Durability testing of heart valve replacement devices, including tissue and biomaterial valves, is typically performed under conditions defined in ISO Standard 5840. This standard sets minimum requirements for pressure differential across the closed valve, percent of each cycle this transvalvular pressure should be maintained, and percent of total cycles that should meet the pressure/time requirement. Historically, in order to meet these requirements, test frequency was generally limited to less than 17Hz for tissue and biomaterial valves. Heart valve manufacturers, while needing to meet these testing requirements, must also be cognizant of the time it takes to develop and test new devices, and to move these products to market. Increasing the frequency at which heart valve replacement devices can be tested, while complying with established test requirements, may shorten the development and evaluation time, and allow manufactures to provide these life-saving devices faster.
We postulate that the limitations on testing frequency have been a reflection of the technology historically used to test the heart valve replacement devices, and that a combination of properly-designed test chambers and advanced control of fluid movement would allow for testing at higher frequencies, while still complying with ISO 5840. Using technology that has been commonly used for fluid motion control for accelerated testing of endovascular devices, and combining this technology with specially-designed device holders and chambers, we have evaluated the feasibility of testing tissue heart valve replacement devices, in compliance with ISO 5840, at higher frequencies that have been historically possible. The results are presented.
