Polyurethane heart valve durability: effects of leaflet thickness and material.

A flexible trileaflet polyurethane valve has been made by dip-moulding leaflets directly onto an injection-moulded frame. The durability of this value is, in part, determined by the thickness of its leaflets. Leaflet thickness is also a major determinant of hydrodynamic function. This study examines valves (n = 31) with leaflets made of a polyetherurethane (PEU, n = 22) or a polyetherurethaneurea (PEUE, n = 9), of varying thickness distributions. The valves were subjected to accelerated fatigue test at 37 degrees C and failure monitored. Leaflet thicknesses ranged from 60 to 200 microns. PEU leaflet thickness bore no relationship to durability, which was less than 400 million cycles. PEUE valves, in contrast, exceeded 800 million cycles. Durability in PEUE valves was directly related to leaflet thickness (r = 0.93, p < 0.001), with good durability achieved with median leaflet thicknesses of approximately 150 microns. Thus polyurethane valves can be made with good hydrodynamic properties and with sufficient durability to consider potential clinical use.