Patient-Specific Fluid–Structure Interaction Modeling of the Sapien 3 Ultra Valve with Clinical Validation in a Small Patient Cohort

Abstract

We developed, verified, and validated a patient-specific Fluid–Structure Interaction (FSI) simulation pipeline to assess the post-operative behavior of the Sapien 3 Ultra transcatheter aortic valve. The study builds on a validated foundation, where 23 mm and 26 mm valve models were first developed, verified, and validated under in-vitro conditions, following ASME V&V 40, 20, and 10 standards. Publicly available literature data were used for the initial validation work.

The initial FSI model replicated an in-vitro setup and was evaluated under a range of flow conditions, including those reported in the literature. Once validated, the model was deployed in anatomies reconstructed from pre-operative CT scans of five patients. Finite element models of the aortic root and valve, including calcifications, were generated to serve as host environments for device deployment.

Simulations were performed using Abaqus/Explicit for structural analysis and FlowVision for fluid dynamics, coupled via the Dassault Systèmes Co-Simulation Engine. The models captured key hemodynamic parameters, including Effective Orifice Area (EOA), mean and peak transvalvular pressure gradients (TPG), and pressure recovery. Predicted results showed consistent agreement with patient-specific clinical data, supporting the model’s credibility and translational relevance.

This work demonstrates the applicability of high-fidelity, patient-specific FSI modeling of TAVR outcomes using validated multiphysics models. By capturing detailed structural and hemodynamic interactions through multiphysics simulation, such simulation frameworks provide better insights into post-implantation behavior, including pressure recovery and transvalvular gradients, and potential paravalvular leaks; paving the way for personalized pre-TAVI planning, patient selection, and improved prediction of procedural outcomes.