First American experience with the Terumo DuraHeart™ left ventricular assist system

Abstract

Since the first implantation of a left ventricular assist system (LVAS) 45 years ago, LVAS therapy has emerged as a viable option for the treatment of advanced heart failure. The current generation of LVASs in clinical evaluation has design features enabling longer and more reliable support durations. We describe the operating characteristics of the DuraHeart™ LVAS (Terumo Heart, Inc., Ann Arbor, MI). The DuraHeart™ LVAS is a magnetically-levitated centrifugal pump that began a FDA-approved clinical trial for evaluation of bridge to transplant indication in July of 2008. Magnetic levitation of the spinning-pump impeller is hypothesized to improve long-term mechanical reliability and biological compatibility of the pump. Other design features make the DuraHeart™ LVAS particularly suited for implantation without cardiopulmonary bypass (CPB). A description of the implant procedure for the first six American implants of the DuraHeart™ LVAS both on-CPB and off-CPB, including CPB techniques employed, are discussed. While it is still very early in the DuraHeart™ LVAS experience, the initial outcomes of the first six patient implants would suggest that the device is a safe and effective LVAS.