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Biomedical subjects

M Vigano

Publications and source records attributed to M Vigano.

At least 19 recordsLinked to original sources

Mechanical circulatory support for advanced heart failure: effect of patient selection on outcome.

BACKGROUND: Use of wearable left ventricular assist systems (LVAS) in the treatment of advanced heart failure has steadily increased since 1993, when these devices became generally available in Europe. The aim of this study was to identify in an unselected cohort of LVAS recipients those aspects of patient selection that have an impact on postimplant survival. METHODS AND RESULTS: Data were obtained from the Novacor European Registry. Between 1993 and 1999, 464 patients were implanted with the Novacor LVAS. The majority had idiopathic (60%) or ischemic (27%) cardiomyopathy; the median age at implant was 49 (16 to 75) years. The median support time was 100 days (4.1 years maximum). Forty-nine percent of the recipients were discharged from the hospital on LVAS; they spent 75% of their time out of the hospital. For a subset of 366 recipients, for whom a complete set of data was available, multivariate analysis revealed that the following preimplant conditions were independent risk factors for survival after LVAS implantation: respiratory failure associated with septicemia (odds ratio 11.2), right heart failure (odds ratio 3.2), age >65 years (odds ratio 3.01), acute postcardiotomy (odds ratio 1.8), and acute infarction (odds ratio 1.7). For patients without any of these factors, the 1-year survival after LVAS implantation including the posttransplantation period was 60%; for the combined group with at least 1 risk factor, it was 24%. CONCLUSIONS: Careful selection, specifically implantation before patients become moribund, and improvement of management may result in improved outcomes of LVAS treatment for advanced heart failure.

Adolescent↗

Lung transplantation: the new point of view of an Italian centre.

Lung transplantation has become an accepted therapy for patients with end-stage lung disease. The survival rate after this operation is not, however, satisfactory, being 40-50% at 5 yrs after lung transplantation; infections and pulmonary rejection (acute and chronic) are the cause of this brief survival. Recently, it has been shown that lung transplantation is an advantageous solution only for selected pathologies. The introduction of alternatives to lung transplantation (lung volume reduction surgery in emphysema, prostacyclin therapy in primary pulmonary hypertension and pulmonary thromboendarterectomy in chronic thromboembolic hypertension) has modified the number of patients admitted to the lung transplantation waiting list. In this study, admission to the lung transplantation waiting list in the first 50 and in the following 50 months of activity of the Pulmonary Division Medical Centre of Montescano were retrospectively compared in order to verify whether experience gained has influenced admission to the lung transplantation waiting list. The mortality rate of patients with idiopathic pulmonary fibrosis (44%), chronic thromboembolic pulmonary hypertension (50%) and primary pulmonary hypertension (52%) before lung transplantation was high; the mortality after lung transplantation was low in idiopathic pulmonary fibrosis (16%), but rather high in primary pulmonary hypertension (55%) and chronic thromboembolic pulmonary hypertension (50%). In contrast, the mortality rate of patients with Eisenmenger's syndrome and emphysema was fairly low while on the lung transplantation waiting list, but rather high after lung transplantation. The trend in admission to the lung transplantation waiting list changed during the two observation periods, with a reduction in the number of patients with Eisenmenger's syndrome and emphysema, but not of those with idiopathic pulmonary fibrosis, chronic thromboembolic pulmonary hypertension and primary pulmonary hypertension. The experience gained modified the authors' approach to lung transplantation, but the "world" of lung transplantation still needs a lot more experience.

Adult↗

The European experience of Novacor left ventricular assist (LVAS) therapy as a bridge to transplant: a retrospective multi-centre study.

OBJECTIVE: Artificial heart devices have suffered from a negative press based on the early Jarvik experience of the 1980s. This is in stark contrast to realities of current left ventricular assist (LVAS) therapy. The Novacor N100 PC wearable left ventricular assist system (LVAS) was introduced in Europe in late 1993. This system allows implanted recipients to be completely autonomous with the system controlled by a small computer and powered by rechargeable batteries. This report represents the initial European experience with the Novacor LVAS. METHODS: Since the system was introduced with regulatory approval as a commercial product, clinicians were not bound by the constraints of a study protocol and only minimal data were collected. This report presents the results of a retrospective study of 118 consecutive patients who had the LVAS implanted as a bridge to transplant, in 19 centres over the three year period ending in November 1996. RESULTS: Mortality and morbidity varied widely between centres. The median implant time was 115 days (0-585 days) and 33% of patients returned home, supported by the LVAS. The overall survival on LVAS was 64%. The major causes of death were infection (14%) and MOF (6%). There were no significant device or system failures despite a cumulative patient experience of 24.8 years outside of a hospital environment. Patient selection and management varied greatly between centres and this was reflected in disparate outcomes. CONCLUSIONS: Optimal selection and management of LVAS patients has still to be established. While the data available for this report lacked the detail necessary to demonstrate direct causal relationships between selection and management, it was clear from the inter-centre differences that these two factors have a major impact on outcomes. This early experience has directed attention towards improved management regimes. Given the results obtained from the best centres and the ability to discharge patients to lead near-normal lives in the community, the authors believe that the Novacor LVAS now offers a real therapeutic alternative for selected end-stage heart failure patients for whom a donor heart is unavailable or who are unsuitable for transplantation.

Adolescent↗

A new enzyme-linked immunosorbent assay to measure anti-endothelial antibodies after cardiac transplantation demonstrates greater inhibition of antibody formation by tacrolimus compared with cyclosporine.

BACKGROUND: Chronic rejection or transplant-associated coronary artery disease (TxCAD) is the most serious complication after human cardiac transplantation. Previous studies, using Western blotting, have shown formation of antibodies against endothelial antigens of 56 and 58 kDa, which are associated with early TxCAD. These antigens were later identified as being vimentin and its breakdown products. The aims of the present study were to devise a robust assay for detection of anti-vimentin antibodies and to compare antibody formation in patients taking different immunosuppressive drugs. METHODS: 106 sequential serum samples from 19 patients taking tacrolimus and 68 sera from 12 patients taking cyclosporine were examined by enzyme-linked immunosorbent assay (ELISA) for anti-vimentin antibodies and Western blotting for reactivity against bands at 56/58 kDa. Serum samples were taken before transplantation and at 1, 3, 6, 9, and 12 months. RESULTS: The vimentin ELISA produced significantly higher numbers of positive episodes per patient (3.92+/-1.08) compared with use of Western blotting (2.54+/-0.52). Serum from patients taking tacrolimus contained significantly less antibodies measured by ELISA (15.8%) or Western blotting (6.5%) than sera from patients taking cyclosporine (46.8% for ELISA; P=0.001 and 21% by Western blotting, P=0.01). Intravascular ultrasound performed on six patients at 12 months showed a correlation between anti-vimentin antibody formation and detection of early coronary disease. CONCLUSIONS: The results demonstrate first, that differences in antibody profiles produced by different immunosuppressive drugs, and second, that detection of anti-vimentin antibodies may be a noninvasive method of detecting disease activity in transplanted vessels.

Antibodies↗

Lung retransplantation 3 yrs after heart-lung transplantation.

The main long-term complication after lung transplantation is chronic rejection in terms of obliterative bronchiolitis; when therapy does not arrest the progression of the airflow obstruction, lung retransplantation seems to be. at present, the only strategy in the management of chronic rejection. We report the 12 month follow-up of a single lung retransplantation in a 21 yr old female who had received a heart-lung transplantation 35 months previously for Eisenmenger syndrome. The patient had excellent first allograft function and quality of life for 26 months, then progressively deteriorated due to the occurrence of obliterative bronchiolitis, and further worsened in the following 9 months. At that time, she underwent left lung retransplantation, based on her negative history of infection, low rate of acute rejection, ambulatory status, and young age. She is now doing well at 12 months after retransplantation and her forced expiratory volume in one second is still improving, p thus justifying both retransplantation and hopeful expectation.

Adolescent↗

Satisfactory recovery and viability of stem cells cryopreserved at high cell concentration.

Peripheral Blood Stem Cells (PBSC) are being extensively used in both oncology-haematology and in solid tumor therapy schedules. The latest generation of cell separators allow the collection of greater numbers of nucleated cells (NC) than is usually obtained in bone marrow transplantation (BMT) settings. Thus, larger volumes of components would be stored if the same NC concentration employed in BMT is to be used. In order to reduce large volume DMSO-infusion related side effects and to avoid storage problems, we froze components from 23 PBSC collections at higher NC concentrations, from 40-200 x 10(6)/mL. After 2-12 months of storage, we thawed the samples and determined if the high NC concentration had a detrimental effect on NC viability and on stem cell clonogenicity. No statistically significant differences emerged in regard to CFU-GM, CFU-GEMM and BFU-E percent recovery even at 200 x 10(6)/mL NC concentration.

Analysis of Variance↗

Rupture of mitral valve annulus after mitral balloon valvotomy: a case report.

We report the case of a 51-year-old woman who underwent percutaneous mitral valvotomy using single balloon technique for restenosis after a previous surgical closed commissurotomy. After the procedure, she presented with severe mitral regurgitation and was referred to our center for mitral valve replacement. At surgery, the underlying cause of the mitral regurgitation was shown to be a tear at the commissural site which extended into the annulus. The mitral valve was successfully replaced and the post-operative course was uneventful. One year later the patient is in good clinical condition.

Catheterization↗

FK506 effectiveness in reducing acute rejection after heart transplantation: a prospective randomized study.

BACKGROUND: Tacrolimus (FK506) has recently become available clinically as an alternative to cyclosporine-based immunosuppression. This study reports the middle-term results of a prospective, randomized trial that compared FK506 with cyclosporine-based immunosuppression in heart transplant recipients. METHODS: Twenty-five consecutive patients were randomized at a 2:1 ratio into two groups, one of which received FK506 (15 patients), the other cyclosporine (10 patients). Both groups received similar concomitant immunosuppression. The patients were followed up for 12 months. The following outcome parameters were analyzed: survival, rejection and infection rate, lymphocyte subsets, new-onset diabetes, renal and hepatic function, hypertension, right-sided heart catheterization data, graft coronary artery disease, and neurologic side effects. RESULTS: The mortality rate (two patients) in the FK506 group was 13% versus 0% in the cyclosporine group (p = NS). The two deaths were the consequences of early infections and higher doses of FK506. From the outset, the FK506 group presented a lower prevalence of acute rejection, a lower requirement for rejection treatments and a higher incidence of infections. Accordingly, we reduced overall immunosuppression for the last seven patients in the FK506 group; the decrease in FK506 and prednisone dosage led to a decrease in the early infection rate without an increase in the rejection rate. There was no difference between the two groups in diabetes incidence, renal and hepatic function, right-sided heart catheterization data, or coronary angiograms. Hypertension was less frequent and milder in the FK506 group. CONCLUSIONS: This experience suggests that FK506 can be safely used in heart transplantation. It can decrease the frequency of rejection episodes. Low-dose administration allows a lower infection rate without an increase in rejection. With a protocol of delayed starting and low dosing, side effects such as renal toxicity, hypertension, and neurologic toxicity seem to be unlikely. Further studies are needed to establish the exact dosage and therapeutic levels of the drug.

Acute Disease↗

Effect of different interventions on heart rate variability after heart transplantation: non-autonomic vs autonomic factors.

1. The human transplanted heart is initially denervated, hence any fluctuation present in the RR interval variability can be either due to reacquired innervation, or to the effect of some non autonomic activity, such as a direct effect of respiration on atrial (sinus node) stretch. 2. In order to distinguish between sympathetic, vagal and non autonomic factors we examined the effects of various physical and pharmacologic manoeuvres on the respiratory and non-respiratory components of heart rate variability. 3. We found that sinusoidal neck suction appears a useful, noninvasive tool to characterise the relative importance of the different factors, which can influence heart rate variability in the transplanted heart.

Autonomic Nervous System↗

Clinical and virological monitoring of human cytomegalovirus infection in 294 heart transplant recipients.

Two hundred and ninety-four heart transplant recipients (HTR) were followed prospectively for a mean of 44.9 +/- 28.4 (range 1.0-100.8 months) after transplantation (tx). Immunosuppression was based on cyclosporine, azathioprine, and steroids, supplemented by a 7-day course of antithymocyte globulins. All patients were virologically monitored by inoculating aliquots of 2 x 10(5) peripheral blood polymorphonuclear leukocytes (PMNs) onto human embryonic lung fibroblasts monolayers grown in shell vials for early cytomegalovirus (CMV) identification and quantification (viremia). The same number of PMNs was cytocentrifuged onto glass slides for direct CMV pp65 antigen detection and quantification (antigenemia). Heparinized blood samples were collected weekly during the first 3 months following tx and at least twice a week if antigenemia and viremia levels were increasing. After 3 months, samples were collected if antigenemia and viremia persisted or when clinically indicated. The overall incidence of CMV infection was 53.4% (157/294). Only 32.4% (51/157) of the viremic patients required antiviral treatment because of symptomatic infection. Of the remaining 106 untreated CMV viremic HTR, 104 were asymptomatic while 2 had only mild clinical symptoms. The overall incidence of CMV infection in pre-tx CMV seropositive (CMV+) HTR was 50.9% (136/267); 75.7% (103/136) were asymptomatic and 24.3% (33/267); 75.7% (103/136) were asymptomatic and 24.3% (33/136) were symptomatic. The overall incidence of CMV infection in pre-tx CMV-seronegative (CMV-) HTR was 77.8% (21/27; P = 0.007 vs. seropositive HTR). Among 22 CMV- HTR with CMV+ donor, 20 (90.9%) had a CMV infection and all of them were symptomatic (versus 1 of 5 (20%) CMV- HTR with CMV- donor; P = 0.002, Fisher's exact test). The median numbers of circulating CMV-infected PMNs detected at the onset of clinical symptoms by the antigenemia and viremia assays were 385/2 x 10(5) and 100/2 x 10(5), respectively.

Adolescent↗

Different results of cardiac transplantation in patients with ischemic and dilated cardiomyopathy.

We retrospectively analyzed 275 consecutive transplanted patients, dividing them into group A (128 patients) affected by ischemic cardiomyopathy and group B (147 patients) affected by dilated cardiomyopathy. The difference in demographic, clinical and hemodynamic preoperative and postoperative data between the groups was studied; group A patients presented at transplantation with a less compromised hemodynamic picture, requiring inotrope infusion and mechanical assistance less frequently. The influence of etiology on early postoperative complications was also analyzed: group A patients needed postoperative mechanical assistance, inotrope, infusion and prolonged mechanical ventilation more often, therefore requiring a longer stay in the intensive care unit (ICU). Hospital mortality was twice as high in group A. The older age of group A patients per se did not influence these results significantly. The long-term follow-up was then studied with particular attention to parenchymal functions, hemodynamics, coronary artery disease, metabolic and surgical complications, and survival. The complication rate was higher in group A, with more severe hypertension and higher cholesterol levels at 1 year, a higher prevalence of accelerated coronary artery disease (CAD) and a more frequent onset of insulin-dependent diabetes. Surgical and vascular complications were also more frequent. The final result was a better 5-year actuarial survival rate for group B patients. Donor and recipient ages at the time of transplant did not influence this result. We conclude that ischemic patients, even if they are transplanted in better condition and operated more electively, have a more critical early and long-term postoperative course and a worse survival rate. These findings are not explained by advanced age, but could be due to the impact of atherosclerosis and metabolic impairments associated with ischemic disease.

Actuarial Analysis↗

Surgical ablation of ventricular tachycardia secondary to congenital ventricular septal aneurysm.

Three patients underwent surgical ablation for ventricular tachycardia resulting from an aneurysm of the membranous portion of the ventricular septum. Two patients had a definite history of cardiac murmur during infancy, and one of them was found at the time of operation to have a left-to-right shunt through the apex of the aneurysm. The earliest ventricular activation sites were located around the neck of the aneurysm and were ablated in 1 patient by encircling the endocardial ventriculotomy and by cryoablation in the remaining 2. After focus resection had been completed, aneurysm resection and ventricular septal reconstruction were performed. All patients were alive and free of ventricular tachycardia and did not need medication as of 61, 66, and 88 months postoperatively. Spontaneous closure of a ventricular septal defect may lead to the formation of an aneurysm in the ventricular septum that may sustain ventricular tachycardias. Such arrhythmias can be effectively treated using electrically guided surgical techniques.

Adolescent↗

The surgical anatomy of the subcutaneous fascial system of the scalp.

The surgical anatomy of the fascial layers and vascularization of the scalp was studied by means of 11 bilateral cadaver dissections. This article is organized as follows: first, a description of the layers and fasciae of the scalp and their relationships with the main vascular structures, and then a description of the histological structure of the subgaleal fascia (composed of multiple connective vascularized sheets that glide over one another) and of its blood supply. In our dissections, we found the constant topographic distribution of the major perforant vessels to the subgaleal tissues as follows: in the temporal region, perforant vessels from the superficial temporal artery near and 10 to 14 cm above the zygomatic arch, where the superficial temporal artery leaves the surface of the galea to enter the superficial subcutaneous tissue, and in the fronto-parieto-occipital region, many small perforant vessels evenly entering the subgaleal plane every 5 to 10 mm. These findings could lead to greater use of fascial or composite flaps from the scalp region.

Arteries↗