Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry

Purpose Catheter ablation is a recommended rhythm control therapy after failed or intolerant antiarrhythmic drug (AAD) treatment for patients with atrial fibrillation (AF). This study evaluates clinical performance and safety of pulmonary vein isolation (PVI) using the cryoballoon (Arctic Front Advance) in Japan. Methods Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) were treated at 10 Japanese hospitals. Efficacy was evaluated by freedom from a ≥ 30-s recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT), AF-related symptoms, and quality of life using the EQ-5D-3L questionnaire. The safety endpoint was serious device- and procedure-related adverse events. Results The study included 352 patients with PAF (65 ± 10 years of age, 36% female, 36% without prior failure of AAD). Mean duration since first diagnosis of AF was 3.0 ± 5.5 years. Serious device- and procedure-related adverse event rate was 2.6% (95% CI : 1.2–4.8%). Freedom from AF/AFL/AT was 88.5% (95% CI : 84.7–91.4%) at 12 months and 86.7% (95% CI : 81.1–90.8%) at 24 months. The number of patients with ≥ 1 AF symptom was significantly decreased from 88% at enrollment to 22% ( p < 0.01) at 12-month follow-up. General quality of life using EQ-5D did not improve significantly after 12 months in the summary score. However, in the visual analog scale score, there was improvement (5.8 ± 18.4; p < 0.01). Conclusions This study demonstrates that cryoablation used for PVI is a safe and effective treatment in real-world use for patients with PAF in Japan.