Zhang, Shu; Singh, Balbir; Rodriguez, Diego A; Chasnoits, Alexandr Robertovich; Hussin, Azlan; Ching, Chi-Keong; Huang, Dejia; Liu, Yen-Bin; Cerkvenik, Jeffrey; Willey, Sarah; Kim, Young-Hoon
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
2015Nov ; 17 ( 11 ) :1720-6.
PMID : 26037794
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Zhang, Shu - State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, 167 North Lishi Road, Beijing 100037, China zsfuwai@vip.163.com.
Singh, Balbir - Medanta, The Medicity Hospital, Sector 38, Gurgaon, Haryana 122041, India.
Rodriguez, Diego A - Instituto de Cardiologia - Fundacion Cardioinfantil, Centro Internacional de Arritmias Calle 163 A #13B- 60, Bogota, Colombia.
Chasnoits, Alexandr Robertovich - Republican Scientific Practical Centre Cardiology, R. Luxembourg Str. 110, Minsk 220036, Belarus.
Hussin, Azlan - Institut Jantung Negara, 145 Jalan Tun Razak, Kuala Lumpur 50400, Malaysia.
Ching, Chi-Keong - National Heart Centre Singapore, 5 Hospital Avenue, Singapore 169609, Singapore.
Huang, Dejia - West China Hospital, Sichuan University, No. 37 Guo Xue St., Chengdu 610041, China.
Liu, Yen-Bin - Cardiovascular Center, 5/F, National Taiwan University Hospital, No. 7, Chung Shan S. Rd, Zhong Zheng District, Taipei City 10002, Taiwan.
Cerkvenik, Jeffrey - Medtronic, CRHF Clinical Research, 8200 Coral Sea Street NE, Mounds View, Minneapolis, MN 55112, USA.
Willey, Sarah - Medtronic, CRHF Clinical Research, 8200 Coral Sea Street NE, Mounds View, Minneapolis, MN 55112, USA.
Kim, Young-Hoon - Korea University Medical Center, A126-1 5th St. Anam-dong Sungbuk-ku, Seoul 136-705, Korea.
ABSTRACT
AIMS: This study aims to demonstrate that primary prevention (PP) patients with one or more additional risk factors are at a similar risk of life-threatening ventricular arrhythmias when compared with secondary prevention (SP) patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy-defibrillator (CRT-D) implant. The study evaluates the benefits of therapy for high-risk patients in countries where defibrillation therapy for PP of SCA is underutilized.
METHODS: Enrolment will consist of 4800 ICD-eligible patients from Asia, Latin America, Eastern Europe, the Middle East, and Africa. Upon enrolment, patients will be categorized as SP or PP. Primary prevention patients will be assessed for additional risk factors: syncope/pre-syncope, non-sustained ventricular tachycardia, frequent premature ventricular contractions, and low left ventricular ejection fraction. Those PP patients with one or more risk factors will be categorized as '1.5' patients. Implant of an ICD/CRT-D will be left to the patient and/or physician's discretion. The primary endpoint will compare the appropriate ICD therapy rate between SP and 1.5 patients. The secondary endpoint compares mortality between 1.5 implanted and non-implanted patients. CONCLUSION: The Improve SCA study will investigate a subset of PP patients, believed to be at similar risk of life-threatening ventricular arrhythmias as SP patients. Results may help clinicians identify and refer the highest risk PP patients for ICDs, help local societies expand guidelines to include PP of SCA utilizing ICDs, and provide additional geographical-relevant evidence to allow patients to make an informed decision whether to receive an ICD. TRIAL REGISTRATION: NCT02099721. CI - ??The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.
keyword
LVEF; NSVT; PVCs; Primary prevention; SCA; Secondary prevention; Syncope
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