Development of a Polymeric TAVR Device Tailored to Bicuspid Aortic Valve Patients Using In Silico Design Optimization and Evaluation.

Abstract

Bicuspid aortic valve (BAV), the most common congenital heart defect, affects ~ 2% of the population but accounts for nearly half of aortic stenosis (AS) cases, typically emerging 10-20 years earlier than in tricuspid aortic valve (TAV) patients. Current tissue-based transcatheter aortic valve replacement (TAVR) devices are designed for TAV anatomy and merely approved for BAV, leading to poor annular fit, paravalvular leak, thrombosis, and limited durability-especially problematic for younger BAV patients. This study presents PolyV-B, a first-of-its-kind polymeric TAVR device tailored to BAV anatomy, aimed at improving durability, hemodynamics, and outcomes through advanced computational modeling. PolyV-B features a sutureless, eccentric valve with asymmetric xSIBS polymeric leaflets and a fatigue-optimized nitinol stent with a centerline groove. The 29-mm device incorporates a rhombic stent profile and large cells to enhance anchoring and coronary access. Developed on the 3DExperience platform, it was virtually deployed in six patient-specific BAV anatomies. Its performance was compared to the Evolut R using finite element modeling and fluid-structure interaction (FSI) simulations. Simulations demonstrated that PolyV-B offers a 50% strain reduction during crimping, improved annular fit, enhanced sealing, and reduced thrombogenic risk. Flow simulations confirmed superior hemodynamics and a larger orifice area compared to Evolut R. The PolyV-B TAVR device introduces design innovations that enhance durability, hemodynamics, and usability. Simulations in six patient-specific BAV anatomies demonstrated advantages over the Evolut R device. Optimization enabled efficient feasibility assessment, supporting the development of a tailored, clinically impactful solution for the BAV patient population facing unmet clinical needs.