International Circulation:  What is your view on ICD defects?  How can we prevent defects clinically and how can we reduce the rate of malfunctions of these implantable devices over the long-term?

    《国际循环》：您如何评价ICD的技术缺陷。在临床如何来防止这些缺陷？如何能够降低长期的ICD故障?

    Bruce Lindsay:  There are two areas where we have seen failures.  One is in the generators themselves， which is actually quite a low incidence of failures.  In recent years when these came out for discussion and had a lot of publicity in national papers， we all realized that this wasn’t really the biggest issue.  The biggest issue is lead failures， which is a much higher incidence of failures.  It is not that the companies haven’t tried， they actually have extremely high standards of quality control.  The heart beats several million times per year and there is a lot of stress put on the leads with movement， muscle mass at the insertion site.  The companies continually try to improve lead designs but one of the problems is， which is a challenge， for bench testing， it is hard to mimic exactly what happens in the human body.  They are working on this though.  It seems to me that between more vigilance， either for devices or leads， the national cardiovascular database registry will help with that.  Some of the ongoing longitudinal trials that the company sponsors will help， as well as remote monitoring.  We will begin to identify things more accurately， do a root cause analysis， and find out what the problem is and improve the design of those leads and hopefully cut down on some of these failures.  I think we shouldn’t lose the forest through the trees， that is， despite these kinds of problems defibrillators do save lives and in the balance the mortality is much better if patients are appropriately selected in the first place.

   Bruce Lindsay教授：有两处我们发现了失效的情况。一是脉冲产生器本身，实际上它失效的几率很低。近年当这些问题引发讨论，且很多发表于国家级论文时，我们均认识到这不是真正的最大问题。最大的问题是导线失效，其发生率很高。并非器械公司没有试着解决，他们实际上质量控制的标准很高。心脏搏动每年有几百万次，运动和插入部位的肌肉组织体积等带给导线的压力很多。各公司不断地尝试改进导线设计，但其中一个问题（即挑战）是，试验测试很难准确模拟人体上发生的事情。尽管如此他们仍在努力。在我看来，无论提高仪器还是导线的警觉性，美国国家心血管数据注册（national cardiovascular database registry）对此会有帮助。一些正在进行的纵向试验和远程监控均能获得公司的支持。我们将开始更准确的确认事情，作根本原因分析，并且找到问题所在，同时改进那些导线的设计，令人期待地防止出现这些失效的情况。我认为我们不能