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Effects of atrial arrhytmias on the regurgitation of a monoleaflet prosthetic heart valve.

Many patients who receive a prosthetic heart valve also have or acquire cardiac arrhythmias. However, most in vitro studies of prosthetic valves examine them under normal rhythms. In this study, a monoleaflet prosthetic heart valve was tested in vitro under conditions that simulated normal sinus rhythm, first degree atrioventricular heart block, and atrial fibrillation (fixed and variable ventricular rates). Atrial contraction was simulated by an active atrial chamber. The timing between the atrium and ventricle was adjusted to simulate various types of arrhythmias. The closing, leakage, and total regurgitant volumes and fractions increased for each type of atrial arrhythmia when compared to normal sinus rhythm. The peak regurgitant flow increased for first degree atrioventricular heart block and atrial fibrillation with a fixed ventricular rate compared to normal sinus rhythm.

Arrhythmias, Cardiac↗

On the closing sounds of a mechanical heart valve.

In the 1994 Replacement Heart Valve Guidance of the U.S. Food and Drug Administration (FDA), in-vitro testing is required to evaluate the potential for cavitation damage of a mechanical heart valve (MHV). To fulfill this requirement, the stroboscopic high-speed imaging method is commonly used to visualize cavitation bubbles at the instant of valve closure. The procedure is expensive; it is also limited because not every cavitation event is detected, thus leaving the possibility of missing the whole cavitation process. As an alternative, some researchers have suggested an acoustic cavitation-detection method, based on the observation that cavitation noise has a broadband spectrum. In practice, however, it is difficult to differentiate between cavitation noise and the valve closing sound, which may also contain high-frequency components. In the present study, the frequency characteristics of the closing sound in air of a Björk-Shiley Convexo-Concave (BSCC) valve are investigated. The occluder closing speed is used as a control parameter, which is measured via a laser sweeping technique. It is found that for the BSCC valve tested, the distribution of the sound energy over its frequency domain changes at different valve closing speeds, but the cut-off frequency remains unchanged at 123.32 +/- 6.12 kHz. The resonant frequencies of the occluder are also identified from the valve closing sound.

Heart, Artificial↗

Long-term relative survival after primary heart valve replacement.

OBJECTIVE: Determination of the optimal timing of primary heart valve replacement is an important issue. The present paper provides a synopsis over early and late survival after primary heart valve replacement, including an evaluation of the excess mortality among heart valve replacement patients compared with the general population. METHODS: Survival was analyzed in 2365 patients (1568 without and 797 with concomitant coronary artery bypass grafting (CABG)) who underwent their first heart valve replacement. Observed survival was related to that expected among persons from the general Swedish population stratified by age, sex, and 5-year calendar period, to calculate the relative survival and estimate the disease-specific survival. RESULTS: Early mortality (death within 30 days after surgery) was 5.9% after aortic valve replacement, 10.4% after mitral valve replacement and 10.6% after combined aortic and mitral valve replacement. Relative survival rates (excluding early deaths) were 84% 10 years after aortic, 68.5% after mitral and 80.9% after both aortic and mitral valve replacement. A multivariate model based on observed survival rates was produced for each group, using the Cox proportional hazards model. Concomitant CABG, advanced New York Heart Association (NYHA) class, preoperative atrial fibrillation, pure aortic regurgitation and higher age increased the late observed survival after aortic valve replacement. NYHA class was the only factor independently related to observed late deaths after mitral valve replacement, and mitral insufficiency the only corresponding factor after both aortic and mitral valve surgery. CONCLUSION: The use of relative survival rates tended to modify the difference between subgroups compared with observed survival rates. Relative survival rates reduced the effect of concomitant CABG on survival, but enhanced for example the effect of aortic regurgitation. In patients > or = 70 years of age and patients submitted to aortic or mitral valve replacement with mild or no symptoms, the survival rate was similar for many years to that in the Swedish population at large.

Adult↗

Heart valve tissue engineering.

Valvular heart disease is a significant cause of morbidity and mortality world-wide. Classical replacement surgery involves the implantation of mechanical valves or biological valves (xeno- or homografts). Tissue engineering of heart valves represents a new experimental concept to improve current modes of therapy in valvular heart surgery. Various approaches have been developed differing either in the choice of scaffold (synthetic biodegradable polymers, decellularised xeno- or homografts) or cell source for the production of living tissue (vascular derived cells, bone marrow cells or progenitor cells from the peripheral blood). The use of autologous bone marrow cells in combination with synthetic biodegradable scaffolds bears advantages over other tissue engineering approaches: it is safe, it leads to complete autologous prostheses and the cells are more easily obtained in the clinical routine. Even though we demonstrated the feasibility to construct living functional tissue engineered heart valves from human bone marrow cells, so far their general potential to differentiate into non-hematopoietic cell lineages is not fully exploited for tissue engineering applications.

Absorbable Implants↗

[Thromboembolic complication following temporary discontinuance of anticoagulant therapy in a patient with mechanical heart valve].

Patients with mechanical heart valves are treated with oral anticoagulant therapy in order to minimize the risk of thromboembolism. During invasive procedures it is recommended to temporarily discontinue the oral anticoagulant therapy and substitute with injections of low-molecular-weight heparin. We describe a case where a patient discontinued the oral anticoagulant therapy and had no substitution with low-molecular-weight heparin. The patient had an embolism to the coronary arteries causing progressive heart failure, and the patient was subsequently heart transplanted.

Adult↗

Estimation of mechanical heart valve cavitation in an electro-hydraulic total artificial heart.

The purpose of this study was to establish a method for estimating mechanical in vitro heart valve cavitation in an electro-hydraulic total artificial heart (EHTAH). The variations in the left driving pressure (LDP) slope of the EHTAH were used as an index of the cavitation intensity. The LDP slope was controlled by changing the stroke volume of the EHTAH. The stroke volume was changed from full-filling and full-eject to partial-filling and partial-eject conditions. A 25-mm Medtronic Hall valve was installed in the mitral position of the EHTAH. Cavitation bubbles were concentrated on the valve stop; the major cause of these cavitation bubbles was determined to be squeeze flow. The valve-closing velocity was found to be proportional to increases in the LDP slope and the stroke volume of the left blood pump. The cavitation intensity and the cavitation event rate increased with increases in the stroke volume of the EHTAH. A consistent correlation was observed between the valve-closing velocity and the cavitation intensity. The LDP slope of the EHTAH may play an important role in estimating the mechanical heart valve cavitation intensity.

Equipment Failure Analysis↗

DeBakey Surgitool mechanical heart valve prosthesis, explanted at 32 years.

Contemporary mechanical heart value prostheses are expected to last "just about forever" or the patient's lifeline. They do however still suffer complications, some of which necessitate premature explantation. Complications today are mainly related to patient compliance with anticoagulant medication, infection and hemorrhage. The DeBakey Surgitool mechanical heart valve was the first such device to have Pyrolyte components. We present a DeBakey surgitool mechanical heart valve that was in place for 32 years! It was explanted for dysfunction related to tissue overgrowth and not to its related components. With good patient compliance, this mechanical heart valve prosthesis is an example of good prosthetic valve durability.

Aortic Valve↗

The porcine heart valve prosthesis.

The development of the prosthetic heart valve has led to the evolution of cardiac intensive care units, a better understanding of cardiac function and biocompatible materials, and new surgical procedures. Initial efforts with formaldehyde-fixed valves did not have long-term success. They led to the development of the stabilized glutaraldehyde process (SGP) valve and the flexible stent. The safety and efficacy of a heart valve bioprosthesis has been demonstrated through laboratory and animal experiments. Data on long-term clinical implants are needed to validate the results of these experiments.

Animals↗

Fabrication of a trileaflet heart valve scaffold from a polyhydroxyalkanoate biopolyester for use in tissue engineering.

Previously, we reported the implantation of a single tissue engineered leaflet in the posterior position of the pulmonary valve in a lamb model. The major problems with this leaflet replacement were the scaffold's inherent stiffness, thickness, and nonpliability. We have now created a scaffold for a trileaflet heart valve using a thermoplastic polyester. In this experiment, we show the suitability of this material in the production of a biodegradable, biocompatible scaffold for tissue engineered heart valves. A heart valve scaffold was constructed from a thermoplastic elastomer. The elastomer belongs to a class of biodegradable, biocompatible polyesters known as polyhydroxyalkanoates (PHAs) and is produced by fermentation (Metabolix Inc., Cambridge, MA). It was modified by a salt leaching technique to create a porous, three-dimensional structure, suitable for tissue engineering. The trileaflet heart valve scaffold consisted of a cylindrical stent (1 mm X 15 mm X 20 mm I.D.) containing three valve leaflets. The leaflets were formed from a single piece of PHA (0.3 mm thick), and were attached to the outside of the stent by thermal processing techniques, which required no suturing. After fabrication, the heart valve construct was allowed to crystallize (4 degrees C for 24 h), and salt particles were leached into doubly distilled water over a period of 5 days to yield pore sizes ranging from 80 to 200 microns. Ten heart valve scaffolds were fabricated and seeded with vascular cells from an ovine carotid artery. After 4 days of incubation, the constructs were examined by scanning electron microscopy. The heart valve scaffold was tested in a pulsatile flow bioreactor and it was noted that the leaflets opened and closed. Cells attached to the polymer and formed a confluent layer after incubation. One advantage of this material is the ability to mold a complete trileaflet heart valve scaffold without the need for suturing leaflets to the conduit. Second advantage is the use of only one polymer material (PHA) as opposed to hybridized polymer scaffolds. Furthermore, the mechanical properties of PHA, such as elasticity and mechanical strength, exceed those of the previously utilized material. This experiment shows that PHAs can be used to fabricate a three-dimensional, biodegradable heart valve scaffold.

Animals↗

The autologous tissue cardiac valve: a new paradigm for heart valve replacement.

This is a report of early clinical experience with an autologous tissue cardiac valve, which demonstrates the feasibility of making a bioprosthesis in the operating room in 10 minutes at the time of the valve replacement operation. There were 30 implant patients (18 men, 12 women), with ages ranging from 32 to 83 years. Diagnoses included calcified aortic stenosis (n = 16), pure aortic insufficiency (n = 9), and mixed aortic stenosis and insufficiency (n = 5). Associated diagnoses have included chronic renal failure treated with dialysis (n = 1), coronary artery disease requiring concomitant coronary bypass (n = 1), ascending aortic aneurysm requiring resection (n = 3), and mitral insufficiency requiring concomitant mitral valvuloplasty (n = 2). All of the valve replacements were in the aortic position. These implanted patients are being followed up carefully according to the protocol that requires examination every 6 months for the first year and every 12 months subsequently. No patient has been lost to follow-up. Twenty-seven patients are alive and well from 1 to 22 months postoperatively. There were three deaths: two perioperative deaths (one perivalvular leak and one hemorrhage) and one infective endocarditis 1.3 years after valve replacement. All surviving patients were followed up by echocardiographic examination (mean gradient, 15.5 +/- 6.8 mm Hg at 1 year). In conclusion, the feasibility of this method and concept has been demonstrated with implants in 30 patients. The validity of the technique will be judged by clinical results and experiences in children.

Adult↗

Relevance of immunologic reactions for tissue failure of bioprosthetic heart valves.

The use of biologic heart valve prostheses is decreasing because of the high incidence of failure of these bioprostheses resulting from tissue degeneration or tearing. Immunologic reactions might play a decisive role in this process. The present experimental and clinical studies were conducted to investigate the relevance of immunologic reactions to the tissue failure of glutaraldehydetanned bovine pericardial and porcine valves. Specimens of the two different types of valve material were implanted in the abdominal muscles of rats. Enzyme-linked immunosorbent assays and tritiated thymidine incorporation tests were performed to detect specific antibodies and activated T cells. All specimens were studied histologically. Identical enzyme-linked immunosorbent assays and tritiated thymidine incorporation tests were performed in 29 patients with bioimplants and in 48 controls. Twenty explanted bioprostheses were investigated using histologic and immune histologic methods. The results of the enzyme-linked immunosorbent assays and lymphocyte proliferation tests showed that glutaraldehyde-tanned bovine pericardial valves can provoke cellular and humoral immunologic reactions in rats and human beings. In explanted bovine valves, macrophages were found invading and degrading implant collagen, starting from surface lesions. The combination of the formation of mechanical lesions, the development of cellular infiltrates, and collagen disruption strongly indicates that initial surface lesions initiate the immunologic reactions in bovine pericardial valves as the result of the exposure of incompletely tanned collagen. These immune responses might accelerate tissue degeneration. Porcine valves do not provoke immunologic reactions.

Animals↗

Laser-induced fluorescence (LIF) recognition of the structural composition of porcine heart valves.

Reconstruction and replacement of heart valves with grafts fro pig tissue is a common procedure. However, bioprosthetic valves wear out in a shorter time span than mechanical valves. Bioprosthetic valve structure may contribute to degenerative changes that lead to valve failure. There is, at present, no method to examine the structure of a tissue valve prior to implant. Laser-induced fluorescence (LIF) of natural fluorophores is an elegant method developed for the detection of tumors, dermal lesions and atherosclerosis. We have studied LIF as a potential diagnostic technique for analysis of valvular tissue. Using excimer laser excitation, we examined natural fluorescence recorded from porcine aortic, mitral and pulmonary valves. All three valve outflow surface tissue layers are less fluorescent at 390-450 nm than the inflow layers. Immunohistochemical analysis of collagen I and elastin content in inflow and outflow surface layers of all three valves correlated well with LIF intensities and dI/d lambda values at selected wavelengths. In conclusion, the differences observed in emitted LIF from valve surface layers are found to correlate well with diversity in the structural protein content. The LIF spectroscopic measurements may provide an appropriate tool for examination of tissue valve structure prior to use for implantation.

Animals↗

The effect of liquid nitrogen submersion on cryopreserved human heart valves.

Cryopreservation and storage of human heart valves have become an accepted means of maintaining a usable supply of heart valves for outflow track reconstructive surgery. Valves are typically stored at the vapor phase temperature of liquid nitrogen, -130 degrees C and below, to reduce the chance of recrystallization within the tissues. Concern over the effects of submersion of the valves in liquid nitrogen, i.e., plunging to -196 degrees C, prompted this study. Cryopreserved valves were plunged into liquid nitrogen, held for 5 min, and then processed (thawed) by standardized protocols. The thawed valves were then assessed using scanning electron microscopy and the more traditional histology at the light microscope level. Cuspal tissues plunged into liquid nitrogen appear to have numerous microfractures over both surfaces of the tissue, penetrating into the collagen/proteoglycan matrix. Control cryopreserved valves do not exhibit these microfractures. Histologically, the submerged valves appear normal. The clinical use of valves which have been submerged in liquid nitrogen is discussed.

Cryopreservation↗

Long-term follow-up of the Hancock bioprosthetic heart valve: a 6-year review.

Clinical experience with the Hancock porcine bioprosthetic heart valve was reviewed in 467 patients (254 men and 213 women, 18--84 years old, average, 56 years) who received 528 valves from January, 1972, to January, 1978. Associated procedures, including coronary bypass graft, ascending aortic aneurysm, and valvuloplasty were done in 102 of the 467 patients (22%). The overall operative mortality was 25/467 (5.6%), 12/226 (5.3%) for aortic valve replacement (AVR), 11/183 (6%) for mitral valve replacement (MVR), and 2/58 (3.4%) for multiple valve replacement. The first 323 patients with a minimum follow-up of 16 months (16--75 months, average 33 months) were analyzed for survival and thromboemboli. Actuarial survival at 66--75 months was 75.7% for AVR, 79% for MVR, and 75.8% for multiple valve replacement. Emboli per 100 patient-years was 0.55 for AVR (no anticoagulants), 3.9 for MVR, and 4.8 for multiple valve replacement (anticoagulants for atrial fibrillation patients only); emboli occurred only in patients with atrial fibrillation. There were seven of 528 primary dysfunctional valves (1.3%): calcification in two, tissue failure in two, and fibrosis in three. A hemodynamic study of four patients with a 21 mm Hancock Modified Orifice aortic valve prosthesis showed improved orifice areas (greater than 1.3 cm2) over the standard aortic valve. The Hancock porcine xenograft bioprosthetic heart valve has been a durable heart valve in excess of 6 years and has a low associated incidence of thromboemboli in patients off anticoagulants except in those with chronic atrial fibrillation.

Adolescent↗

Determination of the curvatures and bending strains in open trileaflet heart valves.

The leaflets of trileaflet artificial heart valves manufactured from polyurethane, gluteraldehyde-treated porcine aortic valves and pericardial tissue are subject to cyclic stresses and strains which can reduce the lifetime of the implanted valves through leaflet calcification and fatigue failure. A detailed knowledge of the stress state within a valve leaflet throughout a cardiac cycle is desirable in order to improve the geometry of the valve leaflets and ultimately improve the valve performance. An experimental method to evaluate the radius of curvature at the free edge of the open valve leaflet is presented. The technique has been applied to polyurethane trileaflet heart valves manufactured within the authors' laboratory and to commercially available bioprosthetic valves in the fully open position under steady and pulsatile flow conditions. Simple bending theory has been applied to the polyurethane valves to calculate bending stresses and strains at the free leaflet edge based on the measured curvature. The results showed that in the fully open position the highest curvatures occurred at the commissural regions for all the valves analysed. Additional areas of high curvature were present along the free leaflet edge. Average curvatures as high as 0.85 mm-1 were observed at the leaflet commissures for the polyurethane valves with a resultant bending stress of 0.72 MPa. The porcine bioprosthetic valves showed average curvatures as high as 2.5 mm-1 which also occurred at the leaflet commissures. The results of the study have been compared to values of stress obtained from numerical analysis of closed polyurethane valve leaflets reported in the literature.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Is there a possibility for a glutaraldehyde-free porcine heart valve to grow?

OBJECTIVE: A challenging issue is to create a heart valve with growth and remodeling potential, which would be of great interest for congenital heart valve surgery. This study was performed to evaluate the growth and remodeling potentials of a decellularized heart valve. METHODS: In 4 juvenile sheep (age 12 +/- 1 weeks) with a weight of 24.3 +/- 4.4 kg, a 17-mm diameter decellularized porcine valve was implanted as pulmonary valve replacement. Valve growth was evaluated by transthoracic echocardiography. At explantation, valves were evaluated by gross examination, light microscopy (hematoxylin and eosin, von Kossa, Sirius red, Weigert and Gomori staining), electron microscopy and immunohistochemistry. Atomic absorption spectrometry was performed to evaluate calcium content. RESULTS: All animals showed fast recovery. The mean follow-up was 9.0 +/- 1.8 months. All sheep at least doubled their weight (54.3 +/- 9.2 kg). Echocardiography showed no regurgitation and a flow velocity of 0.7 +/- 0.1 m/s at the latest follow-up. The valve diameter increased from 17.6 +/- 0.5 to 27.5 +/- 2.1 mm (p < 0.018). Gross examination showed a similar wall thickness of the implanted valve and native pulmonary wall, with smooth and pliable leaflets. Histology showed a monolayer of endothelial cells, fibroblast ingrowth and production of new collagen. No calcification was seen at von Kossa staining, confirmed by low calcium content levels of the valve wall and leaflets at atomic absorption spectrometry. CONCLUSIONS: This glutaraldehyde-free heart valve showed not only the absence of calcification, but also remodeling and growth potential.

Animals↗

Measurement and reconstruction of the leaflet geometry for a pericardial artificial heart valve.

This paper describes the measurement and reconstruction of the leaflet geometry for a pericardial heart valve. Tasks involved include mapping the leaflet geometries by laser digitizing and reconstructing the 3D freeform leaflet surface based on a laser scanned profile. The challenge is to design a prosthetic valve that maximizes the benefits offered to the recipient as compared to the normally operating naturally-occurring valve. This research was prompted by the fact that artificial heart valve bioprostheses do not provide long life durability comparable to the natural heart valve, together with the anticipated benefits associated with defining the valve geometries, especially the leaflet geometries for the bioprosthetic and human valves, in order to create a replicate valve fabricated from synthetic materials. Our method applies the concept of reverse engineering in order to reconstruct the freeform surface geometry. A Brown & Shape coordinate measuring machine (CMM) equipped with a HyMARC laser-digitizing system was used to measure the leaflet profiles of a Baxter Carpentier-Edwards pericardial heart valve. The computer software, Polyworks was used to pre-process the raw data obtained from the scanning, which included merging images, eliminating duplicate points, and adding interpolated points. Three methods, creating a mesh model from cloud points, creating a freeform surface from cloud points, and generating a freeform surface by B-splines are presented in this paper to reconstruct the freeform leaflet surface. The mesh model created using Polyworks can be used for rapid prototyping and visualization. To fit a freeform surface to cloud points is straightforward but the rendering of a smooth surface is usually unpredictable. A surface fitted by a group of B-splines fitted to cloud points was found to be much smoother. This method offers the possibility of manually adjusting the surface curvature, locally. However, the process is complex and requires additional manipulation. Finally, this paper presents a reverse engineered design for the pericardial heart valve which contains three identical leaflets with reconstructed geometry.

Animals↗