BACKGROUND: Transcatheter Aortic Valve Replacement (TAVR) indication expansion in young patients requires enhanced hemodynamics and durability with greater life expectancy. A novel device uses a unique polymer, 1/3 thickness of bioprosthetic tissue, specifically formulated to alleviate the need for lifetime anticoagulation, which is being studied in surgical aortic and mitral valve (EFS). This analysis assesses a novel balloon-expandable TAVR computationally and in vitro. METHODS: Finite element analysis (FEA) to is employed to optimize for adequate stresses and strains in a cobalt-chromium frame and novel polymeric leaflet and skirt. Detailed computational simulations predict failure modes and durability. The physical model is tested on bench for accelerated wear characteristics and deployed in a biosimulator ex vivo model.
RESULTS: Early prototype durability bench testing for accelerated wear shows promising results. Usability of transcatheter deployment in a porcine heart model show ease of placement, alignment, and confirms flow characteristics and leaflet coaptation.
CONCLUSIONS: In this preliminary feasibility study, the TAVR model demonstrates successful deployment, function, and good hydrodynamic results. The results inspire a feasible path from surgically deployed polymeric valve to balloon-expandable transcatheter approach.
