Medtronic Bakken Research Center, Maastricht, The Netherlands.
Ann Biomed Eng. 2010 Apr;38(4):1314-25. doi: 10.1007/s10439-009-9890-z. Epub 2010 Jan 13.
Defibrillation efficacy testing is a common procedure at defibrillator implantation, with the objective to ensure that each patient receives a system with adequate shock efficacy. In this study, defibrillation shock efficacy as a function of shock energy was modeled by a dose response relationship. The frequency distributions of the two parameters characterizing this relationship were estimated from a large clinical study on 634 patients. The estimated parameters were then compared to published data on defibrillation studies performing dose response measurements. After having identified the optimal parameter distributions for the whole population, a Monte Carlo method was used to compare the outcomes of two defibrillation efficacy testing protocols: a safety margin test requiring 2 successes out of 2 trials at 20 J, and the binary search protocol used in the clinical study. Results showed good correspondence with clinical observations. The probabilistic nature of defibrillation success and differences in acceptance and rejection rates of the two protocols were highlighted. The model developed in this study could be used to further understand the differences between various defibrillation testing protocols used in clinical practice.
除颤效果测试是植入除颤器时的常见程序，目的是确保每位患者都能获得具有足够电击效果的系统。在这项研究中，通过剂量反应关系对电击能量的除颤电击效果进行建模。从对 634 名患者进行的大型临床研究中估计了描述该关系的两个参数的频率分布。然后将估计的参数与执行剂量反应测量的除颤研究的已发表数据进行比较。在确定了适用于整个人群的最佳参数分布后，使用蒙特卡罗方法比较了两种除颤效果测试方案的结果：需要在 20 J 下两次试验中有 2 次成功的安全裕度测试，以及在临床研究中使用的二进制搜索方案。结果与临床观察结果相符。突出了除颤成功的概率性质以及两种方案的接受和拒绝率的差异。在这项研究中开发的模型可用于进一步了解临床实践中使用的各种除颤测试方案之间的差异。
