
In Japan the 1st paracorporeal ventricular assist device (VAD) was implanted in 1980. Since then, more than 2,000 VADs were used. Small size continuous-flow VAD (CFVAD) was developed in 1990s, which dramatically improved safety and efficacy of long-term support. EVAHEART and DuraHeart, both of which were developed in Japan, were approved for health insurance coverage in 2011, followed by approval of HeartMate II in 2013 and Jarvik 2000 in 2014. Although these approvals were limited for bridge to transplantation, CFVADs gained rapid acceptance for treatment of end-stage heart failure. As of 2016, 41 hospitals were certified for CFVAD treatment. More than 500 CFVADs were implanted thus far with approximately 150 implants during the recent 1 year according to the J-MACS report. One and 2 year survival is 93% and 90%, which are far superior to those reported in INTERMACS. Waiting period has been lengthened longer than 3 years recently due to severe donor shortage, so that mandates a longer support with less complication. Berlin Heart EXCOR Pediatric was approved in August 2015, which did and will expand treatment capability in neonates and infants. Clinical trial of destination therapy is to be started in September 2016. Thus, VAD treatment will continue to improve and grow from now on.
Heart Failure, Clinical Trials as Topic, Humans, Heart-Assist Devices, Prostheses and Implants
Heart Failure, Clinical Trials as Topic, Humans, Heart-Assist Devices, Prostheses and Implants
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