Hepatitis C-virus (HCV) antibodies in patients after kidney transplantation.

The hepatitis C-virus (HCV) is the main etiologic agent of posttransfusion hepatitis (PTH). Most patients depending on hemodialysis need transfusion of blood before kidney transplantation. Of 272 patients after kidney transplantation, 27 (10%) were found to be anti-HCV-ELISA-positive (HCV-Antibody-ELISA, Ortho Diagnostics). The antibodies could be neutralized by HCV C-100-3 antigen. Eight of 22 patients (36%) who had more than one kidney transplantation were classified anti-HCV positive [30% (8/27) of all anti-HCV positive patients]. The number of transfused blood units ranged from 0 to 99 BU. Receiving more than one kidney graft or the transfusion of more than 5 units of blood increased the risk for HCV infection 3.5 or 4.1 times, respectively, compared with one transplantation or less than 5 units of blood. No significant interactions were seen between these two variables. Of the anti-HCV positive patients, 48% were anti-HBc negative as well as HBs-antigen negative, 52% were anti-HBc positive.

[Hepatitis C virus antibodies in patients following blood transfusion and kidney transplantation]. / Hepatitis C-Virus (HCV) Antikörper bei Patienten nach Bluttransfusionen und Nierentransplantation.

The prevalence of anti-HCV in patients after kidney transplantation was tested by HCV-Antibody-ELISA (Ortho Diagnostics). In addition, reactive samples were tested by HCV-EIA (Abbott Laboratories), neutralization, anti-HBc (Corzyme, Abbott) and by HBs-Ag (Auszyme, Abbott). 27 of 271 patients (10%) were anti-HCV positive. Receiving more than one kidney graft (TPL) or the transfusion of more than four blood units (BU) increases the risk of HCV infection four times (OR: 4.1; p less than 0.01) or 2.5 times (OR: 2.5; p less than 0.05), respectively, compared with one TPL or less than 4 BU. Receiving more than one kidney graft and transfusion of more than four BU raises the risk of HCV infection 6.8 times. 52% of anti-HCV positive patients were anti-HBc positive, 48% were anti-HBc negative as well as HBs-Ag negative.

[Design, goals and preliminary results of the first national breast cancer study--the Federal Ministry of Research and Technology study of "small breast cancer"]. / Design, Ziele und vorläufige Ergebnisse der ersten nationalen Brustkrebsstudie--BMFT-Studie "kleines Mammakarzinom".

In the multicentre trial sponsored by the Federal Ministry for Research and Technology (= BMFT), mastectomy is compared with breast preservation in patients with pT1 NO MO breast cancer. On the basis of that protocol breast preservation can also be performed by smaller institutions thus implementing the health policy programme of effecting new treatment modalities on a broad basis. We can already recognise a substantial improvement in treatment standards applied by the different disciplines in the hospitals involved in the study. Special emphasis is placed on an optimal patient information about the possible treatment modalities involving the patients in the treatment decision. The evaluation of various prognostic factors will result in additional information on the biology of breast cancer. As a consequence, the definition of the group of patients suitable for breast preservation therapy can be clarified further.

Low-fat diet and regular, supervised physical exercise in patients with symptomatic coronary artery disease: reduction of stress-induced myocardial ischemia.

The effects of physical exercise and normalization of serum lipoproteins on stress-induced myocardial ischemia were studied in 18 patients with coronary artery disease, stable angina pectoris, and mild hypercholesterolemia (total serum cholesterol 242 +/- 32 mg/dl). These patients underwent a combined regimen of low-fat/low-cholesterol diet and regular, supervised physical exercise at high intensity for 12 months. At 1 year serum lipoproteins has been lowered to ideal levels (serum cholesterol 202 +/- 31 mg/dl, low-density lipoproteins 130 +/- 30 mg/dl, very low-density lipoproteins 22 +/- 15 mg/dl, serum triglycerides 105 [69 to 304] mg/dl) and physical work capacity was improved by 21% (p less than .01). No significant effect was noted on high-density lipoproteins, probably as a result of the low-fat/high-carbohydrate diet. Stress-induced myocardial ischemia, as assessed by thallium-201 scintigraphy, was decreased by 54% (p less than .05) despite higher myocardial oxygen consumption. Eighteen patients matched for age and severity of coronary artery disease served as a control group and "usual medical care" was rendered by their private physicians. No significant changes with respect to serum lipoproteins, physical work capacity, maximal rate-pressure product, or stress-induced myocardial ischemia were observed in this group. These data indicate that regular physical exercise at high intensity, lowered body weight, and normalization of serum lipoproteins may alleviate compromised myocardial perfusion during stress.

Evaluation of psychosocial aspects in a breast preservation trial.

Our preliminary and exploratory data analysis of the current state of QOL assessment in the ongoing BMFT breast preservation trial indicates that our questionnaire meets criteria of validity, differentiability, and practicability in the context of a large multi-center trial. The results of treatment comparisons tend towards accordance with those of comparable studies, in that they do not show the often-postulated global superiority of breast-preserving therapy over mastectomy with respect to QOL. The special study concept of combining patients with and without treatment preference gives rise to a lot of methodological issues but is the only way to find out whether participation in the therapeutic decision-making process is beneficial to the patient or not.

[Thrombolysis in acute myocardial infarct. An improved long-term prognosis following balloon dilatation]. / Thrombolyse bei akutem Herzinfarkt. Verbesserte Langzeitprognose nach Ballondilatation.

UNLABELLED: A systemic and intracoronary thrombolytic treatment was carried out in 217 patients with acute transmural myocardial infarction between March 1980 and March 1985. 141 patients were only treated with thrombolysis, and 76 were additionally treated by balloon dilation in the same session. Indications for additional balloon dilation were unsuccessful thrombolysis as well as a residual stenosis of more than 50% after primarily successful thrombolysis. Age, sex, proportion of patients with anterior and posterior wall infarction as well as with 1, 2 and 3-vessel disease did not significantly differ in the two groups. The result of therapy (complete reperfusion) was less after thrombolysis than after thrombolysis with balloon dilation (63% as compared to 88%, P less than 0.0003). The patients who were only treated with thrombolysis had a more unfavorable three-year actuarial survival than those in whom thrombolysis and balloon dilation were carried out (70% as compared to 90%, P less than 0.02). CONCLUSION: additional balloon dilation in thrombolytic treatment of acute transmural myocardial infarction improves the long-term prognosis.

Overview of randomized trials of postoperative adjuvant radiotherapy in breast cancer.

An overview of the mortality results of the mature trials in which radiotherapy was a randomized option after simple or radical mastectomy is presented. The principal aim of the overview was to study long-term survival, and recent trials, often including chemotherapy options, have not been included. A total of 7941 patients were entered into these trials and 4148 deaths occurred. No differences were found in survival in the first 10 years of follow-up, in trials employing either radical mastectomy or simple mastectomy. Follow-up information after 10 years came mostly from trials employing radical mastectomy with or without irradiation, and in these trials a significant excess of deaths was observed among patients given radiotherapy (P less than 0.001, all trials; P = 0.002, radical mastectomy trials only). Further data collection will be necessary to determine which causes of death are elevated.

[Determinants of long-term prognosis following prosthetic mitral valve replacement]. / Determinanten der Langzeitprognose nach prothetischem Mitralklappenersatz.

UNLABELLED: Data of 235 patients with chronic mitral valve disease (NYHA class III or IV) were analyzed retrospectively. Mitral valve replacement was performed in all patients between 1974 and 1983, 46 patients underwent additional tricuspid valve repair during the same operation. Preoperatively, right and left heart catheterization as well as coronary angiography were carried out in all patients. Operative mortality was 8%. For all patients 5 year survival rate was 76% and 10 year survival rate was 72%. Patients with pure mitral insufficiency had a poorer long-term prognosis than patients with mitral stenosis or patients with mixed mitral valve disease (5 year survival rate 54 versus 79%, p less than 0.0014). Patients with previous closed mitral commissurotomy had a poorer long-term prognosis than patients without previous surgery (5 year survival rate 62 versus 81%, p less than 0.0019). Age, NYHA class, associated tricuspid valve repair, pulmonary vascular resistance and mean right atrial pressure had no effect on survival. CONCLUSION: Long-term survival is generally good after mitral valve replacement, but pure mitral insufficiency and previous closed mitral commissurotomy are risk factors for long-term prognosis.

[What effect does impaired left ventricular function have on prognosis following prosthetic aortic valve replacement?]. / Welchen Effekt hat eine eingeschränkte linksventrikuläre Funktion auf die Prognose nach prothetischem Aortenklappenersatz?

Data of 286 patients with advanced chronic aortic valve disease (NYHA class III or IV) who underwent aortic valve replacement between 1975 and 1982 were retrospectively analyzed using a multivariate Cox regression analysis. Preoperatively, left ventricular volumes and ejection fraction were determined angiographically in all patients. In patients with aortic stenosis and impaired left ventricular ejection fraction survival rate up to 7 years was identical as compared to those with aortic stenosis and normal ejection fraction. Survival rate in patients with aortic stenosis who were operated within 76 days after heart catheterization was better than in those who were operated after a longer time interval (p less than 0.05). In patients with aortic insufficiency and impaired left ventricular ejection fraction, prognosis was poorer after operation than in patients with aortic insufficiency and normal ejection fraction (p = 0.05). Thus, patients with advanced aortic stenosis should be operated as soon as the diagnosis is established. Impaired left ventricular ejection fraction is not a risk factor for prognosis after valve replacement for aortic stenosis. In contrast, in patients with aortic insufficiency left ventricular dysfunction is a risk factor for prognosis after operation.

[Surgical indications in mitral valve stenosis, combined mitral valve defect or mitral valve insufficiency. Long-term prognosis of operated or drug-treated patients]. / Zur Operationsindikation bei Mitralklappenstenose, kombiniertem Mitralklappenfehler oder Mitralklappeninsuffizienz. Langzeitprognose operierter oder medikamentös behandelter Patienten.

Data obtained from 683 patients with mitral valve disease, NYHA-class III or IV, were retrospectively studied by means of a multivariate Cox regression analysis. Based on symptoms and hemodynamic findings, surgical intervention had been recommended for all patients: closed mitral commissurotomy (n = 361), prosthetic mitral valve replacement (n = 241) and prosthetic mitral valve replacement together with a corrective procedure for the tricuspid valve (n = 81). While the majority of patients underwent surgery during the observation period (n = 528), a substantial number of patients continued on medical treatment (n = 155). The mean observation periods were 52, 49 and 31 months, respectively, in the three collectives. Surgically treated patients in whom closed mitral commissurotomy had been recommended had a better prognosis (p less than 0.0003) than those treated medically (five-year survival rate 89% vs. 63%). Age, clinical severity, previous mitral commissurotomy, pulmonary vascular resistance and right atrial mean pressure had no significant influence on prognosis. In patients in whom prosthetic mitral valve replacement had been recommended, surgical treatment led only to tendencial improvement in prognosis as compared with those treated medically (five-year survival rate 78% vs. 61%). Factors with an unfavorable influence on prognosis were age more than 49 years (p less than 0.05), pure mitral regurgitation (p less than 0.001), NYHA-class IV (p less than 0.02) and right atrial mean pressure in excess of 4 mm Hg (p less than 0.01). In patients in whom prosthetic mitral valve replacement together with a corrective procedure for the tricuspid valve had been considered necessary, surgical treatment had no significant influence on prognosis as compared with those treated medically (five-year survival rate 57% vs. 53%). Patients in whom previous mitral commissurotomy had been performed had an extremely poor prognosis (p less than 0.001). Pulmonary vascular resistance was significantly reduced both after mitral commissurotomy as well as after prosthetic mitral valve replacement; this was associated with a significant decrease in right atrial mean pressure and increase in right ventricular ejection fraction. The indication for closed mitral commissurotomy, thus, appears established in patients with symptoms of class III or IV clinical severity. The indication can be established generously since the surgical mortality is low and long-term prognosis is good.(ABSTRACT TRUNCATED AT 400 WORDS)

[Long-term prognosis of drug and surgery treated patients with acquired aortic valve diseases: survival statistics and multivariate Cox regression analysis]. / Langzeitprognose medikamentös und chirurgisch behandelter Patienten mit erworbenen Aortenklappenfehlern: Uberlebensstatistik und multivariate Cox-Regressionsanalyse.

Data of 417 patients with advanced chronic aortic valve disease were retrospectively analyzed using a life table and Cox regression analysis. Aortic valve replacement was recommended to all patients based on clinical and hemodynamic findings. While most patients underwent prosthetic aortic valve replacement (n = 349), a minority of patients was treated medically (n = 68). Prognosis was better (p less than 0.01 in the Cox model) in surgically treated as compared to medically treated patients with aortic stenosis (4-year survival rate 82 versus 44%). In patients with aortic insufficiency no significant difference of long-term prognosis was found between surgically and medically treated patients.

[Long-term prognosis of acute transmural myocardial infarct after intracoronary thrombolysis treatment]. / Langzeitprognose des akuten transmuralen Herzinfarktes nach intrakoronarer Thrombolysebehandlung.

Reperfusion of the infarct vessel by a combination of intravenous and intracoronary infusion of streptokinase succeeded in 66 of 120 patients with acute transmural infarction in whom the infusion had been started less than six hours after onset of symptoms. The recanalization attempt failed in 26, and 28 were treated conventionally. Size of the infarct was determined by 201Thallium scanning before and 48 hours after the acute treatment phase. Cox analysis indicated that successful recanalization had a significantly positive effect on the long-term prognosis compared with failed thrombolysis or conventional measures. The perfusion defect (as measured by 201Thallium scan) was identical in all three groups, but after successful recanalization with streptokinase it was significantly smaller than in the other two groups. The improved long-term prognosis is presumably due to a decrease in the size of the infarct.

Determinants of survival in patients with congestive cardiomyopathy: quantitative morphologic findings and left ventricular hemodynamics.

We analyzed data from 68 consecutive patients with congestive cardiomyopathy to evaluate the prognostic significance of quantitative morphologic findings in left ventricular myocardium as compared with the prognostic significance of left ventricular hemodynamics. Left ventricular endomyocardial biopsy specimens were obtained from all patients during diagnostic heart catheterization. Myocardial fiber diameter, volume fraction of interstitial fibrosis, and intracellular volume fraction of myofibrils were determined by light-microscopic morphometry. All patients had normal coronary arteriograms, but reduced left ventricular ejection fractions. There were 23 deaths during a mean follow-up period of 1124 days. Multivariate regression analysis (Cox model) revealed that left ventricular ejection fraction (p less than .00001) and left ventricular systolic pressure (p less than .01), but not morphometric findings in biopsy specimens, were independent predictors of cardiac death. Thus, morphologic findings in the left ventricular myocardium do not contribute significantly to the prognostic evaluation in patients with congestive cardiomyopathy studied by hemodynamic and angiographic methods.

[Methodology of controlled clinical studies on the primary treatment of operable breast cancer]. / Zur Methodologie kontrollierter klinischer Studien über die Primärbehandlung des operablen Mammakarzinoms.

We discuss in this paper the thesis that the underlying questions in breast cancer clinical trials are complex in nature and that multivariate procedures are required for statistical analysis. The variety of statistics resulting from multiple significance testing may be insufficient and misleading. Analysis using multivariate methods centres around interactions between treatments and prognostic factors, time dependence of treatment effects, multi-state models of the disease process, and problems of quality of life. Interpretation of results is not an easy task, as can be shown by some recent examples in the field. In the Federal Republic of Germany full informed consent will have to be taken into account. Emphatically we reject the often held view that legal problems can be bypassed by using historical controls instead of controlled clinical trials. As an alternative we favour the concept of a comprehensive cohort study with a randomised trial being just a part of it.

[The value of radiotherapy after modified radical mastectomy. 10-year results of the Heidelberg study]. / Der Wert der Strahlentherapie nach modifiziert radikaler Mastektomie. 10-Jahres-Ergebnisse der Heidelberger Studie.

Modified radical mastectomy was performed in 142 female patients with operable carcinoma of the breast. One of the two prospectively randomised groups received postoperative radiotherapy with 6000 rad. Survival rates were equal for both groups. Follow-up radiotherapy had a beneficial influence on survival rate and rate of distant metastases in median tumour sites. In lateral tumour localization the course of disease was less favourable with radiotherapy than without. Local relapse rates were slightly, however not significantly, lower after irradiation. The decisive prognostic criterium is T- and N-stage at the time of diagnosis.