Search

Purpose: Endovascular carotid artery stenosis treatment is associated with a higher peri- and early post-procedural stroke risk relative to surgery. Dual-layer micromesh carotid stents were specifically designed for improved plaque coverage to reduce the cerebral embolization risk and related ischemic events. ROADSAVER study aims to further confirm the safety and efficacy of the Roadsaver™ dual-layer micromesh stent for the treatment of elective patients with carotid artery stenosis. Materials and Methods: ROADSAVER is a prospective, multi-center, observational study. Between January 2018 and February 2021, a total of 1967 patients featuring asymptomatic or symptomatic, non-occlusive and non-thrombotic carotid stenosis eligible for an elective stenting procedure were enrolled across 13 European countries (52 centers). Follow-up visits are scheduled at 30 days and at 12 months. The primary outcome measure is the major adverse event rate, i.e., cumulative incidence of any death or stroke up to 30 days post-procedure. All deaths, strokes and carotid revascularizations are adjudicated by an independent Clinical Events Committee. Sub-analyses are prespecified and focused on baseline patient characteristics (e.g., age, neurologic status), procedural features (e.g., access route, embolic protection use), advanced imaging, and treatment efficacy up to 12 months. Conclusion: The present study evaluates the Roadsaver™ dual-layer micromesh carotid stent in the real-world clinical practice aiming to provide valuable insights into the contemporary European treatment trends and outcomes of elective carotid artery stenting. The large study population and predefined sub-analyses should help identify the best practices and patient subsets to benefit most from the treatment. Trial Registration: Clinicaltrial.gov identifier: NCT03504228. [ABSTRACT FROM AUTHOR]

Introduction: We analyzed trends in carotid artery stenting (CAS) and carotid endarterectomy (CEA) in hospitalized cases in Germany in the years 2010–2015. Methods: Data from national statistics (DRG statistics) published by the Federal Statistical Office in Germany describing the number of hospitalized patients treated with CEA and CAS were used. In addition, numbers of patients hospitalized with the principal diagnosis stroke associated with precerebral lesions (ICD code I63), transitory cerebral ischemic attacks (G45) and precerebral carotid artery stenosis (I65) treated by CEA and CAS were analyzed for the year 2015. Results: Total number of CEA decreased by 4.0% from 24.067 (2010) to 23.104 (2015) and CAS increased by 5.1% from 5.703 to 5.992. In 2015, 79.4% of all procedures coded concerning the internal carotid artery were CEA and 21.6% CAS. From 27.798 cases hospitalized with the principal diagnosis stroke associated with precerebral lesions, CEA was performed in 3.921 (14.1%) and in 2.132 (7.7%) CAS was documented, with CAS making up one-third of all treatments within the stroke group. In 28.273 cases hospitalized with a TIA, CEA was specified in 853 (3.0%) and CAS in 255 (0.9%) cases. In 27.553 cases with an occlusion and stenosis of precerebral arteries, not resulting in cerebral infarction, 17.036 (61.8%) had a CEA and 3.156 (11.5%) a CAS procedure. Conclusion: CEA is still the primary treatment of extracranial artery stenosis. The impact of CAS becomes mainly apparent in cases presenting with acute strokes. [ABSTRACT FROM AUTHOR]

Atherosclerosis involving the carotid arteries has a high prevalence in the population worldwide. This condition is significant because accidents of the carotid artery plaque are associated with the development of cerebrovascular events. For this reason, carotid atherosclerotic disease needs to be diagnosed and those determinants that are associated to an increased risk of stroke need to be identified. The degree of stenosis typically has been considered the parameter of choice to determine the therapeutical approach, but several recently published investigations have demonstrated that the degree of luminal stenosis is only an indirect indicator of the atherosclerotic process and that direct assessment of the plaque structure and composition may be key to predict the development of future cerebrovascular ischemic events. The concept of 'vulnerable plaque' was born, referring to those plaque's parameters that concur to the instability of the plaque making it more prone to the rupture and distal embolization. The purpose of this review is to describe the imaging characteristics of 'vulnerable carotid plaques.' [ABSTRACT FROM AUTHOR]

In the last two decades, a substantial number of articles have been published to provide diagnostic solutions for patients with carotid atherosclerotic disease. These articles have resulted in a shift of opinion regarding the identification of stroke risk in patients with carotid atherosclerotic disease. In the recent past, the degree of carotid artery stenosis was the sole determinant for performing carotid intervention (carotid endarterectomy or carotid stenting) in these patients. We now know that the degree of stenosis is only one marker for future cerebrovascular events. If one wants to determine the risk of these events more accurately, other parameters must be taken into account; among these parameters are plaque composition, presence and state of the fibrous cap (FC), intraplaque haemorrhage, plaque ulceration, and plaque location. In particular, the FC is an important structure for the stability of the plaque, and its rupture is highly associated with a recent history of transient ischaemic attack or stroke. The subject of this review is imaging of the FC. [ABSTRACT FROM AUTHOR]

We aimed to present our experience with carotid angioplasty and stenting (CAS) and to document how the technique evolved over the last decade (1997-2007). A retrospective study of 333 patients (259 men; median age, 69 years) who underwent 336 CAS procedures. Of these, 118 (35%) patients were symptomatic and 164 (49%) lesions involved the left carotid bifurcation. The first 163 patients received a balloon-expandable stent, whereas the remaining 173 received a self-expandable one. Cerebral protection devices were used in the last 84 (25%) procedures. Access was via the femoral artery in all but six cases, in which direct puncture of the common carotid was necessary. The left common carotid originated from the innominate artery in 18 cases (5%). Conversion to open endarterectomy was necessary in two patients due to inability to remove the filter. Perioperative neurological events included stroke in 6 patients (1.8%), transient ischemic attack in 15 (4.5%), and hyperperfusion syndrome in 10 (3.0%). Three patients died during the first 30 days. As a result, the mortality and the combined stroke/death rate were 0.9 and 2.4%, respectively, with no differences between symptomatic and asymptomatic patients. Bradycardia was noted in 48 patients (14%), and hypotension in 45 (13%). Univariate analysis identified hypertension (P = 0.03), hyperlipidemia (P = 0.02), and current or ex-smoking (P = 0.02) as significant risk factors for death/stroke. On multivariate analysis using logistic regression, only hyperlipidemia [odds ratio (OR), 53.90; 95% confidence interval (CI), 4.19-693.47; P = 0.002] and current or ex-smoking (OR, 63.84; 95% CI,: 4.80-848.68; P = 0.001) remained statistically significant. In conclusion, CAS can be performed safely and effectively, with acceptable mortality, stroke/death, and cardiovascular complication rates. Although technological advances (stent design, cerebral protection devices), perioperative pharmacological management, and increasing experience are all clinically significant factors influencing the short-term results, none appeared to be statistically significant in this patient sample. [ABSTRACT FROM AUTHOR]

We studied the deliverability and safety of a braided, self-expanding, closed-cell nickel-titanium (NiTi) stent (E-volution, Jotec GmbH, Hechingen, Germany) especially designed for the endovascular treatment of carotid artery bifurcation stenosis with special regard to in-stent stenosis and thrombosis compared with a laser-cut reference nitinol stent in a porcine model of percutaneous vascular interventions. We aimed to assess histopathologic response in minipig carotid and subclavian arteries. Eight minipigs received a total of 42 stents: 14 reference stents and 28 E-volution stents. Eleven of the E-volution stents were additionally coated with heparin. Control angiography was obtained immediately before and after vascular intervention as well as 4 weeks after the procedure. Primary endpoints were 28 days of angiographic analyses as well as histomorphometric analysis, including injury score, inflammation score, luminal diameter, vessel diameter, maximal neointimal thickness, and area of in-stent stenosis. Secondary end points were procedural success, 28-day mortality, and stent thrombosis. All stents could be delivered successfully without procedural complications, morbidity, or mortality during our observation time. As confirmed by histology, no in-stent thrombosis was observed. Compared with common carotid arteries, subclavian arteries are significantly more vulnerable to developing in-stent stenosis caused by neointima proliferation (p < 0.05). Compared with the use of 1 single stent/artery, serial application of two stents leads to a more excessive but not significantly different neointimal proliferation (p > 0.05). The E-volution stent, especially when heparin coated, is in line with the comparison to the laser-cut reference stent displaying similar results of angiographic, histologic, and histomorphometric analyses (p > 0.05). Compared with the reference laser-cut stent, the self-expanding nitinol stent (E-volution) with its advanced braiding technology is feasible and safe. In our opinion, the high radial resistive force and the advanced braided design with tight stent-strut interstices may be beneficial in terms of plaque stabilization. Further studies are necessary and warranted. [ABSTRACT FROM AUTHOR]

The decision to intervene surgically in patients with carotid artery disease is based on the presence of symptoms, along with the severity of carotid artery stenosis as assessed by ultrasound or X-ray computed tomography (CT). Optical coherence tomography (OCT) is a relatively new imaging technique that offers potential in the identification of, as well as the distinction between, stable and unstable atherosclerotic plaques. The purpose of our study was to evaluate whether OCT can be used as a noninvasive diagnostic tool to reveal the morphology of carotid stenosis from the adventitial surface of the carotid artery. To achieve this aim, excised atheromatous plaques were scanned by OCT from the external surface. Plaques removed at carotid endarterectomy were scanned by OCT from the external surface within 72 hr of surgery and then examined histologically. The images of the histologic slides and the scans were then compared. We examined 10 carotid endarterectomy specimens and were able to identify calcification, cholesterol crystal clefts, and lipid deposits in the OCT images with histologic correlation. The strong light scattering from the calcified tissue and cholesterol crystal clefts limited the depth of light penetration, making observation of the intimal surface and the detail of the fibrous cap difficult. However, we were able to confidently identify the absence of an atherosclerotic plaque by OCT scans even from the external surface. The results of this pilot study demonstrate that OCT can reveal the main features of carotid stenosis but that plaque vulnerability cannot be reliably and precisely assessed if scanned from the external surface with OCT in its present form. [ABSTRACT FROM AUTHOR]

The article focuses on the topics discussed at a special session on different topics ranging from vena caval pulmonary interventions, interventions in central venous occlusion, interventions in pulmonary embolism. Venous thromboembolic disease is a significant cause of morbidity and mortality in Occidental countries. Pulmonary embolism, the most deadly form of venous thromboembolic disease, results in as many as 240000 deaths per year in the United States. Central venous obstruction is caused by malignancies due to primary or secondary tumors of the mediastinum and retroperitoneum in 95 percent of the cases.