Stone G.W.,Columbia University Medical Center |
Stone G.W.,Cardiovascular Research Foundation |
Abizaid A.,Dante Pazzanese Institute of Cardiology |
Silber S.,ISaR GmbH |
And 12 more authors.
Journal of the American College of Cardiology | Year: 2012
Objectives: This study sought to evaluate the potential utility of a novel polyethylene terephthalate micronet mesh-covered stent (MGuard) in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Background: Suboptimal myocardial reperfusion after PCI in STEMI is common and results in increased infarct size and mortality. The MGuard is a novel thin-strut metal stent with a polyethylene terephthalate micronet covering designed to trap and exclude thrombus and friable atheromatous debris to prevent distal embolization. Methods: A total of 433 patients with STEMI presenting within 12 h of symptom onset undergoing PCI were randomized at 50 sites in 9 countries to the MGuard (n = 217) or commercially available bare metal or drug-eluting stents (n = 216). The primary endpoint was the rate of complete (<70%) ST-segment resolution measured 60 to 90 min post-procedure. Results: Baseline characteristics were well matched between the groups. The primary endpoint of post-procedure complete ST-segment resolution was significantly improved in patients randomized to the MGuard stent compared with control patients (57.8% vs. 44.7%; difference: 13.2%; 95% confidence interval: 3.1% to 23.3%; p = 0.008). By core laboratory analysis, the MGuard stent compared with control stents also resulted in superior rates of Thrombolysis In Myocardial Infarction 3 flow (91.7% vs. 82.9%, p = 0.006) with comparable rates of myocardial blush grade 2 or 3 (83.9% vs. 84.7%, p = 0.81). Mortality (0% vs. 1.9%, p = 0.06) and major adverse cardiac events (1.8% vs. 2.3%, p = 0.75) at 30 days were not significantly different between patients randomized to the MGuard stent and control stent, respectively. Conclusions: Among patients with acute STEMI undergoing emergent PCI, the MGuard micronet mesh-covered stent compared with conventional metal stents resulted in superior rates of epicardial coronary flow and complete ST-segment resolution. A larger randomized trial is warranted to determine whether these benefits result in reduced infarct size and/or improved clinical outcomes. (Safety and Efficacy Study of MGuard Stent After a Heart Attack [MASTER]; NCT01368471) © 2012 American College of Cardiology Foundation.
Agency: European Commission | Branch: FP7 | Program: CSA-CA | Phase: Fission-2008-5.1.1 | Award Amount: 1.97M | Year: 2009
The project covers the structuring, organisation, coordination and implementation of training schemes in cooperation with local, national and international training organisations, to provide training to professionals active in nuclear organisations or their contractors and subcontractors. The training schemes provide a portfolio of courses, training sessions, seminars and workshops for continuous learning, for upgrading knowledge and developing skills. The training schemes allow the individual to acquire qualifications and skills, as required by specific positions in the nuclear sector, which will be documented in a training passport. The essence of such passport is to be recognised within the EU by the whole nuclear sector, which provides mobility to the individual looking for employment and an EU wide recruitment field for the nuclear employers. The recognition is subject to qualification and validation of the training courses according to a set of commonly agreed criteria, which can be ratified by law or established on a consensus basis within a network. The training schemes cover profiles for each of the following: - the basic training in selected nuclear topics of non nuclear engineers and personnel of nuclear facilities contractors and subcontractors; - the technical training for the design and construction challenges of GEN III plants, and the design of GEN IV plants. The training schemes consists of three distinct phases: - Courses, seminars, learning, scientific and technical visits, case studies; - Participation to selected activities within the scope of the training in different organisations; - Autonomous conduction of activities within the scope of the training under supervision of a mentor in one or in different organisations The first phase can be provided by universities and training centers, the second and third phases can be provided by industries, research centers and future employers.
Agency: European Commission | Branch: FP7 | Program: CSA-SA | Phase: Fission-2007-6.0.04;Fission-2007-2.1-04 | Award Amount: 2.25M | Year: 2009
MMOTION is a support action answering the call EURATOM-Fission-2007-2.1.4 targeting a better understanding of Man-Machine-Organization in the operation of nuclear installations. The objective of MMOTION is to analyse the current situation and the future trends concerning MMO and safety related aspects, and to propose an European research road map for the period 2010-2015 to comprehensively address the recognised issues. MMOTION scientific approach will cover all the aspects of human factors. MMOTION will investigate three major themes: Human-System-Interface Design and Automation, Organizational and Cultural factors, and MMO qualitative and quantitative evaluation. Thus, the ten partners have been selected for their expertise and their representativeness of the nuclear industry. MMOTION is featuring a 2-year program with activities such as discussion panels, focussed studies, analysis, a pilot exercise, roadmapping and dissemination. During the first 8 months, MMOTION partners will work on the identification of actual issues related to MMO. Based on the results, the work will be split into three consistent themes in order to identify R&D topics to be addressed in the future. In parallel, a pilot exercise aiming to assess the feasibility of proposed new R&D approaches will be performed. During the last months, a single consolidated roadmap will constitute the main deliverable of the project. A specific management activity will ensure the coordination: methodology, consistency, overlaps between themes. Results of MMOTION will be widely disseminated thanks to a proactive communication strategy initiated early in the project. The main impacts of MMOTION will be support to European common vision in the field of MMO for nuclear, and contribution to the development and the spread of a MMO related safety culture that could, for example, facilitate new suppliers to provide appropriate products for the nuclear market.
Song Y.-H.,University of Houston |
Pinkernell K.,Miltenyi Biotec GmbH |
Alt E.,University of Houston |
Alt E.,ISaR GmbH |
Alt E.,Tulane University
Cell Cycle | Year: 2011
Potentially, adult stem cell-based therapy provides a new therapeutic option for myocardial regeneration. However, to date, with regard to the benefits seen the mechanisms involved in stem cell based therapy are not well understood. Suggested pathways proposed so far include fusion of stem cells with cardiomyocytes, transdifferentiation into cardiac and vascular cells and secretion of paracrine factors. In a recent study, our group examined the fate of human adipose tissue derived stem cells (hASCs) fused with rat cardiomyocytes after treated with fusion-inducing hemagglutinating virus of Japan (HVJ). In this study we demonstrated that cells of fused hASC-cardiomyocytes display a cardiomyocyte phenotype and spontaneous rhythmic contraction and generate an action potential in vitro. As part of the work underlying this paper we co-cultured rat neonatal cardiomyocytes with hASCs or pig bone marrow derived mesenchymal stem cells (MSCs) where ASCs or MSCs had previously been transduced with a lentivirus encoding eGFP. Our data evidence early cardiac contractile proteins such as Titin and MF20 identified in eGFP positive cells, suggesting a cardiomyogenic phenotype. Recent work by others has shown that the myogenic conversion increased when BMSCs were cultured with apoptotic cells. In this extra view article, we review the current understanding of stem cell derived factors, fusion/partial fusion and the manner in which the exchange of cellular contents between stem cells and cardiomyocytes might contribute to the reprogramming of fully differentiated cardiomyocytes based on recently published literature. © 2011 Landes Bioscience.
Hellinger S.,ISaR GmbH
European Musculoskeletal Review | Year: 2011
The first clinical results of the Disc-FX® (elliquence, LLC) provide encouraging findings showing that this method can be included among treatment options for intervertebral disc pathologies. The Disc-FX procedure is at least equivalent to other minimally invasive procedures with the aim of avoiding open surgical procedures. It lies in the area between conservative and semi-invasive therapy and open surgery in the array of treatment options for disc pathologies. The combination of different techniques has been demonstrated as beneficial and appears to be one of the superior percutaneous techniques, as other combinations in studies have shown. The possibility for complications is reduced compared with invasive techniques. Specific problems with post-operative epidural scarring and fibrosis are avoided. As a minimally invasive procedure it leads to quicker rehabilitation, an earlier return to work and lower medical costs. © Touch Briefings 2011.
Steinbock H.,ISaR GmbH
Recht und Psychiatrie | Year: 2012
There is no doubt about the significance of community mental health care for the rehabilitation of forensic inpatients. Therefore, the term of «complementary institutions» for community mental health care is challenged. In order to find out what community mental health care institutions expect of forensic psychiatry, a questionnaire was sent to community care institutions. The results of the survey are presented and discussed.
Nabahungu N.L.,Wageningen University |
Nabahungu N.L.,ISaR GmbH |
Visser S.M.,Wageningen University
Land Degradation and Development | Year: 2013
Most of Rwanda's wetlands are being reclaimed under government schemes with the aim of growing rice as the main crop. In the present study, information on farmers' knowledge and perceptions of agricultural wetland management was collected in Cyabayaga and Rugeramigozi wetlands. The two wetlands were selected as representatives for typical reclaimed wetland agriculture in Rwanda. They provide contrasts in both environmental and social terms. Three tools were used to investigate farmers' knowledge and perception of agricultural wetland management: (i) household survey; (ii) focus group discussions; and (iii) transect walk. The major constraints identified by farmers in the two wetlands were water shortage and lack of availability of improved seeds and high prices of fertilisers. The primary benefits from wetlands for farmers are income generation in Cyabayaga and food security in Rugeramigozi. The most commonly reported concern about the wetlands in the Cyabayaga and Rugerameragozi was that they are a source of malaria. Rice is an important crop in both wetlands, whereas farmers in Cyabahaga wish to continue cultivating rice, Rugeramigozi farmers prefer to grow rice only after it has been tested for its adaptability. Farmers have sufficient knowledge on the causes and the potential solutions to overcome most constraints. They know that soil suitability is closely related to relief. They classify soils by a number of criteria and choose crops accordingly. Any programme designed to address wetland management in the region will have to take account of farmers' knowledge and adopt a holistic view of wetland management. © 2011 John Wiley & Sons, Ltd.
Randomised, double-blind trial on the value of tapered discontinuation of clopidogrel maintenance therapy after drug-eluting stent implantation. Intracoronary Stenting and Antithrombotic Regimen: CAUTION in Discontinuing Clopidogrel Therapy--ISAR-CAUTION
Schulz S.,ISaR GmbH
Thrombosis and haemostasis | Year: 2014
There is little evidence on the optimal mode of clopidogrel discontinuation. Epidemiological studies observed clustering of thrombotic events after cessation of chronic clopidogrel therapy. The underlying mechanism has been ascribed to transient platelet hyper-reactivity. Gradual tapering of clopidogrel may have the potential to attenuate this phenomenon. The objective of the present study was to assess whether in patients with drug-eluting stents (DES) gradual discontinuation of clopidogrel maintenance therapy is superior to conventional, abrupt discontinuation. Patients with planned discontinuation of chronic clopidogrel therapy after DES implantation were randomised in a double-blinded fashion to either gradual discontinuation (according to a tapering schema over four weeks) or abrupt discontinuation (after continued clopidogrel therapy for additional four weeks). The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, stent thrombosis, major bleeding or rehospitalisation due to an acute coronary syndrome at 90 days. Enrollment of 3,000 patients was planned. The study was stopped prematurely due to slow recruitment after enrollment of 782 patients. At 90 days, nine of 392 patients (2.3%) with tapered cessation reached the primary endpoint compared to five of 390 patients (1.3%) with abrupt cessation (p=0.284). The composite of death or myocardial infarction occurred in three patients with tapered and three patients with abrupt discontinuation (p=0.764). In conclusion, tapered discontinuation of chronic clopidogrel therapy is not superior to abrupt discontinuation regarding the primary endpoint in this study. However, the results must be interpreted in view of the premature termination of the trial and low event rates.
Hellinger S.,ISaR GmbH
Acta Neurochirurgica, Supplementum | Year: 2011
As a bridge between open and percutaneous therapy, endoscopy of the cervical spine started to be used at the beginning of the 1990s, following good experiences on the lumbar spine. The principle of microsurgery is combined with the minimally invasive principles by bringing the optical level to the forefront of pathology. Access morbidity has been significantly reduced by the percutaneous access technique. However, this procedure cannot be applied in patients with cervical disc herniation accompanied by segmental instability. In further developing these endoscopic techniques, in view of the experiences with the classical "Cloward procedure", the aim was to do a bony fusion of the intervertebral space of the cervical spine by endoscopic access. Material: A female patient with postraumatic instability of the cervical segments C4/5 underwent a fullendoscopic bony fusion. The technique will be described. The fusional process has been documented by CT and clinical assessment over 3 months. Result: Having preoperative pain of VAS 8, it diminished to VAS 1 after surgery. The Ct-controls demonstrated a good placement of the bony dowel through the endoscopic sheath in the intervertebral space. After 3 months a bony fusion was documented by CT and in bending X-ray. Conclusion: The result of this method displays that a fullendoscopic fusion of the cervical spine with a bone dowel is possible. The clinical result seems to be comparable to the classical Cloward procedure. To the best of my knowledge, this is the first report of a fullendoscopic osseous fusion on the cervical spine. © 2011 Springer-Verlag/Wien.
Hellinger S.,ISaR GmbH
International Journal of Spine Surgery | Year: 2014
Background Patients with radiculopathy caused by contained disc herniations are less likely to have good outcomes following discectomy surgery than patients with disc herniations that are not contained. The author presents his 4-year results from a prospective trial regarding the efficacy and safety of a tubular transforaminal radiofrequency-assisted manual decompression and annulus modulation of contained disc herniations in 58 patients. Methods Fifty-eight patients with lumbar radiculopathy due to a contained disc herniation were enrolled in a prospective clinical study. Visual analog scores (VAS) for back pain and leg pain, quality of life assessment, Macnab criteria, and SF-12 were collected from patients before treatment, at 2-years and 4-years post-treatment. Results At 4 years, results were obtained from 47 (81%) of patients. Compared to mean pretreatment assessments, mean 4-year VAS for back pain improved from 8.6 to 2.3 points, and mean VAS for leg pain improved from 7.8 to 2.3. Eighty-three percent of respondents reported that they were "satisfied" or "very satisifed" with their quality of life at 4-years as per SF-12. At 4 years, recurrence was noted in 3 (6.4%) of respondents and no complications were reported. Conclusions The 2-year and 4-year study results are nearly identical, suggesting durable benefit out to 4 years. These results also suggest that in carefully selected patients with sustained contained disc herniations who have failed conservative treatments, manual decompression combined with radiofrequency-assisted decompression and annulus modulation are very likely to have good outcomes 4 years post-treatment. © 2014 ISASS - International Society for the Advancement of Spine Surgery.