Purpose

Accelerating development of new therapeutic cardiac devices remains a clinical and technical priority. High-performance computing and the emergence of functional and complex in silico models of human anatomy can be an engine to accelerate the commercialization of innovative, safe, and effective devices.

Methods

An existing three-dimensional, nonlinear model of a human heart with flow boundary conditions was evaluated. Its muscular tissues were exercised using electrophysiological boundary conditions, creating a dynamic, electro-mechanical simulation of the kinetics of the human heart. Anatomic metrics were selected to characterize the functional biofidelity of the model based on their significance to the design of cardiac devices. The model output was queried through the cardiac cycle and compared to in vivo literature values.

Results

For the kinematics of mitral and aortic valves and curvature of coronary vessels, the model’s performance was at or above the 95th percentile range of the in vivo data from large patient cohorts. One exception was the kinematics of the tricuspid valve. The model’s mechanical use environment would subject devices to generally conservative use conditions.

Conclusions

This conservative simulated use environment for heart-based medical devices, and its judicious application in the evaluation of medical devices is justified, but careful interpretation of the results is encouraged.

中文翻译：

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建立人类心脏多物理场有限元模型的生物保真度

目的

加速开发新的治疗性心脏设备仍然是临床和技术的优先事项。高性能计算以及功能性和复杂的人体解剖学计算机模型的出现可以成为加速创新、安全和有效设备商业化的引擎。

方法

评估了具有流动边界条件的人类心脏的现有三维非线性模型。它的肌肉组织使用电生理边界条件进行锻炼，创建了人类心脏动力学的动态机电模拟。选择解剖指标来表征模型的功能生物保真度，这是基于它们对心脏装置设计的重要性。通过心动周期查询模型输出并与体内文献值进行比较。

结果

对于二尖瓣和主动脉瓣的运动学以及冠状血管的曲率，该模型的性能处于或高于来自大型患者队列的体内数据的第 95 个百分位范围。一个例外是三尖瓣的运动学。该模型的机械使用环境会使设备受到一般保守的使用条件的影响。

结论

这种基于心脏的医疗器械的保守模拟使用环境及其在医疗器械评估中的明智应用是合理的，但鼓励对结果进行仔细解释。