High Risk For Carotid Endarterectomy Research Articles

Are There Patients Truly at High-Risk for Carotid Endarterectomy or Carotid Stenting? Can They Be Identified?

The field of carotid artery revascularization has seen dramatic changes during the past several years, with emergence of carotid artery stenting (CAS) as a treatment alternative to surgical carotid endarterectomy (CEA). CAS enthusiasts have argued that all North American Symptomatic Carotid Endarterectomy Trial (NASCET)-excluded patients are at high-risk (HR) for CEA and, therefore, should be offered stenting instead, accepting or proposing-by implication-that CAS would achieve a better outcome than surgery. The latter is, of course, completely unproved, and the former can be easily refuted through a current reexamination of such NASCET exclusions and of CEA results in contemporary vascular surgery. HR for CEA does exist, however, and relates mainly to anatomic factors, such as hostile neck situations, carotid artery anatomy, and the nature of the carotid lesion. Some serious medical comorbidities constitute valid HR considerations as well. HR for CAS constitutes the "flip-side" of the above-described. Rapidly accumulating evidence points to the fact that certain patients do poorly with carotid stenting, mainly those with recent symptoms of ipsilateral cerebral ischemia, the elderly, and when arch and carotid artery anatomy are unfavorable for endovascular intervention. At present, CEA remains the standard of care for these and the majority of patients with an appropriate indication for carotid revascularization. Despite the general tone of this article and the type of evidence presented, CAS should still be thought of as a very important addition to our armamentarium. But, today it is a procedure to be applied cautiously and only for the right reasons. On the other hand, CAS techniques and technologies will continue to improve and be refined, especially in the areas of access and embolic protection. In the future, we should not be surprised if CAS ultimately reaches a truly competitive level with CEA.

Are Octogenarians at High Risk for Carotid Endarterectomy?

Several prospective randomized trials have proved carotid endarterectomy to be safe and effective for both symptomatic and asymptomatic patients younger than 80 years of age. Recently, carotid artery stenting (CAS) has been approved for use in selected high-risk patients. It has been proposed that being an octogenarian places patients in this high-risk category. All patients between the ages of 80 to 89 years undergoing carotid endarterectomy during a 12-year period were included in the study. Information included indications for carotid endarterectomy, associated risk factors, length of stay, and hospital course. Perioperative morbidity and mortality, including neurologic events and myocardial infarction, were recorded. A total of 103 carotid endarterectomies were performed in 95 octogenarians. Procedures were performed on 59 men and 36 women. Indications for operation included symptomatic carotid stenosis in 44 patients (43%) and asymptomatic carotid stenosis in 59 (57%). Associated risk factors included diabetes mellitus (17%), hypertension (76%), coronary artery disease (28%), hyperlipidemia (39%), and history of smoking (42%). There were 4 perioperative neurologic complications, which included 1 transient ischemic attack (0.97%), 2 minor strokes (1.94%), and 1 major stroke (0.97%). There were no deaths. Combined end points for adverse events are acceptable in the octogenarian. Carotid endarterectomy remains the gold standard for treatment of extracranial carotid disease in all age groups. Age alone should not place patients in the high-risk category for carotid endarterectomy.

Evolution of Carotid Stenting: Payment Issues

Carotid stent placement received assignment of two Category I Current Procedural Terminology (CPT) codes in 2005, based on the collaborative efforts of 10 medical, surgical, and radiological specialty societies. One code is used to report stent placement with embolic protection, the other without embolic protection. The codes are unusual for interventional procedures because they include all associated catheterizations, diagnostic imaging, angioplasty, and radiologic supervision and interpretation. The Centers for Medicare and Medicaid Services (CMS) issued a coverage policy for carotid stenting in March 2005, imposing major limitations on eligibility. First, the Agency will only pay for carotid stents performed with embolic protection. In addition, each patient must meet three separate criteria to achieve Medicare coverage: (1) lateralizing transient ischemic attack, transient monocular blindness, or minor stroke with Rankin score <3; (2) an angiographically documented stenosis >or=70%, and (3) physiologic or anatomic criteria to indicate the patient is at high risk for carotid endarterectomy. No asymptomatic patients are covered under the current Medicare policy, but coverage criteria are currently under reconsideration. Finally, CMS restricts carotid stent coverage to facilities that meet its certification requirements.

Prospective Randomized Trials of Carotid Artery Stenting Versus Carotid Endarterectomy: An Appraisal of the Current Literature

Carotid artery stenting has emerged as a treatment alternative in patients at high risk for carotid endarterectomy. Recent technological advances in catheter-based intervention have both facilitated the procedure and possibly improved the clinical outcome of this percutaneous intervention. The reduction in device profile of introducer sheaths and stents, as well as the ubiquitous use of neuroprotection devices, has resulted in a greater application of this treatment modality in patients with carotid bifurcation disease. The efficacy of carotid artery stenting must be carefully evaluated against carotid endarterectomy in a prospective randomized manner, as the latter treatment has long been considered the standard treatment of carotid occlusive disease. Several recent clinical trials comparing carotid artery stenting versus carotid endarterectomy have yielded mixed results with regard to the efficacy of this percutaneous intervention. This article analyzed the results of these prospective randomized trials comparing carotid artery stenting and carotid endarterectomy. Critical appraisal of these trials, as well as relevant methodological issues of these investigations, is discussed in this article.

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We experienced STA-MCA anastomoses with 4 symptomatic patients with near occlusion of the internal carotid artery (ICA) who demonstrated hemodynamic ischemia confirmed by cerebral blood flow (CBF) measurement. Although we had usually performed carotid endarterectomy (CEA) for patients with near occlusion of the ICA, we performed STA-MCA anastomosis for these patients. The reasons for performing STA-MCA anastomoses were difficulties of CEA due to highly positioned stenosis and high risk of hyperperfusion after CEA because of preoperative hemodynamic ischemia. There were no perioperative complications or restrokes during follow-up (from 6 months to 5 years and 1 month). Evaluation of the CBF of these patients after CEA showed improvement in both resting CBF and cerebral vascular reactivity. Therefore, STA-MCA anastomosis may be effective for the patient with near occlusion of the internal carotid artery (ICA) who has a high risk of CEA and hemodynamic ischemia.

Risk Factors and Angiographic Technical Considerations to Guide Carotid Intervention

Carotid angioplasty and stenting (CAS) with embolic protection is currently accepted as treatment for patients considered to be at high risk for carotid endarterectomy (CEA). The purpose of this study was (1) to determine what proportion of patients treated with CEA would be categorized as "high" risk by currently accepted criteria, (2) to characterize preoperative angiographic findings in patients with carotid stenosis, and (3) to determine the potential technical challenges of CAS in these patients. Consecutive patients who underwent CEA from January 1999 through August 2004 prior to introduction of CAS at our institution were identified. Demographics, indications, perioperative complications, and deaths were reviewed. Published guidelines defining high risk for CEA were applied, and preoperative angiograms were examined for technical limitations to CAS. Two hundred and seventy-nine CEAs were performed in 259 patients for asymptomatic carotid occlusive disease (57%), transient ischemic attacks (35%), or stroke (8%) during the study period. Of these, 35.5% (n = 99) would have met one or more high-risk criteria. Overall risks of perioperative stroke, myocardial infarction, and death were 1.1%, 2.2%, and 0.4% (n = 279), respectively, with a combined major complication rate of 3.3%. No difference in major complication rates was observed between standard-risk and high-risk patients. Preoperative angiograms were available for review in 83.5% of CEAs (n = 233). The distribution of aortic arch configurations included types I (3.5%), IIa (39.5%), IIb (54.5%), and III (1.3%). Aortic arch anomalies were observed in 15.5% (n = 35) of angiograms. There were 77.7% (n = 181) with one or more angiographic findings that would have increased the technical difficulty of CAS, but only 17.6% had relative angiographic contraindications to CAS. A significant proportion of patients with carotid stenosis previously managed with CEA would be categorized as high risk and considered potential candidates for CAS by currently accepted criteria. Based on preoperative angiography, technically challenging factors, some of which limit the ability to perform CAS, are common and should be anticipated when planning CAS.

The Role of Carotid Stenting

Despite a number of randomized trials, debate continues about the role of carotid angioplasty and stenting (CAS) for both symptomatic and asymptomatic disease. None of the trials has shown superiority of one treatment modality over the other, but protagonists of stenting have encouraged a shift away from conventional surgery. The minimally invasive nature of CAS is appealing, but concerns have been raised about the periprocedural stroke rate in the randomized trials. To counter this evidence, there are increasing numbers of registries and series, many partly or wholly sponsored by the endovascular industry, some of which demonstrate reasonable results. These need to be studied with caution, as patients deemed high risk of carotid endarterectomy may actually be at very low risk of stroke. Furthermore, strict inclusion and exclusion criteria mean that results may not be a true reflection of everyday clinical practice. The aim of this review is to document the evidence to date, predominantly from the randomized trials, for both symptomatic and asymptomatic carotid disease and establish the current role of carotid stenting.

Report on initial experience with transradial access for carotid artery stenting

Carotid artery stenting is emerging as an attractive alternative to surgical endarterectomy for the treatment of carotid artery disease. This study reports our initial experience using the radial artery as access for carotid stenting. A retrospective study was performed in which 20 consecutive patients at high risk for carotid endarterectomy underwent carotid stenting with cerebral protection using radial artery access. All procedures were performed in the operating room from March 2006 to December 2006. Seven lesions were symptomatic, and 13 lesions were asymptomatic. Patients were evaluated for development of stroke or transient ischemic attacks, myocardial infarction, access site complications, procedural success, time to patient mobilization, and need for intravenous analgesia. Procedural success was achieved in 18 patients (90%). Intense radial artery vasospasm resulted in one failure, and the second failure occurred in a patient with a left-sided carotid lesion and type I arch. The 30-day incidence of stroke, transient ischemic attacks, myocardial infarction, and death was 0%. Radial artery occlusion only occurred in the one patient because of the development of intense vasospasm during the procedure. One patient had persistent local pain requiring intravenous medication for relief. All patients were mobilized <or=2 hours of intervention and were discharged on the first postoperative day. Carotid artery stenting with cerebral protection devices can be safely and effectively performed, with acceptable morbidity and high technical success, by using radial artery access. We recommend obtaining imaging of the aortic arch and supra-aortic trunks with computed tomography, as well as a duplex scan of radial artery, before attempting carotid artery stenting using radial artery access. Further study is needed before recommending that femoral access be replaced by radial access for carotid artery intervention.

Intravascular ultrasound identification of intraluminal embolic plaque material during carotid angioplasty with stenting

Carotid angioplasty with stenting (CAS) has evolved as a viable method for treating patients at high risk for carotid endarterectomy. Strokes complicating CAS are most commonly caused by the liberation and distal embolization of embolic material from plaque during the procedure. CAS with distal embolic protection (DEP) was performed using the assistance of intravascular ultrasound (IVUS) in a 68-year-old man with asymptomatic carotid artery stenosis. Evaluation of the plaque pretreatment was performed using virtual histology software. IVUS evaluation was also performed after prestent angioplasty, stenting, and poststent angioplasty. Initial degree of angiographic stenosis was 78.9%. Final degree of stenosis was 15.7%. By IVUS, stenosis by minimum lumen diameter and minimum lumen area were 75.6% and 93.4% pretreatment, respectively, and 42.2% and 47.1% posttreatment, respectively. An intraluminal lesion was noted in the distal aspect of the stent after poststent angioplasty but before DEP device removal. Ultrasonographic characteristics of the intraluminal defect were consistent with ruptured plaque material. Angiographic runs failed to demonstrate the lesion. A repeat IVUS run performed approximately 10 min later failed to depict the lesion, suggesting that distal embolization had occurred. Embolic material was noticed in the DEP device after removal. The patient did not experience any ischemic neurological symptoms. IVUS can identify intraluminal plaque material, which may be a precursor for embolism and delayed ischemic events after CAS. IVUS may allow for treatment before distal embolization of plaque material. Virtual histology IVUS software may help to identify carotid lesions at higher risk for significant embolization during CAS.

Protected Carotid Stenting in High-Risk Patients With Severe Carotid Artery Stenosis

The purpose of this study was to determine the safety of carotid artery stenting with a unique distal embolic protection system in high-risk patients with severe carotid stenosis. Previous studies suggest that some patients with carotid stenosis and serious comorbid conditions are at high risk for carotid endarterectomy, and may be safely treated by carotid artery stenting. A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted between April 2004 and October 2004. Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. The primary outcome was the combined incidence of major adverse cardiac and cerebrovascular events at 30 days after intervention, including death, stroke, and myocardial infarction. A secondary outcome was the technical success, defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%. Technical success was achieved in 408 of 419 patients (97.4%). The primary end point was observed in 26 patients (6.2%), including death in 8 (1.9%), nonfatal stroke in 14 (3.3%), and nonfatal myocardial infarction in 4 (1%). Independent predictors of death or stroke at 30 days included duration of filter deployment, symptomatic carotid stenosis, and baseline renal insufficiency. For some patients with severe carotid stenosis and high-risk features for carotid endarterectomy, carotid artery stenting with distal embolic protection is a reasonable alternative for revascularization.

Transcervical Approach With Protective Flow Reversal for Carotid Angioplasty and Stenting

To report our initial experience using a transcervical approach for carotid angioplasty/stenting (CAS) that employs internal carotid artery (ICA) flow reversal for neuroprotection. Seventeen patients (15 men; mean age 65 years, range 49-77) with significant carotid stenosis (mean 88%, 8 symptomatic) were treated with protected transcervical CAS. Eleven patients were considered at high risk for carotid endarterectomy; 8 were also considered high risk for transfemoral access (unfavorable aortic arch anatomy or advanced aortoiliac occlusive disease). Anesthesia was based on patient and anesthesiologist preferences. The approach consisted of a 2-cm cutdown over the common carotid artery and placement of a 9-F sheath. ICA flow was reversed and shunted into the jugular vein during the carotid intervention. Access and carotid stenting were successful in all cases. Thirteen procedures were performed under general and 4 under local anesthesia. Mean flow reversal time was 34+/-4 minutes (25 minutes in the last 7 cases). The patients tolerated the procedure well and had no neurological events. Four (23%) patients had significant oozing from the operative site; 2 developed small neck hematomas that were treated conservatively. All patients were discharged on the first postoperative day. There were no deaths, changes in neurological status, or restenosis over a mean follow-up of 12 months (range 1-24). Our initial experience demonstrates that a transcervical approach is a viable alternative for CAS. The procedure can be performed safely, with good initial clinical outcomes. The approach allows carotid flow reversal and emboli protection without introducing neuroprotection devices. The method appears best suited for patients at high risk for endarterectomy and transfemoral access.

High-Risk Carotid Endarterectomy

"High-risk" carotid endarterectomy (CEA): fact or fiction? To answer this question we reviewed the available evidence starting from controlled randomized trials, through retrospective population- and large institution-based studies to case-series. CEA can be performed in most "high-risk" patients with low mortality and morbidity. A broad concept of high-risk CEA, based merely on exclusion from previous controlled randomized CEA trials, cannot be justified. The vast majority of evidence suggests that age (> or =80 years) per se should not be considered a high-risk criterion for CEA. However, it appears that there are certain individual risk factors, which may influence outcome adversely. It appears that CEA in the setting of contralateral carotid occlusion may be associated with very slightly increased risk of adverse perioperative events. Local risk factors, namely carotid reoperation and CEA following prior cervical radiation therapy, are associated with slightly increased stroke, death and probably cranial nerve injury rates. If these risk factors are frequent in a particular series the overall outcome of CEA will be worse. In the absence of level-one evidence on the long-term efficacy of carotid artery stenting (CAS) in stroke prophylaxis, selection for CAS should be restricted to well-defined high-risk categories, such as severe medical comorbidities or local-anatomic risk factors.

Invited Commentary

Invited Commentary

Carotid endarterectomy in sapphire-eligible high-risk patients: implications for selecting patients for carotid angioplasty and stenting

Objectives Carotid angioplasty and stenting (CAS) has been proposed as an alternative to carotid endarterectomy (CEA) in patients excluded from the North American Symptomatic Carotid Endarterectomy Trial and the Asymptomatic Carotid Atherosclerosis Study and in those considered at high risk for CEA. In light of recently released CAS data in patients at high risk, we reviewed our experience with CEA. Methods The records for consecutive patients who underwent CEA between 1998 and 2002 were retrospectively reviewed, and risk was stratified according to inclusion and exclusion criteria from a “high-risk” or CAS-CEA trial, The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial. Results Of 776 CEAs performed, 323 (42%) were considered high risk, on the basis of criteria including positive stress test (n = 109, 14%), age older than 80 years (n = 85, 11%), contralateral carotid occlusion (n = 66, 9%), pulmonary dysfunction (n = 56, 7%), high cervical lesion (n = 36, 5%), and repeat carotid operation (n = 27, 3%). Other high-risk criteria included recent myocardial infarction (MI), cardiac surgery, or class III or IV cardiac status; left ventricular ejection fraction less than 30%; contralateral laryngeal palsy; and previous neck irradiation (each <1.5%). Clinical presentation was similar in the high-risk and low-risk groups: asymptomatic (73% versus 73%), transient ischemic attack (23% vs 22%), and previous stroke (4% vs 5%). The overall postoperative stroke rate was 1.4% (symptomatic, 2.9%; asymptomatic, 0.9%). Comparison of high-risk and low-risk CEAs demonstrated no statistical difference in the stroke rate. Factors associated with significantly increased stroke risk included cervical radiation therapy, class III or IV angina, symptomatic presentation, and age 60 years or younger. Overall mortality was 0.3% (symptomatic, 0.5%; asymptomatic, 0.2%), not significantly different between the high-risk (0.6%) and low-risk groups (0.0%). Non-Q-wave MI was more frequent in the high-risk group (3.1 vs 0.9%; P < .05). A composite cluster of adverse clinical events (death, stroke, MI) was more frequent in the symptomatic high-risk group (9.3% vs 1.6%; P < .005), but not in the asymptomatic cohort. There was a trend for more major cranial nerve injuries in patients with local risk factors, such as high carotid bifurcation, repeat operation, and cervical radiation therapy (4.6% vs 1.7%; P < .13). In 121 patients excluded on the basis of synchronous or immediate subsequent operations, who also would have been excluded from SAPPHIRE, the overall rates for stroke (1.65%; P = .69), death (1.65%; P = .09), and MI (0.83%; P = .71) were not significantly different from those in the study population. Conclusions CEA can be performed in patients at high risk, with stroke and death rates well within accepted standards. These data question the use of CAS as an alternative to CEA, even in patients at high risk.

Octogenarians with contralateral carotid artery occlusion: a cohort at higher risk for carotid endarterectomy?

Purpose Carotid angioplasty and stenting has been proposed as a treatment option for carotid occlusive disease in patients at high risk, including those 80 years of age or older or with contralateral carotid occlusion. We analyzed 30-day mortality and stroke risk rates of carotid endarterectomy (CEA) in patients aged 80 years or older with concurrent carotid occlusive disease. Methods From a retrospective review of 1000 patients undergoing 1150 CEA procedures to treat symptomatic and asymptomatic carotid lesions over 13 years, we identified 54 patients (5.4%) aged 80 years or older with concurrent contralateral carotid occlusion. These patients were compared with 38 patients (3.8%) aged 80 years or older with normal or diseased patent contralateral carotid artery and 81 patients (8.1%) younger than 80 years with contralateral carotid occlusion. All CEA procedures involved either standard CEA with patching or eversion CEA, and were performed by the same surgeon, with the patients under deep general anesthesia and cerebral protection involving continuous perioperative electroencephalographic monitoring for selective shunting. Shunting criteria were based exclusively on electroencephalographic abnormalities consistent with cerebral ischemia. Results The 30-day mortality and stroke rate in patients aged 80 years or older with concurrent contralateral carotid occlusion was zero. Conclusions The concept of high-risk CEA needs to be revisited. Patients with two of the criteria considered high risk in the medical literature, that is, age 80 years or older and contralateral carotid occlusion, can undergo CEA with no greater risks or complications. Until prospective randomized trials designed to evaluate the role of carotid angioplasty and stenting have been completed, CEA should remain the standard treatment in such patients.

Quality Improvement Guidelines for the Performance of Cervical Carotid Angioplasty and Stent Placement: Developed by a Collaborative Panel of the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, and the Society of Interventional Radiology

John D. Barr, MD, John J. Connors, III, MD, David Sacks, MD, Joan C. Wojak, MD, Gary J. Becker, MD, John F. Cardella, MD, Bohdan Chopko, MD, PhD, Jacques E. Dion, MD, Allan J. Fox, MD, Randall T. Higashida, MD, Robert W. Hurst, MD, Curtis A. Lewis, MD, MBA, Terence A.S. Matalon, MD, Gary M. Nesbit, MD, J. Arliss Pollock, MD, Eric J. Russell, MD, David J. Seidenwurm, MD, and Robert C. Wallace, MD, for the ASITN, ASNR, and SIR Standards of Practice Committees

Extracranial carotid artery stenting in surgically high-risk patients using the Carotid Wallstent endoprosthesis: midterm clinical and ultrasound follow-up results.

The purpose of this study was to evaluate the feasibility, safety and midterm outcome of elective implantation of the Carotid Wallstent in patients considered to be at high surgical risk. In a prospective study, 54 carotid artery stenoses in 51 patients were stented over a 24-month period. Three patients underwent bilateral carotid artery stenting. Institutional inclusion criteria for invasive treatment of carotid occlusive disease (carotid endarterectomy or carotid artery stenting) are patients presenting with a 70% or more symptomatic stenosis and those with an 80% or more asymptomatic stenosis having a life-expectancy of more than 1 year. All patients treated by carotid artery stenting were considered at high risk for carotid endarterectomy because of a hostile neck (17 patients--31.5%) or because of severe comorbidities (37 patients--68.5%). No cerebral protection device was used. Of the 54 lesions, 33 (61.1%) were symptomatic and 21 (38.8%) were asymptomatic. Follow-up was performed by physical examination and by duplex ultrasonography at 1 month, 6 months, 1 year and 2 years after the procedure. All 54 lesions could be stented successfully without periprocedural stroke. Advert events during follow-up (mean 13.9 +/- 5.7 months) were non-stroke-related death in 6 patients (11.1%), minor stroke in 4 stented hemispheres (7.4%), transient ipsilateral facial pain in 1 patient (1.8%), infection of the stented surgical patch in 1 patient (1.8%) and asymptomatic instent restenosis in 4 patients (7.4%). The percutaneous implantation of the Carotid Wallstent, even without cerebral protection device, appears to be a safe procedure with acceptable clinical and ultrasonographic follow-up results in patients at high surgical risk. But some late adverse events such as ipsilateral recurrence of non-disabling (minor) stroke or instent restenosis still remain real challenging problems.

Response

Response

High-risk carotid endarterectomy: fact or fiction.

It has been proposed that patients whose conditions do not meet North American Symptomatic Carotid Endarterectomy Trial inclusion criteria or have anatomic risk factors constitute a "high-risk" group for carotid endarterectomy (CEA) and might be candidates for primary carotid angioplasty stenting. Our objective was to review a consecutive series of isolated CEAs, identify the number of such patients at high risk, and determine whether their operations were associated with increased complication rate. Consecutive isolated CEAs performed between June 1996 and June 2001 were reviewed. High-risk comorbidities included: age 80 years or more (n = 80), New York Heart Association class III/IV angina (n = 16), Canadian class III/IV heart failure (n = 4), myocardial infarct 6 months or less (n = 11), steroid-dependent or oxygen-dependent pulmonary disease (n = 4), and creatinine level of 3 or more (n = 13). Anatomic high risk was defined by: contralateral occlusion (n = 66), lesion above C(2) or requirement of digastric division (n = 53), reoperation (n = 29), and neck radiation (n = 3). Statistical analysis was with chi(2) analysis. Of 788 patients reviewed, 228 (29%) were classified as high risk by one or more of the previous criteria (63% comorbidity, 28% anatomy, 9% both). Presence of preoperative neurologic symptoms and postoperative results were similar across all patient groups. The total stroke and death rate was 1.1% for all the patients. Six patients had postoperative strokes (0.8%), and three patients died of myocardial infarcts (0.4%). The stroke and death rate was 1.3% in the high-risk group as compared with 1.1% in the normal-risk group (P =.51). The concept of the high-risk CEA must be critically reexamined. Although 29% of patients for CEA were high risk as defined by others, we found no evidence that this influenced the results after CEA. Patients with significant medical comorbidities, contralateral carotid occlusion, and high carotid lesions can undergo operation without increased complications. If a high-risk group exists, it is small and restricted to reoperation or radiated neck (4% in this series). With this possible exception, carotid angioplasty stenting should be restricted to randomized clinical trials.

Initial experience with cerebral protection devices to prevent embolization during carotid artery stenting.

Carotid artery stenting (CAS) for treatment of carotid stenosis has not received wide acceptance because of the availability of carotid endarterectomy (CEA) with its excellent results and because of the risk of embolic stroke associated with CAS. The feasibility and efficacy of cerebral protection devices that may prevent such embolic complications have yet to be shown. We report our initial results with CAS performed with cerebral protection. For a period of 28 months, 31 patients with carotid artery stenosis, most of whom were considered at high risk for CEA (87%), underwent treatment with CAS in conjunction with either the PercuSurge GuardWire (n = 19; Medtronic, Minneapolis, Minn), the Cordis Angioguard filter (n = 7; Cordis, Warren, NJ), or the ArteriA Parodi Anti-embolization catheter (n = 4; ArteriA, San Francisco, Calif) with US Food and Drug Administration-approved investigational device exemptions. Factors that made CEA high risk included restenosis after CEA (n = 6), hostile neck (n = 6), high or low lesions (n = 4), and severe comorbid medical conditions (n = 11). Preoperative neurologic symptoms were present in 58%, and the mean stenosis was 85% +/- 12%. Data were prospectively recorded and analyzed on an intent-to-treat basis. Neurologic evaluation was performed before and after CAS by a protocol neurologist. CAS was performed with local anesthesia with the Wallstent (n = 23; Boston Scientific Corp, Natick, Mass) or the PRECISE carotid stent (n = 7; Cordis) in conjunction with one of the protection devices in an operating room with a mobile C-arm. Each patient received dual antiplatelet therapy before surgery. The overall technical success rate was 97% (30/31). In one patient, the lesion could not be crossed with a guidewire because of a severely stenosed and tortuous lesion. This patient was not a candidate for CEA and was treated conservatively. In the remaining 30 cases, CAS had a good angiographic result (residual stenosis, <10%). All patients tolerated the protection device well, and no intraprocedural neurologic complications occurred. Macroscopic embolic particles were recovered from each case. One patient (3%) with a severely tortuous vessel had a major stroke immediately after CAS, and no deaths occurred. The combined 30 day stroke/death rate was 3%. During a mean follow-up period of 17 months, one subacute occlusion of the stent occurred but did not result in a stroke. Three other patients had duplex scan-proven in-stent restenosis, and two underwent treatment with repeat percutaneous transluminal angioplasty with a good result. No patient had a stroke during the follow-up period. CAS with cerebral protection devices can be performed safely with a high technical success rate. Although many patients who underwent treatment with CAS were at high risk, the neurologic complication rate was low and CAS appears to be an acceptable treatment option for select patients at high risk for CEA. Tight lesions and tortuous anatomy may make the use of distal protection devices difficult. Further study is warranted.