An In Silico Patient-Specific Computational Framework for a Tissue-Engineered Pulmonary Valve Using Fluid-Structure Interaction Analysis.

Tissue-engineered heart valves provide significant promise for pediatric patients by overcoming the shortcomings of existing prostheses, which do not accommodate the patients' growth. The Xeltis pulmonary valve (XPV) has recently shown promising clinical outcomes for endogenous tissue restoration in pediatric patients with congenital heart diseases. In this context, patient-specific computational modeling may be pivotal in the advancement and clinical application of in situ polymer-based cardiac valves, enhancing design, facilitating regulatory approval, and diminishing dependence on preclinical animal testing. This study seeks to establish a computational framework for incorporating the XPV device into patient-specific models and assessing the device's biomechanical performance via fully coupled fluid-structure interaction (FSI) simulations. Hemodynamic parameters were predicted and compared with echocardiographic data from the prior Xeltis clinical trial. FSI analyses showed good agreement with clinical assessments, with errors in the device's transmural pressure gradient ≤ 10%. Simulations further confirmed that XPV maintains favorable hemodynamics and mechanical integrity throughout the cardiac cycle. This computational framework can facilitate design optimization and tailored implantation strategies for innovative tissue-engineered heart valves. Although further validation with extensive clinical data is required to confirm the model's credibility, this framework provides a foundation for in silico trials to evaluate the long-term restorative performance of the XPV device.