Siegenthaler Michael P, Frazier O H, Beyersdorf Friedhelm, Martin Jürgen, Laks Hillel, Elefteriades John, Khaghani Asghar, Kjellman Ulf, Koul Bansi, Pepper John, Jarvik Robert, Westaby Stephen
Center for Cardiovascular Disease, University of Freiburg, Freiburg, Germany.
Ann Thorac Surg. 2006 May;81(5):1752-8; discussion 1758-9. doi: 10.1016/j.athoracsur.2005.12.013.
Device failure is a limitation of permanent mechanical circulatory support. We studied the mechanical reliability of the Jarvik 2000 Heart, an axial flow pump with ceramic bearings designed to provide more than 10 years' durability.
The Jarvik 2000 Heart was implanted in 102 patients between April 2000 and December 2004. Eighty-three pumps with an abdominal driveline were implanted as a bridge-to-transplantation, and 19 with postauricular power supply as lifetime therapy. Eighteen pumps were recovered intact after clinical use and run continuously on the bench to further assess durability.
No implantable component failure occurred either in patients or during bench testing. The cumulative pump run-time was 110 years: 59 years overall in vivo and 51 years in vitro. The mean support time for bridge-to-transplant recipients was 159 days, and for discharged lifetime-therapy recipients 551 days. Six recipients were supported moer than 2 years, with the longest ongoing approaching 5 years. External cables caused three system failures, with a 95% freedom from system failure at 4 years. Device malfunctions, related to external cables (9) and lack of a backup battery (1), caused no adverse consequences. Before introduction of noncorrosive, gold-plated stainless steel connectors, corrosion was observed on three connectors to the retroauricular power supply.
The Jarvik 2000 Heart has had no implantable component failure. Meaningful durability data and failure mode can only be established by real-time testing in patients. The reliability and dependability of this device, in addition to the exchangeability of external components, give promise for long-term circulatory support in critically ill heart failure patients.
设备故障是永久性机械循环支持的一个限制因素。我们研究了Jarvik 2000心脏，这是一种带有陶瓷轴承的轴流泵，设计使用寿命超过10年。
2000年4月至2004年12月期间，102例患者植入了Jarvik 2000心脏。83台带有腹部驱动线的泵作为过渡到移植的桥梁进行植入，19台带有耳后电源的泵作为终身治疗手段。18台泵在临床使用后完整回收，并在试验台上连续运行以进一步评估耐用性。
患者或试验台测试期间均未发生可植入部件故障。泵的累计运行时间为110年：体内总计59年，体外51年。过渡到移植受者的平均支持时间为159天，出院的终身治疗受者为551天。6名受者得到了超过2年的支持，最长的接近5年。外部电缆导致3次系统故障，4年时系统故障的自由度为95%。与外部电缆（9次）和缺乏备用电池（1次）相关的设备故障未造成不良后果。在引入无腐蚀性的镀金不锈钢连接器之前，观察到3个连接耳后电源的连接器出现腐蚀。
Jarvik 2000心脏未发生可植入部件故障。有意义的耐用性数据和故障模式只能通过在患者中进行实时测试来确定。该设备的可靠性和可依赖性，以及外部部件的可互换性，为重症心力衰竭患者的长期循环支持带来了希望。
