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.     

Routine use of cerebral protection during carotid artery stenting: results of a multicenter registry of 753 patients

PURPOSE: To evaluate the short-term outcome of patients who underwent carotid stenting with the routine use of cerebral protection devices. METHODS: In five centers, 808 successful stent procedures (of 815 attempted) were performed in 753 patients (557 [74%] men; mean [+/- SD] age, 70 +/- 8 years). Cerebral protection involved distal filter devices (n=640), occlusive distal balloons (n=144), or proximal balloon protection (n=24). RESULTS: The protection device was positioned successfully in 793 (98.2%) of the 808 attempted vessels. Neurologic complications occurred within 30 days after 46 procedures (5.6%), including seven major strokes, 17 minor strokes, and 22 transient ischemic attacks. There were four deaths (one following a major stroke). The 30-day incidence of stroke and death was 3.3% (27/815). The rate of stroke or death was 3.8% (8/213) for symptomatic lesions and 3.2% (19/602) for asymptomatic lesions (P=0.87), and 3.4% (25/729) in patients aged <80 years and 2% (2/86) in those aged > or =80 years (P=0.81). Protection device-related vascular complications, none of which led to neurologic symptoms, occurred after nine procedures (1.1%). CONCLUSION: In this uncontrolled study, routine cerebral protection during carotid artery stenting was technically feasible and clinically safe. The incidence of major neurologic complications in this study was lower than in previous reports of carotid artery stenting without cerebral protection.     

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.     

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。     

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.     

Carotid artery stenting in surgical high-risk patients.

Recent studies have shown that carotid artery angioplasty and stenting may offer a viable alternative for symptomatic and asymptomatic patients with carotid artery stenosis, especially in high-risk patients. We report the results of a prospective single-center registry designed to evaluate the feasibility and safety of carotid artery angioplasty and stenting with and without distal protection devices in high-risk patients. A total of 116 consecutive patients underwent 126 procedures and 127 stents were deployed successfully in 130 lesions. The majority of patients (63%) had restenosis after a prior carotid endarterectomy; 31% were considered to be ineligible for carotid endarterectomy by both the vascular surgeons and the interventional cardiologist and 9% were considered ineligible for surgery due to hostile neck anatomy. Periprocedural and follow-up evaluation included a thorough independent clinical and neurological assessment. Distal embolic protection devices were used in 44% of all cases. Procedural success was achieved in 122 procedures (97%). The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, and myocardial infarction) was 2.6%. Event rates in patients with prior carotid endarterectomy were comparable to patients with de novo lesions with 5.2% vs. 2.4% death/stroke at 30 days and 8.3% and 6.6% stroke/death rates at 1 year, respectively. When distal protection devices were used, death/stroke rates were 0% as compared to 4.5% when distal protection was not used (P = NS). However, minor embolic phenomena were observed in both primary and secondary lesions independent of the use of distal protection. These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis. In both types of lesions, acceptable results justify its use as a valid revascularization method. While clinical embolic events occur in a minority of patients in both lesion types, they are not entirely prevented by distal protection.     

“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.     

远端保护装置用于重度颈动脉狭窄的介入治疗

目的分析远端保护装置应用于颈动脉狭窄支架成形术的安全性和有效性。方法对26例症状性颈动脉狭窄患者行血管内支架成形术时应用远端保护装置，首先将远端保护装置通过狭窄部位并在狭窄远端展开，然后行保护性颈动脉支架成形术，观察围手术期缺血性脑卒中的发生情况，并观察保护装置滤网内捕获的斑块组织碎片。结果26例患者行远端滤网保护下的颈动脉支架成形术均获成功，回收的保护装置中有14个（54％）发现滤网中有斑块碎片组织和血栓颗粒，无死亡及急性栓塞事件发生，但有3例患者在手术后1～6d经磁共振检查发现了新的无症状性脑梗死病灶，26例患者在出院后临床随访期内未发生严重脑缺血事件。结论颈动脉支架成形术是重度症状性颈动脉狭窄的微创治疗方法，术中常规使用远端保护装置可提高颈动脉支架成形术的安全性和有效性。     

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

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.     

Initial multicenter experience with a novel distal protection filter during carotid artery stent implantation.

Atheroembolization resulting in transient or permanent neurologic impairment is the most common complication of catheter-based percutaneous carotid artery intervention. Protection of the distal cerebral vasculature during carotid stent implantation may enhance procedural safety. Carotid stent implantation with distal cerebral protection using the FilterWire EX was performed in 35 consecutive patients undergoing 36 procedures at six centers. The FilterWire was delivered and deployed successfully in all 36 cases, and embolic material was retrieved from 74% of procedures. The 30-day rate of major adverse events (death, major or minor stroke) was 0%. Transient ipsilateral periprocedural neurologic ischemia developed in two patients (5.7%), both resolving within 30 min. Distal cerebral protection with the FilterWire during carotid stenting is feasible and safe, results in capture and extraction of atheroembolic debris in the majority of patients while affording uninterrupted cerebral perfusion, and in this initial multicenter experience was associated with a high rate of procedural success without major complications.     

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。     

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.     

Carotid sheath rescue with a distal filter retrieval catheter

Sheath placement prior to carotid artery stenting is usually uncomplicated, and provides sufficient support for the procedure. In certain patients, especially those with unfavorable arch anatomy, tortuous vessels, and heavily calcified lesions, the sheath backs out into the aortic arch with compromise of wire and embolic protection device (EPD) position, and risk of “dragging” the EPD back through the lesion. A novel use of the distal filter retrieval catheter to “rescue” a prolapsed guide sheath is described. Use of the filter retrieval catheter as a “body” to retrack the sheath but not recapturing the deployed filter is a useful technique, since the equipment is already available. This avoided the need to pull a retrieved filter through a severe undilated carotid stenosis, reducing the amount of manipulations needed to reposition the sheath and thus reducing the risk of embolic events. © 2008 Wiley‐Liss, Inc.     

European carotid PROCAR Trial: prospective multicenter trial to evaluate the safety and performance of the ev3 Protégé stent in the treatment of carotid artery stenosis--1- and 6-month follow-up

BACKGROUND: The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. METHOD: The Protégé GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018' (6-9 mm stent) or 7 Fr 0.035' (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial. RESULTS: In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis. CONCLUSIONS: The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA).     

Procedural outcome and midterm result of carotid stenting in high-risk patients

Carotid endarterectomy is the standard treatment for carotid stenosis, but carotid artery stenting has emerged as a potential alternative. Elective carotid artery stenting was performed in 42 patients aged 42 to 79 years (mean, 67.05 +/- 8.67 years) after ultrasonography, computed tomography, magnetic resonance angiography and a neurological evaluation. There was bilateral carotid stenosis in 23 patients (55%), with > 90% stenosis in 18 vessels. All patients had significant associated coronary lesions. An emboli protection device and self-expanding stents were used. One year later, the patients were evaluated by Doppler sonography and selective angiography. Technical success was achieved in all procedures. During follow-up, 1 (2.4%) patient died from myocardial infarction, 1 underwent coronary artery bypass and 14 (40%) had minor complaints including occasional dizziness. No other neurological events were noted. Restenosis was found in one case, but selective angiography ruled out a significant lesion. One patient suffered embolization, but recovered completely within 24 hours. In 7 (17%) patients with type C arch interruption and a tortuous carotid course, stenting was successful and they had no embolization or restenosis. Carotid artery stenting is recommended in high-risk patients.     

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.     

Carotid artery stenting: utility of cerebral protection devices

Neurologic deficits secondary to embolic events have been the most significant concern regarding carotid bifurcation stenting. Experimental studies utilizing human carotid plaques have shown that embolic particles were released from all specimens. In addition, transcranial Doppler studies have confirmed the fact that multiple emboli are released during each case. Preliminary experiences with the use of cerebral protection devices for carotid stenting have shown encouraging results with embolic particles recovered from each case, although these experiences have also revealed some of the down sides of its use. The present article provides the rationale for routine use of these protection devices and also reviews various protection devices, some of which are currently undergoing clinical trials.     

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

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

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

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