美国心脏学会评选出二○○四年十大研究进展[图]
美国心脏学会(AHA)日前评选出2004年十大研究进展。AHA十大研究进展评选始于1996年,以心脏病和卒中研究领域近一年以来的重要研究进展为重点。
1、第一种可置入式人工心脏获得FDA批准:美国FDA批准了第一种可置入式人工心脏,它可以维持生命垂危的心力衰竭患者的生命,直到等来可供移植的人体器官。
这种名为“CardioWest完全型人工心脏”的人工心脏是1982年给牙科医师Barney Clark置入的Karvik-7型人工心脏的直接后代产品。这种人工心脏可取代患者衰竭的心室、心房和所有心脏瓣膜。由亚利桑纳州图森市Syncardia Systems公司制造的这种装置,在其他疗法均无效和有不可逆性双心室衰竭的生命垂危患者等待心脏移植过程中起到了“桥梁”作用。
FDA的批准主要是基于一项纳入81例因不可逆性双心室衰竭而生命垂危的患者的人工心脏研究而做出。该研究显示,接受人工心脏治疗的患者79%能生存到心脏移植,而未接受人工心脏治疗者仅46%;接受人工心脏治疗者的一年生存率为70%,而对照组仅31%;心脏移植受者的1年和5年生存率分别为86%和64%。
N Engl J Med. 2004 Aug 26;351(9):859-67.
Cardiac replacement with a total artificial heart as a bridge to transplantation.
Copeland JG, Smith RG, Arabia FA, Nolan PE, Sethi GK, Tsau PH, McClellan D, Slepian MJ; CardioWest Total Artificial Heart Investigators.
Sarver Heart Center, University of Arizona, Tucson 85724-5071, USA.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. ......
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