[Ventricular assist device].

There are 2 kinds of artificial heart used for clinical patients with end-stage heart failure. One is a ventricular assist device (VAD) and the other is a total artificial heart (TAH). Only paracorporeal VADs are commercially available currently in Japan, such as Toyobo VAD and BVS 5000. Paracorporeal Zeon VAD and implantable Novacor LVAD were approved by the MHLW in the past but already disappeared from the Japanese market in 2005 and 2006. A little more than 1,000 LVADs had been implanted since 1980 in Japan until last autumn, while no TAH has been implanted in patients. In the world 1st generation pulsatile implantable LVADs have been taken over by the 2nd and 3rd generation non-pulsatile implantable LVADs in the past 10 years. In Japan 4 kinds of implantable LVADs are under clinical evaluation, HeartMate XVE (1st generation, HeartMate VE was used in the Japanese clinical trial), Jarvik 2000 (2nd generation), Evaheart (2nd generation), and DuraHeart (3rd generation). All 5 patients with HeartMate VE survived more than 1 year during the clinical trial, 13 patients with Evaheart were long survivors or successfully heart-transplanted. Although follow-up interval is relatively short, all 6 patients with DuraHeart and 5 of the 6 patients with Jarvik 2000 recovered from end-stage heart failure and are keeping very good condition. Most of them returned to their home and are waiting for heart transplantation. Especially the 3rd generation of non-pulsatile LVADs is expected to have long-term durability and less frequency of thromboembolic episode.