ARTICLE IN PRESS+ModelDIII-375; No. of Pages 6

Diagnostic and Interventional Imaging (2014) xxx, xxx—xxx

ORIGINAL ARTICLE / Cardiovascular imaging

Carotid artery stenting: Influence ofexperience and cerebrovascular risk factorson outcome

G. Carrafielloa,∗, M.L. De Lodovicib, G. Piffaretti c,N. Rivoltac, A.M. Ierardia, M. Petrillod,A. Facchinetti b, F. Carimatib, E.P. Verrengiab,M. Maurib, D. Tsetise

a Radiology Department, Unisubria, Ospedale di Circolo, Viale Borri 57, 21100 Varese, Italyb Neurological Department and Stroke Unit, Unisubria, Ospedale di Circolo, Viale Borri 57,21100 Varese, Italyc Vascular Surgery Department, Unisubria, Ospedale di Circolo, Viale Borri 57, 21100 Varese,Italyd Radiology Department, Second University of Naples, Piazza Miraglia 8, 84010 Naples, Italye Interventional Radiology, Heraklion University Hospital, Heraklion, Crete

KEYWORDSCarotid stenting;Experience;Cerebrovascular riskfactors;Outcomes

AbstractAim: To evaluate technical success, complications and the influence of the learning curve onoutcome in carotid artery stenting (CAS) performed in patients not suitable for surgery.Patients and methods: One hundred and nine procedures of protected carotid stenting in103 high risk patients were performed. All patients presented at least one factor that poten-tially increased the surgical risk of carotid endoarterectomy (CEA), according to SAPPHIREcriteria. Neurologic complications were quantified by the National Institutes of Health StrokeScale (NIHSS) and were evaluated by median Rankin Scale (mRS). To evaluate the influenceof experience of the operator to perform CAS, we retrospectively analyzed periproceduraland neurological complications of the first 50 procedures compared with that of the following59 interventions.Results: Technical success rate was 98%. Neurological periprocedural complications wererevealed in 4.5% of patients. In-hospital and 30-days neurological complications rate was 7.6and 2.6% respectively. Periprocedural neurological complications rate was lower in the lastprocedures performed, according to a higher confidence of the operators.Conclusions: CAS may be performed as an alternative of CEA for the treatment of severe carotid

Please cite this article in press as: Carrafiello G, et al. Carotid arrisk factors on outcome. Diagnostic and Interventional Imaging

obstructive disease in patients ncomplications rate.© 2013 Éditions francaises de rad

∗ Corresponding author.E-mail address: gcarraf@gmail.com (G. Carrafiello).

2211-5684/$ — see front matter © 2013 Éditions francaises de radiologiehttp://dx.doi.org/10.1016/j.diii.2013.12.003

tery stenting: Influence of experience and cerebrovascular (2014), http://dx.doi.org/10.1016/j.diii.2013.12.003

ot suitable for surgery. The learning curve positively influence

iologie. Published by Elsevier Masson SAS. All rights reserved.

. Published by Elsevier Masson SAS. All rights reserved.

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ARTICLEIII-375; No. of Pages 6

Stroke is the third most common cause of death andhe first cause of infirmity in Europe and North America.ne of the main cause of ischemic stroke is the large ves-el occlusion due to atherosclerosis. Treatment includesedical therapy, carotid endoarterectomy (CEA) and carotid

ngioplasty and stenting (CAS) [1].Randomized controlled trials have demonstrated that

urgical treatment (CEA) of carotid artery stenosis is effec-ive for the prevention of stroke in symptomatic patientsith carotid artery stenosis greater than 70% and a with

ower benefit in patients with a stenosis ranged from 50 to9% [2—4].

CAS is emerging as an efficient alternative procedure toEA especially in high-risk patients at in the setting of CEA5—7] and it represents the procedure of choice for steno-is surgically inaccessible; furthermore the use of cerebralrotection systems might decrease procedural risk of strokend death [8—10].

We report our experience in 109 consecutive carotidtenting procedures in high risk patients, evaluating thenfluence of experience on technical success rate andhe relationship between risk factors for cerebrovascularisease and adverse outcome of CAS (stroke, neurologic-elated death or TIAs), within 30 days of the procedure andt a medium follow-up of 24 months.

atients and methods

ur series represent a retrospective study. One hundrednd three consecutive patients with severe carotid stenosisnderwent CAS in our center; six of them were undergone to

bilateral CAS procedure, for a total of 109 interventions.Carotid stenosis was revealed by Doppler ultrasonography

nd CT scan or magnetic resonance. The degree of steno-is determined at gray-scale and Doppler US (consideringnternal carotid artery (ICA) peak systolic velocity (PSV))hould be stratified into the categories of normal (no steno-is), < 50% stenosis, 50—69% stenosis, ≥ 70% stenosis to nearcclusion, near occlusion, and total occlusion [11]. CT orRI were performed on the basis of their high spatial resolu-

ion, and the possibility to use post-processing techniques tobtain more information. Angiography revealed the exten-ion and the morphology of the plaque.

Thirty patients (29,1%) were symptomatic and had anistory of non-disabling stroke, retinal infarct or had hadransient retinal or hemispheric attack in the last 6 months;eventy-three (70,9%) patients were asymptomatic.

All patients have been evaluated by a team including anxpert on stroke as suggested by the ICCS-SPREAD Joint Com-ittee [7]; in particular on the basis of their risk factors

nd/or comorbidities, asymptomatic patients were consid-red susceptible to CAS.

All patients had at least one coexisting condition onpecific anatomic and comorbid clinical criteria that poten-ially increased the risk posed by CEA, according toAPPHIRE criteria [5]. All patients underwent neurologicalxamination before and after the procedure and were clin-

Please cite this article in press as: Carrafiello G, et al. Carotid arrisk factors on outcome. Diagnostic and Interventional Imaging

cally followed up (visits or telephone calls). Neurologicomplications were quantified by the National Institutes ofealth Stroke Scale (NIHSS) and recovery was evaluated byedian Rankin Scale (mRS)

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We considered the following risk factors for cere-rovascular disease: age, sex, body mass index (BMI),ypertension, atrial fibrillation, diabetes mellitus, smoking,istory of myocardial infarction, multi vessel artery disease,lcoholic abuse and hyperlipemia.

Contralateral carotid stenosis/occlusion, previous CEAnd previous history of stroke or TIAs were also considered.

Patients were under double antiplatelet therapy, acetyl-alicylic acid (100 mg) and clopidogrel (75 mg/day), from ateast three days before procedure, or were treated with aoading dose of 300 mg of clopidogrel before intervention;ow-weight heparin was administered during the procedure.

Written informed consent was obtained from all patients.The procedure was performed by two interventional

adiologists, with an experience of 16 and 7 years respec-ively. In particular first operator performed more than50 cases of CAS before to work in the actual interventionaladiology (IR) department; the second younger operator per-ormed about 20 CAS before to be part of the actual IR team.

All patients received 3000—5000 units of intravenouseparin after establishment of endovascular access. Angiog-aphy of the aortic arch and carotid arteries was performedo quantify the extent of disease and to further assessnatomical suitability for CAS. A 8F sheath was then pos-tioned in the common carotid artery just proximal to thetenosis. Cerebral protection was used in all cases with a.014-inch Cordis Angio Guard (Bridgewater, NJ, USA) orbbott EmboShield (Maidenhead, UK).

In nearly 100% of the cases, after deployment, thetents were balloon dilated to the internal diameter of thendiseased internal carotid artery, as determined from there-procedure angiogram. All patients received intravenouslycopyrrolate (400 lg) before balloon dilatation.

We usually used Carotid Wallstent (Boston Scientificnternational SA, Nanterre Cedex, France) in patients withoft plaques (Fig. 1a, b, c) and Precise Pro RX stent (Cordis;iami Lakes, Florida) to treat calcified plaques.

All femoral puncture sites were closed with Angio-SealSt. Jude’s Medical, St. Paul, MN, USA) closure device.

A satisfactory result was considered when a residualtenosis < 30% was found at post procedural angiographicxamination.

Patient’s neurological status was monitored during in-ospital staying.

Clinical and carotid duplex ultrasonography controls wereerformed 24 hours and 30 days after the procedure andhen required on the basis of the clinical symptomatologyy neurologists and radiologists respectively.

Strokes were documented with neurological examina-ions and brain TC or MRI. Non-neurological proceduralomplications (hypotension, bradycardia, A-V fistulas andccess site bleeding) were monitored too.

The patients were discharged on dual antiplatelet ther-py (clopidogrel 75 mg and aspirin 100 mg per day) for0 days, and subsequently a single antiplatelet agent wasontinued.

Anticoagulant drugs were suggested in some patientsith atrial fibrillation or for those who developed stroke as

tery stenting: Influence of experience and cerebrovascular (2014), http://dx.doi.org/10.1016/j.diii.2013.12.003

omplication.To evaluate the influence of experience of the opera-

or in performing CAS on periprocedural and neurologicalomplications we retrospectively analyzed data of the

ARTICLE IN PRESS+ModelDIII-375; No. of Pages 6

Carotid artery stenting: Influence of experience and cerebrovascular risk factors on outcome 3

Figure 1. Male patient of 73 years old asymptomatic with multi vessel artery disease, alcoholic abuse history and hyperlipemia. 3Dmaximum intensity projection (MIP) reconstruction of CT scan revealed a stenosis of left internal carotid artery (ICA) (a); preliminary

cuments correct deployment of the stent (7 × 40 mm Carotid Wall stent,olution of the stenosis (c).

Table 1 Atherosclerosis risk factors.

Risk factors Number ofpatients

(%)

Hypertension 97 88Alcoholic abuse 13 11.9Smoking 63 57.7Hyperlipidemia 82 75.2Diabetes mellitus 40 36.6History of myocardial infarction 40 36.6Multi vessel artery disease 36 33Atrial fibrillation 10 9.1

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angiogram confirmed the stenosis of left ICA (b); final angiogram doBoston Scientific-International SA, Nanterre Cedex, France) and res

first 50 procedures compared with data of the following59 interventions. �2 Test was used to analyze differencesbetween the groups. The critical value for statistical sig-nificance was set at 0.05. GraphPad© software (MedCalc©

Software, version 5.02) was used for the descriptive analy-ses.

Results

One-hundred three patients with high surgical risk forendoarterectomy were underwent to 109 procedures ofprotected CAS between October 2005 and January 2011;71 patients (68.9%) were male, 32 (31%) female with an aver-age age of 73 ± 6 years (range 56—88 years) and a prevalenceof patients between 65 and 80 years. Twenty-two patients(21%) were older than 80 yrs. In six cases, carotid revascu-larization was bilateral; all that patients were symptomatic.

Eleven patients (9.8%) had a previous aborted carotidendoarterectomy due to severe electroencephalographic(EEG) alterations during carotid clamping; 29 patients (26%)had a bilateral carotid artery disease, 14 (12.8%) with con-tralateral total occlusion. All that patients were part ofsymptomatic group.

Carotid stenosis were located respectively on the left in57 patients (52%) and on the right in 52 patients (48%).

The mean degree of stenosis was 76.5% (range70.5—89.2%)

Atherosclerosis risk factors were widely spread, espe-cially hypertension, hyperlipidemia and smoke (Table 1).

Please cite this article in press as: Carrafiello G, et al. Carotid arrisk factors on outcome. Diagnostic and Interventional Imaging

Most patients had associated multiple risk factors; only infive cases an isolated risk factor was present. 32% of ourpopulation was overweight (BMI > 25) with mean BMI of 26.8and the 29% was obese (BMI > 30).

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Seventy-three patients (70.9%) were asymptomatic andarotid artery stenosis were discovered during evaluationor stroke prevention program; 30 patients (29,1%) had pre-ented symptoms that leaded to CAS; among them 23 hadIA, three a minor stroke and four a major stroke with aavorable outcome. The most frequent neurological defectsere motor or sensitive impairment or speech disturbances.he most common type of plaque was the medium one, a

ow-grade calcified/ulcerate lesion with a length between3 and 20 mm.

Mean follow-up was 24 months in 70% of cases.Non neurological periprocedural complications occurred

n three patients (2.7%), two local bleeding and 1 artero-enous fistula on puncture site (two of them wereymptomatic and the last was asyptomatic). Nine patients8.2%) showed a transitory bradycardia (they were all part of

tery stenting: Influence of experience and cerebrovascular (2014), http://dx.doi.org/10.1016/j.diii.2013.12.003

ymptomatic group) and 2 mild hypotension (one was symp-omatic and the other one was an asymptomatic patient).

ARTICLE IN PRESS+ModelDIII-375; No. of Pages 6

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9 patients.

In eight patients (7.3%) periprocedural aspecific neu-ological complications occurred; they couldn’t be easilyeferred to cerebrovascular disease because of their aspe-ific features: six episodes of confusion and disorientationnd two aspecific sight alterations, reversible after someours. They could be due to microembolic effect or todverse reaction to anesthesia. Seven patients (14%) (sixymptomatic and one asymptomatic) were part of the first0 cases, 1 (1.6%) (sympatomatic patient) of the followingroup. A CT scan was performed in four patients imme-iately after the onset of the symptomatology and after4 hours; in four patients an MRI with diffusion sequencesas performed. Only two patients (part of the first 50 cases)resented slight diffusion alterations due to microembolicffect and resolved completely at following controls.

Procedural success was achieved in 107 cases (98%).During hospital stay three patients (2.7%) (all part of

ymptomatic group) experienced major adverse events withtroke (NHISS ranging from 3 to 8); 2 of them (1.8%) pre-ented a TIA; these events happened just few hours afterhe procedure. The patients with major stroke had a goodecovery in few weeks (mRS 2 at 30 days follow-up). All ofhem had contralateral carotid stenosis.

We considered the reported events as a result of debrisriginated during stent placement. A learning curve thatnfluenced stroke incidence was verified, as 2 of the majoreurological events and TIAs occurred between the first0 patients treated.

One patient had a major stroke and died one month afterospital discharge; he had a contralateral carotid occlu-ion. One had a major stroke 2 weeks after the procedure.nother patient experienced a minor stroke 20 months afterhe procedure; he was in the group of the last treatedatients and had a previous history of an aborted carotidEA.

The overall 30-day stroke and neurologic death rate was.5% (5 events/109 procedures). Neurological complicationsere higher in patients with history of stroke or TIAs

Please cite this article in press as: Carrafiello G, et al. Carotid arrisk factors on outcome. Diagnostic and Interventional Imaging

efore CAS, with statistical significance. For asymptomaticatients, the 30 days stroke and neurologic death rate was.6% (two strokes; two events/76 patients), while for symp-omatic patients it was 7.6% (two strokes, one death;

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rience of the operators. 1◦ group: first 50 patients; 2◦ group: last

hree events/39 procedures) (P < 0.01); in the group of therst 50 patients treated the overall 30-day stroke andeurologic death was 8% but when considering the last9 patients treated it decreased to 1.6% (1 event/59atients). Considering neurologic complications registereduring hospital-stay and in the 30 days after and aspe-ific (without a proven cause) neurological peri-proceduralomplications in the two groups (first 50 patients and last9′) a statistically significative difference was revealedP value = 0,02) (Fig. 2). It confirms that neurologicalomplications are related to a learning experience of theperators.

Adverse outcome were more frequent in older patients> 80 years old) and in symptomatic patients, but with-ut statistical significance. Data analysis in order toiscover correlations between risk factors for cerebrovas-ular disease and complication rate showed no statisticalignificance. No correlation was found between sex,ypertension, smoking, previous IMA, multivessels disease,moking, hyperlipidemia, atrial fibrillation, diabetes, pre-ious CEA, degree of carotid stenosis, contralateral carotidtenosis/occlusion and periprocedural neurological or non-eurological complications.

iscussion

n this study, we have investigated the results of CAS in group of patients with a high risk for carotid surgery,roup that included patients not suitable for CEA becausef the potential increased complications of surgery. In03 patients, 109 carotid arteries stentings were successfullyerformed, with a low but not neglectable rate of neuro-ogical complications; stroke and death rates were higherhan those of the American Heart Association (AHA) guide-ines for carotid interventions in symptomatic cases (3% forsymptomatic patients; 6% for symptomatic patients) [12],ut we can consider them nearby a good result, similar to

tery stenting: Influence of experience and cerebrovascular (2014), http://dx.doi.org/10.1016/j.diii.2013.12.003

hat latest studies report.The EVA-3 s randomized trial [13] showed a CAS

troke/death rate of 9.6% at 30 days in patients with symp-omatic severe carotid stenosis. The SPACE trial reported

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ARTICLEDIII-375; No. of Pages 6

Carotid artery stenting: Influence of experience and cerebro

a stroke/death rate at 30 days of 7.6% for CAS and 6.5 forCEA [14]. In these trials, a limited use of cerebral protec-tion devices, as well as an insufficient operator experiencerequired, were observed.

Lower stroke-death rates have been reported in largeseries of patients with a long-term follow-up, including nohigh risk patients [15].

Our series were characterized by a higher baseline riskprofile. Our results are similar to those obtained in the SAP-PHIRE trial (death/stroke rate 4.5% for CAS) [6], and may beconsidered in the limits of AHA guidelines [12]; these stud-ies excluded patients with high risk as patients older than80 years, with contralateral occlusions and with restenosisafter CEA [16].

In the present study, 22% of patients are older than80 years, 12% and 43% respectively present contralateralcarotid involvement and cardiovascular disease.

Asymptomatic patients were included only when had pro-gressive or bilateral carotid stenosis and a life expectancyover than 4 years, considering that no advantage to preventa stroke is documented in patients with a life expectancyless than 4 years [4].

No neurological complications observed were reversibleand not disabling.

The choice of the stent depends on the anatomy of thecarotid axis, the characteristics of the plaque (calcified ornot) and of the stenosis, their length and the differentcaliber of the common and internal carotid artery. A pre-dilatation of the stenosis is performed only when it is tightand calcified and the passage of the stent delivery systemis difficult. The length and the diameter of the stent werevariable, respectively between 30 and 40 mm and 6 and9 mm. On the basis of their geometry, stents are subdividedin open-cells and closed-cells structure. The first ones aremore flexible and more adapt in tortuous vessels (kinking)and to cover calcified plaques; the other ones are more usedin soft plaques. The conic stents are employed in patientswith different carotid diameters.

Learning curve has influenced outcomes in our CAS series,too. In particular, we registered a death stroke ratio of 8% inthe first 50 patients while the same ratio was of 1.6% in thefollowing 59 cases, even if a statistically significant differ-ence was not observed. Many authors have pointed up therelevance of the operator’s experience, and the importanceof the learning curve has been demonstrated in randomizedstudies [12,17—19].

We have found significantly higher neurological complica-tion rate in patients with previous history of stroke or TIAs,and physician’s decision considered it, in association withlocally available facilities and resources.

Older patients showed higher rate of neurological compli-cation, according with previous other studies [20]; in ourseries, a statistical significance was not demonstrated.

We registered a relatively acceptable in-hospital stay and30 days stroke-death rate in association with a good tech-nical success. Considering that neurological complicationsmay be related to operator’s experience, in early learningcurve patients with a low-risk profile and without any history

Please cite this article in press as: Carrafiello G, et al. Carotid arrisk factors on outcome. Diagnostic and Interventional Imaging

of previous stroke/TIAs should be selected. The stroke-death rate seems to be promising in a long follow-up. Inour experience, protected CAS is a safe and effective tech-nique and it should be considered an alternative treatment

PRESSular risk factors on outcome 5

o surgery in high-risk patients in order to get stroke rates low as possible. The limit of the present study may beonsidered the low number of patients treated, with a con-equence limited statistical power.

Non-invasive carotid artery occlusion treatment may beonsidered after a multidisciplinary approach of the patientneurologist, vascular surgeon, interventional radiologist) inrder to evaluate procedural risk in every patient.

isclosure of interest

he authors declare that they have no conflicts of interestoncerning this article.

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