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Bioprosthetic heart valves are widely used because of their low risk of thromboembolic complications. The major limitation to the long-term success of these prostheses is caused by degenerative processes leading to late primary valve failure, including calcification. Research into these processes has suggested potential approaches for inhibiting calcification and other degradative phenomena.
When I reviewed the 21-year results with the Björk-Shiley tilting disc valves, I found out that to date, we still have to use these disc valves and all mechanical heart valves with anticoagulation therapy. The highest incidence of valve-related postoperative deaths after aortic valve replacements in Stockholm was anticoagulation-related bleeding, which continued at a rate of about 1% year after year. There is a need to improve the quality of life for heart valve patients, especially for children, for young females who want to have children, for the older generation who are on medical treatment, and for all patients in whom long-term anticoagulation of a perfect quality is impossible to guarantee. A series of tests on goats has been performed, using the Björk-Shiley Monostrut valve used in 2,024 patients at the Karolinska Hospital in Stockholm and in 75,000 patients worldwide for up to 8 years with a modification of a microporous surface. In the mitral position, this modified partially microporous-surfaced Björk-Shiley Monostrut valve has permitted goats to live for 5 years with four normal pregnancies without anticoagulation therapy.
BACKGROUND: The St Jude Medical Regent is a new-generation mechanical heart valve that represents a design evolution of the St Jude Hemodynamic Plus Series (HP). The purpose of this study was to evaluate early "in vivo" hemodynamic performance of the Regent valve in patients with aortic stenosis. METHODS: Between March 2000 and December 2001, 32 patients (mean age 59.9 +/- 5.9,56.3% male) with pure aortic stenosis received a Regent mechanical prosthesis in the aortic position. Hemodynamic performance was assessed by Doppler echocardiography at discharge, two months, six months, and one year by calculating peak transprosthetic velocity (Vmax), mean (MG) and peak (PG) transprosthetic gradients, effective orifice area index (EOAI), left ventricular mass index (LVMI), and degree of aortic regurgitation. RESULTS: A significant reduction in mean and peak transaortic gradients (p < 0.001) and a significant increase in EOAI (p < 0.001) over time followed valve replacement, and a bivariate analysis of variance (ANOVA) failed to demonstrate statistical differences by valve size over time (p = ns). A significant reduction in left ventricular hypertrophy occurred over time (p < 0.001) in all valve sizes (p = ns between groups): baseline LVMI was 221 +/- 57 g/cm2; it decreased by 30 g/cm2 (p < 0.001) at discharge. LVMI decreased from 191 +/- 54 g/cm2 to 161 +/- 41 g/cm2 (p < 0.001) from discharge to two months. Further reductions were not significant. At the six-month follow-up no patient in our cohort exhibited moderate or severe aortic regurgitation at Doppler echocardiography. CONCLUSIONS: Early results with the St Jude Medical Regent valve have been satisfactory. Further assessments are necessary to confirm these results.
BACKGROUND: After mechanical heart valve replacement (MHVR), long-term use of unfractionated heparin is sometimes required because vitamin K antagonists (VKA) are temporarily contraindicated or because the time to reach the target international normalized ratio is long. The aim of this study was to investigate the feasibility of low-molecular-weight heparin treatment in these patients. METHODS AND RESULTS: This work was conducted as a prospective study. We selected all patients (n=695) who underwent MHVR and were transferred to a postoperative cardiac rehabilitation center between January 2000 and January 2005. The study focused on patients who had not yet started VKA therapy or who had a below-target international normalized ratio despite VKA therapy. Unfractionated heparin was replaced by enoxaparin (100 IU/kg BID) until VKA treatment was fully effective. Two hundred fifty patients (60+/-11 years old) were enrolled 16+/-11 days after surgery (aortic valve replacement, n=190; mitral valve replacement, n=34; double valve replacement, n=26). Of these, 50% had permanent or transient atrial fibrillation, 40% had hypertension, 13% had diabetes, and 19% had a history of cardiac surgery. The mean duration of low-molecular-weight heparin treatment was 8.3+/-6.0 days. Patients were followed for 90 days, during which there were two major and three minor bleeding episodes and one transient ischemic attack. There were no cases of valve thrombosis and no deaths. CONCLUSIONS: After MHVR, one third of patients leave the cardiac surgery unit before VKA treatment is fully effective. Bridging anticoagulation therapy with enoxaparin appears to be feasible during this high-risk period for thromboembolism and could shorten the length of hospital stay.
OBJECTIVE: Mechanical heart valves can cause thromboembolic complications, possibly due to abnormal flow patterns that produce turbulence downstream of the valve. The objective of this study was to investigate whether three different bileaflet valve designs would exhibit clinically relevant differences in downstream turbulent stresses. METHODS: Three bileaflet mechanical heart valves (Medtronic Advantage), CarboMedics Orbis Universal and St. Jude Medical Standard) were implanted into 19 female 90 kg pigs. Blood velocity was measured during open chest conditions in the cross sectional area downstream of the valves with 10 MHz ultrasonic probes connected to a modified Alfred Pulsed Doppler equipment. As a measure of turbulence, Reynolds normal stress (RNS) was calculated at three different cardiac output ranges (3-4, 4.5-5.5, 6-7 L/min). RESULTS: Data from 12 animals were obtained. RNS correlated with increasing cardiac outputs. The highest instantaneous RNS observed in these experiments was 47 N/m2, and the mean RNS taken spatially over the cross sectional area of the aorta during systole was between 3 N/m2 and 15 N/m2. In none of the cardiac output ranges RNS values exceeded the lower critical limit for erythrocyte or thrombocyte damage for any of the valve designs. CONCLUSIONS: Reynolds normal stress values were below 100 N/m2 for all three valve designs and the difference in design was not reflected in generation of turbulence. Hence, it is unlikely that any of the valve designs causes flow induced damage to platelets or erythrocytes.
BACKGROUND: The United Kingdom Heart Valve Registry (UKHVR) has recently completed collecting information on 52 659 heart valve replacements (in 47 718 patients) performed during the period 1986 to 1995 in the whole of the United Kingdom. Information stored in the UKHVR's computer database was used for this study. Factors affecting the time from first prosthesis to first redo prosthesis were analyzed and provided useful predictive information. The association between prosthesis-induced local pathological processes and redo valve size was investigated. METHODS AND RESULTS: This is a retrospective study of 43 301 patients (from among 47 718 in the database) undergoing single-site replacement of a diseased native mitral or aortic valve over a 10-year period from January 1986 to December 1995 in the United Kingdom. Of these patients, 1051 (2.43%) went on to have a first redo heart valve replacement. Valve survival analysis (Cox regression and Kaplan-Meier curves) was used to study the natural progression to the first redo heart valve replacement. Female sex and having a replacement at the aortic rather than the mitral position were both associated with a longer interval to the first redo operation. Regression analysis showed the size of the redo valve to be influenced by the interoperative time. This effect was more pronounced at the mitral position. CONCLUSIONS: Females and patients having an aortic valve replacement exhibit a longer interval to the first redo operation than do males and patients having mitral valve replacements, respectively. The time from the first replacement to the first redo operation significantly affects the size of the first redo valve.
The need for better low-profile mechanical valves led to the design and development of the Medtronic-Hall (formerly known as the Hall-Kaster valve) pivoting disc heart valve prosthesis in 1976. In vitro flow studies indicate that it has improved pressure drop characteristics compared to the Lillehei-Kaster and convexoconcave Björk-Shiley (60 degrees model) tilting disc valves. It does, however, have a somewhat larger regurgitant volume compared to the Björk-Shiley valve design. Velocity measurements with a laser-Doppler anemometer in the immediate downstream vicinity of the Medtronic-Hall valve indicate no region of stagnation near the outflow face of the disc. Regions of stagnation were, however, observed adjacent to the two titanium "pivot stops" situated on either side of the disc in the major orifice and along the pivot post in the minor orifice, together with a region of flow separation adjacent to the sewing ring of the minor outflow region. The results of the present in vitro study indicate a small but significant improvement in the overall fluid dynamic performance of the Medtronic-Hall valve, compared to the convexo-concave Björk-Shiley (60 degrees model) and Lillehei-Kaster tilting disc prostheses in current clinical use.
BACKGROUND: Tissue-engineered or decellularized heart valves have already been implanted in humans or are currently approaching the clinical setting. The aim of this study was to examine the migratory response of human monocytic cells toward decellularized porcine and human heart valves, a pivotal step in the early immunologic reaction. METHODS AND RESULTS: Porcine and human pulmonary valve conduits were decellularized, and migration of U-937 monocytic cells toward extracted heart valve proteins was examined in a transmigration chamber in vitro. Homogenized tissue specimens were size fractionated by SDS-PAGE. The decellularization procedure effectively reduced the migration of human monocytes toward all heart valve tissue. However, only the antigen reduction of human pulmonary valves abolished the monocytic response (wall, 0.88+/-0.19% versus 30.20+/-3.93% migrated cells [mean+/-SEM]; cusps, 0.10+/-0.06% versus 10.24+/-1.83%) and was significantly lower (P<0.05) than that of the decellularized porcine equivalent (wall, 5.03+/-0.14% versus 24.31+/-2.38%; cusps, 3.18+/-0.38% versus 10.24+/-1.83%). SDS-PAGE of the pulmonary heart valve tissue revealed that considerable amounts of proteins with different molecular weights that were not detected in the human equivalent remain in the decellularized porcine heart valve. CONCLUSIONS: We describe for the first time that the remaining potential of decellularized pulmonary heart valves to attract monocytic cells depends strongly on whether porcine or human scaffolds were used. These findings will have an important impact on further investigations in the field of heart valve tissue engineering.
Quantification of heart valve leaflet deformation during the cardiac cycle is essential in understanding normal and pathological valvular function, as well as in the design of replacement heart valves. Due to the technical complexities involved, little work to date has been performed on dynamic valve leaflet motion. We have developed a novel experimental method utilizing a noncontacting structured laser-light projection technique to investigate dynamic leaflet motion. Using a simulated circulatory loop, a matrix of 150-200 laser light points were projected over the entire leaflet surface. To obtain unobstructed views of the leaflet surface, a stereo system of high-resolution boroscopes was used to track the light points at discrete temporal points during the cardiac cycle. The leaflet surface at each temporal point was reconstructed in three dimensions, and fit using our biquintic hermite finite element approach (Smith et al., Ann. Biomed. Eng. 26:598-611, 2001). To demonstrate our approach, we utilized a bovine pericardial bioprosthetic heart valve, which revealed regions of complex flexural deformation and substantially different shapes during the opening and closing phases. In conclusion, the current method has high spatial and temporal resolution and can reconstruct the entire surface of the cusp simultaneously. Because it is completely noncontacting, this approach is applicable to studies of fatigue and bioreactor technology for tissue engineered heart valves.
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Heart valve allografts are widely used for surgical treatment of the heart. In recent years a new field of research has emerged dealing with allograft modification by cells of recipient by means of tissue engineering. This method involves culturing fibroblasts and endothelial cells, using recipient tissue, followed by introduction of the fibroblasts into tissues of allograft and coating its surface by the endothelial cells. This modification is expected to ensure the structural maintenance of implanted tissues and to reduce its thrombogenecity. This procedure may promote the allograft adhering to the recipient tissues, thus prolonging the terms of the valve normal functioning after implantations. For this purpose, methods of luminescent microscopy are suggested using double staining of tissue with fluorescent dyes Hoechst 33,342 and ethidium bromide, or with fluorescein diacetate and ethidium bromide. Experimental results are presented indicative of fibroblast migration from the surface to the human heart valve leaflets.
OBJECTIVE: Replacement of heart valves in human subjects has become a routine procedure in cardiac operations. We sought to investigate whether commercially available glutaraldehyde-fixed porcine heart valve prostheses cause porcine endogenous retrovirus infection in human subjects because recent studies revealed that human cells can be infected with porcine endogenous retrovirus. METHODS: Blood samples of 18 patients who underwent aortic or mitral valve replacement with porcine heart valves were collected 6 months to 3 years after operation and tested for porcine endogenous retrovirus by means of polymerase chain reaction and reverse transcriptase-polymerase chain reaction. In addition, we tried to trace porcine endogenous retrovirus in 3 commercially available, glutaraldehyde-fixed, porcine heart valves. RESULTS: Porcine endogenous retrovirus can be easily detected in native porcine heart valves and degrades completely within 1 week of fixation in glutaraldehyde. In all 3 commercially available porcine heart valves, no traces of porcine endogenous retrovirus were found. All blood samples showed negative test results for the porcine endogenous retrovirus genome. CONCLUSION: Our results indicate that glutaraldehyde fixation of porcine heart valves reliably prevents cross-species transmission of porcine endogenous retrovirus.
BACKGROUND AND AIM OF THE STUDY: Currently, 95% of all implanted mechanical heart valve prostheses are constructed completely, or at least partially, from pyrolytic carbon. In order to develop a mechanical heart valve prosthesis made from alternative materials, a special hinge design was tested which enabled the integration of wear-resistant tribomaterials into the highly loaded hinges of leaflets. METHODS: The wear behavior of different material couples was investigated in vitro. Wear testing was performed using a specially designed durability tester that controlled the pressure difference across the closed heart valve prosthesis in a water-glycerol mixture with blood analog viscosity. Conditions were set according to FDA and ISO standards for heart valve testing. Qualitative assessment of wear behavior was performed using light microscopy and scanning electron microscopy at intervals of 10, 40, and each subsequent 50 million cycles. RESULTS: None of the investigated heart valve prostheses failed during the durability tests. Compared to the reference valve made from polymeric materials, wear especially in the hinges could be reduced to an acceptable level by integrating wear-resistant tribomaterials into the leaflets. CONCLUSION: A leaflet design which enables the integration of tribomaterials into the highly loaded hinges of leaflets leads to an optimization of wear behavior of a mechanical heart valve prosthesis made from polymeric materials. Abrasive wear in the hinges may be reduced to an acceptable level for the functionality of the heart valve prosthesis. Durability tests will be continued in order to confirm the promising wear behavior of this novel heart valve prosthesis.
BACKGROUND AND AIM OF THE STUDY: Currently, 95% of all implanted mechanical heart valve prostheses are constructed completely, or at least partially, from pyrolytic carbon. In order to develop a mechanical heart valve prosthesis made from alternative materials, a special hinge design was tested which enabled the integration of wear-resistant tribomaterials into the highly loaded hinges of leaflets. METHODS: The wear behavior of different material couples was investigated in vitro. Wear testing was performed using a specially designed durability tester that controlled the pressure difference across the closed heart valve prosthesis in a water-glycerol mixture with blood analog viscosity. Conditions were set according to FDA and ISO standards for heart valve testing. Qualitative assessment of wear behavior was performed using light microscopy and scanning electron microscopy at intervals of 10, 40, and each subsequent 50 million cycles. RESULTS: None of the investigated heart valve prostheses failed during the durability tests. Compared to the reference valve made from polymeric materials, wear especially in the hinges could be reduced to an acceptable level by integrating wear-resistant tribomaterials into the leaflets. CONCLUSION: A leaflet design which enables the integration of tribomaterials into the highly loaded hinges of leaflets leads to an optimization of wear behavior of a mechanical heart valve prosthesis made from polymeric materials. Abrasive wear in the hinges may be reduced to an acceptable level for the functionality of the heart valve prosthesis. Durability tests will be continued in order to confirm the promising wear behavior of this novel heart valve prosthesis.
BACKGROUND: Detection of microemboli signals (MES) in patients with artificial heart valves has been extensively described, but the underlying material remains unclear. We assumed that the detection of MES in the jugular vein of patients with prosthetic valves would clearly argue for gaseous embolic material, since formed emboli are unable to cross through the capillaries. METHODS AND RESULTS: Twenty-five patients with artificial heart valves, 15 patients with asymptomatic carotid artery disease, and 25 normal controls were examined. Monitoring was performed simultaneously over the dominant jugular vein and the ipsilateral middle cerebral artery for 30 min per subject, using 2-MHz transducers of a color duplex scanner for the jugular vein and a pulsed-wave Doppler for the middle cerebral artery. Data were harvested in an eight-channel digital recorder and MES counts evaluated by two separate observers. MES prevalence in the middle cerebral artery was 100, 13 and 0% in patients with artificial heart valves, asymptomatic carotid artery disease, and normal controls, respectively. No MES were detected in the jugular veins of patients with carotid artery disease or in normal controls, while their prevalence was 68% in patients with artificial heart valves. The interobserver agreement was satisfactory. CONCLUSION: Our results suggest that the embolic material of at least a part of MES in patients with artificial heart valves is gaseous.
In order to establish the influence of prosthetic valve replacement on the natural course of mitral, aortic, and double-valve disease of NYHA class III and IV, the progress of 359 patients with Björk-Shiley mitral-valve prostheses (BSM), 317 with aortic valve prostheses, and 107 with double valve prostheses was compared with that of patients who had been treated medically. In this last group of patients, valve replacement had been recommended in the period 1968-1976, but for various reasons had not been carried out. Cumulative survival rates after 8 years were 77% for the BSM group, but only 32% for the medically treated group (p less than 0.0001). One year after operation, 70% of the BSM patients showed an improvement equivalent to one NYHA class, and in the majority this was still apparent after 5 years. In patients with aortic-valve incompetence, cumulative survival rates were 86% for the surgically treated group and 32% for the medically treated group (p less than 0.00001). In aortic-valve stenosis, these differences of cumulative survival rates were even more pronounced (p less than 0.000001), and were calculated to be 85% in surgically treated and 10% in medically treated patients. Clinical improvement in the BSA group averaged 1.5 NYHA classes. The 5-year survival rate for the patients with mitral and aortic-valve disease was 32%, while following doublevalve replacement it was 67% (p less than 0.005). Clinical improvement after double-valve replacement was similar to that following mitral-valve replacement. Prosthetic heart-valve replacement significantly prolongs life in patients with isolated mitral- or aortic-valve lesions as well as in patients with double-valve disease of NYHA classes III and IV. Even in the early years of the study, when the operative mortality was relatively high, the surgically treated groups had a significantly higher survival rate than the conservatively treated groups, and this was already apparent at an early stage in the follow-up period. Improvement of functional capacity and relief of symptoms amount to a difference of approximately one NYHA class in mitral and double-valve disease and of approximately 1.5 NYHA classes in aortic-valve disease.
The hydrodynamics of various prosthetic heart valves currently available commercially were studied in our mock circulation system by analysis of flow-pressure gradient and opening angle. Using the circulation system, various prosthetic heart valves were tested in the simulative states of normal hemodynamics, low output, arrhythmia, hypovolemia, and vasoconstriction. The flow-pressure gradient analysis demonstrated the characteristics of each valves clearly. The St. Jude Medical valve showed the superior valve characteristics over other mechanical valves. The opening angles of the tilting disc prosthetic valves were also studied in the same simulative circulation using the photosensor system with real-time monitoring. In contrast to our clinical experiences of poor opening of Omniscience valve in the mitral position, limitation of the opening angle of the valve was not observed in this in vitro study.
OBJECTIVE: Recently, there has been an increase in case of repeated open-heart valve surgery and the clinical results of the second surgery are only slightly worse than those of the first surgery. However, clinical results of the third open-heart valve surgery at the same position are rarely reported. Clinical features of third open-heart valve surgery at the same position are discussed in this study. METHODS: Between 1995 and 2004, 16 patients underwent third open-heart valve surgery at the same valve position under cardiopulmonary bypass. The average age of the 16 patients, 12 females and 4 males, was 56 +/- 15 years. Clinical features of the 16 cases were retrospectively analyzed. RESULTS: Mechanical valve nonstructural dysfunction was the most common valve malady, followed by bioprosthetic valve dysfunction. The duration of surgery from skin incision to establishment of the cardiopulmonary bypass was 94 +/- 42 minutes. Myocardial ischemia time was 137 +/- 38 minutes and extracorporeal circulation time was 212 +/- 82 minutes. Early mortality was seen in 1 patient (6.25%) and late mortality was seen in 1 patient. CONCLUSION: Mechanical valve nonstructural valve dysfunction leads to repeated valve surgery. The clinical results of the third open-heart valve surgery at the same valve position are acceptable, and the mid-term survival is excellent.