Omnicarbon ™ 21 mm Aortic Valve Prosthesis: In Vitro Hydrodynamic and Echo-Doppler Study

Abstract

The aim of this study was to perform combined hydrodynamic and Doppler echocardiographic tests of the Omnicarbon 21 mm cardiac valve in aortic position in our Pulse Duplicator System for simultaneous assessment of valve performance and valve leakage data. During forward flow conditions, measured mean pressure gradients are between 4.5 and 20.2 mmHg (11.9 ± 4.4 mmHg) for cardiac outputs between 3.6 and 5.3 l/min (4.5 ± 0.4 l/min). Doppler-derived mean pressure gradients are between 2.0 and 17.0 mmHg (9.3 ± 3.9 mmHg) for the same flow conditions. Effective Orifice area is 1.31 ± 0.08 cm² and the performance index is 0.74 ± 0.04, using the actual geometric orifice area, and 0.38 ± 0.02, using the tissue annulus diameter, for a cardiac output of 4.5 ± 0.4 l/min. Regurgitation volumes are below 3 ml. There is a trend to an effect of valve orientation on hemodynamics.