New distal embolic protection device the FiberNet 3 dimensional filter: first carotid human study.

OBJECTIVE: Evaluate the performance and safety of the FiberNet Embolic Protection System during carotid artery intervention. BACKGROUND: Carotid Angioplasty and Stenting (CAS) can be proposed to treat the majority of carotid stenoses. Brain embolization takes place and routine use of Embolic Protection Devices (EPD) is warranted. Many EPDs have significant limitations, which may be addressed by a new EPD, the FiberNet (Lumen Biomedical, Plymouth, MN). METHODS: The system consists of a 3-dimensional expandable filter made of fibers, which expand radially, mounted onto a 0.014' wire and retrieval catheter. FiberNet can capture particles as small as 40 microm without compromising flow. RESULTS: 35 lesions treated in 34 patients. Male 67.6%. Age: 71.4 +/- 8.8 (50-85). Average stenosis 84.5% +/- 7.9 (70-99). 29.4% were symptomatic. Technical success: 34/35 (97%). No stroke or death within 30 days. Neurological events: two permanent amaurosis, one amaurosis fugax. All samples visually contained significant amounts of emboli. The mean surface area of debris caught was 63.8 mm(2) (37.7-107.5). Comparisons were made with other EPDs. The mean surface area of debris caught was 12.2 mm(2) (2.7-34.3). No changes were noted in CT/MRI at 30-day post procedure. CONCLUSION: The first human use of this new novel EPD in carotid artery stenting is encouraging. The FiberNet was easy to use and confirmed the ability to capture particles less than 100 microm. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device.     

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)     

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.     

The SPIDER Embolic Protection Device performance evaluation in the carotid artery during percutaneous transluminal angioplasty and or stenting

Recently completed studies have compared carotid endarterectomy with carotid artery stenting, a nonsurgical method of improving blood flow in the carotid arteries. Embolic protection devices can prevent particles dislodged during carotid artery stenting from causing stroke or death. An ev3 Inc.-sponsored trial (PROTECT) evaluated the performance requirements of the SPIDER Embolic Protection Device in the carotid artery for CE Marking. Patients who were candidates for percutaneous transluminal angioplasty (PTA) and or stenting were enrolled. Performance was assessed by determining the incidence of major adverse neurological events (MANE) through 30 days post-procedure in 74 patients, along with the successful placement and recovery rates of the filter. MANE was defined as stroke or death. There were a total of 5 MANE events reported in 5 patients, 1 major stroke and 4 minor strokes. There were no deaths. The total MANE event rate was 6.8% (5 of 73). The overall SAE rate was 8.2% (6 of 73). An SAE was defined as an event that resulted in the hospitalization or prolongation of hospitalization due to potential disability, or due to danger of life that resulted in an intervention or that was terminal. Technical success of the SPIDER device was defined as placement of the filter at the distal edge of the lesion in the carotid artery, placement of the recovery catheter and successful retrieval of the filter with the recovery catheter. An inability to place or retrieve the filter was concluded to be a system failure. The SPIDER device was successfully placed in the carotid artery and retrieved with an overall successful placement rate of 88.1% (74 of 84), and a retrieval rate of 98.6% (73 of 74). In conclusion, the PROTECT Trial demonstrated that the performance of the SPIDER device in the carotid artery complied with the relevant Product Directives for CE Marking. The incidence of MANE was low and comparable to what has been reported in recently published literature.     

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.     

Optimal treatment of carotid artery disease

Extracranial carotid artery disease accounts for approximately 25% of ischemic strokes. Although carotid endarterectomy (CEA) is the established gold standard for carotid revascularization, carotid artery angioplasty and stenting (CAS) is continually developing into a safer and more efficacious method of stroke prevention. Embolic protection, improving stent designs, and ever-increasing surgeon experience are propelling CAS towards equipoise with and possible superiority to CEA. One multicenter randomized trial and several nonrandomized registries have successfully established CAS as an accepted treatment for high-risk patients. Clinicians must strive to perform well-designed clinical trials that will continue to aid understanding and improve application of both endovascular and open techniques for extracranial carotid revascularization. We review the data published to date regarding the indications for and recent developments in the use of CAS.     

Carotid angioplasty under cerebral protection with the PercuSurge GuardWire System.

The purpose of this study was to examine the possible beneficial effect of the PercuSurge GuardWire cerebral protection device based on balloon occlusion of the distal internal carotid artery and debris aspiration for patients undergoing carotid artery stenting (CAS). A total of 268 CAS procedures were attempted under cerebral protection using the PercuSurge GuardWire system in 242 patients (194 men; mean age, 71.2 +/- 9.4 years; range, 40-91). The lesions were mainly atherosclerotic; 64% were symptomatic. Technical success was 99.3%. All lesions were stented except three postangioplasty restenoses. Prophylactic occlusion during balloon dilatation and stenting was well tolerated in 255 patients (95.9%). Microscopic analysis of the aspirated blood showed different types of particles numbering between 7 and 145 per procedure, with a mean diameter of 250 microm (mean, 56-2,652 microm). The 30-day stroke and death rate was 2.3%, with four periprocedural complications at < 48 hr (one retinal embolism and three transient ischemic attacks), one intracerebral hemorrhage at 3 days, and one death of cardiac failure at 3 weeks. This technique appears safe and efficient with a low rate of periprocedural embolic events. Protection devices seem indispensable to perform CAS and expand the applicability of the procedure. Randomized studies (surgery vs. CAS with and without cerebral protection) are awaited.     

Starting a carotid artery stenting program is safe

Background : Little is known on the performance of newly initiated carotid artery stenting (CAS) programs. The safety of the procedure is being questioned following the publication of the EVA‐3S trial, a study criticized for the limited interventional experience required to enroll patients. Methods : Within a newly started academic CAS program, patient data and outcomes were collected prospectively. The outcomes of the first 100 consecutive patients treated are reported. A CAS‐fellowship‐trained interventionalist was involved in all procedures. All patients underwent clinical assessment by a neurologist before and after the procedure, and serial ECG and cardiac enzymes were routinely obtained. Primary outcome measures included 30‐day major adverse events (MAE), defined as death, stroke, or myocardial infarction, while on follow‐up deaths and ipsilateral strokes were added. Results : Between July 2003 and November 2006, 92 patients had a single internal carotid artery treated, while 7 underwent staged bilateral CAS. In one patient, the procedure was aborted prior to lesion treatment. The 30‐day MAE rate per procedure was 1.9% (one major and one minor stroke). By a mean follow‐up of 16 months (range 2–42 months), one patient had died of refractory heart failure, while one patient had a minor ipsilateral stroke and three had minor contralateral strokes, corresponding to total MAE per patient of 4%. The rate of any stroke or death was 7%. The rate of restenosis ≥50% per lesion by ultrasound was 3.8%. Conclusion : This single center experience suggests that it is safe to start a CAS program following dedicated fellowship. © 2008 Wiley‐Liss, Inc.     

经皮颈动脉支架置入术的临床应用及效果

目的评价经皮颈动脉支架置入术对预防缺血性脑卒中的临床效果。方法对30例患者(共32个严重颈动脉狭窄病变)行经皮颈动脉支架置入术,包括男性26例,女性4例,年龄>56岁,其中13例曾患有脑卒中或反复一过性脑缺血;部分患者有高血压、糖尿病及心肌梗死病史。均在术前行颈动脉超声检查及颈动脉及其颅内段血管造影,将支架置入并覆盖颈动脉病变,部分采用远端脑保护装置;在术后均做心脑血管专科及颈动脉超声检查随访。结果选择性颈动脉造影示32个靶病变均有>70%的狭窄,共置入自膨式支架32个,球囊扩张式支架1个,支架置入成功率为97%;使用远端滤网保护装置21例,使用成功率为95%,在回收的滤网中均发现脱落碎片;4例患者在颈动脉支架置入术后顺利完成外科冠状动脉搭桥术;2例患者在术中分别出现靶病变对侧颅内出血和术后急性肺水肿,3d后死亡。在临床随访观察期间,患者均无脑卒中发生,颈动脉超声检查未发现支架置入段再狭窄。结论经皮颈动脉支架置入术是预防缺血性脑卒中的安全有效方法,也是综合治疗缺血性心脑疾病的新方法。远端保护装置的应用是防止术中脑卒中并发症的必要措施。     

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.     

“No‐reflow” phenomenon during percutaneous carotid angioplasty in a scleroderma patient

Atherosclerosis remains the most common etiology of carotid artery stenosis, but other systemic diseases can also cause this disease. Percutaneous carotid angioplasty and stenting (CAS) with and without distal embolic protection devices is gaining acceptance as the treatment of choice. No‐reflow phenomenon due to distal embolization has been previously described mainly during percutaneous intervention of degenerated saphenous vein graft. We describe a patient with systemic sclerosis who underwent CAS with distal embolic protection device with occurrence of no‐reflow phenomenon during the procedure that resolved after retrieval of the filter device. (Int J Cardiovasc Intervent 2004; 2: 82–84)     

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

ObjectivesThis study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice.BackgroundWhen compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque’s debris prolapsing through stent’s mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems.MethodsFrom January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates.ResultsSymptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%.ConclusionsThis real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.     

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.     

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.     

Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection

Objectives

This study evaluated the safety and performance of the Paladin System, a novel angioplasty balloon with an integrated embolic protection filter designed to increase embolic protection during post-dilation.

Protection filter-related events in extracranial carotid artery stenting: a single-center experience.

PURPOSE: To report the complications, rescue procedures, and consequences related to the use of an embolus protection filter during carotid artery stenting (CAS). METHODS: A retrospective review was undertaken of 72 patients (58 men; mean age 70.0+/-8.2 years, range 56-87) with extracranial atherosclerotic carotid stenosis who underwent 77 CAS procedures under filter protection. Filter-related events and rescue procedures according to each procedural step were retrospectively evaluated on CAS angiograms. In addition, neurological events and outcomes were also assessed. RESULTS: CAS using a filter was successful in 99% of cases, and the overall rate of minor stroke (n=1), major stroke (0), or mortality (n=1) was 2.6% at 30 days. Filter placement was successful in all cases. However, arterial tortuosity made it difficult for a filter to pass through the stenosis in 1 case; this was overcome with an additional supportive wire (0.018-inch). Filter-related events were flow impairment in 6 (7.8%), filter wedging in the catheter tip in 4 (5.2%), vasospasm >50% narrowing in 7 (9.1%), filling defects within the filter membrane in 5 (6.5%), retrieval failure with the provided retriever in 3 (3.9%), and insecure retrieval without filter collapse in 2 (2.6%). Flow impairment caused drowsy mentality and impaired verbal response in 4, which resolved after prompt filter retrieval. All the cases of filter wedging were resolved with a catheter pulled down into the stented segment to separate the filter element from the catheter tip. Significant vasospasm and filling defects were spontaneously resolved in all cases after filter retrieval. Inability to pass a retriever catheter through a stent was overcome with curved 5-F catheter manipulation in all 3 cases. CONCLUSION: The use of a filter during CAS may induce various angiographic or technical events at each step. For a severely stenotic and tortuous carotid lesion with difficult access, a filter may become trapped or irretrievable during flow arrest. Physicians should be aware of the preventive and rescue maneuvers to counter filter-related events, perhaps even considering another type of protection mechanism or carotid endarterectomy.     

Endovascular rescue of a fused monorail balloon and cerebral protection device.

PURPOSE: To present a case of successful endovascular retrieval of a monorail predilation balloon fused to an embolic protection device (EPD) in the distal internal carotid artery (ICA) of a high-risk symptomatic patient. CASE REPORT: A 60-year-old man with documented systemic atherosclerotic disease had a severe (>70%) restenosis in the left ICA 3 years after endarterectomy. He was scheduled for carotid artery stenting (CAS) with cerebral protection; however, he developed unstable angina and was transferred to our facility, where the admitting team decided that staged CAS followed by coronary bypass grafting would be the best option. During the CAS procedure, a 6-mm AccuNet filter was passed across the lesion via a 6-F carotid sheath and deployed in the distal ICA without incident. However, the 4-x20-mm predilation monorail balloon was then advanced without visualizing the markers, resulting in inadvertent aggressive interaction that trapped the balloon's tip in the filter. Several maneuvers to separate the devices were unsuccessful. Finally, the filter/balloon combination was moved gently retrograde until the balloon was straddling the subtotal ICA lesion. The lesion was dilated to 4 mm with the balloon, and the sheath was gently advanced across the lesion as the balloon was deflated. Angiography excluded interval occlusion of the filter from the embolic debris during the aforementioned aggressive maneuvers and documented antegrade flow. The filter was slowly withdrawn into the 6-F sheath with simultaneous aspiration. A second 6-mm filter was deployed, and the procedure was completed satisfactorily. The patient did well, with no neurological sequelae. CONCLUSION: EPDs are an essential in carotid artery stenting and, keeping in mind the potential risks associated with their use, will help the operator avoid complications such as this one.     

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.     

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.     

Focal ischemia of the brain after neuroprotected carotid artery stenting

OBJECTIVES: This study sought to assess the incidence of cerebral ischemia in nonselected patients undergoing neuroprotected carotid angioplasty and stenting (CAS) without preceding multiple-vessel diagnostic angiography. BACKGROUND: Protection devices to prevent distal embolization during CAS are presently under clinical investigation. Diffusion-weighted magnetic resonance imaging (MRI) visualizes recent ischemia of the brain and may aid in assessing the efficacy of protection devices. METHODS: Elective CAS was performed in 42 consecutive patients (15 female, 27 male; mean age, 67 +/- 9 years) using six different types of cerebral protection systems. All patients underwent MRI of the brain before and after a total of 44 interventions. RESULTS: Placement and retrieval of the devices and stent deployment was achieved in all procedures. New ischemic foci were seen on postinterventional MRI in 10 cases (22.7%). One patient had sustained a major stroke, whereas no adverse neurological sequelae were associated with the other nine procedures. In the latter, one to three foci (maximum area 43.0 mm(2)) were detected in cerebral regions subtended by the ipsilateral carotid artery in eight cases and by the contralateral carotid artery in one case. In the stroke patient, 12 ischemic foci (maximum area 84.5 mm(2)) were exclusively located in the contralateral hemisphere. Follow-up MRI at 4.1 months (median, n = 7) identified residuals of cerebral ischemia only in this patient. CONCLUSIONS: Neuroprotected CAS is associated in about 25% of cases with predominantly silent cerebral ischemia. Our findings suggest manipulation of endoluminal equipment in the supraaortic vessels to be a major risk factor for cerebral embolism during neuroprotected CAS.