Different Finite Element Strategies to Satisfy Clinical and Engineering Requirements in Modeling a Novel Percutaneous Device

By taking into account patient-specific properties, finite element (FE) models can aid in the optimization of the devices’ mechanical performances, accelerating the time of development and reducing testing costs. Patient-specific cardiovascular modeling can also drive the development of novel devices [1], by means of anatomical elements that are more representative than animal surrogates [2], and integrating standard in vitro tests with patient-specific loading conditions [3]. Transcatheter heart valve implantation can particularly benefit from a modeling approach. In the field of treatment of valve dysfunctions, percutaneous techniques are relatively new or under development, and modeling tools can contribute to improve these procedures (e.g. design modifications or different routes for device insertion) and increase patient safety in the early introduction of new devices into clinical practice. For a feasible clinical application, computational methods need to be fully validated against physical data, to take into account patient-specific properties, and to provide results in a short time. Instead, from an engineering perspective, models can cost-effectively aid the design phase by improving preclinical testing with more realistic loading conditions for accurate simulation of mechanical behaviour and prediction of durability. This study aims to identify optimal modeling strategies to respond to both clinical and engineering requirements. As a case study, simulations were conducted on a new percutaneous pulmonary valve implantation (PPVI) device [4] tested within a patient-specific right ventricular outflow tract model.