Current status of third-generation implantable left ventricular assist devices in Japan, Duraheart and HeartWare.

Abstract

Recently, left ventricular assist devices (LVADs) have become a viable therapeutic approach as a bridge to cardiac transplantation, as well as destination therapy or as part of the bridge to recovery. In Japan, paracorporeal pneumatic devices are the only choice for such therapy, as implantable LVADs are not yet generally available due to device lag, which represents a serious problem in this field. Clinical trials of four different continuous-flow pumps, both axial and centrifugal flow types, were completed at about the same time, and two of those devices, DuraHeart and EVAHEART, have already been approved for use in Japan. Thus, reports of advanced treatment for severe heart failure with these devices are expected. The DuraHeart (Terumo Heart, Ann Arbor, MI, USA) and another device named the HeartWare (HeartWare Inc, Miami Lakes, FL, USA) are so-called third-generation devices, as they have achieved miniaturization and improvements in performance from the use of magnetic levitation. Based on our experiences from both clinical research and experimental use, we herein discuss the DuraHeart and HeartWare devices, with a focus on the clinical outcomes and management strategies. Because of the long waiting period for heart transplantation in Japan, these two devices are considered to have important roles in the near future for the treatment of severe heart failure, and a comprehensive strategy for LVAD therapy including such third-generation implantable devices is expected.