Scherzer T.-M.,Medical University of Vienna |
Stattermayer A.F.,Medical University of Vienna |
Strasser M.,University of Salzburg |
Laferl H.,Kaiser Franz Josef Spital |
And 6 more authors.
Hepatology | Year: 2011
The IL28B genotype is the most important pretreatment predictor of treatment outcome in patients with chronic hepatitis C. The impact of the rs12979860 genotype on relapse was retrospectively evaluated in genotype 1/4 patients who received response-guided therapy with peginterferon alpha-2a 180 μg/week plus ribavirin 1,000/1,200 mg/day in a large, randomized, multicenter study. Patients with a rapid virologic response (RVR: hepatitis C virus [HCV] RNA <50 IU/mL) at week 4 were treated for 24 weeks; those with a slow virologic response (no RVR but undetectable HCV RNA or ≥2-log 10 decrease at week 12) were randomized to 48 (group A) or 72 weeks of treatment (group B). Relapse rates were compared by rs12979860 genotype (C/C versus combined T/C or T/T [T/*]) in patients with confirmed end-of-treatment response and known end-of-follow-up status (sustained virologic response [SVR] or relapse). The rs12979860 genotype was determined for 340/551 study participants. In patients with RVR and C/C or T/* genotype, relapse rates were similar (10.7% versus 15.2%). In patients randomized to groups A and B, relapse rates were similar in patients with C/C genotype randomized to group A (26.9%) and group B (20.0%). In contrast, relapse rates in T/* patients differed markedly between groups A and B, overall (42.9% and 18.8%; P < 0.025, respectively) and in those with low (<400,000 IU/mL: 37.5% versus 18.8%) and high (≥400,000 IU/mL: 45.0% versus 18.8%) baseline viral loads. Conclusion: The results suggest that the benefits of extended therapy are restricted to patients with a T allele. Relapse rates are highest in patients with T/* genotype and are markedly higher in slow responders treated for 48 weeks compared with 72 weeks. © 2011 American Association for the Study of Liver Diseases.
Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: The randomized VIASTAR trial (viabahn endoprosthesis with propaten bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease)
Lammer J.,Medical University of Vienna |
Zeller T.,Universitaets Herzzentrum Freiburg Bad Krozingen |
Hausegger K.A.,Klinikum Klagenfurt |
Schaefer P.J.,University of Kiel |
And 10 more authors.
Journal of the American College of Cardiology | Year: 2013
Objectives The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested. Background Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. Methods In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Results Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months. Conclusions This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244). © 2013 by the American College of Cardiology Foundation.
Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): Study protocol for a multicenter randomized controlled trial
Eldabe S.,James Cook Hospital |
Kern M.,Elisabethinen Hospital |
Peul W.,Leiden University |
Green C.,University of Exeter |
And 2 more authors.
Trials | Year: 2013
Background: Chronic radicular pain can be effectively treated with spinal cord stimulation, but this therapy is not always sufficient for chronic back pain. Subcutaneous nerve stimulation (SQS) refers to the placement of percutaneous leads in the subcutaneous tissue within the area of pain. Case series data show that failed back surgery syndrome (FBSS) patients experience clinically important levels of pain relief following SQS and may also reduce their levels of analgesic therapy and experience functional well-being. However, to date, there is no randomized controlled trial evidence to support the use of SQS in FBSS.Methods/Design: The SubQStim study is a multicenter randomized controlled trial comparing SQS plus optimized medical management ('SQS arm') versus optimized medical management alone ('OMM arm') in patients with predominant back pain due to FBSS. Up to 400 patients will be recruited from approximately 33 centers in Europe and Australia and will be randomized 1:1 to the SQS or OMM arms. After 9 months, patients who fail to reach the primary outcome will be allowed to switch treatments. Patients will be evaluated at baseline (prior to randomization) and at 1, 3, 6, 9, 12, 18, 24, and 36 months after randomization. The primary outcome is the proportion of patients at 9 months with a ≥50% reduction in back pain intensity compared to baseline. The secondary outcomes are: back and leg pain intensity score, functional disability, health-related quality of life, patient satisfaction, patient global impression of change, healthcare resource utilization/costs, cost-effectiveness analysis and adverse events. Outcomes arms will be compared between SQS and OMM arms at all evaluation points up to and including 9 months. After the 9-month assessment visit, the main analytic focus will be to compare within patient changes in outcomes relative to baseline.Discussion: The SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014.Trial registration: ClinicalTrials.gov NCT01711619. © 2013 Eldabe et al.; licensee BioMed Central Ltd.
Kapral C.,Elisabethinen Hospital |
Muhlberger A.,Johannes Kepler University |
Wewalka F.,Elisabethinen Hospital |
Duller C.,Johannes Kepler University |
And 2 more authors.
European Journal of Gastroenterology and Hepatology | Year: 2012
OBJECTIVE: Endoscopic retrograde cholangiopancreatography (ERCP) has a high risk of various complications. The aim of this study is to report the main ERCP outcome, that means complications and success rates, on the basis of the pooled data of a national continuous quality assessment program. METHODS: This study is an uncontrolled prospective survey and provides data from both academic and community-based endoscopy centers with varying case volumes and expertise. Data were collected within a nationwide voluntary ERCP benchmarking project that was initiated by the Austrian Society of Gastroenterology and Hepatology. RESULTS: In total, 42 sites participated in this program for varying periods (1 month up to 5 years) and reported 13 513 procedures within 5 years. The overall complication rate in nonselected patients was 10.1%. Post-ERCP pancreatitis occurred in 4.2%, bleeding in 3.6% (0.4% clinically relevant), cholangitis in 1.4%, cardiopulmonary complications in 1.2%, perforation in 0.6%, and procedure-related deaths in 0.1% of procedures. The overall therapeutic and diagnostic target was achieved in 80.3% (2009-2011) to 84.8% (2006/2007) of procedures. The desired duct was visualized in 90.7% and cannulated in 88.8% of procedures. CONCLUSION: The aim of the running benchmarking project in ERCP is to improve patient care in Austria. The survey reflects the general effectiveness and safety of ERCP. The overall complication and success rates are consistent with the available literature data. It sets an example as a benchmarking program that might result in international or even pan-European projects in high-risk endoscopic procedures. © 2012 Wolters Kluwer Health / Lippincott.
Zhu R.,Johannes Kepler University |
Howorka S.,Center for Advanced Bioanalysis GmbH |
Howorka S.,University College London |
Proll J.,Elisabethinen Hospital |
And 10 more authors.
Nature Nanotechnology | Year: 2010
Atomic force microscopy (AFM) is a powerful tool for analysing the shapes of individual molecules and the forces acting on them. AFM-based force spectroscopy provides insights into the structural and energetic dynamics of biomolecules by probing the interactions within individual molecules, or between a surface-bound molecule and a cantilever that carries a complementary binding partner. Here, we show that an AFM cantilever with an antibody tether can measure the distances between 5-methylcytidine bases in individual DNA strands with a resolution of 4 Å, thereby revealing the DNA methylation pattern, which has an important role in the epigenetic control of gene expression. The antibody is able to bind two 5-methylcytidine bases of a surface-immobilized DNA strand, and retracting the cantilever results in a unique rupture signature reflecting the spacing between two tagged bases. This nanomechanical approach might also allow related chemical patterns to be retrieved from biopolymers at the single-molecule level. © 2010 Macmillan Publishers Limited. All rights reserved.
Schiller D.,Elisabethinen Hospital |
Maieron A.,Elisabethinen Hospital |
Schofl R.,Elisabethinen Hospital |
Donnerer J.,Medical University of Graz
Pharmacology | Year: 2014
Although proton pump inhibitors (PPI) are generally well tolerated, with most adverse effects being minor and self-limiting, there are singular reports on hypersensitivity immune reactions triggered by a PPI or its metabolites. Here we report a case of acute drug-induced fever with leukocytosis and a transient increase in CRP due to pantoprazole. This was apparently an idiosyncratic reaction (inflammatory fever), showing no cross-sensitivity towards esomeprazole. © 2014 S. Karger AG, Basel.
Dumonceau J.-M.,Gedyt Endoscopy Center |
Andriulli A.,Casa Sollievo Sofferemza Hospital |
Elmunzer B.J.,Medical University of South Carolina |
Mariani A.,Vita-Salute San Raffaele University |
And 7 more authors.
Endoscopy | Year: 2014
This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It addresses the prophylaxis of post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis. Main recommendations 1 ESGE recommends routine rectal administration of 100mg of diclofenac or indomethacin immediately before or after ERCP in all patients without contraindication. In addition to this, in the case of high risk for post-ERCP pancreatitis (PEP), the placement of a 5-Fr prophylactic pancreatic stent should be strongly considered. Sublingually administered glyceryl trinitrate or 250μg somatostatin given in bolus injection might be considered as an option in high risk cases if nonsteroidal anti-inflammatory drugs (NSAIDs) are contraindicated and if prophylactic pancreatic stenting is not possible or successful. 2 ESGE recommends keeping the number of cannulation attempts as low as possible. 3 ESGE suggests restricting the use of a pancreatic guidewire as a backup technique for biliary cannulation to cases with repeated inadvertent cannulation of the pancreatic duct; if this method is used, deep biliary cannulation should be attempted using a guidewire rather than the contrast-assisted method and a prophylactic pancreatic stent should be placed. 4 ESGE suggests that needle-knife fistulotomy should be the preferred precut technique in patients with a bile duct dilated down to the papilla. Conventional precut and transpancreatic sphincterotomy present similar success and complication rates; if conventional precut is selected and pancreatic cannulation is easily obtained, ESGE suggests attempting to place a small-diameter (3-Fr or 5-Fr) pancreatic stent to guide the cut and leaving the pancreatic stent in place at the end of ERCP for a minimum of 12-24 hours. 4 ESGE does not recommend endoscopic papillary balloon dilation as an alternative to sphincterotomy in routine ERCP, but it may be advantageous in selected patients; if this technique is used, the duration of dilation should be longer than 1 minute. © Georg Thieme Verlag KG Stuttgart. New York.
Sommer P.,University of Leipzig |
Piorkowski C.,University of Leipzig |
Gaspar T.,University of Leipzig |
Eitel C.,University of Leipzig |
And 6 more authors.
Europace | Year: 2013
AimsCurrently, fluoroscopy-based catheter visualization is the standard modality in invasive electrophysiological procedures. Recently a new technology for non-fluoroscopic visualization of diagnostic (since 2010) and ablation catheters (since May 2012) has been introduced. The MediGuide™-Technology (MediGuide) projects catheter tips on prerecorded cine loops in a high time resolution.Methods and resultsWe report on MediGuide-based supraventricular tachycardia (SVT) cases [atrioventricular nodal reentry tachycardia (AVNRT), atrioventricular reentry tachycardia (AVRT), Wolff-Parkinson-White syndrome (WPW), ectopic atrial tachycardia (EAT) and typical atrial flutter) from two European centres. In all patients, diagnostic and/or ablation catheters with a special sensor were used to perform the ablation procedures. All procedural data such as acute success, duration of the procedure, fluoroscopy time, and dose and patients' characteristics were analyzed and compared with conventionally ablated patients (n = 1865). Procedure-related complications during the hospital stay were recorded. A total of 24 consecutive patients were analyzed: no significant difference to the control group was seen in the baseline characteristics. The MediGuide patients were predominantly male (66%), aged 58 ± 14 years and were ablated for 6 AVNRT (25%), 4 AVRT/WPW (17%), 1 EAT (4%), and 13 typical atrial flutter (54%). The acute success rate was 100% (98% in the control group, n.s.). The median fluoroscopy time was 0.5 ± 1.4 min (10.2 ± 9.6 in the control group, P < 0.001), the median fluoroscopy dose was 187 ± 554 cGy cm2 (996 ± 2593 cGy cm2, P < 0.05). Mean procedure time was 70 ± 25 min (60 ± 36 min, n.s.). No complications during the hospital stay were recorded.ConclusionIn several different forms of supraventricular tachycardias the MediGuide-Technology contributed to a dramatic reduction in irradiation exposure. With a median fluoroscopy time of 30 s all SVT cases were effectively performed with no complications; the fluoroscopy burden can be significantly reduced not only for the patient but also for the nurses and the physicians performing the case. The overall procedure times are not prolonged due to the use of MediGuide Technology compared with a control group of >1800 patients undergoing conventional ablation procedures. © 2013 The Author.
Beheshti M.,St Vincents Hospital |
Imamovic L.,St Vincents Hospital |
Broinger G.,St Vincents Hospital |
Vali R.,St Vincents Hospital |
And 6 more authors.
Radiology | Year: 2010
Purpose: To prospectively evaluate the potential value of fluorocholine (FCH) positron emission tomography (PET)/computed tomography (CT) in the preoperative staging of patients with prostate cancer who had intermediate or high risk of extracapsular disease. Materials and Methods: Institutional review board approval and written informed consent were obtained. Overall, 132 patients with prostate cancer (mean age, 63 years ± 7 [standard deviation]) were enrolled between October 2003 and June 2008. Two patients were subsequently excluded. In 111 patients, radical prostatectomy with extended pelvic lymph node (LN) dissection was performed. Patients were categorized into groups with intermediate (n = 47) or high (n = 83) risk of extracapsular extension on the basis of their Gleason scores and prostate specific antigen levels. Imaging was performed with an integrated PET/CT system after injection of 4.07 MBq FCH per kilogram of body weight with acquisition of dynamic images in the pelvis and whole-body images. Statistical analysis was performed on a per-patient basis. Results: Significant correlation was found between sections with the highest FCH uptake and sextants with maximal tumor infiltration (r = 0.68; P = .0001). Overall, 912 LNs were histopathologically examined. A per-patient analysis revealed the sensitivity, specificity, and positive and negative predictive values of FCH PET/CT in the detection of malignant LNs were 45%, 96%, 82%, and 83%, respectively. For LN metastases greater than or equal to 5 mm in diameter, sensitivity, specificity, and positive and negative predictive values were 66%, 96%, 82%, and 92%, respectively. In 13 patients, 43 bone metastases were detected. Early bone marrow infiltration was detected with only FCH PET in two patients. FCH PET/CT led to a change in therapy in 15% of all patients and 20% of high-risk patients. Conclusion: FCH PET/CT could be useful in the evaluation of patients with prostate cancer who are at high risk for extracapsular disease, and it could be used to preoperatively exclude distant metastases. © RSNA, 2010.
Kellermair J.,Elisabethinen Hospital
Blood | Year: 2013
Platelet endothelial cell adhesion molecule 1 (PECAM-1) is involved in leukocyte migration and angiogenesis, which are key components of venous thrombus resolution. This study investigated the effect of PECAM-1 deficiency on thrombus resolution in FVB/n mice and the extent to which levels of soluble PECAM-1 (sPECAM-1) correlate with delayed thrombus resolution in humans after acute symptomatic deep vein thrombosis (DVT). In a mouse stagnant flow venous thrombosis model Pecam-1(-/-) thrombi were larger, persisted for longer periods of time, and displayed attenuated macrophage invasion and decreased vessel formation in the presence of increased fibrosis. In humans, higher levels of truncated plasma sPECAM-1 possibly cleaved from cell surfaces, were found in patients with delayed thrombus resolution (assessed via duplex-based thrombus scoring) relative to those whose thrombi resolved (median, 25th/75th percentile): 92.5 (87.7/103.4) ng/mL vs 71.5 (51.1/81.0) ng/mL; P < .001. Furthermore, unresolved human deep vein thrombus specimens stained positively with antibodies specific for the extracellular, but not the cytoplasmic domain of PECAM-1, consistent with accumulation of cleaved PECAM-1. Our data suggest a regulatory role of PECAM-1 in venous thrombus resolution and suggest a predictive value of sPECAM-1 for postthrombotic syndrome (PTS) after acute DVT.