Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial
Haude M.,Lukaskrankenhaus GmbH |
Erbel R.,West German Heart Center Essen |
Erne P.,Luzerner Kantonsspital |
Verheye S.,ZNA Middelheim |
And 8 more authors.
The Lancet | Year: 2013
Background Bioabsorbable vascular scaffolds were developed to overcome limitations of permanent bare-metal or drug-eluting coronary stents-ie, stent thrombosis (despite prolonged dual antiplatelet therapy), the life-long presence of a caged vessel segment that does not allow vasomotion or remodelling, and chronic vessel wall inflammation. We assessed the safety and performance of a new magnesium-based paclitaxel-eluting absorbable metal scaffold in symptomatic patients with de-novo coronary lesions. Methods We did a prospective, multicentre, first-in-man trial (BIOSOLVE-1) of the drug-eluting absorbable metal scaffold (DREAMS). 46 patients with 47 lesions were enrolled at five European centres. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation, at 6 and 12 months. Clinical follow-up was scheduled at 1, 6, 12, 24, and 36 months. Patients were consecutively assigned to angiographic and intravascular ultrasonographic follow-up at 6 months or 12 months. Optical coherence tomography was done in some patients. All patients were recommended to take dual antiplatelet therapy for at least 12 months. This trial is registered with ClinicalTrials.gov, number NCT01168830. Findings Overall device and procedural success was 100%. Two of 46 (4%) patients had target lesion failure at 6 months (both clinically driven target lesion revascularisations), which rose to three of 43 (7%) at 12 months (one periprocedural target vessel myocardial infarction occurred during angiography at the 12 month follow-up visit). We noted no cardiac death or scaffold thrombosis. Interpretation Our results show feasibility, a good safety profile, and promising clinical and angiographic performance results up to 12 months for DREAMS. Our promising clinical results show that absorbable metal scaffolds might be an alternative to polymeric absorbable scaffolds. Funding Biotronik.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2007-3.1-4 | Award Amount: 3.83M | Year: 2009
The main objective of the proposed project is to develop and to validate a system for measurement and feedback of outcome quality and support of decision making. The project will be executed in the areas of postoperative pain management which serves as an example for other fields of medicine with a high variation of care. The project will provide the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. We propose to develop and implement a web-based information system, featuring three functions: Feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice. Clinical Decision Support System for Post-Operative Pain, which responds to queries made by physicians for advice regarding treatment of individual patients. A Knowledge Library which provides clinicians with easily accessible summaries of evidence-based recommendations tailored to specific post-operative situations. The first two functions will draw their information from a large database or registry. The registry will receive data about post-operative patients from x participating clinical sites across Europe. The third function, the Knowledge Library, will draw its information from published, peer-reviewed studies, and will be updated periodically. To increase the benefit of the system to end-users, the registry will be complemented with patient data on side effects and treatment costs. All of these will be integrated into the feedback system. The proposed project is the first comprehensive, concerted European effort in the field of improving clinical decision making. It integrates experience gained from national initiatives, and the expertise of world-leading, European-based, groups dealing with benchmarking, health outcomes and health care utilization research
Emergence of SCCmec type IV and SCCmec type V methicillin-resistant Staphylococcus aureus containing the Panton-Valentine leukocidin genes in a large academic teaching hospital in Central Switzerland: External invaders or persisting circulators?
Valsesia G.,Center for Laboratory Medicine |
Valsesia G.,ETH Zurich |
Rossi M.,Luzerner Kantonsspital |
Bertschy S.,Luzerner Kantonsspital |
Pfyffer G.E.,Center for Laboratory Medicine
Journal of Clinical Microbiology | Year: 2010
The hospital epidemiology of methicillin-resistant Staphylococcus aureus (MRSA) has changed in the past few years due to the encroachment of community-associated MRSA (CA-MRSA) strains into health care settings. MRSA strains that were isolated during a 2-year period from patients of the Luzerner Kantonsspital were analyzed to elucidate their epidemiology. Moreover, extended surveillance of individuals who were contacts of those patients was carried out for 6 months to identify the routes of spread and to assess the quality of the infection control measures used in our setting. Patient data were collected to distinguish CA-MRSA strains from health care-associated MRSA (HA-MRSA) strains by epidemiological criteria, as defined by the Centers for Disease Control and Prevention (CDC). On the basis of the CDC definition, the majority of the strains were considered to be HA-MRSA. However, 87% of them belonged to staphylococcal cassette chromosome mec (SCCmec) types IV and V, which are traditionally associated with CA-MRSA. Surprisingly, classical nosocomial SCCmec types I and II represented a minority, whereas SCCmec type III was completely absent. By PFGE analysis, four predominant clonal lineages and 21 highly variable sporadic genotypes were detected. Twentyeight percent of the MRSA strains studied carried the genes encoding the Panton-Valentine leukocidin (PVL), of which 21% and 83% were associated with SCCmec types IV and V, respectively. Among 289 contact individuals screened for MRSA carriage throughout the extended surveillance, a single secondary patient was discovered. The possibility of nosocomial transmission could be excluded. The high proportions of SCCmec type IV and V strains as well as PVL-positive strains suggest strong infiltration of CA-MRSA into our institution. Moreover, the low endemic prevalence of MRSA demonstrates that current infection control measures are sufficient to limit its spreading and the emergence of large epidemic outbreaks. Copyright © 2010, American Society for Microbiology. All Rights Reserved.
Cuculi F.,John Radcliffe Hospital |
Erne P.,Luzerner Kantonsspital
Expert Opinion on Investigational Drugs | Year: 2011
Introduction: The renin-angiotensin-aldosterone system (RAAS) plays an important role in the pathophysiology of hypertension and heart failure. ACE inhibitors, angiotensin receptor II blockers (AT-II blockers) and aldosterone antagonists have been used to tackle the RAAS in the past but combined ACE and neutral endopeptidase (NEP) inhibitors have been shown to be more potent in reducing blood and especially pulse pressure in patients with hypertension. Areas covered: Different NEP inhibitors have been tested but omapatrilat is the most widely studied in the setting of hypertension, heart failure and chronic angina. We have undertaken a PubMed search on NEP with a special focus on omapatrilat and its efficacy in hypertension and heart failure. The incidence of angioedema is more frequent in patients taking combined ACE and NEP inhibitors and this has prevented these medications from finding a widespread use. Combinations of NEP inhibitors and AT-II blockers are currently being studied and have been shown to reduce the blood pressure significantly. These medications have so far not been associated with angioedema and have a great potential to be safe and effective alternatives in the near future. Expert opinion: NEP inhibitors were effective in the treatment of hypertension and heart failure but the relatively high incidence of angioedema stopped their widespread use. New hope has risen with the introduction of combined NEP inhibitors and AT-II blockers and early studies are encouraging. © 2011 Informa UK, Ltd.
Young M.,Luzerner Kantonsspital |
Cuculi F.,John Radcliffe Hospital |
Erne P.,Luzerner Kantonsspital
Catheterization and Cardiovascular Interventions | Year: 2013
Introduction Drug-coated balloons (DCB) are being increasingly used in interventional cardiology. The effect of DCB on acute changes of coronary flow reserve (CFR) has never been reported. Methods Patients with in-stent restenosis or with contraindication for use of clopidogrel were included in this study. The FloWire was used to assess CFR before and immediately after conventional balloon angioplasty and after the use of In.Pact, a paclitaxel-coated balloon. In a sub-selection of patients, CFR was measured immediately and then 2, 5, and 10 min post-DCB. Results Thirty patients (18 males, 60%) with a total of 32 lesions were studied. Comparison of CFR pre- and post-conventional balloon angioplasty was not statistically significant (P = 0.95). CFR dropped significantly after the use of In.Pact (n = 32, 1.59 ± 0.49 vs. 1.22 ± 0.28, P < 0.0001) and showed a statistically significant improvement over 10 min in a subset of patients (n = 6, P = 0.01). Implantation of a coronary stent after the use of In.Pact rapidly improved CFR (n = 10, P = 0.0004). Conclusions We describe a novel phenomenon of acute decrease in CFR after the use of DCB. This phenomenon is temporary and spontaneously improves after approximately 10 min. The exact pathophysiological mechanism remains unclear and further studies are warranted to study the long-term effects of acute CFR drop after use of DCB. © 2011 Wiley Periodicals, Inc.
Puricel S.,University of Fribourg |
Cuculi F.,Luzerner Kantonsspital |
Weissner M.,University Hospital Mainz |
Weissner M.,German Center for Cardiac and Vascular Research |
And 10 more authors.
Journal of the American College of Cardiology | Year: 2016
Background Recent reports suggest an elevated incidence of bioresorbable vascular scaffold (BVS) thrombosis (scaffold thrombosis [ScT]). Objectives This study investigated occurrence rates, clinical and angiographic characteristics, and possible mechanisms of ScT in all-comer patients undergoing BVS implantation at 2 German and 2 Swiss hospitals. Methods A total of 1,305 consecutive patients (mean age 64 years, 78% male) who received 1,870 BVS (mean 1.4 ± 0.8 BVS/patient) were enrolled. Clinical/procedural characteristics, mortality, and ScT data at 485 days (range 312 to 652 days) were examined. Results ScT occurred in 42 patients. The incidence of probable and definite ScT was 1.8% at 30 days and 3.0% at 12 months, without differences among centers (p = 0.60). A total of 22 (52%) ScTs presented as ST-segment elevation myocardial infarction and 6 (17%) as sudden cardiac death. In multivariable analysis, ostial lesions (p = 0.049) and impaired left ventricular ejection fraction (p = 0.019) were independently associated with ScT. Nine (21%) of the ScTs occurred in patients who had suspended dual antiplatelet therapy, in 6 cases prematurely. Lower post-procedural minimum lumen and reference vessel diameters were hallmarks of ScT (all p < 0.0001). The risk of ScT appeared to rapidly increase for post-procedural minimum lumen diameters below 2.4 mm (for the 2.5- to 3.0-mm BVS) and 2.8 mm (for the 3.5-mm BVS). When a BVS-specific implantation strategy was implemented, 12-month ScT rates fell from 3.3% to 1.0%, an effect that remained significant when adjusted for multivariable propensity score (p = 0.012; hazard ratio: 0.19; 95% confidence interval: 0.05 to 0.70). Conclusions The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed. (retrospective multicentric registry and Mainz Intracoronary Database. © 2016 American College of Cardiology Foundation.
Kohl S.,University of Bern |
Evangelopoulos D.S.,University of Bern |
Siebenrock K.A.,University of Bern |
Beck M.,Luzerner Kantonsspital
Journal of Arthroplasty | Year: 2012
Scarring or detachment of the hip abductors, particularly of the gluteus medius, from their insertion may lead to severe abductor weakness, recurrent dislocations, pain, and diminished quality of life. We performed a retrospective study to evaluate whether vastus lateralis shift is associated with satisfactory results and low rate of complications. Eleven adults underwent vastus lateralis shift to bridge a well-documented abductor muscles' insertion defect. Preoperative and postoperative hip functions were assessed applying the Merle d'Aubigne score, British Medical Council scale, and Visual Analog Scale. Significant postoperative improvement was noted in mean Merle d'Aubigne score, gluteus medius muscle force, and quality of life. Vastus lateralis shift represents a viable treatment option for hip abductor deficiency, significantly improving abductor strength and overall quality of life. © 2012 Elsevier Inc.
Hofer S.,Luzerner Kantonsspital
Memo - Magazine of European Medical Oncology | Year: 2016
Summary: A short statement on the most recent developments in the neuro-oncology field, including the new WHO Classification of Tumors of the Central Nervous System (2016) and current treatment strategies. © 2016 Springer-Verlag Wien
Henzen C.,Luzerner Kantonsspital
Therapeutische Umschau | Year: 2011
Adaequate stimulation of the hypothalamic- pituitary-adrenal axis (cortisol- axis) is essential for the adaptation of the human organism to stress and the preservation of homeostasis. Clinical and laboratory changes in adrenal insufficiency are often non-specific, therefore stimulation tests are needed in the assessment of the cortisol-axis. The most common cause of primary adrenal insufficiency is autoimmune adrenalitis (as part of the polyglandular autoimmune syndrome), while treatment with glucocorticoids is responsible for secondary adrenal insufficiency. Chronic adrenal insufficiency is reliably diagnosed by conventional or low-dose ACTH test. However, in the acute stage or in critically ill patients, cortisol deficiency is diagnosed on clinical grounds, namely hemodynamic instability and catecholamine resistance along with the results of the ACTH test. The dose of glucocorticoid replacement depends on body surface and has to be adjusted in stressful events.
Kothbauer K.F.,Luzerner Kantonsspital |
Deletis V.,Rush University Medical Center
Child's Nervous System | Year: 2010
Purpose: Intraoperative neurophysiological techniques are becoming routine tools for neurosurgical practice. Procedures affecting the lumbosacral nervous system are frequent in adult and pediatric neurosurgery. This review provides an overview of the techniques utilized in cauda and conus operations. Methods: Two basic methodologies of intraoperative neurophysiological testing are utilized during surgery in the lumbosacral spinal canal. Mapping techniques help identify functional neural structures, namely, nerve roots and their respective spinal levels. Monitoring is referred to as the technology to continuously assess the functional integrity of pathways and reflex circuits. For mapping direct electrical stimulation of a structure within the surgical field and recording at a distant site, usually a muscle is the most commonly used setup. Sensory nerve roots or spinal cord areas can be mapped by stimulation of a distant sensory nerve or skin area and recording from a structure within the surgical field. Continuous monitoring of the motor system is done with motor evoked potentials. These are evoked by transcranial electrical stimulation and recorded from lower extremity and sphincter muscles. Presence or absence of muscle responses are the monitored parameters. To monitor the sensory pathways, sensory potentials evoked by tibial, peroneal, or pudendal nerve stimulation and recorded from the dorsal columns with a spinal electrode or as cortical responses from scalp electrodes are used. Amplitudes and latencies of these responses are measured for interpretation. The bulbocavernosus reflex, with stimulation of the pudendal nerve and recording from the external anal sphincter, is used for continuous monitoring of the reflex circuitry. The presence of absence of this response is the pertinent parameter monitored. Stimulation of individual dorsal nerve roots is used to identify those segments that generate spastic activity and which may be cut during selective dorsal rhizotomy. Electromyographic activity can be continuously observed during surgery, and monitoring concepts developed in cranial nerve surgery may be used in the cauda equina as well. Conclusion: A range of intraoperative neurophysiological techniques are available for neurophysiological testing of the neural structures of conus medullaris and cauda equina. © 2009 Springer-Verlag.