| Surgery Section - Extracranial Carotid Angioplasty/Stenting
| Topic: Extracranial Carotid
Angioplasty/Stenting |
Date of Origin: 07/05/2005 |
| Section: Surgery |
Policy No: 93 |
| Effective Date: 10/01/2011 |
|
| |
IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding
coverage in accordance with contract terms. Benefit determinations are based in all cases on
the applicable contract language. To the extent there may be any conflict between the Medical
Policy and contract language, the contract language takes precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that
are considered investigational or cosmetic. Providers may bill members for services or
procedures that are considered investigational or cosmetic. Providers are encouraged to inform
members before rendering such services that the members are likely to be financially responsible
for the cost of these services.
DESCRIPTION
Carotid angioplasty and stenting (CAS) is the insertion
of a stent (wire-mesh tube) into a narrowed carotid
artery. A catheter (a long hollow tube) is inserted
into the groin artery and guided through the arteries
to the narrowing in the carotid artery. A balloon at
the end of the catheter is inflated to push open the
narrowed area, and a metal stent is inserted to keep
this area from narrowing again. The procedure is performed
with the patient fully awake and without sedation.
At present, most practitioners also use a distally
placed embolic protection (DEP) device that is designed
to reduce the risk of stroke caused by thromboembolic
material dislodged during CAS. Carotid angioplasty
is rarely performed without stent placement.
The U.S. Food and Drug Administration (FDA) has approved
several carotid artery stents and DEP devices from
various manufacturers. The FDA has mandated postmarketing
studies for these devices. Each FDA-approved carotid
stent system is indicated for combined use with a DEP
device.
Note: This policy does not address percutaneous
angioplasty and stenting of intracranial or venous vessels,
which are addressed in separate policies (see Cross References
below).
POLICY/CRITERIA
| I. |
Carotid angioplasty
with associated stenting and embolic protection
may be considered medically necessary when all
of the following criteria are met: |
| |
A. |
Documented 50-99% stenosis;
AND |
| |
B. |
Symptoms with duration less than
24 hours of focal ischemia (transient ischemic
attack or monocular blindness) in previous 120
days, or nondisabling stroke; AND |
| |
C. |
One or more of the following anatomic
contraindications for carotid endarterectomy (CEA)
are present: |
| |
|
1. |
Tissue changes from
prior extensive ipsilateral neck radiation |
| |
|
2. |
Prior ipsilateral
radical neck resection |
| |
|
3. |
Anatomical malformation
that prevents collateral circulation to the brain
during open carotid endarterectomy (CEA) |
| |
|
4. |
Lesions surgically
inaccessible (such as high internal carotid lesion
that cannot be accessed from the neck) |
| |
|
5. |
Spinal immobility
preventing open carotid endarterectomy (CEA) |
| |
|
6. |
Tracheostomy |
| II. |
Except as defined in
I. A, B, and C above, carotid angioplasty with
associated stenting and embolic protection, is
considered investigational. |
POSITION STATEMENT [1]
| • |
The evidence is insufficient to permit reliable
conclusions about the benefits of carotid angioplasty,
with or without associated stenting and distal
embolic protection, as a treatment for stenosis
of the carotid artery: |
| |
o |
There is no reliable
evidence from well-designed, well executed, prospective,
randomized controlled trials demonstrating that
carotid artery angioplasty/stenting (CAS) is equally
or more effective than open carotid endarterectomy
(CEA), the current standard of care for carotid
artery stenosis. |
| |
o |
Available evidence does not demonstrate
that CAS, compared to CEA, is performed with acceptable
periprocedural stroke/death rates, or that it provides
a net health benefit to patients at high medical
risk. |
| |
o |
There is limited evidence on the
durability of CAS, as measured by the need for
repeat interventions over subsequent years. |
| |
o |
There is limited evidence on the
long-term effectiveness of CAS in preventing stroke,
neurological complications, or death. |
| |
o |
While there is limited evidence
to suggest that CAS may be beneficial in the group
of patients at high surgical risk due to complications
of anatomy and comorbid conditions, present evidence
has not clearly differentiated outcomes for this
subgroup according to symptomatic status. |
| • |
In a group of highly
selected patients with carotid artery stenosis,
CEA is not performed as it carries unacceptably
high risks. In these patients, CAS may provide
an improvement in health outcomes that could not
otherwise be achieved (see policy criteria). |
Effectiveness
Cochrane Reviews
The 2007 and 2009 Cochrane Reviews assessed the risks
and benefits of endovascular treatment (CAS) compared
to open carotid endarterectomy (CEA). The reviews included
12 and 10 randomized controlled trials respectively.
[2,3]
The review found the data from these studies to be
conflicting and difficult to interpret. Several flaws
undermine the validity of the study findings:
- The overall estimates of effect were imprecise
and difficult to interpret due to substantial heterogeneity
among the trials such as different patient populations,
outcome measures, endovascular procedures, and durations
of follow-up. In addition, stopped and completed
trials were analyzed together.
- Some studies were stopped early due to recruitment,
safety, or futility issues. The early termination
may have lead to an overestimate of the risk or the
benefit of the treatment.
- No intention-to-treat (ITT) or partial ITT analyses
were carried out, which may have biased the estimates
of treatment effect.
- Use of antiplatelet medications before, during,
and after the treatment may have confounded the study
findings.
- Long-term efficacy was difficult to assess because
outcome measures and length of follow-up differed
greatly among the studies
The review concluded that “the data are insufficient
to support a change from routine clinical practice
in the types of patient for which carotid endarterectomy
is the current standard treatment.”
Follow-up of the Trials Included in the Cochrane
Reviews
Subsequent to the publication of the Cochrane reviews,
two long-term follow-up reports of the CAVATAS trial
were published [4,5] Both reports summarize the long-term
effects of CAS compared to CEA on restenosis
and/or the risk of stroke and other major adverse events.
Although both reports found CEA to lead to more favorable
outcomes, the findings are unreliable due to at least
one of the following flaws:
- No intention-to-treat (ITT) was carried out,
which may have biased the estimates of treatment
effect.
- Heterogenous patient populations (e.g. patients
with and without stent placement) may have lead
to biased estimations of treatment effects.
- The study was underpowered (not able to detect
reliably clinically important differences between
the treatment groups).
BlueCross BlueShield Association (BCBSA) Technology
Evaluation Center (TEC) Assessments
The 2007 and the 2010 BCBSA TEC assessments did not
identify reliable evidence in support of CAS. [6,7]
Five major randomized trials of CAS vs. CEA were reviewed
in the TEC Assessments (SPACE, EVA-3S, SAPPHIRE, ICSS,
CREST) and all had significant limitations, including
but not limited to:
- Early termination (SPACE and EVA-3S)
Subsequent to the publication of the first EVA-3S report
and the BCBSA TEC assessment, additional analyses
of the same data have been published.[8] However,
any findings based on the EVA-3S data are unreliable
due to the bias introduced by early termination.
- Disproportionally small number of symptomatic vs.
asymptomatic patients enrolled (≤50) in each treatment
arm (SAPPHIRE)
- Follow-up still ongoing and only interim safety
results have been reported (ICSS).[9]
The ICSS interim safety analysis measured the 120-day rate of stroke, death,
or procedural myocardial infarction. The interim findings suggest that CEA is
safer than CAS for the treatment of symptomatic patients. However, long-term
follow-up is needed to reliably establish the difference between the two treatments.
- Significant loss to follow-up (only 13% of the
original study population available) (CREST)[10]
- Study was underpowered to reliably detect differences
between treatment arms in the whole study population
as well as in the subanalyses (CREST).[10]
Subsequent to the publication the first CREST report[10] and the BCBSA TEC assessment,
additional analyses of the CREST data were published.[11-13] Some of these analyses
focus on comparisons of the safety of CAS vs. CEA in the different subgroups
of the study population, such as by symptomatic status or gender.[12,13] However,
any findings based on the CREST data are unreliable due to the biases introduced
by the loss to follow-up and inadequate statistical power.
Other Meta-analyses
In addition to the Cochrane reviews and TEC Assessments,
several other meta-analyses of the studies that compare
carotid angioplasty/stenting (CAS) with endarterectomy
(CEA) have been published.[14-20] These analyses report
inconsistent findings, some in favor of CAS, others
in favor of CEA. In either case, the reliability
of the conclusions from these meta-analyses is limited
by pooling results from unreliable, heterogenous primary
studies (different patient samples, endovascular procedures,
durations of follow-up and/or completion status of
the trials).
Non-randomized Trials, Case Series and Registries
A number of non-randomized trials, case series and
registries on carotid angioplasty and stenting (CAS)
have been published.[21-32] While these studies contribute
to the body of knowledge by providing direction for
future research, evidence from these studies is unreliable
due to inherent design flaws which introduce significant
bias, such as non-random allocation of treatment and
lack of appropriate comparison groups. In addition,
registry data may be unreliable due to incomplete reporting.
Finally, the technology under investigation may change
over time, further limiting the ability to carry out
reliable comparisons based on the registry data.
Clinical Practice Guidelines
| • |
The
2008 update of the evidence-based guideline on
stroke prevention from the American Heart Association/American
Stroke Association Council on Stroke [33] includes recommendations on interventional approaches
for patients with extracranial carotid artery
atherosclerosis. The guideline affirms that CEA
is the preferred treatment for patients with
recent (i.e., in the past 6 months) transient
ischemic attack or non-disabling ischemic stroke
and severe ipsilateral carotid stenosis (between
70% and 90% of the lumen diameter), when performed
by a surgeon with less than 6% perioperative
morbidity and mortality. The guideline also recommends
considering CEA for similar patients with moderate
carotid stenosis (50% to 69% of the vessel lumen),
depending on patient-specific factors such as
age, gender, comorbidities, and severity of initial
symptoms. Finally, the guideline recommends that
carotid artery angioplasty/stenting (CAS) may
be considered as a reasonable alternative to
CEA for patients with symptomatic severe stenosis
(>70%), in whom the stenosis is difficult
to access surgically, or with medical conditions
that greatly increase the risk for surgery, or
when other specific circumstances exist (e.g.,
radiation-induced stenosis or restenosis after
prior CEA), provided it is performed by operators
with established periprocedural morbidity and
mortality rates of 4% to 6%. The guideline classifies
the evidence in support of CAS as “conflicting
evidence and/or a divergence of opinion about
the usefulness/efficacy of a procedure/treatment” derived
from a single randomized trial or nonrandomized
studies. |
| • |
The 2011 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 [34] specifies the circumstances
in which CAS may be indicated as an alternative
to CEA, as well as the circumstances when it may
be reasonable to choose CAS over CEA. However,
the recommendations are based on B level of evidence,
the lower level of evidence defined in the guideline
as derived from a single randomized trial or non-randomized
studies. Further, the specific randomized trials
referenced for these determinations are the CREST
and SAPPHIRE trials. The findings from these trials
are considered unreliable due to significant study
limitations, as explained in the Effectiveness
section of this policy. |
Safety
Long-term safety and complication rates for carotid
angioplasty/stenting (CAS) are unknown compared to
other therapies; however, several adverse reactions
are reported in the published literature including,
but not limited to death, stroke, myocardial infarction,
intracerebral bleed, restenosis, neurological events,
and hyper-perfusion post procedure.
REFERENCES
- BlueCross BlueShield Association Medical Policy
Reference Manual "Extracranial Carotid Angioplasty/Stenting." Policy
No. 7.01.68
- Ederle, J, Featherstone, RL, Brown, MM. Percutaneous
transluminal angioplasty and stenting for carotid
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controlled trials comparing endarterectomy and endovascular
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19228850
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risk of carotid restenosis in patients randomly assigned
to endovascular treatment or endarterectomy in the
Carotid and Vertebral Artery Transluminal Angioplasty
Study (CAVATAS): long-term follow-up of a randomised
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19717347
- Ederle,
J, Bonati, LH, Dobson, J, et al. Endovascular treatment
with angioplasty or stenting versus endarterectomy
in patients with carotid artery stenosis in the
Carotid and Vertebral Artery Transluminal Angioplasty
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trial. Lancet Neurol. 2009 Oct;8(10):898-907. PMID:
19717345
- TEC
Assessment 2007. "Angioplasty and Stenting
of the Cervical Carotid Artery with Embolic Protection
of the Cerebral Circulation." BlueCross BlueShield
Association Technology Evaluation Center, Vol.
22, Tab 1.
- TEC
Assessment 2010. "Angioplasty and Stenting
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of the Cerebral Circulation." BlueCross BlueShield
Association Technology Evaluation Center, Vol.
24, Tab 12.
- Naggara,
O, Touze, E, Beyssen, B, et al. Anatomical and
technical factors associated with stroke or death
during carotid angioplasty and stenting: results
from the endarterectomy versus angioplasty in patients
with symptomatic severe carotid stenosis (EVA-3S)
trial and systematic review. Stroke. 2011
Feb;42(2):380-8. PMID: 21183750
- Carotid
artery stenting compared with endarterectomy in
patients with symptomatic carotid stenosis (International
Carotid Stenting Study): an interim analysis of
a randomised controlled trial. Lancet.
2010 Feb 25. PMID: 20189239
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TG, Hobson, RW, 2nd, Howard, G, et al. Stenting
versus Endarterectomy for Treatment of Carotid-Artery
Stenosis. N Engl J Med. 2010 May 26. PMID:
20505173
- Blackshear,
JL, Cutlip, DE, Roubin, GS, et al. Myocardial Infarction
After Carotid Stenting and Endarterectomy: Results
From the Carotid Revascularization Endarterectomy
Versus Stenting Trial. Circulation. 2011
Jun 7;123(22):2571-8. PMID: 21606394
- Howard,
VJ, Lutsep, HL, Mackey, A, et al. Influence of
sex on outcomes of stenting versus endarterectomy:
a subgroup analysis of the Carotid Revascularization
Endarterectomy versus Stenting Trial (CREST). Lancet
Neurol. 2011 Jun;10(6):530-7. PMID:
21550314
- Silver,
FL, Mackey, A, Clark, WM, et al. Safety of stenting
and endarterectomy by symptomatic status in the
Carotid Revascularization Endarterectomy Versus
Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. PMID:
21307169
- Luebke,
T, Aleksic, M, Brunkwall, J. Meta-analysis of randomized
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Oct;34(4):470-9. PMID: 17683960
- Ringleb,
PA, Chatellier, G, Hacke, W, et al. Safety of endovascular
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- Brahmanandam,
S, Ding, EL, Conte, MS, Belkin, M, Nguyen, LL.
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Pipinos, II, Garg, N, Johanning, J, Lynch, TG,
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D, Roberts, DJ, Tso, M, Sutherland, GR, Eliasziw,
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KP, Sergentanis, TN, Tsivgoulis, G, Mariolis, AD,
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CJ, Iyer, SS, Hopkins, LN, Katzen, BT, Russell,
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16102616
- Katzen,
BT, Criado, FJ, Ramee, SR, et al. Carotid artery
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17630678
- Spes, CH,
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17694382
- Iyer, SS,
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WALLSTENT and FilterWire EX/EZ: 1-year outcomes
in the BEACH Pivotal Group. J Am Coll Cardiol.
2008 Jan 29;51(4):427-34. PMID: 18222352
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Esterbrooks, D, Kuo, YF, Mooss, A, Mohiuddin, SM,
Uretsky, BF. Outcomes after carotid artery stenting
and endarterectomy in the medicare population. Stroke.
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- Veselka,
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2011 Apr 27. PMID: 21530157
- Longmore,
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- Tallarita,
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18322260
- Brott, TG, Halperin, JL, Abbara, S, et al. 2011
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,
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Cross References
Percutaneous Venous Transluminal Angioplasty
and Stenting, Regence Medical Policy Manual, Surgery,
Policy No. 109
Percutaneous
Transluminal Angioplasty of Intracranial Atherosclerotic
Stenoses With or Without Stenting, Regence Medical
Policy Manual, Surgery, No. 141
| Codes |
Number |
Description |
|
CPT |
37215 |
Transcatheter placement of intravascular stent(s),
cervical carotid artery, percutaneous; with distal
embolic protection |
|
|
37216 |
Transcatheter placement of intravascular stent(s),
cervical carotid artery, percutaneous; without distal
embolic protection |
| |
0075T |
Transcatheter placement of extracranial vertebral
or intrathoracic carotid artery stent(s), including
radiologic supervision and interpretation, percutaneous;
initial vessel |
| |
0076T |
Transcatheter placement of extracranial vertebral
or intrathoracic carotid artery stent(s), including
radiologic supervision and interpretation, percutaneous;
each additional vessel (list separately in addition
to code for primary procedure) |
| HCPCS |
None |
|
Surgery Section Table of Contents 
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