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ORIGINAL ARTICLE
Year : 2020  |  Volume : 5  |  Issue : 1  |  Page : 1-7

Implantable cardioverter defibrillators for sudden cardiac death prevention in China: A regional analysis from the improve SCA clinical trial


1 Division of Cardiology, The General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China
2 Department of Cardiovascular Medicine, Arrythmia Center, Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
3 Department of Cardiovascular Medicine, The Third Xiangya Hospital of Central South University, Changsha, Hunan Province, China
4 Department of Cardiovascular Medicine, Zhejiang Greentown Cardiovascular Hospital, Hangzhou, Zhejiang Province, China
5 Department of Cardiovascular Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China
6 Department of Cardiovascular Medicine, The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang Province, China
7 Department of Cardiovascular Medicine, Zhongshan Hospital, Fudan University, Shanghai, China
8 Cardiac Rhythm Disease Management Clinical Research, Medtronic, Inc., Mounds View, MN, USA
9 Department of Cardiovascular Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China

Correspondence Address:
Dr. Dejia Huang
West China Hospital, Sichuan University, No. 37 Guo Xue St., Chengdu 610041, Sichuan Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/IJHR.IJHR_7_20

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Background: The improve sudden cardiac arrest (SCA) study was a nonrandomized prospective global study that identified a subset of primary prevention (PP) patients at an elevated risk for SCA labeled 1.5PP. These 1.5PP patients had one or more of the following additional risk factors: Syncope, nonsustained ventricular tachycardia, premature ventricular contractions >10/h, and left ventricular ejection fraction <25%. The purpose of this sub-analysis was to examine the China population cohort according to the improve SCA study's primary and secondary objectives. We aim to analyze the improve SCA study objective outcomes explicitly in the Chinese cohort to better understand the utility of PP implantable cardioverter-defibrillator (ICD) therapy in China. Subjects and Methods: The improve SCA study enrolled patients (n = 4222) during March 2014 and July 2017, including 87 sites in 17 countries from the geographies of Asia, Latin America, Eastern Europe, the Middle East, and Africa. In this analysis, the China cohort of improve SCA patients (n = 1654) was analyzed according to the objectives of the main study; the primary objective compared time to first appropriate ventricular tachycardia (VT) or ventricular fibrillation (VF) therapy between 1.5PP (n = 904) and secondary prevention (SP) patients (n = 470). All-cause mortality rates of 1.5PP with ICDs versus no implant, and an analysis of ischemic versus nonischemic results (n = 280) were also analyzed. PP patients without an additional risk factor were labeled 1.0PP (n = 280). Cox-proportional hazards model was used for hazard ratio (HR) calculations. This study was approved by the Ethics Committee of each participating institution and the associated national and local regulatory agencies, and registered with ClinicalTrials.gov (identifier: NCT02099721). Results: The time to first VT/VF therapy for 1.5PP was not within 30% of SP (HR = 0.42, 95% confidence interval [CI]: 0.31–0.56, P < 0.0001). However, there was a 49% reduction (HR = 0.51, 95% CI: 0.35–0.74, P = 0.0004) in all-cause mortality in the 1.5PP implanted versus nonimplanted patients, and a 70% reduction (HR = 0.30, 95% CI: 0.09–0.99, P = 0.05) in 1.0PP implanted patients. Nonischemic cardiomyopathy (NICM) 1.5PP patients showed a 51% reduction (HR = 0.49, 95% CI: 0.34–0.77, P = 0.0012) in all-cause mortality compared to those who did not receive an ICD implant. Conclusion: The China populations of 1.0PP and 1.5PP patients obtain a significant benefit with implantable defibrillation therapy.


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