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Clinical experience with the MicroMed DeBakey ventricular assist device
G P Noon1, D L Morley, S Irwin
1Department of Surgery, Baylor College of Medicine, Houston, Texas, USA. gnoon@bcm.tmc.edu
The Annals of Thoracic Surgery
|March 27, 2001
Summary
The MicroMed DeBakey ventricular assist device (VAD) offers crucial circulatory support for severe heart failure patients awaiting transplantation. Clinical trials show an 81% survival rate at 30 days post-implant.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Surgical Technology
Background:
- The MicroMed DeBakey ventricular assist device (VAD) is a pioneering long-term axial flow device.
- It was the first of its kind to enter clinical trials as a bridge to cardiac transplantation.
- Clinical trials commenced in Europe in 1998 and the US in 2000.
Purpose of the Study:
- To evaluate the efficacy of the MicroMed DeBakey VAD in patients with end-stage heart failure.
- To assess its role as a bridge to cardiac transplantation.
- To understand the device's function and continuous flow in human subjects.
Main Methods:
- Patients selected for the study were listed for cardiac transplantation and exhibited profound cardiac failure.
- Exclusion criteria were limited to those typically preventing cardiac transplantation.
- The study involved implanting the MicroMed DeBakey VAD.
Main Results:
- As of September 2000, 51 patients received the MicroMed DeBakey VAD implant.
- Detailed evaluation of the initial 32 patients was completed.
- The 30-day survival probability following VAD implantation was 81%.
Conclusions:
- The MicroMed DeBakey VAD effectively provides circulatory support for patients with severe heart failure.
- The device enables patients to recover and resume normal activities while awaiting transplantation.
- Significant insights were gained regarding the device's performance and continuous flow in humans.