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Diegeler A.,Herz und Gefass Klinik Bad Neustadt | Borgermann J.,Herz und Diabeteszentrum Bad Oeynhausen | Kappert U.,Herzzentrum Dresden | Breuer M.,Universitatsklinik Jena | And 11 more authors.
New England Journal of Medicine | Year: 2013

BACKGROUND: The benefits of coronary-artery bypass grafting (CABG) without cardiopulmonary bypass in the elderly are still undetermined. METHODS: We randomly assigned patients 75 years of age or older who were scheduled for elective first-time CABG to undergo the procedure either without cardiopulmonary bypass (off-pump CABG) or with it (on-pump CABG). The primary end point was a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 30 days and at 12 months after surgery. RESULTS: A total of 2539 patients underwent randomization. At 30 days after surgery, there was no significant difference between patients who underwent off-pump surgery and those who underwent on-pump surgery in terms of the composite outcome (7.8% vs. 8.2%; odds ratio, 0.95; 95% confidence interval [CI], 0.71 to 1.28; P = 0.74) or four of the components (death, stroke, myocardial infarction, or new renal-replacement therapy). Repeat revascularization occurred more frequently after off-pump CABG than after on-pump CABG (1.3% vs. 0.4%; odds ratio, 2.42; 95% CI, 1.03 to 5.72; P = 0.04). At 12 months, there was no significant between-group difference in the composite end point (13.1% vs. 14.0%; hazard ratio, 0.93; 95% CI, 0.76 to 1.16; P = 0.48) or in any of the individual components. Similar results were obtained in a per-protocol analysis that excluded the 177 patients who crossed over from the assigned treatment to the other treatment. CONCLUSIONS: In patients 75 years of age or older, there was no significant difference between on-pump and off-pump CABG with regard to the composite outcome of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy within 30 days and within 12 months after surgery. (Funded by Maquet; GOPCABE ClinicalTrials.gov number, NCT00719667). Copyright © 2013 Massachusetts Medical Society.

Dieckmann K.-P.,Albertinen Krankenhaus Hamburg | Dralle-Filiz I.,Albertinen Krankenhaus Hamburg | Matthies C.,Bundeswehr Krankenhaus Hamburg | Heinzelbecker J.,Saarland University | And 5 more authors.
Journal of Cancer Research and Clinical Oncology | Year: 2016

Purpose: Clinical stage 1 (CS1) testicular seminoma involves an almost 100 % disease-specific survival in controlled clinical trials. We aimed to find out whether these results can be matched in patients managed on the routine care level. Patients, methods: In total, 725 patients with seminoma CS1 were prospectively enrolled from 130 institutions. Adjuvant management as decided by local physicians involved surveillance (n = 256), radiotherapy (41), 1× Carboplatin (362), and 2× Carboplatin (66). We registered type of management, age, duration of follow-up (F/U), relapse, rete testis invasion (RTI), and tumor size. Actuarial relapse-free survival curves were calculated for treatment modalities and stratified for tumor sizes and RTI. A Cox regression model was calculated to explore for factors influencing relapses. Results: Disease-specific survival was 100 %. Crude relapse rates were 8.2, 2.4, 5.0, and 1.5 % for surveillance, radiotherapy, 1× Carboplatin, and 2× Carboplatin after a median F/U of 30 months. RTI and tumor size were not associated with progression in surveillance patients. One course Carboplatin caused relapses in 6.8 % in tumor sizes >4 cm and 9.3 % (actuarial 13 %) in sizes >5 cm. The Cox model revealed the association of tumor size with recurrence in the entire seminoma population (Hazard ratio 1.17; 95 % confidence intervals 1.03–1.33). Conclusions: The overall outcome of CS1 seminoma managed on the routine care level mirrors that of controlled trials. Unexpectedly, the risk factors in surveillance patients were not confirmed, but tumor size proved to be a risk indicator in the entire group of seminoma. Importantly, one course Carboplatin involved low efficacy to control the disease in large tumors. © 2016 The Author(s)

Dieckmann K.-P.,Albertinen Krankenhaus Hamburg | Struss W.J.,Albertinen Krankenhaus Hamburg | Budde U.,Medilys Laborgemeinschaft MbH
Anticancer Research | Year: 2011

Background: Acute early vascular toxicity of chemotherapy for germ cell tumour (GCT) is poorly understood. To explore the pathogenesis of this complication we evaluated laboratory parameters associated with vascular disease. Patients and Methods: In 33 GCT patients the following parameters were investigated with routine laboratory methods before and after chemotherapy: von Willebrand factor antigen (vWF:AG), collagen binding capacity (vWF:CB), lipoprotein (a), homocysteine, plasminogen activator inhibitor I, total cholesterol, high density lipoprotein, low density lipoprotein, troponine I. Statistical evaluation involved descriptive analysis and the Wilcoxon signed rank test. Results: Levels of vWF:AG and vWF:CB increased significantly upon therapy (p=0.002). All other parameters remained unchanged. Upon late measurement, vWF:AG and vWF:CB were normalised. Conclusion: As von Willebrand factor is released from endothelial cells upon damage, we postulate that early vascular toxicity of chemotherapy is caused by direct damage of the vascular endothelium. Long-term vascular complications of chemotherapy appear to be different, pathogenetically.

Dieckmann K.-P.,Albertinen Krankenhaus Hamburg | Gerl A.,Onkologische Schwerpunktpraxis Munich | Witt J.,Albertinen Krankenhaus Hamburg | Hartmann J.-T.,Universitatsklinik Tubingen
Annals of Oncology | Year: 2010

Background: Chronic vascular morbidity resulting from chemotherapy for testicular germ-cell cancer (TGCC) is recognized. Cardiovascular events (CVEs) occurring early during chemotherapy are less understood. We evaluated the incidence and clinical features of CVEs associated with chemotherapy of TGCC. Patients and methods: A questionnaire was sent to 355 institutions in Germany to explore for early CVEs occurring during 1996-2008. To assess the relative incidence of CVEs, the number of events was put into relation to the total number of patients treated during the time span (n = 8233, calculated from national database). The response rate was 79%. Results: Twenty cases with myocardial infarction (MI), 3 with cerebral stroke, and 2 with arterial thrombosis were recorded. The estimated incidence of MI and of all CVEs during chemotherapy is 0.24% [95% confidence intervals (CIs) 0.137% to 0.349%] and 0.30% (95% CI 0.188% to 0.423%), respectively. This estimate represents a minimum figure because the calculation is on the basis of simplifications. Six MI patients had no risk factors. Coronary angiography was indicative of thromboembolic rather than atherosclerotic origin of MI. Conclusions: There is a small but definite risk of major early CVE associated with chemotherapy of TGCC. Physicians caring for TGCC patients must be aware of this hazard. © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Ruf C.G.,Armed Forces Hospital Hamburg | Gnoss A.,Albertinen Krankenhaus Hamburg | Hartmann M.,University of Hamburg | Matthies C.,Armed Forces Hospital Hamburg | And 4 more authors.
Andrology | Year: 2015

The precursor of testicular germ cell tumours (GCTs), called testicular intra-epithelial neoplasia (TIN/CIS), is safely diagnosed immunohistologically. Testicular biopsy provides a valuable tool for early detection of GCTs in risk groups. Although this knowledge is undisputed, testicular biopsies are utilized poorly. The patterns of care regarding the use of biopsies remain unknown. Uncertainty exists about the prevalence and specific treatment of TIN/CIS. We asked clinical urologists in Germany whether or not they employed contralateral biopsies in GCT patients. We evaluated the prevalence of contralateral TIN/CIS in a retrospective analysis of 780 consecutive GCT patients. All had contralateral double biopsies. Discordance of TIN/CIS findings among biopsy pairs as well as age, histology of the primary tumour and clinical stage was noted. Evaluation of data comprised descriptive statistical methods. To evaluate treatment options for TIN/CIS, we performed a literature search. 52.1% of German urologists always perform the biopsy, 17% do it mostly, 27.3% in select cases, 3.5% never. Curiously, there was a geographic north-south gradient regarding biopsy use. Contralateral TIN/CIS was found in 5%. The median ages of patients with TIN/CIS and those without were 31.8 and 34.9 years respectively (p = 0.02). The discordance rate among biopsy pairs was of 33%. Two-site biopsies provide a 17% gain in diagnostic sensitivity. Local radiotherapy with 20 Gy is the safest treatment of TIN/CIS failing in 2%. Chemotherapy has significantly lower efficacy. Contralateral testicular biopsies in GCT patients are well accepted among German urologists. The prevalence of contralateral TIN/CIS found in this series is in accordance with previous reports. Double biopsies should be the diagnostic standard because of their diagnostic superiority. Local radiotherapy with 20 Gy is the safest way of eradicating TIN/CIS. Failures occur in only 2%, usually many years after irradiation. Cisplatin-based chemotherapy is dose dependent and less effective. © 2014 American Society of Andrology and European Academy of Andrology.

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