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PubMed2004

Functional analysis of bioprosthetic heart valves.

Glutaraldehyde-treated bovine pericardium is used successfully as bioprosthetic material in the manufacturing of heart valves leaflets. The mechanical properties of bovine pericardial aortic valve leaflets seem to influence its mechanical behaviour and the failure mechanisms. In this study the effect of orthotropy on tricuspid bioprosthetic aortic valve was analysed, using a three-dimensional finite element model, during the entire cardiac cycle. Multiaxial tensile tests were also performed to determine the anisotropy of pericardium. Seven different models of the same valve were analysed using different values of mechanical characteristics from one leaflet to another, considering pericardium as an orthotropic material. The results showed that even a small difference between values along the two axes of orthotropy can negatively influence leaflets performance as regard both displacement and stress distribution. Leaflets of bovine pericardium bioprostheses could be manufactured to be similar to natural human heart valves reproducing their well-known anisotropy. In this way it could be possible to improve the manufacturing process, durability and function of pericardial bioprosthetic valves.

Animals↗
PubMed1991

[Doppler echocardiographic determination of the effective orifice area of mechanical heart valve prostheses in a flow model].

In a flow model the effective orifice areas (Ae) of 17 mechanical heart valve prostheses were determined. We measured the Ae-values of several sizes of three types of mechanical prostheses (Medtronic-Hall, St. Jude Medical, and Omnicarbon) under quasi-steady flow conditions using the continuity equation: Ae = flow/maximal transprosthetic velocity. The flow through the model could be determined exactly by directly measuring the decreasing fluid level within the feed tank, while the maximal velocities were calculated from CW-Doppler echocardiographic spectra. It was found that 1) over a range of 200-800 cm3/s Ae was constant for all prostheses and 2) in small aortic prostheses the Ae could be determined with only little scattering of the obtained values, while in large mitral prostheses there was a considerable variation within the results of repeated investigations. For example, in the 21- and 31-Omnicarbon-valves mean values of Ae were calculated as 1.41 and 4.03 cm2, respectively, with standard deviations of 0.05 and 0.49 cm2 as a result of about 70 single calculations in each valve. 3) The absolute values of Ae were smaller than those of comparable in vitro studies based on the Gorlin formula. We conclude that the effective orifice areas of prosthetic heart valves can be easily determined in a flow model by the combination of flow and Doppler echocardiographic measurements. As determinations are based on the same principle, the obtained values should clinically be referred to patients where the corresponding continuity equation for pulsatile flow is used as Ae = stroke volume/time integral of the maximal transvalvular velocity.

Aortic Valve↗
PubMed2003

Numerical simulation of flow in mechanical heart valves: grid resolution and the assumption of flow symmetry.

A numerical method is developed for simulating unsteady, 3-D, laminar flow through a bileaflet mechanical heart valve with the leaflets fixed. The method employs a dual-time-stepping artificial-compressibility approach together with overset (Chimera) grids and is second-order accurate in space and time. Calculations are carried out for the full 3-D valve geometry under steady inflow conditions on meshes with a total number of nodes ranging from 4 x 10(5) to 1.6 x 10(6). The computed results show that downstream of the leaflets the flow is dominated by two pairs of counter-rotating vortices, which originate on either side of the central orifice in the aortic sinus and rotate such that the common flow of each pair is directed away from the aortic wall. These vortices intensify with Reynolds number, and at a Reynolds number of approximately 1200 their complex interaction leads to the onset of unsteady flow and the break of symmetry with respect to both geometric planes of symmetry. Our results show the highly 3-D structure of the flow; question the validity of computationally expedient assumptions of flow symmetry; and demonstrate the need for highly resolved, fully 3-D simulations if computational fluid dynamics is to accurately predict the flow in prosthetic mechanical heart valves.

Blood Flow Velocity↗
PubMed1991

Twelve-year comparison of a Bjork-Shiley mechanical heart valve with porcine bioprostheses.

BACKGROUND: Patients undergoing heart-valve replacement may receive a mechanical prosthesis, necessitating lifelong anticoagulant treatment, or a porcine bioprosthesis, which involves no absolute need for anticoagulants. METHODS: We carried out a randomized, prospective trial to compare the durability of the Bjork-Shiley mechanical prosthesis (spherical tilting-disk model) and the incidence of valve-related complications with those variables in the Hancock and the Carpentier-Edwards porcine prostheses. The mitral valve was replaced in 261 patients, the aortic valve in 211, and both in 61; the survivors have been followed up for a mean of 12 years. RESULTS: We found a trend toward improved actuarial survival after 12 years with the Bjork-Shiley prosthesis, but this trend was not statistically significant (group with Bjork-Shiley valve vs. group with porcine valve [mean +/- SE], 51.5 +/- 3.2 vs. 44.4 +/- 3.2 percent; P = 0.08). There was no significant difference in the actuarial incidence of reoperation after 5 years, but after 12 years significantly more patients with a porcine prosthesis had undergone reoperation (8.5 +/- 2.0 vs. 37.1 +/- 4.1 percent, P less than 0.001). An analysis combining death and reoperation as end points for an actuarial assessment of survival with the original prosthesis intact confirmed that the patients with Bjork-Shiley Shiley prostheses had improved survival (48.6 +/- 3.2 vs. 30.0 +/- 3.0 percent after 12 years, P less than 0.001). Bleeding requiring hospitalization or blood transfusion was significantly more frequent in the patients with Bjork-Shiley prostheses (18.6 +/- 3.2 vs. 7.1 +/- 2.3 percent after 12 years, P less than 0.01). There was no significant difference after 12 years in the actuarial occurrence of embolism (Bjork-Shiley vs. porcine, 21.1 +/- 3.1 vs. 26.4 +/- 3.5 percent) or endocarditis (3.7 +/- 1.4 vs 4.6 +/- 1.6 percent). CONCLUSIONS: Survival with an intact valve is better among patients with the Bjork-Shiley spherical tilting-disk prosthesis than among patients with porcine bioprostheses, but use of the Bjork-Shiley valve carries an attendant increased risk of bleeding associated with the need for anticoagulant treatment.

Actuarial Analysis↗
PubMed2003

Cavitation phenomena in mechanical heart valves: the role of squeeze flow velocity and contact area on cavitation initiation between two impinging rods.

In this study, the closing dynamics of two impinging rods were experimentally analyzed to simulate the cavitation phenomena associated with mechanical heart valve closure. The purpose of this study was to investigate the cavitation phenomena with respect to squeeze flow between two impinging surfaces and the parameter that influences cavitation inception. High-speed flow imaging was employed to visualize and identify regions of cavitation. The images obtained favored squeeze flow as an important mechanism in cavitation inception. A correlation study of the effects of impact velocities, contact areas and squeeze flow velocity on cavitation inception showed that increasing impact velocities results in an increase in the risk of cavitation. It was also shown that for similar impact velocities, regions near the point of impact were found to cavitate later for those with smaller contact areas. It was found that the decrease in contact areas and squeeze flow velocities would delay the onset and reduce the intensity of cavitation. It is also interesting to note that the squeeze flow velocity alone does not provide an indication if cavitation inception will occur. This is corroborated by the wide range of published critical squeeze flow velocity required for cavitation inception. It should be noted that the temporal acceleration of fluid, often neglected in the literature, can also play an important role on cavitation inception for unsteady flow phenomenon. This is especially true in mechanical heart valves, where for the same leaflet closing velocity, valves with a seat stop were observed to cavitate earlier. Based on these results, important inferences may be made to the design of mechanical heart valves with regards to cavitation inception.

Blood Flow Velocity↗
PubMed1995

Low-field magnetic resonance imaging in the evaluation of mechanical and biological heart valve function.

Magnetic resonance imaging (MRI) has been frequently considered unsafe for patients with ferromagnetic implants: risks to be considered include induction of electric current, heating and dislocation of the prosthesis. Previous in vitro and in vivo studies have indicated the possibility of performing MRI examinations on patients with prosthetic heart valves. The aim of our study was to verify the presence of artifacts at the level of the prosthetic heart valve in vivo using a low-field MR unit (0.2 T) and to define the possibility of a functional analysis of the valve in patients with biomedical or mechanical prostheses. We evaluated 14 patients surgically treated for implantation of nine biological and seven mechanical aortic and mitral valves. A low-field MR unit (0.2 T) was employed using cine-MR technique on long- and short-axis view. The images were acquired on planes parallel and perpendicular to the valvular plane. Semiquantitative analysis with double-blind evaluation for definition of the extent of the artifact was performed. Three classes of artifacts were distinguished from minimal to significant. The examinations showed the presence of minimal artifacts in all biological heart valves and moderate artifacts in mechanical valves giving good qualitative data on blood flow near the valve. Analysis of the flow behind the valve showed signs of normal function in 13 prostheses and pathological findings in the remaining three. In these latter cases, MRI was able to define the presence of a pathologic aortic pressure gradient, mitral insufficiency and malpositioning of the mitral valve causing subvalvular turbulence. Nevertheless, we believe that the application of velocity-encoding cine-MR is more promising than semiquantitative analysis of artifacts.

Adult↗
PubMed1987

Production of a factor by cultured human heart valves that is immunologically related to interleukin 1.

Analysis of the conditioned medium from cultured human heart valves showed that these tissues secrete a biologically active factor that induces chondrocytes in cultured cartilage to degrade extracellular matrix proteoglycan. This activity was similar to that described for porcine interleukin-1 (catabolin) and a cytokine secreted by cultured porcine heart valves (cardiac catabolic factor). The biological activity of the material in human valve conditioned medium was unaffected by the presence of low doses of cortisol, but its production by cultured valves was impaired by this steroid or benoxaprofen and abolished by cycloheximide. Addition of the conditioned medium to fibroblast monolayers stimulated the secretion of prostaglandin E and the tissue inhibitor of metalloproteinases (TIMP) but not collagenase. Preincubation of the conditioned medium with antiserum raised to the acidic form of porcine interleukin-1 neutralised the proteoglycan degrading stimulus. The material is biologically similar to other cytokines and antigenically related to porcine interleukin-1.

Animals↗
PubMed1990

A comparative study of the shear stress induced in the leakage backflow produced by four types of heart valve prostheses.

The clinical selection of a prosthetic heart valve requires the consideration of many factors. These include the pressure drop across the prosthesis, the amount of leakage backflow when the valve is closed as well as the associated shear stress within this flow for a particular valve design. Major emphasis has been placed upon the documentation of the pressure drop across prosthetic valves. Consideration of the shear stress induced in the leakage backflow associated with prosthetic valves, however, has received less attention. The purpose of this investigation, therefore, is to determine theoretically the extent of this particular shear stress for four types of currently used mechanical prosthetic cardiac valves. All valves have the same tissue annulus diameter of 27 mm. The leakage backflow is relatively small compared to the main forward flow through the orifice. However, it is important from the haemolysis point of view. The effect of the shear stress on the suspected occurrence of haemolysis is analysed by two theoretical approaches: (a) the laminar flow approach, and (b) the entry flow approach, and then compared with the findings of previous investigators dealing with the critical shear stresses which may damage the red blood cells. It was found that both approaches give practically equal shear stresses under the same pressure differential for all valves investigated. Some haemolysis is expected to occur but it is generally compensated by bone marrow hyperfunction, since that type of shear stress is sustained for only a short duration of time.

Biomechanical Phenomena↗
PubMed2005

Simulated bioprosthetic heart valve deformation under quasi-static loading.

For more than 40 years, the replacement of diseased natural heart valves with prosthetic devices has dramatically extended the quality and length of the lives of millions of patients worldwide. However, bioprosthetic heart valves (BHV) continue to fail due to structural failure resulting from poor tissue durability and faulty design. Clearly, an in-depth understanding of the biomechanical behavior of BHV at both the tissue and functional prosthesis levels is essential to improving BHV design and to reduce rates of failure. In this study, we simulated quasi-static BHV leaflet deformation under 40, 80, and 120 mm Hg quasi-static transvalvular pressures. A Fung-elastic material model was used that incorporated material parameters and axes derived from actual leaflet biaxial tests and measured leaflet collagen fiber structure. Rigorous experimental validation of predicted leaflet strain field was used to validate the model results. An overall maximum discrepancy of 2.36% strain between the finite element (FE) results and experiment measurements was obtained, indicating good agreement between computed and measured major principal strains. Parametric studies utilizing the material parameter set from one leaflet for all three leaflets resulted in substantial variations in leaflet stress and strain distributions. This result suggests that utilization of actual leaflet material properties is essential for accurate BHV FE simulations. The present study also underscores the need for rigorous experimentation and accurate constitutive models in simulating BHV function and design.

Animals↗
PubMed2006

Detecting broken struts of a Björk-Shiley heart valve using ultrasound: a feasibility study.

The Björk-Shiley (BScc) mechanical heart valve has extensively been used in surgery from 1979 to 1986. There is, compared with equivalent valve types, increased occurrence of unexpected mechanical failure of the outlet strut of the valve, with a high incidence of mortality, when it occurs. Many approaches have been attempted to noninvasively determine BScc valve integrity. None of the approaches resulted in adequate assessment, mostly due to a lack of either sensitivity or specificity demonstrated in in vitro and/or in vivo studies. In our study we analyze leg movement of the BScc valves outlet strut during the cardiac cycle with ultrasound. For a broken strut, the movement of both legs will be significantly different, whereas the difference will be negligible for an intact strut. BScc valves were mounted in the mitral position in an in vitro pulse duplicator system. A focused single-element transducer was used to direct ultrasound on a leg of the outlet strut. Correlation-based time delay estimation was used to estimate differences in time of flight of the outlet strut echoes to determine outlet strut leg movement. The movement of an intact valve and a valve with a single-leg fracture with both ends grating against each other (SLF), the most difficult fracture to diagnose, has been studied. The results showed no significant difference in movement between both legs of the outlet strut of the intact BScc valve (amplitude of movement 9.2 microm +/- 0.1 microm). Whereas for the defective valve, the amplitude of movement of the broken leg of the SLF valve was 12 microm +/- 1.6 microm vs. 8.6 microm +/- 0.1 microm for the intact leg. In conclusion, the proposed method has shown to be feasible in vitro and has potentials for in vivo detection of BScc valve outlet strut fracture.

Echocardiography↗
PubMed2002

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

OBJECTIVE: The design of bileaflet mechanical heart valves includes some degree of leakage flow on valve closure for the reverse flow to wash the hinge and pivot region of the valve. It is believed that this reverse flow helps to prevent areas of stasis and inhibit microthrombus formation. However, the magnitude of this retrograde flow may also give rise to unacceptable levels of blood element damage and lead to platelet activation or hemolysis as a result of the increased flow velocities through the hinge region. The purpose of this study was to evaluate the hinge flow dynamics of a 23-mm CarboMedics bileaflet mechanical valve (Sulzer CarboMedics Inc, Austin, Tex) and then to compare the results with those of the St Jude Medical 23-mm Regent (St Jude Medical Inc, Minneapolis, Minn) and Medtronic Parallel (Medtronic, Inc, Minneapolis, Minn) valves studied earlier. This comparison allows new insight into the microflow fields within the hinge region of the CarboMedics bileaflet mechanical valve, which have not been previously assessed during its clinical history. METHODS: Two-dimensional laser Doppler velocimetry was used to measure the velocity and turbulent shear stress fields in the hinge regions. To conduct these measurements, exact dimensional models of the bileaflet hinge regions were cast or machined from transparent plastic materials. The experiment was conducted in a pulsatile flow loop with measurements taken at different levels within the pivot and hinge regions. RESULTS: In the 23-mm CarboMedics valve hinge, the phase-averaged forward velocity obtained at the flat level and levels of 190 microm and 390 microm above flat and 1 mm below flat were 0.54 m/s, 0.77 m/s, 0.3 m/s, and 1.0 m/s, respectively. Corresponding values of the peak phase-averaged leakage velocities were 3.17 m/s, 2.91 m/s, 2.52 m/s, and 0.5 m/s, respectively. Corresponding turbulent shear stresses were 5510 dyne/cm(2), 5640 dyne/cm(2), 4380 dyne/cm(2), and 4810 dyne/cm(2), respectively. CONCLUSIONS: The hinge flow dynamics of the CarboMedics bileaflet design lie somewhere in between those of the St Jude Medical and the Medtronic Parallel valve designs. The fluid dynamics of the investigated valve were found to be similar to those of the St Jude Medical valves, although with slightly higher leakage velocities and turbulent shear stresses. This discrepancy may be a result of the sharper corners associated with the hinge design of the CarboMedics valve. It could also be due to the incremental enlargement of the internal orifice area of the St Jude Medical Regent design.

Adult↗
PubMed1985

In vivo hemodynamics of prosthetic St. Jude Medical and Ionescu-Shiley heart valves analyzed by computer.

Using a method of our own design, we evaluated intraoperatively the function of prosthetic heart valves. The changing hemodynamics induced by a stress test were assessed by simultaneously measuring the mean transvalvular pressure gradient and the stroke volume. The effective orifice area (EOA) of the valves was determined for each stroke by computer analysis, and this value was compared with the actual orifice area. Data were collected from 19 patients undergoing aortic or mitral valve replacement or both with 17 St. Jude Medical and 12 Ionescu-Shiley valves. The mean pressure gradient increased with tachycardia and an increase in mean left atrial pressure in the mitral position, but decreased with a decrease in cardiac output and peak left ventricular pressure in the aortic position. The St. Jude Medical valve had a smaller mean pressure gradient than the Ionescu-Shiley bioprosthesis. For both valves, the EOA increased with valve size. The St. Jude Medical valve had a greater EOA than the Ionescu-Shiley bioprosthesis, regardless of the valve size (p less than 0.005). However, the performance of prosthetic leaflets was better with the Ionescu-Shiley bioprosthesis than with the St. Jude Medical mechanical valve (p less than 0.001). This method involving computer analysis of each cardiac cycle proved to be useful for evaluating prosthetic heart valve function in the presence of changing hemodynamics.

Aortic Valve↗
PubMed1984

Moxalactam penetration into normal heart valve, cardiac vegetations, and myocardium in relation to protein binding and physiological distribution spaces.

Rabbits with catheters implanted in the left ventricle were given a single dose of moxalactam and sacrificed at various times thereafter for measurement of the concentration of this antimicrobial agent in serum, heart muscle, and various heart valves. Penetration into both extravascular sites was rapid; steady state was achieved within 5 min after the dose. Moxalactam showed essentially complete penetration into valve lesions, whereas concentrations in heart muscle were only 20% of those in serum. The physiological distribution of moxalactam in heart muscle was beyond the inulin space, but substantially lower than total body water. This myocardial distribution ratio was not predicted by the serum-free fraction or blood trapped in tissues alone, but was in good agreement with that of extracellular fluid plus blood trapped in tissues. The moxalactam distribution profile was most compatible with that of drugs which are excluded from cells but readily distributed throughout extracellular fluids. This explains its nearly complete penetration into heart valves as well as its incomplete penetration into heart muscle, since the two sites differ in their relative proportions of cells and extracellular fluid spaces.

Animals↗
PubMed1999

Heart valve replacement: a statistical review of 35 years' results.

BACKGROUND AND AIMS OF THE STUDY: Having performed our first heart valve replacement in 1960, we began a prospective lifetime follow up service for all patients, contacting them at least annually to determine survivorship and heart valve complications. METHODS: We reviewed isolated aortic (AVR) and mitral (MVR) valve replacements from 1960 to 1993, with follow up to 1998. In total, 2,942 AVR and 1,579 MVR were performed, with 21,742 and 12,142 patient-years of follow up, respectively. Analysis of the results affords an opportunity to demonstrate the usefulness and necessity of certain statistical methods, including multivariable event-free analyses and cumulative incidence functions. RESULTS: The survival rate was 8% at 30 years for both valve positions. However, an overall survival curve is an artificial composite of patients of increasingly higher risk being served during increasingly safer years of calendar time. One result is that, for AVR, age is not a significant univariate risk factor for operative mortality, but is highly significant after accounting for date of surgery using logistic regression. Long-term mortality is higher for tissue valves than for mechanical valves; but mean age is greater (74 versus 57 years), and after accounting for age using Cox regression, mortality is similar for both valve types. Kaplan-Meier analysis estimates thromboembolism occurrences of 85% for AVR and 95% for MVR at 35 and 34 years, respectively, but the cumulative incidence estimates are only 32% and 41%, respectively. CONCLUSIONS: Prospective follow up for over 35 years has provided an opportunity to illustrate important statistical issues: Multivariate analyses are essential to avoid being misled by excluding important risk factors or including artifactual ones, and the cumulative incidence estimates the percentage of patients who will actually experience a complication.

Adult↗
PubMed1989

Fibrinolytic treatment of acute prosthetic heart valve thrombosis. 5 cases and a review.

Acute thrombotic obstruction of prosthetic heart valves has usually needed an emergency operation and carries a high mortality. Over the past 16 years, sporadic papers have appeared reporting the successful use of fibrinolytic therapy with a low mortality. We report five consecutive cases treated in this way. The diagnosis of valve thrombosis was made on clinical, echocardiographic and cineradiographic grounds. Treatment consisted of streptokinase (SPK) in a loading dose of 250,000 units in one case and 500,000 units in the remaining four cases, followed by 100,000 units hourly. Rapid improvement in clinical state was seen in all five patients. Four patients recovered completely and have been followed up for a minimum of 3 years. One patient died of a retroperitoneal haemorrhage, a recognised complication of fibrinolytic therapy. A review of the literature is presented. Fibrinolytic therapy is recommended in the acute episode and should result in either a return to normal valve function or sufficient improvement in haemodynamics to allow semielective surgery at considerably lower risk.

Adult↗
PubMed1998

[Molecular mechanisms and indicators of thrombogenesis after heart valve replacement].

Complex interactions among constituents of blood, components of the subendothelial extracellular matrix, and artificial surfaces of cardiovascular devices are involved in the thrombogenesis following heart valve replacement. Recently, the molecular basis of some of these interactions has been studied in detail. These insights have extended our understanding of interactive processes between platelet receptors, adhesive macromolecules, and abnormal flow conditions during platelet adhesion and aggregation. On the basis of new experimental data, it is concluded that circulating nonactivated platelets are capable of recognizing surface-bound fibrinogen via their glycoprotein receptor GPIIb-IIIa and become activated as a consequence of this specific interaction. In addition, a molecular mechanism has been proposed indicating that high-shear stress created by prosthetic heart valves can induce platelet aggregation. For this platelet reaction, multimeric von Willebrand factor is essential; its structure function relationship and its interaction with the platelet membrane GPIb receptor have been elucidated. The progress made provides specific targets for selective antithrombotic strategies. Moreover, new molecular activation markers have become available which permit appropriate control of established and experimental antithrombotic regimens. This paper reviews some aspects of recent advances in this area.

Biomarkers↗
PubMed1978

Computer-assisted reporting system for the follow-up of patients with prosthetic heart valves.

The implantation of large numbers of prosthetic heart valves carries with it the responsibility for continual reassessment of all aspects of patient management. Experience with more than 2,000 prosthetic valve operations since 1963 led to the development of a comprehensive computer-assisted data collection, management and reporting system. Over a 5 year period, data forms were developed for the detailed documentation of preoperative, intraoperative and postoperative information. These were designed in the form of checklists suitable for direct computer entry with use of mark-sense document readers. Special emphasis was placed on preoperative assessment of ventricular function, valve selection, intraoperative myocardial preservation, postoperative rehabilitation and prosthetic valve-related complications. This system makes possible rapid computer generation of a variety of reports to the referring physician regarding the individual patient and to the clinical investigator in relation to patient group statistics. Also, questionnaires to patients of physicians, or both, to update patient data can be produced by the computer at appropriate intervals after valve surgery. Experience indicated that a computer-assisted methodology is the only practical way to provide adequate follow-up of large groups of patients. Additionally direct access to relevant information helps to create an environment in which essential research can be carried out in the face of a demanding clinical practice.

Follow-Up Studies↗