Carotid Stent Systems Research Articles

Mid-Term Results of an Italian Multicentric Experience with the RoadsaverTM Dual-Layer Carotid Stent System.

Carotid artery stenting (CAS) using first-generation single-layer stents is widely accepted as a good alternative to standard carotid endarterectomy (CEA) but it is associated with worse outcomes in terms of both plaque prolapse and cerebral embolization. To evaluate the perioperative and midterm outcomes of CAS using the new-generation RoadsaverTM dual-layer micromesh-covered carotid stent. Herein, we present the results of an observational, retrospective, multicentric study on non-consecutive patients who underwent the CAS procedure between January 2017 and December 2022 at three Italian, high-volume vascular surgery centers. The inclusion criteria were the patients' eligibility for the CAS procedure in accordance with the current Italian guidelines, and the implantation of a Roadsaver stent. Both symptomatic and asymptomatic patients were included in the study. The patients requiring reintervention for carotid restenosis following CEA were also included. Perioperative data regarding procedural success was defined as the successful implantation of the device in the desired position, less than 30% residual stenosis, and the absence of intraoperative neurological complications. The primary outcome was any adverse cerebrovascular event such as stroke or transient ischemic attack (TIA) during the procedure and/or after discharge. The secondary outcomes were the need for further intervention, and all-cause death following procedure. Three-hundred-fifty-three (353) patients were included in our study; the mean age was 74.3 years. A total of 5.9% of the patients were symptomatic on their operated side, while 7.3% had contralateral carotid occlusion. A cerebral embolic protection device (CPD) was employed in all patients. A total of 13.3% of the patients were operated on for restenosis after CEA Technical success was achieved in 96.9% of the cases with an intraoperative report of six TIAs (1.7%) and six ipsilateral strokes (1.7%). The mean hospital stay was 1.8 days. The thirty-day follow up showed one TIA and one more stroke. At the mean 35-month follow-up time, the primary outcome was present in six patients (1.7%), where four TIAs (1.1%) and two strokes (0.5%) were reported. Restenosis occurred in five patients (1.4%). Death for any cause was reported in 11 patients (3.1%). As most recent, high-quality studies show, the CAS procedure with second-generation devices such as the Roadsaver stent is safe and effective in preventing carotid-related cerebrovascular events in both symptomatic and asymptomatic patients. The intraoperative and postoperative cerebrovascular complication rate in high volume centers is very low, ensuring confidence in its employment for the CAS procedure along with a CPD as a valid alternative to CEA.

Carotid stenting: Does stent design matter?

Carotid artery stenting (CAS) is considered an important tool in carotid revascularization. Carotid artery stenting is usually performed by using self-expandable stent with different designs. The stent design influences many physical characteristics. Also, it may affect the complication rate with special relevance to perioperative stroke, hemodynamic instability, and late restenosis. This study comprised all consecutive patients who underwent carotid artery stenting for atherosclerotic carotid stenosis from March 2014 to May 2021. Both symptomatic patient and asymptomatic patients were included. Patients with a symptomatic carotid stenosis of ≥50% or asymptomatic carotid stenosis of ≥60% were selected for carotid artery stenting . Patients with fibromuscular dysplasia and acute or unstable plaque were not included. Variables of clinical relevance were tested in multivariable analysis using binary logistic regression model. A total of 728 patients were enrolled. The majority of this cohort was asymptomatic (578/728, 79.4%), while 150/728 (20.6%) were symptomatic. The mean degree of carotid stenosis was 77.82 ± 4.73%, with a mean plaque length of 1.76 ± 0.55cm. A total of 277 (38%) patients were treated with Xact® Carotid Stent System. Successful carotid artery stenting was achieved in 698 (96%) of patients. Of these patients, stroke rate in symptomatic patients was nine (5.8%), while in asymptomatic patients was 20 (3.4%). In a multivariable analysis, the open-cell carotid stent was not associated with a differential risk for combined acute and sub-acute neurologic complications as compared with closed-cell stents. Patients treated with open cell stents had a significantly lower rate of procedural hypotension (P 0.0188) at bivariate analysis. Carotid artery stenting is considered a safe alternative to CEA that can be used in selected average surgical risk patient. Different stent designs can affect the rate of major adverse events in carotid artery stenting patients, but further studies are necessary with avoiding different bias to study the effect of different stent designs.

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

Twelve months results from a prospective real-world multicenter clinical practice of CAS using the CGuard Embolic Prevention System (EPS): the IRONGUARD 2 study

Abstract Objectives When compared to carotid endarterectomy, carotid artery stenting (CAS) has been associated to a higher rate of post procedural neurologic events, potentially related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual layered mesh covered carotid stent systems (DLS). However, recent reports demonstrated that these devices are also associated with a not-negligible restenosis rate among the studies. Aim of this registry was to evaluate 1-year safety and efficacy of DLS for CAS in the clinical practice. 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 (EPS) in 20 centres. The primary endpoint was the occurrence of death and stroke at 1 year; secondary endpoints were transient ischemic attack (TIA), acute myocardial infarction (AMI), restenosis rate and in-stent thrombosis, ECA occlusion at 1 year. Results Among all enrolled subjects, late results were collected for 726 patients (99.04%). Dual antiplatelet therapy was maintained for at least 30 days post-procedurally in all patients, and for 3 months in 295 (40.63%), according with each center routine practice. After 30th post-operative day, new neurological adverse event was detected in 5 patients (0.68%), accounting for 1 minor stroke (0.13%), and 4 (0.55%) transient ischemic attacks. Eight patients (1.10%) died during the study period: 2 fatal acute myocardial infarctions (0.27%), 4 malignancies (0.55%), 1 suicide (0.13%), 1 undefined complication in Guillain-Barré Syndrome (0.13%). At duplex ultrasound examination, internal carotid artery was found patent in all but two patients (0.27%), and 2 asymptomatic in-stent restenosis (0.27%) were judged to be severe (>70%, peak systolic velocity >450cm/sec) and successfully treated by stent-in-stent. External carotid artery patency rate was 98.8% (718/726). At univariate analysis, post-dilatation (p=0.62; OR: 0.67; CI95%: 0.13–3.34), and dual antiplatelet therapy duration (p=0.97; OR: 0.96; CI95%: 0.11–8.31) were found to be not statistically related to occlusion and/or restenosis occurrence. Conclusion This real-world registry suggests that use of EPS in clinical practice is safe and associated to a minimal occurrence of adverse neurological events up to 12 months follow up. Funding Acknowledgement Type of funding sources: None.

Twelve Months Results from a Prospective Real-World Multicenter Clinical Practice of Carotid Artery Stenting Using the CGuard Embolic Prevention System: The IRONGUARD 2 Study

When compared with carotid endarterectomy, carotid artery stenting (CAS) has been associated to a higher rate of postprocedural neurologic events, potentially related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual layered mesh covered carotid stent systems (DLS). However, recent reports demonstrated that these devices are also associated with a not-negligible restenosis rate among the studies. The aim of this registry was to evaluate 1-year safety and efficacy of DLS for CAS in the clinical practice.

Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting

Objective: The aim of this study was to provide early-term evaluation, safety, and efficacy of the novel CGuard (Inspire MD, Tel Aviv, Israel) micromesh self-expanding stent with embolic protection system (EPS) during carotid artery stenting (CAS) procedure. Materials and Methods: All patients who underwent CAS with CGuard carotid stent system from January 2018 to September 2020 in a tertiary center were prospectively evaluated. Primary endpoints included technical success and perioperative neurological events (0–48 hours). Secondary endpoint was the rate of neurologic, cardiac events, and death (major adverse event or MAE) at 30 days. Patency of CGuard, peak systolic velocity (PSV), and end diastolic velocity (EDV) were evaluated at 30 days with duplex ultrasound. Results: A total of 103 patients underwent CAS procedure. Forty patients were symptomatic, and 63 patients were asymptomatic with stenosis greater than 70%. Technical success was 100%. Local anesthesia was applied in 94 patients (93%). Embolic protection devices were used in 6 patients (5.8%). Access site complications were 1.9%. Mean internal carotid artery stenosis diameter reduced from 79.47% to 14.68%. Two patients had transient ischemic attack (1.9%) and 1 patient experienced a cerebral hyperperfusion syndrome (CHS) perioperatively. External carotid artery (ECA) occlusion occurred in 1.9%. Four patients experienced jaw claudication (3.8%) postoperatively. Mean time of operation was 41 minutes. Mean duration of hospitalization was 3.1 days. The 30-day rate of MAE was 0%. CGuard patency was 100%, mean internal carotid PSV was reduced from 251.57 to 77.29 cm/s, and mean internal carotid EDV was reduced from 154.62 to 24.63 cm/s at 30 days. Conclusion: Our study shows that CGuard stent with EPS is an effective and safe device for treatment of carotid artery stenosis with acceptable low perioperative neurologic events, even with low embolic protection device usage. Larger multicenter and randomized studies are necessary to confirm its long-term efficacy.

One-month results from a prospective experience on CAS using C-GUARD stent system: the IRONGUARD-2 study

Abstract Objectives To evaluate 30-day safety and efficacy of dual layered mesh covered carotid stent systems (DLS) for carotid artery stenting (CAS) in the clinical practice. Background When compared to carotid endarterectomy CAS has been associated to an 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 DLS. 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 (EPS) in 20 centres. Primary endpoint was the stroke up to 30 days; secondary endpoints were the technical and procedural success; external carotid artery (ECA) occlusion; in-hospital and 30 days transient ischemic attack (TIA), acute myocardial infarction (AMI) and death rates. Results Symptoms were present in 131 patients (17.87%). An embolic protection device (EPD) was used in 731 patients (99.72%). Procedural success was 100%, technical success was obtained in all but one patient (99.86%), who died in-hospital due to a haemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, ECA occlusion was evident in 8 patients (1.09%). Between hospital discharge and 30-day, 2 TIAs, 1 minor stroke and 3 AMIs occurred. Therefore, the stroke rate at 30 days was 0.13. Conclusion This real-world registry suggests that use of CGuard EPS in clinical practice is safe and associated to a minimal occurrence of adverse neurological events up to 30 days follow up. Funding Acknowledgement Type of funding source: None

Use of dual layered stents in endovascular treatment of extracranial stenosis of the internal carotid artery: one year results of a patient-based meta-analysis of 4 clinical studies

Abstract Background Small sized clinical studies evaluating one year outcomes of CAS performed with two available DLS, Roadsaver® (RS) and CGuard® (CG), have been published. Purpose To evaluate one year safety and efficacy of dual layered mesh covered carotid stent systems (DLS) for carotid artery stenting (CAS). Methods We performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. Primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at one year. Results Patients were divided in two groups according to DLS (RS N=250; CG N=306). At one year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%), 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 (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At one 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%) of the group CG (0.32%). RS use was the only independent restenosis predictor. Conclusions This study suggests that DLS use for CAS is associated to a low one year death and stroke rate and specific DLS stent use could affect restenosis rate. Funding Acknowledgement Type of funding source: None

1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study

ObjectivesThis 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. BackgroundWhen 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. MethodsFrom 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. ResultsSymptoms 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%. ConclusionsThis 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.

Use of Dual-Layered Stents for Carotid Artery Angioplasty: 1-Year Results of a Patient-Based Meta-Analysis

ObjectivesThis study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). BackgroundSmall 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. MethodsThe 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. ResultsPatients 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. ConclusionsThis 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.

Comparison of different carotid stent designs in endovascular therapy of severe carotid artery stenosis

Background: One of the major periprocedural risks of carotid artery stenting is embolism caused either by plaque debris or by local thrombus forming. Double-layer micromesh stent design has shown to lower the chance of debris embolism but might have a slightly higher risk of local thrombus forming. Thus, we compared two different stent designs regarding safety and outcome profile in elective patients with high-grade carotid artery stenosis using a self-expanding, double-layer micromesh carotid stent system (DLCS) or a self-expanding hybrid carotid stent system (HCS). Methods: A single-center, open-label, retrospective cohort study of 67 consecutive, elective patients with high-grade symptomatic and asymptomatic carotid stenosis was executed at a comprehensive stroke center. Outcome measures were reocclusion rate, periprocedural symptomatic ischemic events, as well as other periprocedural complications, and recurrent stroke and mortality at 30 days’ follow-up. Results: Thirty-two patients (24% women, median age 75 years (interquartile range (IQR) 71–80) were treated with DLCS, and 35 patients (29% women, median age 71 years (IQR 63–76) years) with HCS. In both groups, pretreatment carotid stenosis degree was similar (median NASCET of 80%). Successful deployment was achieved in all cases without technical failure, and both groups did not differ in reocclusion rates, recurrent stroke, and mortality within 30 days. Conclusions: DCLS and HCS revealed to have similar safety and outcome profile in elective patients with high-grade symptomatic as well as asymptomatic carotid artery stenosis.

Highly-calcific carotid lesions endovascular management in symptomatic and increased-stroke-risk asymptomatic patients using the CGuard™ dual-layer carotid stent system: Analysis from the PARADIGM study.

To assess feasibility, safety, angiographic, and clinical outcome of highly-calcific carotid stenosis (HCCS) endovascular management using CGuard™ dual-layer carotid stents. HCCS has been a challenge to carotid artery stenting (CAS) using conventional stents. CGuard combines a high-radial-force open-cell frame conformability with MicroNet sealing properties. The PARADIGM study is prospectively assessing routine CGuard use in all-comer carotid revascularization patients; the focus of the present analysis is HCCS versus non-HCCS lesions. Angiographic HCCS (core laboratory evaluation) required calcific segment length to lesion length ≥2/3, minimal calcification thickness ≥3 mm, circularity (≥3 quadrants), and calcification severity grade ≥3 (carotid calcification severity scoring system [CCSS]; G0-G4). One hundred and one consecutive patients (51-86 years, 54.4% symptomatic; 106 lesions) received CAS (16 HCCS and 90 non-HCCS); eight others (two HCCS) were treated surgically. CCSS evaluation was reproducible, with weighted kappa (95% CI) of 0.73 (0.58-0.88) and 0.83 (0.71-0.94) for inter- and intra-observer reproducibility respectively. HCCS postdilatation pressures were higher than those in non-HCCS; 22 (20-24) versus 20 (18-24) atm, p = .028; median (Q1-Q3). Angiography-optimized HCCS-CAS was feasible and free of contrast extravasation or clinical complications. Overall residual diameter stenosis was single-digit but it was higher in HCCS; 9 (4-17) versus 3 (1-7) %, p = .002. At 30 days and 12 months HCCS in-stent velocities were normal and there were no adverse clinical events. CGuard HCCS endovascular management was feasible and safe. A novel algorithm to grade carotid artery calcification severity was reproducible and applicable in clinical study setting. Larger HCCS series and longer-term follow-up are warranted.

Use of Dual-Layered Stents in Endovascular Treatment of Extracranial Stenosis of the Internal Carotid Artery: Results of a Patient-Based Meta-Analysis of 4 Clinical Studies

ObjectivesThe aim of this study was to evaluate the clinical efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). BackgroundThe 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. MethodsA 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. ResultsThe 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. ConclusionsThis 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.

Double layered stents for carotid angioplasty: A meta-analysis of available clinical data.

The objective of this meta-analysis is to evaluate clinical efficacy of double layered mesh covered carotid stent systems in the clinical practice. The need for an increase plaque coverage to decrease the risk of debris dislodgement through the stent struts, following carotid artery stenting (CAS), has brought to the design of a new generation of double layered carotid stents. Several small sized clinical studies evaluating two different devices have been recently published, unfortunately these are not sufficiently powered to test for device related and clinical endpoints and no comparison, between the two available devices, has been reported yet. Ten studies, enrolling 635 patients, were included in the present meta-analysis. Our study analyzed a composite endpoint of 30-day stroke and death and the occurrence of procedural unsuccess after CAS with the use of two different double layered carotid stent systems. Thirty-day stroke and death rate was quite low (patients 635, event rate 0.02, 95% CI: 0.01-0.04, P < 0.0001). The incidence of procedural unsuccess with these devices was relatively low (patients 635, event rate 0.03, 95% CI: 0.01-0.08, P < 0.0001). When a subgroup analysis was performed, according to the specific subtype of carotid stent, no differences in the occurrence of 30-day death and stroke rate and procedural unsuccess were observed (P = 0.979). This meta-analysis suggests that dual layered carotid stents could be safely used for the treatment of extracranial carotid artery stenosis, with a relatively low rate of procedural unsuccess, and allow achieving a quite low rate of postprocedural adverse events.

Venous Sinus Stenting in Idiopathic Intracranial Hypertension: Results of a Prospective Trial.

Our goal was to evaluate the safety and efficacy of stenting of venous sinus stenosis (VSS) in patients with medically-refractory, medically-intolerant or fulminant idiopathic intracranial hypertension (IIH) in a prospective, observational study. Thirteen patients with IIH who were refractory or intolerant to medical therapy or who presented with fulminant visual field (VF) loss underwent stenting of VSS at the transverse-sinus sigmoid sinus junction, using a Precise Pro carotid stent system (Cordis). Inclusion criteria included papilledema-related VF loss with mean deviation (MD) worse than or equal to -6.00 dB, elevated opening pressure (OP) on lumbar puncture (LP), VSS (either bilateral or unilateral in a dominant sinus), and an elevated (≥8 mm Hg) trans-stenotic gradient (TSG). The main outcome measures were pre- to post-stent change in symptoms related to intracranial hypertension, MD (in dB) on automated (Humphrey) VFs, grade of papilledema (1-5), retinal nerve fiber layer (RNFL) thickness as measured by spectral domain optical coherence tomography (SD-OCT), TSG (mm Hg), and OP on LP (cm H20). Improvement or resolution of headaches occurred in 84.7% of patients, pulse-synchronous tinnitus in 100%, diplopia in 100%, and transient visual obscuration in 100%. Out of 26 eyes, 21 showed an improvement in MD, with an average improvement of +5.40 dB. Of 24 eyes with initial papilledema, 20 showed an improvement in Frisen grade, (mean change in grade of 1.90). Of 23 eyes undergoing SD-OCT, 21 (91.3%) demonstrated a reduction in RNFL thickness, with a poststent mean thickness of 90.48 μm. Mean change in OP was -20 cm H2O (reduction in mean from 42 to 22 cm H20) with all subjects demonstrating a reduction, although a second stenting procedure was necessary in one patient. Complications of the stenting procedure included one small, self-limited retroperitoneal hemorrhage, transient head or pelvic pain, and one allergic reaction to contrast. No serious adverse events occurred. Stenting of VSS is safe and results in reduction of intracranial pressure in patients with IIH. This is associated with improvement in papilledema, RNFL thickness, VF parameters, and symptoms associated with intracranial hypertension.

TCT-796 Highly Calcific Carotid Lesions Endovascular Revascularization Using a Novel, Dual-layer Carotid Stent System CGuardTM: Analysis from the PARADIGM Study

TCT-796 Highly Calcific Carotid Lesions Endovascular Revascularization Using a Novel, Dual-layer Carotid Stent System CGuardTM: Analysis from the PARADIGM Study

Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet-covered embolic prevention stent system.

Our aim was to determine (1) periprocedural and 30-day clinical safety and efficacy of the CGuard MicroNet-covered embolic prevention carotid stent system (MN-EPS) in routine use for unselected carotid stenosis (CS) patients undergoing CAS, as well as (2) feasibility of MN-EPS post-dilatation optimisation to minimise residual stenosis after CAS. This was a non-industry-funded, prospective academic study in all-referrals-tracked symptomatic and asymptomatic CS. In asymptomatic lesions, intervention was mandated only in case of increased stroke risk CS features. There was independent neurologist evaluation before CAS, at 48 hours and 30 days. There was external source data verification, angiographic core lab, and statistical analysis. Over 11 months, 108 referrals were recommended by the NeuroVascular Team for revascularisation: 101 (51-86 years, 55 symptomatic, evolving stroke in nine) underwent 106 (100% MN-EPS use) neuroprotection device-assisted (46% proximal, 54% distal) CAS; CEA was performed in seven. MN-EPS device success was 99.1%. Angiographic diameter stenosis was reduced from 83±9% to 6.7±5% (p<0.001). No MN-EPS foreshortening/elongation occurred (30 mm long was 29.82±0.68 mm; 40 mm long was 39.89±0.59 mm). The periprocedural death/major stroke/MI rate was 0%. One event, with no change in NIHSS or modified Rankin Scale and no clinical sequel, was adjudicated by the clinical events committee as minor stroke (0.9%). By 30 days there were no new events (0%). These increased risk consecutive patient data (1) indicate safety and efficacy of routine MN-EPS use in achieving endovascular reconstruction across all-comer CS lesion subsets, and (2) are consistent with MN-EPS protection against cerebral events extending throughout the stent healing period.

Outcome of Carotid Angioplasty With a Novel Open-Cell Carotid Stent System

The choice of carotid stent systems depends primarily on the anatomy of the carotid artery, the lesion morphology, and the patient's risk factors. Design improvements in devices, in terms of crossing profile and the ability to precisely position the stent, may greatly contribute to the procedural success without compromising acute clinical outcomes. The primary objective of this clinical registry was to evaluate the early safety and efficacy of a novel open-cell carotid stent system in an "all comer" population suitable for carotid artery stenting. The primary end point was the composite of ipsilateral stroke and "all-cause mortality" within 30 days after the procedure. Secondary end points entailed the rates of myocardial infarction and other clinical complications within the first 30 days following the procedure and up to the 6-month follow-up. Unsuccessful placement and/or withdrawal of the delivery system, as well as device-related complications involving the carotid artery and the rate of nonlesion-related embolisms, were evaluated relative to other currently available carotid stents. The 30-day composite death/stroke rate was 2.8% (3 of 106) while the overall stent system performance was similar to commonly used carotid stent systems. The utilized open-cell carotid stent system had favorable lesion crossing and positioning characteristics without compromising the 30-day composite death/stroke rate.

Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel Meeting on the ACCULINK and ACCUNET Carotid Artery Stent System

The Circulatory System Devices Panel of the Medical Devices Advisory Committee to the US Food and Drug Administration (FDA) was convened on January 26, 2011, to review the application by Abbott Vascular (Santa Clara, CA) for a post–market approval supplement (PMA-s) to extend the indications for use of their ACCULINK Carotid Stent System. The stent system had received FDA approval in 2004 for patients at high risk for adverse events after carotid endarterectomy (CEA). Abbott Vascular was seeking to extend its approval to patients at standard risk for CEA on the basis of the data and outcomes derived from the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST; ClinicalTrials.gov Identifier NC4732). Herein are presented the essential elements of that day-long meeting. ### Study Conception and Timeline The organizational work on the CREST project was initiated in 1996 by the project's executive committee, which first published on its concept, rationale, and design in 1997.1 The experiential basis for the trial was chiefly 2 small stenting registries in high-surgical-risk, symptomatic patients totaling ≈200 procedures and reporting mortality rates of up to 3% and stroke rates of between 3% and 6%.2,3 The CREST executive committee recognized the novel nature and early stage of the technique, and in accordance with the tenets of clinical equipoise, as well as to provide reassurance to randomizing physicians that a reasonable safety of carotid artery stenting (CAS) had been established at an operator level and across sites, a rigorous credentialing phase was detailed for all participating centers. One of the stated secondary goals of CREST, to describe this experience in the lead-in phase of CREST, has been completed and published elsewhere.4 Although a 3-year enrollment period was originally anticipated for the main randomized trial, based on 50 sites recruiting 20 symptomatic patients per year, CREST ultimately required nearly 8 …

Endarterectomy versus carotid stenting

Some 21 randomized trials involving 19 279 patients have evaluated the roles of carotid endarterectomy (CEA), best medical therapy (BMT) and carotid artery stenting (CAS) in patients with symptomatic and asymptomatic carotid disease. Before 2011, the data were generally interpreted as CEA being preferable in ‘average-risk’ symptomatic patients with 50–99 per cent stenoses and in ‘average-risk’ asymptomatic patients with 60–99 per cent stenoses. CAS was preferred in symptomatic patients deemed ‘high risk’ for CEA, and BMT thought safer in asymptomatic patients considered ‘high risk’ for CEA. This consensus was, however, somewhat fragile as there was an uneasy relationship between surgeons who wanted guidelines to remain unchanged, radiological interventionists who argued that the benefits of CAS were being withheld, and purchasers of healthcare, wary of changes in practice being driven by the ‘medical industrial complex’ rather than evidence. Liberalizing CAS indications might also have financial implications for surgeons and interventionists in privately funded healthcare systems. This consensus effectively collapsed following the 2011 US Food and Drug Administration approval of the RX Acculink Carotid Stent system (Abbott Laboratories, Abbott Park, Illinois, USA) in average-risk patients1. Along with 2011 guidelines from the American Heart Association (AHA)2,3, CAS was declared comparable with CEA in the treatment of average-risk symptomatic and asymptomatic patients. Other countries have advocated a more restricted expansion of CAS. Guidelines from Australia andNewZealand concluded that, although CAS was appropriate in symptomatic patients aged less than 70 years and in ‘high-risk for CEA’ symptomatic patients, they did not recommend CAS in average-risk, asymptomatic patients4. The 2011 National Institute for Health and Clinical Excellence guidelines advised that the evidence supported CAS in recently symptomatic patients (provided that arrangements were made for clinical governance, audit and research), but that CAS should be used only in asymptomatic patients in randomized trials or by ‘special arrangement’5,6. Given past experience, however, it seems likely that the rest of the world will adopt guidelines similar to those of the AHA. Those familiar with the literature will be well versed in what the randomized trials have told us, but many may be less familiar with what they have not told us. Current evidence offers ten key observations7–10: