A Parametric Computational Study of the Impact of Non-circular Configurations on Bioprosthetic Heart Valve Leaflet Deformations and Stresses: Possible Implications for Transcatheter Heart Valves

... The hydrodynamic testing was per- formed using 0.9% saline solution in the commercially available Left Heart Simulator (Vivitro Systems), which simulates function of the heart by generating pulsatile flow through prosthetic heart valves. ...In the EllipMinor and EllipMajor configurations, the maximum principal stress occurred near the center of the free edge of the “stretched” leaflets. These results further affirm recommendations by the International Standards Organization (ISO) that pre-clinical testing should consider non-circular configurations for transcatheter valve durability testing.