Study Design of the Nationwide Japanese Lead Extraction (J‐LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry

Journal of Arrhythmia

the J‐LEX registry investigators¹  Yoko M. Nakao²  Yoshihiro Miyamoto²  Akihiko Nogami³  Yoji Okamoto⁴  Morio Shoda⁵  Masahiko Goya⁶  Kengo Kusano⁷  Katsuhiko Imai⁸  Nobuhiro Nishii⁹  Misa Takegami^1,10 

[1] ;Center for Cerebral and Cardiovascular Disease Information Open Innovation CenterNational Cerebral and Cardiovascular Center Suita Japan;Department of Cardiology Faculty of Medicine University of Tsukuba Tsukuba Japan;Department of Cardiology Kawasaki Medical School General Medical Center Okayama Japan;Department of Cardiology Tokyo Women's Medical University Tokyo Japan;Department of Cardiovascular Medicine Heart Rhythm CenterTokyo Medical and Dental University Tokyo Japan;Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita Japan;Department of Cardiovascular Surgery Kure Medical Center & Chugoku Cancer CenterNational Hospital Organization Kure Japan;Department of Cardiovascular Therapeutics Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama Japan;Department of Preventive Medicine and Epidemiology National Cerebral and Cardiovascular Center Suita Japan;

关键词: cardiac implantable electronic device;    complication;    J‐LEX;    lead extraction;    REDCap;   

DOI  :  10.1002/joa3.12396

来源: DOAJ

【 摘 要 】

Abstract Background Transvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real‐world setting. Methods The Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500‐1000 per year. We will also compare the results with other registries in foreign countries. Result The results of this study are currently under investigation. Conclusion The J‐LEX registry will provide real‐world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan.

【 授权许可】

Unknown