Oldenburg, Germany
Oldenburg, Germany

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Harle T.,Klinikum Oldenburg GGmbH | Bojara W.,Gemeinschaftsklinikum Koblenz Mayen | Meyer S.,Klinikum Oldenburg GGmbH | Meyer S.,University of Groningen | Elsasser A.,Klinikum Oldenburg GGmbH
International Journal of Cardiology | Year: 2015

Background The instantaneous wave-free ratio (iFR) is a new adenosine-independent index of coronary stenosis severity. Most published data have been based on off-line analyses of pressure recordings in a core laboratory. We prospectively compared real-time iFR and fractional flow reserve (FFR) measurements. Methods and results iFR and FFR were measured in 151 coronary stenoses in 108 patients. Repeated iFR measurements were technically simple, showed excellent agreement [rs = 0.99; p < 0.0001], and the mean difference between consecutive iFR values was 0.0035 (limits of agreement: - 0.019, 0.026). Mean iFR showed a significant correlation with FFR [rs = 0.81; p < 0.0001]. Receiver-operating characteristic analysis identified an optimal iFR cut-off value of 0.896 for categorization based on an FFR cut-off value 0.8. We compared two different iFR-based diagnostic strategies (iFR-only and hybrid iFR-FFR) with standard FFR: The iFR-only strategy showed good classification agreement (83.4%) with standard FFR. Use of the hybrid iFR-FFR strategy, assessing lesions in an iFR-gray zone of 0.86-0.93 by FFR, improved classification accuracy to 94.7%, and diagnosis would have been established in 61% of patients without adenosine-induced hyperemia. Notably, both iFR and FFR values were significantly higher in the posterior coronary vessels. Conclusions Real-time iFR measurements are easily performed, have excellent diagnostic performance and confirm available off-line core laboratory data. The excellent agreement between repeated iFR measurements demonstrates the reliability of single measurements. Combining iFR with FFR in a hybrid strategy enhances diagnostic accuracy, exposing fewer patients to adenosine. Overall, iFR is a promising method, but still requires prospective clinical endpoint trial evaluation. © 2015 Elsevier Ireland Ltd. All rights reserved.

Poss J.,Universitatsklinikum Schleswig Holstein | Vollert J.O.,Charité - Medical University of Berlin | Bohm M.,Universitatsklinikum des Saarlandes | Thiele H.,Universitatsklinikum Schleswig Holstein | And 18 more authors.
Kardiologe | Year: 2014

Cardiogenic shock (CS) is a life-threatening complication of acute myocardial infarction which occurs in approximately 10% of the patients. The widespread use of early revascularization has led to a reduction in the incidence of cardiogenic shock; however, despite optimal therapy mortality rates are still approaching 50%. In order to increase survival of cardiogenic shock patients, several correct decisions have to be made within a multidisciplinary team, e.g. regarding the optimal strategy of revascularization, medicinal and if necessary mechanical circulatory support, management of multiorgan dysfunction syndrome, and further supportive intensive care treatment. In the acute situation, adherence to guideline recommendations is challenging. European guidelines do not give condensed recommendations for the treatment of cardiogenic shock. The present manuscript summarizes the most important recommendations of the various European and the German-Austrian guidelines. The recommendations are depicted as an extended event-driven process chain (eEPK) and standard operating procedures. This general and compact representation forms the basis for treatment pathways which are supported by checklists and information technology (IT) applications. This approach will help healthcare professionals involved in the treatment of CS patients to make the right decisions in order to guarantee optimal patient care. © 2014 Springer-Verlag.

Egerer G.,University of Heidelberg | Reichert D.,Klinikum Oldenburg GGmbH | Pletz M.W.,Hannover Medical School | Pletz M.W.,Jena University Hospital | And 3 more authors.
European Journal of Medical Research | Year: 2012

Background: This study is a pre-planned country-specific subanalysis of results in Germany from a multinational multicenter registry to prospectively assess real-world experience with caspofungin administered for treatment of proven or probable invasive aspergillosis (IA). Methods. Data from patients treated with caspofungin for a single episode of IA were collected. Effectiveness was determined by the local investigator as favorable (complete or partial response) or unfavorable (stable disease, failure or death) at the end of caspofungin therapy. Descriptive statistics with binomial exact confidence intervals were employed. Results: Forty-two consecutive patients were identified in three German centers. Three patients (7%) had proven IA and 39/42 (93%) had probable IA (modified European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria). Forty-one patients had pulmonary IA and one had tracheal IA. Caspofungin monotherapy was received by 36/42 patients (86%); of these, 26/36 (72%) received salvage therapy. A favorable response was observed in 29/42 patients (69%; 95% CI 53 to 82%); of these, 21/29 (72%) had a complete and 8/29 (28%) a partial response. Favorable response rate was 69% in patients with monotherapy (95% CI 52% to 84%; 25/36 patients), and 67% in patients receiving combination therapy (95% CI 22% to 96%; 4/6 patients). Favorable response rate in patients with first line therapy was 64% (95% CI 31% to 89%; 7/11 patients), and 73% in patients with second line therapy (95% CI 54% to 88%; 20/30 patients). No adverse events were reported. In total, 35/42 patients (83%; 95% CI 69 to 93%) survived seven days after completion of caspofungin therapy. Conclusions: These real-life findings in Germany are consistent with the international findings from this registry and with findings from randomized studies. © 2012 Egerer et al; licensee BioMed Central Ltd.

Hormansdorfer C.,Klinikum Oldenburg GGmbH | Soergel P.,Leibniz University of Hanover | Hillemanns P.,Leibniz University of Hanover | Schmidt P.,Institute for Prenatal Health
Archives of Gynecology and Obstetrics | Year: 2012

Non-invasive Wrst trimester screening for fetal aneuploidy is based on the consideration of fetal nuchal translucency, biochemical serum markers 'pregnancy associated plasma protein A' (PAPP-A), and 'free beta-humane chorionic gonadotropin' (fβ-hCG). The blood sera of 168 pregnant women in 11+0 to 13+ 6 weeks of gestation were examined by both the COBAS (Roche Holding GmbH, Germany) and KRYPTOR (Brahms GmbH, Germany) immunoassay systems in two quality controlled laboratories. The concentration values were converted into multiple of median (MoM) values and compared through a two-tailed t test. The concentration values of PAPP-A diVered signiWcantly from each other (p < 0.0001). COBAS produced on average 0.09 MoM higher values in comparison to KRYPTOR (CI 95% = 0.06-0.11 MoM). In contrast, the concentration values of fβ-hCG did not diVer signiW -cantly (p value = 0.20). The values produced by COBAS were on average only 0.02 MoM higher in comparison to KRYPTOR (CI 95% = =0.01 to 0.05 MoM). Which of the two systems generates the more precise results should be evaluated in a large-scale prospective study with the pregnancy outcomes. © 2011 Springer-Verlag.

Severe forms of mucositis within the oral cavity can develop during radio/ chemotherapy dependent on dose and choice of intervention. During the last two decades, multiple measures have been published in respect to prophylaxis as well as treatment of this oral complication, however, study sizes were often rather small with conflicting data and limited evaluation of evidence and recommendation as a consequence. Thus, in the case of Gelclair®, Caphosol® and Biotene® the European Society of Medical Oncology (ESMO) concluded that the clinical evidence of those products is rather limited, however, based on the convincing safety profile, some patients may have a clear benefit by these medical devices. In this context, multidisciplinary working groups play an increasing role in order to avoid unnecessary, complex mixtures as well as to bring individualized concepts more forward.

Schostak M.,Charité - Medical University of Berlin | Schostak M.,Universitatsklinikum Magdeburg Aor | Baumunk D.,Charité - Medical University of Berlin | Baumunk D.,Universitatsklinikum Magdeburg Aor | And 18 more authors.
BJU International | Year: 2012

OBJECTIVES To report our experience with an Internet-based multicentre database that enables tumour documentation, as well as the collection of quality-related parameters and follow-up data, in surgically treated patients with prostate cancer. The system was used to assess the quality of prostate cancer surgery and to analyze possible time-dependent trends in the quality of care. PATIENTS AND METHODS An Internet-based database system enabled a standardized collection of treatment data and clinical findings from the participating urological centres for the years 2005-2009. An analysis was performed aiming to evaluate relevant patient characteristics (age, pathological tumour stage, preoperative International Index of Erectile Function-5 score), intra-operative parameters (operating time, percentage of nerve-sparing operations, complication rate, transfusion rate, number of resected lymph nodes) and postoperative parameters (hospitalization time, re-operation rate, catheter indwelling time). Mean values were calculated and compared for each annual cohort from 2005 to 2008. The overall survival rate was also calculated for a subgroup of the Berlin patients. RESULTS A total of 914, 1120, 1434 and 1750 patients submitted to radical prostatectomy in 2005, 2006, 2007 and 2008 were documented in the database. The mean age at the time of surgery remained constant (66 years) during the study period. More than half the patients already had erectile dysfunction before surgery (median International Index of Erectile Function-5 score of 19-20). During the observation period, there was a decrease in the percentage of pT2 tumours (1% in 2005; 64% in 2008) and a slight increase in the percentage of patients with lymph node metastases (8% in 2005; 10% in 2008). No time trend was found for the operating time (142-155 min) or the percentage of nerve-sparing operations (72-78% in patients without erectile dysfunction). A decreasing frequency was observed for the parameters: blood transfusions (1.9% in 2005; 0.5% in 2008), postoperative bleeding (2.6%; 1.2%) and re-operations (4.5%; 2.8%). The mean hospitalization time decreased accordingly (10 days in 2005; 8 days in 2008). The examined subcohort had an overall mortality of 1.5% (median follow-up of 3 years). CONCLUSIONS An Internet-based database system for tumour documentation in patients with prostate cancer enables the collection and assessment of important parameters for the quality of care and outcomes. The participating centres show an improvement in the quality of surgical management, including a reduction of the complication rate. © 2011 BJU International.

Schmidt P.,Institute for Prenatal Health | Hormansdorfer C.,Klinikum Oldenburg gGmbH | Vaske B.,Leibniz University of Hanover | Hillemanns P.,Leibniz University of Hanover | Scharf A.,Institute for Prenatal Health
Prenatal Diagnosis | Year: 2012

Background: A novel screening method for fetal aneuploidies was developed, in which nuchal translucency (NT), pregnancy-associated plasma protein-A (PAPP-A), and free-β human chorionic gonadotropin (free-β hCG) are placed into a three-dimensional scatter plot. Likelihood ratios are directly inferred from the ratio of already observed healthy and diseased fetuses. This method is called 'Three-dimensional Advanced First trimester Screening' (AFS-3D). It was aimed to develop and test a new algorithm based on the results of previous studies. Methods: A new static-sized sphere model was developed. Several scaling factors of the axes and the optional application of the modifications 'simulation' (SIM) and 'empty sphere positive' were tested on 15227 data sets. An additional examination was performed on a second collective (n=458). Results: The application of the new AFS-3D model with static-sized spheres, a re-sampled {increment}NT axis by a scaling factor of 0.125, and the application of SIM and Empty Box Positive resulted in a marked improvement of the test performance (area under curve, AUC=0.9668). Analogous results (AUC=0.9807) were found for the second test collective. Conclusions: This novel approach is promising and should be tested on a larger, independent collective. © 2012 John Wiley & Sons, Ltd.

Muller H.L.,Klinikum Oldenburg GGmbH | Gebhardt U.,Klinikum Oldenburg GGmbH | Schroder S.,Klinikum Oldenburg GGmbH | Pohl F.,University of Regensburg | And 9 more authors.
Hormone Research in Paediatrics | Year: 2010

Background: Controversies surround various treatment variables for patients with childhood craniopharyngioma such as growth hormone (GH) replacement, which some believe can exacerbate recurrence/progression. We prospectively assessed the risk of tumor recurrence/progression in survivors of childhood craniopharyngioma. Methods: Multivariable analyses of risk factors (age at diagnosis, degree of resection, irradiation, GH treatment and gender) and descriptive analyses of overall survival (OS) and event-free survival (EFS) rates were performed in 117 patients, recruited prospectively and evaluated after 3 years of follow-up in the German, Austrian and Swiss multicenter trial KRANIOPHARYNGEOM 2000. Results: We observed a 3-year OS of 0.97 and a 3-year EFS of 0.46, indicating high recurrence rates after complete resection (CR) (n = 47; 3-year-EFS: 0.64) and high progression rates after incomplete resection (IR) (n = 64; 3-year EFS: 0.31). The risk of an event decreased by 80% after CR compared to IR (hazard ratio = 0.20; p < 0.001). Irradiation had protective effects on EFS: irradiated patients had an 88% lower risk of recurrence/progression compared to patients without/before irradiation (hazard ratio = 0.12; p < 0.001). GH treatment had no impact on 3-year EFS rates. Conclusions: Tumor recurrences/progressions are frequent and occur early after initial treatment of childhood craniopharyngioma. A radical resection preserving the integrity of hypothalamic structures appears optimal at original diagnosis. Irradiation was efficient in preventing recurrences/progressions. GH treatment had no impact on the low 3-year EFS observed in our study. However, further conclusions on the influence of GH on recurrence rates have to be refined to long-term follow-up studies of patients with childhood craniopharyngioma. Copyright © 2010 S. Karger AG, Basel.

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