Vollkron Michael, Schima Heinrich, Huber Leopold, Benkowski Robert, Morello Gino, Wieselthaler Georg
Ludwig-Boltzmann-Institute for Cardiosurgical Research, Medical University of Vienna, Vienna, Austria.
Artif Organs. 2006 Sep;30(9):665-70. doi: 10.1111/j.1525-1594.2006.00282.x.
An automatic detection system for ventricular collapse was developed and tested in a first clinical trial as part of a physiological speed control concept for axial flow pumps. From this clinical experience, and based on the acquired data during this trial, an optimization of the developed system was performed. An already-existing database of 784 individual cases was extended. For harmonization of this database an additional 412 snap files were extracted from continuous data recordings and classified manually using a standardized procedure. The already-developed and clinically tested algorithms were supplemented by one additional indicator derived from a preexisting criterion. One threshold value was replaced by application of a numerically optimized nonlinear characteristic curve dependent on heart rate. Finally, in a multidimensional optimization process of the entire suction detection system, 7 individual indicators were adjusted by using 17 independent threshold values. The optimization criteria were applied using a three-level hierarchical system. Within the final database consisting of 1196 snap shots the overall amount of maldetections could be reduced to 23 cases including 5 false positive events (0.42%) and 18 false negative decisions (1.5%). By application of the clinical experience from the first clinical trial of a physiologic control system it became possible to optimize the sensitivity and specificity of the suction detection system to unprecedented accuracy.
作为轴流泵生理速度控制概念的一部分,开发了一种心室塌陷自动检测系统并在首次临床试验中进行了测试。根据这一临床经验,并基于该试验期间获取的数据,对所开发的系统进行了优化。扩展了一个已有的包含784个个体病例的数据库。为了使该数据库协调一致,从连续数据记录中提取了另外412个快照文件,并使用标准化程序进行手动分类。已开发并经过临床测试的算法通过从现有标准派生的一个额外指标进行补充。通过应用数值优化的依赖于心率的非线性特征曲线,替换了一个阈值。最后,在整个吸力检测系统的多维优化过程中,使用17个独立阈值对7个个体指标进行了调整。优化标准通过一个三级层次系统应用。在由1196个快照组成的最终数据库中,误检测总数可减少到23例,包括5例假阳性事件(0.42%)和18例假阴性判定(1.5%)。通过应用生理控制系统首次临床试验的临床经验,有可能以前所未有的精度优化吸力检测系统的敏感性和特异性。