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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.)

Objective: In cases of juxtarenal abdominal aortic aneurysm (jAAA), endovascular aneurysm repair (EVAR) involves the use of custom-made fenestrated stent grafts, which usually need large-diameter access vessels, superior costs, and a certain time between graft planning and delivery. We report our preliminary experience using the bare renal stent technique (called vent) in combination with the ultralow-profile stent graft Ovation (Endologix, Irvine, Calif) to seal jAAAs in patients evaluated to be unfit for open surgery and not suitable for fenestrated endograft., Methods: A single-center retrospective review of jAAAs treated by Ovation vent technique from January 2015 to December 2018 was conduced. The vent procedure consisted of a modified, off-label deployment of the sealing ring of the ultralow-profile Ovation stent graft close to renal orifices in combination with short bare-metal stents. The exclusion criterion was a diameter >31 mm at the level of the lowest renal artery. Early technical and clinical results, estimated midterm survival, renal artery patency, freedom from type IA endoleak, freedom from reintervention, and freedom from neck enlargement (>2 mm) were reported., Results: Overall, 38 patients had jAAA and were considered unfit for open repair and not eligible for fenestrated EVAR. The proximal neck was <5 mm in all cases (mean, 3.3 ± 1.2 mm). Vent renal stents were implanted bilaterally in 16 patients. Primary technical success was 94.7% (36/38), with satisfactory cannulation of all renal arteries and sealing of the aneurysm in all but two cases because of type IA endoleaks that were treated immediately with success. Primary clinical success at 1 month was 100%. During a median follow-up period of 22.4 ± 3.6 months (range, 1-46 months), no abdominal aortic aneurysm-related deaths occurred, and no patient was lost to follow-up. The survival curve at 1 year and 2 years was, respectively, 96.4% and 91.6% (standard error, 0.57%). There were no cases of neck dilation or endograft migration. Freedom from reintervention at 12 months and 24 months was 100% and 89.5%, respectively (standard error, 0.7%); freedom from type IA endoleak was 100% and patency of the renal artery was 100% at 2 years., Conclusions: The described technique includes the use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stents that are not competing for the same room. This early experience shows that the vent technique is safe and feasible and increases the range of treatment of those patients with jAAA who are unfit for open repair and for fenestrated EVAR because of several anatomic constraints., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction : Optical Coherence Tomography (OCT) is an intravascular imaging providing high-resolution images of morphological features of arterial wall. Nowadays, OCT is an accepted intravascular modality to study coronary arteries, stent implantation, and vessel injury. In the last decade, an increasing interest have been focused on the application of OCT in carotid arteries. Areas covered : Literature evidence in the application of OCT in carotid arteries still remains debated. So far, OCT has been used as a research tool, aiming to evaluate atherosclerotic plaques' features and stents' behavior after implantation. This paper is intended to summarize clinical evidences and practices in the use of OCT in carotid arteries district and during CAS procedures. Literature review was completed via Pubmed search using Keywords. Expert opinion : CAS is a safe and effective procedure when performed by trained physicians with a tailored approach. In this scenario, ambiguous pictures at ultrasound, angiography, and IVUS might be clarified using OCT.By providing unprecedented microstructural information on atherosclerotic plaques, OCT may identify the features of vulnerable carotid plaque and, by identifying possible defects after stent implantation as malapposition and plaque prolapse, it may help the tailoring approach to CAS.

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.)

Multicenter clinical trials level 1 evidence favors the application of carotid endarterectomy in symptomatic patients, especially the in the elderly cohort. Carotid artery stenting has been proposed as a possible early alternative in selected patients after onset of ipsilateral neurologic symptoms. It is well known that treatment of acute stroke is time-dependent in patients with acute ischemic stroke caused by high-grade stenosis of the internal carotid artery, but intensive medical treatment in conjunction with intervention to improve stroke severity and clinical outcomes has not been established. Two major clinical concerns exist: (1) the risk of hemorrhagic infarction after cerebral revascularization in the acute stage and (2) application of carotid stenting in the acute embolic stage, which may be associated with continued embolic risk after carotid artery stenting compared to carotid endarterectomy, which removes the symptomatic plaque. This review summarizes the indications and results of early carotid artery stenting after onset of neurologic symptoms, considering the new carotid stents and cerebral protection systems available for clinical use and enhanced stenting techniques., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aims: The aim of the present study was to evaluate periprocedural and 30-day outcomes in a prospective series of patients treated with the CGuard Embolic Prevention System (EPS)., Methods and Results: From April 2015 to June 2016, a physician-initiated prospective multicentre study was performed in 200 consecutive patients admitted for protected carotid artery stenting (CAS) and treated using the CGuard EPS in twelve vascular centres. Outcome measures were: technical success, periprocedural (0-24 hours) and post-procedural (24 hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischaemic attack (TIA), and external carotid occlusion. In three centres, consecutive diffusion-weighted magnetic resonance cerebral imaging (DW-MRI) was performed ≤72 hours prior to and within 72 hours after the intervention. A distal embolic protection device was employed in 182 patients (91%). Technical success was 100%. No death, AMI or major stroke occurred periprocedurally. There were two TIAs and five periprocedural minor strokes (2.5%), including one thrombosis solved by surgery. In the remaining patients (199/200; 99.5%) one-month follow-up duplex ultrasound revealed optimal technical results. Post-procedural clinical follow-up was uneventful. No external carotid artery occlusion occurred. New post-procedural DW-MRI lesions were detected in 12 patients out of 61 (19.6%), including bilateral in five (8.2%) and isolated ipsilateral in six (9.8%), whereas one patient (1.6%) had contralateral only lesions., Conclusions: Multicentre multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major periprocedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.

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'.

Background: The aim of this study was to compare the adverse effects of iodixanol and iopamidol in terms of patient's discomfort in subjects undergoing carotid artery stenting (CAS)., Methods: We retrospectively analyzed data of all successful CAS procedures performed in our department during a 15-year period study. All patients judged to be collaborative were included. From December 2000 to December 2005, we adopted iopamidol as contrast media (CM), thereafter iodixanol. Any transient unpleasant sensation of bitter taste or warmth perceived by the patient after intra-arterial injection of CM was recorded. Injection-associated discomfort was assessed by visual analog scale (VAS) score. Comparison between the 2 CMs with regard to the overall discomfort was carried out by using the Mann-Whitney test. Spearman correlation was performed to assess the correlation among discomfort, age, and CM used. A univariate analysis was performed for slightly bitter taste and warmth sensation to compare these clinical outcomes and CM used; subsequently, a logistic multivariate analysis regression was performed with the "backward elimination.", Results: Data from 1,633 patients were evaluated. A total of 608 patients underwent CAS procedure using iopamidol, and 1,025 using iodixanol. The total amount of CM used during a single procedure was 85 ± 17 mL/patient (range 60-135). The median VAS value was statistically significantly lower in the iodixanol group than in the iopamidol group (P < 0.001). A significant Spearman correlation coefficient was found between age and discomfort for both CMs used (Spearman rho 0.18 for iodixanol, 0.17 for iopamidol). The univariate analysis showed that patients undergoing CAS with iopamidol had an odds ratio (OR) of 8.48 (P < 0.001) to perceive warmth sensation. When adjusted for age and gender, the multivariate analysis still showed an OR of 8.03. For slightly bitter taste sensation, the crude analysis showed an OR of 1.31 (P = 0.018); adjusting for age and gender, OR became 1.15 and the difference was not statistically significant (P = 0.257)., Conclusions: During CAS, less overall discomfort was reported in patients receiving iodixanol than iopamidol; in terms of warmth sensation, patients undergoing procedure using iopamidol as CM have a higher risk to perceive this clinical symptom than iodixanol. Slightly bitter taste seems to have a statistically significant relation with age and gender, and not with CM used., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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.

Objective: Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force., Methods: This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries., Results: Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P = .05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0)., Conclusions: No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

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: To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting., Methods: The BRAVISSIMO study is a prospective, nonrandomized, multicenter, multinational, monitored registry including 325 patients with aortoiliac lesions. The end point is the primary patency at 24 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A & B versus TASC C & D population is performed., Results: Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the balloon-expandable stent, and 75.3% for patients treated with a combination of both stents (P = 0.06). Univariate and multivariable regression analyses using Cox proportional hazards model identified only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis., Conclusion: The 24-month data from this large, prospective, multicenter study confirm that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Implantation of a vascular prosthesis increases surgical site infection risk by producing a microenvironment conducive to bacterial attachment and biofilm formation, which sustains bacterial colonization and protects encased organisms from host defenses and antimicrobial therapy. Many maneuvers are used in an attempt to reduce infection in arterial reconstructions, but there are no clear guidelines on the most appropriate or effective. As well, there is no good evidence to guide management. A general principle is that indication for removal of the entire infected graft is mandatory when a suture line is involved in the infectious process, an infected anastomotic aneurism and a suture-line hemorrhage is evident, or when a graft-enteric fistula is diagnosed. Conservative, non-resectional management of graft infection is still a respectable solution for selected patients, as those with significant comorbidities, or those where the implanted aortic graft is in a location that precludes excision without causing a high likelihood of morbidity and/or mortality. Anyway, definitive management depends on the patient's condition and a tailored approach should be always offered. Surgical techniques favor in terms of mortality, patency and reinfection rate the in situ reconstruction. Currently, the choice of the technique used relies on center and operator's experience. This article summarizes the incidence of graft infection, analyze the predisponding factors to graft infection, and review current strategies for prevention and treatment of prosthesis and endograft infection.

We report a clinical evolution of a 85-years old male admitted to our Emergency Department for ruptured abdominal aortic aneurysm (rAAA). One month later a huge type I proximal endoleak was detected and corrected by proximal aortic extension. We decided to fix the stent-graft to the aortic wall using EndoAnchors. However, an asymptomatic type III endoleak due to controlateral limb disconnection was detected at the followed schedulated CT angio and corrected by a relining of the endograft. The patient is now in good clinical condition with no evidence of endoleaks at 1-year follow-up., (© The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Aim: The aim of this paper was to evaluate the influence of a challenging neck on mid-term results using the Endurant I stent-graft system in high risk patients., Methods: A retrospective study was conducted on a prospectively compiled database of 72 elective patients with challenging neck treated with the Endurant I system (Endurant Stent Graft, Medtronic AVE, Santa Rosa, CA, USA). These patients were compared to a control group (65 patients) without significant neck problems. The endpoints were mid-term 2-years technical, clinical success and the event free survival of all treated patients., Results: Mean age was 76.12 years; 76.6% of patients were males. Risk factors and preoperative variables did not differ significantly between the two groups. Only 4 (5.5%) patients of the study group vs. 2 (3.1%) in the control group developed type I endoleak during the follow-up. Three (4.1%) study group patients developed type III endoleak vs. 2 (3.1%) in the control group. All these patients required an adjunct procedure of relining with a new endograft. No type II endoleaks requiring adjunctive endovascular procedures were detected in our series. The 2-year event free survival rate did not differ statistically between the two groups (P=0.425)., Conclusion: Treatment with the Endurant stent-graft is technically feasible and safe, yielding satisfactory results even in challenging anatomies. Mid-term results are promising and challenge current opinion concerning the negative influence of challenging neck anatomy on EVAR especially after a longer follow-up.

When Juan Parodi implanted an endograft in a human body for the first time on September 7, 1990 in Buenos Aires, Argentina, the delivery system of the handmade device was primitive, extremely rigid, and had a bulky profile of 27 French (F). Since then, stent-graft technology has evolved rapidly, limitations of earlier-generation devices have been overtaken, and endovascular aneurysm repair (EVAR) eligibility has increased enormously. Nevertheless (still) challenging aortoiliac anatomy such as short and complex proximal aortic neck seal zones and narrow access vessels are responsible for EVAR ineligibility in up to 50% of cases. The Ovation Prime abdominal stent-graft system (TriVascular, Inc., Santa Rosa, CA, USA) is a trimodular device designed with the aortic body delivered via a flexible, hydrophilic-coated, ultra-low profile catheter (14-F outer diameter - OD). The aortic body is provided with a suprarenal nitinol stent with anchors that provide active fixation, while a network of rings and channels that are inflated with a low-viscosity radiopaque polymer during stent-graft deployment, provides effective sealing. The previous EVAR technology aimed to both anchor and seal using stents combined with fabric, with neither optimized for their roles and each forced to compete for the same space within their delivery catheters, which inevitably led to larger profile of the delivery system. The technical revolution of the Ovation endograft includes the idea to truly uncouple the stages of stent-graft fixation and seal during the procedure. In the Ovation endograft platform, stent and fabric are not competing the same space within the delivery system and an ultra-low profile delivery can be achieved without compromise. With such a low-profile delivery catheter, approximately 90% of men and 70% of women with abdominal aortic aneurysm have access vessel diameters considered fit for endovascular repair. The aim of this review paper was to analyze the main properties of Ovation endograft, to emphasize the advantage of the ultra-low profile device, and to sum up current literature.

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.)

Objectives: This study aims to evaluate the rate of stent malapposition, plaque prolapse and fibrous cap rupture detected by optical coherence tomography (OCT) imaging according to carotid stent design., Design: It was a prospective single-centre study., Materials and Methods: Forty consecutive patients undergoing protected carotid artery stenting (CAS) and high-definition OCT image acquisition were enrolled in the study. OCT frames were analysed off-line, in a dedicated core laboratory by two independent physicians. Cross-sectional OCT images within the stented segment of the internal carotid artery were evaluated at 1-mm intervals for the presence of strut malapposition, plaque prolapse and fibrous cap rupture according to stent design., Results: Closed-cell design stents (CC) were used in 17 patients (42.5%), open-cell design stents (OC) in 13 (32.5%) and hybrid design stents (Hyb) in 10 (25%). No procedural or post-procedural neurological complications occurred (stroke/death 0% at 30 days). On OCT analysis the frequencies of malapposed struts were higher with CC compared to OC and Hyb (34.5% vs 15% and 16.3%, respectively; p < 0.01). Plaque prolapse was more frequent with OC vs CC (68.6% vs 23.3%; p < 0.01) and vs Hyb stents (30.8%; p < 0.01). Significant differences were also noted in the rates of fibrous cap rupture between CC and OC (24.2% vs 43.8%; p < 0.01), and between CC and Hyb (24.2% vs 39.6%; p < 0.01), but not between OC and Hyb stents (p = 0.4)., Conclusion: Intravascular OCT after CAS revealed that micro-defects after stent deployment are frequent and are related to the design of implanted stents. Stent malapposition is more frequent with CC stents, while plaque prolapse is more common with OC stents. It remains, however, unknown whether these figures now detected with OCT are of any clinical and prognostic significance., (Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

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.

Objectives: The efficacy and safety of endovascular aneurysm repair is disputable in aneurysms with a short, angulated, wide, conical, or thrombus-lined neck making a reliable seal difficult to achieve. The influence of a challenging neck on early results using the Endurant stent-graft system in high risk patients was investigated., Materials and Methods: A retrospective study conducted on a prospectively compiled database of 72 elective patients with challenging neck treated with the Endurant system (Endurant Stent Graft, Medtronic AVE, Santa Rosa, CA, USA). These patients were compared to a control group (n = 65) without significant neck problems. Endpoints were early technical and clinical success, deployment accuracy and differences in operative details at one month follow-up. Data are reported as mean and standard deviation or as absolute frequency and percentage (%). Normality distribution and homogeneity of variances were tested by Shapiro-Wilks and Levene tests, respectively. Inter-group comparisons for each variable were made by t-test or χ2-test or Fisher exact test. A p < 0.05 was considered statistically significant., Results: Mean age was 76.12 years; 76.6% were males. Risk factors and pre-operative variables did not differ significantly between the two groups. Mean neck length was 10.56 mm in patients with challenging anatomies and 22.85 mm in controls. Patients with a challenging neck differed significantly (p < 0.001) from controls in terms of mean infrarenal (37.67° vs. 20.12°) and suprarenal angle (19.63° vs. 15.57°); 82% of patients with a challenging neck were ASA III/IV (vs. 86%). Technical success was 100%, with four unplanned proximal extension in challenging group. No type I endoleaks or aneurysm-related deaths occurred in either group; major complications were 1.54% vs. 1.39% (p = 0.942). Operative details were similar in both groups., Conclusion: Treatment with the Endurant stent-graft is technically feasible and safe, yielding satisfactory results even in challenging anatomies. Medium- and long-term data are needed to verify durability, but early results are promising., (Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

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.

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.

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.)

Incidence, clinical presentation and management of aortic grafts infection after open surgical repair are well described in the literature. Infective complications involving endografts after endovascular aneurysm repair (EVAR) have been scarcely investigated, since more attention has been given to the technical aspects of the procedure, including endoleaks, device migration, neck dilatation, endotension and aneurysm rupture. Nevertheless, that is a rare but severe complication occurring after EVAR; potentially difficult to diagnose and treat. Since 1991 only 102 cases of abdominal endograft infections have been reported in the literature. Treatment of infected abdominal endografts is controversial. Although reports have shown that high-risk patients with infected stent grafts treated conservatively with antimicrobial therapy and percutaneous drainage can still survive, most authors agree that an infected endograft should be removed if patient's conditions allow intervention. Standard treatment for infected abdominal endografts includes complete graft excision and local debridement followed by extra-anatomical bypass revascularization or in situ reconstruction with an aortic-bisiliac or bifemoral graft (Dacron or PTFE) or with a homograft. Lower overall mortality was observed for surgical management by explantation of infected endograft followed by in situ replacement as compared to other surgical solutions, but no definitive conclusions can be drawn about the optimal treatment strategy for aortic reconstruction.

Peripheral artery rupture as a late complication of an endovascular stenting, due to the protrusion of a stent, has never been described in the literature in thigh arteries. Here we describe two anecdotic cases of artery rupture after superficial femoral artery (SFA) stenting. In both cases the endovascular procedure was performed as a reintervention at 2 and 27 months after a failed surgical or hybrid procedure for limb revascularization. The stent had been delivered in the first part of the SFA and the rupture occurred at the junction between the common femoral artery and SFA, which is one of the most flexible parts of the femoral artery. The cause of rupture was probably caused by an ulcer of the stent against the artery wall concomitant with a status of local or systemic infection. A huge pseudoaneurysm developed in both cases. The massive bleeding was stopped by an emergency surgical bypass, with the removal of the stented artery. These two cases show the possibility of SFA rupture after stenting. Previous surgical treatment, the site of stenting (first part of the SFA) and an active infection could predispose patients to this life-threatening complication.

Purpose: To compare the outcome of endovascular aneurysm repair (EVAR) versus conventional open repair (OR) in patients with a short, angulated or otherwise challenging proximal neck., Methods: The definition of a challenging proximal neck was based on diameter (>or=28 mm), length (or=60 degrees ), shape (reverse tapered or bulging), and thrombus lining (>50%). Between January 2005 and December 2007, 187 consecutive patients (159 men; mean age 73 years, range 48-92) operated for asymptomatic abdominal aortic aneurysm (AAA) were identified as having challenging proximal neck morphology. Of these, 61 patients were treated with OR at center I (group A), 71 with standard EVAR (group B; 45 center I, 29 center II) and 52 with fenestrated EVAR (group C) at center II. Clinical examination and computed tomography were performed at 1 month and yearly thereafter., Results: There was no statistically significant difference between groups A, B, and C regarding primary technical success rate, 30-day mortality, or late AAA-related mortality. The mean length of follow-up was 19.5 months (range 0-40). Freedom from reintervention at 3 years was 91.8%, 79.7%, and 82.7% for groups A, B, and C, respectively (p = 0.042). The only statistically significant difference between standard and fenestrated EVAR was a higher incidence of late sac expansion [9 (12.2%) versus 1 (1.9%), p = 0.036] in the standard stent-graft group. Reinterventions were more frequent after EVAR (p = NS), but open reinterventions were more common after OR. Reinterventions after EVAR were related to the presence of an angulated (p = 0.039) or short neck (p = 0.024)., Conclusion: The results of EVAR and OR were similar for AAAs with a challenging proximal neck. Endovascular reinterventions were more frequent after EVAR, particularly in patients with an angulated or short neck. Open reinterventions were more common after OR. More patients and long-term data are needed to confirm these findings.

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 evaluate the technical success and clinical outcome of surgical revascularization, angioplasty and/or stenting for renal artery stenosis (RAS) in patients with renovascular hypertension (RVH). The secondary aim was to identify independent negative predictors of blood pressure control after successful renal revascularization., Methods: From January 1998 to July 2006, we treated 97 cases of RAS in 83 RVH patients. Inclusion criteria were RAS > or =80% associated with hypertension refractory to medical control with at least three drugs including a diuretic. Therapeutic options were surgical revascularization in 15 cases (11 renal endarterectomies, 4 aortorenal bypasses) and endoluminal treatment in 82 (14 balloon angioplasties, 68 stents)., Results: Technical success was 100% for both surgical and endovascular procedures; 13 cases of restenosis (> or =80%) were detected: 12 (14.6%) in the endoluminal group and one (6.6%) in the surgical group (P=0.68). During the follow-up period (average 37 months, range 6-94), blood pressure control improved in 43% of patients, disease stabilized in 37% and the natural course of RVH deteriorated in 20%. Multivariate Cox regression analysis showed that only a long history of antihypertensive drug use was a predictor of inefficacy of blood pressure control after revascularization (P<0.04)., Conclusion: The complete resolution of RVH associated with severe RAS appears unrealistic in several cases. Early and long-term results in terms of technical success and restenosis were acceptable and similar for surgical and endovascular renal intervention. An early diagnosis of RVH could improve the control of hypertension after successful renal revascularization.

Objectives: The goal of this study was to review our experience with embolic protection devices (EPDs) during carotid artery stenting (CAS). Specifically, we aimed to verify their clinical effectiveness and to compare clinical outcomes between specific devices and types of EPDs., Methods: The CAS databases at four participating centers were reviewed. Adverse events were defined as death, stroke (>24 hours), or transient ischemic attack (TIA) (<24 hours). We compared the risk of procedural and 30-day events between patients treated with and without an EPD. We also compared these risks between different EPDs and between the different types of EPDs., Results: A total of 3160 CAS procedures using nine EPDs were analyzed. The risk of a procedural adverse event was 0.9% in protected and 2.3% in unprotected procedures (P = .12). Compared with the most frequently used device (FilterWire, Boston Scientific, Natick, Mass), there was no significant difference in the risk of procedural adverse events for any of the other EPDs. There was, however, an increased risk of 30-day adverse events with the Accunet (Abbott Vascular, Redwood, Calif) filter compared with the FilterWire (relative risk [RR] 2.67, confidence interval [CI] 1.41 to 5.04, P = .005). Pairwise comparison of proximal occlusion balloons to filters, distal occlusion balloons to filters, and proximal to distal occlusion balloons revealed no significant difference in the risk of procedural or 30-day adverse events. There was no significant difference in risk of procedural events between eccentric and concentric filters, however, the relative risk of eccentric compared with concentric filters at 30 days was 0.59 (unadjusted, CI 0.38 to 0.92, P = .04). This difference was still apparent after adjustment for risk factors (RR 0.61, CI 0.39 to 0.95, P = .06), but not after adjustment for risk factors and stent-type [(open-cell vs closed-cell) RR 0.76, CI 0.47 to 1.22, P = .51]., Conclusion: The use of EPDs is associated with a low risk of procedural adverse events. We were unable to detect significant differences in risks of procedural adverse events between different devices or types of devices. We speculate that the observed differences seen at 30 days are largely attributable to differences in stent-type used.

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.