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

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.