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.

2nd Division of Cardiology Cardiac Thoracic and Vascular Department Azienda Ospedaliero Universitaria Pisana Pisa Italy

Cardioangiologisches Centrum Bethanien Frankfurt Germany

Centre Hospitalier Régional de la Citadelle Liège Belgium

Department of Cardiology Kepler University Hospital Linz Linz Austria

Gottsegen György Országos Kardiológiai Intézet Budapest Hungary

Liverpool Heart and Chest Hospital Liverpool UK

Med Klinik 2 Universtätsklinikum Schleswig Holstein Campus Lübeck

Medical University of Łódź Central University Hospital Łódź Poland

Medtronic Inc Minneapolis Minnesota USA

Na Homolce Hospital Prague Czech Republic

Sana Klinikum Berlin Lichtenberg Klinik für Innere Medizin 2 Kardiologie Berlin Germany

Východoslovenský ústav srdcovych a cievnych chorôb a s Košice Slovakia

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