Key result
The novel sutureless prosthetic aortic valve showed satisfactory hydrodynamic characteristics with an average trans-prosthetic gradient of 6.1–11.1 mm Hg and effective orifice area of 1.60–1.81 cm2.
Why the study?
The study evaluated the in vitro hydrodynamic performance of a novel second-generation prosthetic heart valve designed for valve-in-valve implantation.
Does a novel sutureless prosthetic aortic valve demonstrate satisfactory hydrodynamic performance compared to a commercial bioprosthesis in an in vitro model?
Does a novel sutureless prosthetic aortic valve demonstrate satisfactory hydrodynamic performance compared to a commercial bioprosthesis in an in vitro model?
A novel sutureless prosthetic aortic valve designed for valve-in-valve implantation demonstrated satisfactory in vitro hydrodynamic performance, supporting its viability for future development.
Provides initial hydrodynamic data for a new valve-in-valve bioprosthesis; leaves open in vivo validation and clinical outcomes.
The aimof the study was an in vitro hydrodynamic study of the developed prosthetic heart valve of the second generation, designed to carry out an implantation using «valve-in-valve» method.Material and methods.Prototypes of the developed prosthesis were studied under simulated physiological conditions of the heart using a Vivitro Labs pulse duplicator (Canada) in a comparative aspect with «UniLine» clinical commercial aortic valve bioprosthesis (Russia). Samples were tested by simulating sutureless implantation procedure.Results. The developed valves showed satisfactory hydrodynamic characteristics – for all cases of «implantation» from the position of the average trans-prosthetic gradient (6.1–11.1 mm Hg) and the effective orifice area (1.60–1.81 cm2 ). The analysis of the regurgitation fraction allowed us to determine the optimal sizes for implantation using «valvein-valve» method, which subsequently will form the basis of sizing guidelines for size selection. A qualitative analysis of the leaflet’s work demonstrated the presence of slight asymmetry for a number of prostheses – in case of mismatch of sizes when simulating «valve-in-valve» procedure.Conclusion. The tests demonstrate the viability of the developed design from the standpoint of hydrodynamic efficiency and determines the basic rules of selecting a prosthesis for reimplantation relative to the primary valve.
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Klyshnikov et al. (2020) studied this question. Novel sutureless prosthetic aortic valve vs. UniLine clinical commercial aortic valve bioprosthesis was evaluated on Hydrodynamic characteristics (average trans-prosthetic gradient and effective orifice area). The novel sutureless prosthetic aortic valve showed satisfactory hydrodynamic characteristics with an average trans-prosthetic gradient of 6.1–11.1 mm Hg and effective orifice area of 1.60–1.81 cm2.
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