TY - JOUR
T1 - Prediction of sudden cardiac death in Japanese heart failure patients
T2 - International validation of the Seattle Proportional Risk Model
AU - Fukuoka, Ryoma
AU - Kono, Takashi
AU - Kohsaka, Shun
AU - Shiraishi, Yasuyuki
AU - Sawano, Mitsuaki
AU - Abe, Takayuki
AU - Nagatomo, Yuji
AU - Goda, Ayumi
AU - Mizuno, Atsushi
AU - Fukuda, Keiichi
AU - Shadman, Ramin
AU - Dardas, Todd F.
AU - Levy, Wayne C.
AU - Yoshikawa, Tsutomu
N1 - Funding Information:
This study was supported by Grant-in-Aid for Young Scientists (JPSS KAKENHI, 18K15860 to Y.S.), Grant-in-Aid for Scientific Research (23591062, 26461088 to T.Y., 17K09526 to T.K.), Grant-in-Aid for Clinical Research from the Japanese Circulation Society (2019 to Y.S.), Health Labour Sciences Research Grant (14528506 to S.K.), the Sakakibara Clinical Research Grant for Promotion of Sciences (2012, 2013, 2014 to T.Y.), and Grant from the Japan Agency for Medical Research and Development (201439013C to S.K.). Seattle Proportional Risk Model and Seattle Heart Failure Model copyrights are held by and licensing fees are paid to University of Washington CoMotion.
Funding Information:
Conflict of interest: Y.S. received honoraria from Otsuka Pharma Inc. S.K. received an unrestricted research grant for the Department of Cardiology, Keio University School of Medicine from Bayer Pharmaceutical Co., Ltd and Daiichi Sankyo Co. Ltd. W.C.L. is a member of the GE Healthcare, Steering Committee; Novartis, Abbott, and EBR Systems clinical endpoint committee; and was a local principal investigator for the research trial by Novartis. Other authors have no conflict of interest to disclose. There are no patents, products in development, or marketed products to declare.
Publisher Copyright:
© 2020 Published on behalf of the European Society of Cardiology. All rights reserved.
PY - 2020/4/1
Y1 - 2020/4/1
N2 - Aims: 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). Methods and results: 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). Conclusion: 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.
AB - Aims: 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). Methods and results: 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). Conclusion: 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.
KW - Heart failure
KW - Implantable cardioverter-defibrillator
KW - Risk prediction model
KW - Sudden cardiac death
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U2 - 10.1093/europace/euaa002
DO - 10.1093/europace/euaa002
M3 - Article
C2 - 32155253
AN - SCOPUS:85083041486
SN - 1099-5129
VL - 22
SP - 588
EP - 597
JO - Europace
JF - Europace
IS - 4
ER -