Since the first successful implantation of a prosthetic heart valve four decades ago, over 50 different designs have been developed including both mechanical and bioprosthetic valves. Today, the most widely implanted design is the mechanical bileaflet, with over 170,000 implants worldwide each year. Several different mechanical valves are currently available and many of them have good bulk forward flow hemodynamics, with lower transvalvular pressure drops, larger effective orifice areas, and fewer regions of forward flow stasis than their earlier-generation counterparts such as the ball-and-cage and tilting-disc valves. However, mechanical valve implants suffer from complications resulting from thrombus deposition and patients implanted with these valves need to be under long-term anti-coagulant therapy. In general, blood thinners are not needed with bioprosthetic implants, but tissue valves suffer from structural failure with, an average life-time of 10-12 years, before replacement is needed. Flow-induced stresses on the formed elements in blood have been implicated in thrombus initiation within the mechanical valve prostheses. Regions of stress concentration on the leaflets during the complex motion of the leaflets have been implicated with structural failure of the leaflets with bioprosthetic valves. In vivo and in vitro experimental studies have yielded valuable information on the relationship between hemodynamic stresses and the problems associated with the implants. More recently, Computational Fluid Dynamics (CFD) has emerged as a promising tool, which, alongside experimentation, can yield insights of unprecedented detail into the hemodynamics of prosthetic heart valves. For CFD to realize its full potential, however, it must rely on numerical techniques that can handle the enormous geometrical complexities of prosthetic devices with spatial and temporal resolution sufficiently high to accurately capture all hemodynamically relevant scales of motion. Such algorithms do not exist today and their development should be a major research priority. For CFD to further gain the confidence of valve designers and medical practitioners it must also undergo comprehensive validation with experimental data. Such validation requires the use of high-resolution flow measuring tools and techniques and the integration of experimental studies with CFD modeling.

Flow in prosthetic heart valves: state-of-the-art and future directions.

The hemodynamic and the thrombogenic performance of two commercially available bileaflet mechanical heart valves (MHVs)--the ATS Open Pivot Valve (ATS) and the St. Jude Regent Valve (SJM), was compared using a state of the art computational fluid dynamics-fluid structure interaction (CFD-FSI) methodology. A transient simulation of the ATS and SJM valves was conducted in a three-dimensional model geometry of a straight conduit with sudden expansion distal the valves, including the valve housing and detailed hinge geometry. An aortic flow waveform (60 beats/min, cardiac output 4 l/min) was applied at the inlet. The FSI formulation utilized a fully implicit coupling procedure using a separate solver for the fluid problem (FLUENT) and for the structural problem. Valve leaflet excursion and pressure differences were calculated, as well as shear stress on the leaflets and accumulated shear stress on particles released during both forward and backward flow phases through the open and closed valve, respectively. In contrast to the SJM, the ATS valve opened to less than maximal opening angle. Nevertheless, maximal and mean pressure gradients and velocity patterns through the valve orifices were comparable. Platelet stress accumulation during forward flow indicated that no platelets experienced a stress accumulation higher than 35 dyne x s/cm2, the threshold for platelet activation (Hellums criterion). However, during the regurgitation flow phase, 0.81% of the platelets in the SJM valve experienced a stress accumulation higher than 35 dyne x s/cm2, compared with 0.63% for the ATS valve. The numerical results indicate that the designs of the ATS and SJM valves, which differ mostly in their hinge mechanism, lead to different potential for platelet activation, especially during the regurgitation phase. This numerical methodology can be used to assess the effects of design parameters on the flow induced thrombogenic potential of blood recirculating devices.

Comparison of the Hemodynamic and Thrombogenic Performance of Two Bileaflet Mechanical Heart Valves Using a CFD/FSI Model

The regurgitant flow fields of clinically used mechanical heart valves have been traditionally studied in vitro using flow visualization, ultrasound techniques, and laser Doppler velocimetry under steady and pulsatile flow. Detailed investigation of the forward and regurgitant flow fields of these valves can elucidate a valve's propensity for blood element damage, thrombus formation, or cavitation. Advances in particle image velocimetry (PIV) have allowed its use in the study of the flow fields of prosthetic valves. Unlike other flow field diagnostic systems, recent work using PIV has been able to relate particular regurgitant flow field characteristics of the Bjork-Shiley Monostrut valve to a propensity for cavitation. In this study, the regurgitant flow field of the St. Jude Medical bileaflet mechanical heart valve was assessed using PIV under physiologic pulsatile flow conditions. Data collected at selected time points prior to and after valve closure demonstrated the typical regurgitant jet flow patterns associated with the St. Jude valve, and indicated the formation of a strong regurgitant jet, in the B-datum plane, along with twin vortices near the leaflets. Estimated ensemble-average viscous shear rates suggested little potential for hemolysis when the hinge jets collided. However, the vortex motion near the occluder tips potentially provides a low-pressure environment for cavitation.

Regurgitant flow field characteristics of the St. Jude bileaflet mechanical heart valve under physiologic pulsatile flow using particle image velocimetry

A major drawback in the operation of mechanical heart valve prostheses is thrombus formation in the near valve region. Detailed flow analysis in this region during the valve closure phase is of interest in understanding the relationship between shear stress and platelet activation. A fixed-grid Cartesian mesh flow solver is used to simulate the blood flow through a bi-leaflet mechanical valve employing a two-dimensional geometry of the leaflet with a pivot point representing the hinge region. A local mesh refinement algorithm allows efficient and fast flow computations with mesh adaptation based on the gradients of the flow field in the leaflet-housing gap at the instant of valve closure. Leaflet motion is calculated dynamically based on the fluid forces acting on it employing a fluid-structure interaction algorithm. Platelets are modeled and tracked as point particles by a Lagrangian particle tracking method which incorporates the hemodynamic forces on the particles. A platelet activation model is included to predict regions which are prone to platelet activation. Closure time of the leaflet is validated against experimental studies. Results show that the orientation of the jet flow through the gap between the housing and the leaflet causes the boundary layer from the valve housing to be drawn in by the shear layer separating from the leaflet. The interaction between the separating shear layers is seen to cause a region of intensely rotating flow with high shear stress and high residence time of particles leading to high likelihood of platelet activation in that region.

Two-dimensional dynamic simulation of platelet activation during mechanical heart valve closure.

Microflow fields in the hinge region of the CarboMedics bileaflet mechanical heart valve design.

BACKGROUND AND AIM OF THE STUDY Fluid stresses occurring in retrograde flow fields during valve closure may play a significant role in thrombogenesis The squeeze flow and regurgitant jets can cause damage to formed blood elements due to high levels of turbulent shear stress The aim of this study was to characterize in detail the spatial structure and temporal behavior of the retrograde flow fields of the St Jude Medical and Medtronic Parallel bileaflet mechanical heart valves METHODS Three-component, coincident laser Doppler anemometry (LDA) velocity measurements were obtained facilitating the determination of the full Reynolds stress tensor and the principal stresses in the valve flow fields The experiments were performed in the Georgia Tech aortic flow chamber under physiologic pulsatile flow conditions Data were collected over several hundred cardiac cycles for subsequent phase window averaging and generation of mean velocity and turbulence statistics over 20 ms intervals A region approximately 8 mm x 10 mm was mapped 10 mm upstream of one hinge of each valve with an incremental resolution of 013-025 mm Animation of the data allowed the visualization of the flow fields and a quantitative display of mean velocity and turbulent stress values RESULTS In the St Jude Medical squeeze flow, the peak turbulent shear stress was 800 dynes/cm2 and the peak reverse velocity was 060 m/s In the Medtronic Parallel squeeze flow, the peak turbulent shear stress was 1,000 dynes/cm2 and the peak velocity 070 m/s The leakage jet fields of the two valves were very different: in the case of the St Jude Medical valve, turbulent shear stresses reached 1,800 dynes/cm2 and peak jet velocity was 080 m/s; in the case of the Medtronic Parallel valve, turbulent shear stresses reached 3,690 dynes/cm2 and the peak jet velocity was 19 m/s CONCLUSIONS The retrograde flow fields of these two bileaflet mechanical heart valves appear to be design-dependent The elevated turbulent shear stresses generated by both valve designs may indicate a propensity for blood element damage during the reverse flow phase of the cardiac cycle, but the extent of flow disturbance was twice as high with the Medtronic Parallel than with the St Jude Medical valve This research should yield a better understanding of the significance of retrograde flow to the functionality and potential thrombogenicity of bileaflet mechanical heart valves and aid in the development of new designs

An in vitro investigation of the retrograde flow fields of two bileaflet mechanical heart valves.

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An in vitro investigation of the retrograde flow fields of two bileaflet mechanical heart valves.