Fukuoka Ryoma, Kohno Takashi, Kohsaka Shun, Shiraishi Yasuyuki, Sawano Mitsuaki, Abe Takayuki, Nagatomo Yuji, Goda Ayumi, Mizuno Atsushi, Fukuda Keiichi, Shadman Ramin, Dardas Todd F, Levy Wayne C, Yoshikawa Tsutomu
Department of Cardiology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.
Department of Cardiovascular Medicine, Kyorin University School of Medicine, Tokyo, Japan.
Europace. 2020 Apr 1;22(4):588-597. doi: 10.1093/europace/euaa002.
Heart failure (HF) is associated with an increased risk of sudden cardiac death (SCD). This study sought to demonstrate the incidence of SCD within a multicentre Japanese registry of HF patients hospitalized for acute decompensation, and externally validate the Seattle Proportional Risk Model (SPRM).
We consecutively registered 2240 acute HF patients from academic institutions in Tokyo, Japan. The discrimination and calibration of the SPRM were assessed by the c-statistic, Hosmer-Lemeshow statistic, and visual plotting among non-survivors. Patient-level SPRM predictions and implantable cardioverter-defibrillator (ICD) benefit [ICD estimated hazard ratio (HR), derived from the Cox proportional hazards model in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)] was calculated. During the 2-year follow-up, 356 deaths (15.9%) occurred, which included 76 adjudicated SCDs (3.4%) and 280 non-SCDs (12.5%). The SPRM showed acceptable discrimination [c-index = 0.63; 95% confidence interval (CI) 0.56-0.70], similar to that of original SPRM-derivation cohort. The calibration plot showed reasonable conformance. Among HF patients with reduced ejection fraction (EF; < 40%), SPRM showed improved discrimination compared with the ICD eligibility criteria (e.g. New York Heart Association functional Class II-III with EF ≤ 35%): c-index = 0.53 (95% CI 0.42-0.63) vs. 0.65 (95% CI 0.55-0.75) for SPRM. Finally, in the subgroup of 246 patients with both EF ≤ 35% and SPRM-predicted risk of ≥ 42.0% (SCD-HeFT defined ICD benefit threshold), mean ICD estimated HR was 0.70 (30% reduction of all-cause mortality by ICD).
The cumulative incidence of SCD was 3.4% in Japanese HF registry. The SPRM performed reasonably well in Japanese patients and may aid in improving SCD prediction.
心力衰竭(HF)与心源性猝死(SCD)风险增加相关。本研究旨在证明日本多中心急性失代偿性住院HF患者登记系统中心源性猝死的发生率,并对外验证西雅图比例风险模型(SPRM)。
我们连续登记了来自日本东京学术机构的2240例急性HF患者。通过c统计量、Hosmer-Lemeshow统计量以及非幸存者中的可视化绘图对SPRM的区分度和校准度进行评估。计算患者水平的SPRM预测值和植入式心脏复律除颤器(ICD)获益情况[ICD估计风险比(HR),源自心力衰竭试验(SCD-HeFT)中的Cox比例风险模型]。在2年随访期间,发生356例死亡(15.9%),其中包括76例判定的心源性猝死(3.4%)和280例非心源性猝死(12.5%)。SPRM显示出可接受的区分度[c指数 = 0.63;95%置信区间(CI)0.56 - 0.70],与原始SPRM推导队列相似。校准图显示出合理的一致性。在射血分数降低(EF;<40%)的HF患者中,与ICD适用标准(例如纽约心脏协会功能分级II - III级且EF≤35%)相比,SPRM显示出更好的区分度:SPRM的c指数 = 0.53(95%CI 0.42 - 0.63),而ICD适用标准的c指数为0.65(95%CI 0.55 - 0.75)。最后,在246例EF≤35%且SPRM预测风险≥42.0%(SCD-HeFT定义的ICD获益阈值)患者的亚组中,ICD估计的平均HR为0.70(ICD使全因死亡率降低30%)。
在日本HF登记系统中心源性猝死的累积发生率为3.4%。SPRM在日本患者中表现良好,可能有助于改善心源性猝死的预测。