New polyurethane heart valve prosthesis: design, manufacture and evaluation.

In light of the thrombogenicity of mechanical valves and the limited durability of bioprosthetic valves, alternative designs and materials are being considered for prosthetic heart valves. A new tri-leaflet valve, made entirely from polyurethane, has been developed. The valve comprises three thin polyurethane leaflets (approximately 100 microns thick) suspended from the inside of a flexible polyurethane frame. The closed leaflet geometry is elliptical in the radial direction and hyperbolic in the circumferential direction. Valve leaflets are formed and integrated with their support frame in a single dip coating operation. The dipping process consistently gives rise to tolerably uniform leaflet thickness distributions. In hydrodynamic tests, the polyurethane valve exhibits pressure gradients similar to those for a bioprosthetic valve (St Jude Bioimplant), and levels of regurgitation and leakage are considerably less than those for either a bi-leaflet mechanical valve (St Jude Medical) or the bioprosthetic valve. Six out of six consecutively manufactured polyurethane valves have exceeded the equivalent of 10 years function without failure in accelerated fatigue tests. The only failure to date occurred after the equivalent of approximately 12 years cycling, and three valves have reached 527 million cycles (approximately 13 years equivalent). The simplicity of valve manufacture, combined with promising results from in vitro testing, indicate that further evaluation is warranted.

In vitro function and durability assessment of a novel polyurethane heart valve prosthesis.

While flexible-leaflet, central-flow prosthetic heart valves promise relief from anticoagulation therapy, they continue to be restricted by inadequate durability. In consequence, a novel trileaflet valve, made entirely from polyurethane, has been developed. A batch of 6 consecutively manufactured polyurethane valves was subjected to hydrodynamic function and accelerated fatigue testing. Computerized data acquisition and control systems have been introduced to improve valve testing methodologies. In terms of hydrodynamic function, the polyurethane valve demonstrates transvalvular pressure gradients similar to those for a bioprosthetic valve (Carpentier-Edwards) and levels of retrograde flow significantly less than those for either the bioprosthetic valve or a bileaflet mechanical valve (St Jude Medical). The equivalent of 10 years of cycling without failure has been exceeded by all 6 polyurethane valves in accelerated fatigue tests with 2 valves remaining intact after 674 million cycles (equivalent to approximately 17 years) in continuing tests. Highspeed photography revealed considerable differences in leaflet motion between valves cycled at accelerated and physiological rates.