Outcomes of pulmonary vein isolation with radiofrequency balloon vs. cryoballoon ablation: a multi-centric study.

Aims: Cryoballoon (CB) ablation is the mainstay of single-shot pulmonary vein isolation (PVI). A radiofrequency balloon (RFB) catheter has recently emerged as an alternative. However, these two technologies have not been compared. This study aims to evaluate the freedom from atrial tachyarrhythmias (ATas) at 1 year: procedural characteristics, efficacy, and safety of the novel RFB compared with CB for PVI in patients with paroxysmal atrial fibrillation (AF).
Methods and Results: This prospective multi-centre study included consecutive patients with symptomatic drug-resistant paroxysmal AF who underwent PVI with RFB or CB between July 2021 and January 2022 from three European centres. A total of 375 consecutive patients were included, 125 in the RFB group and 250 in the CB. Both groups had comparable clinical characteristics. At 12.33 ± 4.91 months, ATas-free rates were 83.20% and 82.00% in the RFB and CB groups, respectively (P > 0.05). Compared with the CB group, the RFB group showed a shorter procedure time [59.91 (45.80-77.12) vs. 77.0 (35.13-122.71) min (P < 0.001)], dwell time [19.59 (14.41-30.24) vs. 27.03 (17.11-57.21) min (P = 0.04)], time to isolation, and thermal energy delivery in all pulmonary veins (P < 0.001). First-pass isolation was comparable. No major complications occurred in either group, with no stroke, atrio-oesophageal fistula, or permanent phrenic nerve injury. Transient phrenic nerve palsy occurred more frequently with CB than RFB (7.20% vs. 3.20%; P = 0.02). Oesophageal temperature rise occurred in 21 (16.8%) patients in the RFB group, and gastroscopy showed erythema in two of them with complete recovery after 30 days.
Conclusions: The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. Shorter procedural times appear to be driven by shorter left atrial dwell and thermal delivery times.
Competing Interests: Conflict of interest: A.A. received research grants and compensation for teaching purposes from Abbott, Biosense-Webster, Medtronic, and Microport. A.S. received research grants from Daiichi-Sankyo and Bayer; he has received speaker fees from Menarini and Bayer. M.E.H. is a consultant for Biosense-Webster Inc. not related to this work. S.B. is a consultant for Medtronic, Boston Scientific, Microport, and Zoll. G.-B.C. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, and Acutus Medical. C.d.A. received research grants from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, and Acutus; C.d.A. received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. All remaining authors have declared no conflicts of interest.
(© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)