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.
Long-term outcomes in this study suggest that the pulmonary vein isolation using the cryoballoon technique is relatively an effective method especially in the treatment of paroxysmal atrial fibrillation.
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