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 transplantation. Clinical trials began in Europe in November 1998 and in the United 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 patients who would typically be excluded from cardiac transplantation.


RESULTS
As of September 2000, 51 patients have been implanted with the MicroMed 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 severe heart failure, sufficient to recover and return to normal activities while awaiting a heart transplantation. Much has been learned about the function of the device and its continuous flow in humans.
Noon
G P
GP
Department of Surgery, Baylor College of Medicine, Houston, Texas, USA. gnoon@bcm.tmc.edu
Morley
D L
DL
Irwin
S
S
Abdelsayed
S V
SV
Benkowski
R J
RJ
Lynch
B E
BE
D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D019919:Prosthesis Implantation / Q000379:methods