Korean Circ J.  2022 Oct;52(10):755-767. 10.4070/kcj.2022.0127.

Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry

• Lim HE
• Oh IY
• Kueffer FJ
• Bragt KAv
• On YK

• KMID: 2534039
• DOI: http://doi.org/10.4070/kcj.2022.0127

Abstract

Background and Objectives
Cryoballoon catheter ablation for the treatment of patients with symptomatic atrial fibrillation (AF) has been adopted globally, but there are limited multicenter reports of 12-month outcomes in the Korean patient population. This analysis evaluated the clinical performance and safety of cryoballoon ablation (CBA) according to standard-of-care practices in Korea.
Methods
This evaluation of Korean patients with AF was conducted within the larger Cryo Global Registry, which is a prospective, multicenter, post-market registry. Freedom from a ≥30-second recurrence of atrial arrhythmias (after a 90-day blanking period until 12 months) and procedural safety were examined in subjects treated with CBA at 3 Korean centers.
Results
Overall, 299 patients with AF (60±11 years old, 24.7% female, 50.5% paroxysmal AF) underwent CBA using the Arctic Front Advance cryoballoon. Of those, 298 were followed-up for at least 12 months. Mean procedure-, left atrial dwell- and fluoroscopy time was 76±21 minutes, 56±23 minutes, and 27±23 minutes, respectively. Freedom from AF recurrence at 12 months was 83.9% (95% confidence interval [CI], 76.9–88.9%) in the paroxysmal and 61.6% (95% CI, 53.1–69.0%) in the persistent AF cohort. Rhythm monitoring was performed on average 4.7±1.4 times during the follow-up period. Serious device- or procedure-related adverse events occurred in 2 patients (0.7%). The 12-month Kaplan-Meier estimate of freedom from repeat ablation and cardiovascular-related hospitalization was 93.8% (95% CI, 90.4–96.1%) and 89.7% (95% CI, 85.6–92.7%), respectively.
Conclusions
CBA is an efficient, effective, and safe procedure for the treatment of AF patients when used according to real-world practices in Korea. Trial Registration: ClinicalTrials.gov Identifier: NCT02752737

Keyword

Atrial fibrillation; Catheter ablation; Registries; Korea

Figure

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  Figure 1 Atrial arrhythmia recurrence. (A) Kaplan-Meier estimate of 12-month freedom from ≥30-second recurrence of AF in PAF (navy lines) and persistent AF (orange lines) after a 90-day blanking period. (B) Kaplan-Meier estimate of freedom from ≥30-second recurrence of AF/AFL/AT at 12 months after a 90-day blanking period in patients with PAF (navy lines) and persistent AF (orange lines). (C) Type of first arrhythmia recurrence in patients with PAF (navy bars) and persistent AF (orange bars).AF = atrial fibrillation; AFL = atrial flutter; AT = atrial tachycardia.

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  Figure 2 Post-ablation standard-of-care and distribution of AF-related symptoms. (A) AAD prescription in 290 patients with information available at discharge (navy bar) and 12 months (orange bar). (B) Proportion of patients monitored for atrial arrhythmia recurrences during the 12-month follow-up period with one (navy), 2 (orange) or 3 or more (yellow-green) 12-lead ECGs, Holter monitors, and all combined methods for arrhythmia monitoring. Patients with continuous monitoring methods (pacemaker/implantable cardiac monitor) are also depicted in red. All patients, including patients with continuous monitoring devices, received ECG monitoring at least once during the follow-up period. (C) Distribution of patients reporting on the presence of pre-specified AF-related symptoms at baseline (navy bars) and at the 12-month (orange bars) follow-up visit.AAD = anti-arrhythmic drug; AF = atrial fibrillation; ECG = electrocardiogram.

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  Figure 3 Healthcare utilization. Kaplan-Meier estimate of 12-month freedom from (A) repeat ablations, (B) all-cause hospitalizations, and (C) CV-related hospitalizations in 299 patients.CI = confidence interval; CV = cardiovascular.

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