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. 2021 Jan 25;37(2):356-367.
doi: 10.1002/joa3.12504. eCollection 2021 Apr.

Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real-world global setting: Results from the Cryo AF Global Registry

Kyoung Ryul Julian Chun  1 , Ken Okumura  2 , Fernando Scazzuso  3 , Young Keun On  4 , Fred J Kueffer  5 , Kendra M Braegelmann  5 , Surinder Kaur Khelae  6 , Fawzia Al-Kandari  7 , Csaba Földesi  8 ; Cryo Global Registry Investigators
Affiliations

Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real-world global setting: Results from the Cryo AF Global Registry

Kyoung Ryul Julian Chun et al. J Arrhythm. .

Abstract

Background: Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF).

Objectives: Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a single registry.

Methods: The Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) or persistent AF (PsAF) were treated with the cryoballoon catheter according to routine practices at 93 sites across 36 countries. Primary efficacy endpoints included freedom from AF and freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) ≥30 seconds. The primary safety endpoint was serious device- or procedure-related adverse events over 12 month follow-up.

Results: During this evaluation window, 2922 subjects completed an index cryoballoon procedure, and 1440 completed 12 month follow-up. The cohort was 61 ± 12 years of age, 36.3% female, and 78.7% PAF. Serious device- and procedure-related adverse event rates were 1.5% and 3.4%, respectively. Freedom from AF/AFL/AT after the 90 day blanking period was 86.4% (95% CI: 84.3%-88.3%) in patients with PAF and 70.9% (95% CI: 64.6%-76.4%) in patients with PsAF. Freedom from AF/AFL/AT in first-line PAF and PsAF was 90.0% (95% CI: 86.4%-92.7%) and 72.9% (95% CI: 58.6%-83.0%) at 12 months, respectively.

Conclusions: The Cryo Global AF Registry is the largest evaluation to demonstrate cryoablation is an efficient, safe, and effective treatment for patients with AF worldwide. Cryoablation was commonly used to treat patients prior to an AAD failure and may facilitate earlier therapy for patients on the AF disease continuum.

Keywords: antiarrhythmic drug; atrial fibrillation; catheter ablation; cryoballoon; pulmonary vein isolation.

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Conflict of interest statement

This study was sponsored by Medtronic, Inc, Minneapolis, MN. FJ Kueffer and KM Braegelmann are employees of Medtronic. Dr Földesi has received compensation for teaching and proctoring from Medtronic, The Johnson & Johnson Co., Abbott Laboratories, and Biotronik SE & Co. The remaining authors declare no conflict of interests for this article.

Figures

FIGURE 1
FIGURE 1
Patient Flow. Subject enrollment and criteria for the Procedure Analysis Cohort and Efficacy Analysis Cohort. Efficacy analyses were completed on the subset of subjects who were a minimum of 12 months post cryoablation at the time of the analysis
FIGURE 2
FIGURE 2
Monitoring Methods for Atrial Arrhythmia Recurrence. The proportion of the Efficacy Analysis Cohort to be monitored for atrial arrhythmia recurrence during the 12 month follow‐up period with one (blue), two (yellow), or three or more (green) ECGs, ≥24 hour Holter Monitors, and all combined methods for arrhythmia monitoring is depicted. Patients who were evaluated with continuous monitoring methods (black) are also presented. In total, 79.9% of patients underwent monitoring for atrial arrhythmia recurrence at least once during the follow‐up period
FIGURE 3
FIGURE 3
Rate of Serious Adverse Events. Serious device‐related and serious procedure‐related adverse events rates for subjects with paroxysmal (green) and persistent AF (blue). Fisher's exact tests identified no difference in the serious device‐related adverse event rates (1.3% vs 1.8%; P = .57) or the serious procedure‐related adverse event rates (3.4% vs 3.5%; P = .80) between paroxysmal and persistent AF cohorts, respectively
FIGURE 4
FIGURE 4
Freedom from Atrial Arrhythmia Recurrence. (A) Kaplan‐Meier 12 month estimate of freedom from ≥30 second recurrences of AF/AFL/AT in paroxysmal (green) and persistent AF (blue) after a 90 day blanking period. The 12 month freedom from arrhythmia recurrence was significantly higher in the paroxysmal AF cohort (86.4% [95% CI: 84.3%‐88.3%]) than the persistent AF cohort (70.9% (95% CI: 64.6%‐76.4%); P < .01) (B) Kaplan‐Meier estimate of freedom from ≥30 second recurrences of AF/AFL/AT at 12 months after a 90 day blanking period in patients with paroxysmal AF (green lines) and persistent AF (blue lines) who were drug refractory (solid lines) or treated with first‐line cryoballoon ablation (dashed lines). Cox regression model identified that patients who were drug refractory prior to cryoballoon ablation had lower rates of freedom from atrial arrhythmia recurrence than first‐line cryoablation patients (P = .02). *A total of 46 patients were missing baseline AAD information; therefore, 1394/1440 patients were included in the drug refractory vs first‐line Kaplan‐Meier estimates of freedom from atrial arrhythmia recurrence.
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References

    1. Packer DL, Kowal RC, Wheelan KR, et al. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013;61(16):1713–23. - PubMed
    1. Kuck K‐H, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374(23):2235–45. - PubMed
    1. Boveda S, Metzner A, Nguyen DQ, et al. Single‐procedure outcomes and quality‐of‐life improvement 12 months post‐cryoballoon ablation in persistent atrial fibrillation: results from the multicenter CRYO4PERSISTENT AF trial. JACC Clin Electrophysiol. 2018;4(11):1440–7. - PubMed
    1. Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, et al. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: results from the Multicenter STOP persistent AF trial. Heart Rhythm. 2020;17(11):1841–7. 10.1016/j.hrthm.2020.06.020 - DOI - PubMed
    1. Kuniss M, Pavlovic N, Velagic V, et al.Cryoballoon catheter ablation versus antiarrhythmic drugs as a first‐line therapy for patients with paroxysmal atrial fibrillation: the Cryo FIRST trial. DGK Conference; Mannheim Germany. 2020. - PubMed

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