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ABSTRACT: PURPOSE: To assess the effectiveness of flow reversal as an alternative means of cerebral protection by using transcranial Doppler recordings and diffusion-weighted imaging (DWI) as surrogate markers of brain injury. MATERIALS AND METHODS: Eighteen patients with symptomatic carotid artery disease were recruited. Magnetic resonance imaging was performed before the intervention and at 3 and 24 hours and 30 days after the intervention to detect new ischemic lesions with DWI. Transcranial Doppler recordings were made during the procedure to assess for microembolic signals (MESs). Data were compared against data from a historical control cohort of patients who underwent CAS placement with or without filter protection (n = 15 each) under the same protocol in a different study. RESULTS: There were fewer periprocedural new lesions on DWI in the reverse-flow cohort compared with the historical control cohort with filter protection (P = .084). Reverse flow revealed significantly fewer MESs during the whole procedure compared with the filter-protected group (P = .01) but not the unprotected group (P = .55). There was a marked decrease in MES counts for reverse flow protection during the embologenic stages of the procedure (P = .004). CONCLUSIONS: Use of the reverse flow device was associated with fewer overall lesions on DWI and proportionately fewer positive scans compared with the use of filter-type devices (P = .08, not significant). Transcranial Doppler recordings demonstrated a significant reduction in embolization to the brain during carotid artery stent placement with the use of reverse-flow cerebral protection.
Journal of vascular and interventional radiology: JVIR 02/2013; · 1.81 Impact Factor
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Henrik Gensicke,
Thomas Zumbrunn,
Lisa M Jongen,
Paul J Nederkoorn, Sumaira Macdonald,
Peter A Gaines,
Philippe A Lyrer,
Stephan G Wetzel,
Aad van der Lugt,
Willem P Th M Mali,
Martin M Brown,
H Bart van der Worp,
Stefan T Engelter,
Leo H Bonati
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ABSTRACT: BACKGROUND AND PURPOSE: In a substudy of the International Carotid Stenting Study (ICSS), more patients had new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (MRI) after stenting (CAS) than after endarterectomy (CEA). In the present analysis, we compared characteristics of diffusion-weighted MRI lesions. METHODS: Number, individual and total volumes, and location of new diffusion-weighted MRI lesions were compared in patients with symptomatic carotid stenosis randomized to CAS (n=124) or CEA (n=107) in the ICSS-MRI substudy. RESULTS: CAS patients had higher lesion numbers than CEA patients (1 lesion, 15% vs 8%; 2-5 lesions, 19% vs 5%; >5 lesions, 16% vs 4%). The overall risk ratio for the expected lesion count with CAS versus CEA was 8.8 (95% confidence interval, 4.4-17.5; P<0.0001) and significantly increased among patients with lower blood pressure at randomization, diabetes mellitus, stroke as the qualifying event, left-side stenosis, and if patients were treated at centers routinely using filter-type protection devices during CAS. Individual lesions were smaller in the CAS group than in the CEA group (P<0.0001). Total lesion volume per patient did not differ significantly. Lesions in the CAS group were more likely to occur in cortical areas and subjacent white matter supplied by leptomeningeal arteries than lesions in the CEA group (odds ratio, 4.2; 95% confidence interval, 1.7-10.2; P=0.002). CONCLUSIONS: Compared with patients undergoing CEA, patients treated with CAS had higher numbers of periprocedural ischemic brain lesions, and lesions were smaller and more likely to occur in cortical areas and subjacent white matter. These findings may reflect differences in underlying mechanisms of cerebral ischemia.Clinical Trial Registration-URL: http://www.isrctn.org. Unique identifier: ISRCTN25337470.
Stroke 12/2012; · 5.73 Impact Factor
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Sumaira Macdonald
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ABSTRACT: The carotid stenting trialists have demonstrated persistence and determination in comparing an evolving technique, carotid artery stenting (CAS), against a mature and exacting standard for carotid revascularisation, carotid endarterectomy (CEA). This review focuses on their endeavours. A total of 12 1-on-1 randomised trials comparing CAS and CEA have been reported; 6 of these can be considered major, and 5 of these reflect (in part) current CAS standards of practice and form the basis of this review. At least 18 meta-analyses seeking to compare CAS and CEA exist. These are limited by the quality and heterogeneity of the data informing them (e.g., five trials were stopped prematurely such that they collectively failed to reach recruitment target by >4000 patients). The Carotid Stenting Trialists' Collaboration Publication represents a prespecified meta-analysis of European trials that were sufficiently similar to allow valid conclusions to be drawn; these trials and conclusions will be explored. When the rate of myocardial infarction (MI) is rigorously assessed, CAS and CEA are equivalent for the composite end point of stroke/death and MI, with more minor strokes for CAS and more MIs for CEA. These outcomes have a discrepant impact on quality of life and subsequent mortality. The all-stroke death outcomes for patients <70 years old are equivalent, with more minor strokes occurring in the elderly during CAS than CEA. There are significantly more severe haematomas and cranial nerve injuries after CEA. The influence of experience on outcome cannot be underestimated.
CardioVascular and Interventional Radiology 07/2011; 35(1):15-29. · 2.09 Impact Factor
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Gerard Stansby, Sumaira Macdonald,
Robert Allison,
Mark de Belder,
Martin M Brown,
John Dark,
Roland Featherstone,
Marcus Flather,
Gary A Ford,
Alison Halliday,
Iqbal Malik,
Ross Naylor,
John Pepper,
Peter M Rothwell
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ABSTRACT: The Carotid Disease and Cardiac Surgery Consensus Meeting was convened as a multidisciplinary gathering to consider the management of patients undergoing cardiac surgery who are found to have asymptomatic carotid artery disease. There are no randomized trials concerning whether carotid interventions are of value in this situation and the natural history is unclear. Bilateral carotid artery disease (≥70% stenosis) should be regarded clinically relevant when considering hemodynamic and short-term surgical stroke risk. However, this may be because the presence of significant carotid disease is also a marker for aortic arch and intracerebral disease. A natural history study is urgently needed to determine the incidence, predictive factors, and natural history of asymptomatic carotid disease in patients undergoing contemporary cardiac surgical interventions to inform the design of any future randomized trial.
Angiology 03/2011; 62(6):457-60. · 1.51 Impact Factor
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ABSTRACT: To investigate the evidence for the relationship between volume and outcome for carotid artery stenting. We performed a systematic review of the literature to examine the influence of experience and/or volume on outcome for carotid artery stenting. The primary search strategy was to identify studies presenting year-on-year data. The Pubmed, Embase, Medline and the Cochrane Collaboration databases were searched. Studies with over 100 interventions were included. The main outcome measure compared across studies was all stroke/death. Where possible, comparable data were pooled and analysed using meta-regression techniques. It was not possible to perform a standard systematic review and meta-analysis because of the lack of data from randomised studies. When redundant studies were excluded, four sizeable case series and one registry met the inclusion criteria. When the case series results were pooled, the χ²-test for trend demonstrated a significant reduction in the combined stroke and death rate over time. Meta-regression analysis of case series data allowed the setting of thresholds for 'acceptable' stroke/death rates. Where year-on-year data are available, published stroke and death rates for carotid artery stenting show improvements over time. While advances in technology and pharmacology may in part be responsible, temporal improvement in outcomes demonstrated in both early and contemporary time-frames together with the consistency of the results suggests the presence of a learning curve. In active carotid artery stenting units, it may take almost 2-years before the stroke/death rates fall below an arbitrary 5% threshold.
International Journal of Stroke 12/2010; 5(6):477-82. · 2.38 Impact Factor
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ABSTRACT: Percutaneous carotid interventions are a rapidly emerging treatment modality, accompanied by rapid technological and methodological
development. There is now a large evidence base for the procedure, by which individual results can be compared and judged,
in relation to acceptability of outcome measures and complications. In the contemporary setting, in most countries, it is
no longer acceptable for practitioners to start on new procedures without some form of training and, ideally, accreditation.
For carotid interventions, the debate has been further complicated by the fact that several disciplines have been involved
with its development to date — vascular surgeons, neurosurgeons, inter-ventional radiologists, and cardiologists. When regarded
as an experimental procedure, it was perhaps acceptable for individuals to construct their own training and move into the
field when they felt it appropriate. This may not now be the case in many countries. An experimental procedure (also sometimes
referred to as an investigational procedure) is usually considered to be one which has not been accepted into clinical practice
and has not been critically assessed in peer-reviewed medical literature or academic meetings. A procedure is not experimental
if sufficient studies are available to prove its efficacy and safety. Carotid artery stenting (CAS) in general, by these definitions,
can no longer be regarded as experimental. A procedure cannot be classified as “experimental” or “investigational” simply
because of the inexperience of the practitioner or institution.
03/2010: pages 31-39;
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ABSTRACT: Careful case selection is an absolute prerequisite for safe carotid artery stenting (CAS) practice. All patients being considered
for CAS require “overview” anatomic imaging, i.e., from the arch origins of the great vessels to the circle of Willis. This
may be achieved by arch aortography, or if there is local enthusiasm and expertise (and bearing in mind that noninvasive imaging
modalities have not been validated for assessment of the arch origins), by contrast-enhanced magnetic resonance angiography
(CEMRA) or computed tomographic angiography (CTA) (see Chap. 5)
03/2010: pages 75-80;
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Leo H Bonati,
Lisa M Jongen,
Sven Haller,
H Zwenneke Flach,
Joanna Dobson,
Paul J Nederkoorn, Sumaira Macdonald,
Peter A Gaines,
Annet Waaijer,
Annet Waajier,
Peter Stierli,
H Rolf Jäger,
Philippe A Lyrer,
L Jaap Kappelle,
Stephan G Wetzel,
Aad van der Lugt,
Willem P Mali,
Martin M Brown,
H Bart van der Worp,
Stefan T Engelter
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ABSTRACT: The International Carotid Stenting Study (ICSS) of stenting and endarterectomy for symptomatic carotid stenosis found a higher incidence of stroke within 30 days of stenting compared with endarterectomy. We aimed to compare the rate of ischaemic brain injury detectable on MRI between the two groups.
Patients with recently symptomatic carotid artery stenosis enrolled in ICSS were randomly assigned in a 1:1 ratio to receive carotid artery stenting or endarterectomy. Of 50 centres in ICSS, seven took part in the MRI substudy. The protocol specified that MRI was done 1-7 days before treatment, 1-3 days after treatment (post-treatment scan), and 27-33 days after treatment. Scans were analysed by two or three investigators who were masked to treatment. The primary endpoint was the presence of at least one new ischaemic brain lesion on diffusion-weighted imaging (DWI) on the post-treatment scan. Analysis was per protocol. This is a substudy of a registered trial, ISRCTN 25337470.
231 patients (124 in the stenting group and 107 in the endarterectomy group) had MRI before and after treatment. 62 (50%) of 124 patients in the stenting group and 18 (17%) of 107 patients in the endarterectomy group had at least one new DWI lesion detected on post-treatment scans done a median of 1 day after treatment (adjusted odds ratio [OR] 5.21, 95% CI 2.78-9.79; p<0.0001). At 1 month, there were changes on fluid-attenuated inversion recovery sequences in 28 (33%) of 86 patients in the stenting group and six (8%) of 75 in the endarterectomy group (adjusted OR 5.93, 95% CI 2.25-15.62; p=0.0003). In patients treated at a centre with a policy of using cerebral protection devices, 37 (73%) of 51 in the stenting group and eight (17%) of 46 in the endarterectomy group had at least one new DWI lesion on post-treatment scans (adjusted OR 12.20, 95% CI 4.53-32.84), whereas in those treated at a centre with a policy of unprotected stenting, 25 (34%) of 73 patients in the stenting group and ten (16%) of 61 in the endarterectomy group had new lesions on DWI (adjusted OR 2.70, 1.16-6.24; interaction p=0.019).
About three times more patients in the stenting group than in the endarterectomy group had new ischaemic lesions on DWI on post-treatment scans. The difference in clinical stroke risk in ICSS is therefore unlikely to have been caused by ascertainment bias. Protection devices did not seem to be effective in preventing cerebral ischaemia during stenting. DWI might serve as a surrogate outcome measure in future trials of carotid interventions.
UK Medical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union, Netherlands Heart Foundation, and Mach-Gaensslen Foundation.
The Lancet Neurology 02/2010; 9(4):353-62. · 23.46 Impact Factor
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ABSTRACT: Our aim was to determine whether filter protection reduces embolisation to the brain during carotid artery stenting (CAS).
Thirty patients with symptomatic carotid artery stenosis > or =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.
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 patients, respectively (p = 0.1). On TCD there were significantly more signals in total as well as particulate emboli during filter-protected CAS (426.5 and 251.3) than during unprotected CAS (165.2 and 92) - p = 0.01 and 0.03, respectively.
Filter-protected CAS is associated with an increase in new lesions on DWI and significantly higher rates of total and particulate microembolisation on TCD than unprotected CAS. The clinical significance of these findings requires further study.
Cerebrovascular Diseases 02/2010; 29(3):282-9. · 2.72 Impact Factor
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ABSTRACT: To develop a scoring system to facilitate case selection for carotid artery stenting based on anatomic features.
Twelve experts comprising a multinational and multispecialty panel were convened. Delphi consensus methodology was applied over 4 "rounds" involving emailed questionnaires, private decision-making, structured interaction and explicit aggregation. In round 1 panelists proposed individual anatomic features that were considered relevant during carotid artery stenting. In round 2 each criterion was scored from 1 (straightforward) to 9 (difficult). Round 3 involved removing some factors based on individual scores to reduce the number of subsequent combination anatomies. The final round involved scoring 96 combination anatomies (representing a "full factorial" design) plus a dichotomous response, ie, whether carotid artery stenting should or should not be advised for a "novice."
There were 1164 responses, providing a score for 12 individual anatomic features and for 96 combinations anatomies with good level of agreement between panelists. After derivation of mean (and standard deviation) of the cutting scores for 1152 yes/no responses a scoring system for combination anatomy was produced, comprising broad agreement bands presented as traffic light colors: red for particularly difficult anatomy, amber for moderate difficulty and green for lesser difficulty.
A scoring system has been developed, based on objective expert consensus, which can be used to categorise expected difficulty of carotid artery stenting and aid case selection.
Stroke 04/2009; 40(5):1698-703. · 5.73 Impact Factor
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Robin Edward Thomas Williams,
Claude Y Angel,
Ryad Bourkaib,
Philippe Brenot,
Philippe Commeau,
Robert Kendall Fisher,
Ralph Jackson,
Caroline Helen Kay,
Olivier Le Dref,
Jean-Yves Riou,
John Rose, Sumaira Macdonald
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ABSTRACT: To evaluate the safety and efficacy of the StarClose device for closure of antegrade punctures following infrainguinal endovascular interventions.
A retrospective review was conducted of 221 consecutive patients treated with the StarClose device in a 12-month period at 5 centers (4 French and 1 British). Of these, 107 patients (69 men; median age 75 years, range 44-93) were from the UK cohort (111 closures), and 94 patients (75 men; median age 67 years, range 32-95) were from the French cohort (111 closures). Technical success, complication rates, demographic data, medical history, and procedural details were gathered for all patients. Residual bleeding and the requirement for additional manual compression were recorded when the device failed. Clinical evaluation was performed at discharge; color-coded duplex ultrasonography was done in a subset of French patients.
The overall technical success rate was 94.6% (210/222; 95% CI 3.1%-9.2%). The results were similar in the 2 cohorts: 95.5% (106/111; 95% CI 1.9%-10.1%) in the UK and 93.7% (104/111; 95% CI 3.1%-12.4%) in France. The 12 failures (5 UK and 7 France) were due to several mechanisms: device failure (n=5), obesity (n=1), groin scarring (n=2), and unexplained (n=4). In 2 failed cases, open surgical closure of the arteriotomy was performed because pressure hemostasis failed. Two pseudoaneurysms were observed: one after immediate failure was successfully treated by prolonged pressure; the other, after apparent success of the device, required surgical therapy. The incidence of serious vascular complication was 1.8% (4/222; 95% CI 0.7%-4.5%); 2 patients from each cohort.
The StarClose device safely and effectively closes antegrade punctures after infrainguinal endovascular intervention, even in patients who would be considered to be at high risk for puncture-site bleeding. However, a randomized trial would be required to support any definitive recommendations.
Journal of Endovascular Therapy 09/2007; 14(4):498-505. · 2.86 Impact Factor
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Sumaira Macdonald
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ABSTRACT: Causes of brain injury during endovascular carotid intervention are protean. Mechanisms of injury include embolic and hemodynamic events, acute carotid occlusions occurring through a variety of means, and the relatively rare contrast-induced encephalopathy. Embolic injury may result from micro- and macroembolization and most commonly causes ischemic stroke when sufficiently severe. Hemodynamic injury may proceed from hemodynamic depression and hypoperfusion (which may result in watershed infarction) or the hyperperfusion syndrome, which may, if severe, result in hemorrhagic stroke. Embolic and dynamic causes of stroke may either occur intraprocedurally or at a variable time after stent placement and may be co-related. Impaired clearance of emboli due to relative hypoperfusion may exacerbate their clinical relevance. Other causes of stroke include acute carotid occlusions, which most commonly occur procedurally due to flow-limiting spasm, acute dissection, and, if a filter-type cerebral protection device has been used, filter occlusion due to a large trapped embolic load. These scenarios may result in stroke if not recognized and dealt with appropriately. Acute stent thrombosis may occur within 24 hours of the procedure as a result of adverse hemodynamic factors or suboptimal patient response to procedural heparin and antiplatelet agents, or it may occur after the procedure, again perhaps as a result of suboptimal response to antiaggregate drugs.
Journal of Endovascular Therapy 05/2007; 14(2):219-31. · 2.86 Impact Factor
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Sumaira Macdonald
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ABSTRACT: It has been considered likely that the majority of cerebral ischaemic episodes following carotid artery stenting are due to cerebral embolisation. It is intuitive therefore, to attempt to prevent these presumptive emboli, whether they are comprised of air or formed elements, from reaching the brain. Various pharmacological and mechanical solutions are being used. The available literature is hampered by comparisons against historical controls of unprotected CAS with many confounding variables that may influence outcome. There is no clinical Level-I evidence to support the use of protection devices but Level-III and Level-IV evidence suggest benefit.
European Journal of Radiology 11/2006; 60(1):20-5. · 2.61 Impact Factor
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ABSTRACT: To report a novel technique for safely closing antegrade common femoral artery (CFA) punctures using the StarClose device after proximal superficial femoral artery (SFA) angioplasty.
The vessel locator of the StarClose device should not be deployed within a recently dilated vessel, so after proximal SFA angioplasty, the sheath is withdrawn into the CFA. A second guidewire is inserted into the profunda femoris artery followed by insertion of the StarClose sheath. The vessel locator is deployed in the profunda main stem and withdrawn into the CFA until resistance is felt, indicating apposition to the luminal aspect of the vessel wall. The device is subsequently deployed according to the manufacturer's instructions.
Use of profunda femoris artery allows safe closure of the CFA using the StarClose device following antegrade puncture for proximal SFA angioplasty.
Journal of Endovascular Therapy 09/2006; 13(4):522-6. · 2.86 Impact Factor
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ABSTRACT: The cerebral hemodynamic sequelae of interventions in patients with severe internal carotid artery (ICA) stenoses are not fully understood. In this study, we sought to determine the immediate changes in cerebral perfusion characteristics, determined by MR imaging in patients who have undergone unilateral transluminal angioplasty and stent placement.
Eleven patients with symptomatic high-grade ICA stenosis underwent MR imaging within 4 hours before and within 3 hours after carotid stent placement. First-pass gadolinium-enhanced imaging of perfusion was performed by using a gradient-recalled echo-planar technique. Localized relative cerebral blood volume (rCBV) and bolus first-moment transit time (TT(FM)) were calculated for different vascular territories (middle, anterior, and posterior cerebral arteries) in each hemisphere.
Significantly longer TT(FM) (P <.005) was observed in the symptomatic territory of the middle cerebral artery before intervention. After intervention, TT(FM) remained significantly longer in this territory (P <.05). However, the magnitude of the interhemispheric asymmetry had declined significantly (50-60% reduction; P <.05). No significant differences or changes in rCBV were identified between hemispheres, between images, or in areas of unilateral leptomeningeal enhancement after intervention.
MR can demonstrate short-term partial resolution of timing asymmetry in interhemispheric perfusion after angioplasty and stent insertion for severe stenosis of the ICA.
American Journal of Neuroradiology 10/2003; 24(8):1501-7. · 2.93 Impact Factor
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ABSTRACT: Major advances in the endovascular treatment of carotid artery stenosis are underway, with an emphasis on improving the safety profile of the technique. This review highlights key areas in the concepts and design of available mechanical neuroprotection devices utilized during carotid stenting to minimize procedural cerebral embolization. The advantages and disadvantages of each system are explored and the available clinical experience is given. The size threshold of particulate material likely to be clinically relevant is examined and compared with pathological analysis of particles trapped by protection systems reported in the world literature. It is shown that the adverse neurological event rate in those protected is lower than that in historical studies of unprotected carotid stenting. Furthermore, the size range and numbers of particles trapped by protections systems are sufficient to cause potential neurological injury if allowed passage to the brain. Further improvements in outcomes may require further refinement of protection technology.
Vascular Medicine 02/2003; 8(1):25-32. · 1.46 Impact Factor
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ABSTRACT: To compare outcomes for two nonrandomized cohorts of patients with high-grade carotid disease who underwent either unprotected carotid stenting or stent implantation protected by the NeuroShield filter.
Under this protocol, symptomatic patients with carotid stenoses >70% or asymptomatic patients with bilateral carotid stenoses who were being evaluated for coronary artery bypass grafting were eligible for carotid stenting. Between December 1998 and November 2001, 75 consecutive patients (57 men; median age 67 years range 45-85) underwent carotid stenting without cerebral protection; concurrently, 75 carotid stent procedures protected with the NeuroShield filter were performed in 73 patients (51 men; median age 66 years, range 47-83). A neurologist reviewed all patients before and after treatment. The groups were comparable for age, sex, and symptoms, but the protected group had a higher proportion of postsurgical restenoses (14.7% versus 1.3%; p=0.003). Outcome measures included death and neurological events at 24 hours and 30 days.
There were minor technical difficulties in 12 of the protected group, but none were clinically relevant. The procedural all-stroke/death rates in the unprotected versus protected groups, respectively, were 5.3% (4/75) and 2.7% (2/75; p=0.681), while the disabling stroke/death rates were 4% (3/75) and 1.3% (1/75; p=0.620). At 30 days, the all-stroke/death rates were 10.7% (8/75) in the unprotected group and 4.0% (3/75) in the protected group (p=0.117); the death/major-disability-from-stroke rates were 6.7% (5/75) and 2.7% (2/75), respectively (p=0.442).
Filter-related complications are well tolerated. Neuroprotection devices have the potential to reduce the procedural neurological event rate. Larger series and/or randomized trials are required for further evaluation.
Journal of Endovascular Therapy 12/2002; 9(6):777-85. · 2.86 Impact Factor
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Journal of Endovascular Therapy 07/2002; 9(3):383; author reply 383-4. · 2.86 Impact Factor
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ABSTRACT: 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).
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.
The technical success rate was 50/50 (100%) for stenting and 49/50 (98%) for filter placement/retrieval. Technical complications comprised nonsymptomatic spasm at the filter site (flow limiting in two cases and non-flow limiting in five cases). Procedural events were one minor stroke (patient fully recovered within 48 hours) in a complex clinical setting and one ventricular fibrillation arrest in a patient before coronary artery bypass grafting who was resuscitated without neurologic event. At 30 days, the death or major disability from stroke rate was 2/50 (4%). No cases were atheroembolic. The all-stroke/death rate was 3/50 (6%). The two deaths were the result of a fatal hemorrhagic stroke that occurred at 4 days and was thought to be caused by reperfusion and a perforated ventricle caused by a temporary pacing wire. One femoral pseudoaneurysm followed failed closure device deployment and required percutaneous thrombin injection. The mean particle number per patient was 12 (range, 0 to 41). The mean particle diameter was 284.9 microm(range, 31 to 1430 microm). The mean ellipsoid volume load was 0.1602 mm(3) (range, 0.0005 to 0.1968 mm(3)).
Carotid stenting protected with NeuroShield is safe. The filter traps embolic debris liberated during the procedure.
Journal of Vascular Surgery 06/2002; 35(5):966-72. · 3.21 Impact Factor
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Journal of Endovascular Therapy 05/2002; 9(2):253. · 2.86 Impact Factor
