Noon G P, Morley D L, Irwin S, Abdelsayed S V, Benkowski R J, Lynch B E
Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Ann Thorac Surg. 2001 Mar;71(3 Suppl):S133-8; discussion S144-6. doi: 10.1016/s0003-4975(00)02634-5.
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.
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.
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%.
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.
MicroMed DeBakey心室辅助装置（VAD）（MicroMed Technology, Inc, 休斯顿，德克萨斯州）是首个作为移植桥梁被引入临床试验的长期轴流循环辅助装置。临床试验于1998年11月在欧洲启动，2000年6月在美国启动。
为符合该研究条件，患者必须被列入心脏移植名单且必须已表现出严重心力衰竭。除了那些通常会被排除在心脏移植之外的患者，没有其他排除MicroMed DeBakey VAD植入的情况。
截至2000年9月，已有51例患者植入了MicroMed DeBakey VAD。对前32例患者的详细评估已经完成。根据目前的数据，VAD植入后30天的生存率为81%。
该临床试验表明，MicroMed DeBakey VAD能够为严重心力衰竭患者提供足够的循环支持，足以使患者在等待心脏移植期间恢复并回归正常活动。关于该装置的功能及其在人体中的持续血流情况，我们已经有了很多了解。
