II. LEFT VENTRICULAR ASSIST DEVICE A. Systems
C. Perspective
This remarkable study is the first randomized study to ascertain whether a left ventricular assist device could provide long-term benefits and enhance survival in patients awaiting transplantation. The study clearly shows that the device can prolong life beyond optimal medical therapy in desperately ill New York Heart Association class IV patients, but only for up to 6 months. The device was a failure at 24 months. In addition, complications and suffering remain intolerable and perhaps not justifiable: few patients who received the assist device survived longer than 2 years, the incidence of infection was 28% at 3 months, the incidence of bleeding by 6 months was 42%, and a probability of device failure was 35% at two years. Pulsatile ventricular assist device (VAD) has recently been approved by the FDA as a suitable alterna¬tive treatment for patients who are not candidates for heart transplantation. The drawbacks of these VADs include:
• Large size and noisy
• High incidence of device-related infection.
• Malfunction
Goldstein et al. reported on the safety and feasibility trial of the MicroMed DeBakey ventricular assist device as a bridge to transplantation (J. Am. Coll. Cardiol. 45:2005). The MicroMed DeBakey VAD is a miniaturized, implant¬able, electromagnetically actuated titanium axial flow pump with a single moving impeller. ‘‘The rotating motion of the impeller produces continuous flow. An ultrasonic flow probe provides direct measurements of pump flow. Wiring from the pump and the flow probe exit the skin and connect to a portable controller.’’