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Thiele H.,University of Leipzig | Wohrle J.,University of Ulm | Hambrecht R.,Klinikum Links der Weser | Rittger H.,Klinikum Coburg | And 11 more authors.
The Lancet | Year: 2012

Background: Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial. Methods: The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 μg/kg per min (maximum 10 μg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov, NCT00712101. Findings: Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0 vs 7·6; odds ratio [OR] 0·91; 95 CI 0·64-1·28; p=0·58). The incidence of death (4·5 vs 3·6; 1·24; 0·78-1·97; p=0·36) and reinfarction (1·8 vs 1·8; 1·0; 0·51-1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2·4 vs 4·1; 0·57; 0·33-0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups. Interpretation: In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated. Funding: Lilly, Germany. University of Leipzig - Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF). © 2012 Elsevier Ltd.


Costa R.A.,Dante Pazzanese Institute of Cardiology | Costa R.A.,Cardiovascular Research Center | Abizaid A.,Dante Pazzanese Institute of Cardiology | Abizaid A.,Cardiovascular Research Center | And 7 more authors.
JACC: Cardiovascular Interventions | Year: 2016

Objectives The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions. Background The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland). Methods A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany. Results Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported. Conclusions The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119) © 2016 American College of Cardiology Foundation.


Ntoukas V.,Krankenhaus der Barmherzigen Bruder | Tappe D.,University of Würzburg | Pfutze D.,Krankenhaus der Barmherzigen Bruder | Simon M.,University of Regensburg | Holzmann T.,University of Regensburg
Emerging Infectious Diseases | Year: 2013

Human cysticercosis caused by Taenia crassiceps tapeworm larvae involves the muscles and subcutis mostly in immunocompromised patients and the eye in immunocompetent persons. We report a successfully treated cerebellar infection in an immunocompetent woman. We developed serologic tests, and the parasite was identified by histologic examination and 12s rDNA PCR and sequencing.


Oppl B.,Hanusch Hospital | Michitsch G.,Apallic Care Unit | Misof B.,Hanusch Hospital | Kudlacek S.,Krankenhaus der Barmherzigen Bruder | And 4 more authors.
Journal of Bone and Mineral Research | Year: 2014

Disuse of the musculoskeletal system causes bone loss. Whether patients in vegetative state, a dramatic example of immobilization after severe brain injury, suffer from bone loss and fractures is currently unknown. Serum markers of bone turnover, bone mineral density (BMD) measurements, and clinical data were cross-sectionally analyzed in 30 consecutive vegetative state patients of a dedicated apallic care unit between 2003 and 2007 and compared with age- and sex-matched healthy individuals. Vegetative state patients showed low calcium levels and vitamin D deficiency compared with healthy controls. Serum bone turnover markers revealed high turnover as evidenced by markedly elevated carboxy-terminal telopeptide of type I collagen (β-crosslaps) and increased levels of alkaline phosphatase. BMD measured by dual-energy X-ray absorptiometry (DXA) scanning showed strongly decreased T- and Z-scores for hip and spine. Over a period of 5 years, 8 fragility fractures occurred at peripheral sites in 6 of 30 patients (n=3 femur, n=2 tibia, n=2 fibula, n=1 humerus). In conclusion, high bone turnover and low BMD is highly prevalent in vegetative state patients, translating into a clinically relevant problem as shown by fragility fractures in 20% of patients over a time period of 5 years. © 2014 American Society for Bone and Mineral Research.


Thiele H.,University of Leipzig | Rach J.,University of Leipzig | Klein N.,University of Leipzig | Pfeiffer D.,University of Leipzig | And 6 more authors.
European Heart Journal | Year: 2012

AimsThe optimal timing of intervention in non-ST-elevation myocardial infarction (NSTEMI) remains uncertain. The aim of this multicentre trial was to assess whether an immediate invasive approach is superior to an early invasive or a selective invasive approach with respect to reduction of large infarction. Methods and resultsPatients with NSTEMI were randomized to either an immediate (<2 h after randomization; n = 201), an early (1048 h after randomization; n = 200), or a selective invasive approach with high invasive percentage (n = 201). The primary outcome was the peak creatine kinase (CK)-myocardial band (MB) activity during index hospitalization; key secondary clinical endpoints were the composite of (i) death and non-fatal infarction; (ii) death, non-fatal infarction, and refractory ischaemia; (iii) death, non-fatal infarction, refractory ischaemia, and rehospitalization for unstable angina within 6 months.The median time from randomization to angiography was 1.1 h in the immediate vs. 18.6 h in the early and 67.2 h in the selective invasive group (P< 0.001). There was no significant difference in the peak CK-MB activity between groups. The key secondary clinical endpoints were similar between groups at 6-month follow-up: death and infarction: 21.0 vs. 16.0 vs. 14.5; P = 0.17; death, infarction, refractory ischaemia: 20.9 vs. 21.5 vs. 22.0; P = 0.98; death, infarction, refractory ischaemia, rehospitalization: 26.0 vs. 26.5 vs. 24.5; P = 0.91, respectively. ConclusionsIn NSTEMI patients, an immediate invasive approach does not offer an advantage over an early or a selective invasive approach with respect to large myocardial infarctions as defined by peak CK-MB levels, which is supported by similar clinical outcomes. © 2012 The Author.


Fleischmann G.,Krankenhaus der Barmherzigen Bruder | Fillafer G.,Krankenhaus der Barmherzigen Bruder | Matterer H.,Krankenhaus der Barmherzigen Bruder | Skrabal F.,Krankenhaus der Barmherzigen Bruder | And 2 more authors.
Nephrology Dialysis Transplantation | Year: 2010

Background. Little is known about the epidemiology of chronic kidney disease (CKD) in patients with suspected sleep apnoea (SA).Methods. Glomerular filtration rate (eGFR) was calculated in consecutive patients referred for full-night observed in-hospital polysomnography. SA was defined as the respiratory disturbance index (RDI) > 5.Results. One hundred and fifty-eight patients were studied. The age (mean ± SD) was 61.2 ± 12.7 years, body mass index 29.5 ± 5.9 kgm2 and eGFR 86.1 ± 21.7 mLmin1.73 m2. SA was present in 133 patients (85). The eGFR was 94.6 7 mLmin1.73 m2 in patients without SA and 84.5 7 mLmin1.73 m 2 in patients with SA mean difference (95 confidence interval) 10.0 (0.6-19.4) mLmin1.73 m2; P = 0.037. Seventy patients had eGFR ≥ 90 mLmin1.73 m2 (group 1), and 70 patients had between 60 and 89 mLmin1.73 m2 (group 2), and 18 patients had 30-59 mLmin1.73 m 2 (CKD 3). Although the prevalence of SA did not differ among the groups (group 1: 80; group 2: 86; CKD 3: 94), the number of central sleep apnoeas (CSA) per hour was 5.9 ± 12.2 in CKD 3, six times greater compared to patients with eGFR ≥ 60 mLmin1.73 m2 (1.0 ± 2.1; P = 0.01). The prevalence of obstructive SA did not differ between the groups. After adjustment for age, gender, BMI, hypertension, diabetes mellitus and smoking status, CKD 3 (P = 0.0004) and New York Heart Association class ≥3 (P = 0.0001) remained predictive of CSA events per hour.Conclusions. eGFR is reduced in patients with SA, particularly in those with episodes of CSA.


Levin N.W.,Renal Research Institute | Chertow G.M.,Stanford University | Larive B.,Cleveland Clinic | Schulman G.,Vanderbilt University | Kotanko P.,Krankenhaus der Barmherzigen Bruder
Clinical Journal of the American Society of Nephrology | Year: 2010

Background and objectives: Cardiovascular events are common in patients with ESRD. Whether sympathetic overactivity or vagal withdrawal contribute to cardiovascular events is unclear. We determined the general prevalence and clinical correlates of heart rate variability in patients on hemodialysis. Design, setting, participants, & measurements: We collected baseline information on demographics, clinical conditions, laboratory values, medications, physical performance, left ventricular mass (LVM), and 24-hour Holter monitoring on 239 subjects enrolled in the Frequent Hemodialysis Network Daily Trial. Results: The mean R-R interval was 812 ± 217 ms. The SD of R-R intervals was 79.1 ± 40.3 ms. Spectral power analyses showed low-frequency (sympathetic modulation of heart rate) and high-frequency power (HF; vagal modulation of heart rate) to be 106.0 (interquartile range, 48.0 to 204 ms2) and 42.4 ms2 (interquartile range, 29.4 to 56.3 ms2), respectively. LVM was inversely correlated with log HF (-0.02 [-0.0035; -0.0043]) and the R-R interval (-1.00 [-1.96; -0.032]). Physical performance was associated with mean R-R intervals (1.98 [0.09; 3.87]) and SD of R-R intervals (0.58 [0.049; 1.10]). After adjustment for age, race, ESRD vintage, diabetes, and physical performance, the relationship between log HF and LVM (per 10 g) remained significant (-0.025 [-0.042; -0.0085]). Conclusions: Holter findings in patients on hemodialysis are characterized by sympathetic overactivity and vagal withdrawal and are associated with higher LVM and impaired physical performance. Understanding the spectrum of autonomic heart rate modulation and its determinants could help to guide preventive and therapeutic strategies. Copyright © 2010 by the American Society of Nephrology.


Reddy V.Y.,Mount Sinai School of Medicine | Mobius-Winkler S.,University of Leipzig | Miller M.A.,Mount Sinai School of Medicine | Neuzil P.,Homolka Hospital | And 4 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy. Background The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation. Methods A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death. Results The mean CHADS2 score and CHA2DS2-VASc (CHADS2 score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS2 scores of the patient cohort. Conclusions LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ASAP]; NCT00851578).© 2013 by the American College of Cardiology Foundation Published by Elsevier Inc.


Grube E.,Heart Center | Schofer J.,Cardiovascular Medical Care Center | Hauptmann K.E.,Krankenhaus der Barmherzigen Bruder | Nickenig D.,Poliklinik Universittsklinikum Bonn | And 3 more authors.
JACC: Cardiovascular Interventions | Year: 2010

Objectives: The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions. Background: The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Libert (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 μm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 μg each of polymer and paclitaxel per 16-mm stent). Methods: In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Libert-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%). Results: The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 ± 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 ± 11.2%. Conclusions: The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Libert (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. © 2010 American College of Cardiology Foundation.


Ntoukas V.,Krankenhaus der Barmherzigen Bruder | Muller A.,Krankenhaus der Barmherzigen Bruder
Minimally Invasive Neurosurgery | Year: 2010

Objective: While over the last ten years minimally invasive posterior lumbar interbody fusion (PLIF) has been acknowledged to (i) reduce approach-related morbidity associated with quicker recovery, (ii) require a shorter hospital stay and (iii) deliver similar clinical outcomes when compared to a traditional approach, it is still not the current gold standard. In order to demonstrate the efficacy of the minimally invasive lumbar PLIF approach, a retrospective study was conducted comparing both approaches. Methods: A retrospective study was conducted with 40 patients treated for one level, degenerative lumbar instability. 20 patients received lumbar PLIF though a standard open approach, while another 20 underwent a minimally invasive approach using the SpiRIT-system. Spinal pathological features, stabilized segments, number of implanted pedicle screws, surgical time, radiation time, blood loss, complications, radiographic images and standardized patient questionnaires (VAS, ODI) were evaluated. The follow-up period was one year. Results: One year after the performed surgery, we found no significant difference between the two groups with regard to clinical and radiographic outcome. However, in the minimally invasive group we noticed less blood loss, less postoperative pain, a shorter recovery time and a shorter hospital stay. Despite these benefits, the minimally invasive group also experienced a longer surgical and radiation time as compared to the open group. Conclusions: This study confirmed the results of previous studies which advocated the advantages of less blood loss, less postoperative pain, quicker recovery and shorter duration of hospitalization. However, in the long run, one year after surgery, both groups showed no significant difference with regards to clinical and radiographic outcome. Therefore long-term controlled studies are necessary to validate the role of the minimally invasive PLIF in degenerative lumbar instability. © Georg Thieme Verlag KG Stuttgart · New York.

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