Long-Term Durability of a New Surgical Aortic Valve: A One Billion Cycle In Vitro Study

Abstract BACKGROUND This study assessed the long-term hemodynamic functional performance of the new INSPIRIS RESILIA aortic valve after accelerated wear testing (AWT). Methods Three 21mm and 23 mm INSPIRIS valves were used for the AWT test. After one billion cycles (equivalent to 25 years), the valves’ hemodynamic performance was compared to the corresponding zero cycled condition. Next, one AWT cycled valve from each valve size was selected randomly for particle image velocimetry (PIV) and leaflet kinematic tests and compared with an uncycled INSPIRIS RESILIA aortic valve of the same sizes. PIV was used to quantitatively evaluate flow fields downstream of the valve. Valves were tested according to International Standards Organization 5840-2:2015 protocols. Results The 21 and 23mm valves met the ISO durability performance requirements to one billion cycles. The effective orifice areas for the 21 mm and 23 mm zero and billion cycled valves were 1.89±0.02cm2 vs 1.94±0.01cm2 (p Conclusions The INSPIRIS RESILIA aortic valve demonstrated very good durability and hemodynamic performance after an equivalent of 25 years of simulated in vitro accelerated wear. The study valves successfully passed one billion cycles of simulated wear, 5 times longer than the standard requirement for a tissue valve as stipulated in ISO 5840-2:2015.