pentaspline PFA catheter, no learning curve was observed regarding procedural parameters over the course of 40 procedures. With the circular PFA catheter, there was a statistically significant decrease in LA dwell time and fluoroscopy duration comparing the first and last 10 procedures.
Conclusion: Both PFA systems could be safely and rapidly implemented into clinical practice of an experienced center. Large-scale clinical trials are needed to compare long-term outcome between different PFA systems currently introduced into clinical practice.
Keywords: Atrial fibrillation; Catheter ablation; Complications; Pulmonary vein isolation; Pulsed field ablation.
Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Disclosures Dr Zylla has received lecture fees, honoraria, and travel support from Medtronic, Boston Scientific, Bayer Vital, Pfizer, Abbott, and ZOLL CMS. Dr Mages has received educational grants from Biosense Webster and Biotronik. Dr Rahm has received educational grants and travel support from Medtronic, Biosense Webster, and Boston Scientific. Dr Wiedmann has received lecture fees and honoraria from Medtronic, Boston Scientific, Biotronik, and Abbott. Dr Schweizer has received lecture fees/honoraria and travel support from AstraZeneca, Boehringer Ingelheim Pharma, Biosense Webster, Boston Scientific, Medtronic, and Pfizer Pharma. Dr Thomas has received lecture fees and honoraria from AstraZeneca, Bayer Vital, Boehringer Ingelheim Pharma, Bristol-Myers Squibb, Daiichi Sankyo, Medtronic, Pfizer Pharma, Sanofi-Aventis, St Jude Medical/Abbott, and ZOLL CMS. Dr Frey has received lecture fees and honoraria from AstraZeneca, Bayer Vital, Boehringer Ingelheim Pharma, Daiichi Sankyo, Novartis, and Pfizer Pharma, none of which is related to the content of this manuscript. Dr Lugenbiel has received lecture fees and honoraria from Bayer Vital, Boston Scientific, Biosense Webster, Bristol-Myers Squibb, Pfizer, and Medtronic.
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