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一种用于心脏标测系统临床前评估的计算建模框架。

A computational modeling framework for pre-clinical evaluation of cardiac mapping systems.

作者信息

Galappaththige Suran, Pathmanathan Pras, Gray Richard A

机构信息

Division of Biomedical Physics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, United States.

出版信息

Front Physiol. 2023 Jul 6;14:1074527. doi: 10.3389/fphys.2023.1074527. eCollection 2023.

Abstract

There are a variety of difficulties in evaluating clinical cardiac mapping systems, most notably the inability to record the transmembrane potential throughout the entire heart during patient procedures which prevents the comparison to a relevant "gold standard". Cardiac mapping systems are comprised of hardware and software elements including sophisticated mathematical algorithms, both of which continue to undergo rapid innovation. The purpose of this study is to develop a computational modeling framework to evaluate the performance of cardiac mapping systems. The framework enables rigorous evaluation of a mapping system's ability to localize and characterize (i.e., focal or reentrant) arrhythmogenic sources in the heart. The main component of our tool is a library of computer simulations of various dynamic patterns throughout the entire heart in which the type and location of the arrhythmogenic sources are known. Our framework allows for performance evaluation for various electrode configurations, heart geometries, arrhythmias, and electrogram noise levels and involves blind comparison of mapping systems against a "silver standard" comprised of computer simulations in which the precise transmembrane potential patterns throughout the heart are known. A feasibility study was performed using simulations of patterns in the human left atria and three hypothetical virtual catheter electrode arrays. Activation times (AcT) and patterns (AcP) were computed for three virtual electrode arrays: two basket arrays with good and poor contact and one high-resolution grid with uniform spacing. The average root mean squared difference of AcTs of electrograms and those of the nearest endocardial action potential was less than 1 ms and therefore appears to be a poor performance metric. In an effort to standardize performance evaluation of mapping systems a novel performance metric is introduced based on the number of AcPs identified correctly and those considered spurious as well as misclassifications of arrhythmia type; spatial and temporal localization accuracy of correctly identified patterns was also quantified. This approach provides a rigorous quantitative analysis of cardiac mapping system performance. Proof of concept of this computational evaluation framework suggests that it could help safeguard that mapping systems perform as expected as well as provide estimates of system accuracy.

摘要

评估临床心脏标测系统存在多种困难,最显著的是在患者手术过程中无法记录整个心脏的跨膜电位,这使得无法与相关的“金标准”进行比较。心脏标测系统由硬件和软件元素组成,包括复杂的数学算法,两者都在不断快速创新。本研究的目的是开发一个计算建模框架来评估心脏标测系统的性能。该框架能够严格评估标测系统在心脏中定位和表征(即局灶性或折返性)致心律失常源的能力。我们工具的主要组件是一个计算机模拟库,模拟整个心脏的各种动态模式,其中致心律失常源的类型和位置是已知的。我们的框架允许对各种电极配置、心脏几何形状、心律失常和心电图噪声水平进行性能评估,并涉及将标测系统与由计算机模拟组成的“银标准”进行盲法比较,在这些模拟中,整个心脏精确的跨膜电位模式是已知的。使用人类左心房的模式模拟和三个假设的虚拟导管电极阵列进行了可行性研究。计算了三个虚拟电极阵列的激活时间(AcT)和模式(AcP):两个接触良好和接触不良的篮状阵列以及一个间距均匀的高分辨率网格。心电图的AcT与最近的心内膜动作电位的AcT的平均均方根差小于1毫秒,因此似乎是一个较差的性能指标。为了标准化标测系统的性能评估,引入了一种基于正确识别的AcP数量、被认为是虚假的AcP数量以及心律失常类型错误分类的新型性能指标;还对正确识别模式的空间和时间定位准确性进行了量化。这种方法提供了对心脏标测系统性能的严格定量分析。这种计算评估框架的概念验证表明,它有助于确保标测系统按预期运行,并提供系统准确性的估计。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/03a1/10358980/d6abe825db11/fphys-14-1074527-g001.jpg

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