A three-dimensional mechanical analysis of a stentless fibre-reinforced aortic valve prosthesis

Failure of bioprosthetic and synthetic three-leaflet valves has been shown to occur as a consequence of high tensile and bending stresses, acting on the leaflets during opening and closing. Moreover, in the stented prostheses, whether synthetic or biological, the absence of contraction of the aortic base, due to the rigid stent, causes the leaflets to be subjected to an unphysiological degree of flexure, which is related to calcification. It is shown that the absence of the stent, which gives a flexible aortic base and leaflet attachment, and leaflet fibre-reinforcement result in reduced stresses in the weaker parts of the leaflets in their closed configuration. It is postulated that this leads to a decrease of tears and perforations, which may result in a improved long-term behaviour. The effect of a flexible leaflet attachment and aortic base of a synthetic valve is investigated with a finite element model. Different fibre-reinforced structures are analysed with respect to the stresses that are likely to contribute to the failure of fibre-reinforced prostheses and compared with the results obtained for a stented prosthesis. Results show that for the stentless models a reduction of stresses up to 75% is obtained with respect to stented models with the same type of reinforcement.     

A mechanical analysis of the closed Hancock heart valve prosthesis

In order to obtain mechanical specifications for the design of an artificial leaflet valve prosthesis, a geometrically non-linear numerical model is developed of a closed Hancock leaflet valve prosthesis. In this model, the fibre reinforcement of the leaflet and the viscoelastic properties of frame and leaflets are incorporated. The calculations are primarily restricted to 1/6 part of the valve and a time varying pressure load is applied. The calculations are verified experimentally by measuring the commissure displacements and leaflet centre displacement of a Hancock valve. The numerically obtained commissure displacements are found to be linearly dependent on the pressure load, and the slope of the curves is hardly dependent on loading type and loading velocity. Experimentally a difference is found between the three commissure displacements, which is also predicted numerically using a simplified asymmetric total valve model. Besides, experimentally a clear dependency of commissure displacements on frame size is found. For the leaflet centre displacement, a qualitative agreement exists between numerical prediction and experimental result, although the numerical predicted values are systematically higher. The numerically obtained stress distributions revealed that the maximum von Mises intensity in the membranes occurs in the vicinity of the commissure in the free leaflet area (0.2 N mm-2). Wrinkling of the membranes may occur in the coaptation area near the leaflet suspension. The maximum fibre stress is found near the aortic ring in the fibres which form the boundaries of the coaptation area (0.64 N mm-2). These locations seem to correlate with some common regions of tissue valve failure.     

Modeling the mechanics of tissue-engineered human heart valve leaflets

Mathematical models can provide valuable information to assess and evaluate the mechanical behavior of tissue-engineered constructs. In this study, a structurally based model is applied to describe and analyze the mechanics of tissue-engineered human heart valve leaflets. The results from two orthogonal uniaxial tensile tests are used to determine the model parameters of the constructs after two, three and four weeks of culturing. Subsequently, finite element analyses are performed to simulate the mechanical response of the engineered leaflets to a pressure load. The stresses in the leaflets induced by the pressure load increase monotonically with culture time due to a decrease in the construct's thickness. The strains, on the other hand, eventually decrease as a result of an increase in the elastic modulus. Compared to native porcine leaflets, the mechanical response of the engineered tissues after four weeks of culturing is more linear, stiffer and less anisotropic.     

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.     

Micromechanics of the fibrosa and the ventricularis in aortic valve leaflets.

The elastic response of aortic valve cusps is a summation of its fibrous components. To investigate the micromechanical function of valve leaflet constituents, we separated the fibrosa and the ventricularis from fresh and glutaraldehyde-fixed leaflets and tested them individually. The ventricularis was stiffer circumferentially than radially (7.41 kPa vs 3.68 kPa, p less than 0.00001) and was more extensible radially (62.7% vs 21.8% strain to high modulus phase, p less than 0.00001). The fibrosa was also stiffer circumferentially than radially (13.02 kPa vs 4.65 kPa, p less than 0.0008), but had uniform extensibility. Glutaraldehyde fixation did not affect the circumferential elastic modulus of the fibrosa, but reduced its radial modulus from 4.65 kPa to 2.32 kPa (p less than 0.0078). The elastic modulus of the ventricularis remained unchanged. Fixation also reduced the extensibility of the ventricularis circumferentially (from 21.8% to 15.2% strain, p less than 0.018), but not radially, and increased the radial extensibility of the fibrosa from 27.7% to 46.1% (p less than 0.0048). These data show that while the ventricularis contains a large amount of elastin, the amount of radially oriented collagen is similar to that of the fibrosa. The fibrosa, by itself, has the same extensibility in both directions (about 23% strain), but can extend much more radially when connected to the rest of the leaflet because it is attached to the ventricularis in a highly folded configuration. The two layers therefore complement each other during aortic valve function, and become detrimentally altered by fixation in glutaraldehyde.     

Motion of both mitral valve leaflets: a cineroentgenographic study in intact dogs.

Motion and position of both mitral leaflets were studied in five normal dogs 1-11 wk after radiopaque markers were sutured on the valve cusps and on the mitral annulus. Cinefluorograms and cineangiograms (100-120 frames/s) of left atrium and left ventricle were used to study cusp motion and intraventricular flow patterns, and to detect mitral regurgitation during sinus rhythm (42-184 beats/min) and during isolated atrial or ventricular contractions. Time-motion of both leaflets was similar throughout diastole with the exception of delayed posterior cusp opening. Peak opening and closing speeds, opening and closing times, and time of complete closure, measured from the Q wave of the ECG, were not significantly affected by the variations in heart rate. Diastolic leaflet closure began immediately after opening, while the ventricular cavity was small, and was caused by flow eddies behind the cusps. Isolated ventricular contractions closed the valve leaflets completely and symmetric valve closure was ensured by the different rates of leaflet edge approximation. In contrast, atrial closure was slow, partial, and of very short duration.     

Development of a twin-flap,porous ceramic mitral valve prosthesis

The pressure drop in most existing cardiac valve prostheses is at least ten times greater than for healthy valves. Steady flow testing indicates that the causes are (i) poor orifice diameter/sewing ring diameter ratio; (ii) occluding mechanism causes obstruction in the region of highest blood velocity. A new mitral prosthesis was constructed to overcome these deficiencies. The significant features are (a) tubular construction to maximize flow area; (b) twin flaps with hinges well above the outlet to minimize obstruction; (c) divergent nozzle to aid pressure recovery. Prostheses were manufactured from porous alumina, promoting firmly anchored, thin tissue growth to reduce haemolysis and thromboembolism. Preliminary trials in mini-pigs show good valve function. The ceramic behaves especially well. Future models will use ceramic flaps to replace the delrin flaps used at present, which encourage fibrin deposits.     

Comparative study of the amount of backflow produced by four types of aortic valve prostheses

To determine the extent of backflow encountered with currently used prosthetic valves, four types of aortic valves with comparable orifice diameters were tested in a pulse duplicating system. These were a Hancock porcine valve, a Lillehei-Kaster pivoting disk valve, a St. Jude bileaflet valve and a Bj?rk-Shiley tilting disk valve. Mean aortic pressure was sequentially increased from 83 to 147 mmHg, keeping the pump rate essentially constant (69-73 strokes/min). The porcine valve produced the least amount of total backflow (backflow due to closure plus leakage backflow) (1.6 to 2.4 mL/stroke). Among the mechanical valves the Bj?rk-Shiley valve showed the least amount of total backflow (5.0 to 6.0 mL/stroke). At a mean aortic pressure of 100 mmHg and a low cardiac output of 2 L/min, the total backflow with the porcine valve was only 6 percent of forward flow; whereas it was 19 percent with the Lillehei-Kaster valve, 22 percent with the St. Jude valve and 18 percent with the Bj?rk-Shiley valve. Leakage backflow at a given level of mean aortic pressure was, as expected, directly related to the annular clearance area. It is concluded that the Hancock valve showed the least amount of backward flow, which would be particularly beneficial in low output states. In the presence of normal hemodynamics, the amount of backflow with the three mechanical valves appeared to be well below the level of backflow considered to be clinically significant.     

Function of the left cardiac ventricle in "pure" aortic insufficiency prior to and following valve replacement with a biological prosthesis

Contractibility of the left ventricle was investigated in 15 patients with chronic aortic insufficiency with class II and III NYHA lesions. The patients were examined prior to and 6 months-2 years after valve replacement with biological prosthesis. The following parameters have been determined: end-systolic and end-diastolic left ventricular volumes, ejection fraction, mean rate of circular muscle fibers shortening, and segmental contractibility of the left ventricle. Valve replacement with biological prosthesis improved contract ability of the left ventricle in the great majority of the operated patients with chronic aortic insufficiency. Assessed parameters did not correlate well with those obtained following valve replacement.     

Stress–strain behavior of mitral valve leaflets in the beating ovine heart

Excised anterior mitral leaflets exhibit anisotropic, non-linear material behavior with pre-transitional stiffness ranging from 0.06 to 0.09 N/mm² and post-transitional stiffness from 2 to 9 N/mm². We used inverse finite element (FE) analysis to test, for the first time, whether the anterior mitral leaflet (AML), in vivo, exhibits similar non-linear behavior during isovolumic relaxation (IVR). Miniature radiopaque markers were sewn to the mitral annulus, AML, and papillary muscles in 8 sheep. Four-dimensional marker coordinates were obtained using biplane videofluoroscopic imaging during three consecutive cardiac cycles. A FE model of the AML was developed using marker coordinates at the end of isovolumic relaxation (when pressure difference across the valve is approximately zero), as the reference state. AML displacements were simulated during IVR using measured left ventricular and atrial pressures. AML elastic moduli in the radial and circumferential directions were obtained for each heartbeat by inverse FEA, minimizing the difference between simulated and measured displacements. Stress–strain curves for each beat were obtained from the FE model at incrementally increasing transmitral pressure intervals during IVR. Linear regression of 24 individual stress–strain curves (8 hearts, 3 beats each) yielded a mean (±SD) linear correlation coefficient (r²) of 0.994±0.003 for the circumferential direction and 0.995±0.003 for the radial direction. Thus, unlike isolated leaflets, the AML, in vivo, operates linearly over a physiologic range of pressures in the closed mitral valve.     

A numerical simulation of mechanical heart valve closure fluid dynamics

A computational fluid dynamics model for the analysis of the bileaflet mechanical heart valve closure process is presented. The objective of the study is to demonstrate the ability of the numerical model to simulate the leaflet motion during the closing phase in order to investigate the closure fluid dynamics and to evaluate the effect of alterations in the leaflet tip geometry. The model has been applied to six different combinations of the leaflet tip geometry and the gap width between the leaflet tip and the housing. The results show that the negative pressure quickly develops on the atrial side of the leaflet tip. The pressure becomes more negative as the leaflet closure progresses and the lowest pressure is reached before the leaflet comes to a stop in the closed position. The flow dynamics at the instant of valve closure is strongly dependent on the leaflet velocity during the closing phase. Decrease of the tip velocity by a factor of three in the last four degrees of leaflet motion leads to a 50% reduction in the negative pressure magnitude.