FSI Modeling of the Sapien 3 Ultra Valve: Development, Verification, and Validation per ASME V&V 40

Abstract

We report a computational Fluid–Structure Interaction (FSI) model of the 23 mm and 26 mm Sapien 3 Ultra transcatheter aortic valve to evaluate device performance under physiological flow conditions. The primary aim was to establish a validated FSI model for the device for the downstream patient-specific simulation studies for TAVI procedure planning. We follow the ASME V&V 40 framework for model credibility as well as V&V 10 and V&V 20, where applicable.

The model was designed to replicate an in-vitro test environment, enabling controlled evaluation of valve mechanics and hemodynamics. Geometry and material properties were defined based on publicly available manufacturer data and experimental literature. The FSI simulations were performed using Abaqus/Explicit for structural dynamics and FlowVision for computational fluid dynamics. The coupling was implemented using a tightly coupled explicit approach.

To verify and validate model behavior, simulations were conducted across multiple flow regimes, including conditions reported in the literature. Key hemodynamic metrics i.e. Effective Orifice Area (EOA), transvalvular pressure gradient (TPG), and regurgitant fraction (RF) were extracted and compared to published experimental data. The results demonstrated consistent agreement across valve sizes and stent expansion conditions, supporting the model’s credibility.

This work establishes a robust and validated FSI model for downstream evaluation of the Sapien 3 Ultra in patient-specific anatomies. By combining mechanical fidelity with clinically relevant hemodynamics, the model provides a foundation for future studies in TAVR procedure planning, device design, and performance optimization.