A microstructural flow analysis within a bileaflet mechanical heart valve hinge.
OBJECTIVE
During recent clinical trials, the Medtronic Parallel bileaflet heart valve was found to have an unacceptable thrombosis complication rate. As patient- and material-related factors proved negative causes for this outcome, it was hypothesized that the flow fields within the valve's hinge pocket contributed to the thrombus formation.


METHODS
A microstructural flow analysis within the hinge pocket is presented which uses the techniques of flow visualization, computational fluid dynamics (CFD), and laser Doppler velocimetry (LDV). The application of these techniques towards solving this problem has become possible through (i) the ability to manufacture dimensionally correct 1-X transparent heart valve housings, (ii) advances in CFD technology, and (iii) advances in LDV measurement techniques.


RESULTS
This analysis showed that a vortex was present at the hinge pocket's inflow channel during forward flow and degenerated to a disturbed three-dimensional structure during reverse flow with zones of turbulent shear stress large enough to cause blood cell damage. In addition, multiple zones of flow stagnation and disturbed flow existed along the leaflet's pivot throughout the entire cardiac cycle. It was felt that these complex fluid structures created conditions which resulted in the formation of thrombus within the hinges of the Medtronic Parallel valve. These findings were supported by limited clinical explant data which illustrated early thrombus formation within the Parallel valve's hinge pocket at sites predicted by the analysis.


CONCLUSIONS
This study provides, for the first time, an understanding of the detailed flow structures within the hinges of a mechanical heart valve and demonstrates an analysis technique by which future mechanical heart valve designs may be assessed for the potential of thrombus formation within the valve's hinge regions.
Gross
J M
JM
Medtronic Heart Valves, Inc., Irvine, CA 92614, USA.
Shu
M C
MC
Dai
F F
FF
Ellis
J
J
Yoganathan
A P
AP
D003198:Computer Simulation; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D017078:Laser-Doppler Flowmetry; D011474:Prosthesis Design; D013927:Thrombosis / Q000209:etiology