Establishing the Biofidelity of a Multiphysics Finite Element Model of the Human Heart.

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.