Use of a novel embolic filter in carotid artery stenting: 30 ‐Day results from the EMBOLDEN Clinical Study

Abstract ObjectivesThe EMBOLDEN study was conducted to test the safety and efficacy of a novel emboli protection filter design for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who were at high risk of operative complications from carotid endarterectomy (CEA). BackgroundGeneral considerations for filter design usually involve trade‐offs between trackability/profile and wall apposition/capture efficiency. The GORE® Embolic Filter (GEF) is intended to address these design goals via a hybrid construction. MethodsPatients at high risk for CEA (N = 250) were treated with CAS using the GEF study device paired with an FDA‐approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days, compared to a pre‐determined performance goal. Neurologic outcomes were judged by an independent assessor and angiographic results evaluated by an independent central core lab. ResultsThe GEF study device was successfully deployed in 96.4% of procedures. The primary endpoint of 30‐day death, stroke, and MI occurred in 4.0% of subjects and was significantly lower than the pre‐defined performance goal (P 
Source: Catheterization and Cardiovascular Interventions - Category: Cardiovascular & Thoracic Surgery Authors: Tags: CORONARY ARTERY DISEASE Source Type: research

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Conclusions: Embolism associated with asymptomatic carotid stenosis shows circadian variation with highest rates 4–6 h before midday. This corresponds with peak circadian incidence of stroke and other vascular complications. These and ASED Study results show that monitoring frequency, duration, and time of day are important in ES detection. Introduction Transcranial Doppler (TCD) detected microembolism in the ipsilateral middle cerebral artery (MCA) may help stratify the risk of stroke and other arterial disease complications in persons with advanced (≥60%) asymptomatic carotid stenosis. If so, this techniqu...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
CONCLUSION:: Critical CVD was the strongest risk factor for long-term stroke after CABG. However, survival and MACE-free rates were equivalent in patients with critical CVD and those without critical CVD. PMID: 30444180 [PubMed - as supplied by publisher]
Source: Perfusion - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Perfusion Source Type: research
ConclusionIn patients with RSNOFC, CEA may be considered a potential treatment option. Although procedural risks in this small subgroup may be higher as compared to patients with low-to-moderate risk anatomy, this risk may outbalance the natural course.
Source: Journal of Neurology - Category: Neurology Source Type: research
BackgroundRecent research evidence has impacted the practice of carotid endarterectomy (CEA). We aim to characterize changes in the practice and outcome of CEA over time in a single large‐volume stroke centre. MethodsAll patients who underwent CEA from 2004 to 2014 and carotid angioplasty and stenting (CAS) from 2003 to 2008 at an Australian metropolitan tertiary stroke centre hospital were included. Clinical data were analysed to identify time trends in choice of intervention, patient selection, preoperative imaging utilization, surgical timing and outcome. ResultsThere were 510 CEAs performed during 2004–2014 and...
Source: ANZ Journal of Surgery - Category: Surgery Authors: Tags: Original Article Source Type: research
Conclusion Simultaneous coronary bypass grafting as a single procedure or in combination with valve replacement and endarterectomy of severe carotid lesions with or without patients' history of previous stroke can be performed with a calculated low surgical risk. The complication rate for neurologic and myocardial events is low compared with the hazard of a single surgical repair. The in-hospital mortality is not significantly different to isolated procedures. The concomitant appearance of coronary stenosis and carotid artery disease is reasonable due to the nature of arteriosclerosis. In our opinion these patients be...
Source: The Thoracic and Cardiovascular Surgeon - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Thorac Cardiovasc Surg Source Type: research
Conclusion Simultaneous coronary bypass grafting as a single procedure or in combination with valve replacement and endarterectomy of severe carotid lesions with or without patients' history of previous stroke can be performed with a calculated low surgical risk. The complication rate for neurologic and myocardial events is low compared with the hazard of a single surgical repair. The in-hospital mortality is not significantly different to isolated procedures. The concomitant appearance of coronary stenosis and carotid artery disease is reasonable due to the nature of arteriosclerosis. In our opinion these patients be...
Source: The Thoracic and Cardiovascular Surgeon - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Original Cardiovascular Source Type: research
This study aimed to evaluate the short-term surgical risks and long-term outcomes of patients with subclinical CAD who underwent CEA. METHODS The authors performed a retrospective study of data from a prospective CEA registry. They analyzed a total of 702 cases involving patients without a history of CAD who received preoperative cardiac risk assessment by radionuclide myocardial perfusion imaging (MPI) and underwent CEA over a 10-year period. The management strategy (the necessity, sequence, and treatment modality of coronary revascularization and optimal perioperative medical treatment) was determined according to the pr...
Source: Journal of Neurosurgery - Category: Neurosurgery Authors: Tags: J Neurosurg Source Type: research
Conclusion According to our experiences and results, the simultaneous performance of CEA and CABG in patients with severe coexisting carotid artery disease who require coronary revascularization has proved to be a safe and efficacious operative strategy in these high-risk patients.
Source: Cor et Vasa - Category: Cardiology Source Type: research
CONCLUSION: Our results suggest that CAS should be avoided in patients with multiple anatomic risk factors. High presenting National Institutes of Health Stroke Scale score and renal disease also increase the complication risk. The CAS scoring system devised here is simple, reproducible, and clinically valuable in predicting complications risk in symptomatic patients undergoing CAS. ABBREVIATIONS: BRASS, Buffalo Risk Assessment Scale CAS, carotid artery stenting CCA, common carotid artery CEA, carotid endarterectomy CTA, computed tomographic angiogram ICA, internal carotid artery MI, myocardial infarction NASCET, North Ame...
Source: Neurosurgery - Category: Neurosurgery Tags: Research-Human-Clinical Studies Source Type: research
CONCLUSIONS: Severe coronary stenosis was identified herein as an independent predictor of an adverse early vascular outcome. PMID: 26320844 [PubMed - as supplied by publisher]
Source: Journal of Clinical Neurology - Category: Neurology Tags: J Clin Neurol Source Type: research
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