Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 6;25(12):euad329.
doi: 10.1093/europace/euad329.

Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation

Patrick Badertscher  1   2 , Simon Weidlich  1   2 , Sven Knecht  1   2 , Niklas Stauffer  1   2 , Philipp Krisai  1   2 , Gian Voellmin  1   2 , Stefan Osswald  1   2 , Christian Sticherling  1   2 , Michael Kühne  1   2
Affiliations

Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation

Patrick Badertscher et al. Europace. .

Abstract

Aims: Pulsed-field ablation (PFA) has emerged as a novel treatment technology for patients with atrial fibrillation (AF). Cryoballoon (CB) is the most frequently used single shot technology. A direct comparison to a novel CB system is lacking. We aimed to compare pulmonary vein isolation (PVI) using PFA vs. a novel CB system regarding efficiency, safety, myocardial injury, and outcomes.

Methods and results: One hundred and eighty-one consecutive patients underwent PVI and were included (age 64 ± 9.7 years, ejection fraction 0.58 ± 0.09, left atrial size 40 ± 6.4 mm, paroxysmal AF 64%). 106 patients (59%) underwent PFA (FARAPULSE, Boston Scientific) and 75 patients (41%) underwent CB ablation (PolarX, Boston Scientific). The median procedure time, left atrial dwell time and fluoroscopic time were similar between the PFA and the CB group with 55 [interquartile range (IQR) 43-64] min vs. 58 (IQR 48-69) min (P < 0.087), 38 (30-49) min vs. 37 (31-48) min, (P = 0.871), and 11 (IQR 9.3-14) min vs. 11 (IQR 8.7-16) min, (P < 0.81), respectively. Three procedural complications were observed in the PFA group (two tamponades, one temporary ST elevation) and three complications in the CB group (3× reversible phrenic nerve palsies). During the median follow-up of 404 days (IQR 208-560), AF recurrence was similar in the PFA group and the CB group with 24 vs. 30%, P = 0.406.

Conclusion: Procedural characteristics were very similar between PFA and CB in regard to procedure duration fluoroscopy time and complications. Atrial fibrillation free survival did not differ between the PFA and CB groups.

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

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: P.B. has received research funding from the ‘University of Basel’, the ‘Stiftung für Herzschrittmacher und Elektrophysiologie’, the ‘Freiwillige Akademische Gesellschaft Basel’, the ‘Swiss Heart Foundation’ and Johnson&Johnson, and reports personal fees from BMS, Boston Scientific, and Abbott, all outside the submitted work. P.K. reports speaker fees from BMS. S.K. has received funding from the ‘Stiftung für Herzschrittmacher und Elektrophysiologie’. C.S.: Member of Medtronic Advisory Board Europe and Boston Scientitic Advisory Board Europe, received educational grants from Biosense Webster and Biotronik and a research grant from the European Union’s FP7 program and Biosense Webster and lecture and consulting fees from Abbott, Medtronic, Biosense-Webster, Boston Scientific, Microport, and Biotronik all outside the submitted work. M.K. reports grants from the Swiss National Science Foundation (Grant numbers 33CS30_148474, 33CS30_177520, 32473B_176178, and 32003B_197524), the Swiss Heart Foundation, the Foundation for Cardiovascular Research Basel and the University of Basel, grants from Bayer, grants from Pfizer, grants from Boston Scientific, grants from BMS, grants from Biotronik, grants and personal fees from Daiichi Sankyo, all outside the submitted work. Others have nothing to declare.

Figures

Graphical Abstract
Graphical Abstract
Comparison between pulsed field ablation and cryoballoon PolarX. AF, atrial fibrillation.
Figure 1
Figure 1
Simple scatter plot representing total procedure duration and left atrial dwell-time over time. The validity of this stratification was confirmed by linear regression modelling. CB, cryoballoon; PFA, pulsed field ablation.
Figure 2
Figure 2
Comparison of Kaplan–Meier curves for recurrence-free survival in the first 365 days after PVI for CB and PFA. CB, cryoballoon; PFA, pulsed field ablation.
See this image and copyright information in PMC

References

    1. Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J et al. Cryoablation or drug therapy for initial treatment of atrial fibrillation. N Engl J Med 2021;384:305–15. - PubMed
    1. Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S et al. Cryoballoon ablation as initial therapy for atrial fibrillation. N Engl J Med 2021;384:316–24. - PubMed
    1. van Belle Y, Janse P, Rivero-Ayerza MJ, Thornton AS, Jessurun ER, Theuns D et al. Pulmonary vein isolation using an occluding cryoballoon for circumferential ablation: feasibility, complications, and short-term outcome. Eur Heart J 2007;28:2231–7. - PubMed
    1. Straube F, Dorwarth U, Pongratz J, Brück B, Wankerl M, Hartl S et al. The fourth cryoballoon generation with a shorter tip to facilitate real-time pulmonary vein potential recording: feasibility and safety results. J Cardiovasc Electrophysiol 2019;30:918–25. - PubMed
    1. Anic A, Lever N, Martin A, Breskovic T, Sulkin MS, Duffy E et al. Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience. Europace 2021;23:1237–43. - PMC - PubMed

Grants and funding