Latest Review Date: May 2024

Category: Surgery                                                                 

POLICY:

Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered investigational for the management of extracranial vertebral artery disease.

POLICY GUIDELINES:

The extracranial vertebral artery is considered to be segments V1 to V3 of the vertebral artery from its origin at the subclavian artery until it crosses the dura mater.

DESCRIPTION OF PROCEDURE OR SERVICE:

Vertebral artery diseases, including atherosclerotic stenosis, dissections, and aneurysms, can lead to ischemia of the posterior cerebral circulation. Conventional management of extracranial vertebral artery diseases may include medical therapy (e.g. antiplatelet or anticoagulant medications), medications to reduce atherosclerotic disease risk (e.g., statins), and/or surgical revascularization. Endovascular therapies have been investigated as an alternative to conventional management.

Vertebrobasilar Circulation Ischemia

Ischemia of the vertebrobasilar or posterior circulation accounts for about 20% of all strokes. Posterior circulation strokes may arise from occlusion of the innominate and subclavian arteries, the extracranial vertebral arteries, or the intracranial vertebral, basilar, or posterior cerebral arteries. Compared with carotid artery disease, relatively little is known about the true prevalence of specific causes of posterior circulation strokes, particularly the prevalence of vertebral artery disease. In a report from a stroke registry, Guili et al (2013) estimated that in 9% cases, posterior circulation strokes are due to stenosis of the proximal vertebral artery. Individuals who experience strokes or transient ischemic attacks (TIAs) of the vertebrobasilar circulation face a 25 to 35% risk of stroke within the subsequent five years. In particular, the presence of vertebral artery stenosis increases the 90-day risk of recurrent stroke by about four fold.

Relevant Clinical Anatomy and Pathophysiology

Large artery disease of the posterior circulation may be due to atherosclerosis (stenosis), embolism, dissection, or aneurysms. In about a third of cases, posterior circulation strokes are due to stenosis of the extracranial vertebral arteries or the intracranial vertebral, basilar, and posterior cerebral arteries. The proximal portion of the vertebral artery in the neck is the most common location of atherosclerotic stenosis in the posterior circulation. Dissection of the extracranial or intracranial vertebral arteries may also cause posterior circulation ischemia. By contrast, posterior cerebral artery ischemic events are more likely to be secondary to embolism from more proximal vessels.

The vertebral artery is divided into 4 segments, V1 though V4, of which segments V1, V2, and V3 are extracranial. V1 originates at the subclavian artery and extends to the C5 or C6 vertebrae; V2 crosses the bony canal of the transverse foramina from C2 to C5; V3 starts as the artery exits the transverse foramina at C2 and ends as the vessel crosses the dura mater and becomes an intracranial vessel. The most proximal segment (V1) is the most common location for atherosclerotic occlusive disease to occur, while arterial dissections are most likely to involve the extracranial vertebral artery just before the vessel crosses the dura mater. Compared with the carotid circulation, the vertebral artery system is more likely to be associated with anatomic variants, including a unilateral artery.

Atherosclerotic disease of the vertebral artery is associated with conventional risk factors for cerebrovascular disease. However, risk factors and the underlying pathophysiology of vertebral artery dissection and aneurysms differ. Extracranial vertebral artery aneurysms and dissections are most often secondary to trauma, particularly those with excessive rotation, distraction, or flexion/extension, or iatrogenic injury, such as during cervical spine surgeries. Spontaneous vertebral artery dissections are rare, and in many cases are associated with connective tissue disorders, including Ehlers-Danlos syndrome type IV, Marfan syndrome, autosomal dominant polycystic kidney disease, and osteogenesis imperfecta type I.

Management of Extracranial Vertebral Artery Disease

The optimal management of occlusive extracranial vertebral artery disease is not well defined. Medical treatment with antiplatelet or anticoagulant medications is a mainstay of therapy to reduce stroke risk. Medical therapy also typically involves risk reduction for classical cardiovascular risk factors. However, no randomized trials have compared specific antiplatelet or anticoagulant regimens.

Surgical revascularization may be used for vertebral artery atherosclerotic disease, but open surgical repair is considered technically challenging due to poor access to the vessel origin. Surgical repair may involve vertebral endarterectomy, bypass grafting, or transposition of the vertebral artery, usually to the common or internal carotid artery. Moderately sized, single-center case series of surgical vertebral artery repair from 2012 and 2013 have reported overall survival rates of 91% and 77% at 3 and 6 years postoperatively, respectively, and arterial patency rates of 80% after 1 year of follow-up. Surgical revascularization may be used when symptomatic vertebral artery stenosis is not responsive to medical therapy, particularly when bilateral vertebral artery stenosis is present or when unilateral stenosis is present in the presence of an occluded or hypoplastic contralateral vertebral artery. Surgical revascularization may also be considered in individuals with concomitant symptomatic carotid and vertebral disease who do not have relief from vertebrobasilar ischemia after carotid revascularization.

The management of extracranial vertebral artery aneurysms or dissections is controversial due to uncertainty about the risk of thromboembolic events associated with aneurysms and dissections. Antiplatelet therapy is typically used; surgical repair, which may include vertebral bypass, external carotid autograft, and vertebral artery transposition to the internal carotid artery, or endovascular treatment with stent placement or coil embolization, may also be used.

Given the technical difficulties related to surgically accessing the extracranial vertebral artery, endovascular therapies have been investigated for extracranial vertebral artery disease. Endovascular therapy may consist of percutaneous transluminal angioplasty, with or without stent implantation.

KEY POINTS:

The most recent literature review was updated through April 3, 2024.

Summary of Evidence

For individuals who have extracranial vertebral artery stenosis who receive percutaneous transluminal angioplasty (PTA) with or without stent implantation, the evidence includes a randomized controlled trial (RCT) and non-comparative studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Two RCTs, the Vertebral Artery Ischaemia Stenting Trial (VIST) and the Vertebral Artery Stenting Trial (VAST), found no advantage for endovascular intervention compared to best medical therapy alone.  Evidence from non-comparative studies has shown that vertebral artery stenting can be performed with high rates of technical success and low periprocedural morbidity and mortality, and that vessel patency can be achieved in a high percentage of cases. However, long-term follow-up has demonstrated high rates of in-stent stenosis. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have extracranial vertebral artery aneurysm(s), dissection(s), or arteriovenous (AV) fistula (e) who receive percutaneous transluminal angioplasty with stent implantation, the evidence includes small case series and reports. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. The available evidence has indicated that endovascular therapy for extracranial vertebral artery disorders other than stenosis is feasible and may be associated with favorable outcomes. However, given the lack of data comparing endovascular therapies to alternatives, the evidence is insufficient to determine whether endovascular therapy for extracranial vertebral artery aneurysms, dissections, or AV fistulae improves the net health outcome. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

American Heart Association and American Stroke Association

The American Heart Association (AHA) and American Stroke Association (ASA) (2014) issued guidelines on prevention of stroke in patients with stroke and transient ischemia attack (TIA) with recommendations about treatment of extracranial vertebrobasilar disease. These guidelines were updated in 2021 and the most recent recommendations and evidence statements about treatment of extracranial vertebrobasilar disease are listed in Table 1.

Table 1. Guidelines on Stroke Prevention in Patients with Stroke and Transient Ischemic Attack

BP: blood pressure; COR: class of recommendation; LOE: level of evidence; TIA: transient ischemic attack. Level of Evidence: A: high-quality evidence from more than 1 RCT; B-R: moderate quality of evidence from 1 or more randomized controlled trials; C-EO: consensus of expert opinion based on clinical experience.

American Stroke Association et al

In 2011, a multi-society task force issued guidelines on the management of extracranial vertebral and carotid artery disease with made the following statements about catheter-based revascularization of extracranial vertebral artery disease: “Although angioplasty and stenting of the vertebral vessels are technically feasible, as for high-risk patients with carotid disease, there is insufficient evidence from randomized trials to demonstrate that endovascular management is superior to best medical management.” No specific recommendations are made regarding endovascular therapies.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Endovascular, extracranial, vertebral artery, percutaneous transluminal angioplasty, PTA, extracranial stenting, extracranial angioplasty, angioplasty, vertebral artery stenosis, vertebral artery aneurysm, vertebral artery dissection, vertebral artery arteriovenous fistulae, Neurolink System®, Wingspan™ Stent System

APPROVED BY GOVERNING BODIES:

Currently, no endovascular therapies have been approved by the U.S. Food and Drug Administration (FDA) specifically for treatment of extracranial vertebral artery disease.

Various stents, approved for use in the carotid or coronary circulation, have been use for extracranial vertebral artery disease. These stents may be self- or balloon-expandable.

Two devices have been approved by the FDA through the humanitarian device exemption process for intracranial atherosclerotic disease. This form of FDA approval is available for devices used to treat conditions with an incidence of 4000 or less per year; the FDA only requires data showing "probable safety and effectiveness." Devices with their labeled indications are as follows:

1. Neurolink System® (Guidant):  "The Neurolink system is indicated for the treatment of patients with recurrent intracranial stroke attributable to atherosclerotic disease refractory to medical therapy in intracranial vessels ranging from 2.5 to 4.5mm in diameter with ≥50% stenosis and that are accessible to the stent system."

2. Wingspan™ Stent System (Boston Scientific): "The Wingspan Stent System with Gateway PTA [percutaneous transluminal angioplasty] Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥50% stenosis that are accessible to the system."

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

REFERENCES:

1. Ambekar S, Sharma M, Smith D, et al. Successful treatment of iatrogenic vertebral pseudoaneurysm using pipeline embolization device. Case Rep Vasc Med. 2014; 2014:341748.
2. Badve MS, Henderson RD, O'Sullivan JD, et al. Vertebrobasilar dissections: Case series comparing patients with and without dissecting aneurysms. J Clin Neurosci. Nov 2014; 21(11):2028-2030.
3. 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. 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 Neuro Interventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. Jul 26 2011; 124(4):e54-130.
4. Coleman DM, Obi A, Criado E, et al. Contemporary outcomes after distal vertebral reconstruction. J Vasc Surg. Jul 2013; 58(1):152-157.
5. Compter A, van der Worp HB, Schonewille WJ, et al. Stenting versus medical treatment in patients with symptomatic vertebral artery stenosis: a randomised open-label Phase 2 trial. Lancet Neurol. Jun 2015; 14(6):606-614.
6. Felber S, Henkes H, Weber W, et al. Treatment of extracranial and intracranial aneurysms and arteriovenous fistulae using stent grafts. Neurosurgery. Sep 2004; 55(3):631-638; discussion 638-639.
7. Gulli G, Marquardt L, Rothwell PM, et al. Stroke risk after posterior circulation stroke/transient ischemic attack and its relationship to site of vertebrobasilar stenosis: pooled data analysis from prospective studies. Stroke. Mar 2013; 44(3):598-604.
8. Hatano T, Tsukahara T, Miyakoshi A, et al. Stent placement for atherosclerotic stenosis of the vertebral artery ostium: angiographic and clinical outcomes in 117 consecutive patients. Neurosurgery. Jan 2011; 68(1):108-116; discussion 116.
9. Herrera DA, Vargas SA, Dublin AB. Endovascular treatment of traumatic injuries of the vertebral artery. AJNR Am J Neuroradiol. Sep 2008; 29(8):1585-1589.
10. Horowitz MB, Miller G, 3rd, Meyer Y, et al. Use of intravascular stents in the treatment of internal carotid and extracranial vertebral artery pseudoaneurysms. AJNR Am J Neuroradiol. Apr 1996; 17(4):693-696.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. Jang HJ, Oh SY, Shim YS, et al. Endovascular treatment of symptomatic high-flow vertebral arteriovenous fistula as a complication after c1 screw insertion. J Korean Neurosurg Soc. Oct 2014; 56(4):348-352.
13. Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. Jul 2014; 45(7):2160-2236.
14. Kikuchi T, Ishii A, Nakahara I, et al. Japanese Registry of Neuroendovascular Therapy: extracranial steno-occlusive diseases except for internal carotid artery stenosis. Neurol Med Chir (Tokyo). 2014; 54(1):40-45.
15. Kleindorfer DO, Towfighi A, Chaturvedi S, et al. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. Jul2021; 52(7): e364-e467.
16. Kondo R, Ishihara S, Uemiya N, et al. Endovascular Treatment for Acute Ischaemic Stroke Caused by Vertebral Artery Dissection: A Report of Three Cases and Literature Review. NMC Case Rep J. 2021; 8(1): 817-825.
17. Lattanzi S, Brigo F, Di Napoli, M, et al. Endovascular treatment of symptomatic vertebral artery stenosis: A systematic review and meta-analysis.. J. Neurol. Sci., 2018 Aug 15; 391:48-53.
18. Markus HS, Harshfield EL, Compter A, et al. Stenting for symptomatic vertebral artery stenosis: a preplanned pooled individual patient data analysis. Lancet Neurol. Jul 2019; 18(7): 666-673.
19. Markus HS, Larsson SC, Dennis J, et al. Vertebral artery stenting to prevent recurrent stroke in symptomatic vertebral artery stenosis: the VIST RCT. Health Technol Assess. Aug 2019; 23(41): 1-30.
20. Markus HS, Larsson SC, Kuker W, et al. Stenting for symptomatic vertebral artery stenosis: The Vertebral Artery Ischaemia Stenting Trial. Neurology. Sep 19 2017; 89(12):1229-1236.
21. Mohammadian R, Sharifipour E, Mansourizadeh R, et al. Angioplasty and stenting of symptomatic vertebral artery stenosis. Clinical and angiographic follow-up of 206 cases from Northwest Iran. Neuroradiol J. Aug 2013; 26(4):454-463.
22. Morasch MD, Phade SV, Naughton P, et al. Primary extracranial vertebral artery aneurysms. Ann Vasc Surg. May 2013; 27(4):418-423.
23. Pham MH, Rahme RJ, Arnaout O, et al. Endovascular stenting of extracranial carotid and vertebral artery dissections: a systematic review of the literature. Neurosurgery. Apr 2011; 68(4):856-866; discussion 866.
24. Ramirez CA, Febrer G, Gaudric J, et al. Open repair of vertebral artery: a 7-year single-center report. Ann Vasc Surg. Jan 2012; 26(1):79-85.
25. Shang EK, Fairman RM, Foley PJ, et al. Endovascular treatment of a symptomatic extracranial vertebral artery aneurysm. J Vasc Surg. Nov 2013; 58(5):1391-1393.
26. Sun X, Ma N, Wang B, et al. The long term results of vertebral artery ostium stenting in a single center. J Neurointerv Surg. Dec 2015; 7(12): 888-91.
27. Takahashi S, Katayama K, Tatsugawa T, et al. A successful hybrid repair for vertebral arteriovenous fistula with extracranial vertebral artery aneurysm. Ann Vasc Surg. Jan 2015; 29(1):126 e125-128.
28. Xu R, Zhang X, Liu S, et al. Percutaneous transluminal angioplasty and stenting for vertebral artery stenosis. Cochrane Database SystRev. May 17 2022; 5(5): CD013692.

POLICY HISTORY:

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (4): Policy adopted from Association

Medical Policy Administration Committee, March 2015

Available for comment February 25 through April 10, 2015

Medical Policy Panel, May 2016

Medical Policy Group, May 2016 (4): 2016 Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, May 2017

Medical Policy Group, May 2017 (4) Updates to Description and Key Points.  No change to policy statement.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, May 2019

Medical Policy Group, May 2019 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021 (3): 2021 Updates to Key Points. Policy statement updated to remove “not medically necessary,” no change to policy statement or intent.

Medical Policy Panel, May 2022

Medical Policy Group, June 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent.

Medical Policy Panel, May 2023

Medical Policy Group, June 2023 (3): 2023 Updates to Key Points, Approved By Governing Bodies, Benefit Applications, and References. Added Policy Guidelines section. No changes to policy statement or intent.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (3): Updates to Key Points, Approved By Governing Bodies, and References. No changes to policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.