Copeland J G, Smith R G, Arabia F A, Nolan P E, Banchy M E
The Marshall Foundation Artificial Heart Program, University of Arizona Sarver Heart Center, Tucson, USA.
Semin Thorac Cardiovasc Surg. 2000 Jul;12(3):238-42. doi: 10.1053/stcs.2000.9668.
The CardioWest total artificial heart (TAH), formerly known as the Jarvik-7 and then the Symbion heart, is the only TAH in current clinical use. A new study, approved by the Food and Drug Administration (FDA), was initiated in 1993 with the goal of approving this pump for commercial release. Since then, 145 CardioWest TAHs have been implanted, including 37 pumps in 36 patients at our center. Our 36 patients were studied prospectively according to the investigational device exemption protocol approved by the FDA. Clinical and hemodynamic data obtained upon patients' entry into the study identified this group as mortally ill. After receiving a CardioWest TAH, 29 of the 36 patients (81%) survived to heart transplantation, and 26 (72% of the total group and 90% of the transplant recipients) have survived for up to 7 years (average, 24 months). Multicomponent anticoagulation, based on readily available tests, and the intrinsic properties of the TAH have resulted in a low linearized stroke rate of 0.48 event per patient-year. There have been no device-related mediastinal infections. In dying patients with nonexistent or severely compromised biventricular function, the CardioWest TAH has proved safe and effective, allowing a 72% survival rate for an average of 24 months.
CardioWest全人工心脏（TAH），前身为Jarvik - 7，后又称为Symbion心脏，是目前临床使用的唯一一款全人工心脏。一项经美国食品药品监督管理局（FDA）批准的新研究于1993年启动，目标是批准这款泵用于商业销售。从那时起，已有145例CardioWest全人工心脏被植入，其中包括我们中心为36名患者植入的37个泵。我们对这36名患者按照FDA批准的研究性器械豁免方案进行了前瞻性研究。患者进入研究时获得的临床和血流动力学数据表明，该组患者病情严重。在接受CardioWest全人工心脏后，36名患者中的29名（81%）存活至心脏移植，其中26名（占总患者数的72%，占移植受者的90%）存活长达7年（平均24个月）。基于易于获得的检测结果以及全人工心脏的内在特性进行的多组分抗凝，使线性化卒中发生率低至每名患者每年0.48次。未发生与器械相关的纵隔感染。对于双心室功能不存在或严重受损的濒死患者，CardioWest全人工心脏已证明是安全有效的，平均24个月的生存率为72%。
