Hong Euy Lim1, Il-Young Oh2, Fred J Kueffer3, Kelly Anna van Bragt3, Young Keun On4. 1. Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea. 2. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul, Korea. 3. Cardiac Ablation Solutions, Medtronic, Inc., Minneapolis, MN, USA. 4. Division of Cardiology, Department of Medicine, Cardiac Arrhythmia Center, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. yk.on@samsung.com.
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.
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.
Authors: Daniel J Friedman; DaJuanicia Holmes; Anne B Curtis; Kenneth A Ellenbogen; David S Frankel; Bradley P Knight; Andrea M Russo; Roland Matsouaka; Mintu P Turakhia; William R Lewis; Jonathan P Piccini Journal: J Cardiovasc Electrophysiol Date: 2021-01-06
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Authors: Ellen Hoffmann; Florian Straube; Karl Wegscheider; Malte Kuniss; Dietrich Andresen; Li-Qun Wu; Jürgen Tebbenjohanns; Georg Noelker; Roland Richard Tilz; Julian Kyoung Ryul Chun; Andreas Franke; Christoph Stellbrink; Arcadi Garcia-Alberola; Uwe Dorwarth; Andreas Metzner; Taoufik Ouarrak; Johannes Brachmann; Karl-Heinz Kuck; Jochen Senges Journal: Europace Date: 2019-09-01 Impact factor: 5.214