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CH
31
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CH
31
PREVENTION AND TREATMENT OF STROKE

CHAPTER
32 Carotid Artery Stenting
Sriram S. Iyer, Jonathon Habersberger, Jiri Vitek, Christina Brennan,
Gary Roubin
On May 6th, 2011, the U.S. Food and Drug Administration (FDA)
followed up on the January 2011 recommendation of the FDA
Circulatory System Device Panel
1
and approved the RX Acculink
carotid stent (Abbott Vascular, Santa Clara, Calif.) for use in conjunction with Abbott's embolic protection device (EPD), the
Accunet filter. The expanded label as a result of the FDA's approval
was for treatment of extracranial carotid stenosis in symptomatic
and asymptomatic patients who would otherwise be considered
standard risk for surgical carotid endarterectomy (CEA). This was a
landmark event because for the first time, carotid stenting, at least
in the United States, qualified as a standard-of-care treatment and
was no longer investigational or experimental for the majority of
patients with carotid artery disease. (Earlier in [2004], the FDA had
approved carotid artery stenting [CAS] for high CEA risk patients).
This chapter reviews historical aspects and development of CAS,
discusses stenting technique in detail, and reviews clinical trial
data that support current indications for this procedure.
Historical Perspective
Carotid Endarterectomy
Surgical treatment for carotid artery stenoses was introduced in
the early 1950s.
efit for surgery over medical therapy, large prospective randomized
trials investigating the beneficial effect of CEA on stroke reduction
were not initiated until the late 1980s and early 1990s. Landmark
studies including the North American Symptomatic Carotid
Endarterectomy Trial (NASCET),
(ECST),
and Asymptomatic Carotid Surgery Trial (ACST)
benefits of surgery over best available medical treatment for reducing the risk of stroke in both symptomatic (NASCET, ECST) and
asymptomatic patients (ACAS, ACST). Carotid endarterectomy surgery is comprehensively discussed in Chapter 33.
Patients included in these surgical studies were carefully
selected; specifically, subjects who were considered high CEA risk
were excluded from participation. Thus, octogenarians, patients
with recurrent stenosis following prior ipsilateral endarterectomy,
intracranial stenosis that was more severe than the surgically
accessible lesion in the neck, unstable angina pectoris, recent
myocardial infarction (MI), contralateral CEA, patients on longterm anticoagulation therapy, and surgically inaccessible lesions
were all excluded from these trials.
Endovascular Approaches to Treat Carotid
Stenosis
The mission to develop safer percutaneous endovascular solutions to treat arterial stenosis was pioneered by Dotter
Gruntzig and Hopff
an interventional radiologist, described a catheter system that
could be used for performing balloon angioplasty of cervical
carotid stenosis,
of successful carotid angioplasty performed in the surgical
13,14
suite.
the University of Alabama at Birmingham (UAB)
plasty of the innominate artery aided by balloon occlusion protection of the common carotid artery (CCA). This early report
represents the first percutaneous intervention performed with
the benefit of distal embolic protection. During the 1980s, clinical
reports of carotid angioplasty were sporadic and limited to small
2
Although early observational data suggested ben-
3–6
7
Asymptomatic Carotid Atherosclerosis Study (ACAS),8
11
in the 1960s and 1970s. In 1977, Klaus Mathias,
12
and this was followed by a few case reports
In 1984, Vitek and his neuroradiology colleagues from
European Carotid Surgery Trial
9
confirmed the
3,8
10
and
15
reported angio-
single-center series of patients.16 Kachel et al. summarized the
results of carotid angioplasty published in the literature through
1995 and noted that 503 of the 523 (96%) procedures were technically successful. There were no deaths, major strokes occurred in
2.1%, and minor complications were in the single digits (6.3%).
17
In 1985, Rabkin and Germashev began using early-generation nitinol (an alloy of nickel and titanium) stents as an endovascular
prosthesis and subsequently reported their 5-year experience.
18
Resistance to widespread acceptance and the slow progress of
angioplasty involving the supraaortic vessels was largely due to
two major concerns: (1) local vessel injury related to balloon inflation causing a flow-limiting dissection with a risk of acute vessel
closure (prestent era), and (2) the risk of distal embolization. In
later years, these key limitations would be overcome by the introduction and widespread adoption of stents and EPDs.
In March 1994, Iyer, Vitek, and Roubin initiated the carotid angioplasty program at UAB under carefully scrutinized institutional pro-
19
tocols.
Initial interventions were performed using stand-alone
balloon angioplasty (no stents). To maximize the luminal result, a
long inflation was performed using a 5-mm over-the-wire balloon;
the center port of this balloon could accommodate a 0.035-inch
guidewire. Once the balloon was in place, the wire was withdrawn,
and oxygenated arterial blood withdrawn from the femoral artery
was infused through the center port of the balloon with the help of
a special pump device, permitting a long 10-minute balloon inflation. The first four patients were treated without complications.
Patient #5, a woman with contralateral carotid occlusion, presented
with a transient ischemic attack (TIA) related to a high-grade stenosis in the index carotid artery and underwent an uncomplicated
balloon angioplasty procedure. Despite a perfectly acceptable angiographic result, approximately an hour after the procedure, there was
acute closure of the angioplastied carotid artery. Although a technically successful, urgent reintervention with recanalization and
stenting of the occluded vessel was performed, the patient did not
recover from the major stroke related to the acute closure and subsequently expired. This case triggered the decision by the UAB group to
perform elective carotid stenting—irrespective of the angiographic
results of balloon angioplasty—and primary stenting became the
intervention of choice for treatment of cervical carotid stenosis. The
subsequent rapid adoption of this approach by interventional cardiologists in particular, and the endovascular interventional community in general, heralded the modern era of endovascular treatment
for extracranial carotid bifurcation disease.
19–22
Although balloon expandable stents were used in the first 100
patients, by the summer of 1995 (when the initial patients returned
for their follow-up angiograms) it became clear that these stents
were prone to deformation (stent crush) because of the superficial location of the carotid artery and the associated movements
of the neck.
complication, seen in approximately 15% of patients at 6-month
follow-up.
23
The Alabama group were the first to report this
23
Fortunately, stent deformation was largely a cosmetic
issue, with only one patient presenting with symptoms in this
series. This observation, as well as the recognition that chances
for regulatory approval for balloon expandable stents for treating
extracranial carotid stenosis were slim, led to the rapid introduction, testing, and adoption of self-expanding stents. Stents have all
but abolished acute carotid vessel closure, and in contemporary
practice, primary carotid stenting is the norm. The reader should
note that unlike in coronary arteries, the risk of acute stent thrombosis and instant restenosis, two major limitations of coronary
stents, are nonissues when stents are deployed in the extracranial
carotid location.
386

In 1996, Theron et al.24 reported results from his seminal work
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using his triple coaxial catheter that incorporated distal balloon
occlusion for providing embolic protection during carotid bifurcation angioplasty. Unfortunately, this early-generation distal protection balloon could only be used with balloon angioplasty (and
not with stents). By 2000, the first investigational distal balloon
occlusion EPD, the Percusurge Guardwire (Medtronic, Minneapolis,
Minn.) was introduced into clinical trials in the United States.
This was soon followed by a number of clinical trials, all of which
included a filter as the distal EPD. Unlike Theron's distal occlusion
balloon, the Percusurge balloon—as well as all such filters—can
be used with both over-the-wire and monorail stent delivery systems. As increasing clinical data became available, use of distal
protection devices was recognized and accepted by many (but
25
not all
) as an integral if not mandatory part of carotid artery dila-
tion and stenting.
26–31
In our opinion, EPDs, when selected and used
appropriately, improve procedure safety by significantly reducing
the risk of procedure related embolic major and fatal strokes.
The multicenter Carotid and Vertebral Artery Transluminal
Angioplasty Study (CAVATAS-I)
9
was conducted between 1992
and 1997 in the United Kingdom during an era when stents were
neither widely available nor perceived as integral. This prospective randomized trial compared outcomes of balloon angioplasty
and CEA in 504 patients; only 55 patients (26%) within the group
assigned to endovascular treatment received stents. Initially, stents
were used only as a bailout treatment, with increased elective use
toward the end of the study; distal protection devices were not
used. Major event rates within 30 days after treatment did not differ significantly between endovascular treatment and surgery: disabling stroke or death (6.4% vs. 5.9%) and any major stroke lasting
more than 7 days or death (10.0% vs. 9.9%). This study also demonstrated that endovascular techniques were superior to surgery
when considering other risks related to the incision in the neck
and use of general anesthesia. Cranial nerve injury was reported
in 8.7% of surgical patients; no events occurred in patients undergoing endovascular procedures (P < 0.0001). Major groin or neck
hematomas occurred less often after endovascular treatment than
after surgery (1.2% vs. 6.7%, P < 0.0015). The results of this early clinical trial set the stage for investigation of carotid stenting.
Indications and Contraindications
The indications for carotid artery revascularization have been well
delineated in the recent American Stroke Association/American
College of Cardiology Foundation/American Heart Association
(ASA/ACCF/AHA) et al. Guideline on the Management of Patients
with Extracranial Carotid and Vertebral Artery Disease
tially depend on symptomatic status and severity (degree) of stenosis. Hence, before an informed decision on a treatment option
can be made (surgery or percutaneous intervention), it is critically
important for patients and physicians to have a good understanding of the operator as well as the center's procedural and 30-day
experience and outcomes.
Symptomatic Patients
Symptomatic carotid stenosis refers to ischemia or infarction in
the distribution of the internal carotid artery (ICA) causing neurological abnormalities that include but are not limited to contralateral motor and/or sensory events, speech, and/or visual problems
(monocular blindness, field defects). Amaurosis fugax refers to
transient monocular visual loss, typically described by the patient
as a shade being drawn down or across the eye (amaurosis, Greek
for “darkening,” and fugax, Latin for “fleeting”). Dizziness and problems with balance are symptoms that typically result from ischemia or infarction in the vertebrobasilar system, and the presence
of a carotid artery stenosis in a patient presenting with dizziness
is almost always incidental i.e., the carotid stenosis is most often
asymptomatic and NOT causally related to the symptoms. The culprit stenosis is considered symptomatic for 6 months beyond the
32
and essen-
event. Additionally, the risk of recurrent stroke is lower in patients
who present with amaurosis as the sole symptom in comparison to
patients who present with a hemispheric TIA.
It is well accepted that revascularization should be offered to all
symptomatic patients if the diameter of the ICA is reduced more
than 70% as documented by noninvasive imaging, or more than 50%
as documented by catheter angiography (
Table 32-1). There is, how-
ever, one important caveat: the periprocedural risk of stroke or death
related to the revascularization procedure (CEA or CAS) should be
under 6%.
relation between increasing stenosis severity and stroke risk. The
NASCET study
32
In symptomatic patients, there is a well- established cor-
3
demonstrated the benefit of CEA over medical treatment for reducing the risk of future stroke in symptomatic patients
with carotid stenosis between 70% and 99%. The NASCET results also
showed that symptomatic patients with a lesser degree of stenosis
(between 50% and 70%) benefit less. Revascularization is typically
recommended in this group if there are additional unfavorable angiographic features (e.g., ulceration or other features associated with
increased risk of vessel-to-vessel embolization).
An important, albeit controversial and unsettled, issue in the
treatment of symptomatic patients relates to the timing of the revascularization procedure after the index symptomatic event.
33–37
Risk of a recurrent neurological event after a TIA or stroke is estimated to be between 15% and 20%, and this elevated risk persists
for approximately 6 months after the initial event and underlies
the rationale for the 6-month threshold for defining symptomatic
patients. Proponents of early intervention i.e., within a few days of
the symptomatic event. Argue that the highest risk of a recurrent
event is during this early period and any delay in treatment will
significantly diminish its therapeutic value, since a substantial portion of these patients would have already experienced a neurological event during the waiting period. A key reason underlying
the reluctance of operators to perform revascularization (CEA or
CAS) soon after a stroke (less so after a TIA) is the concern that
TABLE 32-1
Modified American Heart Association
Recommendations for Carotid Artery
Revascularization
INDICATION
LEVEL
Proven 70%-99% stenosis >80% stenosis
Acceptable 50%-69% stenosis >60% stenosis
Unacceptable <49% stenosis or <60% stenosis or
*Lesion severity is determined according to the North American Symptomatic Carotid
Endarterectomy Trial (NASCET) methodology (i.e., the ratio between lumen diameter at the
point of maximal stenosis and the lumen diameter of the non tapered segment of the distal
internal carotid artery).
CABG, coronary artery bypass graft surgery.
Modified from Brott TG, Halperin JL, Abbara S, et al: ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial
carotid and vertebral artery disease: executive summary. A Report of the American College
of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and
the American Stroke Association, American Association of Neuroscience Nurses, American
Association of Neurological Surgeons, American College of Radiology, American Society of
Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and
Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional
Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society
for Vascular Surgery, developed in collaboration with the American Academy of Neurology and
Society of Cardiovascular Computed Tomography. J Am Coll Cardiol 57:1002–1044, 2011; and
Roubin GS, Iyer S, Halkin A, et al. Realizing the potential of carotid artery stenting: proposed
paradigms for patient selection and procedural technique. Circulation 113:2021–2030, 2006.
SYMPTOMATIC
STENOSIS*
Periprocedural
complication risk <6%
Periprocedural
complication risk <3%
Periprocedural
complication risk >6%
153
ASYMPTOMATIC
STENOSIS*
Periprocedural
complication risk <3%
Life expectancy >
Periprocedural
complication risk <3%
Planned CABG
Periprocedural
complication risk >5%
5 years
387
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32
CAROTID ARTERY STENTING

388
early treatment increases the risk of hemorrhagic transformation of
the culprit, (nonhemorrhagic) infarct. Although the increased risk
of intracranial hemorrhage following early intervention has been
challenged,
33
a recent retrospective analysis38 of a large national
inpatient database involving more than 57 million in-hospital
admissions, conducted to determine the prevalence and risk fac-
CH
tors of intracranial hemorrhage among patients undergoing CEA
32
(N = 215,012) and CAS (N = 13,884), arrived at a different conclusion. Symptomatic presentations represented the minority of indications for CEA (n = 10,049 [5%]), as well as CAS (n = 1251 [10%]).
Intracranial hemorrhage occurred significantly more frequently
after CAS than CEA in both symptomatic (4.4% vs. 0.8%; P <0.0001)
and asymptomatic presentations (0.5% vs. 0.06%; P <0.0001).
Multivariate regression suggested that symptomatic presentations
(vs. asymptomatic) and CAS procedures (vs. CEA) were both independently predictive of six- to sevenfold increases in the frequency
of postoperative intracranial hemorrhage. The observations from
this retrospective population-based analysis are at variance with
observations from recent large prospective randomized trials
involving symptomatic and asymptomatic patients, wherein the risk
of mortality and major stroke was uniformly low in both CEA and
CAS arms, and the higher incidence of neurological events in the
CAS arm was a result of minor strokes (ischemic rather than hemorrhagic).
39–41
Pending resolution of this issue by future studies,
the current approach of waiting a minimum of 3 weeks following
the index event (longer for larger strokes) is likely to continue.
Asymptomatic Patients
Asymptomatic carotid disease refers to the presence of a stenosis
resulting in a 60% or greater reduction of the luminal diameter of
the extracranial ICA without symptoms of ipsilateral stroke, TIA, or
amaurosis fugax. Treatment of patients with asymptomatic carotid
artery stenosis has become extremely controversial, with two main
issues fuelling this ongoing debate
1. Which asymptomatic patients (if any) are appropriate for
intervention (CEA or CAS)? Current guidelines suggest that
it is reasonable to refer asymptomatic patients for ICA revascularization in the setting of more than 80% stenosis and low
periprocedural risk.
32
2. What should be the choice of treatment? In the event revascularization is to be performed in an asymptomatic patient,
should the patient be referred for CEA or CAS?
MEDICAL TREATMENT VS. INTERVENTION (CEA/CAS)
FOR ASYMPTOMATIC CAROTID DISEASE
Despite publication of several guidelines that provide a best assessment of current research, considerable divergence of opinion
regarding care of the carotid artery remains an issue among physicians worldwide.
45
One reason why enthusiasm for revascularization may be low is recognition that the annualized risk of a stroke
in patients with asymptomatic carotid artery disease treated with
contemporary medical treatment is low and dropping (
This reduction in stroke risk has been attributed to the benefits
of risk-factor modification, use of antihypertensive medications,
antiplatelet agents,
47
smoking cessation, and statin therapy.
The guidelines respond to this concern by limiting revascular-
ization to those asymptomatic patients in whom periprocedural
42–44
:
Table 32-2) .
48,49
Annualized Stroke Risk in Asymptomatic
TABLE 32-2
Patients with Greater Than 50% Carotid
Artery Stenosis Treated with Best Medical
Therapy Available During Trial Period
Annualized Risk
STUDY YEAR ANY STROKE IPSILATERAL STROKE
8
ACAS
151
ACST
154
ACSRS
55
ASED
ACAS, Asymptomatic Carotid Atherosclerosis Study; ACSRS, Asymptomatic Carotid Stenosis
and Risk of Stroke; ACST, Asymptomatic Carotid Surgery Trial; ASED, Asymptomatic Stenosis
Embolus Detection.
risk of a stroke or death is expected to be below 3%.
1995 3.5% 2.2%
2004 2.4% 1.1%
2005 2.1% 1.7%
2005 2.2% 1.0%
32
Hence, some
clinicians argue that there is an urgent need for a new three-arm
randomized clinical trial for asymptomatic carotid disease that
includes not only CEA and CAS but also has a medical treatment arm.
A critical message from the asymptomatic CEA trials was that for
surgical revascularization to be beneficial in reducing future stroke
risk in asymptomatic patients (
Table 32-3), the periprocedural risk
of revascularization should not exceed 3%. If the risk breaches the
3% threshold, the difference in stroke risk between the medically
treated arm and the surgical arm will not be significant (i.e., the
benefit of stroke reduction from the surgery no longer accrues to
the patient). The second Carotid Revascularization Endarterectomy
versus Stenting Trial (CREST II) will be a three-arm study involving
asymptomatic patients, and this protocol is currently under review
for funding by the National Institutes of Health (NIH).
IDENTIFYING THE ASYMPTOMATIC PATIENT AT HIGH
RISK FOR DEVELOPING A STROKE
Much of the controversy surrounding treatment of asymptomatic carotid stenosis could be resolved if physicians had
a method of reliably identifying the asymptomatic patient at
high risk for a future stroke; interventional treatment could
then be selectively directed at these patients. Understandably,
such an approach would greatly improve the yield and costeffectiveness of prophylactic invasive treatment with either
CEA or CAS.
50
Some of the metrics that have been proposed
as predictors of increased risk of ipsilateral ischemic events
in asymptomatic patients with carotid stenosis include higher
grades of stenosis or substantial progression of carotid stenosis to a higher grade,
51,52
unfavorable plaque characteristics and
composition, including plaque ulceration and echolucency,
or verifying the presence or absence of microemboli by using
transcranial Doppler.
55–58
Other clinical and radiological markers for predicting an increased risk of stroke in asymptomatic
patients include occult cerebral infarction on brain imaging
59
studies,
plaque hemorrhage by magnetic resonance imaging (MRI).
46
Nicolaides et al.62 have suggested that combining clinical risk
contralateral carotid occlusion,60 or detection of intra-
factors, such as diabetes and smoking, with high-risk ultrasound
features (e.g., echolucent plaque) may help identify the highrisk asymptomatic patient. These are listed in
Table 32-4.
53,54
61
TABLE 32-3 Event Rates from the Two Major Randomized Carotid Surgical Trials in Asymptomatic Patients
Five-Year Stroke Risk
STUDY
8
ACAS
151
ACST
ACAS, Asymptomatic Carotid Atherosclerosis Study; ACST, Asymptomatic Carotid Surgery Trial; CEA, carotid endarterectomy.
N
1662 1995 5.1% 11% 0.46
3120 2004 3.8% 11.0% 0.29
YEAR
CEA
MEDICAL THERAPY
CEA VS. MEDICAL THERAPY
HAZARD RATIO

Postulated Clinical/Investigative Features
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TABLE 32-4
to Identify High Stroke Risk Patients with
Asymptomatic Carotid Disease
CRITERIA AUTHORS/REFERENCE
Anatomical
High-grade carotid stenosis
with substantial progression
Contralateral carotid occlusion AbuRahma
Plaque Characteristics
Plaque composition, ulceration,
or echolucency
Intraplaque hemorrhage Altaf
Plaque composition and
clinical risk factors
Imaging
Microembolization Abbott,55 Markus,56 Spence
Occult cerebral infarction Norris
51
52
Hirt
Bock,
60
Nicolaides,53 Spence
61
Nicolaides
62
59
54
57,58
Although one cannot dispute the clinical appeal and practical
usefulness of being able to identify the asymptomatic patient at
high risk for a stroke, none of the approaches outlined thus far have
been validated to justify and provide clinically relevant recommendations. Hence, at present, degree of carotid diameter stenosis severity remains the predominant basis for clinically deciding
whether or not to treat patients with asymptomatic carotid stenosis.
In contemporary practice, most clinicians will (should) only
treat an angiographically confirmed 80% or greater, unilateral, incidentally discovered (i.e., diagnosed on routine duplex screening,
following workup of a carotid bruit) asymptomatic carotid stenosis. Patients with stenosis less than 60% are managed medically,
with periodic (usually annual) ultrasound surveillance to monitor
stenosis progression. Although stenosis severity between 60% and
80% is typically managed with conservative medical treatment, this
recommendation may have to be altered based on individual circumstances. Some examples include:
l Contralateral carotid occlusion and a stenosis between 60%
and 80% in the index carotid artery that also supplies the territory of occluded carotid artery via collaterals.
l Bilateral greater than 70% but less than 80% stenosis.
l Magnetic resonance imaging or computed tomography (CT) find-
ings of clinically silent (asymptomatic) prior ipsilateral stroke(s).
l Patients scheduled to undergo coronary artery bypass grafting
(CABG) and/or valve surgery (especially if surgery will be performed on-pump).
In the absence of an established reliable method of identifying the asymptomatic patient with carotid stenosis at high risk for
developing a future neurological event, the decision to treat is predominantly based on degree of stenosis, an approach supported
by the large CEA clinical trials. The threshold for treating asymptomatic carotid stenosis is 80% or greater stenosis confirmed by
angio graphy (NASCET criteria), with corresponding elevated
duplex velocities. Although standard risk-factor modification
approaches should be implemented in all these patients, there is
no convincing evidence to date that risk-modifying measures by
themselves will reduce stroke risk in patients with severe degrees
of stenosis that cannot be further improved with revascularization
when the periprocedural risk is 3% or less. This nonnegotiable low
tolerance for periprocedural complications constitutes what the
authors have framed as the 3% Rule of Carotid Stenting.
63
How to
avoid breaching this rule is central to the theme of patient selection for carotid stenting. The critical all-important task of identifying the standard-risk patient for carotid stenting (not CEA) is
discussed later in the chapter.
Deciding on the type of intervention, CAS or CEA, is also dis-
cussed later.
Patient Selection for Carotid Stenting
Prior to recommending carotid stenting as a choice for therapeutic intervention, it is important for both physician and patient to
understand the natural history of the condition without intervention, the procedure-related risks (which can immediately erode the
benefits of a procedure done purely with the intent of future benefit), and the clinical durability of the stenting procedure.
Procedure-Related Risks
Over the past decade, one of the most important advances in
the field of carotid stenting relates to our understanding of what
constitutes “high stent risk.” It is important to remember that
CEA was first performed in the 1950s, and over the course of the
next several years, surgeons identified both anatomical features
and comorbidities that would increase the risk of endarterectomy (high–CEA risk group). Furthermore, these high–CEA risk
patients were excluded from participating in the major randomized CEA trials.
EVOLUTION IN OUR UNDERSTANDING OF THE CONCEPT
OF HIGH STENT RISK
To help the interventionist decide whether stenting is an appropriate treatment for a particular patient (and lesion), it is important for the operator to understand, recognize, and differentiate
the standard-risk (
determination, based on an individualized analysis, is the single
most important element of the CAS risk stratification process and
should be performed for every patient. The designation of high
stent risk has evolved over time, and in retrospect was a critical
component of the learning curve of the early adopters of the CAS
treatment modality. Because the attributes that define high CEA
risk (
Box 32-2) are distinct from those that define high stent risk,
a patient who is high risk for CEA does not automatically become
suitable (i.e., standard risk) for CAS. The presence of high-risk features for stenting was unrecognized during the early clinical trials
and the criteria for inclusion in these trials only specified “high–
CEA risk patients,” thus permitting unbalanced comparisons of
technique. Hence, the high event rates observed in early high–
CEA risk stent registries resulted in large part from the unwitting inclusion of high stent risk patients. With the more recent
Box 32-1 Standard Risk for Carotid Stenting:
Recognize the Ideal Patient for Carotid Stenting
■ Male or female patient, <75 years of age
■ Preserved brain function (no compromise of brain reserve)
■ Asymptomatic carotid bruit
■ Good LV function, no aortic stenosis
■ Known coronary anatomy
■ Normal renal function
■ Duplex ultrasound PSV: 450 cm/s; EDV: 130 cm/s
Recognize Ideal Lesion and ICA Morphology
for Carotid Stenting
■ Angle between the ICA and ECA is <90 degrees
■ Minimal vessel tortuosity (i.e., no carotid redundancy)
■ Minimal calcification
■ No ulceration or obvious filling defects
■ Stenosis severity and whether plaque is concentric or eccentric are less
important, as long as flow is normal (i.e. TIMI III)
■ Lesion located in a straight segment (as opposed to a bend) of the ICA
■ Artery cephalad to the stenosis is straight (minimal bends and vessel
tortuosity)
■ ICA: 4-5 mm; CCA: 8-10 mm
CCA, common carotid artery; ECA, external carotid artery; EDV, end-diastolic velocity; ICA,
internal carotid artery; LV, left ventricular; PSV, peak systolic velocity; TIMI, Thrombolysis in
Myocardial Infarction.
Box 32-1) from the high-risk CAS patient. This
Patient and Lesion Characteristics
389
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32
CAROTID ARTERY STENTING

390
AB
Box 32-2 Anatomical Features and Comorbidities
Associated with High Carotid
Endarterectomy Risk
Anatomical
Surgically inaccessible lesions above C-2 or below the level of the clavicle
CH
Contralateral carotid artery occlusion
32
Restenosis after a previous ipsilateral CEA
Previous head/neck radiation therapy or surgery that included the area of
stenosis
Ipsilateral radical neck dissection for the treatment of cancer
Obese/short neck
Fibromuscular dysplasia
Spinal immobility of the neck due to cervical arthritis
Presence of laryngeal palsy
Presence of a tracheostoma
Comorbidities
Chronic Obstructive pulmonary disease (COPD) with a forced expiratory
volume (FEV) 1 less than 30%
Requirement for staged and scheduled coronary artery bypass graft (CABG)
or valve replacement procedures more than 30 days following the stent
procedure
Age 80 years or more
Recent myocardial infarction more than 72 hours and less than 30 days
Severe lung disease
Two or more major diseased coronary arteries that require revascularization
(70% or more)
CAD, coronary artery disease; CEA, carotid endarterectomy.
exclusion of high stent risk patients, a corresponding improvement in procedural outcomes has been noted. For example, by
2005 the concept of high stent risk was better established, and
in the second half of the CREST study, many of these high-risk
stent patients were generally excluded (since the CREST protocol
written in the late 1990s did not specifically call out high stent
risk exclusions).
that specifically excludes high stent risk patients, is in progress
(NCT00106938).
39
The Asymptomatic Carotid Trial (ACT-I), a trial
STANDARD STENT RISK
Although carotid stenting outcomes are not influenced by gender,
age is a very important determinant. The concept of brain reserve
is akin to cardiac reserve—a patient with poor left ventricular (LV)
function is more likely to manifest and experience complications
related to a percutaneous coronary intervention (PCI) or CABG procedure. Similarly, a patient with compromised brain function (diminished brain reserve) is more likely to clinically manifest neurological
events related to periprocedural embolization. Embolization is a universal occurrence with all CAS procedures and happens despite the
use of EPDs. Patients with prior large strokes, multiple small strokes, or
lacunar infarcts and those with dementia are examples of patients
with compromised brain reserve. Dementia in particular is a problem. Despite having a perfectly acceptable angiographic and clinical result (i.e., no procedure-related events) in the follow-up period,
anecdotal reports suggest a marked deterioration in memory and
other cognitive functions. The reason for this is unclear, but dementia should be considered at least a relative contraindication for CAS.
Close attention should be paid to the end-diastolic ultrasound
flow velocity. If this value exceeds 100 cm/s (especially >120 cm/s),
the angio graphic stenosis severity will exceed 80% (as defined by
the NASCET criteria; Fig. 32-1) and will meet the treatment thresh-
old for treating asymptomatic lesions.
Figure 32-2 illustrates lesion and vessel features that are ideal
for stenting using distal embolic protection. These features include:
l A narrow acute angle between the ICA and external carotid artery
(ECA). The wider this bifurcation (i.e., the angle approaches
90 degrees or is frankly obtuse), the greater the technical difficulty in advancing a distal embolic protection filter device with
a fixed-wire system (
Fig. 32-3). The technical difficulty imparted
by an open ICA/ECA angle is compounded if there is additional
tortuosity in the ICA distal to the stenosis (
l Minimal calcification and no ulceration. Some degree of cal-
Fig. 32-4).
cification is nearly ubiquitous in a diseased carotid bifurcation, but heavy concentric calcification in association with a
severe stenosis is a major problem. Although the demonstration of carotid calcification is straightforward and requires
only fluoroscopy (
Fig. 32-5), the distinction between deep
FIGURE 321 Ideal lesion and vessel morphology for carotid
stenting. Ideal lesion (A) has high-grade (>80%) internal carotid artery
(ICA) stenosis (enddiastolic velocity 124 cm/s). Note that ICA/external
carotid artery angle is acute, and the artery cephalad to stenosis is free
of significant bends. B, Same lesion following carotid stenting using a
distal embolic protection device (EPD [filter]).

391
AB
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32
CAROTID ARTERY STENTING
FIGURE 322 This lesion is unsuitable for carotid artery stenting. The
high grade of stenosis, 90-degree angle between the internal carotid artery and
external carotid artery, and proximal calcification make passage of wires and
equipment hazardous.
FIGURE 324 Extensive circumferential calcification of the internal
carotid artery makes this lesion unsuitable for carotid artery stenting.
Subtraction imaging without contrast shows calcification of both the internal
carotid artery and external carotid artery.
FIGURE 323 These lesions are unsuitable for carotid artery stenting
using a distal embolic protection device. This is due to the high degree of
tortuosity of the internal carotid artery distal to the lesion, preventing safe and
effective positioning of a filter device.
FIGURE 325 This vessel demonstrates a string sign with high-grade
stenosis and reduced cranial flow and internal carotid artery filling
(arrow). Note the relatively complete filling of the external carotid artery vessels
in comparison.

392
vessel wall calcium and superficial calcium encroaching on
the vessel lumen may be difficult, and the decision to declare
the case unsuitable for CAS is largely subjective. We arbitrarily
define heavy calcification
width, with concentricity defined by imaging in two orthogo-
CH
32
nal views. The unyielding nature of calcium, along with the
stiffness it imparts to the involved vessel segment, makes it
difficult to predilate and advance the EPD and stent delivery
system through the lesion (especially the stent). Forcing these
devices in an attempt to cross the stenosis not only increases
the chances of prolapsing the sheath out of the CCA, it also
increases the risk of embolization, spasm, and dissection.
Inability to completely dilate and expand the deployed stent
despite using larger and/or high-pressure balloons (resulting
in a stent with an hourglass appearance) is an intraprocedural nightmare.
l The artery, especially cephalad to the stenosis, is free of any
significant kinks or bends. Presence or absence of this key
unfavorable feature is extremely important to note on preprocedure magnetic resonance angiography (MRA), computed
tomographic angiography (CTA), or invasive angiography,
since it increases the degree of difficulty when attempting
to place a distal filter EPD. Excessive vascular tortuosity is
defined as two or more bend points that are 90 degrees or
greater (see
Fig. 32-4). At times the tortuosity can be extreme
and may impart a hairpin bend to the ICA (see
Worsening grades of tortuosity increase the difficulty when
attempting to cross the stenosis and may make device delivery difficult or impossible. Straightening of the tortuous vessel
segment by stiff wires or devices may result in vessel spasm
and reduced antegrade flow. Thus, despite filter placement,
the patient does not receive the benefit of brisk antegrade
flow and may manifest ischemic symptoms in the absence
of adequate collaterals. Additionally, slow flow increases the
risk of fibrin deposition within the filter. The longer the dwell
time of the EPD, the higher the risk of an iatrogenic thrombus.
Iatrogenic tortuosity can also be introduced by placement of
the sheath in a redundant carotid artery, so tortuosity should
be assessed after the sheath is in place below the carotid
bifurcation.
Stenosis severity and eccentricity/concentricity are not problems as long as the flow in the vessel is normal (Thrombolysis in
Myocardial Infarction [TIMI] grade III). A severe stenosis in association with less than TIMI III flow (string sign,
occluded artery are contraindications (
is often noted, even on angiograms from asymptomatic patients,
and although not a contraindication, operators should be aware
that the risk of embolization might be higher, particularly during
the phase of poststent balloon dilation. Angiographic filling defects
that are consistent with a thrombus are a contraindication to CAS
(
Fig. 32-8). Note that both calcium and thrombus may appear as fill-
ing defects, and the differentiation is based on the clinical presentation. Whereas a filling defect in a symptomatic patient should be
presumed to be thrombus (see
tomatic patients are frequently a result of calcium encroaching on
the vessel lumen (
Fig. 32-9).
As a rule, unfavorable anatomical features (
also see
Figs. 32-3 through 32-9) should be considered contraindi-
cations for CAS. Although special techniques (e.g., use of a heavygauge buddy wire to straighten tortuous vessel segments, use of
cutting balloons to dilate unyielding lesions) may result in a satisfactory angiographic outcome, the risk of a procedure-related
neurological event should be presumed to breach the accepted
periprocedural complication threshold.
as calcification 3 mm or more in
Fig. 32-6) and an
Fig. 32-7) for CAS. Ulceration
Fig. 32-7), filling defects in asymp-
Figs. 32-10 and 32-11;
Fig. 32-4) .
FIGURE 326 An occluded carotid artery is an absolute contraindication
to stenting.
Durability of Carotid Artery Stenting
Durability is defined by the ability to reduce the risk of a future
stroke (the reason why these procedures are performed) and by
the frequency of in-stent restenosis (discussed later in this chapter.)
FIGURE 327 Thrombus located in proximal internal carotid artery in
a patient with symptomatic carotid artery disease. This is identified by the
hazy appearance and is only visible following contrast injection.

FIGURE 328 This patient demonstrates eccentric calcification, which
AB
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may at times closely resemble thrombus. Fluoroscopy without contrast
injection will typically reveal calcification, as also shown in Figure 32-5.
Procedural Considerations for Carotid
Artery Stenting
Initial Evaluation
PATIENT INTERVIEW, CLINICAL EXAM, AND
DIAGNOSTIC STUDIES
Except in rare instances, nearly all carotid revascularization procedures are elective, and there is no justification for an ad hoc carotid
procedure (e.g., combining a carotid intervention with another
scheduled invasive procedure such as coronary angiography).
A comprehensive history and physical examination, including a
detailed neurological exam, are mandatory first steps when evaluating a patient for a possible carotid intervention. Often, patients
referred for treatment of “symptomatic” carotid artery stenosis have
other reasons for their symptoms, including posterior circulation
(vertebrobasilar) disease, cardiac arrhythmias, or a cardioembolic
source (e.g., a patient with atrial fibrillation with a clot in the atrial
appendage). These patients have incidental (i.e., asymptomatic)
carotid disease; the risk assessment and approach to treatment of
these patients are very different from the patient with true symptomatic carotid artery stenosis. A formal neurological consultation
and additional diagnostic imaging are often helpful in sorting out
these patients.
Another frequently encountered problem relates to suboptimal images that result in unreliable noninvasive diagnostic studies
(carotid duplex ultrasound and MRA). Whereas quality and reliability of a duplex ultrasound study are very technician dependent,
quality of the MRA study is influenced not only by the generation
status of the equipment but also by the scanning protocol (with or
without gadolinium), the correct timing sequence, and the skill and
experience of the interpreting radiologist. It is critical that the ultrasound evaluation be performed in an Intersocietal Commission for
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32
CAROTID ARTERY STENTING
FIGURE 329 Unfavorable vessel morphology for carotid
stenting. A, Unfavorable lesion. Note obtuse internal carotid artery/
external carotid artery (ICA/ECA) angle, high-grade eccentric stenosis
immediately distal to bifurcation, and ulcer proximal to stenosis near
carotid bulb. Vessel distal to stenosis is straight. B, Result can be
seen after treatment using an Emboshield (Abbott Vascular, Santa
Clara, Calif.) filter. Wire is independent of filter, and negotiating the
unfavorable bifurcation and severe eccentric stenosis is far easier
with a wire uncoupled from the filter element. Pre-predilation may
be needed. Open-cell stent was used to treat the lesion on the bend;
this stent design does not introduce any additional bends in ICA
post stenting. Care should be taken to place proximal end of stent
flush with origin of ICA. If it hangs between ICA origin and common
carotid artery (CCA), stent edge can cause problems in advancing
postdilatation balloon as well as filter retrieval catheter. Note that
ulcer is excluded, not obliterated, and no attempt should be made to
obliterate ulcer by using larger balloons. Flow to ulcer crater will seal
off in time.
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