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PubMed2003

Extracellular matrix degrading enzymes are active in porcine stentless aortic bioprosthetic heart valves.

Glutaraldehyde-fixed porcine aortic valve tissues are widely used for heart valve replacement surgery in the form of bioprosthetic heart valves (BHVs). The durability of BHVs in the clinical setting is limited by tissue degeneration, mechanical failure, and calcification. BHVs rely on the putative ability of glutaraldehyde to render biologic tissues metabolically inert and fully resistant to enzymatic attack. In the present study, we detected and partially characterized the activity of collagen and elastin-degrading enzymes in unimplanted, glutaraldehyde-fixed porcine aortic cusp and wall tissues and compared enzyme activities with those extracted from fresh tissues. Active enzymes capable of degrading extracellular matrix were found to be present in soluble form as well as immobilized on glutaraldehyde-crosslinked tissue matrix. Total levels of collagenolytic activities were evaluated to approximately 0.25 microg of degraded collagen/mg of dry tissue/24 h for both glutaraldehyde-fixed wall and cusp tissues. A major finding of this study was the ability of soluble tissue enzymes to partially degrade glutaraldehyde-fixed collagen and particularly large amounts of glutaraldehyde-fixed elastin. These calcium-dependent gelatinases share many biochemical similarities with matrix metalloproteinases. These data strongly indicate that glutaraldehyde-fixed porcine valvular tissues are not metabolically inert and are not entirely resistant to enzymatic attack, thereby rendering BHVs vulnerable to biologic degeneration and subsequent chronic failure.

Animals↗
PubMed1999

Founder's Award, 25th Annual Meeting of the Society for Biomaterials, perspectives. Providence, RI, April 28-May 2, 1999. Tissue heart valves: current challenges and future research perspectives.

Substitute heart valves composed of human or animal tissues have been used since the early 1960s, when aortic valves obtained fresh from human cadavers were transplanted to other individuals as allografts. Today, tissue valves are used in 40% or more of valve replacements worldwide, predominantly as stented porcine aortic valves (PAV) and bovine pericardial valves (BPV) preserved by glutaraldehyde (GLUT) (collectively termed bioprostheses). The principal disadvantage of tissue valves is progressive calcific and noncalcific deterioration, limiting durability. Native heart valves (typified by the aortic valve) are cellular and layered, with regional specializations of the extracellular matrix (ECM). These elements facilitate marked repetitive changes in shape and dimension throughout the cardiac cycle, effective stress transfer to the adjacent aortic wall, and ongoing repair of injury incurred during normal function. Although GLUT bioprostheses mimic natural aortic valve structure (a) their cells are nonviable and thereby incapable of normal turnover or remodeling ECM proteins; (b) their cuspal microstructure is locked into a configuration which is at best characteristic of one phase of the cardiac cycle (usually diastole); and (c) their mechanical properties are markedly different from those of natural aortic valve cusps. Consequently, tissue valves suffer a high rate of progressive and age-dependent structural valve deterioration resulting in stenosis or regurgitation (>50% of PAV overall fail within 10-15 years; the failure rate is nearly 100% in 5 years in those <35 years old but only 10% in 10 years in those >65). Two distinct processes-intrinsic calcification and noncalcific degradation of the ECM-account for structural valve deterioration. Calcification is a direct consequence of the inability of the nonviable cells of the GLUT-preserved tissue to maintain normally low intracellular calcium. Consequently, nucleation of calcium-phosphate crystals occurs at the phospholipid-rich membranes and their remnants. Collagen and elastin also calcify. Tissue valve mineralization has complex host, implant, and mechanical determinants. Noncalcific degradation in the absence of physiological repair mechanisms of the valvular structural matrix is increasingly being appreciated as a critical yet independent mechanism of valve deterioration. These degradation mechanisms are largely rationalized on the basis of the changes to natural valves when they are fabricated into a tissue valve (mentioned above), and the subsequent interactions with the physiologic environment that are induced following implantation. The "Holy Grail" is a nonobstructive, nonthrombogenic tissue valve which will last the lifetime of the patient (and potentially grow in maturing recipients). There is considerable activity in basic research, industrial development, and clinical investigation to improve tissue valves. Particularly exciting in concept, yet early in practice is tissue engineering, a technique in which an anatomically appropriate construct containing cells seeded on a resorbable scaffold is fabricated in vitro, then implanted. Remodeling in vivo, stimulated and guided by appropriate biological signals incorporated into the construct, is intended to recapitulate normal functional architecture.

Animals↗
PubMed2002

Construction of autologous human heart valves based on an acellular allograft matrix.

OBJECTIVE: Tissue engineered heart valves based on polymeric or xenogeneic matrices have several disadvantages, such as instability of biodegradable polymeric scaffolds, unknown transfer of animal related infectious diseases, and xenogeneic rejection patterns. To overcome these limitations we developed tissue engineered heart valves based on human matrices reseeded with autologous cells. METHODS AND RESULTS: Aortic (n=5) and pulmonary (n=6) human allografts were harvested from cadavers (6.2+/-3.1 hours after death) under sterile conditions. Homografts stored in Earle's Medium 199 enriched with 100 IU/mL Penicillin-Streptomycin for 2 to 28 days (mean 7.3+/-10.2 days) showed partially preserved cellular viability (MTT assay) and morphological integrity of the extracellular matrix (H-E staining). For decellularization, valves were treated with Trypsin/EDTA resulting in cell-free scaffolds (DNA-assay) with preserved extracellular matrix (confocal microscopy). Primary human venous endothelial cells (HEC) were cultivated and labeled with carboxy-fluorescein diacetate-succinimidyl ester in vitro. After recellularization under fluid conditions, EC were detected on the luminal surfaces of the matrix. They appeared as a monolayer of positively labeled cells for PECAM-1, VE-cadherin and Flk-1. Reseeded EC on the acellular allograft scaffold exhibited high metabolic activity (MTT assay). CONCLUSIONS: Earle's Medium 199 enriched with low concentration of antibiotics represents an excellent medium for long time preservation of extracellular matrix. After complete acellularization with Trypsin/EDTA, recellularization under shear stress conditions of the allogeneic scaffold results in the formation of a viable confluent HEC monolayer. These results represent a promising step toward the construction of autologous heart valves based on acellular human allograft matrix.

Aortic Valve↗
PubMed1975

Pathogenesis of fungal infection on heart valve prosthesis.

Four patients with heart valve prostheses developed Candidate endocarditis. At autopsy the foci of infection were confined to patches of neoendocardium that appeared to have developed as ingrowths of host endocardium onto the sewing cloth of the artificial valve. This suggested that one mechanism of fungal infection is related to the presence of the neoendocardium rather than to the cloth or metallic substances of the valve itself. Future studies might be directed toward inhibiting the development of the neoendocardium or to agents preventing its susceptibility to infection.

Adult↗
PubMedDate not supplied

Real-time in vitro observation of cavitation in a prosthetic heart valve.

A technique for real-time in vitro observation of cavitation on a prosthetic heart valve operating in a ventricular assist device under normal physiologic conditions has been developed. Considering the documented observation of cavitation erosion in heart valve components from human explants, and the potential risk of blood damage that cavitation presents, the technique developed in this study may prove useful in the design of prosthetic heart valves and ventricular assist devices. Cavitation of a glycerol blood analog fluid has been documented for a Medtronic/Hall prosthetic heart valve operating in a Penn State Electric Ventricular Assist Device. The ventricular assist device was operated in a mock circulatory system under normal physiologic conditions. The valve was located in the mitral position, with the cavitation occurring on the inlet side after valve closure. Bubble cavitation was seen on the valve occluder face, and vortex cavitation was observed at two locations in the vicinity of the valve occluder and housing. The cavity growth and collapse cycle for these forms of vaporous cavitation was less than 1 msec. Stroboscopic photography and stroboscopic videography with frame grabbing were used to document the cavity life cycle. With beat rate held constant, the cavity duration time was found to decrease with increasing mean venous return pressure.

Heart Valve Prosthesis↗
PubMed2004

Sculpting heart valves with NFATc and VEGF.

Heart valves are of vital importance for our moment-to-moment existence, but how they form remains a mystery. In this issue of Cell, Chang et al. reveal a novel role for calcineurin, NFATs, and VEGF in valve formation. Dynamic changes in NFAT/VEGF expression in regional myocardial and endocardial fields and developmental windows orchestrate this complex process.

Animals↗
PubMed1976

Exercise tests before and after heart valve replacement.

A simple progressive exercise test was performed before and after operation on five subjects undergoing mitral valve replacement and on five subjects undergoing aortic valve replacement. The responses of heart rate and ventilation were related to work rate )kilopond metres/min). The patients were also assessed clinically by the New York Heart Association grading and radiologically before each exercise test. The clinical grading was shown to be a poor guide to observed exercise tolerance, as the improvement noted in symptoms was not matched by the objective measurement of working capacity. Only two patients had normal exercise tolerance after surgery, although six of the ten patients claimed that they had no exertional dyspnoea after operation. The changes in simple ventilatory function tests before and after operation were generally small. We suggest that measurements of exercise tolerance before and after operation should be an essential part of heart valve replacement surgery.

Adult↗
PubMed1990

[The patient following heart valve replacement].

Results of heart-valve-surgery based on a large group of patients of the University-hospitals in Vienna are given. Problems such as anticoagulant therapy and the prevention of prosthesis-endocarditis are shown.

Anticoagulants↗
PubMed2006

Human mesenchymal stem cells induce T cell anergy and downregulate T cell allo-responses via the TH2 pathway: relevance to tissue engineering human heart valves.

To generate an ''off the shelf'' tissue-engineered heart valve, the cells would need to be of allogeneic origin. Here, we report the possibility of using human bone marrow-derived mesenchymal stem cells (MSCs) as a suitable allogeneic cell source for tissue-engineered heart valves. Proliferative responses of primary and primed CD4+ T cells to allogeneic MSCs were examined. A protein microarray system was used to detect soluble factors from supernatants collected from the T cell assays. MSCs are poor stimulators of primary and primed CD4+ T cell proliferation, despite provision of B7-1 trans-co-stimulation. MSCs not only directly inhibited primary and primed T cell responses to allogeneic peripheral blood mononuclear cells (PBMCs), but 24-h pre-culture of T cells with MSCs suppressed subsequent T cell proliferative responses to allogeneic PBMCs in a contact-dependent manner. Analysis of supernatants revealed a distinctly different cytokine profile after co-culture of T cells with MSCs than with PBMCs or endothelial cells. Pro-inflammatory Th1 cytokines interleukin (IL)-1alpha and beta, interferon (IFN)gamma, and tumor necrosis factor (TNF)alpha were downregulated, whereas, anti-inflammatory Th2 cytokines IL-3, IL-5, IL-10, and IL-13 and the Th2 chemokine I-309, a chemoattractant for regulatory T cells, were upregulated. Further analysis revealed that after co-culture with MSCs, the T cells exhibited a regulatory phenotype (CD4+ CD25(lo) CD69(lo) FoxP3+). MSCs downregulate T cell responses through direct contact and secretion of anti-inflammatory and tolerogenic cytokines, which may involve the recruitment of regulatory T cells. This implies that allogeneic MSCs could be a suitable cell source for tissue engineering a heart valve.

Cells, Cultured↗
PubMed1988

Creatine and membrane sialic acid contents of erythrocytes in patients with heart valve prostheses.

The red cell damage induced by heart valve prostheses was investigated in 2 groups of patients with different heart valve replacements (mechanical or biological devices) by the determination of the creatine and membrane sialic acid contents in the erythrocytes. Red cell creatine did not increase, whereas sialic acid was lowered in both groups of patients, when compared with healthy controls. These findings were briefly discussed.

Creatine↗
PubMedDate not supplied

The Edwards MIRA heart valve prosthesis: a 2-year study.

BACKGROUND: The Edwards MIRA mechanical heart valve is designed to optimize hemodynamics, reduce thrombogenicity, and avoid mechanical failure with a special hinge mechanism. The purpose of the study was to investigate the clinical performance and postoperative hemodynamic results of the first European patients receiving Edwards MIRA mechanical heart valves. METHODS: From March 1998 to March 1999 a total of 54 Edwards MIRA valves model numbers 3600 (aortic, n = 44) and 9600 (mitral, n = 10) were implanted in 52 (36 male, 16 female; mean age 61 +/- 10.1 years) consecutive patients undergoing mechanical valve replacement in a prospective study. Follow-up of the patients including physical examination, ECG, blood tests, and Doppler were performed prior to discharge, at 6 months, at 1 year, and at least 2 years postoperatively. RESULTS: Through October 2001 a total of 172 follow-up examinations were completed (51 patients at discharge, 46 patients at 6 months, 43 patients at 12 months, 32 patients at 2 years or beyond). All patients were in NYHA class I and II at the 6-month and 2+-year follow-up. All the patients stated an improved quality of life. Hospital mortality was 1.9%. There were no complications related to anticoagulation. Mean international normalized ratio at 6 months was 3.2 (range 1.9 to 4.3); lactate dehydrogenase was slightly increased with 264 +/- 103 U/L on average (normal value 80 to 240 U/L). No signs of valvular dysfunction or paravalvular leakage were observed. Mean pressure gradients were related to valve diameter: after mitral valve replacement (size 27, 29, 31 mm: 4.8, 3.2, 2.1 mmHg); after aortic valve replacement (size 19, 21, 23, 25 mm: 12.1, 13.1, 9.3, 8.2 mmHg). CONCLUSIONS: These preliminary data suggest good hemodynamic function and a low rate of valve-related complications of the Edwards-MIRA mechanical prosthesis.

Adult↗
PubMed1994

Prophylactic reoperation for strut fractures of the Björk-Shiley convexo-concave heart valve.

Outlet strut fracture of the Björk-Shiley Convexo-Concave (C/C) heart valve is the current paradigm of structural failure of mechanical heart valve prostheses. The estimated risk of fracture for C/C valves varies from 0.02% to 2.5% per patient-year, depending on valve size, opening angle, date of manufacture and position as a mitral or aortic replacement. This report examines our experience with 396 implants, comprising 346 C/C 60 degrees valves and 50 C/C 70 degrees valves. The 30-day mortality was 1.8%. Through April 1993, mean follow up was 8.9 years, incorporating 2971 patient-years and knowledge of the current status of 91.5% (356/389) of operative survivors. Late mortality was 3.7% per patient-year, including one 60 degrees and one 70 degrees outlet strut fracture. To evaluate the risk of semi-elective valve re-replacement at our institution, we reviewed the results of isolated re-replacements of failing or incipiently failing bioprostheses in 65 patients who had no serious co-morbidity and who were NYHA Class III or lower immediately before the procedure. The 30-day mortality was 4.6% and the overall serious morbidity rate was 10.8%, necessitating six repeat reoperations. When these factors were balanced against the life expectancy and general status of five patients with large-size, higher-fracture-risk 70 degrees C/C valves, it was concluded that only two patients remained possible reoperation candidates. Consideration for re-replacement of a normally functioning C/C heart valve should take into account institution-specific experience because structural failure remains a low risk compared to valve-related complications engendered by reoperation.

Adult↗
PubMed2001

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.

Biomechanical Phenomena↗
PubMed1993

Cineradiography for determination of normal and abnormal function in mechanical heart valves.

To determine the diagnostic value of cineradiography of mechanical heart valves, 112 cinefluoroscopic studies were performed in 76 patients with 95 valve prostheses (caged ball or disk valves, tilting disk and bileaflet valves). A patient group (n = 45) presenting with clinical or echocardiographic findings suggestive of valve-related complications was compared with a control group (n = 31) without such symptoms. Disk-opening angles (mean +/- SD) for Medtronic Hall aortic valves were found to be significantly smaller (62.8 +/- 11.1 degrees) in patients than in control subjects (73.9 +/- 1.6 degrees; p < 0.05). Tissue ingrowth or thrombus formation, or both, demonstrated in 3 patients on subsequent reoperation, are considered as the main cause of incomplete or asymmetric disk opening. Opening and closing times did not differ significantly between patients and control subjects. Besides abnormal valve motion, structural defects such as strut fracture or leaflet escape could be rapidly detected by cineradiography if x-ray projections according to the particular valve design were used. Together with quantitative Doppler echocardiographic and clinical data, this method can help to give specific answers if the question is to either confirm or exclude imminent or acute valve malfunction. Thus, modern cineradiography is a highly valuable noninvasive diagnostic tool for both rapid management of emergency cases and routine follow-up of patients with mechanical heart valves.

Aortic Valve↗
PubMed1989

Pregnant women with prosthetic heart valves.

Pregnant women with prosthetic heart valves present the same myriad of problems and challenges inherent in other patients with severe cardiac disease. Care for these patients should involve counseling to determine the advisability of attempting or continuing pregnancy. Combined team care with several specialists is necessary for the optimal management of these patients. Family planning is very important for these patients.

Anticoagulants↗
PubMedDate not supplied

[Functional characteristics of flexible supporting structures for heart valve bioprosthesis].

Hydraulic characteristics of heart valve bioprostheses mounted on supporting structures of various rigidity have been studied under physiologic conditions. An actual mobility of the supporting structures made of different polymers is determined. Static and dynamic components of the support displacements have been shown to develop as the bioprosthesis is under the load, the dynamic component being strongly dependent upon the rigidity of fastening the bioprosthesis on the axis. It is noted that considerable improvements in hydraulic characteristics of bioprostheses are achieved through the use of flexible supporting structures.

Biomechanical Phenomena↗
PubMed1990

[The determination of trace amounts of protein in solutions containing surface-active substances].

A rapid and sensitive method for protein determination (0.5-16 micrograms) in samples of any volume containing various surfactants in concentration up to 1% is suggested. The method includes the protein acid denaturation, the solution of acid insoluble precipitate of detergent in ethanol (25-30%), the protein determination on nitrocellulose filter, dyeing by aminoblack 10 B, elution of dyed complex and colorimetric determination at 630 nm.

Amido Black↗