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Issues surrounding the preservation of viable allograft heart valves.

Allograft heart valves have been used for over 30 years. During the first decades of use, the research and clinical objectives were to find a means for long-term storage of tissue. Methods such as irradiation, glutaraldehyde fixation, long-term antibiotic storage at 4 degrees C and other methods were common. These methods, however, were found to give reduced long-term clinical performance when compared with viable fresh tissue or tissue which had been cryopreserved. Recognizing this fact, more recent emphasis has been to address issues surrounding means by which allografts can be cryopreserved and thawed to retain maximum viability. An additional concern was to find a means to maximize donor retrieval by salvaging tissue which normally would be discarded because of bacterial contamination. This study demonstrates that when a proper cryopreservation technique is used, with stringent antibiotic treatments, biomechanical parameters remain normal with only a slight decrease in cell viability.

Adult↗

Platelets are deposited early post-operatively on the leaflet of a mechanical heart valve in sheep without post-operative anticoagulants or antiplatelet agents. A scanning electron microscopic observation of the pyrolytic carbon surface in a mechanical heart valve.

Pyrolytic carbon has been used for mechanical heart valves as a thromboresistant, wear resistant, and fatigue resistant material. Thrombosis and thromboembolism, however, remain major mechanical heart valve associated complications and may frequently occur during the early post-operative period. In depth morphologic studies on blood-pyrolytic carbon surface interactions are limited. The purpose of this study was to evaluate the blood compatibility of the pyrolytic carbon surface of St. Jude Medical mechanical heart valves that were implanted in the mitral position of sheep without the administration of post-operative anticoagulants or antiplatelet agents for 2, 4, and 6 weeks. Almost the entire leaflet and orifice ring surfaces were observed by scanning electron microscopy. Although the surfaces appeared clean macroscopically, when observed by electron microscopy, the surface were mottled, mainly by solitary platelets and aggregations. There were only a few leukocytes or red blood cells observed. No fibrin clots were observed on the leaflets. The density of platelet deposition was higher in the vicinity of the pivots and near the edges of the leaflets. The sizes of the platelet aggregations decreased with longer duration. The outer surfaces of the pivot guards were covered by various amounts of deposition composed of platelet aggregations and thrombi. Thus, the administration of antiplatelet agents is recommended during the early post-operative period after mechanical heart valve implantation.

Animals↗

Pathology of infectious and inflammatory diseases in prosthetic heart valves.

Prosthetic heart valves, both mechanical and biological (xenograft valves, stented or unstented), show an inflammatory reaction (infective endocarditis), associated predominantly with bacterial/fungal infection. Somewhat surprisingly, no immune-mediated reaction has been reported thus far. This may, among other reasons, be related to the fact that the tissues are "fixed" with aldehydes and are virtually isolated from host circulation, separated by synthetic material (the valve stent and the fabric covering it). Stentless valves (especially these without fabric covering them), however, have no such "isolation" from the host circulation. While the Toronto-Stentless Porcine Valve has a covering of fabric, the Medtronic Freestyle valve has no such covering. It is perhaps not so surprising therefore that at the intermediate time point of 5 to 6 years, some valves are beginning to show such an immune reaction.

Heart Diseases↗

Management of intracranial bleeding associated with anticoagulation: balancing the risk of further bleeding against thromboembolism from prosthetic heart valves.

Mechanical heart valves are associated with a risk of thromboembolism and anticoagulation is generally recommended. However, this is inevitably associated with a risk of intracranial bleeding. The case of a patient who sustained an intracranial bleed while taking warfarin for a prosthetic aortic valve and a further two intracranial bleeds while on heparin as an inpatient is discussed and the literature on the management of intracranial haemorrhage in patients on warfarin with prosthetic valves is reviewed.

Aged↗

Pathology of explanted cryopreserved allograft heart valves: comparison with aortic valves from orthotopic heart transplants.

OBJECTIVE: We sought to determine the morphology, mechanisms of deterioration, cellular viability, extracellular matrix integrity, and the role of immune responses in the dysfunction of cryopreserved aortic and pulmonic valve allografts. METHODS: We studied 33 explanted left-sided (n = 20) or right-sided (n = 13) cryopreserved human allograft heart valves explanted several hours to 9 years after operation, 14 nonimplanted allografts, and 16 aortic valves removed from transplanted allograft hearts 2 days to 4 years after operation. Analysis included gross inspection, radiography, light microscopy, electron microscopy, and immunohistochemical studies. RESULTS: Allografts implanted for more than 1 day had progressive collagen hyalinization and loss of normal structural complexity and cellularity, including endothelium and deep connective tissue cells. Inflammatory cells were generally minimal or absent in the allografts. Transmission electron microscopy of long-term cryopreserved allograft valves revealed no viable cells, focal calcification centered around dead cell remnants, and distorted but preserved collagen. In contrast, aortic valves from transplanted hearts showed remarkable structural preservation, including endothelium and abundant deep connective tissue cells; inflammatory infiltrates were generally mild and of no apparent deleterious consequence, including valves from patients who died of fatal rejection. CONCLUSIONS: Cryopreserved allografts are morphologically nonviable; their collagen is flattened but largely preserved. They are unlikely to grow, remodel, or exhibit active metabolic functions, and their usual degeneration cannot be attributed to immunologic responses. In contrast, aortic valves of transplanted hearts maintain near-normal overall architecture and cellularity and do not show apparent immunologic injury, even in the setting of fatal myocardial parenchymal rejection or graft arteriosclerosis.

Adolescent↗

Observation of cavitation in a mechanical heart valve in a total artificial heart.

Recently, cavitation on the surface of mechanical heart valves has been studied as a cause of fractures occurring in implanted mechanical heart valves. The cause of cavitation in mechanical heart valves was investigated using the 25 mm Medtronic Hall valve and the 23 mm Omnicarbon valve. Closing of these valves in the mitral position was simulated in an electrohydraulic totally artificial heart. Tests were conducted under physiologic pressures at heart rates from 60 to 100 beats per minute with cardiac outputs from 4.8 to 7.7 L/min. The disk closing motion was measured by a laser displacement sensor. A high-speed video camera was used to observe the cavitation bubbles in the mechanical heart valves. The maximum closing velocity of the Omnicarbon valve was faster than that of the Medtronic Hall valve. In both valves, the closing velocity of the leaflet, used as the cavitation threshold, was approximately 1.3-1.5 m/s. In the case of the Medtronic Hall valve, cavitation bubbles were generated by the squeeze flow and by the effects of the venturi and the water hammer. With the Omnicarbon valve, the cavitation bubbles were generated by the squeeze flow and the water hammer. The mechanism leading to the development of cavitation bubbles depended on the valve closing velocity and the valve stop geometry. Most of the cavitation bubbles were observed around the valve stop and were generated by the squeeze flow.

Biomechanical Phenomena↗

Innervation of the atrioventricular and semi-lunar heart valves: a review.

Heart valves were historically considered passive structures that function through the haemodynamic forces created by the contraction and relaxation of the myocardium. However, research into valvular structures has revealed that heart valves are very complex, specialized structures that contain both smooth muscle cells and nerve fibres. This is particularly true for the atrioventricular valves, which are by far the most well studied to date. The various heart valves have been shown to contract independently during different moments of the heart cycle, suggesting that compensatory adaptation mechanisms exist to mediate the timing and efficacy of heart valve closure. These adaptations occur via different mechanisms, including neural mechanisms that influence the heart valves. Accumulating evidence continues to improve our understanding of the nerve fibres in the heart (adrenergic, cholinergic, etc.). Future studies will no doubt add to this exciting picture. Here, we review the current morphological knowledge of human and animal heart valve innervation, including discussions of the chordae tendineae and the papillary muscles, as well as the differences between the atrioventricular (AV) valves and the semi-lunar (SL) valves.

Animals↗

An editorial view on the reporting of results in heart valve bioprostheses.

Heart valve bioprostheses are most commonly analyzed as a group rather than individualized. Mechanical valves are usually referred to by specific name and manufacturer, while bioprostheses are pooled together as "tissue valves". Each specific bioprosthesis has its own structural characteristics and therefore a different level of performance and durability. Most large centers have an adequate number of these implants and a follow-up long enough to warrant separate analysis of each valve type. This review analyzes the differences among the most commonly used bioprostheses and reaffirms the reasons for their separate analysis. Authors, reviewers and editors must standardize their criteria to prevent this problem from recurring or escalating. New bioprostheses are now being released and unless we simplify their evaluation our questions will remain unanswered.

Adult↗

Fluid mechanics of heart valves.

Valvular heart disease is a life-threatening disease that afflicts millions of people worldwide and leads to approximately 250,000 valve repairs and/or replacements each year. Malfunction of a native valve impairs its efficient fluid mechanic/hemodynamic performance. Artificial heart valves have been used since 1960 to replace diseased native valves and have saved millions of lives. Unfortunately, despite four decades of use, these devices are less than ideal and lead to many complications. Many of these complications/problems are directly related to the fluid mechanics associated with the various mechanical and bioprosthetic valve designs. This review focuses on the state-of-the-art experimental and computational fluid mechanics of native and prosthetic heart valves in current clinical use. The fluid dynamic performance characteristics of caged-ball, tilting-disc, bileaflet mechanical valves and porcine and pericardial stented and nonstented bioprostheic valves are reviewed. Other issues related to heart valve performance, such as biomaterials, solid mechanics, tissue mechanics, and durability, are not addressed in this review.

Animals↗

Design and hydrodynamic evaluation of a novel pulsatile bioreactor for biologically active heart valves.

Biologically active heart valves (tissue engineered and recellularized tissue-derived heart valves) have the potential to offer enhanced function when compared to current replacement value therapies since they can possibly remodel, and grow to meet the needs of the patient, and not require chronic medication. However, this technology is still in its infancy and many fundamental questions remain as to how these valves will function in vivo. It has been shown that exposing biologically active tissue constructs to pulsatile pressures and flows during in vitro culture produces enhanced extracellular matrix protein expression and cellularity, although the ideal hydrodynamic conditioning regime is as yet unknown. Moreover, in vitro organ-level studies of living heart valves aimed at studying the remodeling processes require environments that can accurately reproduce in vivo hemodynamics under sterile conditions. To this end, we have developed a system to study the effects of subjecting biologically active heart valves to highly controlled pulsatile pressure and flow waveforms under sterile conditions. The device fits inside a standard incubator and utilizes a computer-controlled closed loop feedback system to provide a high degree of control. The mean pressure, mean flow rate, driving frequency, and shape of the pulsatile pressure waveform can be changed automatically in order to simulate both physiologic and nonphysiologic hemodynamic conditions. Extensive testing and evaluation demonstrated the device's ability to subject a biologically active heart valve to highly controlled pulsatile waveforms that can be modulated during the course of sterile incubation.

Bioprosthesis↗

Closing behavior of the mechanical heart valve in a total artificial heart.

Recently, cavitation on the surface of mechanical heart valves has been studied as a cause of fractures occurring in implanted mechanical heart valves. The cause of cavitation in mechanical heart valve was investigated in both 25-mm Björk-Shiley and 25-mm Medtronic Hall valves. The closing events of these valves in the mitral position were simulated in an electrohydraulic total artificial heart with a stroke volume of 85 ml. The tests were conducted under physiologic pressures at heart rates of 60, 70, 80, and 90 beats/min with cardiac outputs of 4.5, 5.5, 6.4, and 7.5 l/min, respectively. The disk closing behavior was measured by a laser displacement sensor. The closing behaviors were investigated under various atrial and aortic pressures. In both valves, the duration of closing decreased with an increase in the cardiac output. The greater the amount of atrial pressure, the shorter the closing duration of both valves. The maximum closing velocity of the Medtronic Hall monostrut valve ranged from 0.8 to 0.9 m/s, and that of the Björk-Shiley monostrut valve ranged from 0.73 to 0.78 m/s. In both valves, the maximum closing velocities were less than the reported cavitation thresholds. This suggests that there should be no possibility of occurrence of cavitation in an electrohydraulic total artificial heart with mechanical heart valve.

Biomechanical Phenomena↗

[A study of isolated tricuspid valve surgery late after left heart valve operation].

Management of severe tricuspid regurgitation late after left heart valve operation is controversial. There has been reluctance to the operation due to the high risk of repeat operation, coexistent right ventricular dysfunction and pulmonary hypertension. We investigated 6 cases of isolated tricuspid valve surgery (tricuspid valve replacement: 2, tricuspid valve plasty: 4) late after left heart valve operation. Before operation, these patients showed poor general condition (4 cases were NYHA III or IV) but good left ventricular function [mean ejection fraction (EF) 66 +/- 9.6%]. Hospital mortality was 0% and the mean mid-term actual event-free survival over 2 +/- 1.8 years was 80%. Most of patients demonstrated NYHA I and improvement of hepatomegaly after operation. There were many complications in 2 cases that had been performed previous operation more than 20 years before. In summary, the patient who complained symptoms due to right heart ventricular failure and showed good left ventricular function after left heart valve surgery should be considered to undergo tricuspid valve operation before the occurrence of other complications.

Aged↗

[Risks of combined surgical treatment of acquired heart valve defects and coronary heart disease].

In the past years the number of patients with combined treatment of the heart valves and coronary arteries rised as well as the patients age did. In 1980-1987 the rate of patients with aortic valve replacement and simultaneous aorto-coronary bypass was 10.9% in those who underwent aortic valve replacement and 2.9% in those who had aorto-coronary bypass operation. Since 1988 the ratios changed to 18.2% and 4.9%. For the calculation of the operative risk of the combined operative treatment (AVR + CABG, MVR + CABG) we compared these groups with those patients with isolated operations (MVR, AVR, CABG). We studied all patients during 1980 and July 1989. The hospital mortality of combined procedures was significantly increased. The mortality among female patients was higher as compared to the male group. The age of patients treated by the combined procedures was higher as compared to the isolated procedures. The mean age of the patients which died was severely increased as compared to the isolated procedures. However, in the combined procedures this increase was not as pronounced as in the isolated groups. Patients with combined procedures had a higher NYHA class. The risk factors of the combined procedures were comparable to isolated CABG.

Aortic Valve↗

[Heart valves in rheumatic heart disease in the light of scanning electron microscopy].

In case of rheumatic sclerosis the micro-relief of the surface of the mitral and aortic valves changes considerably: the first order plicas disappear, a new chaotic micro-relief is formed that depends on the deep specific changes in the collagen-elastic structures of the valves. In rheumatic heart diseases the valves are characterized by focal disendothelization of the surface, which permits to examine the valve in layers, and to study not only its surface, but also its internal subendothelial structures. Scanning electron microscopy permitted to visualize for the first time in a full three-dimentional image the severely altered collagen structures of the disendothelialized portions of rhumatic valves. The changes in the micro-telief consisting in the appearance of amall, irregularly located plicas, crossing each other under various angles, are caused by the development of new subendothelial collagen fibers. The initial forms of calcification are characterized by the appearance of micro-plates of calcination in the zones of the destroyed micro-relief, the subsequent forms -- by the formation of large clusters of calcination due to the fusion of the micro-plates. The destroyed micro-relief of the valves causes the adhesion of erythrocytes on their surfaces, which may be considered a factor halping thrombus formation.

Adult↗

Generic, simple risk stratification model for heart valve surgery.

BACKGROUND: Heart valve surgery has an associated in-hospital mortality rate of 4% to 8%. This study aims to develop a simple risk model to predict the risk of in-hospital mortality for patients undergoing heart valve surgery to provide information to patients and clinicians and to facilitate institutional comparisons. METHODS AND RESULTS: Data on 32,839 patients were obtained from the Society of Cardiothoracic Surgeons of Great Britain and Ireland on patients who underwent heart valve surgery between April 1995 and March 2003. Data from the first 5 years (n=16,679) were used to develop the model; its performance was evaluated on the remaining data (n=16,160). The risk model presented here is based on the combined data. The overall in-hospital mortality was 6.4%. The risk model included, in order of importance (all P<0.01), operative priority, age, renal failure, operation sequence, ejection fraction, concomitant tricuspid valve surgery, type of valve operation, concomitant CABG surgery, body mass index, preoperative arrhythmias, diabetes, gender, and hypertension. The risk model exhibited good predictive ability (Hosmer-Lemeshow test, P=0.78) and discriminated between high- and low-risk patients reasonably well (receiver-operating characteristics curve area, 0.77). CONCLUSIONS: This is the first risk model that predicts in-hospital mortality for aortic and/or mitral heart valve patients with or without concomitant CABG. Based on a large national database of heart valve patients, this model has been evaluated successfully on patients who had valve surgery during a subsequent time period. It is simple to use, includes routinely collected variables, and provides a useful tool for patient advice and institutional comparisons.

Cardiac Surgical Procedures↗

[Long-term clinical results after aortic valve replacement with mechanical heart valves and mitral valve replacement with porcine valves].

Long-term clinical results of aortic valve replacement (AVR) with mechanical heart valves and mitral valve replacement (MVR) with porcine valves were analysed. Sixty-three patients received isolated AVR and 48 received isolated MVR. Sixty-eight patients with MVR including double or triple valve replacement were also added in order to evaluate the primary tissue failure (PTF). The patients with operative deaths were excluded. Survival rate at 11 years in AVR was 68 +/- 10% and 67 +/- 15% in MVR without statistical difference. At 11 years, 76 +/- 8% of the patients in AVR were free from valve-related complications in contrast with the poor result of 34 +/- 31% in MVR (p less than 0.01). Main cause of this poor result in MVR was PTF as indicated in following event free rates; 83 +/- 9% at 7 years, 61 +/- 25% at 10 years and 49 +/- 31% at 13 years. There was no statistical difference between patients of above 50 years and below 49 years in PTF. Valve-related death event free was 93 +/- 5% in AVR and 86 +/- 11% in MVR at 11 years (not significant), however, there was statistical difference in re-operation event free rate as 94 +/- 5% in AVR and 76 +/- 11% in MVR at 11 years (p less than 0.001). These results suggest that the use of porcine valves in mitral position is confined to the selected patients.

Adult↗