Copeland Jack G, Smith Richard G, Arabia Francisco A, Nolan Paul E, Sethi Gulshan K, Tsau Pei H, McClellan Douglas, Slepian Marvin J
Sarver Heart Center, University of Arizona, Tucson 85724-5071, USA.
N Engl J Med. 2004 Aug 26;351(9):859-67. doi: 10.1056/NEJMoa040186.
The CardioWest Total Artificial Heart orthotopically replaces both native cardiac ventricles and all cardiac valves, thus eliminating problems commonly seen in the bridge to transplantation with left ventricular and biventricular assist devices, such as right heart failure, valvular regurgitation, cardiac arrhythmias, ventricular clots, intraventricular communications, and low blood flows.
We conducted a nonrandomized, prospective study in five centers with the use of historical controls. The purpose was to assess the safety and efficacy of the CardioWest Total Artificial Heart in transplant-eligible patients at risk for imminent death from irreversible biventricular cardiac failure. The primary end points included the rates of survival to heart transplantation and of survival after transplantation.
Eighty-one patients received the artificial-heart device. The rate of survival to transplantation was 79 percent (95 percent confidence interval, 68 to 87 percent). Of the 35 control patients who met the same entry criteria but did not receive the artificial heart, 46 percent survived to transplantation (P<0.001). Overall, the one-year survival rate among the patients who received the artificial heart was 70 percent, as compared with 31 percent among the controls (P<0.001). One-year and five-year survival rates after transplantation among patients who had received a total artificial heart as a bridge to transplantation were 86 and 64 percent.
Implantation of the total artificial heart improved the rate of survival to cardiac transplantation and survival after transplantation. This device prevents death in critically ill patients who have irreversible biventricular failure and are candidates for cardiac transplantation.
CardioWest全人工心脏原位替代了两个天然心室及所有心脏瓣膜，从而消除了在使用左心室和双心室辅助装置进行移植过渡时常见的问题，如右心衰竭、瓣膜反流、心律失常、心室血栓、心室内交通及低血流。
我们在五个中心进行了一项采用历史对照的非随机前瞻性研究。目的是评估CardioWest全人工心脏在有不可逆双心室心力衰竭而濒死风险、适合移植的患者中的安全性和有效性。主要终点包括心脏移植生存率和移植后生存率。
81例患者接受了人工心脏装置。移植生存率为79%（95%置信区间为68%至87%）。35例符合相同入选标准但未接受人工心脏的对照患者中，46%存活至移植（P<0.001）。总体而言，接受人工心脏的患者一年生存率为70%，而对照组为31%（P<0.001）。接受全人工心脏作为移植过渡的患者移植后一年和五年生存率分别为86%和64%。
植入全人工心脏提高了心脏移植生存率和移植后生存率。该装置可防止患有不可逆双心室衰竭且适合心脏移植的重症患者死亡。
