Key result
UniLine bioprostheses demonstrate satisfactory in vitro hemodynamics with mean gradients under ~16 mmHg.
The UniLine aortic bioprosthesis shows satisfactory baseline hydrodynamic performance in vitro, though leaflet design optimization may be needed to prevent long-term structural degeneration.
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Supports preclinical refinement of UniLine valves; leaves open in vivo durability and clinical translation.
The aim of the work was to evaluate the hydrodynamic characteristics of the heart valve bioprosthesis «UniLine», intended for prosthetics of the aortic valve. Materials and methods . In the contest three prostheses «UniLine» with a size of 21, 23, 25 mm, intended for clinical use. The evaluation of the hydrodynamic parameters was carried out in a Vivitro pulsating flow setup (Vivitro Labs, Canada) simulating the operation of the «left» half of the heart. Estimated hydrodynamic function of all prostheses when creating the physiological mode of operation of the unit - impact volume = 70 ml, minute volume = 5 l/min, mean aortic pressure = 100 mmHg. Results . The average trans-prosthetic gradient was 5,4-15,5 mmHg.; the maximum trans-prosthetic gradient was 11,9-25,2 mmHg; effective orifice area 1,38-2,15 cm2; regurgitation fraction 1,5-3,905%; productivity index, calculated from the inner orifice diameter 47,4-68,5%. Conclusion . Bioprostheses «UniLine», intended for aortic position, demonstrated satisfactory hydrodynamic in vitro characteristics, comparable with existing world analogues. The existing design has the potential to increase hydrodynamic efficiency, but requires advanced approaches and methods, such as FSI, for its implementation.
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Klyshnikov et al. (2017) studied Aortic valve replacement (in vitro model) (n=3). UniLine bioprosthesis was evaluated on Hydrodynamic characteristics (trans-prosthetic gradient, effective orifice area, regurgitation fraction). The UniLine bioprostheses demonstrated satisfactory in vitro hydrodynamic characteristics, with an average trans-prosthetic gradient of 5.4-15.5 mmHg and effective orifice area of 1.38-2.15 cm2.
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