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Published on: December 11, 2017
Long-term Mechanical Durability of Inspiris RESILIA Surgical Aortic Valves
Sanchita S Bhat1, Jae Hyun Kim1, Shweta Karnik1
1Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, Georgia.
Background:
Prolonged mechanical durability and hemodynamic characteristics after durability tests of surgical valves need to be studied. Inspiris RESILIA (Edwards Lifesciences), a relatively recent and novel surgical aortic valve, was evaluated after accelerated wear testing.
Methods:
Three 21-mm and 3 23-mm Inspiris valves were cycled in the durability tester for 2 billion cycles (equivalent to 50 years) and were compared with a control valve of respective size. All valves were subjected to analysis, including particle image velocimetry for downstream flow fields and en face imaging for geometric orifice area. Valves were tested according to International Standards Organization 5840 protocols.
Results:
All tested valves met the International Standards Organization durability requirements. The mean effective orifice areas for the 21-mm Inspiris control and test valves were 1.82 cm2 and 2.04 ± 0.01 cm2, respectively. The mean effective orifice areas for the 23-mm Inspiris control and test valves were 2.13 cm2 and 2.41 ± 0.16 cm2, respectively. Hemodynamics, leaflet kinematics, and local flow fields of the test valves all remained consistent with those of the control valves.
Conclusions:
Inspiris RESILIA surgical aortic valves demonstrated very good hemodynamic performance after an equivalent of 50 years of simulated in vitro durability. In the absence of biologic agents, the valves showed no signs of gross damage. The Inspiris RESILIA showed a performance similar to that of 1 billion cycled valves from our previous study.
