Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study.

Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date. A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%. In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve.

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© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

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Conflict of interest: C.-H.H. received travel grants and research grants by Boston Scientific, Biosense Webster and Cardiofocus and Speaker’s Honoraria from Boston Scientific, Biosense Webster, Bayer and Cardiofocus. He is a consultant of Medtronic, Boston Scientific, Biosense Webster and Cardiofocus. R.R.T. is a consultant of Boston Scientific, Biotronik and Biosense Webster and received Speaker’s Honoraria from Biosense Webster, Medtronic, Boston Scientific and Abbot Medical. K.-H.K. reports grants and personal fees from Abbott Vascular, Medtronic, Biosense Webster outside submitted work. A.M. received speaker's honoraria and travel grants from Medtronic, Biosense Webster and Cardiofocus. A.P. received speaker’s honoraria and consulting fees from Medtronic, Biosense Webster, Daiichi-Sankyo, Bayer and is invited fellow of the Boston Scientific EP training programme. T.D. received speaker’s honoraria and consulting fees from Medtronic, Biosense Webster, Boerhringer-Ingelheim, Bayer, Daiichi-Sankyo. C.T. received Speaker’s and Proctor’s fees from Boston Scientific, Medtronic, Abbott and Biosense Webster. He serves in the Advisory Board of Medtronic, Boston Scientific. All remaining authors have declared no conflicts of interest.