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.     

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.     

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.     

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.     

Carotid stenting in high-risk patients: early and late outcomes

Purpose: Some patients with severe carotid stenosis have anatomical or clinical comorbidities that place them at high risk for carotid endarterectomy (CEA). The early and late outcomes after carotid artery stenting (CAS) were evaluated in patients at high risk for CEA. Methods: Between 2002 and 2009, 186 patients were enrolled in a high‐risk CAS institutional registry. The primary outcome was major adverse cardiac and cerberovascular events (MACCEs) at 30 days, including death, stroke, and myocardial infarction. Secondary outcomes were technical, procedural, and clinical success; nonstroke neurological events; and death and ipsilateral stroke at 5 years. Results: Twenty‐five patients (13.2%) were symptomatic. Thirty day MACCE occurred in 2.6%, including death in 1 (0.5%), stroke in 3 (1.6%), and myocardial infraction in 1 (0.5%) patient. Strokes were nonfatal in 3 (1.6%), major in 2 (1.1%), and minor in 1 (0.5%) patients. Other neurological events included transient ischemic attack in 9 (4.7%) and retinal artery occlusion in 2 (1.1%) patients. After stroke, 2 patients had complete resolution of neurological deficit within 30 days, and 1 patient had improvement in neurological deficit. By Kaplan–Meier analysis, all‐cause mortality was 47.5% and ipsilateral stroke was 4.5% at 5 years. Conclusions: In patients who are high risk for CEA, CAS can be performed with low MACCE at 30 days and ipsilateral stroke at 5 years. However, nearly half of these patients die within 5 years from causes unrelated to stroke. (J Interven Cardiol 2011;24:247–253)     

Multidisciplinary approach to carotid stenting

Background: Stroke neurologists, vascular surgeons, interventional neuroradiologists and interventional cardiologists have embraced carotid angioplasty and stenting (CAS) because of potential advantages over carotid endarterectomy (CEA). At Austin Health, a multidisciplinary neuro‐interventional group was formed to standardise indications and facilitate training. The aims of this study were to describe our organisational model and to determine whether 30‐day complications and early outcomes were similar to those of major trials. Methods: A clinical protocol was developed to ensure optimal management. CAS was performed on patients with high medical risk for CEA, with technically difficult anatomy for CEA, or who were randomised to CAS in a trial. Results: From October 2003 to May 2008, 47 patients (34 male, mean age 71.5) underwent CAS of 50 carotid arteries. Forty‐three cases had ipsilateral carotid territory symptoms within the previous 12 months. The main indications for CAS were high risk for CEA (n= 17) and randomised to CAS (n= 21). Interventionists were proctored in 27 cases. The procedural success rate was 94% with two cases abandoned because of anatomical problems and one because of on‐table angina. Hypotension requiring vasopressor therapy occurred in 12 cases (24%). The duration of follow up was one to 44 months (mean 6.8 months). The 30‐day rate of peri‐procedural stroke or death was 6% and the one‐year rate of peri‐procedural stroke or death or subsequent ipsilateral stroke was 10.6%. Restenosis occurred in 13% (all asymptomatic). Conclusion: A multidisciplinary approach is a useful strategy for initiating and sustaining a CAS programme.     

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.     

Bilateral carotid angioplasty and stenting.

Bilateral carotid stenosis is generally treated by staged stenting procedure and rarely simultaneously due to concerns about hemodynamic impairment from stimulation of the carotid sinus baroreflex (severe bradycardia, hypotension) and the risk of cerebral hyperperfusion syndrome. Most of the accounts of bilateral carotid stenting are of small series. The aim of this study was to evaluate the feasibility and safety of simultaneous bilateral carotid angioplasty and stenting (CAS) in comparison with staged procedure. We retrospectively analyzed the procedural outcome and complications of bilateral CAS done between February 1995 and June 2004 in a consecutive series of 57 high-risk patients. Mean age was 64 +/- 9 years (male, 43; female 14). One hundred fifteen arteries were treated (one patient had bilateral internal carotid artery stenosis associated to an ostial common carotid artery stenosis). Thirty-nine patients were symptomatic (70%). Thirty-six patients had severe coronary artery disease. Seventeen patients underwent a simultaneous bilateral CAS (group 1), 40 in a staged manner (group 2). Among these 40 patients 10 were treated with a time interval of 24 hr, while the 30 other ones were treated with a time interval of 2 days to 2 months. A neuroprotection device was used in the last 42 patients. There was technical success in all patients and transient bradycardia and/or hypotension in 25 patients (44%). There was no prolonged bradycardia or hypotension. At 30 days, we observed in group 1 (simultaneous bilateral CAS) no transient ischemic attack (TIA), no minor stroke, one (5.8%) major stroke (hyperperfusion syndrome with brain hemorrhage leading to death in a patient under IIb/IIIa inhibitors), one myocardial infarction leading to death, and two (11.7%) death/stroke/myocardial infarction; in group 2 (staged procedure), two (5%) TIAs, no minor stroke, no major stroke, and one (2.5%) hyperperfusion syndrome with rapid recovery. Among the 10 patients treated with a time interval of 24 hr, we observed one TIA. Among carefully selected patients, bilateral CAS is feasible simultaneously or the day after, with a safety and complication rate comparable to that of large published series of CAS or endarterectomies in high-risk patients. Nevertheless, careful monitoring of the patient, blood pressure, and heart rate is mandatory to avoid complications related to hyperperfusion syndrome. Routine use of neuroprotection device and meticulous technique should improve the outcomes of bilateral CAS.     

Carotid Artery Stenting for Stroke Prevention

Stroke is a global epidemic with a significant economic burden to patients, families, and societies at large. In the industrialized world, stroke is the third most common cause of death, the second most common cause of dementia, and the most common reason for acquired disability in adulthood. Overall, 20%-30% of ischemic strokes are related to extracranial carotid artery stenosis. Revascularization with carotid endarterectomy (CEA) is the gold-standard treatment for patients with significant carotid stenosis. Carotid artery stenting (CAS) has become an accepted alternative to CEA over the past decade for patients at high surgical risk, and has progressively evolved into an elegant procedure over the past 3 decades, with dedicated equipment including proximal embolic occlusion devices that have minimized procedural strokes. High–surgical-risk CAS registries have established this procedure as an alternative to CEA for high-risk patients. The Carotid Revascularization Endarterectomy vs Stent Trial (CREST) has shown similar outcomes with CAS and CEA for patients at standard risk, although CAS is associated with higher minor stroke events and CEA is associated with higher myocardial infarction (MI) events. However, CAS is technically challenging and requires a meticulous approach, with a protracted learning curve that should involve experience with > 70 cases. Careful patient selection is instrumental in avoiding procedural complications, and the procedure should be avoided in patients with prohibitive anatomy. This article reviews the use of CAS for extracranial carotid artery stenosis, considering technical aspects, registry and clinical trial outcomes data, determinants of success, and contemporary guidelines.     

Safety and efficacy of carotid stenting in the very elderly

Background : Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA) in patients at high risk for complications from surgery. The very elderly (≥80‐year‐old) are one subgroup of patients identified as being at increased risk for carotid surgery. However, there is concern that the very elderly are also at increased risk for complications of CAS. A stroke and death rate of 12% was reported in very elderly patients during the roll‐in phase of Carotid Revascularization Endarterectomy versus Stent Trial (CREST). We are reporting on a large clinical series of CAS with independent neurological assessment in the very elderly. Methods : Between 1994 and 2008, a consecutive series of 418 CAS patients (≥80‐year‐old) were treated at four high‐volume centers with extensive CAS experience. Independent neurologic assessment was performed after CAS procedures. Thirty‐day follow‐up information was available in 389 patients. Results : The average age was 83.2 ± 2.8 years. Most patients were male (63.2%), and the target lesion carotid stenosis was asymptomatic in two‐thirds (68.2%) of patients. The majority of patients treated with CAS had a history of coronary artery disease (74.4%), hypertension (87.8%), and dyslipidemia (71.1%). One third (30.1%) were diabetic and more than half (56.5%) were current or former smokers. Embolic protection devices (EPD) were used in 78.7% of cases with the CAS procedure being performed before EPD availability being the most common reason for not using them. The overall 30‐day incidence of stroke and death was 2.8% (11/389). The cumulative incidence of major cardiovascular events (stroke, death, or myocardial infarction) during that time period was 3.3% (13/389). Conclusions : This large series of CAS with independent neurologic assessment is convincing evidence that the very elderly (≥80 years) can safely undergo CAS with stroke and death rates comparable to younger patients. The key to obtaining these excellent results is that CAS be performed by high volume, experienced operators who exercise restraint regarding patient selection. © 2009 Wiley‐Liss, Inc.     

Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry.

PURPOSE: To evaluate the feasibility of cerebral protection during carotid artery stenting (CAS) using the Mo.Ma device, which prevents cerebral embolization by proximal endovascular blockage of blood flow in the internal and external carotid arteries. METHODS: In 14 European centers, 157 patients (121 men; mean age 68.0+/-8.3 years) were enrolled in a prospective registry between March 2002 and March 2003. Eligible patients had a symptomatic (>50%) or asymptomatic (>70%) stenosis of the internal carotid artery suitable for carotid stenting. Protected carotid stenting was performed with the Mo.Ma system, which occludes both the common and external carotid arteries via 2 independently inflatable compliant low-pressure balloons before any device is advanced across the lesion. Blood is aspirated through the catheter intermittently or at the end of the procedure. RESULTS: The device was successfully positioned and stents were implanted in all cases. Diameter stenosis was reduced from 84.1%+/-7.8% to 6.7%+/-5.1%. The mean duration of flow blockage was 7.6+/-5.9 minutes. In 12 (7.6%) patients, transient intolerance to flow blockade was observed, but the procedures were completed successfully. In 124 (79.6%) cases, there was macroscopic evidence of debris after filtering the aspirated blood. In-hospital complications included 4 (2.5%) minor strokes, 8 (5.1%) transient ischemic attacks, no deaths, and no major strokes, resulting in a 2.5% death/stroke rate at discharge. At 30-day follow-up, there was 1 cardiac death, 1 major stroke, and 3 minor strokes, for an overall 5.7% 30-day death/stroke rate and a 30-day major stroke and death rate of 1.3%. CONCLUSIONS: Cerebral protection with proximal endovascular blood flow blockage during CAS is feasible, with a high procedural success rate.     

Long‐Term Results after Carotid Stent Implantation

Background

Though carotid artery stenting (CS) has gained popularity as an alternative to carotid endarterectomy, studies examining long‐term results are limited.

Methods

All consecutive patients who underwent unilateral CS between 7/1993 and 8/2005 with no or non‐significant contralateral stenosis were included. Follow‐up with duplex sonography and/or angiography and neurological assessment was performed at 6 and/or 12 months. Thereafter, annually, a questionnaire was sent to the patients and their referring physicians.

Results

Two‐hundred and seventy‐nine patients underwent CS. In 99% of procedures stent delivery was successful. The periprocedural major and minor stroke rates were 2.2%, respectively. The periprocedural major stroke or death rate was 2.9%. Median clinical follow‐up was 49 ± 32 months (range: 30 days–12.1 years). Excluding perioperative (<30 days) events, the annual major and minor stroke rate was 1.3% and the annual ipsilateral major and minor stroke rate was 0.6%. In symptomatic and asymptomatic patients, the annual major and minor stroke rates were 2.2% and 0.8%, respectively, and the ipsilateral major and minor stroke rates were 1.1% and 0.3%, respectively. There was no significant difference between ipsilateral and contralateral major or minor strokes at long‐term follow‐up. At last sonographic follow‐up (median 36 ± 32 months), restenosis rates for symptomatic and asymptomatic stenoses were 5% and 3%, respectively.

Conclusion

The results of our study demonstrate very low long‐term cerebral event rates after CS supporting the long‐term safety of CS. Importantly, there was no significant difference in long‐term ipsilateral versus contralateral cerebral events lending support to the hypothesis of plaque stabilization.

     

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 in octogenarians using a proximal endovascular occlusion cerebral protection device: A multicenter registry

Background : Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians. Purpose : The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high‐volume centers by experienced operators. Methods : From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days. Results : 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In‐hospital complications: Two minor and two major strokes (2.02%) occurred. No device‐related complications and no serious access site complication were noted. Between discharge and 30‐day follow‐up, one patient died due to a cardiac arrest. The overall 30‐day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender. Conclusion : This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines. © 2010 Wiley‐Liss, Inc.     

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.     

Multicenter evaluation of carotid artery stenting with a filter protection system

OBJECTIVES: The aim of this study was to evaluate the feasibility and safety of carotid artery stenting (CAS) with a filter protection system. BACKGROUND: Neurologic events linked to the embolization of particulate matter to the cerebral circulation may complicate CAS. Strategies designed to capture embolic particles during carotid intervention are being evaluated for their efficacy in reducing the risk of these events. METHODS: Between September 1999 and July 2001, a total of 162 patients (164 hemispheres) underwent CAS with filter protection (NeuroShield, MedNova Ltd., Galway, Ireland) according to prospective protocols evaluating the filter system at three institutions. RESULTS: Angiographic success was achieved in 162 of the procedures (99%) and filter placement was successful in 154 (94%) procedures. Carotid access was unsuccessful in two cases (1%) and filter placement in eight cases (5%). Of the latter, five procedures were completed with no protection and three were completed using alternative protection devices. On an intention-to-treat basis, the overall combined 30-day rate of all-stroke and death was 2% (four events: two minor strokes and two deaths). This includes one minor stroke in a patient with failed filter placement and CAS completed without protection. There was one cardiac arrhythmic death and one death from hyperperfusion-related intracerebral hemorrhage. There were no major embolic strokes. CONCLUSIONS: Carotid artery stenting with filter protection is technically feasible and safe. Early clinical outcomes appear to be favorable and need to be confirmed in a larger comparative study.     

Embolic protection devices for carotid artery stenting: better results than stenting without protection?

AIMS: Carotid artery stenting (CAS) for carotid artery stenoses has become an alternative to carotid endarterectomy. However, CAS itself can cause cerebral ischaemic events. Embolic protection devices (PD) promise to reduce the incidence of these events. METHODS AND RESULTS: From July 1996 to March 2003, 1483 patients from 26 hospitals were included in the prospective CAS Registry of the ALKK study group. A PD was used in 668 of 1483 patients (45%). The use of a PD has grown rapidly over the years and reached 100% in 2003. Patients treated with a PD had prior carotid artery dilatation more often (3.5% versus 1%, p < 0.001), a prior myocardial infarction (34% versus 27.4%, p = 0.007) and a history of arterial hypertension (89.9% versus 78.6%, p = 0.007) compared to patients treated without a PD. A thrombus was more often visible in patients treated under distal protection (16.5% versus 8%, p < 0.001). The use of a PD led to a 10-min longer intervention (45 min versus 35 min median, p < 0.001). Patients treated with a PD had a lower rate of ipsilateral stroke (1.7% versus 4.1%, p = 0.007) and a lower rate of all non-fatal strokes and all deaths (2.1% versus 4.9%, p = 0.004) during the hospital stay. This was confirmed by multiple logistic regression analysis (adjusted OR = 0.45, 95% CI: 0.23-0.91, p = 0.026). A similar reduction could be found for symptomatic as well as asymptomatic carotid artery stenoses. CONCLUSION: Since 1996 there has been a steady increase in the use of PDs for CAS, with a 100% use in 2003. The use of a PD may lower the rate of ipsilateral strokes during CAS.     

Percutaneous internal carotid artery angioplasty with stenting: early and long-term results

BACKGROUND. Cerebro-vascular accidents are the third most common cause of death. The most frequent localisation of lesions responsible for stroke are bifurcation of the common carotid artery or the proximal internal carotid artery (ICA). Surgical carotid endarterectomy (CEA) and carotid artery stenting (CAS) are the non-pharmacological methods used to treat carotid artery stenosis. AIM. To assess the efficacy and safety of CAS of ICA. METHODS. CAS was performed in 75 patients (49 males, 26 females) with a mean age of 65.2+/-9.1 years. Twenty (26.7%) patients underwent CAS with the use of the central nervous system (CNS) protective devices. The immediate, mid-term, and long-term results were analysed. RESULTS. In total, 84 stents were implanted to 80 ICA in 73 patients. In two patients stent implantation was not possible. In 7 (9%) patients with a stenosis of both ICA, a bilateral procedure was performed. In two patients concomitant dilatations of the vertebral artery, and in the other two - of subclavian artery, were performed. In 38 patients coronary angiography was performed directly before CAS; one patient underwent coronary angioplasty. In 20 patients protective CNS devices were used. During the procedure four patients developed ischaemic stroke on the side of CAS. In one patient neurological symptoms completely disappeared within 48 hours. The type of technique used during CAS did not influence the frequency of ischaemic complications. Four patients developed hyperperfusion syndrome which disappeared after a few days. There were fire deaths during follow-up: three due to myocardial infarction (MI), one - after urgent CABG, and one due to pulmonary embolism. There were no deaths due to stroke. No new ischaemic changes in CNS nor significant changes in the neurological status, using the UNSS or Barthel scales, were observed. Asymptomatic restenosis was documented in six patients whereas one patient developed symptomatic restenosis due to stent deformation. CONCLUSIONS. Percutaneous angioplasty of an internal carotid artery carries a risk not exceeding that of surgical endarterectomy. In our study, a one-year follow-up revealed a minor risk of ischaemic stroke. Percutaneous angioplasty with the use of protective devices should be tested in larger groups of patients in order to establish the real clinical usefulness and improved safety of this technique.     

Percutaneous versus surgical revascularization for symptomatic carotid artery disease

Stroke is the third leading cause of death worldwide and the number one disease associated with permanent disability. In 2006, the estimated total cost of stroke in the United States was a staggering $60 billion. Significant stenosis of the internal carotid artery is responsible for 10% to 20% of all strokes, and current recommendations suggest that patients with symptomatic carotid artery stenosis undergo revascularization for stroke prevention or risk reduction. Since the 1950s, carotid endarterectomy (CEA) has been the dominant modality of revascularization. However, carotid artery angioplasty, introduced in the 1980s, and subsequent carotid artery stenting (CAS), have greatly improved in recent years and provide a viable alternative to CEA, particularly for certain high-risk patients. Encouraging results from clinical studies of CAS and CEA have played pivotal roles in shaping current practice guidelines. We review the published studies on CAS and discuss appropriate use of this procedure for symptomatic carotid artery disease.     

Filter-protected carotid stenting via a minimal cervical access with transitory aspirated reversed flow during initial passage of the target lesion.

PURPOSE: To evaluate the preliminary results of filter-protected carotid artery stenting (CAS) via a minimal cervical access, with temporary common carotid artery (CCA) occlusion and aspiration in selected high-risk candidates for carotid endarterectomy. METHODS: Since February 2002, 26 patients (17 men; mean age 73.7 years, range 54-98) at high surgical risk according to the SAPPHIRE eligibility criteria underwent 29 transcervical CAS procedures under filter protection. Under general anesthesia, a 6-F short introducer sheath was directly mounted in the CCA through a small (2-4 cm) laterocervical cutdown. The CCA was briefly clamped, and blood was aspirated while the filter device was positioned above the target lesion. With the filter in place and the clamp released, nitinol stents were deployed under filter protection. Hemostasis was achieved by direct suture. RESULTS: Twenty-eight (96%) interventions were technically successful; 1 complex lesion could not be crossed and was converted to surgery. Mean clamping time was 1.7 (range 1.0-3.5) minutes. Combined 30-day stroke/mortality was 0%. Ultrasound surveillance demonstrated a < 60% asymptomatic in-stent restenosis in 1 (4%) patient with radiation-induced arteritis after 28 months. During a mean follow-up of 11.6 months (range 3-38), 1 (4%) minor ipsilateral stroke was noted at 6 months in a patient whose antiplatelet therapy was transitorily interrupted. CONCLUSION: Our preliminary observations from this small early experience suggest that this variant CAS technique is feasible and probably diminishes the neuroembolic risk during initial navigation of the ICA target stenosis.