Subject:
Endovascular Therapies for Extracranial Vertebral Artery Disease
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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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 (eg, antiplatelet or anticoagulant medications), medications to reduce atherosclerotic disease risk (eg, statins), and/or surgical revascularization. Endovascular therapies have been investigated as an alternative to conventional management.
Populations | Interventions | Comparators | Outcomes |
Individuals:
- With extracranial vertebral artery stenosis
| Interventions of interest are:
- Percutaneous transluminal angioplasty with or without stent implantation
| Comparators of interest are:
| Relevant outcomes include:
- Overall survival
- Symptoms
- Morbid events
- Treatment-related mortality
- Treatment-related morbidity
|
Individuals:
- With extracranial vertebral artery aneurysm(s)
|
Interventions of interest are:
- Percutaneous transluminal angioplasty with stent implantation
| Comparators of interest are:
- Observation
- Surgical treatment
| Relevant outcomes include:
- Overall survival
- Symptoms
- Morbid events
- Treatment-related mortality
- Treatment-related morbidity
|
Individuals:
- With extracranial vertebral artery dissection(s)
|
Interventions of interest are:
- Percutaneous transluminal angioplasty with stent implantation
| Comparators of interest are:
- Observation
- Surgical treatment
| Relevant outcomes include:
- Overall survival
- Symptoms
- Morbid events
- Treatment-related mortality
- Treatment-related morbidity
|
Individuals:
- With extracranial vertebral artery arteriovenous fistula(e)
|
Interventions of interest are:
- Percutaneous transluminal angioplasty with stent implantation
| Comparators of interest are:
- Observation
- Surgical treatment
| Relevant outcomes include:
- Overall survival
- Symptoms
- Morbid events
- Treatment-related mortality
- Treatment-related morbidity
|
Background
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, Gulli et al (2013) estimated that, in 9% of cases, posterior circulation strokes are due to stenosis of the proximal vertebral artery.1, Patients who experience strokes or transient ischemic attacks of the vertebrobasilar circulation face a 25% to 35% risk of stroke within the subsequent 5 years. In particular, the presence of vertebral artery stenosis increases the 90-day risk of recurrent stroke by about 4-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 four 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.2,
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.3,4, 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 patients 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.
Regulatory Status
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 used 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 the 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 4.5 mm 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."
Related Policies
- Extracranial Carotid Artery Stenting (Policy #053 in the Surgery Section)
- Endovascular Procedures for Intracranial Arterial Disease (Atherosclerosis and Aneurysms) (Policy #123 in the Surgery Section)
Policy:
(Note: Effective July 15, 2019, Horizon Blue Cross Blue Shield of New Jersey (“Horizon BCBSNJ”) contracted with TurningPoint Healthcare Solutions, LLC (TurningPoint) to manage our Surgical and Implantable Device Management Program (“the Program”). TurningPoint conducts Prior Authorization and Medical Necessity Determination reviews of certain cardiac services to be provided to members included in the scope of the Program. The scope of the program includes members enrolled in the Horizon BCBSNJ plans for the effective dates noted below.
For services rendered July 15, 2019 and after, the Program includes members enrolled in Horizon BCBSNJ Fully Insured plans.
For services to be rendered January 20, 2020 and after, the Program will also include members enrolled in New Jersey State Health Benefits Program (SHBP)/School Employees’ Health Benefits Program (SEHBP) plans.
Please note that this policy’s criteria and guidelines only apply to members enrolled in plans that DO NOT participate in the Program. Visit our TurningPoint webpage for instructions on accessing the policy criteria and guidelines that TurningPoint will follow as they conduct PA/MND reviews as part of the Program. You may also call TurningPoint at 1-833-436-4083, Monday through Friday between 8 a.m. and 5 p.m., Eastern Time to request policy content.
For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered investigational for the management of extracranial vertebral artery disease.
Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.)
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.
Medicare Coverage:
Per National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) (20.7), percutaneous transluminal angioplasty (PTA) is covered for the treatment of atherosclerotic obstructive lesions of the lower or the upper extremities, of a single coronary artery, of renal arteries, and of AV dialysis fistulas and grafts when NCD 20.7 criteria is met.
National Coverage Determination (NCD) 20.7 for Percutaneous Transluminal Angioplasty (PTA) also addresses the use of PTA concurrent with carotid stent placement in Food and Drug Administration (FDA) investigational device exemption clinical trials, in FDA-approved postapproval studies, and in individuals at high risk for carotid endarterectomy. Documentation to support the covered indications per the NCD must be maintained in the individual's medical record and available upon request.
Per NCD 20.7, all other indications for PTA with or without stenting to treat obstructive lesions of the vertebral and cerebral arteries are noncovered. Therefore, CPT codes 0075T and 0076T are noncovered.
For additional information, refer to Per National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) (20.7). Available at: Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=201&bc=AgAAQAAAAAAA&ncdver=9.
[RATIONALE: This policy was created in 2015 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through March 23, 2020.
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The RCT is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
Angioplasty With or Without Stenting for Extracranial Vertebral Artery Stenosis
Clinical Context and Therapy Purpose
The purpose of percutaneous transluminal angioplasty (PTA) with or without stent implantation in patients who have extracranial vertebral artery stenosis is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this policy is: Does PTA with or without stent implantation improve the net health outcome in patients with extracranial vertebral artery stenosis?
The following PICO was used to select literature to inform this policy.
Patients
The relevant population of interest is patients with extracranial vertebral artery stenosis.
Interventions
The therapy being considered is PTA with or without stent implantation.
Comparators
The following therapies are currently being used to make decisions about PTA with or without stent implantation; 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. The optimal management of occlusive extracranial vertebral artery disease is not well-defined.
Outcomes
The general outcomes of interest are overall survival, symptoms, morbid events, treatment-related mortality, and treatment-related morbidity.
Study Selection Criteria
Methodologically credible studies were selected using the following principles:
- To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
- In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
- To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
Studies with duplicative or overlapping populations were excluded.
Review of Evidence
The evidence base for the efficacy of endovascular interventions for vertebral artery stenosis consists of a large number of case series, most of which are small and retrospective. A small number of controlled trials have been published, which is the emphasis for this review.
Systematic Reviews
Several systematic reviews of published studies were identified. These systematic reviews were published prior to the Vertebral Artery Ischaemia Stenting Trial (VIST)5, and the Vertebral Artery Stenting Trial (VAST),6, which are described in the Randomized Controlled Trials section. Meta-analysis of the Stenting and Aggressive Medical Management of Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial, VAST, and VIST showed no advantage for stenting/angioplasty for stroke prevention compared with medical therapy alone.7,
Lattanzi et al (2018) conducted a systematic review and meta-analysis of 4 RCTs of endovascular treatment compared to medical treatment in patients with symptomatic vertebral artery stenosis, including VAST and VIST.8, Consistent with previous systematic reviews, the researchers found no overall effect of endovascular treatment on any primary or secondary outcome, including any stroke, any vertebrobasilar territory stroke, ischemic stroke, transient ischemic attack (TIA), myocardial infarction, vascular death, and the composite vascular outcome either within or after 30 days.8,
Randomized Controlled Trials
The VIST trial is the largest RCT published to date comparing stenting with medical therapy in patients who had symptomatic vertebral artery disease.5,9, Enrollment was originally planned for 1302 patients, but was stopped after 182 participants entered due to slow recruitment and the end of funding. Patients with symptomatic extracranial or intracranial vertebral artery stenosis and vertebrobasilar transient ischemic attack or stroke in the previous three months were randomized to vertebral artery stenting plus best medical therapy or best medical therapy alone. Of the 91 patients randomized to stenting, 33% did not undergo the procedure. The primary endpoint of fatal or nonfatal stroke occurred in 5 patients in the stent group and 12 in the medical management group (hazard ratio, 0.40; 95% confidence interval, 0.14 to 1.13; p=0.08 by intention-to-treat analysis). Although this trial found no benefit of stenting, it was underpowered and lacked the precision to exclude a benefit from stenting.
VAST was a multicenter phase 2 trial that included 115 patients who had transient ischemic attack or minor stroke attributed to vertebral artery stenosis.6, Randomization to stenting plus medical therapy or medical therapy was stratified by center and level of stenosis; 83.5% of patients had extracranial lesions and the rest had intracranial lesions. Stent selection was by surgeon preference. The primary outcome was the composite of vascular death, stroke, or myocardial infarction within 30 days. Patients were followed yearly by telephone. The median follow-up was 3.0 years (range, 1.3-4.1 years). Endovascular therapy plus best medical therapy was not superior to best medical therapy alone in this trial. The primary outcome occurred in 3 (5%) of 57 patients (95% confidence interval, 0% to 11%) in the stenting group and 1 (2%) of 58 patients (95% confidence interval, 0% to 5%) in the medical treatment group. During follow-up, the composite primary outcome occurred in 11 (19%) patients in the stenting group and in 10 (17%) patients in the medical therapy group. The periprocedural risk of a major vascular event in the stenting group was 5%.
Noncomparative Studies
A large number of noncomparative studies, most often enroll few patients, have described outcomes for patients treated with endovascular therapies for extracranial vertebral artery disease. Some cohort studies reporting prospectively collected complication and restenosis rates are shown in Table 1.
Table 1. Cohort Studies of Endovascular Treatment of Extracranial Vertebral Artery Stenosis
Study | Study Design | Population | FU | Main Results | ISR Rate |
Kikuchi et al (2014)10, | Retrospective review of prospectively collected data | 404 patients from registry treated with endovascular therapy | 30 d | Postprocedural morbidity: 2.0%
Postprocedural mortality: 0.3% | Not reported |
Sun et al (2015)11, | Retrospective review of prospectively collected data | 188 patients with posterior circulation TIA or stroke and mRS score ≤2 | 16.5 moa | Technical success rate: 100%
34 patients had recurrent TIA after 30 d
No cases of stroke or death occurred | 21.2% |
Mohammadian et al (2013)12, | Prospective interventional study | 206 patients with clinical signs of vertebral occlusion (239 treated lesions, 202 extracranial) | 13.15 moa | Technical success rate: 100%.
89.2% were balloon-expandable bare-metal stents
Periprocedural complication rate: 7.2%
Complications during FU: overall 6.3% | 15.9% |
Hatano et al (2011)13, | Retrospective review of prospectively collected data | 117 patients (108 symptomatic, 9 asymptomatic) | 48 moa | Technical success rate: 99%
During FU, 5 patients had posterior circulation ischemia, 1 had cerebellar infarction with ISR, 2 had posterior circulation strokes without ISR | 9.6% at 6 mo |
FU: follow-up; ISR: in-stent restenosis; mRS: modified Rankin Scale; TIA: transient ischemic attack.
a Mean value.
Section Summary: Angioplasty With or Without Stenting for Extracranial Vertebral Artery Stenosis
The evidence on the overall efficacy of endovascular therapies for extracranial vertebral artery stenosis includes a phase 3 and a phase 2 RCT that compared endovascular therapy with best medical therapy alone for vertebral artery stenosis. These trials found no advantage of endovascular intervention over best medical therapy alone, with a periprocedural adverse event rate of 5% for the invasive procedures in the VAST trial. Evidence from noncomparative studies has indicated 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.
Angioplasty With Stenting for Extracranial Vertebral Artery Aneurysms, Dissections, and Arteriovenous Fistula(e)
Clinical Context and Therapy Purpose
The purpose of PTA with stent implantation in patients who have extracranial vertebral artery aneurysms, dissections, and AV fistula(e)is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this policy is: Does PTA with stent implantation improve the net health outcome in patients with extracranial vertebral artery aneurysms, dissections, and AV fistula(e)?
The following PICO was used to select literature to inform this policy.
Patients
The relevant population of interest is patients with extracranial vertebral artery aneurysms, dissections, and AV fistula(e).
Interventions
The therapy being considered is PTA with stent implantation.
Comparators
The following therapies and practices are currently being used to make decisions about PTA with stent implantation: continued clinical observation, medical therapy and surgical repair. 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.
Outcomes
The general outcomes of interest are overall survival, symptoms, morbid events, treatment-related mortality, and treatment-related morbidity.
Study Selection Criteria
Methodologically credible studies were selected using the following principles:
- To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
- In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
- To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
Studies with duplicative or overlapping populations were excluded.
Review of Evidence
A smaller body of literature has addressed the use of endovascular procedures for extracranial vertebral artery aneurysms, dissections, and AV) fistula(e). These lesions most commonly occur after trauma or iatrogenic injury. Because aneurysms, dissections, and AV fistulae may coexist in the same vessel, studies reporting outcomes for endovascular treatment of these conditions are discussed together. The available literature consists entirely of case reports, case series, and a systematic review of case series.
Systematic Reviews
Pham et al (2011) conducted a systematic review of studies evaluating endovascular stenting for extracranial carotid and vertebral artery dissections. Eight studies of extracranial vertebral artery stenting with 10 patients (12 vessels) were included.14, Of the 10 patients included, 70% had associated pseudoaneurysms and 20% had bilateral lesions. Most dissections (60%) were traumatic in etiology, while 20% were spontaneous and 20% were iatrogenic. The indications for stenting were failure of medical management in 40% (defined as a new ischemic event, progression of initial symptoms, or demonstration of an enlarging pseudoaneurysm despite adequate anticoagulation or antiplatelet treatment), contraindication to anticoagulation in 20%, and/or severity of dissection hemodynamics in 60%. No stent-related complications or mortalities were reported in any study. One dissection-related death was reported, although stenting was considered technically successful.
Case Series and Reports
Since the publication of the Pham et al (2011) systematic review, additional case series on the use of endovascular therapies for extracranial vertebral artery dissections have been published.
Badve et al (2014) retrospectively compared the clinical characteristics of patients who had vertebrobasilar dissections with and without aneurysmal dissection treated at a single institution from 2002 to 2010.15, Thirty patients were identified, 7 with aneurysmal dissections (one of which was extracranial) and 23 with nonaneurysmal dissections (10 of which were extracranial, 12 of which were combined intracranial/extracranial). Patients were treated with antiplatelet agents (aspirin or clopidogrel; n=8), anticoagulation with warfarin (n=13), or neurointerventional procedures (n=6). One patient in the nonaneurysmal dissection group treated with aspirin died.
The use of endovascular therapy for extracranial vertebral artery aneurysms and AV fistulae is similarly limited to small case series and reports. In an early report, Horowitz et al (1996) described a left-sided vertebral artery pseudoaneurysm with dissection between the vessel media and adventitia at the C7 vertebra that was treated with a balloon-expandable stent.16, Follow-up angiography three months postprocedure showed no filling of the pseudoaneurysm and normal patency of the parent artery. Felber et al (2004) reported on outcomes from endovascular treatment with stent grafts of 11 patients who had aneurysms or AV fistulae of craniocervical arteries, 2 of whom were treated for extracranial vertebral artery disorders with coronary stents (1 aneurysm, 1 traumatic AV fistula).17, The procedure was technically successful in both subjects, without complications. At follow-up (5 years and 14 months postprocedure in the aneurysm and fistula patients, respectively), the target vessel was patent without stenosis. Herrera et al (2008) reported on outcomes for a single-center series of 18 traumatic vertebral artery injuries, including 16 AV fistulae (7 of which had an associated pseudoaneurysm) and 2 isolated pseudoaneurysms, treated with endovascular therapy.18, Endovascular therapy consisted of balloon occlusion of the parent vessel and AV fistula in 12 (66.6%) patients, coil embolization in 2 (11.1%) patients, and detachable balloon and coil embolization, balloon occlusion, and stent delivery with coil and n-butyl cyanoacrylate embolization of a AV fistulae each in 1 (5.5% each) patient. Angiography immediately after endovascular treatment demonstrated complete occlusion in 16 (88.9%) patients and partial occlusion in 2 (11.1%) patients. Seventeen (94.5%) patients had complete resolution of symptoms.
Other case reports have described successful use of endovascular treatment with stenting for iatrogenic vertebral artery pseudoaneurysms,19, iatrogenic vertebral artery AV fistula,20, extracranial vertebral artery aneurysm with an unknown cause,21, and extracranial vertebral artery aneurysm with a cervical vertebral AV fistula.22,
Section Summary: Angioplasty With Stenting for Extracranial Vertebral Artery Aneurysms, Dissections, and AV Fistula(e)
The evidence on use of endovascular therapies for the treatment of extracranial vertebral artery dissections, aneurysms, and AV fistula(e) consists of small case series and case reports. These reports and series have indicated that endovascular therapy for extracranial vertebral artery disorders other than stenosis is feasible and might be associated with favorable outcomes. However, given the lack of evidence comparing endovascular therapies with alternatives, the evidence is insufficient to draw conclusions about the efficacy of endovascular therapy for treating extracranial vertebral artery dissections, aneurysms, and AV fistula(e) vs existing alternative therapies.
Summary of Evidence
For individuals who have extracranial vertebral artery stenosis who receive percutaneous transluminal angioplasty with or without stent implantation, the evidence includes randomized controlled trials and noncomparative studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Two randomized controlled trials, the Vertebral Artery Ischaemia Stenting Trial and the Vertebral Artery Stenting Trial, found no advantage for endovascular intervention compared with best medical therapy alone. Evidence from noncomparative 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 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 permit conclusions about the efficacy of endovascular therapy for extracranial vertebral artery aneurysms, dissections, or arteriovenous fistulae. The evidence is insufficient to determine the effects of the technology on health outcomes.
SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements
American Heart Association and American Stroke Association
The American Heart Association and American Stroke Association (2014) issued joint guidelines on prevention of stroke in patients with stroke and transient ischemic attack, which made the following recommendations about treatment of extracranial vertebrobasilar disease (see Table 2).23,
Table 2. Guidelines on Stroke Prevention in Patients With Stroke and Transient Ischemic Attack
Recommendation | COR | LOE |
"Routine preventive therapy with emphasis on anti-thrombotic therapy, lipid lowering, BP control, and lifestyle optimization is recommended for all patients with recently symptomatic extracranial vertebral artery stenosis" | I | C |
"Endovascular stenting of patients with extracranial vertebral stenosis may be considered when patients are having symptoms despite optimal medical treatment." | IIb | C |
"Open surgical procedures, including vertebral endarterectomy and vertebral artery transposition, may be considered when patients are having symptoms despite optimal medical treatment." | IIb | C |
BP: blood pressure; COR: class of recommendation; LOE: level of evidence.
American Stroke Association et al
In 2011, a multisociety task force issued guidelines on the management of extracranial vertebral and carotid artery disease, which 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."24, No specific recommendations were made about endovascular therapies.
European Society for Vascular Surgery
The European Society for Vascular Surgery (2017) made the following recommendation: "Patients with recurrent vertebrobasilar territory symptoms (despite best medical therapy) and who have a 50 to 99% extracranial vertebral artery stenosis may be considered for revascularisation." The recommendation was based on Level B evidence (data derived from a single randomized controlled trial or large non-randomized studies) and considered Class IIb (i.e., the usefulness/efficacy is less well established).25,
U.S. Preventive Services Task Force Recommendations
Not applicable.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in March 2020 did not identify any ongoing or unpublished trials that would likely influence this review.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Endovascular Therapies for Extracranial Vertebral Artery Disease
Extracranial Vertebral Artery Disease
Vertebral Artery Disease
References:
1. 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. PMID 23386676
2. Morasch MD, Phade SV, Naughton P, et al. Primary extracranial vertebral artery aneurysms. Ann Vasc Surg. May 2013; 27(4): 418-23. PMID 23540677
3. Coleman DM, Obi A, Criado E, et al. Contemporary outcomes after distal vertebral reconstruction. J Vasc Surg. Jul 2013; 58(1): 152-7. PMID 23478503
4. 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. PMID 22176877
5. 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. PMID 28835400
6. 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): 606-14. PMID 25908089
7. 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. PMID 31130429
8. 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. Aug 15 2018; 391: 48-53. PMID 30103970
9. 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. PMID 31422789
10. 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): 40-5. PMID 24257542
11. 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. PMID 25332411
12. 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): 454-63. PMID 24007733
13. 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): 108-16; discussion 116. PMID 21099720
14. 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): 856-66; discussion 866. PMID 21242839
15. 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): 2028-30. PMID 24913932
16. Horowitz MB, Miller G, 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): 693-6. PMID 8730189
17. 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): 631-8; discussion 638-9. PMID 15335430
18. Herrera DA, Vargas SA, Dublin AB. Endovascular treatment of traumatic injuries of the vertebral artery. AJNR Am J Neuroradiol. Sep 2008; 29(8): 1585-9. PMID 18499790
19. 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. PMID 25276469
20. 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): 348-52. PMID 25371787
21. Shang EK, Fairman RM, Foley PJ, et al. Endovascular treatment of a symptomatic extracranial vertebral artery aneurysm. J Vasc Surg. Nov 2013; 58(5): 1391-3. PMID 23561429
22. 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.e5-8. PMID 25304908
23. 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): 2160-236. PMID 24788967
24. 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 NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. Jul 26 2011; 124(4): e54-130. PMID 21282504
25. Eckstein HH. European Society for Vascular Surgery Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. Jan 2018; 55(1): 1-2. PMID 28851595
26. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) (20.7). 2013; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=201&ncdver=10&bc=AgAAgAAAAAAAAA%3d%3d&. Accessed March 24, 2020.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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