Carotid artery stent placement is safe in the very elderly (≥80 years)

Background: Carotid artery stent (CAS) placement is an alternative to carotid endarterectomy (CEA) for stroke prevention. Clinical adoption of CAS depends on its safety and efficacy compared to CEA. There are conflicting reports in the literature regarding the safety of CAS in the elderly. To address these safety concerns, we report our single‐center 13‐year CAS experience in very elderly (≥80 years of age) patients. Methods: Between 1994 and 2007, 816 CAS procedures were performed at the Ochsner Clinic Foundation. Very elderly patients, those ≥80 years of age, accounted for 126 (15%) of all CAS procedures. Independent neurologic examination was performed before and after the CAS procedure. Results: The average patient age was 82.9 ± 2.9 years. Almost one‐half (44%) were women and 40% were symptomatic from their carotid stenoses. One‐third of the elderly patients met anatomic criteria for high surgical risk as their indication for CAS. The procedural success rate was 100% with embolic protection devices used in 50%. The 30‐day major adverse coronary or cerebral events (MACCE) rate was 2.7% (n = 3) with all events occurring in the symptomatic patient group [death = 0.9% (n = 1), myocardial infarction = 0%, major (disabling) stroke = 0.9% (n = 1), and minor stroke = 0.9% (n = 1)]. Conclusion: Elderly patients, ≥80 years of age, may undergo successful CAS with a very low adverse event rate as determined by an independent neurological examination. We believe that careful case selection and experienced operators were keys to our success. © 2008 Wiley‐Liss, Inc.     

Outcomes following extracranial carotid artery stenting in high-risk patients

BACKGROUND: Carotid artery angioplasty and stenting has become a viable alternative to carotid endarterectomy (CEA), especially for patients considered at high risk for post-operative complications. This study investigated the feasibility, safety and long-term outcome of carotid artery stenting (CAS) in high-risk patients. METHODS: From July 1995 to November 2000, sixty-two consecutive patients considered to be at high risk for post-operative complications of CEA were followed prospectively after undergoing extracranial CAS procedures. RESULTS: Sixty-two patients [37 men (60%) and 25 women (40%)] underwent a total of 69 CAS procedures. The mean age was 67 +/- 9 years (range, 32-89 years). Comorbid conditions included hypertension in 95% and severe coronary artery disease in 58%. Sixteen patients (26%) had a previous ipsilateral CEA, twenty-one percent had a history of neck radiation and 32% had a history of significant contralateral carotid artery disease. Fifty-two patients (84%) were symptomatic. All 69 CAS procedures were technically successful. The major post-operative complications were two minor strokes (2.8%), one major stroke (1.4%) and one fatal major stroke (1.4%). The mean length of follow-up was 17 months (range, 4 months to 5.6 years). Two patients (2.8%) have suffered ipsilateral neurologic events following CAS. Long-term follow-up revealed restenosis at 6 months in 4 patients (5.7%). CONCLUSIONS: Carotid artery angioplasty and stenting is safe and feasible. This procedure produces satisfactory outcomes in patients who are at high risk for post-operative complications of CEA.     

Comparative Review of the Treatment Methodologies of Carotid Stenosis

The treatment of carotid stenosis entails three methodologies, namely, medical management, carotid angioplasty and stenting (CAS), as well as carotid endarterectomy (CEA). The North American Symptomatic Carotid Endarterectomy Trial (NASCET) and European Carotid Surgery Trial (ECST) have shown that symptomatic carotid stenosis greater than 70% is best treated with CEA. In asymptomatic patients with carotid stenosis greater than 60%, CEA was more beneficial than treatment with aspirin alone according to the Asymptomatic Carotid Atherosclerosis (ACAS) and Asymptomatic Carotid Stenosis Trial (ACST) trials. When CAS is compared with CEA, the CREST resulted in similar rates of ipsilateral stroke and death rates regardless of symptoms. However, CAS not only increased adverse effects in women, it also amplified stroke rates and death in elderly patients compared with CEA. CAS can maximize its utility in treating focal restenosis after CEA and patients with overwhelming cardiac risk or prior neck irradiation. When performing CEA, using a patch was equated to a more durable result than primary closure, whereas eversion technique is a new methodology deserving a spotlight. Comparing the three major treatment strategies of carotid stenosis has intrinsic drawbacks, as most trials are outdated and they vary in their premises, definitions, and study designs. With the newly codified best medical management including antiplatelet therapies with aspirin and clopidogrel, statin, antihypertensive agents, strict diabetes control, smoking cessation, and life style change, the current trials may demonstrate that asymptomatic carotid stenosis is best treated with best medical therapy. The ongoing trials will illuminate and reshape the treatment paradigm for symptomatic and asymptomatic carotid stenosis.     

Carotid artery stenting: acute and long-term results

The objective of this study was to evaluate the safety and efficacy of carotid artery stenting (CAS) in high-risk patients. Carotid endarterectomy (CEA) has been shown to be more effective than medical therapy but has limitations. CAS may be a reasonable alternative, particularly in high-risk patients. The authors evaluated prospectively the safety and efficacy of CAS in 299 consecutive patients who underwent CAS of 343 extracranial carotid arteries. Of the patients enrolled, 210 (70%) would have been excluded from the major trials of CEA, and 84 (28%) were referred by vascular surgeons. This series represents a very high-risk group that included patients with unstable angina, previous ipsilateral CEA, contralateral carotid occlusion, and other severe comorbid illnesses. Seventy-four (25%) patients were aged 80 years or more. All patients had independent neurologic examination before and after the procedure. Three hundred seventy-six stents were deployed in 343 arteries. Procedural success was 99%. Mean stenosis was 75 +/- 12% before and 7 +/- 8% after the procedure. Ninety-two patients had coronary intervention. Only 56 (19%) patients were North American Symptomatic Carotid Endarterectomy Trial (NASCET) eligible. During the initial hospitalization and 30 days post-CAS, there were two (0.6%) major and seven (2.3%) minor strokes. There were no myocardial infarctions or deaths during or within 30 days of CAS. None of the NASCET-eligible patients had a stroke. At a mean follow-up period of 26 +/- 13 months, eight (2.7%) patients had asymptomatic restenosis. No additional major strokes or neurologic deaths occurred. In conclusion, CAS is feasible, can be performed even in high-risk patients, and is associated with a low restenosis rate.     

Carotid angioplasty and stenting in octogenarians: Is it safe?

Purpose: Elderly patients have a higher risk of complications in carotid endarterectomy. The aim of the study was to evaluate whether carotid artery stenting (CAS) performed in octogenarians also increases the procedure related risk. Methods: 870 patients (male 626) mean age 70.9 ± 9.3 years underwent 930 CAS for de novo lesions (n = 851) restenoses (n = 54) post radiation (n = 14) inflammatory arteritis (n = 9) post trauma aneurysms (n = 2). Indications for treatment: symptomatic carotid stenosis ≥ 70% (n = 577) or asymptomatic stenosis ≥ 80%. Patients were separated into two age groups: <80 years (749 patients, 806 CAS) and >80 years (121 patients, 124 CAS). 187 CAS performed without protection (N.P?) 6 patients >80 years, 743 with protection (NP+) (occlusion balloon: 334, filters: 404, reversal flow: 6) 118 patients >80 years. Data analysis included neurological complications, death and myocardial infarction (MI) rate at 30 days, anatomical particularities. Technical points will be described depending on the age of the patient. Results: Technical success 804/806 in patients <80 years, 123/124 in patients >80 years (NS). 30 days outcomes: in the patient group <80 years we observed 9 TIA (1.1%) 3 without NP (1.7%) 6 with NP (0.9%), 5 minor strokes (0.6%) 2 without NP (1.1%) 3 with NP (0.5%), 3 major strokes: 2 without NP (1.1%) 1 with NP (0.2%), 5 deaths (0.6%) 2 without NP (1.1%) 3 with NP (0.5%). Death/stroke/MI: 14 (1.8%) 6 without NP (3.3%), 8 with NP (1.3%). In the group >80 years, we observed 2 TIA (1.7%) 1 without NP 1 with NP (0.92%) 1 minor stroke without NP (17%) no major stroke, no death. Death/stroke/MI 1 without NP (17%). Conclusion: CAS can be performed in elderly patients without higher risk than in younger patients. But good indications, a meticulous technique, protection devices are mandatory and some technical points must be pointed out to avoid neurological complications and failures. © 2008 Wiley‐Liss, Inc.     

Carotid artery stenting

From the earliest experiences with carotid artery stenting (CAS) presumptive high risk features have included thrombus‐containing lesions, heavily calcified lesions, very tortuous vessels, and near occlusions. In addition patients have been routinely excluded from CAS trials if they have contra‐indications to dual antiplatelet therapy (aspirin and thienopyridines), a history of bleeding complications and severe peripheral arterial disease (PAD) making femoral artery vascular access difficult. Variables that increase the risk of CAS complications can be attributed to patient characteristics, anatomic or lesion features, and procedural factors. Clinical features such as older age (≥80 years), decreased cerebral reserve (dementia, multiple prior strokes, or intracranial microangiopathy) and angiographic characteristics such as excessive tortuosity (more than two 90° bends within 5 cm of the target lesion) and heavy calcification (concentric calcification ≥ 3 mm in width) have been associated with increased CAS complications. Other high risk CAS features include those that prolong catheter or guide wire manipulation in the aortic arch, make crossing a carotid stenosis more difficult, decrease the likelihood of successful deployment or retrieval of an embolic protection device (EPD), or make stent delivery or placement more difficult. Procedure volume for the operator and the catheterization laboratory team are critical elements in reducing the risk of the procedure. In this article, we help CAS operators better understand procedure risk to allow more intelligent case selection, further improving the outcomes of this emerging procedure.© 2013 Wiley Periodicals, Inc.     

Carotid artery revascularization with distal protection in high‐surgical‐risk patients in routine clinical practice: Rationale and design of the CABANA safety surveillance program

Background: Continuous improvement in carotid artery stenting (CAS) outcomes, especially for periprocedural death and stroke in high‐surgical‐risk patients, have been seen in recent randomized trials of CAS versus carotid endarterectomy and CAS registries. However, these studies use stringent inclusion/exclusion criteria for patient, institution, and physician selection. The Carotid Stenting Boston Scientific Surveillance Program (CABANA) study was initiated to evaluate periprocedural outcomes with modern versions of the Carotid Wallstent and FilterWire EZ System for operators with a wide range of clinical specialties, CAS experience and training levels, in patients with a broad range of high‐surgical‐risk conditions and lesion types. Methods: This prospective, single‐arm study enrolled 1,097 subjects with 1,098 carotid artery lesions at 99 study centers. Investigators were grouped into one of three tiers according to whether they had a high, medium, or low level of previous CAS experience and were also categorized by their CAS‐credential‐based training requirements for the CABANA study. Follow‐up at 30 days includes clinical evaluation and independent neurological and NIH stroke scale assessments. The primary endpoint rate of 30‐day composite stroke, death, and MI, as well as the rates of these individual events, will be evaluated across the overall study, by physician experience tier, and by physician training tier. Discussion: The evaluation of periprocedural CAS safety in a real‐world environment with modern devices in high‐surgical‐risk patients treated by physicians with a broad range of training and experience will better inform treatment decisions in the future. © 2011 Wiley Periodicals, Inc.     

Carotid angioplasty and stenting versus carotid endarterectomy: randomized trial in a community hospital.

OBJECTIVES: The goal of this study was to determine whether carotid angioplasty and stenting (CAS) is equivalent to carotid endarterectomy (CEA) in patients with symptomatic carotid stenosis >70% by a randomized, controlled trial in a community hospital. BACKGROUND: Carotid angioplasty and stenting has been suggested to be as effective as CEA for treatment of symptomatic carotid artery stenosis. METHODS: A total of 104 patients presenting with cerebrovascular ischemia ipsilateral to carotid stenosis were selected randomly for CEA or carotid stenting and followed for two years. RESULTS: Stenosis decreased to an average of 5% after CAS. The patency of the reconstructed artery remained satisfactory regardless of the technique as determined by sequential ultrasound. One death occurred in the CEA group (1/51); one transient ischemic attack occurred in the CAS group (1/53); no individual sustained a stroke. The perception of procedurally related pain/discomfort was similar. Hospital stay was similar, although the CAS group tended to be discharged earlier (mean = 1.8 days vs. 2.7 days). Complications associated with CAS prolonged hospitalization when compared with those sustaining a CEA-related complication (mean = 5.6 days vs. 3.8 days). Return to full activity was achieved within one week by 80% of the CAS group and 67% of the patients receiving CEA. Hospital charges were slightly higher for CAS. CONCLUSIONS: Carotid stenting is equivalent to CEA in reducing carotid stenosis without increased risk for major complications of death/stroke. Because of shortened hospitalization and convalescence, CAS challenges CEA as the preferred treatment of symptomatic carotid stenosis if a reduction in costs can be achieved.     

The carotid artery revascularization and endarterectomy (CARE) registry: Objectives,design, and implications

This is the first comprehensive national registry that will provide data characterizing contemporary results of carotid endarterectomy (CEA) and carotid artery stenting (CAS). Carotid endarterectomy (CEA) has become the standard revascularization therapy to prevent stroke in patients with carotid artery disease, while carotid artery stenting (CAS) offers a percutaneous alternative in selected patients. Given the rapid growth in the numbers of CAS procedures being performed, there is a critical need for a national program to assess quality outcomes. The Carotid Artery Revascularization and Endarterectomy (CARE) Registry was developed through a multispecialty collaboration resulting in a comprehensive data collection tool for carotid revascularization procedures. The intent of the CARE registry is to collect and analyze clinical data to measure clinical practice, patient outcomes, and enable quality improvement for carotid revascularization. Finally, the CARE Registry satisfies the Center for Medicare and Medicaid Services (CMS) data reporting criteria for reimbursement. © 2008 Wiley‐Liss, Inc.     

Carotid artery stenting in high surgical risk patients using the FiberNet® embolic protection system: The EPIC trial results

Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single‐arm trial evaluated the 30‐day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Background: Embolic protection filters available for use during CAS include fixed and over‐the‐wire systems that rely on embolic material capture within a “basket” structure. The FiberNet® Embolic Protection System (EPS), which features a very low crossing profile, consists of a three‐dimensional fiber‐based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30‐day follow‐up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30‐day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30‐day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). © 2009 Wiley‐Liss, Inc.     

Safety and efficacy of elective carotid artery stenting in high-risk patients

OBJECTIVES

We sought to evaluate the safety and efficacy of carotid artery stenting (CAS) in high risk patients.

BACKGROUND

Carotid endarterectomy (CE) has been shown to be more effective than medical therapy, but it has limitations. Carotid artery stenting may be a reasonable alternative, particularly in high-risk patients.

METHODS

We prospectively evaluated the safety and efficacy of CAS in 170 consecutive patients who underwent the procedure in 192 carotid arteries. Of the patients enrolled, 129 (76%) would have been excluded from the major trials of CE and 54 (32%) were referred by vascular surgeons. This series represents a very high-risk group that included patients with unstable angina, previous ipsilateral CE, contralateral carotid artery occlusion and other severe comorbid illnesses. Only 25 (24%) of 104 symptomatic patients would have met the North American Symptomatic Carotid Endarterectomy Trial (NASCET) entry criteria. The patients’ mean age was 73 ± 8 years (95 confidence interval [CI] 57 to 89), and 42 patients (25%) were ≥80 years old. Patients had an independent neurologic examination before and after the procedure.

RESULTS

The procedural success rate was 99%, including 73 patients who had a coronary intervention. Mean carotid artery stenosis was 78 ± 10% before (95 CI 58 to 98) and 2 ± 3% after the procedure (95 CI −4 to 8). During the initial hospital period and 30 days after CAS, there was one major and two category 2 minor strokes, as well as two category 1 minor strokes (total 30-day stroke rate was 2.9% for treated patients or 2.6% for treated arteries). There were no myocardial infarctions or deaths during or within 30 days of CAS. None of the NASCET-eligible patients had a stroke. At a mean follow-up of 19 ± 11 months, three patients (2%) had asymptomatic restenosis. No other major strokes or neurologic deaths occurred.

CONCLUSIONS

Carotid artery stenting is feasible, can be performed even in high-risk patients and is associated with a low restenosis rate.     

Symptomatic carotid artery stenosis: what is the preferred treatment?

Stroke is a major cause of mortality, morbidity, and disability. Carotid artery disease is the etiology for 15% to 20% of stroke. Carotid endarterectomy (CEA) reduces the risk of ipsilateral stroke and death in symptomatic patients with 50% to 99% carotid artery stenosis when the operative risk of stroke or death is less than 6%. Treatment benefit is greater with earlier surgery, more severe stenoses, and older age. Recently, carotid artery stenting (CAS) has emerged as a treatment option, especially in patients with high surgical risk due to anatomic or clinical variables. Nondisabling stroke risk may be higher with CAS than CEA, but the difference is narrowed with the use of embolic protection devices. The risk for myocardial infarction is lower with CAS than CEA. There is no difference in risk for disabling stroke or death. Worse results with new or low-volume CAS operators is a concern. CEA and CAS are complementary revascularization strategies. CEA may be preferred in older patients with complex anatomy or bulky plaques. CAS may be preferred in younger patients and those with restenosis, history of neck radiation, surgical contraindications, or surgically inaccessible lesions. The role for optimal medical therapy as an alternative treatment strategy remains to be defined. Nevertheless, all patients should be treated with lifestyle interventions and secondary risk factor control to target levels to reduce the risk of subsequent atherosclerotic events.     

Carotid artery stenting with distal filter protection: single-center experience in high-surgical-risk patients

Carotid artery stenting (CAS) is an efficient alternative procedure for the treatment of high-surgical-risk patients with symptomatic and asymptomatic carotid stenosis. The use of cerebral protection systems might decrease procedural risk of stroke and death. We report our initial experience with protected carotid stenting in high-risk patients with severe carotid artery disease. From January 2006 until July 2008 we routinely performed CAS using a distal filter protection device in 65 consecutive high-surgical-risk patients with 72 high-grade carotid stenoses. Technical success rate was 97.2%. Neurologic periprocedural complications included two transient ischemic attacks and one major stroke. Three filter-related complications were managed without negative results to the patients. The overall in-hospital and 30-days MACE rate was 1.5%, 3.6% in symptomatic patients and 0% in asymptomatic patients. In our series of high-risk patients, CAS with the use of a distal filter protection system was safe and effective with a low incidence of periprocedural complications.     

Comparison of in-hospital outcomes of patients with versus without previous carotid endarterectomy undergoing carotid stenting (from the German ALKK CAS Registry)

Repeat carotid endarterectomy (CEA) for recurrent stenosis remains a challenging treatment option associated with high morbidity and mortality. Carotid artery stenting (CAS) is an attractive alternative management option for these patients. However, data about the effectiveness and safety of CAS in a large number of unselected patients are less known. We evaluated 3,070 patients who underwent CAS enrolled in a German registry from 1996 to 2006 at 31 sites. We compared clinical and angiographic features and in-hospital outcomes of patients with and without previous CEA who underwent CAS. Of 3,070 patients in the registry, 223 (7.3%) underwent CAS for restenosis after previous CEA. Median age was similar in patients with and without previous CEA (70 years, interquartile range 64 to 76 vs 71 years, interquartile range 65 to 76). Ipsilateral neurologic symptoms occurred in approximately 1/2 the patients in both groups. Other co-morbid conditions and angiographic or procedural factors did not differ between the 2 groups. In-hospital events including death (0% vs 0.4%), ipsilateral major stroke (1.4% vs 1.5%), death or major ipsilateral stroke (1.4% vs 1.7%), ipsilateral transient ischemic attack (1.9% vs 2.8%), myocardial infarction (0.4% vs 0.1%), and reintervention (0.7% vs 0.4%) were all low and not significantly different between those with and without previous CEA (p >0.05 for all comparisons). In conclusion, our data for a large number of patients who underwent CAS in a recent contemporary community-based practice attests to the low risk of periprocedural events in patients with recurrent stenosis after previous CEA. This low risk along with the less invasive nature of the procedure should make CAS an attractive and perhaps preferred option for the treatment of these patients.     

The CAPTURE registry: predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval setting.

BACKGROUND: The use of carotid artery stenting with embolic protection has been practiced for over a decade in the United States, and increasingly so since carotid stenting received FDA approval in 2004. While there have been attempts at establishing predictors of outcomes in carotid artery stenting, they have generally been limited to single center experiences and/or multicenter retrospective surveys. This report examines predictors of outcomes in carotid stenting in the earliest and largest prospective multicenter neurologist-adjudicated experience in the United States post device approval. METHODS: The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry conducted to assess outcomes of carotid artery stenting (CAS) in the noninvestigational setting following device approval for high surgical risk patients (symptomatic with > or =50% stenosis; asymptomatic > or =80% stenosis). A neurologist examined the patients before the procedure, at 24 hr and 30-days post-procedure. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30-days post-procedure. Strokes and neurological events suspected to be strokes were adjudicated by an independent Clinical Events Adjudication Committee (CEAC) using prespecified definitions. Logistic regression analysis was performed to determine clinical, procedural, and anatomic predictors of endpoint outcomes. RESULTS: Three thousand five hundred patients were enrolled at 144 sites by 353 physicians of varying specialty backgrounds and CAS experience. The 30-day primary endpoint event rate of death, stroke and MI was 6.3% [95% CI: 5.5-7.1%], and the rate of major stroke and death 2.9% [95% CI: 2.4-3.5]. Predictors of adverse outcomes included age, symptomatic patients, predilation prior to embolic protection device placement, time from symptoms to CAS procedure, and the use of multiple stents. CONCLUSIONS: In general, carotid stenting is performed safely in patients with severe stenosis at high surgical risk, with best outcomes in younger asymptomatic patients. However, there are certain patient and procedural characteristics that are associated with poorer outcomes. In these patients, the risk of stenting should be considered vis-à-vis both the anticipated benefit as well as the alternative surgical and medical options.     

Carotid Artery Stenting

Carotid artery stenting (CAS) has achieved clinical equipoise with carotid endarterectomy (CEA), as evidenced by 2 large U.S. randomized clinical trials, multiple pivotal registry trials, and 2 multispecialty guideline documents endorsed by 14 professional societies. The largest randomized trial conducted in patients at average surgical risk of CEA, CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) found no difference between CAS and CEA for the combined endpoint of stroke, death, and myocardial infarction (MI) after 4 years of follow-up. The largest randomized trial comparing CAS and CEA in patients at increased surgical risk, SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy), looked at 1-year stroke, death, and MI incidence and found no difference in symptomatic patients, but a significantly better outcome in asymptomatic patients for CAS (9.9% vs. 21.5%; p = 0.02). Given that >70% of carotid revascularization procedures are performed in asymptomatic patients for primary prevention of stroke, it is incumbent upon clinicians to demonstrate that revascularization has an incremental benefit over highly effective modern medical therapy alone.     

Feasibility and efficacy of balloon-based neuroprotection during carotid artery stenting in a single-center setting

We sought to prospectively assess the feasibility and in-hospital efficacy of the PercuSurge GuardWire temporary balloon-occlusive system for neuroprotection during carotid angioplasty and stenting (CAS).Carotid angioplasty and stenting harbors a risk of distal embolization. Cerebral protection devices are currently under clinical investigation.Ninety-six consecutive patients with carotid bifurcation disease underwent a total of 102 CAS procedures with the intention to use the GuardWire for neuroprotection.GuardWire deployment was achieved in 99 procedures performed in 93 patients (97%). Device failure (n = 3) and severe neurologic responses to balloon occlusion of the targeted carotid artery (n = 2) accounted for five additional procedures that were essentially concluded without neuroprotection, for a total of 94 procedures completed as intended in 88 patients (92% procedural feasibility rate). Carotid angioplasty and stenting was performed successfully in 94 patients (100 procedures). There were no in-hospital deaths; but three patients (3.1%) sustained strokes, and two patients experienced transient ischemic attacks, for a total periprocedural complication rate of 5.2%. One major stroke occurred with the GuardWire in place, whereas two minor strokes were observed in patients in whom the device could not be deployed. Thus, successful neuroprotected CAS without major neurologic events was achieved in 87 patients (91%).The GuardWire temporary balloon-occlusive system is feasible as an adjunct to CAS in the majority of patients. It is associated with a 3.1% rate of major periprocedural neurologic complications. Adverse neurologic reactions to balloon occlusion may prohibit effective use of the system in about 2% of patients.     

Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study

Background : Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single‐arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain. Methods : The study evaluated 30‐day outcomes in 245 pivotal high‐surgical‐risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80‐years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. Results : The MAE rate was 4.5% (11 patients; P = 0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. Conclusion : The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population. © 2010 Wiley‐Liss, Inc.     

Embolic Protection Devices for Carotid Artery Stenting: Is There a Difference Between Filter and Distal Occlusive Devices?

OBJECTIVES: We sought to compare the efficacy of a filter embolic protection device (F-EPD) and a distal occlusive embolic protection device (DO-EPD) in patients undergoing carotid artery stenting (CAS). BACKGROUND: The embolic protection device (EPD) may lower the periprocedural rate of cerebral ischemic events during CAS. However, it is unclear whether there is a difference in effectiveness between the different types of EPD. METHODS: We analyzed data from the Carotid Artery Stent (CAS) Registry. RESULTS: From July 1996 to July 2003, 1,734 patients were included in the prospective CAS Registry. Of these patients, 729 patients were treated with an EPD, 553 (75.9%) with F-EPD, and 176 (24.1%) with DO-EPD. Patients treated with DO-EPD were more likely to be treated for symptomatic stenosis (64.5% vs. 53.4%, p = 0.011). The carotid lesions in patients treated under DO-EPD seemed to be more complicated, as expressed by a higher proportion of ulcers (p = 0.035), severe calcification (p = 0.039), a longer lesion length (p = 0.025), and a higher pre-interventional grade of stenosis (p < 0.001). The median duration of the CAS intervention was 30 min in the DO-EPD group, compared with 48 min in the filter group (p < 0.001). No differences in clinical events rate between the two groups of protection devices were observed. Multivariate analysis on the occurrence of the combined end point of in-hospital death or stroke found no difference between filter- and DO-EPD (4 of 176 [2.3%] for DO-EPD vs. 10 of 551 [1.8%] for F-EPD; adjusted odds ratio = 1.04, 95% confidence interval 0.24 to 4.44; p = 0.958). CONCLUSIONS: Filter EPD is the currently preferred method of EPD in clinical practice. Both F-EPD and DO-EPD seem to be equally effective during CAS.     

Protected Carotid Stenting in High‐Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial

Purpose: A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high‐risk features for carotid endarterectomy was conducted during the 3‐month period from March to May 2005. Methods: Carotid artery stenting (CAS) was performed with the SpideRX? Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration. Results: The primary end‐point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end‐point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05). Conclusion: CAS with distal embolic protection using the SpideRX? Embolic Protection System is a reasonable alternative for revascularization of some high‐risk patients with severe carotid stenosis. (J Interven Cardiol 2010;23:491–498)