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Scholz K.H.,St Bernward Hospital | Maier S.K.G.,Julius Maximilians University Wrzburg | Jung J.,Klinikum Worms | Fleischmann C.,Klinikum Wolfsburg | And 9 more authors.
JACC: Cardiovascular Interventions | Year: 2012

Objectives This study sought to evaluate the effect of systematic data analysis and standardized feedback on treatment times and outcome in a prospective multicenter trial. Background Formalized data feedback may reduce treatment times in ST-segment elevation myocardial infarction (STEMI). Methods Over a 15-month period, 1,183 patients presenting with STEMI were enrolled. Six primary percutaneous coronary intervention hospitals in Germany and 29 associated nonpercutaneous coronary intervention hospitals participated. Data from patient contact to balloon inflation were collected and analyzed. Pre-defined quality indicators, including the percentage of patients with pre-announced STEMI, direct handoff in the catheterization laboratory, contact-to-balloon time <90 min, door-to-balloon time <60 min, and door-to-balloon time <30 min were discussed with staff on a quarterly basis. Results Median door-to-balloon time decreased from 71 to 58 min and contact-to-balloon time from 129 to 103 min between the first and the fifth quarter (p < 0.05 for both). Contributing were shorter stays in the emergency department, more direct handoffs from ambulances to the catheterization laboratory (from 22% to 38%, p < 0.05), and a slight increase in the number of patients transported directly to the percutaneous coronary intervention facility (primary transport). One-year mortality was reduced in the total group of patients and in the subgroup of patients with primary transport (p < 0.05). The sharpest fall in mortality was observed in patients with primary transport and TIMI (Thrombolysis In Myocardial Infarction) risk score <3 (n = 521) with a decrease in 30-day mortality from 23.1% to 13.3% (p < 0.05) and in 1-year mortality from 25.6% to 16.7% (p < 0.05). Conclusions Formalized data feedback is associated with a reduction in treatment times for STEMI and with an improved prognosis, which is most pronounced in high-risk patients. (Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction [FITT-STEMI]; NCT00794001) © 2012 American College of Cardiology Foundation.


Regula J.U.,University of Heidelberg | Schill J.,Klinikum Darmstadt | Ringleb P.A.,University of Heidelberg | Sykora M.,University of Heidelberg
Neurocritical Care | Year: 2014

Background: Intracerebral hemorrhage (ICH) with intraventricular extension (IVH) is a devastating disease with a particular high mortality. In some aspects, IVH may resemble subarachnoid hemorrhage. The incidence and role of cerebral vasospasm in ICH with IVH are poorly understood. Here, we aimed to analyze the incidence and relationship of cerebral vasospasm to clinical characteristics, in-hospital mortality, and functional outcome at 3 months in patients suffering ICH with IVH. Methods: Patients with ICH and IVH treated on a neurological intensive care unit were prospectively enrolled in a single-center observational study. Vasospasm was defined using established ultrasound criteria. Delayed cerebral ischemia (DCI) was defined as a new hypodensity on follow-up cranial CT. Functional outcome at 3 months was assessed using the modified Rankin Scale. Results: 129 patients with ICH and IVH were screened for the study. 62 patients entered the final analysis. The incidence of significant vasospasm was 37 %. A strong trend was found for the association between all cerebral vasospasm and DCI (P = 0.046). Early (up to 48 h) vasospasm was significantly associated with a DCI (P = 0.033). Overall mortality and outcome after 3 months did not differ between the groups. Conclusion: Cerebral vasospasm seems to be a frequent complication after ICH with IVH and might be associated with DCI. Larger studies are warranted to confirm this hypothesis. © 2013 Springer Science+Business Media.


Decousus H.,Jean Monnet University | Prandoni P.,University of Padua | Mismetti P.,Jean Monnet University | Bauersachs R.M.,Klinikum Darmstadt | And 7 more authors.
New England Journal of Medicine | Year: 2010

Background: The efficacy and safety of anticoagulant treatment for patients with acute, symptomatic superficial-vein thrombosis in the legs, but without concomitant deep-vein thrombosis or symptomatic pulmonary embolism at presentation, have not been established. Methods: In a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily, or placebo for 45 days. The primary efficacy outcome was a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day 47. The main safety outcome was major bleeding. The patients were followed until day 77. Results: The primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinux group and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001). The incidence of each component of the primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the placebo group, except for the outcome of death (0.1% in both groups). The rate of pulmonary embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the placebo group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77. A total of 88 patients would need to be treated to prevent one instance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurred in one patient in each group. The incidence of serious adverse events was 0.7% with fondaparinux and 1.1% with placebo. Conclusions: Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00443053.) Copyright © 2010 Massachusetts Medical Society.


Prins M.H.,Maastricht University | Lensing A.W.A.,Bayer AG | Bauersachs R.,Klinikum Darmstadt | van Bellen B.,Hospital Beneficencia Portuguesa | And 8 more authors.
Thrombosis Journal | Year: 2013

Background: Standard treatment for venous thromboembolism (VTE) consists of a heparin combined with vitamin K antagonists. Direct oral anticoagulants have been investigated for acute and extended treatment of symptomatic VTE; their use could avoid parenteral treatment and/or laboratory monitoring of anticoagulant effects.Methods: A prespecified pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies compared the efficacy and safety of rivaroxaban (15 mg twice-daily for 21 days, followed by 20 mg once-daily) with standard-therapy (enoxaparin 1.0 mg/kg twice-daily and warfarin or acenocoumarol). Patients were treated for 3, 6, or 12 months and followed for suspected recurrent VTE and bleeding. The prespecified noninferiority margin was 1.75.Results: A total of 8282 patients were enrolled; 4151 received rivaroxaban and 4131 received standard-therapy. The primary efficacy outcome occurred in 86 (2.1%) rivaroxaban-treated patients compared with 95 (2.3%) standard-therapy-treated patients (hazard ratio, 0.89; 95% confidence interval [CI], 0.66-1.19; pnoninferiority < 0.001). Major bleeding was observed in 40 (1.0%) and 72 (1.7%) patients in the rivaroxaban and standard-therapy groups, respectively (hazard ratio, 0.54; 95% CI, 0.37-0.79; p = 0.002). In key subgroups, including fragile patients, cancer patients, patients presenting with large clots, and those with a history of recurrent VTE, the efficacy and safety of rivaroxaban were similar compared with standard-therapy.Conclusion: The single-drug approach with rivaroxaban resulted in similar efficacy to standard-therapy and was associated with a significantly lower rate of major bleeding. Efficacy and safety results were consistent among key patient subgroups.Trial registration: EINSTEIN-PE: ClinicalTrials.gov, NCT00439777; EINSTEIN-DVT: ClinicalTrials.gov, NCT00440193. © 2013 Prins et al.; licensee BioMed Central Ltd.


Betsch M.,Heinrich Heine University Düsseldorf | Schneppendahl J.,Heinrich Heine University Düsseldorf | Thuns S.,Heinrich Heine University Düsseldorf | Herten M.,University Hospital Muenster | And 4 more authors.
PLoS ONE | Year: 2013

Background:Bone marrow aspiration concentrate (BMAC) may possess a high potency for cartilage and osseous defect healing because it contains stem cells and multiple growth factors. Alternatively, platelet rich plasma (PRP), which contains a cocktail of multiple growth factors released from enriched activated thrombocytes may potentially stimulate the mesenchymal stem cells (MSCs) in bone marrow to proliferate and differentiate.Methods:A critical size osteochondral defect (10×6 mm) in both medial femoral condyles was created in 14 Goettinger mini-pigs. All animals were randomized into the following four groups: biphasic scaffold alone (TRUFIT BGS, Smith & Nephew, USA), scaffold with PRP, scaffold with BMAC and scaffold in combination with BMAC and PRP. After 26 weeks all animals were euthanized and histological slides were cut, stained and evaluated using a histological score and immunohistochemistry.Results:The thrombocyte number was significantly increased (p = 0.049) in PRP compared to whole blood. In addition the concentration of the measured growth factors in PRP such as BMP-2, BMP-7, VEGF, TGF-β1 and PDGF were significantly increased when compared to whole blood (p<0.05). In the defects of the therapy groups areas of chondrogenic tissue were present, which stained blue with toluidine blue and positively for collagen type II. Adding BMAC or PRP in a biphasic scaffold led to a significant improvement of the histological score compared to the control group, but the combination of BMAC and PRP did not further enhance the histological score.Conclusions:The clinical application of BMAC or PRP in osteochondral defect healing is attractive because of their autologous origin and cost-effectiveness. Adding either PRP or BMAC to a biphasic scaffold led to a significantly better healing of osteochondral defects compared with the control group. However, the combination of both therapies did not further enhance healing. © 2013 Betsch et al.


Van Der Hoeven N.W.,VU University Amsterdam | Teunissen P.F.,VU University Amsterdam | Werner G.S.,Klinikum Darmstadt | Delewi R.,University of Amsterdam | And 7 more authors.
Heart | Year: 2013

Objective Well-developed collaterals provide survival benefit in patients with obstructive coronary artery disease (CAD). Therefore, in this study we sought to determine which clinical variables are associated with arteriogenesis. Design Clinical and laboratory variables were collected before percutaneous coronary intervention. Multivariate analysis was performed to determine which variables are associated with the collateral flow index (CFI). Patients Data from 295 chronic total occlusion (CTO) patients (Bern, Switzerland, Amsterdam, the Netherlands and Jena, Germany) were pooled. In earlier studies, patients had varying degrees of stenosis. Therefore, different stages of development of the collaterals were used. In our study, a unique group of patients with CTO was analysed. Interventions Instead of angiography used earlier, we used a more accurate method to determine CFI using intracoronary pressure measurements. CFI was calculated from the occlusive pressure distal of the coronary lesion, the aortic pressure and central venous pressure. Results The mean CFI was 0.39±0.14. After multivariate analysis, â blockers, hypertension and angina pectoris duration were positively associated with CFI (B: correlation coefficient β=0.07, SE=0.03, p=0.02, B=0.040, SE=0.02, p=0.042 and B=0.001, SE=0.000, p=0.02). Furthermore also after multivariate analysis, high serum leucocytes, prior myocardial infarction and high diastolic blood pressure were negatively associated with CFI (B=.0.01, SE=0.005, p=0.03, B=.0.04, SE=0.02, p=0.03 and B=.0.002, SE=0.001, p=0.011). Conclusions In this unique cohort, high serum leucocytes and high diastolic blood pressure are associated with poorly developed collaterals. Interestingly, the use of â blockers is associated with well-developed collaterals, shedding new light on the potential action mode of this drug in patients with CAD.


Nombela-Franco L.,Hospital Universitario Puerta Of Hierro Majadahonda | Werner G.S.,Klinikum Darmstadt
Journal of Invasive Cardiology | Year: 2010

Chronic total coronary occlusions (CTO) still remain one of the most technically challenging clinical scenearios in which to perform interventions. Although the antegrade approach is the most common method of CTO recanalization, a retrograde attempt improves the success rate and its usage has been increasingly adopted in the recent years. However, the retrograde method requires exceptional expertise and skills in order to apply a wide variety of strategies, devices and imaging modalities. We report a case of retrograde recanalization of an ostial left anterior descending artery CTO of at least 10 years duration, and discuss some specific issues of a new channel dilating catheter, and practical precautions to keep in mind in the retrograde approach such as the availability of snare technique to facilitate retrograde wire capture and externalization.


Nombela-Franco L.,Hospital Universitario Puerta Of Hierro Majadahonda | Mitroi C.D.,Hospital Universitario Puerta Of Hierro Majadahonda | Fernandez-Lozano I.,Hospital Universitario Puerta Of Hierro Majadahonda | Garcia-Touchard A.,Hospital Universitario Puerta Of Hierro Majadahonda | And 9 more authors.
Circulation: Arrhythmia and Electrophysiology | Year: 2012

Background-An implantable cardioverter-defibrillator (ICD) is the therapy of choice for primary prevention in patients with ischemia who are at risk for sudden cardiac death (SCD). One third of patients with significant coronary disease have chronic total coronary occlusion (CTO), which is associated with long-term mortality in patients with previous myocardial infarction. However, the impact of CTO on the occurrence of ventricular arrhythmias and long-term mortality in ICD recipients remains unknown. Methods and Results-All consecutive patients with coronary artery disease receiving ICD therapy for the prevention of SCD were included in the study. Among other characteristics, the existence of CTO was assessed. During follow-up, the occurrence of appropriate device delivery because of ventricular arrhythmias as well as mortality were noted. A total of 162 patients (mean age, 62± 9 years; 93% men) with an ICD were included and followed for a median of 26 months (interquartile range, 12-42). At least 1 CTO was present in 71 (44%) patients. Appropriate device therapy was detected in 18% of the patients during the follow-up. The presence of CTO was associated with higher ventricular arrhythmia and mortality rates (log-rank test, -0.01). Multivariable analysis revealed that CTO was independently associated with appropriate ICD intervention (hazard ratio, 3.5; P <0.003). Conclusions-In patients with ischemic heart disease receiving ICDs for primary prevention of SCD, CTO is an independent predictor for the occurrence of ventricular arrhythmias and has an adverse impact on long-term mortality. © 2012 American Heart Association, Inc.


Ertongur-Fauth T.,BRAIN AG | Hochheimer A.,BRAIN AG | Hochheimer A.,Amgen Research GmbH | Buescher J.M.,BRAIN AG | And 2 more authors.
Experimental Dermatology | Year: 2014

Sweating is an important physiological process to regulate body temperature in humans, and various disorders are associated with dysregulated sweat formation. Primary sweat secretion in human eccrine sweat glands involves Ca2+-activated Cl- channels (CaCC). Recently, members of the TMEM16 family were identified as CaCCs in various secretory epithelia; however, their molecular identity in sweat glands remained elusive. Here, we investigated the function of TMEM16A in sweat glands. Gene expression analysis revealed that TMEM16A is expressed in human NCL-SG3 sweat gland cells as well as in isolated human eccrine sweat gland biopsy samples. Sweat gland cells express several previously described TMEM16A splice variants, as well as one novel splice variant, TMEM16A(acΔe3) lacking the TMEM16A-dimerization domain. Chloride flux assays using halide-sensitive YFP revealed that TMEM16A is functionally involved in Ca2+-dependent Cl- secretion in NCL-SG3 cells. Recombinant expression in NCL-SG3 cells showed that TMEM16A(acΔe3) is forming a functional CaCC, with basal and Ca2+-activated Cl- permeability distinct from canonical TMEM16A(ac). Our results suggest that various TMEM16A isoforms contribute to sweat gland-specific Cl- secretion providing opportunities to develop sweat gland-specific therapeutics for treatment of sweating disorders. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.


Wagner N.,Klinikum Darmstadt | Otto L.,Klinikum Darmstadt | Podda M.,Klinikum Darmstadt | Schmitt Y.,Institute for Laboratory Medicine and Microbiology | Tappe D.,University of Würzburg
Journal of Travel Medicine | Year: 2013

Shewanella algae is an emerging seawater-associated bacterium. In immunocompromised patients, infections may result in bacteremia, osteomyelitis, and necrotizing fasciitis. Our patient, suffering from autoimmune vasculitis and myasthenia gravis, developed typical hemorrhagic bullae and leg ulcers because of S algae. She was treated efficiently with a combination of ciprofloxacin and piperacillin. © 2013 International Society of Travel Medicine.

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