Unprotected Carotid Artery Stenting Research Articles

"Modified No-touch technique using floating wire"- a novel technique of Unprotected Carotid Artery Stenting for aorto-ostial lesion.

Takayasu arteritis (TA) is chronic inflammatory large vessel vasculitis where aorta and its main branches bear the maximum burden. Here, we report a case of 23-yr-old hypertensive male that had an episode of transient ischemic attack (TIA) three months back. He was diagnosed with type I Takayasu’s arteritis (TA) showing long segment osteo-proximal lesion of right common carotid artery (RCC) with near total occlusion, along with lesion involving bifurcation and proximal part of internal carotid artery having similar degree of severity on computed tomographic angiography of aorta. It was successfully stented with two overlapping 6x19, and 6x18 mm Herculink stent (Abott Vascular, USA) distally at 12 atm pressure while aorto-ostial lesion was stented using 7x19, and 7x18 mm overlapping Herculink stents at 14 atm pressure achieving excellent results with no residual stenosis. Carotid artery stenting (CAS) was unprotected as no embolic protection device was used, and aorto-ostial lesion was stented keeping a floating wire in subclavian artery as a modification of no touch technique. At 4-year follow up, computed tomographic imaging revealed well apposed stents with excellent patency.

Unprotected carotid artery stenting in symptomatic elderly patients: a single-center experience

Background and purposeSurgery is known to have fewer adverse events in patients aged >75 years with carotid stenosis, but some are not candidates due to comorbidity. Stenting using protection devices...

Unprotected carotid artery stenting in modern practice

Embolic protection devices (EPD) may provide a mechanism to reduce peri-procedural strokes. They are advocated by consensus guidelines and mandated for Medicare reimbursement. However, outcomes data remain mixed. We aimed to characterize the population of patients undergoing unprotected carotid artery stenting (CAS) and assess the utility of distal filter EPD (F-EPD) in elective CAS. We analyzed patients enrolled in the CARE Registry® undergoing CAS between May, 2005 and January, 2012. We assessed the relationship between distal F-EPD use versus no use (No-EPD) and the composite of in-hospital death or stroke (MAE) in unadjusted and 1:3 propensity-matched analyses. Embolic protection was not attempted in a total of 579 out of 13,263 cases performed (4.4%). Patients in the No-EPD group had worse preprocedure neurologic risk factors including higher rates of acute evolving stroke, prior TIA/stroke, symptomatic lesion status, spontaneous carotid artery dissection, and use of general anesthesia intraprocedurally (all Standardized Differences{sd} >10). After exclusion of nonelective cases there was no significant difference in MAE between the No-EPD and F-EPD groups (1.6% vs. 2.3%, sd = 4.72). Additionally, after propensity matching, rates of MAE did not differ between the No-EPD (n = 355) and F-EPD (n = 1065) groups (1.7% vs. 2.5%, sd = 5.87). Patients selected to undergo unprotected CAS in contemporary practice have high rates of adverse preprocedure neurologic risk factors. Our propensity-matched analysis did not demonstrate evidence of significant benefit or harm associated with use of F-EPD in elective CAS patients.

Unprotected Carotid Artery Stenting in Symptomatic Patients with High-Grade Stenosis: Results and Long-Term Follow-Up in a Single-Center Experience

The use of cerebral protection during CAS is an extended practice. Paradoxically it is open to question because it can lead to potential embolic complications. The aim of this study was to evaluate the safety and efficacy of CASWPD in patients with severe symptomatic carotid artery stenosis. A prospective study was performed including 210 consecutive patients (201 symptomatic and 9 asymptomatic) with carotid artery stenosis >70%. All patients were treated by CASWPD. Angiographic results and neurologic complications were recorded during the procedure and within 30 days after it. All patients underwent clinical evaluation and Doppler sonography follow-up at 3, 6, and 12 months after the procedure. Two hundred twenty carotid arteries were treated. The average degree of stenosis was 88.9%. The procedure was successfully completed in 212 (96.4%) arteries. After stent placement, 98.6% of arteries showed no residual stenosis or <30%. Balloon angioplasty dilation before stent placement was performed in 16% of cases. During the 30-day periprocedural period, there were 3 major complications (1.4%), including 1 disabling ischemic stroke, 1 acute stent thrombosis, and 1 MI. The last 2 patients died from these complications. At 1-year follow-up 24 (12.8%) restenoses, 2 new ipsilateral strokes, 1 contralateral stroke, and 5 deaths (2.7%) had occurred. None of these deaths were related to the initial stroke. In our study, unprotected stent placement in symptomatic patients with severe carotid artery stenosis has demonstrated a low incidence of complications. We believe that this is due to the reduction of maneuvering and manipulation through the stenosis and to the protective effect of the stent placement before angioplasty balloon dilation.

Comparison of Stent Free Cell Area and Cerebral Lesions after Unprotected Carotid Artery Stent Placement

Objective This study evaluates the correlation between closed, semi-closed and open-cell stent design and the association between stent type and clinical outcome as well as magnetic resonance imaging (MRI) findings. Design A total of 194 patients who underwent unprotected carotid artery stenting (CAS) as well as diffusion-weighted magnetic resonance imaging (DW-MRI) before and after intervention were retrospectively reviewed. Materials and methods Three stent designs were studied: closed cell, semi-closed cell and open cell. Spearman’s Rho test was performed between the stent free cell area and the number and area of ischaemic lesions found after intervention. Adverse events were evaluated. Results There was no significant difference in clinical outcome between the three stent groups (Zilver, Cook Europe, Denmark; Smart, Codman, MA; and Wallstent, Stryker, MN, USA). A significant correlation was found between the stent free cell area and the number and area of new ischaemic lesions on DW-MRI ( P = 0.023). There were significantly fewer new lesions with an open-cell design (Zilver; 12.76 mm 2 free cell area) than with a closed-cell design (Wallstent; 1.08 mm 2 free cell area). Conclusions Open-cell stent was related to a lower number and area of silent cerebral ischaemic lesions after unprotected CAS. However, clinical outcome, measured by incidence of adverse events and clinical neurologic assessment, was not significantly different between patients with different stent designs.

Letter by Naggara et al Regarding Article, “Are Distal Protection Devices ‘Protective' During Carotid Angioplasty and Stenting?”

To the Editor: The usefulness of embolic brain protection (EBP) devices in patients treated by carotid artery stenting is a matter of continuous debate. To date, as all available evidence comes from observational studies, no definite conclusions can be established. Tallarita et al1 published their experience with 357 patients treated with carotid artery stenting, including 252 patients treated with EBP. The observed risks of stroke, myocardial infarction, or death were 5/252 (2.0%) and 5/105 (4.8%) in patients treated with and without EBP, respectively. As there were no significant differences between protected and unprotected carotid artery stenting, they concluded that the real efficacy of EBP must be questioned. However, they missed some important previous data and, more importantly, misinterpreted the nonsignificant result of their …

Response to Letter by Naggara et al Regarding Article, “Are Distal Protection Devices ‘Protective' During Carotid Angioplasty and Stenting?”

HomeStrokeVol. 42, No. 11Response to Letter by Naggara et al Regarding Article, “Are Distal Protection Devices ‘Protective' During Carotid Angioplasty and Stenting?” Free AccessReplyPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReplyPDF/EPUBResponse to Letter by Naggara et al Regarding Article, “Are Distal Protection Devices ‘Protective' During Carotid Angioplasty and Stenting?” Tiziano Tallarita, MD and Giuseppe Lanzino, MD Tiziano TallaritaTiziano Tallarita Search for more papers by this author and Giuseppe LanzinoGiuseppe Lanzino Search for more papers by this author Originally published29 Sep 2011https://doi.org/10.1161/STROKEAHA.111.629709Stroke. 2011;42:e581Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2011: Previous Version 1 Response:Embolic protection devices (EPD) are currently considered the standard of care during both angioplasty and stenting for carotid stenosis. However, there are limitations associated with the use of these devices, including their relative stiffness; the need for some to cross the lesion before protection is achieved; relative prolonged occlusion time for some; and the recatching phase with crossing of a freshly stented segment, with potential risk to generate distal emboli. In their systematic review of mostly single-institution observational studies, Naggara et al1 found that the pooled relative risk of stroke or death in patients treated with EPDs (EPD+) compared with those undergoing unprotected carotid artery stenting (EPD−) was 0.55 (95% CI, 0.41–0.73), and they cite methodological shortcomings in our own single-institution study.2 We routinely use protection devices during angioplasty and stenting because we believe their use makes sense despite the lack of strong evidence supporting routine use. However, we also believe there are situations where the EPD itself is the most problematic part of the procedure; in such cases, it is reasonable to perform portions of the procedure or the entire procedure without this protection. Most studies in the analysis of Naggara et al were single-institution series just like our own, with all the methodological shortcomings associated with such studies. Moreover, Naggara and colleagues ignored that most series reported in their updated systematic review (and our own is no exception) included historical EPD− controls for comparison. These patients were treated in the first phase of the learning curve for most operators, and with devices not quite as sophisticated as are ones used in more recent years. In addition, as it is common in the early phases of new technology, such as angioplasty and stenting at that time, patients considered for this treatment were true high-risk surgical candidates with significant comorbidities. This was also reflected in our series where patients treated without an EPD had significantly higher rates of hypertension, symptomatic lesions, and history of myocardial infarction, all factors shown to be associated with higher risk of periprocedural complications after angioplasty and stenting.3 The statement by Naggara et al that in our series the relative risk of stroke, myocardial infarction, or death was 0.42 in EPD+ patients is highly misleading because it does not take into account that these patients were healthier, and were treated by much more experienced operators and with much better devices than were patients who underwent EPD−.Although the evidence for EPDs comes mostly from observational, single-institution studies, there is strong evidence against them from randomized studies like in International Carotid Stenting Study (ICSS),4 and these high-quality data cannot be ignored. In conclusion, although we support the use of protection embolic devices in most cases, we do not feel that their use is absolutely necessary, and there may be situations where it is better to go unprotected; this is especially the case when placement of the protection device itself is the riskiest portion of the procedure. The main aim of our article was to trigger a healthy debate on this topic in light of ICSS data.Tiziano Tallarita, MD Division of Vascular Surgery Mayo Clinic Rochester, MNGiuseppe Lanzino, MD Department of Radiology Department of Neurosurgery Mayo Clinic Rochester, MNDisclosuresNone.FootnotesStroke welcomes Letters to the Editor and will publish them, if suitable, as space permits. Letters must reference a Stroke published-ahead-of-print article or an article printed within the past 3 weeks. The maximum length is 750 words including no more than 5 references and 3 authors. Please submit letters typed double-spaced. Letters may be shortened or edited. Include a completed copyright transfer agreement form (available online at http://stroke.ahajournals.org and http://submit-stroke.ahajournals.org).

Unprotected carotid artery stenting: complications in 6 months follow-up

The most serious complications of carotid artery stenting (CAS) are related to the release of particles into the cerebral circulation. Although embolic protection devices may reduce the incidence of cerebral embolization, their use may be associated with additional complications including spasm or dissection. In this report, we present our experience with patients who underwent unprotected CAS. We prospectively enrolled patients with symptomatic internal carotid artery stenosis from October 2008 to June 2010.Stenosis diagnosed based on carotid duplex and/or CT angiography findings and confirmed by digital subtraction angiography. All stenting procedures were done without using a protection device. Neurologist evaluated neurological situation of the patients, 24h, 30days, 3 and 6months after stenting. Patients had carotid duplex scan scheduled on the third and sixth month after the procedure. Overall, 116patients underwent stenting; technical success rate was 100% .Mean age of patients was 68.48 ± 9.84years, and 69% of the patients were male. One patient (1/116, 0.86%) developed transient ischemic attack during the procedure. One non-neurologic death (1/116, 0.86%) occurred 18h after the procedure because of myocardial infarction. In 1-month follow-up, only one patient (1/115, 0.87%) presented with neurological complication as a consequence of thalamic hemorrhagic. Six months follow-up revealed two cases (2/115, 1.74%) with in-stent restenosis which one of them was severe and symptomatic and underwent angioplasty. Unprotected carotid stenting appears to accompany with low early and late complications. Cerebral embolization during CAS is not the only cause of these complications and the use of cerebral protection devices may therefore not prevent all major complications including myocardial infarction, hyperperfusion syndrome, and re-stenosis.

New Ischemic Brain Lesions on MRI after Stenting or Endarterectomy for Symptomatic Carotid Stenosis: A Sub-Study of the International Carotid Stenting Study (ICSS)

Conclusion: In a substudy of patients randomized in the International Carotid Stenting Study (ICSS) comparing carotid artery stenting with carotid endarterectomy for symptomatic carotid stenosis, patients randomized to the stenting group had three times more ischemic lesions found by post-treatment magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) than patients randomized to the endarterectomy group. Cerebral protection devices did not seem to be effective in preventing ischemic DWI lesions after stenting. Summary: The ICSS randomized patients with symptomatic carotid artery stenosis to carotid stenting or carotid endarterectomy. Of the 50 centers that participated in the ICSS study, 7 took part in an MRI substudy, the results of which were reported in this article. In the MRI substudy, MRI was done 1 to 7 days before treatment (endarterectomy or stenting), at 1 to 3 days after treatment (post-treatment scan), and again at 27 to 33 days. The primary end point of this substudy was the presence of at least one new ischemic brain lesion on DWI on the post-treatment scan. Analysis was per protocol, and investigators who read the scans were blinded to whether the patient had received endarterectomy or carotid stenting. The substudy comprised 231 patients (107 in the endarterectomy group and 124 in the stenting group). The detection of one new DWI lesion on post-treatment scans done a median of 1 day after treatment occurred more frequently in the stenting group (50% of the 124 patients) than in the endarterectomy group (17% of the 107 patients; odds ratio [OR], 5.21; 95% confidence interval [CI], 2.78-9.79; P < .0001). There were changes at 1 month on fluid-attenuated inversion recovery sequences in 28 of 86 patients (33%) in the stenting group and in 6 of 75 patients (8%) in the endarterectomy group, (adjusted OR, 5.93; 95% CI, 2.25-15.62; P = .0003). In centers with a policy of using cerebral protection devices, new DWI lesions were present after treatment in 37 of 51 patients (73%) in the stenting group and in 8 of 46 (17%) in the endarterectomy group (adjusted OR, 12.20; 95% CI, 4.53-32.84). In centers with a policy of using unprotected carotid artery stenting, new DWI lesions were present in 25 of 73 patients (34%) in the stenting group and in 10 of 61 patients (16%) in the endarterectomy group (adjusted OR, 2.70; 95% CI, 1.16-6.24; interaction P = .019). Subanalyses of age <71 years, sex, whether the qualifying event was a TIA or stroke, and whether there were DWI lesions present on the pretreatment scan all indicated higher rates of new DWI lesions after stenting compared with endarterectomy. Comment: Previous nonrandomized studies have also suggested higher rates of ischemic lesions detected on DWI imaging after stenting compared with endarterectomy. A meta-analysis of these studies is presented in Fig 4 of this article and indicated the OR of new ischemic lesion after treatment was 6.71 (95% CI, 4.57-9.87) favoring endarterectomy. The authors' OR of 5.21 is very similar to that obtained from the meta-analysis. The clinical significance of DWI lesions in the long run is unknown but is postulated to eventually lead to cognitive decline and dementia (Pendlbury ST et al [Lancet Neurol 2009;8:1006-18]). Of particular interest is the apparent lack of protection against DWI lesions afforded by cerebral protection devices. One might postulate, given the relative ORs for DWI lesions with and without protection devices, that protection devices actually increase the risk of DWI lesions! There are a number of reasons why cerebral protection devices may have been ineffective in this study. For instance, all protection devices in this study were of the filter type, and conclusions about other types of devices cannot be made. Another possible conclusion is that cerebral protection during carotid artery stenting is another idea that seems like a good idea but does not hold up to proper scrutiny when one actually examines data collected by unbiased observers.

Complication rate in unprotected carotid artery stenting with closed-cell stents

The discussion on the use of protection devices (PDs) in carotid artery stenting (CAS) is gaining an increasing role in lowering the periprocedural complication rates. While many reviews and reports with retrospective data analysis do promote the use of PDs the most recent multi-centre trials are showing advantages for unprotected CAS combined with closed-cell stent designs. We retrospectively analysed 358 unprotected CAS procedures performed from January 2003 to June 2009 in our clinic. Male/female ratio was 2.68/1. The average age was 69.3 years. Seventy-three percent (261/358) showed initial neurological symptoms. All patients were treated on a standardised interventional protocol. A closed and small-sized cell designed stent was implanted in most cases (85.2%). One hundred seventy-one (47.8%) were controlled by Doppler ultrasonography usually at first in a 3-month and later in 6-month intervals. The peri-interventional and 30-day mortality/stroke rate was 4.19% (15/358). These events included three deaths, five hyperperfusion syndromes (comprising one death by a secondary fatal intracranial haemorrhage), one subarachnoid haemorrhage and seven ischaemic strokes. Only 20% (3/15) of all complications occurred directly peri-interventional. The overall peri-interventional complication rate was 0.8% (3/358). Most complications occurred in initial symptomatic patients (5.36%). The in-stent restenosis rate for more than 70% was 7% (12/171) detected at an average of 9.8 month. Our clinical outcome demonstrates that unprotected CAS with small cell designed stents results in a very low procedural complication rate, which makes the use of a protection device dispensable.

Filter-Protected versus Unprotected Carotid Artery Stenting: A Randomised Trial

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 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. Conclusions: 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.

Cerebral Protection Devices Reduce Periprocedural Strokes During Carotid Angioplasty and Stenting:A Systematic Review of the Current Literature

To compare through a systematic review of published literature the stroke outcomes in protected and unprotected carotid artery stenting (CAS). PubMed and Cochrane electronic databases were queried to identify peer-reviewed publications from 1995 to 2007 meeting our pre-defined criteria for inclusion (English language, human only, at least 20 patients reported) and exclusion (procedures performed for the treatment of total occlusion, dissection, or aneurysmal disease; urgently performed procedures; use of covered stents; access other than transfemoral). Information was collected on a standardized data abstraction form for pooled analysis of total strokes within 30 days of procedure in all patients and in symptomatic and asymptomatic subgroups. A random effects meta-analysis of studies with concurrently reported data on protected and unprotected CAS was performed. Initial database query resulted in 2485 articles, of which 134 were included in the final analyses (12,263 protected CAS patients and 11,198 unprotected CAS patients). Twenty-four studies included data on both protected and unprotected CAS. Using pooled analysis of all 134 reports, the relative risk (RR) for stroke was 0.62 (95% CI 0.54 to 0.72) in favor of protected CAS. Subgroup analysis revealed a significant benefit for protected CAS in both symptomatic (RR 0.67; 95% CI 0.52 to 0.56) and asymptomatic (RR 0.61; 95% CI 0.41 to 0.90) patients (p<0.05). Meta-analysis of the 24 studies reporting data on both protected and unprotected stenting demonstrated a relative risk of 0.59 (95% CI 0.47 to 0.73) for stroke, again favoring protected CAS (p<0.001). Our systematic review indicated that the use of cerebral protection devices decreased the risk of perioperative stroke with CAS. A well designed randomized trial can further confirm our findings and possibly indicate the device with the best outcomes.

Lesion load in unprotected carotid artery stenting

The purpose of the study was to determine the incidence of new ischemic lesions found on diffusion-weighted MR imaging (DWI) in nonselected patients after unprotected carotid artery stent placement. We retrospectively reviewed a nonrandomized cohort of 197 patients presenting with carotid occlusive disease who underwent unprotected carotid artery stent placement between 2003 and 2006. Mean degree of stenosis was 86.94% +/- 9.72. In all patients, DWI was obtained before and 24 h after stent placement. New lesions were evaluated according to size and location. In 59 of 197 patients (29.9%), new ischemic lesions were found on DWI in the vessel dependent area. In 23 of 197 patients (11.7%), new ischemic lesions were found in the vessel independent area. Combined stroke/death rate was 3.63%. In our series of unprotected carotid angioplasty with stent, we found new DWI lesions in 34% of the patients. Further studies should now show in how far protection devices can reduce these lesions.

Complications and Follow-up after Unprotected Carotid Artery Stenting

This prospective study was undertaken to determine the success rate, complications, and outcome of carotid artery stenting (CAS) without the use of cerebral protection devices. During 12 months, 94 high-grade stenoses of the carotid artery in 91 consecutive patients were treated. Sixty-six (70%) of the stenoses were symptomatic and 28 (30%) were asymptomatic. In all 94 carotid stenoses CAS was successfully performed. During the procedure and within the 30 days afterwards, there were 2 deaths and 3 major strokes in the 66 symptomatic patients, resulting in a combined death and stroke rate of 5 of 66 (7%). Only one of these complications, a major stroke, occurred during the procedure. In the 6-month follow-up, one additional major stroke occurred in a originally symptomatic patient resulting in a combined death and stroke rate of 6 of 66 (10%) for symptomatic patients at 6 months. No major complications occurred in asymptomatic patients during the procedure or in the 6-month follow-up period. At 6 months angiographic follow-up the restenosis rate with a degree of >50% was 3 of 49 (6%) and the rate with a degree of >or=70% was 1 of 49 (2%). Cerebral embolization during CAS is not the only cause of the stroke and death rate associated with the procedure. The use of cerebral protection devices during the procedure may therefore not prevent all major complications following CAS.

Procedure-Related Complications and Early Neurological Adverse Events of Unprotected and Protected Carotid Stenting:Temporal Trends in a Consecutive Patient Series

To report procedure-related complications and neurological adverse events of unprotected over-the-wire (OTW) and protected rapid exchange (RX) carotid artery stenting (CAS) in a single-center patient series during an 8-year period. Between 1997 and 2004, 651 consecutive patients (445 men; median age 72 years, interquartile range 64-77) were enrolled in a registry database of carotid stent procedures; from 1997 to 2002, 471 patients underwent unprotected CAS using an OTW technique, while the other 180 patients were treated with protected CAS using RX monorail systems from 2003 to 2004. Technical success and complications (neurological, hemodynamic instability, and access site) up to 30 days post intervention were analyzed. Technical success improved from 95% with unprotected OTW CAS to 99% with protected RX CAS (p=0.025). Procedure-related complications occurred in 86 (18.3%) of 471 unprotected OTW CAS versus 18 (10.0%) of 180 protected RX CAS procedures (p=0.010). Transient ischemic attacks (3.2% versus 2.8%), minor stroke (1.7% versus 0.6%), and major stroke (2.1% versus 0.6%) showed a trend toward a difference between unprotected OTW and protected RX CAS (p=0.076); combined 30-day stroke/death rates were 3.8% for OTW versus 1.2% for RX CAS (p=0.073). During the 8-year period from 1997 to 2004, the annual rates of procedure-related complications (p=0.002), neurological events (p=0.040), and stroke and death (p=0.14) markedly decreased. Carotid stenting became substantially safer in the era of protected RX technology. In addition to a reduction in neurological complications, which may be due to cerebral protection devices, the improved technical success and reduced non-neurological procedure-related complications are likely due to recent technical advances unrelated to cerebral protection.