After years of development and preclinical testing, clinical trials of the MicroMed DeBakey VAD began in November 1998 in Europe and in June 2000 in the United States. As of August 2000, 44 patients in Europe and 3 patients in the United States have undergone implantation with the MicroMed DeBakey VAD. In conclusion, data from the European clinical trial of the MicroMed DeBakey VAD support the safety and performance of the device. Results show that the device provides adequate left ventricular and circulatory support in patients with end-stage heart failure without unduly jeopardizing patient safety. Moreover, the device provides advantages not inherent to commercially available pulsatile devices: (1) miniature size, enabling implantation in smaller patients; (2) ease of implantation; (3) reduced surgical bleeding; and (4) a low incidence of postoperative infections, often a limiting factor with other devices. The MicroMed DeBakey VAD European clinical trial is the first demonstration of the compatibility of continuous blood flow with adequate tissue perfusion and overall maintenance of life for up to 4.5 months. This initial experience with the MicroMed DeBakey VAD suggests that the pump can provide circulatory support to bridge patients to cardiac transplantation and may provide an improved quality of life for the patient with end-stage heart failure.

Background: The MicroMed DeBakey VADTM is a miniaturized, titanium, electromagnetically actuated continuous flow pump weighing approximately 93 g. The pump is designed to provide mechanical assistance to the failing left ventricle while allowing the recipient a suitable quality of life. Methods: The MicroMed DeBakey VADTM has been implanted in 22 (19 M, 3 F) patients in a European clinical trial assessing safety and performance of the device as a bridge to cardiac transplant. Implants have been performed according to protocol with routine anticoagulation and post-operative wound care. Patients are ambulated as soon as ready. Pump parameters, hemodynamics, blood analyses, adverse/device events and support duration were recorded. Results: Cardiopulmonary bypass time (average 88.29 mins) and intraoperative blood replacement were minimal. Patient support with the MicroMed DeBakey VADTM ranged from 9 to 123 days (average duration 78.5 days). Eight patients received cardiac transplant following MicroMed DeBakey VADTM support and one patient was a bridge-to-recovery. Five patients died (1 cerebral hemorrhage, 3 multi-organ failure, 1 pulmonary hypertension) while on support, and three patients had the device exchanged (2 thrombus, 1 connector fault). Patients with this continuous flow pump usually demonstrate some flow pulsatility resulting from the changing delta p between the left ventricle and aorta. End organ function has been maintained or improved with MicroMed DeBakey VADTM support. Patients became fully ambulatory and exercised without postural hemodynamic change. Several patients were able to leave the hospital on short, supervised excursions and one patient went home waiting for transplant. Conclusion: In conclusion, the MicroMed DeBakey VADTM provides a new alternative for bridging patients to cardiac transplant with mechanical support. Data suggest the potential for long-term and bridge-to-recovery applications.