Development and clinical application of the MicroMed DeBakey VAD.

A miniaturized axial flow pump to provide left ventricular assistance has been developed. Such a device has the potential to address limitations of the larger pulsatile devices. Clinical trials of the MicroMed DeBakey VAD (ventricular assist device) began in Europe in November 1998. As of December 1, 1999, 18 patients have been implanted with the MicroMed DeBakey VAD. Hemodynamic evaluations along with blood chemistry analysis were recorded routinely. Exercise tolerance was observed. In most patients, end-organ function has improved and has not deteriorated in any patient. Patients have been able to perform normal low-level activity and have tolerated positional changes without evidence of postural hemodynamic changes. Select patients have taken supervised out-of-hospital excursions. This initial clinical experience with the MicroMed DeBakey VAD suggests that the miniaturized axial flow pump can provide ventricular support to bridge patients to cardiac transplant and may provide an improved quality of life for the end-stage heart failure recipient.