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Safety of cryoballoon ablation for the treatment of atrial fibrillation: First European results from the cryo AF Global Registry
Author(s) -
Földesi Csaba,
Misiková Silvia,
Ptaszyński Paweł,
Todd Derick,
Herzet JeanManuel,
Braegelmann Kendra M.,
Kueffer Fred J.,
Drephal Christian,
Steinwender Clemens,
Zucchelli Giulio,
Neuzil Petr,
Chun Kyoung Ryul Julian
Publication year - 2021
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.14237
Subject(s) - medicine , cryoablation , atrial fibrillation , atrial flutter , atrial tachycardia , adverse effect , catheter ablation , cardiology , ablation , radiofrequency ablation
Background Cryoballoon ablation for the treatment of patients with atrial fibrillation (AF) has been utilized in Europe for >15 years. Objectives Report patient and procedural characteristics that influence the safety of cryoablation for the treatment of AF. Methods Patients enrolled in the prospective, multicenter Cryo AF Global Registry were treated at 38 European centers. Freedom from a ≥30s episode of AF/atrial flutter (AFL)/atrial tachycardia (AT) at 12‐months and serious complications were analyzed. Univariate and multivariable models identified baseline patient and procedural characteristics that predicted a procedure‐related complication. Results Of the 1418 subjects who completed an index procedure, the cohort was 62 ± 11 years of age, 37.7% female, and 72.2% paroxysmal AF (PAF). The mean procedure, left atrial dwell, and fluoroscopy times were 81 ± 34, 54 ± 25, and 14 ± 13 min, respectively. Among the 766 patients with 12‐month follow‐up, freedom from a ≥30 s AF/AFL/AT recurrence was 83.3% (95% CI: 79.8%–86.3%) and 71.6% (95% CI: 64.6%–77.4%) in patients with PAF and persistent AF. The serious procedure‐ and device‐related adverse event rates were 4.7% and 2.0%. No baseline patient characteristic independently predicted a procedure‐related adverse event; however, prolonged procedure duration (OR = 1.01 [95% CI: 1.00–1.01]), use of general anesthesia (OR = 1.71 [95% CI: 1.01–2.92]), and delivery of a cavotricuspid isthmus line (OR = 3.04 [95% CI: 1.01–9.20]) were each independently associated with the occurrence of a serious procedural safety event (all p < .05). Conclusions Cryoballoon ablation is safe and effective in real‐world use across a broad cohort of patients with AF.