Milestone #8: Verification and Validation of the Finite Element Model of the Third Heart Valve Successfully Achieved

As part of the SimInSitu project, finite element (FE) models of three different heart valves are being developed through a comprehensive model verification and validation process. Following the development of the Sapien-3 Ultra TAVI device from Edwards Lifesciences (S3) and the Pulmonary Heart Valve from Xeltis (XPV) FE models, the third heart valve selected is the Sapien-3 ETR (S3 ETR). This is a conceptual heart valve that integrates the verified and validated structural model of the S3 device while replacing the leaflet and skirt materials with those from the verified and validated XPV device. The use of in-silico methods enables the easy virtual creation of such fictitious devices, allowing researchers and designers to explore various scenarios efficiently and cost-effectively.

Given that the parent models and materials have already been validated, minimal effort was required to verify the updated finite element (FE) model of the S3 ETR's leaflet and skirt components. Assessments conducted included discretization error (DE), numerical code verification (NCV), and numerical solver error (NSE), in accordance with the VVUQ Master Plan.

Although the S3 ETR is a fictitious device and validation activities cannot be performed, sensitivity analysis (SA) and uncertainty quantification (UQ) can still be conducted on the device model. This study concentrated on input uncertainty parameters related to leaflet geometry and materials. A local sensitivity approach was employed to derive sensitivity parameters, and Monte Carlo simulations were executed using a linear regression model to quantify the model uncertainty (UQ) for each output parameter.

The successful completion of this milestone marks the conclusion of the FE model development activities for the heart valves under investigation in the SimInSitu project.