POPULARITY
Background: To report an unplanned interim analysis of a prospective, one-armed, single center phase I/II trial (NCT01566123). Methods: Between 2007 and 2013, 27 patients (pts) with primary/recurrent retroperitoneal sarcomas (size > 5 cm, M0, at least marginally resectable) were enrolled. The protocol attempted neoadjuvant IMRT using an integrated boost with doses of 45-50 Gy to PTV and 50-56 Gy to GTV in 25 fractions, followed by surgery and IOERT (10-12 Gy). Primary endpoint was 5-year-LC, secondary endpoints included PFS, OS, resectability, and acute/late toxicity. The majority of patients showed high grade lesions (FNCLCC G1:18%, G2:52%, G3:30%), predominantly liposarcomas (70%). Median tumor size was 15 cm (6-31). Results: Median follow-up was 33 months (5-75). Neoadjuvant IMRT was performed as planned (median dose 50 Gy, 26-55) in all except 2 pts (93%). Gross total resection was feasible in all except one patient. Final margin status was R0 in 6 (22%) and R1 in 20 pts (74%). Contiguous-organ resection was needed in all grossly resected patients. IOERT was performed in 23 pts (85%) with a median dose of 12 Gy (10-20 Gy). We observed 7 local recurrences, transferring into estimated 3- and 5-year-LC rates of 72%. Two were located outside the EBRT area and two were observed after more than 5 years. Locally recurrent situation had a significantly negative impact on local control. Distant failure was found in 8 pts, resulting in 3-and 5-year-DC rates of 63%. Patients with leiomyosarcoma had a significantly increased risk of distant failure. Estimated 3-and 5-year-rates were 40% for PFS and 74% for OS. Severe acute toxicity (grade 3) was present in 4 pts (15%). Severe postoperative complications were found in 9 pts (33%), of whom 2 finally died after multiple re-interventions. Severe late toxicity (grade 3) was scored in 6% of surviving patients after 1 year and none after 2 years. Conclusion: Combination of neoadjuvant IMRT, surgery and IOERT is feasible with acceptable toxicity and yields good results in terms of LC and OS in patients with high-risk retroperitoneal sarcomas. Long term follow-up seems mandatory given the observation of late recurrences. Accrual of patients will be continued with extended follow-up.
Medizinische Fakultät - Digitale Hochschulschriften der LMU - Teil 14/19
Aims: Survival to out-of-hospital (OHCA) cardiac arrest is due to many prehospital and inhospital variables. While many studies have identified positive prehospital variables, there is still great variability regarding postresuscitation care in hospitals. We examined basic hospital variables in order to detect differences among hospitals. Methods: Between 2007 and 2009, 30-day survival in 949 admitted ROSC-patients after OHCA was retrospectively identified. 18 hospitals were included in our analysis. We created two groups regarding hospital volume and level of medical structure. Results: A total of 298 (31,4%) out of 949 ROSC-patients survived. Survival of each hospital ranged from 14,3% to 60,5%. Hospital volume in terms of the number of treated ROSC-patients per year, had no positive effect on survival whereas the level of medical structure mattered significantly (p
Background: Graft hypertrophy is the most common complication of periosteal autologous chondrocyte implantation (p-ACI). Purpose: The aim of this prospective study was to analyze the development, the incidence rate, and the persistence of graft hypertrophy after matrix-based autologous chondrocyte implantation (mb-ACI) in the knee joint within a 2-year postoperative course. Study Design: Case series; Level of evidence, 4. Methods: Between 2004 and 2007, a total of 41 patients with 44 isolated cartilage defects of the knee were treated with the mb-ACI technique. The mean age of the patients was 35.8 years (standard deviation [SD], 11.3 years), and the mean body mass index was 25.9 (SD, 4.2; range, 19-35.3). The cartilage defects were arthroscopically classified as Outerbridge grades III and IV. The mean area of the cartilage defect measured 6.14 cm2 (SD, 2.3 cm2). Postoperative clinical and magnetic resonance imaging (MRI) examinations were conducted at 3, 6, 12, and 24 months to analyze the incidence and course of the graft. Results: Graft hypertrophy developed in 25% of the patients treated with mb-ACI within a postoperative course of 1 year; 16% of the patients developed hypertrophy grade 2, and 9% developed hypertrophy grade 1. Graft hypertrophy occurred primarily in the first 12 months and regressed in most cases within 2 years. The International Knee Documentation Committee (IKDC) and visual analog scale (VAS) scores improved during the postoperative follow-up time of 2 years. There was no difference between the clinical results regarding the IKDC and VAS pain scores and the presence of graft hypertrophy. Conclusion: The mb-ACI technique does not lead to graft hypertrophy requiring treatment as opposed to classic p-ACI. The frequency of occurrence of graft hypertrophy after p-ACI and mb-ACI is comparable. Graft hypertrophy can be considered as a temporary excessive growth of regenerative cartilage tissue rather than a true graft hypertrophy. It is therefore usually not a persistent or systematic complication in the treatment of circumscribed cartilage defects with mb-ACI.
Background: Since 2002 MI and stroke, not cancer, are leading causes of death in women. We studied 30-days and 1 year mortality of 3441 patients undergoing coronary artery bypass grafting (CABG) operations in our institution performed either conventionally or off pump (OPCAB). Our objective was to investigate the gender-related mortality in both groups. Patients and Methods: Between 2004 and 2008, 3441 patients (733 women, 2708 men) underwent CABG. 252 women and 854 men were operated using OPCAB, 481 women and 1854 men using extracorporeal circulation (ECC). Medical data was prospectively entered and retrospectively reviewed. 30-days and one year mortality rates were analyzed with Kaplan-Meier estimates and Cox proportional hazards models. Linear and logistic regression models were used to test gender differences. Results: a) 30-day mortality using ECC: 5.2% in women vs. 2.5% in men (p = 0.001). One year ECC mortality: 8.7% in women vs. 4.8% in men (p = 0.0008). b) OPCAB: 30-days and 1 year mortality in women measured 1.7%. Mortality in men was 2.1% after 30 days and 3.7% after one year c) gender specific mortality: 30 days mortality in women was 1.7% using OPCAB and 5.2% using ECC (p = 0.002), one year mortality in women was 1.7% using OPCAB vs. 8.7% using ECC (p = 0.0004). In men, 30-days mortality in OPCAB was 2.1%, one year mortality was 3.7%; using ECC early and late mortality was 2.5% and 4.8%. Conclusions: Female gender is a strong independent predictor and risk factor of increased early and midterm postoperative mortality rates when ECC is used. OPCAB significantly reduces early and midterm postoperative mortality in women and may therefore be proposed as the preferred revascularization technique in female patients.
Objective: The aim of the current prospective study was to analyse the validity of MRI based diagnosis of brainstem gliomas which was verified by stereotactic biopsy and follow-up evaluation as well as to assess prognostic factors and risk profile. Methods: Between 1998 and 2007, all consecutive adult patients with radiologically suspected brainstem glioma were included. The MRI based diagnosis of the lesions was made independently by an experienced neuroradiologist. Histopathological evaluation was performed in all patients from paraffin embedded specimens obtained by multimodal image guided stereotactic serial biopsy technique. Histopathological results were compared with prior radiological assessment. Length of survival was estimated with the Kaplan–Meier method and prognostic factors were calculated using the Cox model. Results: 46 adult patients were included. Histological evaluation revealed pilocytic astrocytoma (n=2), WHO grade II glioma (n=14), malignant glioma (n=12), metastasis (n=7), lymphoma (n=5), cavernoma (n=1), inflammatory disease (n=2) or no tumour/ gliosis (n=3). Perioperative morbidity was 2.5% (n=1). There was no permanent morbidity and no mortality. All patients with ‘‘no tumour’’ or ‘‘inflammatory disease’’ survived. Patients with low grade glioma and malignant glioma showed a 1 year survival rate of 75% and 25%, respectively; the 1 year survival rate for patients with lymphoma or metastasis was 30%. In the subgroup with a verified brainstem glioma, negative predictors for length of survival were higher tumour grade (p=0.002) and Karnofsky performance score (70 (p=0.004). Conclusion: Intra-axial brainstem lesions with a radiological pattern of glioma represent a very heterogeneous tumour group with completely different outcomes. Radiological features alone are not reliable for diagnostic classification. Stereotactic biopsy is a safe method to obtain a valid tissue diagnosis, which is indispensible for treatment decision.
Background: With the current increase of international travel to tropical endemic areas, the incidence of malaria being imported into nonendemic countries has increased significantly. Disagreement concerning malaria chemoprophylaxis and inadequate knowledge of malarious areas, morbidity, and pretravel advise has led to confusion among both health professionals as well as travelers. Therefore, this study was conducted to investigate malaria imported into Germany by identifying the high-risk endemic areas, clinical presentations, and chemoprophylactic and therapeutic regimens related to reported cases. Methods: Between 1990 and 1993, the 160 nonimmune travelers, all German nationals or residents for more than 10 years, presenting to our travel clinic with microscopically confirmed malaria were investigated. For each, the travel history, chemoprophylaxis used during travel, symptoms, pathological diagnosis, and treatment efficacy were analyzed. Results: Africa (73%), Asia (21%), and Central South America (6%) were the endemic countries visited by our patients, of whom only 3% used the chemoprophylaxis recommended for their destination. Plasmodium falciparum was the most common pathogen, found in more than half of our patients, and P. vivax (29%), P. ova le (6%), P. malariae(6%), a mixed infection with P.falciparum and P vivax (3%) were also detected. All patients presented with fever and headaches, a majority with profuse night sweats, insomnia, arthralgias, and myalgias, and diarrhea and abdominal cramps were experienced in 13% and 8%, respectively. In falciparum malaria, a recrudescence was observed in all patients who received chloroquine only, whereas quinine, halofantrine, and mefloquine were highly effective. In vivax malaria, a relapse rate of 14% was noted in the patients treated with the currently recommended regimen of chloroquine and primaquine. Conclusions: Visitors to endemic countries, especially to Africa, are of significant risk. Given the low compliance rate of chemoprophylaxis, a high percentage of malaria in our patients could have been avoided by an appropriate prophylaxis regimen and optimal pretravel counseling.