Modeling technique of prosthetic heart valves

This paper demonstrates a modeling technique of prosthetic heart valves. In the modeling, a pumping cycle is divided into four phases, in which the state of the valve and flow is different. The pressure-flow relation across the valve is formulated separately in each phase. This technique is developed to build a mathematical model used in the real time estimation of the hemodynamic state under artificial heart pumping. The model built by this technique is simple enough for saving the computational time in the real time estimation. The model is described by the first-order ordinary differential equation with 12 parameters. These parameters can be uniquely determined beforehand from in-vitro experimental data. It is shown that the model can adapt, with sufficient accuracy, to a change in the practical pumping condition and the viscosity of the fluid in their practical range, and is also demonstrated that the estimated backflow volume by model agrees closely with the actual one.     

Pregnancy in women with prosthetic heart valves

Pregnancy in women with mechanical valve prostheses has a high maternal complication rate including valve thrombosis and death. Coumarin derivatives are relatively safe for the mother with a lower incidence of valve thrombosis than un-fractionated and low-molecular-weight heparin, but carry the risk of embryopathy, which is probably dose-dependent. The different anticoagulation regimens are discussed in this review. When valve thrombosis occurs during pregnancy, thrombolysis is the preferable therapeutic option. Bioprostheses have a more favourable pregnancy outcome than mechanical prostheses but due to the high re-operation rate in young women they do not constitute the ideal alternative. When women with native valve stenosis need pre-pregnancy intervention, mitral balloon valvuloplasty is the best option in mitral stenosis, while the Ross operation or homograft implantation may be the preferable surgical regimen in aortic stenosis. (Neth Heart J 2008;16:406-11.)     

The influence of the leaflets' curvature on the flow field in two bileaflet prosthetic heart valves

A successful mechanical prosthetic heart valve design is the bileaflet valve, which has been implanted for the first time more than 20 years ago. A key feature of bileaflet valves is the geometry of the two leaflets, which can be very important in determining the flow field. Laser Doppler anemometry (LDA) was used to perform an accurate study of the velocity and turbulence shear stress peak values (TSS(max)) fields at four distances from the valve plane. TSS(max) is a relevant parameter to assess the risk of hemolysis and platelet activation associated to the implantation of a prosthetic device, continuously interacting with blood. Two bileaflet valves were tested: the St. Jude HP and the Sorin Bicarbon, of the same nominal size (19mm). The former has flat leaflets, whereas the latter's leaflets have a cylindrical surface. A high regime (CO: 6l/min) was imposed, in order to test the two valves at maximum Reynolds number and consequent turbulence generation. The flat-leaflet design of the St. Jude generates a TSS field constant with distance; on the contrary, the Bicarbon's shear stress field undergoes an evident development, with an unexpected central peak at a distance comparable to the valve's dimensions (21mm). The two bileaflet valves tested, although very similar in design, behave very differently as for their turbulence properties. In particular, the concept of curved wake leads to conclude that the curvature of the leaflets' surface must be identified as an important parameter, which deserves careful attention in PHV design and development.     

A comparative computational study of blood flow through prosthetic heart valves using the finite element method

The steady flow of blood through three common types of prosthetic heart valves was simulated numerically using the finite element method. The velocity, pressure and stress fields were obtained for the disk-type, tilting-disk and ball-type prosthetic heart valves in aortic position, for increasing Reynolds numbers up to 900, 1500 and 2000 respectively. Computer graphics of calculated velocities are presented, showing in detail the accelerated flow, recirculation and stagnation areas developed in the prosthesis. Maximum wall shear stresses were found at 0.5, 1.4, and 1.2 diameters from the sewing ring downstream for the disk, tilting-disk and ball valves being the values of 55, 18 and 33 dyn cm-2 respectively. In the vicinity of the occluder, maximum shear stresses of 38, 30 and 47 dyn cm-2 respectively were computed. The flow characteristics and performance for each valve are compared, the results are presented in terms of energy loss and maximum shear stress. The velocity and stress fields are compared with in vitro evaluations found in the literature.     

Study of the velocity and strain fields in the flow through prosthetic heart valves

A comparative experimental study of the velocity field and the strain field produced down-stream of biological and mechanical artificial valves is presented. In order to determine the spatial and temporal distributions of these fields, a phase-locked stereoscopic particle image velocimetry (or 3D-PIV) technique was implemented. Emphasis was placed on the identification of the fundamental differences between the extensional and the shear components of the strain tensor. The analysis of the characteristic flows reveal that the strains in every direction may reach high values at different times during the cardiac cycle. It was found that elevated strain levels persist throughout the cardiac cycle as a result of all these contributions. Finally, it is suggested that the frequency with which the strain variations occur at particular instants and locations could be associated to the cumulative damage process of the blood constituents and should be taken into account in the overall assessment of existing valve types, as well as in future design efforts.     

新型机械心脏瓣膜的研究

目前临床使用的各种机械心脏瓣膜的主要问题是血栓栓塞和与抗凝治疗有关的出血,其缺陷在于瓣膜开启时,碟片和支架将瓣膜的整个血流通道分隔成三至四个较小的血流通道。在这种受阻隔的血流通宫,形成容易诱发血栓的高剪应力区、紊流和滞流区。我们研制的两种机械心脏瓣膜在瓣膜开启时,没有任何支架和碟片分隔瓣膜的血流通道,使血流与天然心脏瓣膜中的相类似,可减少对血液的危害,从而可减少换瓣病人对抗凝治疗的依赖程度。     

Free emboli formation in the wake of bi-leaflet mechanical heart valves and the effects of implantation techniques

The high incidence of thromboembolic complications of mechanical heart valves (MHV), primarily due to platelet activation by contact with foreign surfaces and by non-physiological flow patterns past the valve, still limits their success as permanent implants. The latter include elevated shear and turbulent stresses and shed vortices formed in the wake of the valve's leaflets during the deceleration phase, potentially entrapping activated and aggregated platelets. It is hypothesized that these flow patterns induce the formation of free emboli which are the source of cerebrovascular microemboli associated with MHV. Implicit to this hypothesis is that free emboli formation will be affected by the implantation technique employed and the valve orientation, as those will alter the flow characteristics past the valve and the interaction of the platelets with the flow. In this study, numerical simulations of turbulent pulsatile flow past a St. Jude Medical bi-leaflet MHV were conducted. Platelet shear histories were calculated along pertinent turbulent platelet trajectories, and the effect of a misaligned valve on platelet activation was quantified and compared to that of an aligned valve. It demonstrated that the combination of a tilted valve and subannularly sutured pledgets had an explicit detrimental effect on platelet activation, with the following entrapment of the platelets within the shed vortices of the wake leading to a significant increase of the thromboembolic potential of the valve. This numerical model depicted a viable course for free emboli formation, and indicated how the implantation technique may enhance the risk of cardioembolism.     

Dynamic modelling of prosthetic chorded mitral valves using the immersed boundary method

Current artificial heart valves either have limited lifespan or require the recipient to be on permanent anticoagulation therapy. In this paper, effort is made to assess a newly developed bileaflet valve prosthesis made of synthetic flexible leaflet materials, whose geometry and material properties are based on those of the native mitral valve, with a view to providing superior options for mitral valve replacement. Computational analysis is employed to evaluate the geometric and material design of the valve, by investigation of its mechanical behaviour and unsteady flow characteristics. The immersed boundary (IB) method is used for the dynamic modelling of the large deformation of the valve leaflets and the fluid-structure interactions. The IB simulation is first validated for the aortic prosthesis subjected to a hydrostatic loading. The predicted displacement fields by IB are compared with those obtained using ANSYS, as well as with experimental measurements. Good quantitative agreement is obtained. Moreover, known failure regions of aortic prostheses are identified. The dynamic behaviour of the valve designs is then simulated under four physiological pulsatile flows. Experimental pressure gradients for opening and closure of the valves are in good agreement with IB predictions for all flow rates for both aortic and mitral designs. Importantly, the simulations predicted improved physiological haemodynamics for the novel mitral design. Limitation of the current IB model is also discussed. We conclude that the IB model can be developed to be an extremely effective dynamic simulation tool to aid prosthesis design.     

Comparison of the hemodynamic and thrombogenic performance of two bileaflet mechanical heart valves using a CFD/FSI model

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.     

Numerical simulation of cardiovascular dynamics with healthy and diseased heart valves

This paper presents a new concentrated parameter model for cardiovascular dynamics that includes an innovative model of heart valve dynamics, which is embedded in the overall model of the four chambers of the heart and the systemic and pulmonary circulation loops. The heart chambers are described with a variable elastance model, and the systemic and pulmonary loops are described with modified Windkessel models. In modelling the heart valve dynamics, the various factors that influence the valve motion are examined, and the governing differential equation for valve motion is derived. The heart valve model includes the influence of the blood pressure effect, the friction effect from the tissue, and from blood motion. As improvement from previous works, the contribution of the blood vortex effect in the vicinity of the valve leaflets to valve motion is specially considered. The proposed model is then used in simulation of healthy and certain pathological conditions such as mitral valve stenosis and aortic regurgitation. The predicted results agree well with results illustrated in cardiology textbooks.     

Mechanical simulator of the cardiovascular system

To devise and to build a mechanical simulator of the cardiovascular system of increasing complexity is a fascinating experience for a medical Physicist. We did it, and the effort to match the solutions with the objectives forced us to deepen the knowledge of the physiological aspects, to devise different solutions and to compare their results. This paper describes the final solution and shows the results, discussing the theoretical and practical aspects of the different choices.The ventricle is simulated by a pumping syringe with an external pulsing chamber to accomplish the Frank–Starling mechanism; the coronary circulation by a nonlinear hydraulic resistance device; the aorta by different wall thickness rubber tubes; the arterial vascular resistance by a thin, variable length tube; the venous reservoir by a variable volume chamber connected to a reservoir simulating the atrium.The simulator was mainly devoted to teaching purposes, but the possibility to modify the mechanical characteristics of the single components moved it to be used also for research, with an unexpected satisfaction.     

Velocity profiles in stenosed tube models using magnetic resonance imaging

A time-of-flight MRI velocity measurement technique is evaluated against corresponding LDV measurements in a constriction tube model over a range of physiologic flow conditions. Results from this study show that MR displacement images can: 1) be obtained within both laminar and turbulent jets (maximum stenotic Re approximately equal to 4,200), 2) measure mean jet velocities up to 172 cm/s, and, 3) detect low forward and reverse stenosis (0 less than or equal to L/D less than or equal to 2). Regions between the jet termination point and re-establishment of laminar flow (Re greater than or equal to 1500, greater than or equal to 1000, and greater than or equal to 110 downstream of 40, 60, and 80 percent stenosis, respectively) cannot presently be detected by this technique.     

A new integrated method for analyzing heart mechanics using a cell-hemodynamics-autonomic nerve control coupled model of the cardiovascular system

A model of the cardiovascular system coupling cell, hemodynamics, and autonomic nerve control function is proposed for analyzing heart mechanics. We developed a comprehensive cardiovascular model with multi-physics and multi-scale characteristics that simulates the physiological events from membrane excitation of a cardiac cell to contraction of the human heart and systemic blood circulation and ultimately to autonomic nerve control. A lumped parameter model is used to compute the systemic and pulmonary circulations interacting with the cardiac cell mechanism. For autonomic control of the cardiovascular system, we used the approach suggested by Heldt et al. [2002. Computational modeling of cardiovascular response to orthostatic stress. J. Appl. Physiol. 92, 1239–1254] (Heldt model), including baroreflex and cardiopulmonary reflexes. We assumed sympathetic and parasympathetic pathways for the nerve control system. The cardiac muscle response to these reflex control systems was implemented using the activation-level changes in the L-type calcium channel and sarcoplasmic/endoplasmic reticulum calcium ATPase function based on experimental observations. Using this model, we delineated the cellular mechanism of heart contractility mediated by nerve control function. To verify the integrated method, we simulated a 10% hemorrhage, which involves cardiac cell mechanics, circulatory hemodynamics, and nerve control function. The computed and experimental results were compared. Using this methodology, the state of cardiac contractility, influenced by diverse properties such as the afterload and nerve control systems, is easily assessed in an integrated manner.     

Detection of infectious agents in heart valves during endocarditis using PCR technique

Infectious endocarditis can be caused by various microorganisms. Diagnostics of local infection by microbiological methods is not always effective. For that reason we performed a study aimed for direct detection of potential infectious agents by polymerase chain reaction in patients' heart valve tissue. DNA of infectious agents was revealed in 72% of heart valve tissue samples from patients with septic endocarditis; in studied samples, along with bacterial DNA, herpesviruses' DNA was detected. Obtained results confirm the presence of infection, which allows to perform specific diagnostics of infectious complications after implantation of prosthetic cardiac valves.     

Validity of an algorithm for determining sleep/wake states using a new actigraph

Background

This study aimed to develop an algorithm for determining sleep/wake states by using chronological data on the amount of physical activity (activity intensity) measured with the FS-750 actigraph, a device that can be worn at the waist, allows for its data to be downloaded at home, and is suitable for use in both sleep research and remote sleep medicine.

Methods

Participants were 34 healthy young adults randomly assigned to two groups, A (n =17) and B (n =17), who underwent an 8-hour polysomnography (PSG) in the laboratory environment. Simultaneous activity data were obtained using the FS-750 attached at the front waist. Sleep/wake state and activity intensity were calculated every 2 minutes (1 epoch). To determine the central epoch of the sleep/wake states (x), a five-variable linear model was developed using the activity intensity of Group A for five epochs (x_-2, x_-1, x, x₊₁, x₊₂; 10 minutes). The optimal coefficients were calculated using discriminant analysis. The agreement rate of the developed algorithm was then retested with Group B, and its validity was examined.

Results

The overall agreement rates for group A and group B calculated using the sleep/wake score algorithm developed were 84.7% and 85.4%, respectively. Mean sensitivity (agreement rate for sleep state) was 88.3% and 90.0% and mean specificity (agreement rate for wakeful state) was 66.0% and 64.9%, respectively. These results confirmed comparable agreement rates between the two groups. Furthermore, when applying an estimation rule developed for the sleep parameters measured by the FS-750, no differences were found in the average values between the calculated scores and PSG results, and we also observed a correlation between the two sets of results. Thus, the validity of these evaluation indices based on measurements from the FS-750 is confirmed.

Conclusions

The developed algorithm could determine sleep/wake states from activity intensity data obtained with the FS-750 with sensitivity and specificity equivalent to that determined with conventional actigraphs. The FS-750, which is smaller, less expensive, and able to take measurements over longer periods than conventional devices, is a promising tool for advancing sleep studies at home and in remote sleep medicine.     

A new method for evaluation of cavitation near mechanical heart valves

Evaluation of cavitation in vivo is often based on recordings of high-pass filtered random high-frequency pressure fluctuations. We hypothesized that cavitation signal components are more appropriately assessed by a new method for extraction of random signal components of the pressure signals. We investigated three different valve types and found a high correlation between the two methods (r2: 0.8806-0.9887). The new method showed that the cavitation signal could be extracted without a priori knowledge needed for setting the high-pass filter cut off frequency, nor did it introduce bandwidth limitation of the cavitation signal.     

Physiologically-based testing system for the mechanical characterization of prosthetic vein valves

Due to the relatively limited amount of work done to date on developing prosthetic vein (as opposed to cardiac) valves, advances in this topic require progress in three distinct areas: 1) improved device design, 2) relevant device testing conditions, and, 3) appropriate parameters for evaluation of results. It is the purpose of this paper to address two of these issues (#2 and #3) by: 1) performing a study of normal volunteers to quantify the anatomy and hemodynamic features of healthy venous valves, 2) construction of a 2-step, in vitro testing procedure, which simulates both physiologic and postural conditions seen in the lower extremity venous system, and, 3) defining several modified and new parameters which quantify dynamic valve characteristics.