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

Area of Science:

• Cardiovascular Engineering
• Biomaterials Science
• Computational Fluid Dynamics

Background:

• Bicuspid aortic valve (BAV) affects ~2% of the population and causes nearly half of aortic stenosis (AS) cases.
• Current transcatheter aortic valve replacement (TAVR) devices, designed for tricuspid aortic valves (TAV), have limitations in BAV patients, including poor fit and reduced durability.
• Younger BAV patients face particular challenges due to early onset AS and the limitations of existing TAVR devices.

Purpose of the Study:

• To introduce PolyV-B, a novel polymeric TAVR device specifically designed for BAV anatomy.
• To computationally model and assess the performance of PolyV-B, focusing on durability, hemodynamics, and annular fit.
• To compare the simulated performance of PolyV-B against a current TAVR device (Evolut R) in patient-specific BAV anatomies.

Main Methods:

• Development of the PolyV-B device featuring asymmetric xSIBS polymeric leaflets and a fatigue-optimized nitinol stent with a rhombic profile.
• Virtual deployment of the 29-mm PolyV-B device in six patient-specific BAV anatomies using the 3DExperience platform.
• Finite element modeling and fluid-structure interaction (FSI) simulations to compare PolyV-B performance with the Evolut R device.

Main Results:

• PolyV-B demonstrated a 50% reduction in crimping strain, improved annular fit, enhanced sealing, and reduced thrombogenic risk compared to Evolut R.
• Flow simulations indicated superior hemodynamics and a larger effective orifice area for PolyV-B.
• The computational approach facilitated efficient feasibility assessment of the novel TAVR design.

Conclusions:

• The PolyV-B TAVR device incorporates innovative design features to enhance durability, hemodynamics, and usability for BAV patients.
• Simulations in patient-specific BAV anatomies show PolyV-B's advantages over the Evolut R device.
• This tailored polymeric TAVR offers a promising solution for the unmet clinical needs of the BAV population.