Results of a comparative in vitro study of Duromedics and Björk-Shiley monostrut mitral heart valve prostheses

Two different mechanical heart valves with annulus diameters 21–29 mm, (five Björk-Shiley monostrut tilting disc valves and five Duromedics bileaflet valves) have been tested in pulsatile flow in the mitral position of a mock circulation. Reflux, pressure, and orifice area have been measured while cardiac output was varied between 2 and 6 1 min⁻¹. Insufficiency, mean orifice area, discharge coefficient, and performance and efficiency indices have been calculated. Mean values of insufficiency for the Björk-Shiley monostrut valves varied between 4.8 and 17.2% while the corresponding values for the Duromedics valves were in the range 6.1–17.3%. Mean values for orifice areas of the Björk-Shiley monostrut valves increased with the larger valve sizes from 101.1 to 210.2 mm²; for the Duromedics valves the area range was 134.5–262.9 mm². Because of the larger orifice areas the values of discharge coefficient and performance index for the Duromedic valves were higher than those for the Björk-Shiley monostrut valves. As the insufficiency of the two mechanical valves was similar, and the orifice area of the bileaflet valves was greater than that of the tilting disc valves, Duromedics valves gave higher values for the efficiency index, which varied between 0.31 and 0.39; for Björk-Shiley monostrut valves the index varied between 0.24 and 0.28 under the same test conditions. This hydrodynamic in vitro comparison of mechanical heart valves showed that the Duromedics bileaflet valves were superior to the Björk-Shiley tilting disc valves.     

Turbulent stress measurements downstream of six mechanical aortic valves in a pulsatile flow model

In a pulsatile flow model aortic Bj?rk-Shiley Standard, Convex-Concave and Monostrut valves were investigated together with the Hall-Kaster (Medtronic-Hall), St Jude Medical and Starr-Edwards Silastic Ball valve using hot-film anemometry. Three-dimensional visualization of average systolic Reynolds normal stresses (RNS) reflected the design of the valves. Mean average RNS were used for comparison of the fluid dynamic performance along with Velocity Energy Ratio (VER100) and Turbulence Energy Ratio (TER) as a relative turbulence intensity for pulsatile flow. Mean average RNS ranged from 13.2 to 37.6 Nm-2 for all the valves with the highest levels for the Bj?rk-Shiley Standard and Starr-Edwards Ball valve and lowest values for the St Jude Medical valve and with the Hall-Kaster (Medtronic-Hall), Bj?rk-Shiley Convex-Concave and Monostrut valves in between.     

The central axis prosthetic cardiac valve: an in vitro study of pressure drop assessment under steady-state flow conditions

In this work, a new mechanical prosthetic heart valve, the central axis valve, is presented. This new prosthesis has been tested in vitro, and compared with four other common prosthetic cardiac valves (Starr-Edwards 6120, Bjork-Shiley monostrut, Medtronic-Hall, and St Jude Medical valves). All valves studied have the same orifice diameter of 22 mm. The prostheses were installed inside a transparent mitral test chamber, which enables pressure drop measurement to be made under steady-state flow conditions using a blood analogue fluid. Pressure drop loss is one important factor affecting the overall performance of a prosthetic heart valve. Steady-state flow tests are essential to predict certain flow characteristics and pressure gradient loss before more complicated, expensive, and difficult-to-interpret pulsatile flow tests are conducted. All experiments were performed in vitro and at steady volumetric flow rates of 10 to 30 l/min. The Starr-Edwards SE 6120 showed the highest values for pressure drop. The St Jude Medical valve offers the minimum resistance to flow. The central axis valve comes second to the Starr-Edwards valve for this type of measurement. The new valve is promising. A complete valve evaluation programme, covering initial conceptional design through to clinical use, is in progress. Materials for the fabrication of the new valve are also under consideration.     

A “sweet-spot” for fluid-induced oscillations in the conditioning of stem cell-based engineered heart valve tissues

Fluid-induced shear stresses are involved in the development of cardiovascular tissues. In a tissue engineering framework, this stimulus has also been considered as a mechanical regulator of stem cell differentiation. We recently demonstrated that the fluid-oscillating effect in combination with a physiologically-relevant shear stress magnitude contributes to the formation of stem cell-derived de novo heart valve tissues. However, the range of oscillations necessary to induce favorable gene expression and engineered tissue formation is unknown. In this study, we took a computational approach to establish a range of oscillatory shear stresses that may optimize in vitro valvular tissue growth. Taking a biomimetic approach, three physiologically-relevant flow waveforms from the human: (i) aorta, (ii) pulmonary artery and (iii) superior vena cava were utilized to simulate pulsatile flow conditions within a bioreactor that housed 3 tissue specimens. Results were compared to non-physiological pulsatile flow (NPPF) and cyclic flexure-steady flow (Flex-Flow) conditions. The oscillatory shear index (OSI) was used to quantify the fluid-induced oscillations occurring on the specimen surfaces. The range of mean OSI under the physiological conditions investigated was found to be 0.18 ≤ OSI ≤ 0.23. On the other hand, NPPF and Flex-Flow environments yielded a mean OSI of 0.37 and 0.11 respectively, which were 46% higher and 45% lower than physiological conditions. Moreover, we subsequently conducted OSI-based human bone marrow stem cell (HBMSC) culture experiments which resulted in preferential valvular gene expression and phenotype (significant upregulation of BMP, KLF2A, CD31 and α-SMA using an OSI of 0.23 in comparison to a lower OSI of 0.10 or a higher OSI of 0.38; p < .05). These findings suggest that a distinct range or a “sweet-spot” for physiological OSI exists in the mechanical conditioning of tissue engineered heart valves grown from stem cell sources. We conclude that in vitro heart valve matrix development could be further enhanced by simultaneous exposure of the engineered tissues to physiologically-relevant magnitudes of both fluid-induced oscillations and shear stresses.     

Laser anemometry measurements of pulsatile flow past aortic valve prostheses

Experimental results are presented on physiological pulsatile flow past caged ball and tilting disc aortic valve prostheses mounted in an axisymmetric chamber incorporated in a mock circulatory system. The measurements of velocity profiles and turbulent normal stresses during several times in a cardiac cycle were obtained using laser-Doppler anemometry. Our results show that with increased angle of opening for the tilting disc valves, a large but locally confined vortex is observed along the wall in the minor flow region throughout most of the cardiac cycle. The turbulent normal stresses measured downstream to the tilting disc in the minor flow region parallel to the tilt axis were found to be larger than those measured downstream to the caged ball valves. Comparison of measurements with steady flow at flow rates comparable to peak pulsatile flow rate show that the turbulent normal stresses are larger by a factor of two in pulsatile flow with a frequency of 1.2 Hz.     

Laser assessment of leaflet closing motion in prosthetic heart valves

The dynamics of leaflet motion in heart valve prostheses (HVP), and in particular the closing velocity, is believed to be related to the valve sound and possibly to the phenomenon of valve cavitation. This paper describes a non-intrusive laser sweeping technique enabling the study of leaflet motion. The principle of measurement and the equipment involved are presented, together with the results of two commerially available, 29 mm bileaflet mitral valves, a St. Jude Medical, and an Edwards Duromedic valve. Experiments were carried out in a pulsatile mock flow testing loop designed to mimic physiological pressure waveforms and ventricular contraction. Measurements of heart rate were made in the range 70–120 beats min⁻¹, with a ventricular pressure slope range of 1800–5600 mm Hgs⁻¹ and a cardiac output range of 5.0–7.5 litres min⁻¹. Motion analysis of the measured data focuses on the velocity of the leaflet immediately before closure.     

Pulsatile flow past aortic valve bioprostheses in a model human aorta

Pulsatile flow development past tissue valve prostheses in a model human aorta has been studied using qualitative flow visualization and quantitative laser-Doppler techniques. Experiments were conducted both in steady and physiological pulsatile flow situations and the measurements included the pressure drop across the valve, the instantaneous flow rate as well as the velocity profiles and turbulent stresses downstream to the valves. Our study shows that the velocity profiles with pericardial valves are closer to those measured past natural aortic valves. The porcine valves with a smaller valve opening area produce a narrower and stronger jet downstream from the valve with relatively larger turbulent axial stresses in the boundary of the jet. Our study suggests that the pericardial valves with turbulent stresses comparable to those of caged ball and tilting disc valves are preferable from a hemodynamic point of view.     

Turbulence downstream of subcoronary stentless and stented aortic valves

Regions of turbulence downstream of bioprosthetic heart valves may cause damage to blood components, vessel wall as well as to aortic valve leaflets. Stentless aortic heart valves are known to posses several hemodynamic benefits such as larger effective orifice areas, lower aortic transvalvular pressure difference and faster left ventricular mass regression compared with their stented counterpart. Whether this is reflected by diminished turbulence formation, remains to be shown. We implanted either stented pericardial valve prostheses (Mitroflow), stentless valve prostheses (Solo or Toronto SPV) in pigs or they preserved their native valves. Following surgery, blood velocity was measured in the cross sectional area downstream of the valves using 10MHz ultrasonic probes connected to a dedicated pulsed Doppler equipment. As a measure of turbulence, Reynolds normal stress (RNS) was calculated at two different blood pressures (baseline and 50% increase). We found no difference in maximum RNS measurements between any of the investigated valve groups. The native valve had significantly lower mean RNS values than the Mitroflow (p=0.004), Toronto SPV (p=0.008) and Solo valve (p=0.02). There were no statistically significant differences between the artificial valve groups (p=0.3). The mean RNS was significantly larger when increasing blood pressure (p=0.0006). We, thus, found no advantages for the stentless aortic valves compared with stented prosthesis in terms of lower maximum or mean RNS values. Native valves have a significantly lower mean RNS value than all investigated bioprostheses.     

In vitro flow dynamics of four prosthetic aortic valves: a comparative analysis

The velocity fields downstream of four prosthetic heart valves were mapped in vitro over the entire cross-section of a model aortic root using laser Doppler anemometry. THe Bj?rk-Shiley 60 degrees convexo-concave tilting disc valve, the Smeloff-Cutter caged ball valve, the St. Jude Medical bileaflet valve, and the Ionescu-Shiley standard bioprosthesis were examined under both steady and pulsatile flows. Velocity profiles under steady flow conditions were a good approximation for pulsatile profiles only during midsystole. The pulsatile flow characteristics of the four valves showed variation in large scale flow structures. Comparison of the valves according to pressure drop, shear stress and maximum velocities are also provided.     

In-vitro fluid dynamic characteristics of the abiomed trileaflet heart valve prosthesis

The need for better and longer lasting trileaflet valves has led to the design and development of the Abiomed polymeric trileaflet valve prosthesis. In-vitro fluid dynamic studies on sizes 25 and 21 mm valves in the aortic position indicate an overall improvement in performance compared to the Carpentier-Edwards and Ionescu-Shiley tissue valves in current clinical use. The pressure drop studies yielded effective orifice areas of 1.99 and 1.54 cm2, and performance indices of 0.41 and 0.45 for the Nos. 25 and 21 valves, respectively. Leaflet photography studies indicated that the two valve sizes had maximum opening areas of 225 and 145 mm2, respectively, at a normal resting cardiac output. Steady and pulsatile flow velocity measurements with a laser-Doppler anemometer (LDA) system indicate that the flow field downstream of the Abiomed valve is jetlike and turbulent. Maximum mean square axial velocity fluctuations of 55 and 83 cm/s, and turbulent shear stresses of 220 and 450 N/m2 were measured in the immediate vicinity of the nos. 25 and 21 valves, respectively. The Abiomed valves studied had been originally configured for use in valved conduits, and it is therefore our opinion that further improvements can be made to the valve and stent design, which would enhance its fluid dynamic performance.     

An in vitro comparative study of St. Jude Medical and Edwards-Duromedics bileaflet valves using laser anemometry

An in vitro comparative study of St. Jude (SJ) and Edwards-Duromedics (DM) Bileaflet valves was performed under steady and physiological pulsatile flow conditions in an axisymmetric chamber using Laser Doppler Anemometry (LDA). LDA measurements were conducted in two different orientations; in the first orientation, the LDA traverse was perpendicular and, in the second orientation, parallel to the tilt axis of the leaflets. The axial velocities were measured in both orientations at two different locations distal to the valves. The velocity profiles at peak systole show the presence of stronger vortex in the sinus region for flow past SJ valve in the first orientation compared to the DM valve. Velocity profile distal to the SJ valve in second orientation was relatively flat where as for the DM valve, a jet-like flow was present. The differences found in the velocity profiles between the two valves can be attributed to the differences in geometry with thicker leaflets, smaller angle of leaflets opening and the presence of the leaflet curvature for the DM valve. The results obtained in this study do not show any fluid dynamic advantages due to the curved leaflet geometry of the DM valve.     

Computational model for the transition from peristaltic to pulsatile flow in the embryonic heart tube

Early in development, the heart is a single muscle-wrapped tube without formed valves. Yet survival of the embryo depends on the ability of this tube to pump blood at steadily increasing rates and pressures. Developmental biologists historically have speculated that the heart tube pumps via a peristaltic mechanism, with a wave of contraction propagating from the inflow to the outflow end. Physiological measurements, however, have shown that the flow becomes pulsatile in character quite early in development, before the valves form. Here, we use a computational model for flow though the embryonic heart to explore the pumping mechanism. Results from the model show that endocardial cushions, which are valve primordia arising near the ends of the tube, induce a transition from peristaltic to pulsatile flow. Comparison of numerical results with published experimental data shows reasonably good agreement for various pressure and flow parameters. This study illustrates the interrelationship between form and function in the early embryonic heart.     

Two-dimensional color-mapping of turbulent shear stress distribution downstream of two aortic bioprosthetic valves in vitro.

Since artificial heart valve related complications such as thrombus formation, hemolysis and calcification are considered related to flow disturbances caused by the inserted valve, a thorough hemodynamic characterization of heart valve prostheses is essential. In a pulsatile flow model, fluid velocities were measured one diameter downstream of a Hancock Porcine (HAPO) and a Ionescu-Shiley Pericardial Standard (ISPS) aortic valve. Hot-film anemometry (HFA) was used for velocity measurements at 41 points in the cross-sectional area of the ascending aorta. Three-dimensional visualization of the velocity profiles, at 100 different instants during one mean pump cycle, was performed. Turbulence analysis was performed as a function of time by calculating the axial turbulence energy within 50 ms overlapping time windows during the systole. The turbulent shear stresses were estimated by using the correlation equation between Reynolds normal stress and turbulent (Reynolds) shear stress. The turbulent shear stress distribution was visualized by two-dimensional color-mapping at different instants during one mean pump cycle. Based on the velocity profiles and the turbulent shear stress distribution, a relative blood damage index (RBDI) was calculated. It has the feature of combining the magnitude and exposure time of the estimated shear stresses in one index, covering the entire cross-sectional area. The HAPO valve showed a skewed jet-type velocity profile with the highest velocities towards the left posterior aortic wall. The ISPS valve revealed a more parabolic-shaped velocity profile during systole. The turbulent shear stresses were highest in areas of high or rapidly changing velocity gradients. For the HAPO valve the maximum estimated turbulent shear stress was 194 N m-2 and for the ISPS valve 154 Nm-2. The RBDI was the same for the two valves. The turbulent shear stresses had magnitudes and exposure times that might cause endothelial damage and sublethal or lethal damage to blood corpuscules. The RBDI makes comparison between different heart valves easier and may prove important when making correlation with clinical observations.     

Protocol for Relative Hydrodynamic Assessment of Tri-leaflet Polymer Valves

Limitations of currently available prosthetic valves, xenografts, and homografts have prompted a recent resurgence of developments in the area of tri-leaflet polymer valve prostheses. However, identification of a protocol for initial assessment of polymer valve hydrodynamic functionality is paramount during the early stages of the design process. Traditional in vitro pulse duplicator systems are not configured to accommodate flexible tri-leaflet materials; in addition, assessment of polymer valve functionality needs to be made in a relative context to native and prosthetic heart valves under identical test conditions so that variability in measurements from different instruments can be avoided. Accordingly, we conducted hydrodynamic assessment of i) native (n = 4, mean diameter, D = 20 mm), ii) bi-leaflet mechanical (n= 2, D = 23 mm) and iii) polymer valves (n = 5, D = 22 mm) via the use of a commercially available pulse duplicator system (ViVitro Labs Inc, Victoria, BC) that was modified to accommodate tri-leaflet valve geometries. Tri-leaflet silicone valves developed at the University of Florida comprised the polymer valve group. A mixture in the ratio of 35:65 glycerin to water was used to mimic blood physical properties. Instantaneous flow rate was measured at the interface of the left ventricle and aortic units while pressure was recorded at the ventricular and aortic positions. Bi-leaflet and native valve data from the literature was used to validate flow and pressure readings. The following hydrodynamic metrics were reported: forward flow pressure drop, aortic root mean square forward flow rate, aortic closing, leakage and regurgitant volume, transaortic closing, leakage, and total energy losses. Representative results indicated that hydrodynamic metrics from the three valve groups could be successfully obtained by incorporating a custom-built assembly into a commercially available pulse duplicator system and subsequently, objectively compared to provide insights on functional aspects of polymer valve design.     

Hydrodynamic in vitro comparison of a new artificial heart valve with the Bj?rk-Shiley valve (standard)

Measurements performed to compare a newly developed tilting disc valve with the Bj?rk-Shiley valve included velocity profiles downstream of the heart valves, valve-induced flow turbulence and pressure drop across the opened valves. The velocity profiles measured with pulsed Doppler ultrasound are similar, although they do not permit a quantitative comparison of the valves. The interpretation of the 90 degrees-component of Doppler signals as a measure of the turbulence permits a quantitative comparison without the need for extensive measurements. However, only large vortices are recorded, so that our turbulent shear stresses are lower than these reported in the literature. The pressure drop across the opened valve is a measure of the energy loss, and important parameters for the valve can be derived from it. The pressure drop is dependent on the test conditions, and is therefore not a characteristic constant of the valve. The transformation of the power law Q = C delta P beta into a relation between Re- and Eu-number gives a nondimensional similarity number that is characteristic for tilting disc valves. Its verification requires more investigations, involving variation of valve size and the viscosity of the test fluid.     

The 12 cc Penn State pulsatile pediatric ventricular assist device: fluid dynamics associated with valve selection

The mortality rate for infants awaiting a heart transplant is 40% because of the extremely limited number of donor organs. Ventricular assist devices (VADs), a common bridge-to-transplant solution in adults, are becoming a viable option for pediatric patients. A major obstacle faced by VAD designers is thromboembolism. Previous studies have shown that the interrelated flow characteristics necessary for the prevention of thrombosis in a pulsatile VAD are a strong inlet jet, a late diastolic recirculating flow, and a wall shear rate greater than 500 s(-1). Particle image velocimetry was used to compare the flow fields in the chamber of the 12 cc Penn State pediatric pulsatile VAD using two mechanical heart valves: Bjork-Shiley monostrut (BSM) tilting disk valves and CarboMedics (CM) bileaflet valves. In conjunction with the flow evaluation, wall shear data were calculated and analyzed to help quantify wall washing. The major orifice inlet jet of the device containing BSM valves was more intense, which led to better recirculation and wall washing than the three jets produced by the CM valves. Regurgitation through the CM valve served as a significant hindrance to the development of the rotational flow.     

In vitro pulsatile flow velocity and shear stress measurements in the vicinity of mechanical mitral heart valve prostheses

A three beam laser Doppler anemometer system was used to study the flow fields created by various types of mitral heart valve prostheses under physiological pulsatile flow conditions. The prosthetic valves studied were: Beall caged disc valve, Bjork-Shiley tilting disc valve, Medtronic-Hall tilting disc valve and St. Jude bileaflet valve. The results indicate that all four prosthetic valve designs studied create very disturbed flow fields with elevated turbulent shear stresses and regions of flow separation and/or stagnation. The observed elevated turbulent shear stresses could cause sublethal and/or lethal damage to red cells and platelets. The regions of flow separation and/or stagnation, could lead to thrombus formation and/or tissue overgrowth on the valve structure, as observed on clinically recovered prosthetic valves.     

Evaluation of an aortic valve prosthesis: Fluid-structure interaction or structural simulation?

Bio-inspired polymeric heart valves (PHVs) are excellent candidates to mimic the structural and the fluid dynamic features of the native valve. PHVs can be implanted as prosthetic alternative to currently clinically used mechanical and biological valves or as potential candidate for a minimally invasive treatment, like the transcatheter aortic valve implantation. Nevertheless, PHVs are not currently used for clinical applications due to their lack of reliability. In order to investigate the main features of this new class of prostheses, pulsatile tests in an in-house pulse duplicator were carried out and reproduced in silico with both structural Finite-Element (FE) and Fluid-Structure interaction (FSI) analyses. Valve kinematics and geometric orifice area (GOA) were evaluated to compare the in vitro and the in silico tests. Numerical results showed better similarity with experiments for the FSI than for the FE simulations. The maximum difference between experimental and FSI GOA at maximum opening time was only 5%, as compared to the 46.5% between experimental and structural FE GOA. The stress distribution on the valve leaflets clearly reflected the difference in valve kinematics. Higher stress values were found in the FSI simulations with respect to those obtained in the FE simulation. This study demonstrates that FSI simulations are more appropriate than FE simulations to describe the actual behaviour of PHVs as they can replicate the valve-fluid interaction while providing realistic fluid dynamic results.     

Design of a system for the accelerated loading of heart valve prostheses

In this paper an equipment is described for the loading of heart valve prostheses under physiological pressure conditions at a frequency of 10 Hz. The system consists essentially of two reservoirs between which a housing is mounted for holding the valve prosthesis. The reservoirs are partly filled with liquid. The physiological pressure variation across the valve is obtained by pressure control within the two reservoirs. A phase difference between the pressures in the two reservoirs compensates for the mass-inertia effects which normally occur at these high frequencies. The system without a valve has been analysed on the basis of simplified relationships between pressure and flow. The predicted values for the phase difference between the flow and the pressure curves within the valve housing, have been verified experimentally for various values of phase difference and amplitude ratios of the pressure variations within the reservoirs. The agreement between theory and experiment is fair. For the system with a valve the experimentally observed patterns closely resemble the theoretically predicted ones. From experiments with a Bj?rk-Shiley ( 21ABP ) and a Hancock (242-A21) valve prosthesis it is concluded that the valves open and close completely and that the pressure and flow patterns around the valves mimic the essential features of the in-vivo signals.     

Numerical and experimental investigations of pulsatile blood flow pattern through a dysfunctional mechanical heart valve

Around 250,000 heart valve replacements are performed every year around the world. Due their higher durability, approximately 2/3 of these replacements use mechanical prosthetic heart valves (mainly bileaflet valves). Although very efficient, these valves can be subject to valve leaflet malfunctions. These malfunctions are usually the consequence of pannus ingrowth and/or thrombus formation and represent serious and potentially fatal complications. Hence, it is important to investigate the flow field downstream of a dysfunctional mechanical heart valve to better understand its impact on blood components (red blood cells, platelets and coagulation factors) and to improve the current diagnosis techniques. Therefore, the objective of this study will be to numerically and experimentally investigate the pulsatile turbulent flow downstream of a dysfunctional bileaflet mechanical heart valve in terms of velocity field, vortex formation and potential negative effect on blood components. The results show that the flow downstream of a dysfunctional valve was characterized by abnormally elevated velocities and shear stresses as well as large scale vortices. These characteristics can predispose to blood components damage. Furthermore, valve malfunction led to an underestimation of maximal transvalvular pressure gradient, using Doppler echocardiography, when compared to numerical results. This could be explained by the shifting of the maximal velocity towards the normally functioning leaflet. As a consequence, clinicians should try, when possible, to check the maximal velocity position not only at the central orifice but also through the lateral orifices. Finding the maximal velocity in the lateral orifice could be an indication of valve dysfunction.