Safety and Efficacy of Cryoballoon Ablation for Paroxysmal Atrial Fibrillation in Japan – Results From the Japanese Prospective Post-Market Surveillance Study –
2016; Japanese Circulation Society; Volume: 80; Issue: 8 Linguagem: Inglês
10.1253/circj.cj-16-0285
ISSN1347-4820
AutoresKen Okumura, Kazuo Matsumoto, Yoshinori Kobayashi, Akihiko Nogami, Robert B. Hokanson, Fred Kueffer,
Tópico(s)Cardiac electrophysiology and arrhythmias
ResumoOutcomes of cryoballoon ablation for paroxysmal atrial fibrillation (PAF) have been reported in the Western countries but not in Japan. The CRYO-Japan PMS study was a single-arm, observational, multicenter, prospective study of the 2nd-generation cryoballoon Arctic Front Advance(TM). We evaluated device- and procedure-related complications and clinical outcomes at 6 months.The 616 patients (male, 72%; mean age, 63±11 years) were enrolled from 33 Japanese hospitals. Of all patients, 610 had PAF, and procedural data were analyzed in 607. A subset of 328 patients was followed for 6 months for the primary efficacy analysis. AF recurrence outside the 3-month blanking period or repeat ablation was considered treatment failure. Pulmonary vein isolation was achieved in 606/607 patients (99.8%); 1 patient (0.3%) had a repeat ablation during the blanking period. Freedom from AF at 6 months was 88.4% (95% CI: 84.1-91.6%). Device- and/or procedure-related adverse events included phrenic nerve injury unresolved at hospital discharge in 9/616 patients (1.5%), which resolved within 6 months in 7, pericardial effusion in 5/616 (0.8%), and tamponade in 4/616 (0.6%). One non-device-related death from pneumonia was reported 6 days post-procedure.Cryoballoon ablation is safe and effective for Japanese PAF patients, with 88.4% AF freedom at 6 months post-ablation. (Circ J 2016; 80: 1744-1749).
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