Copeland J G, Arabía F A, Banchy M E, Sethi G K, Foy B, Long J, Kormos R L, Smith R G
Cardiothoracic Surgery and Artificial Heart Program, University of Arizona Health Sciences Center, Tucson 85724, USA.
Ann Thorac Surg. 1998 Nov;66(5):1662-9. doi: 10.1016/s0003-4975(98)00896-0.
We performed a controlled study of a total artificial heart in bridge to transplantation. We hypothesized that the CardioWest total artificial heart used in a selected population of decompensating cardiac transplantation candidates would result in improved survival compared with matched controls.
The CardioWest trial started in 1993 in six United States institutions under an investigational device exemption from the Food and Drug Administration. Four centers contributed 27 implant and 18 matched retrospective control patients.
Of the implant patients, 25 (93%) received a transplant, 24 (89% of the total, 96% of those transplanted) were discharged and are currently surviving. In the control group, 10 patients died awaiting transplantation, 8 received a transplant, and 7 were discharged with 6 surviving (p = 0.00001). All adverse events were documented with respect to time. Thirteen serious adverse events occurred, 11 of which occurred in the 2 patients that died during implant.
In a selected group of patients with endstage heart disease, use of the CardioWest total artificial heart is lifesaving. When compared with the series of matched retrospective controls, a significant improvement in survival was found in the CardioWest implant group.
我们对用于心脏移植过渡的全人工心脏进行了一项对照研究。我们假设，在选定的失代偿性心脏移植候选人群中使用CardioWest全人工心脏，与匹配的对照组相比，将提高生存率。
CardioWest试验于1993年在美国的六个机构启动，依据食品药品监督管理局的研究器械豁免规定进行。四个中心提供了27例植入患者和18例匹配的回顾性对照患者。
在植入患者中，25例（93%）接受了移植，24例（占总数的89%，移植患者的96%）出院，目前仍存活。在对照组中，10例患者在等待移植期间死亡，8例接受了移植，7例出院，6例存活（p = 0.00001）。所有不良事件均按时间记录。发生了13起严重不良事件，其中11起发生在植入期间死亡的2例患者中。
在选定的终末期心脏病患者组中，使用CardioWest全人工心脏可挽救生命。与一系列匹配的回顾性对照组相比，CardioWest植入组的生存率有显著提高。
