Pitfalls and outcomes from accelerated wear testing of mechanical heart valves.

摘要: In 1990 Sorin Biomedica introduced a new bileaflet heart valve called the Bicarbon valve. This design was reported to eliminate wear in hinge mechanism. Clinical quality Bicarbon, CarboMedics, St. Jude Medical, Duromedics and Jyros valves were obtained test this claim compare pivot of other available valves. The visually inspected then subjected 4,000 cycles at physiological beat rate vitro. re-inspected 400 million Reul type accelerated tester. Scanning electron microscope photographs taken all contact areas 40, 80, 120, 160, 200, 240, 280 cycles. Wear marks on inflow side Sorin, CarboMedics leaflets measured compared. Orifice not quantified because difficulty with measuring inside complex depressions. After testing CarboFilmTM coating orifice showed signs erosion. components only exhibited minor burnishing after Following completion an tester, approximately ten years vivo, significant wear. face deepest marks. CarboFilm orifices removed from most leaflet contact. transition between remaining eroded created rough edge. tips contacted bottom pivot, contrast Medical designs, which had minimal orifice.