Key result
Eight prototypes of a newly developed tri-leaflet polymeric heart valve prosthesis met ISO 5840 Standard requirements for regurgitation and effective orifice area during in vitro testing.
A newly developed tri-leaflet polymeric heart valve made from styrenic block copolymers met ISO 5840 standards for regurgitation and effective orifice area in vitro, demonstrating potential as a heart valve prosthesis.
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Polymeric valve prototypes meet ISO standards in vitro; leaves open durability and in vivo performance before clinical translation.
The potential of polymeric heart valves (PHV) prostheses is to combine the hemodynamic performances of biological valves with the durability of mechanical valves. The aim of this work is to design and develop a new tri-leaflet prosthetic heart valve (HV) made from styrenic block copolymers. A computational finite element model was implemented to optimize the thickness of the leaflets, to improve PHV mechanical and hydrodynamic performances. Based on the model outcomes, 8 prototypes of the designed valve were produced and tested in vitro under continuous and pulsatile flow conditions, as prescribed by ISO 5840 Standard. A specially designed pulse duplicator allowed testing the PHVs at different flow rates and frequency conditions. All the PHVs met the requirements specified in ISO 5840 Standard in terms of both regurgitation and effective orifice area (EOA), demonstrating their potential as HV prostheses.
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Gaetano et al. (2015) studied this question. Tri-leaflet polymeric heart valve prosthesis made from styrenic block copolymers was evaluated on Regurgitation and effective orifice area (EOA) according to ISO 5840 Standard. Eight prototypes of a newly developed tri-leaflet polymeric heart valve prosthesis met ISO 5840 Standard requirements for regurgitation and effective orifice area during in vitro testing.
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