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Objectives: The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry., Background: DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year., Methods: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion., Results: At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence., Conclusions: This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice., Background: When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems., Methods: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates., Results: Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%., Conclusions: This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published., Methods: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year., Results: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis., Conclusions: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the clinical efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: The need to minimize the risk for plaque debris prolapsing between stent struts following CAS has resulted in the development of DLS. Small clinical studies evaluating 2 available devices, Roadsaver and CGuard, have been recently published; none of these studies is sufficiently powered to test the role of common risk factors on the occurrence of stroke at 30 days post-CAS., Methods: A search was performed of multiple electronic databases for studies larger than 100 cases of CAS with DLS. Four single-arm prospective studies were identified, and individual patient data were collected. The primary endpoint was the occurrence of stroke at 30 days; secondary endpoints were technical and procedural success, periprocedural stroke, and in-hospital and 30-day rates of death., Results: The Roadsaver and CGuard stents were used in similar proportions, and technical success was achieved in all procedures (100% [n = 556]). There were 6 periprocedural strokes (1.08%; all minor). During 30-day follow-up, there was 1 death (0.17%) from myocardial infarction and 1 additional minor stroke (0.17%). The cumulative 30-day mortality rate was 0.17%, and the incidence of stroke at 30 days was 1.25%. No predictors of stroke at 30 days could be identified., Conclusions: This meta-analysis suggests that DLS can be safely used for CAS, and their use minimizes the incremental risk related to symptomatic status and other risk factors., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to identify the findings (by optical coherence tomography [OCT]) after carotid artery stenting (CAS) with two different types of new-generation mesh-covered stent., Methods and Results: Sixteen consecutive patients undergoing CAS with mesh-covered stents and highdefinition OCT image acquisition were enrolled in the study. Cross-sectional OCT images for the presence of strut malapposition (SM) and plaque prolapse (PP) were evaluated using a proximal or distal embolic protection device (EPD). CGuard stents were used in 11 patients (68.8%) and RoadSaver stents in five (31.2%). With OCT analysis, the incidence of SM was 20.5% for CGuard vs. 26.8% for RoadSaver, p=0.26, and the incidence of PP was 10.8% for CGuard vs. 20.7% for RoadSaver, p=0.05. No neurological complications (stroke/TIA) occurred during the procedural and post-procedural periods., Conclusions: The OCT findings of two different types of mesh-covered stent after CAS were obtained safely. Our work indicates that current mesh-covered carotid stents may show differences in SM and PP. The effect of stent design and implantation technique on OCT findings post CAS, and their relation to longterm clinical outcomes, require further evaluation.

Introduction: Carotid artery stenting (CAS) has recently changed the status in the treatment of the extracranial carotid atheromasic disease. In recent years, evolution in both stents and protection devices as well as in carotid stenting techniques, has resulted in an important reduction in the rate of stroke in patients undergoing CAS procedures. Areas covered: The purpose of this article is reviewing the literature and summarizing the current evidence of the new available materials to underline the importance of the correct choice of the devices during the procedure. Expert commentary: Certainly a key issue in order to limit the periprocedural events to the lowest possible, is to select the appropriate device for the appropriate patient anatomy and clinical syndrome, the so called 'tailored approach'.

Data from randomized controlled trials (RCTs) demonstrated significant differences between carotid artery stenting (CAS) and carotid endarterectomy (CEA) in terms of early neurological outcomes (from 0 to 30 days), although mid- and long-term neurological results are indistinguishable. CAS in symptomatic standard risk patients is coupled with a higher risk of any stroke, and death or any stroke at 30 days, while the rates of disabling or major stroke do not vary remarkably between treatments. Since the micro-embolization through the stent struts is the primary suspected cause of suspected early postoperative neurological complications (i.e., non-disabling stroke), surgical technology has focused on the production of a new generation of stents with a double layer of mesh to reduce the "free area" of the cells, and on new cerebral protection devices. Another major determinant of early negative outcomes is believed to be the intraluminal manipulation occurring during carotid engagement from the aortic arch, the crossing maneuvers at the level of the culprit lesion and vessel trauma during angioplasty. To address these subject matters, new embolic protection devices and innovative strategies have been developed, consequently. This review is designed to furnish the current status of CAS results, to update the ongoing RCTs comparing CAS vs. CEA outcomes, and to recapitulate the features and clinical outcomes for a new carotid stent design, the so called "mesh-stents", and new embolic protection tools.

Aims: Carotid artery stenting (CAS) is still associated with higher periprocedural cerebrovascular events (CEs) compared to vascular surgery. The Roadsaver carotid artery stent is a double layer micromesh stent which reduces plaque prolapse and embolisation by improving plaque coverage. Its clinical impact on neurological outcome was unknown. The aim of this study was therefore to report the clinical results of a large real-world population from three different centres receiving a Roadsaver stent to treat carotid artery disease., Methods and Results: One hundred and fifty (150) patients (age 74±8 yrs, 75% male, symptomatic 29%) treated with CAS using the Roadsaver carotid stent in three high-volume Italian centres were included in the study. Intraprocedural optical coherence tomography (OCT) evaluation was performed in 26 patients, with an off-line analysis by a dedicated core laboratory. All patients underwent duplex ultrasound and neurological evaluation at 24 hours and at 30 days. CAS was technically successful in all cases (stent diameter: 8.6±0.8 mm, stent length: 25.0±4.5 mm). No in-hospital or 30-day CEs were observed. OCT evaluation detected a low rate of plaque prolapse (two patients, 7.7%). Duplex ultrasound showed stent and external carotid artery patency in all cases both before discharge and at 30-day follow-up., Conclusions: The Roadsaver stent is a safe and promising technology for CAS, with a low percentage of plaque prolapse and good short-term clinical outcome. Larger studies with longer follow-up are necessary to confirm this favourable clinical outcome.

Aims: Conflicting data exist on the impact on outcome of the use of different stent types during carotid artery stenting (CAS). The aim of this study was to evaluate clinical outcomes according to different carotid stent design among the population of the European Registry of Carotid Artery Stenting (ERCAS)., Methods and Results: The present study was conducted in 1,604 patients who underwent neuroprotected CAS in ERCAS. All types of commercially available carotid stent were used. Open-cell design stents were classified according to free cell area into <7.5 mm2 or >7.5 mm2. A total of 713 closed-cell, 456 hybrid-cell, 238 <7.5 mm2 open-cell, and 197 >7.5 mm2 open-cell stents were implanted. Overall, the 30-day stroke and death rate was 1.37%. At 30 days, 19 strokes occurred (1.18%): eight in the group of patients treated with a closed-cell (1.12%), two in those with a hybrid-cell (0.44%), three in those with a <7.5 mm2 open-cell (1.26%), and six in those treated with a >7.5 mm2 open-cell stent (3.05%) (p=0.045)., Conclusions: Data of the present study suggest that, in the setting of neuroprotected CAS performed in high-volume centres by properly trained operators, the use of an open-cell design stent with a free cell area >7.5 mm2 may be associated with an increased 30-day stroke risk.

According to the World Health Organization, every year, 5 million peoples die for stroke and another 5 million are permanently disabled. Although there are many causes of acute stroke, a common treatable cause of acute stroke is atheromatous narrowing at the carotid bifurcation. Carotid endarterectomy is still the standard of car, even if carotid artery stenting (CAS) has become an effective, less invasive alterantive. Unfortunately, CAS procedure is not yet perfect; regardless the use of an embolic protection device (EPD), percutaneous treatment has been correlated with a risk of cerebral ischemic events related to distal embolization. The objective of the IRON-Guard Registry is to evaluate the clinical outcome of treatment by means of stenting with the C-Guard (InspireMD, Boston, MA, USA) in subjects requiring CAS due to significant extracranial carotid artery stenosis with a physician-initiated, Italian, prospective, multicenter, single-arm study. A total of 200 enrolled subjects divided over different centers are planned to be enrolled. CAS will performed by implanting of C-Guard stent. Procedure will be performed according to the physician's standard of care. Standard procedures will be followed based on the Instructions for Use, for the C-Guard device of Inspire. The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any periprocedural (≤30 days postprocedure) death, stroke or myocardial infarction. Secondary endpoints are rate of late ipsilateral stroke (31 through 365 days), system technical success, device malfunctions, major adverse events (MAEs), serious device-related and procedure-related adverse events, target lesion revascularization, and in-stent restenosis rates.

Stent fracture has been well documented in the Literature and in the majority of cases arises from the exposition of the stent to unfavourable stresses and biomechanical forces. We report a case of carotid false aneurysm after stent placement for post-surgery restenosis. Stent fracture is a clinical reality that sometimes should be considered prior to stent deployment and may require monitoring or treatment after occurrence., (© The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Background: A major debate in cerebrovascular medicine today is over the choice of the best treatment to implement for stenosis of the carotid artery. Carotid artery stenting is a less invasive technique than endarterectomy for the treatment of carotid stenosis, and is becoming more widely performed, particularly on patients with carotid artery stenosis who present also with comorbidities. To address the aspects related to the use of carotid artery stenting, an Italian multidisciplinary task force comprising the most representative scientific societies concerned with carotid artery disease was set up to provide neurologists, radiologists, cardiologists, vascular surgeons, and all those involved in stroke prevention and treatment with an updated, evidence-based consensus document., Summary: The task force followed a structured methodology to assess the literature on carotid stenosis in order to provide a summary of the main issues related to carotid artery stenting, including the definition of the grade of symptomatic carotid artery stenosis, indications for intervening on the carotid artery stenosis, establishing whether to perform either a surgical or an endovascular procedure, the training, credentialization, and competency needed by physicians to perform carotid artery stenting, acceptable complication rates and risk certification for carotid artery stenting, management of stented patients, durability of carotid artery stenting, and future tasks. Here, we outline the main findings of this effort., Key Messages: As for any guideline or consensus statement, each point is valid as long as the evidence on which it is based remains up to date. In a fast-evolving field of medicine such as that of carotid artery stenosis management, and in particular carotid artery stenting, the stimulation of continuous and fruitful discussion among all professionals involved is mandatory. We hope that this document may provide a standardized basis for the application of carotid artery stenting as implemented today., (© 2014 S. Karger AG, Basel.)

Background: Carotid artery stenting (CAS) is currently considered a valid alternative to carotid endarterectomy (CEA) for the prevention of stroke in high-risk patients. One of the most important issues for both of these techniques is carotid restenosis. The aim of our study was to evaluate the incidence of post-CEA and post-CAS restenosis in a large cohort of patients in a single high-volume center., Methods: Between December 2000 and December 2010, 2453 CEA and 2628 CAS procedures were performed in the Vascular and Endovascular Surgery Unit at our institution. The mean age of patients was 73.8 years (range 55‒89 years), 78% of whom were men. Indications for carotid revascularization were: presence of symptomatic carotid artery stenosis of >70%, or asymptomatic stenosis of at least 80%, especially in patients with vulnerable plaques., Results: Mild and long-term results after CEA and CAS were similar. The overall perioperative neurologic complication rate (minor and major stroke) was similar in the 2 groups. At 1-year follow-up the restenosis rate after CEA was 1.58%. In-stent restenosis after CAS occurred in 1.67% of the procedures. All but 3 arteries had been treated for postsurgical restenosis. All lesions were approached secondarily with endovascular procedures. Statistical analysis demonstrated that post-CEA restenosis was the most important predictive factor for the development of in-stent restenosis after CAS., Conclusions: This review of our 10-year experience confirms that patients who develop restenosis after CEA are also prone to developing in-stent restenosis after CAS., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Treatment of acute stroke is time-dependent, with the best outcomes resulting from the earliest interventions. However, for patients with acute ischemic stroke due to a high-grade stenosis of the internal carotid artery, despite maximal medical treatment, an effective intervention to improve their neurologic symptoms and clinical outcome has not yet been established. There are two major concerns: first, cerebral revascularization in the acute stage remains challenging because of the possibility that hemorrhagic infarction or hyperperfusion syndrome will occur after revascularization; second, alarms about carotid artery stenting in patients with acute symptoms are related to the fact that, while with carotid endarterectomy the plaque is completely removed, after stenting it is only remodelled and its stabilization is essential to avoid embolic events during the procedure and in the post-operative period. Although level 1 evidence seems clearly in favor of carotid endarterectomy in symptomatic patients, carotid stenting has been proposed as a possible alternative in selected cases if the procedure is performed in high-volume center with documented low perioperative stroke and death rates. This review summarizes indications and results for carotid artery stenting in recently symptomatic patients.

Execution of carotid artery stenting (CAS) requires not only excellent manual dexterity, and a high level of competence, but also in-depth knowledge of the carotid pathology, of the materials available on the market and of the different techniques to apply in given situations. Actually each individual moment of the procedure can be determining for the final result. This review describes each individual step of CAS, including arterial access, carotid engagement, pre-dilatation, the characteristics and use of cerebral protection devices, stent selection and deployment, and post-dilatation. Technical notes and some suggestions are provided on how to minimize the event of periprocedural neurological complications.

Background: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers., Methods: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events., Results: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%., Conclusions: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities., (Copyright © 2012 Wiley Periodicals, Inc.)

Purpose: To evaluate the safety and feasibility of optical coherence tomography (OCT) in patients with carotid stenosis undergoing carotid artery stenting (CAS)., Methods: In a prospective study, 25 consecutive patients (15 men; mean age 74±4 years) undergoing protected CAS were enrolled and underwent high-definition (homoaxial resolution 10 µm) OCT image acquisition before stent deployment, immediately after stent placement, and following postdilation of the stent (3 scans/patient). Pullbacks were started during a nonocclusive flush, mechanically injecting 24 mL of 50% diluted contrast at 6 mL/s to displace blood from the artery. Two independent physicians judged the quality of images on a predefined 1-10 scale. The proportions of specific agreement and kappa values (κ) were calculated., Results: No procedural or in-hospital neurological complications occurred (any stroke/death 0%). The technical success of OCT pullbacks was 97.3% (73/75). The total amount of contrast was 86±18 mL/patient. No significant alteration in glomerular filtration rate or any other significant adverse event occurred. The images obtained were of high quality (mean value 8.1 out of 10), with good inter- and intraobserver agreement (κ = 0.81-0.87 and κ = 0.95, respectively). OCT images revealed innovative features such as rupture of the fibrous cap, plaque prolapse, and stent malapposition in a high percentage of the patients (range 24%-100%)., Conclusion: Intravascular OCT during a nonocclusive flush appears to be feasible and safe in carotid arteries. Since some original and unexpected information after CAS has been made available for the first time at such a high definition, future studies with OCT should focus on the interaction between carotid plaque and stent design, which might revolutionize our understanding of the mechanisms of carotid stenting, as well as influence our clinical policies.

Purpose: To document a heretofore unreported complication of the contrast agent iodixanol during an endovascular procedure., Case Report: A 76-year-old woman with a history of coronary artery disease was admitted to the emergency department for recurrent transient ischemic attacks. Before combined percutaneous transluminal coronary angioplasty and carotid artery stenting (CAS) using iodixanol, the patient suffered from concomitant unstable angina and recurrent transient ischemic attacks. The total amount of iodixanol used during the CAS procedure was 300 mL. Contrast-induced encephalopathy, which manifested as aphasia, stupor, and full hemiparesis immediately after the combined procedure, was diagnosed by urgent computed tomography. Treatment was based on anti-edema drugs, and the patient made a complete recovery within 48 hours, without any neurological sequelae., Conclusion: Although previously reported in relation to other types of contrast media, contrast-induced encephalopathy has never been described as a complication of an endovascular procedure using iodixanol.

Aim: The literature continues reporting a high complication rate for carotid artery stenting (CAS) during the learning-curve phase (LCP). The aim of this study was to report a simple and reproducible method designed to improve CAS results during the LCP., Methods: Between February 2007 and December 2009, a qualified vascular surgeon ran a proctorship program for CAS. The program was divided into four practical phases: in the teaching phase (a) the first 20 CAS were performed by the proctor assisted by a trainee surgeon; in the training phase (b) for the 21st to the 50th CAS the trainee surgeon was supervised by the proctor; in the skilled phase (c), between the 51st and the 80th procedure, a trainee surgeon performed CAS while the proctor was scrubbed-in but operating only on demand; in the final phase (d), following the 81st CAS, the procedure was performed without the proctor's presence. The inclusion criterion was carotid stenosis ≥70% and patient selection was performed for the first 40 cases based on patient and lesion characteristics. The procedure for CAS was standardized., Results: Four trainees performed 604 CASs in two centers. The procedural success rate of CAS was 98.8% (N.=594/604) without any differences among the four trainees (P=0.902). The overall TIA, myocardial infarction, minor, major and fatal stroke rate at 30 days was respectively 1.7% (N.=10), 0.8% (N.=5), 1.2% (N.=7), 0.64% (N.=4) and 0.3% (N.=2). The effectiveness of this program was demonstrated by a significant decrease in the proctor's intervention between phase b and phase c (P<0.001) and by a similar trend in the complication rate achieved by the four trainees, in all phases and centers (P=0.075 and 0.788, respectively)., Conclusion: This preliminary experience of a proctorship program in the LCP, together with patient selection and standardization of the procedure and materials used, seems to be safe and reproducible. Moreover, possibly randomized, studies comparing different CAS training techniques are needed in order to validate our findings.

Background and Purpose: Carotid artery stenting (CAS) still entails a considerable peri-interventional risk of serious neurological adverse events. The aim of this study was to generate a score to grade this risk for CAS in individual patients., Methods: This is a 9-year prospective study. Consecutive patients with > or =70% carotid artery stenosis were treated with a standardized CAS procedure. All patients included underwent independent neurological evaluation before and after the procedure and at 30 days. The rates of transient ischemic attack and minor, major, and fatal stroke were recorded. Stroke predictors were analyzed and a score system was generated using Arabic numerals for all variables to preoperatively grade the individual patient risk of stroke., Results: Two thousand one-hundred twenty-four successful CAS procedures were performed. The transient ischemic attack and minor, major, and fatal stroke rates at 30 days were, respectively, 2.72% (n=60), 1.55% (n=33), 1.18% (n=25), and 0.61% (n=13). Multiple regression analysis showed that the following significantly predicted the 30-day risk of treatment-related stroke: cardiac disease, symptomatic patient, diabetes, calcification or ulceration at the level of the lesion, native and ostial lesion, lesion length >15 mm, the need for predilatation, type III arch, bovine arch, arch calcification, procedure time >30 minutes, and the operator's experience of <50 CAS procedures. The operator's experience of >100 CAS procedures was the only protective factor against the development of stroke at 30 days (odds ratio, 0.81; confidence interval, 0.67-0.95). The Siena CAS score was developed from these variables and predicted the risk of CAS within the 3 categories of low risk (<1%; CAS I), medium risk (1% to 3%; CAS II), and high risk (>3%; CAS III), with a sensitivity of 0.82 and specificity of 0.79., Conclusions: The Siena CAS risk score seems to be a useful tool to help predict stroke after CAS but needs to be validated in independent cohorts at a variety of centers before it can be recommended for application, preferably in a randomized comparison with carotid endarterectomy.

Proteins play a fundamental role in the formation and progression of plaque, but proteomic analysis of plaque as a whole is difficult, due to its heterogeneous cellular composition and an abundance of plasma proteins. Several approaches to this problem are reported in the literature; they include proteomic analysis of vascular tissues, analysis of proteins released by normal and pathological arterial walls, proteomic analysis of vascular cells and proteomic analysis of blood. In a previous study, we proposed a new strategy for studying of proteome of plaque, which permits to select the proteins exclusive to plaque by the constructing of a reference synthetic gel. In the present work, we matched the spots of the reference synthetic gel with the spots of a pool of carotid plaque, in order to select only spots exclusive to plaque from the 2-dimensional electrophoresis of the pool of plaque. We selected some spots between those exclusive and identified them by mass spectrometry. Some proteins identified are involved in transport, others take part in elimination of toxic radicals, others are metabolic enzymes or structural proteins. This study represents an example of application of the new approach which we have proposed: the reference gel of proteome of plaque permits to select, on every sample of interest, only the spots exclusive to plaque; once selected, spots can be identified by mass spectrometry and, being typical of plaque composition, could represent novel markers of lesions and vascular risk., (2009 Elsevier Masson SAS. All rights reserved.)

Background: The effective and early management of patients with acute symptoms due to carotid stenosis remains the subject of debate. The inability to predict who is at higher early risk of a recurrent stroke after a cerebrovascular event (transient ischemic attack [TIA] or stroke) may explain the variation in management of acute strokes from physician to physician and institution to institution. The aim of this study is to evaluate the clinical outcome of recently symptomatic patients with carotid stenosis treated with urgent or deferred carotid artery stenting (CAS) on the basis of a preidentified protocol in a single center., Methods: From January 2006 to October 2008, 43 patients with symptomatic carotid stenosis greater than 70% underwent urgent or deferred CAS (26 TIA, 17 minor stroke). The exclusion criteria were major stroke, cerebral ischemic lesion greater than 2.5 cm as documented by a computed tomography scan, loss of consciousness, and signs of intracranial hemorrhage. Patients who had a TIA underwent urgent CAS within 24 hours of the cerebral event, while patients who had had a minor stroke underwent deferred CAS, performed within a short space of time from the event (treatment within 1 to 30 days from the onset of symptoms, according to the stabilization of cerebral symptoms: mean time, 6.5 days; range, 2 to 28 days)., Results: Successful stent implantation was achieved in all cases (100%), respecting the use of a cerebral protection device (filter device: 76%, proximal occlusion device: 24%). The new adverse events in the TIA patients at 1 month were 1 non-neurological death (3.8%) and 1 TIA (3.8%). In the minor stroke group, at 1 month, 10 of 17 patients (58.8%) experienced an improvement in their initial neurological deficit (decrease in National Institutes of Health Stroke Scale less than 2), while in 35.3% of patients (6 of 17), the deficit remained stable, and only one patient had a neurological impairment., Conclusion: Our study demonstrated that early treatment with protected carotid stenting is both feasible and safe in selected patients with first episode or recurrent TIA or minor stroke. This preliminary study in a limited series of patients revealed that an urgent endovascular approach is associated with a satisfactory outcome considering the very high-risk profile of the patient population., (Copyright 2010 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

Aim: Severe highly-calcified de-novo lesions of carotid arteries are important predictors of haemodynamic depression (HD) after carotid artery stenting (CAS). Cutting-balloon angioplasty (CBA) using low-inflation pressures has been described as an effective method to achieve important luminal gain and avoid HD., Methods: from January 2005 to December 2007 102 consecutive patients (mean age 76.36+/-7.54 years) with severe highly-calcified de novo lesions of carotid artery undergoing CAS were prospectively observed and randomized in two groups: group 1 (N=50) underwent standard CAS, group 2 (N=52) underwent CAS with CBA. Patients with prior ipsilateral carotid endarterectomy (CEA), betablockers therapy or arrhytmias were excluded. HD was defined as periprocedural hypotension (systolic blood pressure <90 mmHg) or bradycardia (heart rate <60 beats/min). CBA angioplasty was carried out using CB coronary device, 0.014 inch compatible, from 3 to 4 mm or CB peripheral device, 0.018 inch compatible, from 5 to 6 mm in diameter, inflated at a mean-maximum value of 8.6 atmospheres; the average number of cuts per lesion was 2.7., Results: Demographic and clinical characteristic of both groups at the basal conditions were comparable. HD occurred in 18/50 (36%) procedures in group 1, and in 3/52 (5.76%) in group 2. The difference between the two groups concerning HD incidence was statistically significant (P<0.001). There was a strong (P<0.001) association between HD and CBA and the OR=0.109 (95%CI 0.019-0.425) confirmed the protective role of CBA. No major intraprocedural complications were observed in this series. Postprocedural Doppler ultrasound scan showed one case (2%) of in-stent restenosis in group 1 representing early failure due to recoil, and only 1 (1.92%) neurological adverse event (transient ischemic attack, TIA) in group 2., Conclusions: HD is a common occurrence after CAS, especially in patients with both long and calcified plaque. Only a tailored procedure with a correct remodelling of the plaque allows to avoid both HD and elastic recoil of the target lesion.

Objective: Data regarding the long-term efficacy of carotid artery stenting (CAS) are still scarce. As demonstrated by several major randomized controlled trials (RCT) comparing the efficacy of carotid endarterectomy (CEA) vs medical therapy, even after successful carotid revascularization late ipsilateral stroke occurs in 5-13% at 5 years. Therefore, major concerns also remain about the durability of the CAS procedure in terms of stroke prevention. The purpose of this study was to review long-term results after carotid stent implantation in a large cohort of patients., Methods: This retrospective investigation involved 3179 CAS procedures performed at four European carotid high-volume centers. Echo-duplex scan using modified velocity criteria to recognize in-stent restenosis (ISR) and neurological examinations of all patients were carried out every 6 months after the procedure. Life-table analysis was used to determine freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any ipsilateral stroke. Freedom from ISR and from reintervention were also reported. The secondary aim was to identify predictive risk factors for neurological complications and ISR., Results: At 5 years freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any stroke rate were 82%, 93.5%, 93.3%, and 91.9%, respectively. The only predictor for neurological complications was the presence of neurological symptoms before CAS (hazard ratio 1.38 [CI 1.05, 1.82] P = .02). Freedom from restenosis at 1, 3, and 5 years was, respectively, 98.4%, 96.1%, and 94%. Uni- and multi-variate analyses showed that stent characteristics (material/design/free-cell area) were not significantly associated with time to in-stent restenosis or time to reintervention., Conclusion: Our long-term results in a large cohort of patients validated CAS as a durable procedure for stroke prevention. The annual rate of neurological complications after CAS was comparable to that of conventional surgery as demonstrated by large RCTs involving both symptomatic patients (North American Symptomatic Carotid Endarterectomy Trial [NASCET] and European Carotid Surgery Trial [ECST]) and asymptomatic patients (Asymptomatic Carotid Atherosclerosis Study [ACAS] and Asymptomatic Carotid Surgery Trial [ACST]).

EUCAS is a multicenter Registry of carotid artery stenting (CAS) in patients with acute cerebral ischemia (TIA or minor stroke), designed to determine the role of early endovascular intervention in a selected population with a vulnerable lesion of carotid bifurcation. The aim of the registry is to study the safety and efficacy of emergent/urgent CAS and to improve patient selection and consequently reduce the time loss between the index event and the intervention. Secondary aim is to study the plasma levels of plaque vulnerability biomarkers before and after carotid intervention in high risk patients to compare these value with a control group of patients with asymptomatic severe carotid stenosis, and to test the hypothesis that carotid stenting stabilizes the plaque at 1 month. The Registry is open to expert interventionists performing carotid stenting with a documented experience of at least 100 CAS, and the participants are free to apply the preferred endovascular techniques and devices, remembering to include the use of the cerebral protection device. All changes in the neurological status and all new cerebral ischemic events following the procedure will be reported. Follow-up surveillance to 1 month will include Duplex scanning, neurological examinations and blood collections for inflammatory biomarkers determination.

Introduction: The aim of this prospective observational registry was to study the outcome of symptomatic patients presenting with recent TIA or minor stroke and severe carotid stenosis, submitted to early percutaneous treatment by stenting. A secondary aim was to evaluate the biological activity of the symptomatic carotid plaques by serial serum and urinary markers (PAPP-A, hs-CRP, MMP-2/MMP-9, IL-6/IL-8, TNF alpha, CD40L) measured by enzyme-linked immunosorbent assay before and after treatment., Methods: From May 2005 to June 2006, 57 patients were enrolled in this prospective registry. All patients underwent carotid stenting using a concentric filter for cerebral protection. The procedure was performed within 24-48hrs of the last attack in patients with TIA (n=24, 42%) and between 14 and 30 days in patients with stroke (n=33, 58%)., Results: Successful stent implantation was achieved in all cases (100%). Adverse events at 1 month were 1 death (1.7%) and 2 TIAs (3.5%). Some of the vulnerability markers, in particular those reflecting an active systemic inflammatory process of the plaque (PAPP-A, hs-CR, and IL-6), were significantly elevated at the time of enrolment, increased after stenting and decreased after 30 days., Conclusion: Deferred CAS is feasible and safe in selected patients with symptomatic carotid stenosis. This preliminary study in a limited series of patients with unstable carotid plaques revealed that endovascular treatment has a satisfactory outcome considering the very high risk profile of the patient population. The evaluation of some biomarkers suggested an inflammatory role in the process of an unstable carotid plaque generating an acute cerebral event.

Background and Purpose: The accuracy of carotid ultrasound has not been well established in predicting intrastent restenosis (ISR) after carotid artery stenting (CAS). The aim of this study is to determine different degrees of ISR using ultrasound velocity criteria compared to percentage of stenosis at angiography., Methods: This is a 6-year prospective study. After CAS procedure, each patient underwent angiography for measuring ISR (NASCET method) which was compared to peak systolic velocity (PSV), end diastolic velocity (EDV), and the ratio between PSV of internal carotid artery and common carotid artery (ICA/CCA). This was done within 48 hours, thus creating a baseline value. Ultrasound (US) examination was performed at day 30, at 3, 6, 9, and 12 months, and then yearly. Patients with an increase in PSV greater than 3 times the baseline value or in presence of PSV >or=200 cm/s underwent angiography., Results: 814 CAS procedures, 6427 US examinations, and 1123 angiographies were performed. ISR >or=70% and ISR >or=50% was detected, respectively, in 22 patients and in 73 patients. We defined velocity criteria for grading carotid ISR: PSV or=300 cm/s, EDV >or=140 cm/s, and ICA/CCA >or=3.8 if a >or=70% stenosis. Receiver operator characteristic (ROC) curves for ISR >or=70% were, respectively, for PSV, EDV, and ICA/CCA: 0.99, 0.98, and 0.99., Conclusions: US grading of carotid ISR can guarantee a correct follow-up after CAS if new customized velocity criteria are validated by skilled operators using a specific protocol of follow-up in a certified laboratory.

Objectives: This study aims to determine safety, short and mid-term outcomes of Carotid Artery Stenting (CAS) and Endarterectomy (CEA) during the last 6 years in a single vascular surgery center., Methods: We retrospectively reviewed 2624 consecutive carotid revascularizations performed between December 2000 and December 2006 in 2176 patients with severe carotid artery stenosis (symptomatic > or = 70%, asymptomatic > or = 80%), of which 1589 were CEA and 1035 CAS. Patients were followed up at 1, 3, 6 and 12 months after the procedure and then yearly., Results: The percutaneous procedure was successful in 99.2% of the cases. No intra-procedural death occurred. The overall death and stroke rates at 30 days, 1 year and 3 years were 1.54%, 2.86%, 7.43% in the CAS group and 2.07%, 3.55%, 6.95% in the CEA group, respectively (p value not significant in any case)., Conclusions: At our vascular surgery centre the results of CEA and CAS are similar. CAS has become our standard of care in preventing strokes and is an effective alternative to CEA for low-risk patients as well.

Aim: The aim of this study was to identify predictive risk factors for complications during and after carotid artery stenting (CAS)., Methods: A multivariate analysis was performed on the databases of 4 European high-volume centers regarding risk factor distribution between patients presenting with or without neurological complications 30 days after CAS. The cumulative 30-day neurological complication rate (death, major stroke, minor stroke and transient ischemic attack) was 2.8% in the total examined cohort of 3 179 consecutive CAS procedures. The following risk factors were taken into consideration for statistical analysis: age, symptomatic, male gender, nicotine abuse, hypertension, hypercholesterolemia, polyvascular disease, diabetes, restenosis after carotid endarterectomy (CEA)/CAS, calcified internal carotid artery., Results: Symptomatic (P=0.02) or hypercholesterolemic (P=0.02) patients are at significantly increased risk for neurological events 30 days after CAS. Asymptomatic women and men without hypercholesterolemia have the lowest risk on any 30-day neurological complications after CAS., Conclusions: CAS is a safe technique in experienced hands. Preprocedural neurological complaints and hypercholesterolemia can be defined as predisposing factors for 30-day neurological complications after CAS.

Objectives: To identify if carotid stent design, especially free cell area, impacts on the 30-day rates for stroke, death and TIA after carotid artery stenting (CAS)., Material and Methods: A CAS database of 3179 consecutive CAS patients was retrospectively assessed. The distribution of neurological complications were analysed for association with the different stent types and designs. Events where subdivided into procedural and postprocedural events., Results: The overall combined rate of TIA, stroke and death was 2.8% at 30 days (late events 1.9%). The post-procedural event rate analyzed for differences stents varied from 1.2% using BSCI Carotid Wallstent to 5.9% using Medtronic Exponent. The late event rates varied from 1.2% to 3.4% for free cell areas <2.5mm(2) and >7.5mm(2) respectively (p<0.05). Post-procedural event rate was 1.3% for closed cells and 3.4% for open cells. All these differences were highly pronounced among symptomatic patients (p<0.0001)., Conclusions: After carotid stenting, complication rates vary according to stent type, free cell area and cell design. In the symptomatic population (and also in the total population), post-procedural complication rates are highest for the open cell types and increase with larger free cell area.

Purpose: To evaluate the immediate and midterm outcome and analyze the debris captured after repeat endovascular intervention for the treatment of in-stent restenosis after carotid artery stenting (CAS)., Methods: Thirty-one consecutive patients (27 men; mean age 63.7+/-13.0 years, range 53- 81) underwent repeat endovascular intervention (balloon angioplasty and provisional stenting) for the treatment of 32 in-stent restenoses following CAS., Results: Procedural success was achieved in all patients. An additional stent was implanted in 10 (31%) cases. No procedural complication was observed. Filter analysis was performed in 17 (53%) procedures; on 12 (71%), macroscopically visible material was captured. The histomorphometric analysis performed on 6 (19%) filters showed fibrin nets entrapping erythrocytes, leucocytes, platelets, and in 2 cases, fibrous hypercellular tissue fragments. At 30 days and during follow-up (mean 17+/-5 months), no deaths, transient ischemic attacks, or strokes were observed. In 1 (3.1%) patient, asymptomatic recurrence of ISR was found on Doppler ultrasonography and successfully treated with balloon angioplasty., Conclusion: Repeat endovascular intervention using balloon angioplasty with provisional stenting and routine cerebral protection appears to be a feasible, safe, and clinically effective strategy for the treatment of in-stent restenosis after CAS.

Purpose: To evaluate (1) whether carotid artery stenting (CAS) performed in octogenarians increases the procedure-related risk and (2) the incidence of complex anatomy of the aortic arch and supra-aortic vessels in patients >80 years old, which can increase the technical difficulty of CAS., Methods: Between December 2000 and September 2005, 1053 patients (903 men; mean age 72+/-2.2 years, range 46-90) underwent 1222 CAS procedures in 2 centers for de novo (n=1192) and restenotic (n=30) lesions (139 staged bilateral procedures). Indications for treatment were the presence of a symptomatic carotid artery stenosis >/=70% (n=798, 65.3%) or an asymptomatic stenosis of at least 80%. The patients were separated into 2 age categories: under 80 (n=1078 procedures, 88.2%) and 80 or older (n=144 procedures, 11.8%) for this analysis. Data analysis included death and stroke rate at discharge and at 30 days. Anatomical characteristics evaluated were aortic arch elongation, arch and supra-aortic vessel calcification and tortuosity, anatomical tortuosity of the lesion, and carotid plaque composition., Results: Three lesions in octogenarians could not be treated because of failure to access the vessel in 1 case and extremely tortuous arteries in 2. The overall death and stroke rate at 30 days was 2.12% in the older group (2 fatal strokes, 1 minor stroke) and 1.11% in the younger group (3 deaths, 3 major strokes, 6 minor strokes); the difference was not statistically significant (p=0.40). Significantly higher frequencies of tortuosity and calcification of the arch and supra-aortic vessels and of type III aortic arch were observed in the older group (p<0.001)., Conclusion: In our experience, CAS has proven to be safe and effective in elderly patients. Different age-related anatomical features can represent an adjunctive technical challenge, but these difficulties can be successfully managed without increased perioperative risk if CAS is performed in high-volume centers by highly skilled operators.

We report three cases of symptomatic acute carotid thrombosis occurring after carotid artery stenting (CAS). CASE 1: A patient presented with crescendo transient ischemic attacks on the second day after CAS. Ultrasound images demonstrated incomplete in-stent thrombosis due to plaque protrusion. The urgent surgical procedure consisted of stent removal and carotid thromboendarterectomy. CASE 2: A case of complete thrombosis of a carotid stent occurred 4 days after implantation in a patient with essential thrombocythemia diagnosed by chance. The surgical strategy included stent removal and carotid thromboendarterectomy. CASE 3: Cardiac multiple embolisms in a patient with chronic atrial fibrillation caused concomitant leg ischemia and acute carotid stent occlusion 2 hours after CAS. Cerebral reperfusion was established by embolectomy, without removing the stent. At the same time, the right leg ischemia was resolved by a thromboembolectomy with a Fogarty catheter. These three cases demonstrate that acute thrombosis after carotid stenting can be managed successfully with emergent surgical intervention. Thromboendarterectomy with stent removal or in selected cases, simple thromboembolectomy, can minimize neurologic sequelae in patients suffering from acute post-stenting carotid thrombosis.

Purpose: This study aims to review the incidence of in-stent restenosis (ISR), the factors which determine restenosis, and to evaluate the use of various endovascular techniques for the management of ISR following carotid artery stenting (CAS)., Methods: Four hundred and seven patients (334 men, mean age 63 years, range 46-86, median 65 years) were treated with CAS between December 2000 and March 2004. Three hundred and seventy-two (89%) patients had at least one ultrasound evaluation performed 6 months after procedure (range 6-40). Recurrent stenosis >80% detected with duplex ultrasound scans were further evaluated by angiography and treated with repeat endovascular procedure., Results: CAS was performed successfully in all cases with a Carotid WallStent (Boston Scientific) using a cerebral protection device (filter). Perioperative complications included four (0.9%) minor and two (0.4%) major strokes these latter two patients died at 5 and 12 days after the operation. No other deaths occurred. A total of 15 carotid arteries (3.6%) in 14 patients had ISR. All ISR were treated with a repeat endovascular procedure: three balloon angioplasty alone, eight angioplasty and secondary stenting, four angioplasty with cutting balloon. Postsurgical restenosis was confirmed to be the only predictive factor for the development of in-stent restenosis (OR 14.5, 95% CI 2.3-113.4, p=0.005). Endovascular treatment of ISR achieved technical success without periprocedurale complications and the absence of significant restenosis over a median follow up time of 12.4 months (range 3.5-30.7)., Conclusion: Our experience with a large cohort of CAS showed an encouragingly low incidence of ISR (3.6%) and successful treatment by repeat endovascular intervention. We recommend attempting all endovascular possibilities before performing stent removal.

Purpose: To report a retrospective study that sought to identify clinical factors contributing to the development of in-stent restenosis in the carotid arteries, to profile the patients at greatest risk, and to review the treatment modalities evolved from our experience., Methods: Between December 2000 and April 2003, 195 carotid angioplasty/stenting (CAS) procedures (12 bilateral) were performed in 183 patients (131 men; median age 65.9 years, interquartile range 55.2-72.7). Stenting for de novo stenoses was performed in 119 (61%) carotid arteries; 76 (39%) vessels were treated for postsurgical restenosis. Nearly two thirds of the patients (117, 64%) were symptomatic. Patients were evaluated at 3 and 6 months and at 6-month intervals thereafter with duplex ultrasonography. Angiography was used to confirm any recurrent lesion detected on the ultrasound scan., Results: Overall perioperative neurological complications included 4 (2.2%) minor strokes, 1 (0.5%) intracranial hemorrhage, and 1 (0.5%) major stroke; both patients with major neurological complications died at 5 and 12 days, respectively, after the procedure. During the 12.5-month follow-up (range 0-27.2), 3 non-procedure-related late deaths and another 9 (4.9%) neurological events occurred (2 strokes and 7 transient ischemic attacks). In-stent restenosis after CAS was present in 10 (5.2%) of 193 carotid arteries (9/181 patients) in follow-up; all but 1 artery had been treated for postsurgical restenosis. All lesions were treated secondarily with endovascular procedures. Statistical analysis demonstrated that postsurgical restenosis was the only predictive factor for the development of in-stent restenosis (OR 15.5, 95% CI 2.05 to 125.6, p=0.001) in this cohort., Conclusions: The present study, far from being exhaustive on the subject, indicates that patients who develop restenosis after carotid endarterectomy are also prone to develop restenosis after CAS; moreover, although strongly recommended for postsurgical restenosis, CAS carries a greater risk of in-stent restenosis in this subgroup, thus reducing the benefits of this procedure.