부산대학교 도서관

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. [ABSTRACT FROM AUTHOR]