Evaluation of clinically relevant operating conditions for left ventricular assist device investigations.

Standardized boundary conditions for flow rate and pressure difference are currently not available for the development and certification process of ventricular assist devices. Thus, interdisciplinary studies lack comparability and quantitative assessment. Universally valid boundary conditions could be used for the application of numerical and experimental investigations and the approval procedure of ventricular assist devices. In order to define such boundaries, physiological data from INCOR® patients were evaluated. A total of 599 out of possible 627 ventricular assist device patients were analyzed regarding their cardiac demands of flow rate and pressure head. An analysis of long-term data was performed, in order to provide respective, static mean values for benchmark testing. Furthermore, the short-term data of 188 patients delivered field data-based dynamic flow and pressure curves. The results of the study revealed physiologically reasonable boundary conditions, which can be applied in numerical or experimental investigations of ventricular assist devices. For steady flow analysis, single values for flow rate (4.46 L/min) and pressure head (62 mmHg) are suggested. For the support of pulsatile and unsteady flow studies, seven typical patients and one representative dynamic curve for flow rate and pressure head are proposed.The standardized results provided in this article, can be used in favor of interdisciplinary comparability of future numerical computations or in vitro ventricular assist device tests in research, development, and approval.

CFD simulation of a novel bileaflet mechanical heart valve prosthesis: an estimation of the Venturi passage formed by the leaflets.

The aim of this study was to validate the flow characteristics of the novel Helmholtz-Institute Aachen Bileaflet (HIA-BL) heart valve prosthesis. The curved leaflets of the HIA-BL valve form a Venturi passage between the leaflets at peak systole. By narrowing the cross section the flow accelerates and the static pressure at the central passage decreases according to the Venturi effect. The low-pressure zone between the leaflets is expected to stabilize the leaflets in fully open position at peak systole. To investigate the Venturi passage, the flow fields of two valve geometries were investigated by CFD (Computational Fluid Dynamics): one geometry exhibits curved leaflets resulting in a Venturi passage; the other geometry features straight leaflets. The flow profiles, pressure distribution and resulting torque of both passages were compared and investigated. Although flow profiles downstream of both valves were similar, the flow passages between the leaflets were different for the investigated leaflet geometries. The straight leaflet passage showed a large boundary layer separation zone near the leaflets and the lowest pressure at the leading edge of the leaflet. The Venturi passage showed a reduction of the boundary layer separation zones and the lowest pressure between the leaflets could be found in the narrowest flow cross section of the Venturi passage. Additionally, the resulting torque showed that the Venturi passage produced an opening momentum. The results demonstrate that the Venturi passage stabilizes the leaflets in open position at peak systole.

Design and in vitro performance of a novel bileaflet mechanical heart valve prosthesis.

Design and in vitro performance of a novel bileaflet mechanical heart valve prosthesis are presented. The novel heart valve exhibits three main design characteristics: (i) The leaflets form a Venturi passage in open position. Thus, a beneficial pressure distribution is obtained and the leaflets are stabilised in opened position. (ii) The orifice inlet is nozzle-shaped. Flow is convectively accelerated and flow separation at the orifice inlet is avoided. (iii) The hinge design facilitates an additional axial movement of the leaflets and leads to a self cleaning effect and enhances washout of the hinges. The design of the leaflet hinges is of main importance for the functional reliability and durability of mechanical heart valves. After manufacturing first prototypes from titanium and polymeric materials the hydrodynamic performance was evaluated according to ISO 5840 and FDA guidelines. Hydrodynamic performance is comparable with the results of commonly available bileaflet mechanical heart valve prostheses. Initial durability tests showed suitable material couples for further long term studies.