Clinical experience with the MicroMed DeBakey ventricular assist device

Background. The MicroMed DeBakey ventricular assist device (VAD) (MicroMed Technology, Inc, Houston, TX) is the first long-term axial flow circulatory assist device to be introduced into clinical trials as a bridge to transpl antation. Clinical trials began in Europe in November 1998 and in the Unite d States in June 2000. Methods, To qualify for the study, the patients must be listed for cardiac transplantation and must have demonstrated profound cardiac failure. There were no exclusions to the MicroMed DeBakey VAD implant other than those pat ients who would typically be excluded from cardiac transplantation. Results. As of September 2000, 51 patients have been implanted with the Mic roMed DeBakey VAD. A detailed evaluation of the first 32 patients has been completed. With current data, the probability of survival at 30 days after VAD implant is 81%. Conclusions. The clinical trial demonstrated that the MicroMed DeBakey VAD is capable of providing adequate circulatory support in patients with sever e heart failure, sufficient to recover and return to normal activities whil e awaiting a heart transplantation. Much has been learned about the functio n of the device and its continuous flow in humans. (C) 2001 by The Society of Thoracic Surgeons.