Cryoballoon ablation in 1226 Japanese patients with persistent AF resulted in 84.4% freedom from atrial arrhythmia at 12 months with 1.6% serious adverse events.
Does cryoballoon ablation prevent atrial arrhythmia recurrence in patients with persistent atrial fibrillation?
Cryoballoon ablation is a safe and effective real-world treatment for persistent atrial fibrillation in Japan, with additional ablation beyond PVI potentially offering higher freedom from arrhythmia recurrence.
Absolute Event Rate: 0% vs 0%
ABSTRACT Background Atrial fibrillation (AF) prevalence has increased with Japan's aging population. Data on cryoballoon ablation (CBA) for persistent AF (PsAF) in Japan is limited. This study reports CBA clinical outcomes in PsAF patients in Japan from the prospective Cryo Global Registry. Methods Data was analyzed from 60 Japanese centers with 1226 PsAF patients that underwent CBA. The primary endpoints were serious adverse events and freedom from atrial arrhythmia (AA) recurrence, at 12 months. The effect of ablation strategy (pulmonary vein isolation PVI or PVI with additional ablations PVI+) was evaluated. Quality‐of‐life (QoL) was measured by EQ‐5D‐3L questionnaire. Results The patient mean age was 68 ± 10 years and 29.0% were female. The overall 12‐months Kaplan–Meier (KM) estimate for freedom from AA recurrence was 84.4% (95% CI: 82.2%–86.3%). Among PVI+ patients, 33.0% received cavotricuspid isthmus (CTI) and 34.6% received non‐CTI ablation (majority being left‐atrial roofline 27.2%). The 12‐months KM estimate for freedom from AA recurrence was higher for PVI+ subgroup (86.6% CI: 83.6%–89.1%) than PVI subgroup (82.0% CI: 78.6%–84.9%) (HR adj = 1.40, p = 0.025). Twenty‐two serious adverse events were reported in 1.6% patients. At 12 months, compared to baseline, QoL improved with a mean summary‐index score difference of 0.03 ± 0.16 ( p < 0.001) and a mean EQ visual analogue scale score difference of 7.9 ± 18.5 ( p < 0.001). Conclusion This study showed CBA is safe and effective for PsAF treatment in real‐world use in Japan. Trial Registration Cryo Global Registry, ClinicalTrials.gov ID NCT02752737
Fukunaga et al. (Sun,) reported a other. Cryoballoon ablation in 1226 Japanese patients with persistent AF resulted in 84.4% freedom from atrial arrhythmia at 12 months with 1.6% serious adverse events.