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

Purpose: 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. Methods: 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. Results: 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. Conclusion: 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.