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.     

Protected carotid artery stenting in patients with severe stenosis

Intraplaque hemorrhage (IPH) and ulcers are the major findings of unstable plaques. In addition, initial symptoms are associated with postprocedural complications after carotid artery stenting (CAS). The aim of this study was to determine the safety of CAS using an embolic protection device in symptomatic patients with severe carotid artery stenosis and unstable plaques such as IPH and ulcers.This retrospective study included 140 consecutive patients with severe carotid stenosis. These patients underwent preprocedural carotid vessel wall imaging to evaluate the plaque status. We analyzed the incidence of initial clinical symptoms, such as headache, nausea, and vomiting, after CAS. The primary outcomes analyzed were the incidence of stroke, myocardial infarction, and death within 30 days of CAS.Sixty-seven patients (47.9%) had IPH, and 53 (38.9%) had ulcers on carotid wall imaging/angiography. Sixty-three patients (45.0%) had acute neurological symptoms with positive diffusion-weighted image findings. Intraluminal thrombi on initial angiography and flow arrest during CAS were significantly higher in patients with IPH and symptomatic patients. Symptoms were significantly higher in patients with IPH than in those without (63.5% vs 35.1%, P < .001). There were no significant differences in clinical symptoms after stenting or in primary outcomes, regardless of IPH, ulcer, or initial symptoms.IPH and plaque ulceration are risk factors in symptomatic carotid stenosis. However, IPH and plaque ulceration were not a significant risk factors for cerebral embolism during protected carotid artery stent placement in patients with carotid stenosis. Protected CAS might be feasible and safe despite the presence of unstable plaques.     

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.     

The CAPTURE registry: results of carotid stenting with embolic protection in the post approval setting.

BACKGROUND: Pivotal study data examining carotid stenting with embolic protection as a less invasive alternative to endarterectomy for high surgical risk patients have been acquired under controlled conditions with highly selected physicians and hospitals. This report examines outcomes of carotid stenting post-approval after diffusion of this technology to a broader cross-section of physicians and hospitals. METHODS: The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry to assess two important aspects of the post-IDE experience: the safety of carotid stenting by physicians with varying levels of experience as a measure of the adequacy of physician training, and the identification of rare/unexpected device-related complications. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30 days post-procedure. RESULTS: 3,500 patients were enrolled by 353 physicians at 144 sites. The 30-day primary endpoint event rate was 6.3% (95% CI: 5.5-7.1%) and did not differ among the three operator experience levels (5.3%, 6.0%, and 7.4%; P = 0.31) from most to least experienced, respectively. There were no differences in outcomes among physician specialties when adjusted for case mix. There were no unanticipated device related adverse events. CONCLUSIONS: The results of the CAPTURE study compare favorably to those achieved in the predicate pivotal investigations, and suggest that the post-approval transfer of this new therapy to the community practice setting via carotid stent training programs is effective in preparing physicians with varying experience levels and specialty training backgrounds.     

颈动脉支架置入术与内膜切除术治疗颈动脉狭窄的远期转归比较:随机对照试验的汇总分析

目的 通过汇总分析评价颈动脉内膜切除术(carotid endarterectomy, CEA)与颈动脉支架置入术(carotid artery stenting, CAS)治疗颈动脉狭窄的远期转归.方法 检索PubMed、EMBASE和Cochrane数据库,纳入在颈动脉狭窄患者中比较CEA与CAS治疗的随机对照试验,提取研究基本特征以及远期转归,包括卒中或死亡联合终点、任何卒中、任何死亡等数据,应用Stata软件进行统计分析.结果 共纳入7项随机对照试验和8 210例患者,随访时间中位数为2~7.4年.纳入研究的质量整体较高,产生偏倚的风险较低.汇总分析显示,CAS组卒中或死亡联合终点[风险比(hazard risk, HR) 1.21,95% CI 1.04~1.39]、任何卒中(HR 1.32,95% CI 1.15~1.51)和同侧卒中(HR 1.26,95% CI 1.02~1.55)风险显著高于CEA组;CAS组死亡(HR 1.06,95% CI 0.95~1.18)、致残性卒中(HR 1.23,95% CI 0.95~1.60)、非同侧卒中(HR 1.12,95% CI 0.81~1.55)和再狭窄(HR 1.18,95% CI 0.91~1.52)风险均与CEA组无显著性差异,但.结论 CAS在远期死亡、致残性卒中、非同侧卒中和再狭窄风险方面与CEA相近,但CAS的远期卒中或死亡联合终点、任何卒中和同侧卒中风险显著更高.这些结果提示,CEA仍是颈动脉狭窄的治疗选择.     

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

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

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)     

老年症状性颈动脉狭窄患者的临床干预研究

目的探讨老年症状性颈动脉狭窄患者的支架成形术和(或)内科治疗的安全性和短期疗效。方法选择我院经数字减影血管造影术(DSA)证实有颈动脉狭窄且有相关临床症状的老年患者85例,均给予内科治疗,其中58例行颈动脉支架成形术,分析其临床、影像学、治疗和随访观察资料。结果68例患者临床症状改善或消失;住院及随访期间6例(7.1%)发生脑卒中,无脑卒中相关死亡。本组中58例患者共置入支架67个,支架成形术成功率为100%,动脉狭窄率由术前(86.8±9.3)%降至(10.9±2.5)%(t=21.1,P=0.000);术后30天内2例发生支架相关脑卒中;58例支架成形术患者平均随访28.3个月,50例(86.2%)症状改善或消失,2例发生同侧颈内动脉供血区域脑卒中;36例复查颈部血管超声,2例显示支架内再狭窄;10例复查DSA均未发现支架内再狭窄。结论老年症状性颈动脉狭窄患者的综合临床干预短期疗效良好;狭窄的支架成形术方法可行,相对安全。     

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 with filter protection

BACKGROUND: Neurologic events associated with distal embolization of debris during percutaneous carotid artery stenting complicate the procedure. Filter devices for cerebral protection potentially reduce the risk of embolization and other neurologic events. We studied the feasibility, safety, and efficacy of carotid artery stenting with a filter device. METHODS AND RESULTS: Between January 2002 and January 2003, a total of 22 consecutive patients (30 lesions) who had >70% diameter stenosis of the internal carotid artery underwent carotid artery stenting with filter protection at our institute. The mean age of the patients was 64+/-9 years; 14 were men and 8 women, and 15 had neurologic symptoms. A stent was successfully implanted in 29 lesions. It was possible to position a filter device in all the 29 lesions. Neurologic complications during the procedure, in the hospital, and at 30-day clinical follow-up occurred in 2 patients. One patient suffered a minor stroke that resolved within 24 hours. None of the patients had a major embolic stroke. There was one death from intracerebral hemorrhage related to hyperperfusion and the use of a glycoprotein IIb/IIIa inhibitor. CONCLUSIONS: Filter protection during carotid artery stenting seems technically feasible, safe, and effective. In the present study, the incidence of embolic neurologic events was low.     

Interventional Management of Asymptomatic Extracranial Carotid Stenosis

Carotid artery stenosis is a major risk factor for stroke and transient ischemic attack. Although carotid endarterectomy is the established gold standard for carotid revascularization, carotid artery angioplasty and stenting (CAS)—proven by large randomized clinical trials and rigorous registries and supported by improving stent designs, embolic protection, and increasing neurointerventionalist experience—is developing into a safer and more efficacious method of stroke prevention. Today, protected CAS is approved for symptomatic and asymptomatic patients with severe carotid stenosis with high surgical risk. We reviewed recently published data regarding new developments in the use of protected CAS, particularly in patients with carotid stenosis who are either asymptomatic or at low surgical risk.     

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.     

脑保护装置下高龄重度颈动脉狭窄患者颈动脉支架成形术的有效性和安全性评价

目的评价脑保护装置下高龄重度颈动脉狭窄患者颈动脉支架成形术(CAS)的有效性及安全性。方法选择2009年1月—2012年1月在青岛大学医学院附属医院行CAS的高龄重度颈动脉狭窄患者37例,术中均应用脑保护装置,观察患者狭窄改善情况、围术期并发症发生情况、回收脑保护装置内脱落栓子情况,随访1年观察患者缺血性脑血管事件发生情况。结果 36例患者脑保护伞均一次性顺利通过狭窄段放置到位成功释放;术后残余狭窄率均30%,平均狭窄程度从(83.0±6.7)%降至(13.0±6.1)%;回收的脑保护装置中有26个发现脱落的组织碎片;围术期均未出现脑出血、症状性脑梗死、支架内血栓形成等严重并发症;37例患者随访1年,无短暂性脑缺血发作(TIA)、卒中、死亡发生。结论脑保护装置下对高龄重度颈动脉狭窄患者行CAS成功率和安全性较高。     

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。     

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.     

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: Is There a Difference Between Filter and Distal Occlusive Devices?

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

心脏直视手术前颈动脉支架术的初步探讨

目的 评估心脏疾病合并严重颈动脉狭窄患者于心脏直视手术前行颈动脉支架术预防围手术期缺血性卒中的有效性和安全性.方法 前瞻性队列研究,对心脏疾病合并严重颈动脉狭窄患者于心脏直视手术前行颈动脉支架术,评估颈动脉支架术至心脏直视术后30 d的终点事件(卒中、心肌梗死和死亡).结果 自2005年1月至2007年12月,本研究共连续入选42例患者.颈动脉支架技术成功率100%.远端栓塞防护装置使用率为97.6%(41/42).心脏直视手术包括:冠状动脉旁路移植术36例(85.7%),冠状动脉旁路移植术加瓣膜置换术5例(11.9%),瓣膜置换术1例(2.4%).自颈动脉支架术至心脏直视术后30 d的卒中率为2.4%(1/42),心肌梗死率为0%,死亡率为0%.结论 这一小样本前瞻性队列研究表明,心脏直视手术前行颈动脉支架术预防围手术期缺血性卒中安全有效,优于文献报告的分期颈动脉内膜剥脱术的结果,但由于本研究样本量小,需进一步研究验证.     

Symptomatic carotid artery stenosis: what is the preferred treatment?

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

Carotid artery stenting 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.