Cerebral Protection With Filter Devices During Carotid Artery Stenting (original) (raw)
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Cerebral Protection During Carotid Artery Stenting
Stroke, 2002
Background and Purpose — Histopathologic analysis was performed to better understand quantity, particle size, and composition of embolized debris collected in protection filters during carotid artery stent implantation. Methods — Elective carotid stent implantation with the use of a distal filter protection was attempted in 38 consecutive lesions (36 patients) of the internal carotid artery presenting >70% diameter stenosis (mean, 82.1±11.1%). Mean age of the patients was 70.7±7.7 years; 75% were men, and 50% of patients had previous neurological symptoms. Results — In 37 lesions (97.4%) it was possible to position the filter device, and in all lesions a stent was successfully implanted. The only complication occurring in the hospital and during the 30-day follow-up was 1 death due to acute myocardial infarction. Neurological sequelae did not occur. Histomorphometric analysis was performed on the filters. Presence of debris was detected in 83.7% of filters. The mean surface area ...
A randomized trial of carotid artery stenting with and without cerebral protection
Journal of Vascular Surgery, 2008
The use of a distal filter cerebral protection device with carotid artery stenting is commonplace. There is little evidence, however, that filters are effective in preventing embolic lesions. This study examined the incidence of embolic phenomenon during carotid artery stenting with and without filter use. Methods: This was a prospective, randomized, single-center study of carotid artery stenting with or without a distal cerebral protection filter. A 1:1 scheme was used to randomize 36 carotid artery stenting procedures in 35 patients. Diffusion-weighted magnetic resonance imaging (DW MRI) 24 hours after stenting was used to assess the occurrence of new embolic lesions. Blinded observers calculated lesion number and volume. Results: The mean age was 78.6 ؎ 7.0 in the cerebral protection group compared with 74.1 ؎ 8.7 in the no cerebral protection group (P ؍ .92). Despite similar average age, the percentage of octogenarians was higher in the cerebral protection group (61.1% vs 22.2%; P ؍ .04). Two procedures in the cerebral protection group were not successful. One was completed without protection because of inability to track the filter, and the second was aborted because of severe tortuosity with a later carotid endarterectomy. New MRI lesions were noted in 72% of the cerebral protection group compared with 44% in the no cerebral protection group (P ؍ .09). The average number of lesions in these patients was 6.1 and 6.2, respectively, with mean DW MRI lesion size of 16.63 mm 3 vs 15.61 mm 3 (P ؍ .79 and .49, respectively). Four strokes occurred (11%), two in each group, in patients aged 75, 80, 82, and 84 years. The only major stroke occurred in the no cerebral protection group. Conclusions: The use of filters during carotid artery stenting provided no demonstrable reduction of microemboli, as expected. Routine use of cerebral protection filters should undergo a more critical assessment before mandatory universal adoption. ( J Vasc Surg 2008;47:760-5.) From the Divisions of Vascular Surgery,
Evaluation of Carotid Artery Stenting with Distal Filter Protection Device
International Journal of Recent Surgical and Medical Sciences
Objectives To assess the use of proximal protection devices in consecutive patients as the preferred means of cerebral embolic protection for primary carotid stenting. Methods and Results This was a prospective single-center study to evaluate the technical and clinical success of proximal protection devices as the first choice for embolic protection in symptomatic (≥ 50%) and asymptomatic (≥ 70%) carotid stenosis. Proximal protection devices were used for embolic protection in 115 consecutive patients. No patients were excluded for anatomical reasons. The filter used was of diameters 6 mm in all cases (Emboshield NAV filter device, Abbotts Healthcare Pvt. Ltd. [Lake Bluff, Il]). In all cases, self-expanding closed-cell designed stent was used (X-act closed-cell self-expanding nitinol carotid-tapered stent, Abbotts Healthcare Pvt. Ltd.). Plaque characterization was done by using real-time high-resolution ultrasound (HR USG) equipment (Aloka Prosound Alpha 7 [Chiyoda, Tokyo, Japan]) u...
Impact of Cerebral Protection Devices on Early Outcome of Carotid Stenting
Journal of Endovascular Therapy, 2002
To evaluate the impact of cerebral protection devices on the procedural safety and outcome of carotid stent procedures. Methods: From June 1997 to July 2001, 275 consecutive patients (208 men; mean age 71 Ϯ 7.4 years) underwent percutaneous angioplasty and/or stenting of the extracranial carotid artery. In the first 125 (45.4%) patients, the procedures were performed without cerebral protection. After January 2000, protection devices were routinely used (150 [54.6%] patients), including the Angioguard filter, GuardWire occlusion system, TRAP Vascular Filtration System, EPI Filter Wire, NeuroShield, Parodi Anti-Embolism System, and Medicorp occlusive balloon. Results: The percutaneous procedures were effective in 273 (99.3%) patients. No death or major stroke occurred in either group. In the unprotected group, 5 (4.0%) complications occurred: 3 (2.4%) minor strokes, 1 (0.8%) transient ischemic attack (TIA), and 1 (0.8%) subarachnoid hemorrhage. In the patients treated under cerebral protection, there were 2 (1.3%) complications: 1 (0.7%) minor stroke and 1 (0.7%) subarachnoid hemorrhage. There were 4 (3.2%) periprocedural embolic complications in the unprotected group versus 1 (0.7%) in the protected patients. Conclusions: Our data suggest that percutaneous dilation and stenting of the carotid arteries protected by cerebral protection devices is feasible and effective. In a consecutive series, the use of the cerebral protection systems reduced the acute neurological event rate related to embolic complications by 79%.
Protected carotid stenting: Safety and efficacy of the MedNova NeuroShield filter
Journal of Vascular Surgery, 2002
Objective: Neuroprotection during carotid stenting has the potential to reduce procedural atheroembolic sequelae. We report the United Kingdom experience of NeuroShield (MedNova Ltd, Horsham, West Sussex, United Kingdom). Methods: We performed a prospective cohort analysis of 50 consecutive patients (50 lesions) in a regional vascular tertiary referral center (catchment area one million) that provides an institutional service for the short term. The subjects were all the patients referred for carotid stenting after preassessment by a multidisciplinary team. All the patients underwent pretreatment with antiplatelet agents. Forty-two patients had atherosclerotic stenosis of the carotid bifurcation between 70% and 95% (with North American Symptomatic Carotid Endarterectomy Trial criteria). Six patients had restenosis after endarterectomy. Two had previous local radiotherapy. Forty-two patients were symptomatic (amaurosis fugax/ central retinal artery occlusion in 11 cases, and hemispheric transient ischemic attack/cerebrovascular accident in 31 cases). Eight patients were asymptomatic with bilateral high-grade stenoses, with six cases before coronary artery bypass grafting. The intervention performed was protected primary carotid stenting. Outcome measures were procedural atheroembolic events, including all-stroke and death rates up to 30 days, and analysis of retrieved debris in a subset of 11 cases.
2011
OBJECTIVES The goal of this study was to compare the rate of cerebral microembolization during carotid artery stenting (CAS) with proximal versus distal cerebral protection in patients with high-risk, lipid-rich plaque. BACKGROUND Cerebral protection with filters partially reduces the cerebral embolization rate during CAS. Proximal protection has been introduced to further decrease embolization risk. METHODS Fifty-three consecutive patients with carotid artery stenosis and lipid-rich plaque were randomized to undergo CAS with proximal protection (MO.MA system, n = 26) or distal protection with a filter (FilterWire EZ, n = 27). Microembolic signals (MES) were assessed by using transcranial Doppler during: 1) lesion wiring; 2) pre-dilation; 3) stent crossing; 4) stent deployment; 5) stent dilation; and 6) device retrieval/deflation. Diffusion-weighted magnetic resonance imaging was conducted before CAS, after 48 h, and after 30 days. RESULTS Patients in the MO.MA group had higher perc...
JACC: Cardiovascular Interventions, 2020
The aim of this study was to randomly compare the double-layer Roadsaver stent (RS) (Terumo, Tokyo, Japan) with the single-layer Carotid Wallstent (CW) (Boston Scientific, Santa Clara, California) in association with either distal embolic protection with the FilterWire (FW) device (Boston Scientific) or proximal protection with the Mo.Ma Ultra device (Medtronic, Santa Rosa, California) in patients with lipid-rich carotid plaques. BACKGROUND The role of both stent type and brain protection during carotid artery stenting (CAS) remains unsettled. METHODS A total of 104 consecutive patients with carotid artery stenosis were randomized to CAS with FW þ RS (group 1, n ¼ 27), FW þ CW (group 2, n ¼ 25), Mo.Ma þ RS (group 3, n ¼ 27), or Mo.Ma þ CW (group 4, n ¼ 25). The primary endpoint was the number of microembolic signals (MES) on transcranial Doppler among groups in the following CAS steps: 1 and 2) target vessel access; 3) lesion wiring; 4) pre-dilation; 5) stent crossing; 6) stent deployment; 7) stent dilation; and 8) device retrieval and deflation. RESULTS No significant differences in baseline characteristics were found among the 4 groups. Compared with the FW device, the Mo.Ma Ultra device significantly reduced mean MES count (p < 0.0001) during lesion crossing, stent crossing, stent deployment, and post-dilation. Compared with the CW, the RS significantly reduced MES count (p ¼ 0.016) in steps 6 to 8, including spontaneous MES (29% of patients). The combination of Mo.Ma þ RS performed significantly better than Mo.Ma þ CW (p ¼ 0.043). Clinical major adverse cardiac and cerebrovascular events occurred in 3 patients (p ¼ 0.51). After CAS, peak systolic velocity significantly decreased in all patients. In-stent restenosis developed in 1 patient (0.98%) at 6-month follow-up. The RS was an independent predictor of external carotid artery patency over time. CONCLUSIONS In patients with high-risk, lipid-rich plaque undergoing CAS, Mo.Ma þ RS led to the lowest microembolic signals count. (Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid
Filter-Protected versus Unprotected Carotid Artery Stenting: A Randomised Trial
Cerebrovascular Diseases, 2010
Background: Our aim was to determine whether filter protection reduces embolisation to the brain during carotid artery stenting (CAS). Methods: Thirty patients with symptomatic carotid artery stenosis ≧70% (North American Symptomatic Carotid Endarterectomy Trial) were randomly assigned to filter-protected or unprotected CAS. Diffusion-weighted magnetic resonance imaging (DWI) of the brain was performed before and at 3 time points after CAS. In a subset of patients, high-intensity transient signals on transcranial Doppler (TCD) were recorded with categorisation of emboli. Data were independently reviewed off-site. Results: There were no significant differences in mean age, proportion of octogenarians or presenting symptoms between the groups. On procedural DWI (1–3 and 24 h after stenting), there were 7/24 (29%) and 4/22 (18%) new lesions in protected and unprotected patients respectively (p = 0.38). At 30 days there were 9/33 (26%) and 4/33 (12%) lesions in protected and unprotected...
The American Journal of Medicine, 2004
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 [Ϯ SD] age, 70 Ϯ 8 years). Cerebral protection involved distal filter devices (n ϭ 640), occlusive distal balloons (n ϭ 144), or proximal balloon protection (n ϭ 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 ϭ 0.87), and 3.4% (25/729) in patients aged Ͻ80 years and 2% (2/86) in those aged Ն80 years (P ϭ 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. Am J Med.