In Vitro Function and Durability Assessment of a Novel Polyurethane Heart Valve Prosthesis |
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Authors: | TG Mackay GM Bernacca AC Fisher CS Hindle† DJ Wheatley |
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Institution: | Department of Cardiac Surgery, Royal Infirmary, Napier University, Edinburgh, United Kingdom;Bioengineering Unit, University of Strathclyde, Glasgow, Napier University, Edinburgh, United Kingdom;Department of Applied Chemical and Physical Sciences, Napier University, Edinburgh, United Kingdom |
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Abstract: | Abstract 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. |
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Keywords: | Polyurethane– Heart valve– Prosthesis– Hydrodynamic– Durability |
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