Malfunction of bileaflet mechanical heart valves in the mitral position could either be due to patient-prosthesis mismatch (PPM) or leaflet obstruction. The aim of this article is to investigate the validity of current echocardiographic criteria used for diagnosis of mitral prosthesis malfunction, namely maximum velocity, mean transvalvular pressure gradient, effective orifice area, and Doppler velocity index. In vitro testing was performed on a double activation left heart duplicator. Both PPM and leaflet obstruction were investigated on a St. Jude Medical Master. PPM was studied by varying the St. Jude prosthesis size (21, 25, and 29 mm) and stroke volume (70 and 90 mL). Prosthesis leaflet obstruction was studied by partially or totally blocking the movement of one valve leaflet. Mitral flow conditions were altered in terms of E/A ratios (0.5, 1.0, and 1.5) to simulate physiologic panel of diastolic function. Maximum velocity, effective orifice area, and Doppler velocity index are shown to be insufficient to distinguish normal from malfunctioning St. Jude prostheses. Doppler velocity index and effective orifice area were 1.3 +/- 0.49 and 1.83 +/- 0.43 cm(2) for testing conditions with no malfunction below the 2.2 and 2 cm(2) thresholds (1.19 cm(2) for severe PPM and 1.23 cm(2) for fully blocked leaflet). The mean pressure gradient reached 5 mm Hg thresholds for several conditions of severe PPM only (6.9 mm Hg and mean maximum velocity value: 183.4 cm/s) whereas such value was never attained in the case of leaflet obstruction. In the case of leaflet obstruction, the maximum velocity averaged over the nine pulsed-wave Doppler locations increased by 38% for partial leaflet obstruction and 75% for a fully blocked leaflet when compared with normal conditions. Current echocardiographic criteria might be suboptimal for the detection of bileaflet mechanical heart valve malfunction. Further developments and investigations are required in order to further improve current guidelines.