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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
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
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
CH 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
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
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
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 AUTHORS/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
CH 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.
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 321 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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CH 32
CAROTID ARTERY STENTING
FIGURE 322 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 324 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 323 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 325 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-
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 326 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 327 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 328 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
393
CH 32
CAROTID ARTERY STENTING
FIGURE 329 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.