In vitro function and durability of a polyurethane heart valve: material considerations

Abstract

Background and aims of the study: Flexible trileaflet polyurethane heart valves can be designed which have good hydrodynamic function in vitro. The choice of polyurethane for fabrication of such valves is not simple; several similar polyurethanes are available, but relatively minor differences in their structure and composition may have profound effects on long term fatigue behavior with little effect on their short term mechanical properties.

Methods: The relative functional characteristics of flexible trileaflet polyurethane valves made from two different polyetherurethanes were compared before and after long term fatigue testing. The polyetherurethanes had similar gross mechanical properties, differing in that one was chain-extended with butanediol (PEU) and the other with ethylene diamine (PEUE). Six valves of each type, with similar leaflet thickness distributions, were studied.

Results: Hydrodynamic function of both valve types was similar to a similarly sized porcine aortic valve. Mean pressure drop across the open valve was higher in PEU valves than in PEUE valves, although PEUE valves had greater energy losses during closure and when closed. Reverse flow decreased with time in the fatigue tester. In long term fatigue tests, all six PEU valves failed by 307 million cycles, with failure primarily by development of holes at the coaptation region of the leaflets associated with localized calcification. Three PEUE valves exceeded 800 million cycles without failure and all PEUE valves exceeded 450 million cycles.

Conclusions: A combination of good phase separation of polyurethane soft and hard segments with good rubbery characteristics can explain the better results achieved in the PEUE valves compared with similar PEU valves. These results suggest the general type of polyurethane structure suitable for heart valve fabrication and have implications for development of novel polyurethanes for this application.