Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study.

BACKGROUND: In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. PATIENTS AND METHODS: The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. RESULTS: The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. CONCLUSIONS: In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile.

[Mentoring and workplace-based assessments for final year medical students : An effective way to increase satisfaction and competence?] / Mentoring und arbeitsplatzbasierte Prüfungen im Praktischen Jahr : Ein effektiver Weg zur Steigerung von Zufriedenheit und Kompetenz?

BACKGROUND: The final year of medical training in Germany is one of the least structured and standardized years of medical school. Medical students often complain about a lack of guidance, supervision and feedback. They are mostly asked to perform delegable nonmedical tasks even though student experiences in this period critically determine future decisions for certain medical specialties. Consequently, right from the beginning many young professionals feel overburdened especially by the time pressure of everyday clinical practice. The planned amendment of the medical licensing regulations will make competence-based training even more important. This article therefore aims to examine the extent to which a mentoring-based curriculum with workplace-based examinations during the final year of medical studies can make a valuable contribution to this. METHODS: After a needs assessment (structured literature search, results evaluation and focus groups with both students and medical specialists), a mentoring-based curriculum for final year medical students was developed following the Kern cycle. In 2 work sessions 10 discipline-specific competencies for the fields of anesthesiology, critical care, emergency and pain medicine were established and prioritized, which had to be mastered by every student independently at the end of the training period. Assessment of these competencies was performed on a regular basis by trained mentors in the form of workplace-based assessments (mini-clinical evaluation exercise, mini-CEX, direct observation of procedural skills, DOPS). Multiperspective evaluation was and is the foundation of continuous program development. By September 2019 a total of 40 students had completed the modified curriculum and were subsequently interviewed online about various aspects of the tertial. RESULTS: The response rate to the survey was 80% (n = 32). The gender ratio was balanced (male = 50%, female = 50%). Prioritization and assessment of 10 competencies by trained mentors enabled a focused, demand-driven and high-quality training of final year medical students. Surveyed students found the section mentoring and feedback to be very positive and it supported their learning success (grade 1.5). Despite firmly established feedback structures, in retrospect almost half (51.6%) wanted more structured feedback. Workplace-based assessments were mostly previously unknown (64.6%) but were experienced as helpful and meaningful (76.7%). Students felt confident and prepared for the final state examination (81.3%) and their career start (71.0%) after being part of the program. These findings were accompanied by a high level of satisfaction (grade 1.7) as well as a high recommendation rate for this institution (as a training program for final year medical students and as a career start for residents, both with 93.7%). Thus, the good evaluation results of the department before the start of the project could again be slightly improved. CONCLUSION: A demand-driven, mentoring-based curriculum with integrated workplace-based assessments not only led to high overall student satisfaction but also promoted the quality of teaching in an effective and resource-saving way. Mentoring promotes learning success mainly through feedback and individual learning support and also supports the communicative and social skills of students and mentors alike.

Heart failure among people with Type 2 diabetes mellitus: real-world data of 289 954 people from a diabetes database.

AIM: Comparing people with Type 2 diabetes mellitus with and without heart failure in terms of metabolic control, therapeutic regimen and comorbidities. METHODS: The Prospective Diabetes Registry (DPV) is a longitudinal documentation system for demographics, medical care and outcome in people with diabetes mellitus. It consists of follow-up data from people with diabetes mellitus who have agreed to be recorded in the registry. Clinical data are submitted by general practitioners, specialists and clinics throughout Germany and Austria. Some 289 954 people with Type 2 diabetes mellitus (years 2000 to 2015) were analysed using demographic statistics and adjustment for confounders based on linear and logistic regression analysis. RESULTS: People with Type 2 diabetes mellitus (ICD code: E11) and heart failure (ICD code: I50) (N = 14 723) were older, more often women and presented with longer diabetes duration compared with those without heart failure. After adjustment for age, gender and diabetes duration, people with heart failure showed lower HbA1c , higher BMI and more intense insulin therapy. Analysis revealed that people with heart failure were more often treated with insulin, and more frequently received anti-hypertensives and lipid-lowering medication. They presented with lower systolic and diastolic BP. People with heart failure more frequently showed a history of comorbidities. CONCLUSION: Heart failure is common in diabetes mellitus, but the prevalence in the DPV is lower frequent than expected. The reason for improved metabolic control in heart failure may be intensified therapy with insulin, lipid-lowering medication and anti-hypertensives in this cohort.

[Systemic and local therapy options for sudden sensorineural hearing loss in diabetics]. / Systemische und lokale Hörsturztherapie bei Diabetes mellitus.

Sudden sensorineural hearing loss is not an emergency, but an urgency. Depending on severity, the disease may have a major impact on quality of life. Gold standard in Germany is a systemic, high-dosage glucocorticoid therapy. During oral or intravenous therapy with glucocorticoids, systemic side effects may occur. Especially in diabetics, this therapy may cause acute prominent disorders in glucose metabolism and therefore may be contraindicated. An alternative therapeutic option is intratympanic injection of steroids into the middle ear. Hereby the systemic side effects are absent and only local otologic complications may occasionally occur.

An interdisciplinary review of current and future approaches to improving human-predator relations.

In a world of shrinking habitats and increasing competition for natural resources, potentially dangerous predators bring the challenges of coexisting with wildlife sharply into focus. Through interdisciplinary collaboration among authors trained in the humanities, social sciences, and natural sciences, we reviewed current approaches to mitigating adverse human-predator encounters and devised a vision for future approaches to understanding and mitigating such encounters. Limitations to current approaches to mitigation include too much focus on negative impacts; oversimplified equating of levels of damage with levels of conflict; and unsuccessful technical fixes resulting from failure to engage locals, address hidden costs, or understand cultural (nonscientific) explanations of the causality of attacks. An emerging interdisciplinary literature suggests that to better frame and successfully mitigate negative human-predator relations conservation professionals need to consider dispensing with conflict as the dominant framework for thinking about human-predator encounters; work out what conflicts are really about (they may be human-human conflicts); unravel the historical contexts of particular conflicts; and explore different cultural ways of thinking about animals. The idea of cosmopolitan natures may help conservation professionals think more clearly about human-predator relations in both local and global context. These new perspectives for future research practice include a recommendation for focused interdisciplinary research and the use of new approaches, including human-animal geography, multispecies ethnography, and approaches from the environmental humanities notably environmental history. Managers should think carefully about how they engage with local cultural beliefs about wildlife, work with all parties to agree on what constitutes good evidence, develop processes and methods to mitigate conflicts, and decide how to monitor and evaluate these. Demand for immediate solutions that benefit both conservation and development favors dispute resolution and technical fixes, which obscures important underlying drivers of conflicts. If these drivers are not considered, well-intentioned efforts focused on human-wildlife conflicts will fail.

Relationship between weight change and glycaemic control in patients with type 2 diabetes receiving once-weekly dulaglutide treatment.

AIM: To assess the relationship between weight change and glycated haemoglobin (HbA1c) change in dulaglutide-treated patients by analysing data from six head-to-head phase III AWARD clinical trials. METHODS: At 26 weeks, the relationship between weight and HbA1c was analysed in each trial rather than by pooling data because of differences in design and background therapy. The effect of baseline characteristics was also evaluated with regard to weight and HbA1c response. RESULTS: Across the studies, 87-97% and 83-95% of patients treated with dulaglutide 1.5 and 0.75 mg, respectively, had reductions in HbA1c levels, while 57-88% and 43-84% of patients treated with dulaglutide 1.5 and 0.75 mg, respectively, experienced weight loss. The majority (55-83%) of patients receiving dulaglutide 1.5 mg experienced weight loss and HbA1c reductions, while 41-79% of patients in the dulaglutide 0.75 mg arm lost weight and had reductions in HbA1c level. A weak and inconsistent correlation was observed between the changes in weight and HbA1c (range from -0.223 to 0.267) in patients treated with dulaglutide. The baseline characteristics of gender, age, duration of diabetes, HbA1c, body weight and BMI were not related to different combinations of weight and HbA1c responses. CONCLUSIONS: Dulaglutide is an effective treatment option across the type 2 diabetes treatment spectrum. Dulaglutide showed dose-dependent effects on both weight loss and HbA1c reduction. These effects had a weak correlation and appeared to be independent.

[Indications and results of endovascular therapy of critical limb ischemia]. / Indikationen und Ergebnisse der endovaskulären Therapie der kritischen Extremitätenischämie.

BACKGROUND: Critical limb ischemia (CLI) is the most severe form of peripheral artery occlusive disease and is characterized by high amputation, morbidity and mortality rates. Therefore, revascularization is the essential step in therapy for retention of the affected limb. OBJECTIVES: Although for a long time bypass surgery represented the gold standard in the treatment of CLI, in recent years there has been a disproportionate increase of endovascular treatment despite the lack of level-data. In this review the indications and results of endovascular therapy of CLI are presented on the basis of published data. METHODS: A literature search was carried out to identify publications that compared the results of endovascular and surgical therapy as well as observational studies about different endovascular techniques. RESULTS: The BASIL study provided the highest quality data comparing endovascular and surgical treatment of CLI. The long-term data of the BASIL trial showed that apart from patients with a suitable vein and a life expectancy of more than 2 years, first line endovascular therapy is equivalent to surgical treatment. The equivalence could also be demonstrated in a meta-analysis comparing operative and endovascular treatment of CLI. CONCLUSION: The CLI is a disease with high mortality and morbidity risks. Due to the comparable amputation-free survival times with lower complication rates in the published data, in most patients an endovascular first strategy in experienced centers can be justified.

Constitutive and inducible co-expression systems for non-viral osteoinductive gene therapy.

Tissue regenerative gene therapy requires expression strategies that deliver therapeutic effective amounts of transgenes. As physiological expression patterns are more complex than high-level expression of a singular therapeutic gene, we aimed at constitutive or inducible co-expression of 2 transgenes simultaneously. Co-expression of human bone morphogenetic protein 2 and 7 (BMP2/7) from constitutively expressing and doxycycline inducible plasmids was evaluated in vitro in C2C12 cells with osteocalcin reporter gene assays and standard assays for osteogenic differentiation. The constitutive systems were additionally tested in an in vivo pilot for ectopic bone formation after repeated naked DNA injection to murine muscle tissue. Inductor controlled differentiation was demonstrated in vitro for inducible co-expression. Both co-expression systems, inducible and constitutive, achieved significantly better osteogenic differentiation than single factor expression. The potency of the constitutive co-expression systems was dependent on relative expression cassette topology. In vivo, ectopic bone formation was demonstrated in 6/13 animals (46% bone formation efficacy) at days 14 and 28 in hind limb muscles as proven by in vivo µCT and histological evaluation. In vitro findings demonstrated that the devised single vector BMP2/7 co-expression strategy mediates superior osteoinduction, can be applied in an inductor controlled fashion and that its efficiency is dependent on expression cassette topology. In vivo results indicatethatco-expression of BMP2/7 applied by non-viral naked DNA gene transfer effectively mediates bone formation without the application of biomaterials, cells or recombinant growth factors, offering a promising alternative to current treatment strategies with potential for clinical translation in the future.

Preoperative left ventricular hypertrophy is associated with reduced patient survival after liver transplantation.

UNLABELLED: Left ventricular hypertrophy (LVH) has been described in the context of cirrhotic cardiomyopathy. The influence of LVH on survival of liver transplant (LT) recipients has not been clarified. Therefore, we evaluated the effect of LVH on survival in LT recipients. In total, data from 352 LT patients were analyzed. LVH was diagnosed by echocardiographic measurement of left ventricular wall thickness before LT. Patients were followed up for a mean of 4.2 yr. LVH was diagnosed in 135 (38.4%) patients. Patients with LVH had significantly more frequently male gender (p = 0.046), diastolic dysfunction (p < 0.001), and hepatocellular carcinoma (HCC; p = 0.004). Furthermore, LVH patients were older (p < 0.001) and had a higher body mass index (BMI; p = 0.001). There was no difference in frequency of arterial hypertension, pre-transplant diabetes mellitus, or etiology of liver cirrhosis. Patients without LVH had a better survival (log rank: p = 0.05) compared with LVH patients. In a multivariate Cox regression LVH (p = 0.031), end-stage renal disease (ESRD; p = 0.003) and lack of arterial hypertension (p = 0.004) but not MELD score (p = 0.885) were associated with poorer survival. CONCLUSION: LVH is frequently diagnosed in patients on the waiting list and influences survival after LT.

[The transition of palliative care from the hospital to the ambulatory care of the general practitioner: the experience in the canton of Fribourg]. / Soins palliatifs: de l'hôpital de soins aigus au cabinet du praticien. L'expérience fribourgeoise.

Thanks to medical progress, the life expectancy of a majority of severely ill patients has greatly improved. The fact that these patients will live longer with their disease encourages new solutions to respond to the challenges of care continuity, coordination, interprofessional and interinstitutional collaboration. Palliative care represents a chain management based on the involvement of every professional in acute care hospitals, palliative care units, nursing homes and private homes. The collaboration among the different players as well as their education are essential elements linked to the quality of care, to the quality of life for both patients and their relatives.

Deregulation of DNA-dependent protein kinase catalytic subunit contributes to human hepatocarcinogenesis development and has a putative prognostic value.

BACKGROUND: The DNA-repair gene DNA-dependent kinase catalytic subunit (DNA-PKcs) favours or inhibits carcinogenesis, depending on the cancer type. Its role in human hepatocellular carcinoma (HCC) is unknown. METHODS: DNA-dependent protein kinase catalytic subunit, H2A histone family member X (H2AFX) and heat shock transcription factor-1 (HSF1) levels were assessed by immunohistochemistry and/or immunoblotting and qRT-PCR in a collection of human HCC. Rates of proliferation, apoptosis, microvessel density and genomic instability were also determined. Heat shock factor-1 cDNA or DNA-PKcs-specific siRNA were used to explore the role of both genes in HCC. Activator protein 1 (AP-1) binding to DNA-PKcs promoter was evaluated by chromatin immunoprecipitation. Kaplan-Meier curves and multivariate Cox model were used to study the impact on clinical outcome. RESULTS: Total and phosphorylated DNA-PKcs and H2AFX were upregulated in HCC. Activated DNA-PKcs positively correlated with HCC proliferation, genomic instability and microvessel density, and negatively with apoptosis and patient's survival. Proliferation decline and massive apoptosis followed DNA-PKcs silencing in HCC cell lines. Total and phosphorylated HSF1 protein, mRNA and activity were upregulated in HCC. Mechanistically, we demonstrated that HSF1 induces DNA-PKcs upregulation through the activation of the MAPK/JNK/AP-1 axis. CONCLUSION: DNA-dependent protein kinase catalytic subunit transduces HSF1 effects in HCC cells, and might represent a novel target and prognostic factor in human HCC.

Ambiguous genitalia and hypertension in a patient with congenital adrenal hyperplasia.

Congenital adrenal hyperplasia (CAH) is an uncommon condition. Its clinical presentation with hypertension is rare. Deficiency of the steroid 11-beta-hydroxylase accounts for less than 10% of CAH. We report a case of a 19-year-old patient who presents with hypertension with ambiguous genitalia secondary to adrenal steroidogenesis dysfunction. We also discuss the defects in adrenal steroidogenesis and clinical phenotypes of CAH.

Pharmacotherapy for sarcoidosis: an example of an off-label procedure.

Sarcoidosis is a granulomatous multiorgan diseases with an unknown etiology, with the predominant lung involvement. Immunosuppressive agents such as corticosteroids, methotrexate, azathioprinum, ciclosporinum A, chlorambucil, cyclophosphamide, hydroxychlorochinum, indomethacin, pentoxyfillinum, thalidomide, leflunomidum, and adalimumab, or infliximab have been used in its treatment. It should be emphasized that the Summary of Products Characteristics (SPC) of these drugs does not specifically recommend their use in the therapy for sarcoidosis. That makes the application of the drugs in sarcoidosis an off-label use, which is not formally accepted by the authorities but is supported by medical bibliography or recommendations given by scientific bodies. Thus the off-label drugs raise legal, but also ethical and medical problems. The dosing regimen and the required duration of therapy for sarcoidosis are missing. In effect the therapy usually follows the recommendations from the American and European Respiratory Societies (ATS/ERS), based on the long-term medical research. The American Food and Drug Administration recognizes the existence of the off-label use. European legislations do not precisely specify the rules for the admissibility of the off-label use. The doctrine of law assumes that the off-label use constitutes a medical experiment. Therefore, the commencement of therapy with such drugs requires patients' informed consent, which must be kept along with other medical records. Insufficient knowledge of the legal regulations may result in civil and professional liability of a physician supervising the therapy of a sarcoidosis patient, especially in case of adverse effects.

Sarcoidosis and tuberculosis: a connection to the human leukocyte antigen system.

Infectious, genetic factors, and autoimmunity have been considered as potential causes of sarcoidosis (SA). Pathological similarities between SA and tuberculosis (TB) suggest M. tuberculosis antigen(s) as causative agent(s). Our published comparative analysis of the human leukocyte antigens (HLA) system in patients with SA or TB in the same ethnic group revealed that some antigens were connected with high risk of developing of SA or TB, but other were comparable in both patient populations. Is it possible that the predominating occurrence of HLA antigens characteristic for TB may cause tuberculosis in patients with SA? To answer this question we evaluated the HLA class I and II alleles frequency by PCR amplification with sequence-specific primers in three women with histopathologically proven pulmonary SA, who developed bacteriologically confirmed TB on a corticosteroids (CS) therapy. Analysis of HLA in every case separately revealed a trend for higher occurrence of both alleles predisposing and protecting from TB than SA, in comparison with healthy individuals in our previously mentioned HLA genotyping study. Overall, the number of alleles predisposing to TB was statistically greater than the number of alleles connected with a high risk of developing SA. Also, the frequency of protecting alleles was statistically higher for TB than for SA. Therefore, SA in these patients developed at first, and the presence of additional environmental factors, e.g., age, CS might decrease an immune response and provoked TB. There is a possibility that the occurrence of HLA antigen more associated with high risk of developing TB than SA causes the development of tuberculosis in our patients with sarcoidosis.

[Aspects of perioperative care in patients with diabetes]. / Aspekte der perioperativen Behandlung von Diabetespatienten.

Diabetes is a common disease in Germany. Due to diabetes-associated end-organ disease, such as large and small vessel disease and neuropathy, diabetic patients require more intense anesthesia care during the perioperative phase. An in-depth and comprehensive medical history focusing on hemodynamic alterations, gastroparesis, neuropathy and stiff joint syndrome is a cornerstone of perioperative care and may affect outcome of diabetes patients more than specific anesthetic medications or the anesthetic procedure. Intraoperative anesthetic care needs to focus on preservation of hemodynamic stability, perioperative infection control and maintenance of glucose homeostasis. Whereas some years ago strict glucose control by aggressive insulin therapy was adamantly advocated, the results of recent studies have put the risk of such therapeutic algorithms into perspective. Therefore, optimized perioperative care of diabetic patients consists of setting a predefined targeted blood glucose level, evidence-based therapeutic approaches to reach that goal and finally adequate and continuous monitoring and amendment of the therapeutic approach if required.

Novel fatty acid gentamicin salts as slow-release drug carrier systems for anti-infective protection of vascular biomaterials.

Infections of vascular prostheses are still a major risk in surgery. The current work presents an in vitro evaluation of novel slow release antibiotic coatings based on new gentamicin fatty acid salts for polytetrafluoroethylene grafts. These grafts were coated with gentamicin sodium dodecyl sulfate, gentamicin laurate and gentamicin palmitate. Drug release kinetics, anti-infective characteristics, biocompatibility and haemocompatibility of developed coatings were compared to commercially available gelatin sealed PTFE grafts (SEALPTFE™) and knitted silver coated Dacron(®) grafts (InterGard(®)). Each gentamicin fatty acid coating showed a continuous drug release in the first eight hours followed by a low continuous release. Grafts coated with gentamicin fatty acids reduced bacterial growth even beyond pathologically relevant high concentrations. Cytotoxicity levels depending on drug formulation bringing up gentamicin palmitate as the most promising biocompatible coating. Thrombelastography studies, ELISA assays and an amidolytic substrate assay confirmed haemocompatibility of developed gentamicin fatty acid coatings comparable to commercially available grafts.

Therapeutic effects and safety of Rhodiola rosea extract WS® 1375 in subjects with life-stress symptoms--results of an open-label study.

The trial was conducted to investigate the therapeutic effects and safety of a 4 week treatment with Rhodiola rosea extract WS® 1375 in subjects with life-stress symptoms. This was a multicentre, non-randomized, open-label, single-arm trial. One hundred and one subjects were enrolled in this clinical study and received the study drug at a dose of 200 mg twice daily for 4 weeks. Assessments with seven questionnaires included Numerical Analogue Scales of Subjective Stress Symptoms, Perceived Stress Questionnaire, Multidimensional Fatigue Inventory 20, Numbers Connecting Test, Sheehan Disability Scale and Clinical Global Impressions to cover various aspects of stress symptoms and adverse events. Invariably, all tests showed clinically relevant improvements with regard to stress symptoms, disability, functional impairment and overall therapeutic effect. Improvements were observed even after 3 days of treatment, as were continuing improvements after 1 and 4 weeks. Rhodiola rosea extract WS® 1375 was safe and generally well tolerated. Adverse events were mostly of mild intensity and no serious adverse events were reported. Rhodiola extract at a dose of 200 mg twice daily for 4 weeks is safe and effective in improving life-stress symptoms to a clinically relevant degree.

Efficacy of manual lymphatic drainage in preventing secondary lymphedema after breast cancer surgery.

This study evaluated the effectiveness of manual lymphatic drainage (MLD) in the prevention of secondary lymphedema after treatment of breast cancer. The study consisted of 67 women, who underwent breast surgery for primary breast cancer. From the second day of surgery, 33 randomly chosen women were given MLD. The control group consisted of 34 women who did not receive MLD. Measurements of the volumes of both the arms were taken before surgery and on days 2, 7, 14, and at 3 and 6 months after surgery. At 6 months after breast cancer surgery, among the women who did not undergo MLD, a significant increase in the arm volume on the operated side was observed (p=0.0033) when compared with the arm volume before surgery. At this time, there was no statistically significant increase in the volume of the upper limb on the operated side in women who underwent MLD. This study demonstrates that regardless of the surgery type and the number of the lymph nodes removed, MLD effectively prevented lymphedema of the arm on the operated side. Even in high risk breast cancer treatments (operation plus irradiation), MLD was demonstrated to be effective against arm volume increase. Even though confirmatory studies are needed, this study demonstrates that MLD administered early after operation for breast cancer should be considered for the prevention of lymphedema.

Differences in patterns of peripheral arterial occlusive disease and eligibility for endovascular treatment.

BACKGROUND: To analyze differences in morphological changes in the vascular tree among patients presenting with intermittent claudication (IC) and critical limb ischemia (CLI). In addition, suitability for endovascular treatment was evaluated. PATIENTS AND METHODS: Our study included 690 lower extremities with IC or CLI in 500 consecutive patients who were assessed by magnetic resonance angiography (MRA) according to the TASC II classification and in terms of the below the knee run-off status. Multivariable logistic regressions models adjusted for cardiovascular risk factors were used to evaluate differences in arteriosclerotic lesion patterns and eligibility for endovascular treatment. RESULTS: Multivariable analysis showed that compared with IC extremities, CLI extremities have significantly more severe arteriosclerotic lesions at the aortoiliac (p < 0.001), femoropopliteal (p < 0.001), and crural levels (p < 0.001), with a greater risk of multilevel disease (odds ratio [OR], 1.71; 95 % confidence interval [CI] 1.10 - 2.66; p = 0.018). More than 80 % of extremities with IC and more than 50 % of extremities with CLI appeared to be eligible for endovascular treatment in an isolated evaluation of the aortoiliac and femoropopliteal axis. For combined evaluation of the aortoiliac and femoropopliteal axis, the proportion of endovascular suitability (TASC A+B lesions) decreased to 65 % (IC) and 41 % (CLI). For TASC A+B+C lesions, the proportions were 79 % (IC) and 41 % (CLI). CONCLUSIONS: Lower extremities with IC and CLI significantly differ in terms of arteriosclerotic lesion morphology and patterns of lesion localization. The majority of IC and CLI extremities appear to be eligible for endovascular treatment. Because of further improvement in endovascular equipment, even more patients will be eligible for treatment.

[Significance of autopsy in patients with head and neck cancer]. / Stellenwert der Autopsie bei Patienten mit Kopf-Halstumoren.

BACKGROUND: Nowadays, the morphological assessment of samples obtained from living patients has a greater importance than the scientific knowledge which is gained by autopsy. Therefore, the aim of the study was a retrospective analysis of causes of death in patients with head and neck cancer. MATERIAL AND METHODS: The autopsy rate, clinical parameters of oncologic patients as well as autopsy findings like lethal complications, distant metastases and second primary tumors were retrospectively analyzed. RESULTS: From 1968 to 2007 in 91 patients with malignant tumors of the head and neck an autopsy was performed. In these 39 years an autopsy was performed in 45.9% of dead oncologic patients. Autopsy findings revealed distant metastases in 46.2% and second primary tumors in 17.6% of the patients. 49.5% of the patients died from pneumonia, 20.9% from tumor bleeding and 10% from progressive cachexia. CONCLUSION: The study confirms the global trend of a decline in autopsy numbers in the last 3 decades. However, as an important instrument of quality assurance autopsies continue to play an essential and indispensable role in medical research.