Advancing Patient-Specific Modeling for Heart Valve Testing – SimInSitu Project Update

The H2020 SimInSitu project is developing a validated computational platform of the human aorta to test tissue-engineered heart valves (THVs). This milestone focused on the verification, validation, and uncertainty quantification (VVUQ) of a patient-specific transcatheter aortic valve implantation (TAVI) model, using clinical data from patients implanted with the Sapien 3 (S3) Ultra device by Edwards Lifesciences.

Key steps included refining the dataset to 20 representative cases and analyzing uncertainties related to model segmentation and device measurements. Finite-element (FEA) and fluid-solid interaction (FSI) simulations were conducted to evaluate structural and hemodynamic performance metrics, such as device diameter (DD), effective orifice area (EOA), and transmural pressure gradient (TPG). Validation results showed excellent agreement with clinical data for structural predictions, with errors below 10%, while highlighting variability in fluid-dynamic performance influenced by implantation depth and material properties.

The findings reinforce the credibility of the SimInSitu computational platform for testing next-generation heart valves, including the biodegradable TAVI device by Xeltis, to be assessed under WP07. This work demonstrates the potential of in-silico models to accelerate the design, testing, and regulatory approval of innovative biomedical devices.

By integrating hierarchical VVUQ frameworks, SimInSitu is paving the way for more efficient, accurate, and patient-specific testing methodologies, aligning with the broader goals of advancing precision medicine and regenerative therapies.