Journal of arrhythmia · 2026
Cryoballoon Ablation for Persistent Atrial Fibrillation in Japan: Cryo Global Registry 12-Months Results.
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Fukunaga Hiroshi, Murakami Masato, Yoshida Yukihiko, Inaba Osamu, Miura Fumiharu, Yamauchi Yasuteru, Shizuta Satoshi, Yagishita Atsuhiko, Kumagai Koichiro, Nakahara Shiro, Egami Yasuyuki, Sawhney Neha, Obidigbo Valentine, Ando Kenji, Nitta Junichi, Cryo Global Registry
Аннотация
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.
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.