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PubMed2003

Anticoagulation of pregnant women with mechanical heart valves.

The management of pregnant women with mechanical heart valves is challenging. Recently, based on small numbers of patients and poor-quality data, correspondence from Aventis Pharmaceuticals Inc has described treatment "failures" and concerns about teratogenicity with the use of the low-molecular-weight heparin (LMWH) enoxaparin. The company issued a "Warning" that enoxaparin should not be used in patients with prosthetic heart valves and a "Precaution" about potential teratogenicity. This has created a huge problem for physicians managing pregnant women with prosthetic heart valves because the alternatives, unfractionated heparin and warfarin, are problematic. There have been case reports of failures (including death from thrombosed valves) with unfractionated heparin, whereas the package insert for warfarin states that the drug is contraindicated during pregnancy because of potential teratogenicity. Initially, LMWHs appeared suitable for pregnant patients with prosthetic heart valves. Unfortunately, the company correspondence, presumably supported by the Food and Drug Administration (FDA), raises medicolegal concerns with use of any LMWH. We believe that pharmaceutical companies and the FDA should not endorse scientifically unsupported claims that eliminate acceptable therapeutic options. This correspondence has created considerable confusion among patients and treating physicians and is likely to lead to frivolous lawsuits and preclude the performance of properly designed trials in pregnant women. We believe a consensus conference among experts in the field to identify key unresolved issues and a commitment by the FDA and industry to perform appropriate studies are now critical.

Adult↗
PubMed2003

Is tissue-engineered heart valve replacement clinically applicable?

Tissue engineering of a heart valve has progressed dramatically in three different arenas: a biodegradable stented valve seeded with autogenous cells, decellularized allograft and xenograft valves that are seeded with autogenous cells, and decellularized allograft and xenograft valves that repopulate by adaptive remodeling in vivo. Preclinical evaluation and implants in sheep have been accomplished in each of these arenas, and clinical use of this emerging technology is occurring in the latter two. The clinical use of decellularized allografts that repopulate in vivo is expanding; however, its impact on allograft durability remains unknown.

Aortic Valve↗
PubMed1992

The United Kingdom Heart Valve Registry.

The United Kingdom Heart Valve Registry project began in 1986 following discussions between the Department of Health (DOH) and the Society of Cardiothoracic Surgeons of the United Kingdom and Ireland. The intention was to establish a computerized database for valve replacement operations carried out in the UK Health Service cardiac units. This paper describes the experience gained over the first five years of this project. Around 30,000 patients were entered in the registry between 1986 and 1990. All Uk Health Service cardiac surgical units contribute their data, which is processed by the central Registry Office. The accuracy of the mortality data is ensured by tracking the registered patients through the Office of Population Census and Surveys (OPCS). The pattern of valve replacement surgery over the period 1986-90 revealed several interesting trends. Although the number of procedures remained static at around 5,000 valve transplants per year, the number of aortic replacements increased and the number of mitrals decreased. The use of prosthetic valves increased from 54% in 1986 to over 70% in 1990. The mean age of the patients increased from 58.31 years in 1986 to 60.97 years in 1990, with over 22% of the valve replacement operations in 1990 being performed on patients over 70 years of age. The five year survival rate for patients over 70 years at the time of the valve implant is significantly lower than for patients under 70 years (p < 0.005).

Aged↗
PubMed1984

Penetration of cefotaxime into heart valves, subcutaneous and muscle tissue of patients undergoing open-heart surgery.

Twenty-nine adult patients undergoing open-heart surgery were given 2 g cefotaxime as 5 min intravenous bolus injection preoperatively. Within 6 h cefotaxime serum concentrations declined from 81.0 to 6.3 mg/l. Subcutaneous tissue and muscle concentrations varied between 0.3 and 8.7 micrograms/g, heart valve concentrations varied between 2.2 and 13.0 micrograms/g. Cefotaxime concentrations in heart valves are high enough to inhibit most Gram-negative organisms causing postoperative wound infections and endocarditis.

Cardiac Surgical Procedures↗
PubMed2005

A thin film nitinol heart valve.

In order to create a less thrombogenic heart valve with improved longevity, a prosthetic heart valve was developed using thin film nitinol (NiTi). A "butterfly" valve was constructed using a single, elliptical piece of thin film NiTi and a scaffold made from Teflon tubing and NiTi wire. Flow tests and pressure readings across the valve were performed in vitro in a pulsatile flow loop. Bio-corrosion experiments were conducted on untreated and passivated thin film nitinol. To determine the material's in vivo biocompatibility, thin film nitinol was implanted in pigs using stents covered with thin film NiTi. Flow rates and pressure tracings across the valve were comparable to those through a commercially available 19 mm Perimount Edwards tissue valve. No signs of corrosion were present on thin film nitinol samples after immersion in Hank's solution for one month. Finally, organ and tissue samples explanted from four pigs at 2, 3, 4, and 6 weeks after thin film NiTi implantation appeared without disease, and the thin film nitinol itself was without thrombus formation. Although long term testing is still necessary, thin film NiTi may be very well suited for use in artificial heart valves.

Alloys↗
PubMed1978

A simple method for estimating stresses in natural and prosthetic heart valves.

Flexible-leaflet prosthetic heart valves offer certain advantages over the lateral-flow central-occluding devices in current use. However, achieving sufficient strength and fatigue resistance in the flexible leaflets is a difficult design problem. The present paper contributes to the solution of this problem by describing a simple step-by-step method for estimating the stress in a flexible leaflet valve. The method is especially suited for evaluating preliminary proposed designs since it requires only a few simple measurements and calculations. An example is presented in which stresses estimated by the method are compared with those obtained from a finite element analysis. In addition, an error is pointed out in a previously-published method for estimating stresses in leaflet valves.

Heart Valve Prosthesis↗
PubMed2003

Mitral mechanical heart valves: in vitro studies of their closure, vortex and microbubble formation with possible medical implications.

OBJECTIVE: The goal of the present work was to create the closest possible in vitro fluid dynamic environment in which prosthetic mitral valves in the patients' hearts function, in order to demonstrate whether microbubbles are generated, and if yes, under what conditions and at which stage of the cardiac cycle. Microbubbles were observed in the blood of patients with mitral mechanical heart valves (MHV) by means of echocardiography. The phenomenon, often referred to as high-intensity transient signals (HITS), appears as bright, intense, high-velocity and persistent echoes detected by Doppler echocardiography at the instant of valve closure. The question is no longer whether microbubbles are being formed in patients with MHV. as an inherent aspect of their design, but rather how they evolve and when. The answer to this question was the objective of the present paper. METHODS: Hemodynamic conditions in which microbubbles were observed in patients with mitral MHV were simulated in our laboratory. We were able to describe the bubble formation process, as one consisting of nucleation and microbubble growth. While mild growth of nuclei is governed by diffusion, extensive growth of microbubbles is controlled by pressure drop during deceleration of the leaflets on the housing on the atrial side of the mitral MHV. RESULTS: The present study has shown that bubbles form in a fluid at the instant of closure of mechanical valves. The formation of vortices after valve closure, although clinically not yet observed, was also demonstrated in the present in vitro studies. We believe that impact of such vortices on the endothelial layer of the left atrial wall may have clinical significance. These two phenomena were not observed in bioprosthetic valves. CONCLUSIONS: As demonstrated, there exist two distinct phenomena characteristic of mechanical heart valves, which take place during valve closure, namely, that of vortex formation and that of microbubble growth. Both phenomena may have far reaching clinical implications.

Blood Flow Velocity↗
PubMed1999

Successful anticoagulation with dalteparin in a patient with mechanical heart valves.

BACKGROUND: Standard thromboprophylaxis of patients with mechanical heart valves is achieved using warfarin. In certain patients this may be very difficult; thus, alternative pharmacotherapy must be used. OBJECTIVE: To report a case of a patient who successfully used dalteparin, a low-molecular-weight heparin, for anticoagulation. CASE SUMMARY: A 58-year-old white woman with mechanical aortic and mitral heart valves initially received warfarin for anticoagulation. Thromboprophylaxis was very challenging. Her international normalized ratios (INRs) were erratic and occasionally responded paradoxically to changes in dose. Finally, she experienced a left hemispheric stroke when her INR was extremely subtherapeutic. Subsequently, despite best efforts, her INR again was subtherapeutic; warfarin was discontinued and dalteparin was initiated with daily self-administered subcutaneous injections of 16 000 units. No complications have arisen since initiation of the new pharmacotherapy approximately 18 months ago. DISCUSSION: The use of low-molecular-weight heparin for the treatment and prevention of venous thromboembolism is well described. There are few reports of its use for thromboprophylaxis of patients with mechanical heart valves. Our patient has been managed successfully with dalteparin. CONCLUSIONS: Dalteparin was effectively and safely used for the thromboprophylaxis of a patient with mechanical heart valves whose anticoagulation was previously difficult to manage with warfarin. Dalteparin deserves further study in patients who are unable to tolerate warfarin.

Anticoagulants↗
PubMed2000

Effects of myocardial contractility on microemboli production by mechanical heart valves in a bovine model.

Microemboli caused by mechanical heart valves have the potential to cause cerebrovascular events. We investigated the effects of myocardial contractility and heart rate on microemboli production in association with conventional and experimental mechanical heart valves implanted in the mitral position in a bovine model. In 10 calves, the mitral valves were replaced with mechanical valves. Doppler recordings were analyzed for high-intensity transient signals, which are ultrasound reflections from circulating microemboli. The animals were studied at rest, during pacing at 160 bpm, after dobutamine infusion, and after esmolol infusion. The incidence of high intensity transient signals was expressed as signal frequency (signals per hour) and as signal rate (signals per 100 heart cycles). With a 68% increase in the heart rate, signal frequency increased by 135%, but signal rate increased by only 41 %. With a 144% increase in myocardial contractility, signal rate increased by 264 %. With a 31 % decrease in contractility, signal rate decreased by 62 %. We conclude that microemboli production by mechanical heart valves varies with myocardial contractility and heart rate. The fact that contractility affects the incidence of high-intensity transient signals suggests that the microemboli are gaseous in nature, that their production is pressure driven, and that cavitation is a possible cause. It is likely that mechanical heart valve design is responsible for the quantity of microemboli production.

Adrenergic beta-Agonists↗
PubMed2006

Twenty-two years without anticoagulation with metallic heart valve.

Anticoagulation is essential and vital for mechanical heart valves to prevent lethal complications such as valve thrombosis and systemic embolism. Herein, we reported the third longest survived case with a metallic aortic valve without anticoagulation and reviewed the role of anticoagulation in mechanical heart valves.

Adult↗
PubMed1998

[Self management of peroral anticoagulant therapy in patients with artificial heart valves].

Twenty-one heart valve operated patients (age 19-70 years) were trained in self-managed oral anticoagulant therapy using a home coagulometer (CoaguChek). Twenty patients accomplished between eight and 29 (median 24) months of self management and were fully capable of self management after 30 weeks of training. No patients experienced major bleeds or thrombo-embolic events. A control group of 20 patients from our department was matched, retrospectively, to the study group. The self-managing patients were within the therapeutic INR range 78% of the study period compared to 54% for the control patients. All self-managing patients had their median INR-value within the therapeutic range, versus only 14 in the control group. Self-management of oral anticoagulant therapy seems feasible for selected patients.

Adult↗
PubMed1999

Unalloyed pyrolytic carbon for implanted mechanical heart valves.

Materials for implanted heart valves face challenges unmatched for most mechanical applications. The valves must function without interruption for lifetimes in the order of 10(9) cycles in a corrosive, hostile environment. A particular carbon has been widely used for the past three decades. The mechanical behavior of this isotropic pyrolytic carbon (PyC), with and without silicon alloying, was studied in this research program. Several questions were addressed: the fatigue strength at lifetimes of 10(9) cycles, the threshold for crack growth, the validity of fracture mechanics for PyC, and the statistics of ultra-high survival under cyclic stress. It was found that cyclic stressing within the scatter band of the static strength did not initiate cracks. Furthermore, artificially induced cracks did not grow under cyclic stressing below a threshold stress intensity factor. This threshold stress intensity factor was valid over a wide range of crack lengths. No failures occurred when batches of 29 specimens were tested above the service stress at 6 x 10(8) cycles. Cyclic stressing did not reduce the static strength. The service stress is a small fraction of the fracture strength; thus, a very high probability of survival can be ensured by a proof test of the assembly.

Biocompatible Materials↗
PubMed1989

[Late results after heart valve surgery in the elderly].

Heart valve surgery was performed in 133 patients over the age of 60 between 1976 and 1981. There were 54 men and 79 women. Their ages ranged from 60 to 74 years (mean age 64.3 years). In this study, 54 valve prostheses (15 porcine and 39 mechanical) in the aortic position, 79 prostheses (69 porcine and 10 mechanical) in the mitral position and 3 prostheses (3 porcine) in the tricuspid position were implanted in 121 patients. Fifteen patients (11.3%) died in the hospital. The hospital mortality was high in the cases of MVR (14.6%), MVR + TAP (12.5%) and emergency (50%). The mean follow-up was 37.2 months (range 4 to 129 months, total 367.3 patient-years). There were 10 late deaths (8.5%). Actuarial survival for hospital survivors at 5 years was 89.2 per cent. At follow-up, 95.8% of the surviving patients were in New York Heart Association functional class I or II. Valve-related complications were thromboembolism (2.0% pt/year), periprosthetic leak (1.7% pt/year), primary tissue failure (0.5% pt/year) and thrombosed valve (0.3% pt/year). Anticoagulant-related hemorrhage necessitating hospitalization occurred in 2 patients (1.0% pt/year). The freedom from all events at 5 years was 72.8 per cent. This study suggests that heart valve surgery in the elderly can be performed with an acceptable mortality. Advanced age alone should not be a contraindication to surgical management.

Aged↗
PubMed2006

Living autologous heart valves engineered from human prenatally harvested progenitors.

BACKGROUND: Heart valve tissue engineering is a promising strategy to overcome the lack of autologous growing replacements, particularly for the repair of congenital malformations. Here, we present a novel concept using human prenatal progenitor cells as new and exclusive cell source to generate autologous implants ready for use at birth. METHODS AND RESULTS: Human fetal mesenchymal progenitors were isolated from routinely sampled prenatal chorionic villus specimens and expanded in vitro. A portion was cryopreserved. After phenotyping and genotyping, cells were seeded onto synthetic biodegradable leaflet scaffolds (n=12) and conditioned in a bioreactor. After 21 days, leaflets were endothelialized with umbilical cord blood-derived endothelial progenitor cells and conditioned for additional 7 days. Resulting tissues were analyzed by histology, immunohistochemistry, biochemistry (amounts of extracellular matrix, DNA), mechanical testing, and scanning electron microscopy (SEM) and were compared with native neonatal heart valve leaflets. Fresh and cryopreserved cells showed comparable myofibroblast-like phenotypes. Genotyping confirmed their fetal origin. Neo-tissues exhibited organization, cell phenotypes, extracellular matrix production, and DNA content comparable to their native counterparts. Leaflet surfaces were covered with functional endothelia. SEM showed cellular distribution throughout the polymer and smooth surfaces. Mechanical profiles approximated those of native heart valves. CONCLUSIONS: Prenatal fetal progenitors obtained from routine chorionic villus sampling were successfully used as an exclusive, new cell source for the engineering of living heart valve leaflets. This concept may enable autologous replacements with growth potential ready for use at birth. Combined with the use of cell banking technology, this approach may be applied also for postnatal applications.

Absorbable Implants↗
PubMed2001

Repeat heart valve surgery: risk factors for operative mortality.

BACKGROUND: Patients undergoing repeat heart valve operations are a diverse population. We assessed risk factors for operative mortality in patients undergoing a first heart valve reoperation. METHODS: A retrospective review of hospital records was performed for 671 patients who underwent first repeat heart valve operations between 1969 and 1998. Univariable and multivariable analyses were performed. RESULTS: Operative mortality was 8.6%. Mortality fell each decade to 4.8% in the most recent period (adjusted chi(2) for linear trend P <.0005). Mortality increased from 3.0% for reoperation for a failed repair or reoperation at a new valve site to 10.6% for prosthetic valve dysfunction or periprosthetic leak and to 29.4% for endocarditis or valve thrombosis. Concomitant coronary artery bypass grafting was associated with a mortality of 15.4% compared with 8.2% when it was not required. Mortality for aortic valve replacement was 6.4%, mitral valve replacement 7.4%, aortic and mitral valve replacement 11.5%, tricuspid valve replacement 25.6%, periprosthetic leak repair 9.1%, and isolated valve repair 2.2%. Among 336 patients requiring replacement of prosthetic valves, mortality was 26.1% for replacement of a mechanical valve compared with 8.6% for replacement of a tissue valve (P <.0005). Multivariable analyses identified year of reoperation, age, coronary artery bypass grafting, indication, and replacement of a mechanical valve rather than a tissue valve as significant explanatory variables for operative mortality. CONCLUSIONS: Heart valve reoperations can be performed with an acceptable operative mortality. However, we have identified several categories of patients in whom reoperation carries an increased risk.

Aortic Valve↗
PubMed2005

[Tissue engineering for heart valves and vascular grafts].

Current prosthetic substitutes for heart valves and blood vessels have numerous limitations such as limited durability (biological valves), susceptibility to infection, the necessity of lifelong anticoagulation therapy (prosthetic valves), and reduced patency in small-caliber grafts, for example. Tissue engineering using either polymers or decellularized native allogeneic or xenogenic heart valve/vascular matrices may provide the techniques to develop the ideal heart valve or vascular graft. The matrix scaffold serves as a basis on which seeded cells can organise and develop into the valve or vascular tissue prior to or following implantation. The scaffold is either degraded or metabolised during the formation and organisation of the newly generated matrix, leading to vital living tissue. This paper summarises current research and first clinical developments in the tissue engineering of heart valves and vascular grafts.

Animals↗