Medical Policy: 07.01.32 

Original Effective Date: July 2006 

Reviewed: June 2021 

Revised: June 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Intracranial arterial disease includes thromboembolic events, vascular stenosis, and aneurysms. Endovascular techniques have been investigated for the treatment of intracranial arterial disease. Endovascular therapy is used as an alternative or adjunct to intravenous tissue plasminogen activator (tPA) and supportive for acute stenosis and as an adjunct to risk factor modification for chronic stenosis. For cerebral aneurysms, stent-assisted coiling and the use of flow-diverting stents have been evaluated as an alternative to endovascular coding in patients whose anatomy is not amendable to simple coiling.

 

Acute stroke is the fifth leading cause of death in the United States; further, it is a leading cause of adult disability. Eighty-seven percent of strokes are ischemic and 13% hemorrhagic. Differentiation between the 2 types of stroke is necessary to determine the appropriate treatment. Ischemic stroke occurs when an artery to the brain is blocked by a blood clot, which forms in the artery (thrombotic), or when another substance (i.e., plaque, fatty material) travels to an artery in the brain causing a blockage (embolism). Recanalization of the artery, particularly in the first few hours after occlusion, reduces rates of disability and death.

 

It is estimated that intracranial atherosclerotic lesions (stenosis) causes about 8% of all ischemic strokes. Intracranial stenosis may contribute to stroke in two ways: either due to embolism or low flow ischemia in the absence of collateral circulation. Recurrent annual stroke rates are estimated at 4%-12% per year with atherosclerosis of the intracranial anterior circulation, and 2.5%-15% per year with lesions of the posterior (vertebrobasilar) circulation. Medical treatment typically includes either anticoagulant therapy (i.e.,warfarin) or antiplatelet therapy (i.e.,aspirin).

 

Two devices were approved by the FDA through humanitarian device exemption process for artherosclerotic disease. This form of the FDA approval is available for devices used to treat conditions with an incident rate of 4000 or fewer cases per year; the FDA only requires data showing “probable safety and effectiveness.” Devices with their labeled indications are as follows.

 

  • Neurolink System: The Neurolink System [Guidant] 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.
  • Wingspan Stent System: The Wingspan Stent System [Boston Scientific] 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.

 

Compared with acute ischemic stroke, cerebral aneurysms (intracranial aneurysms) have a much lower incidence in the United States, with prevalence between 0.5% and 6% of the population. However, they are associated with significant morbidity and mortality due to subarachnoid hemorrhage resulting from aneurysm rupture. 

 

Endovascular Interventions for Symptomatic Intracranial Atherosclerotic Disease

Clinical Context and Therapy Purpose

The purpose of endovascular interventions in patients with intracranial atherosclerotic disease is to prevent stroke or recurrent stroke.

 

Populations

Patients with severe stenosis (70 to 99% of the diameter of a major intracranial artery).

 

Interventions

Devices for treatment of intracranial stenosis have received the FDA approval through the humanitarian device exemption process. The Neurolink System was approved based on the Stenting of Symptomatic Atherosclerosis Lesions in the Vertebral or Intracranial Arteries (SSYLVIA) trial, a prospective, nonrandomized, multicenter, international study of 61 patients. The Wingspan Stent System was evaluated in a prospective study of 45 patients enrolled at 12 international centers. The SSYLVIA study reported an all-stroke rate of 13.1% over a mean follow-up of 216 days; the Wingspan study reported an all-stroke rate of 9.5% over a mean follow-up of 174 days.

 

The FDA summary of safety and effectiveness for the Wingspan device offered the following conclusions and the FDA appears to have based its approval of Wingspan in part on the favorable comparison with the Neurolink device: "the probable benefit to health from using the Wingspan Stent System with Gateway PTA Balloon Catheter for treating transcranial stenosis outweighs the risk of illness or injury when used in accordance with the Instructions for Use and when taking into account the probable risks and benefits of currently available alternative forms of treatment."

 

Comparators

Medical treatment typically includes either anticoagulant therapy (i.e., warfarin) or antiplatelet therapy (e.g., aspirin). The Warfarin-Aspirin Symptomatic Intracranial Disease trial assessed the incidence of stroke brain hemorrhage or death among patients randomized to aspirin or warfarin. The trial found that over a mean 1.8 years of follow-up, warfarin provided no benefit over aspirin and was associated with a significantly higher rate of complications. Also, if symptoms could be attributed to low-flow ischemia, agents to increase mean arterial blood pressure and avoid orthostatic hypotension may be recommended. However, medical therapy has been considered less than optimal. For example, in patients with persistent symptoms despite antithrombotic therapy, the subsequent rate of stroke or death has been extremely high, estimated in 1 study at 45%, with recurrent events within 1 month of the initial event. Surgical approaches have met with limited success. The widely cited extracranial-intracranial bypass study randomized 1377 patients with symptomatic atherosclerosis of the internal carotid or middle cerebral arteries to medical care or extracranial-intracranial bypass. Outcomes in both groups were similar, suggesting that the extracranial-intracranial bypass is ineffective in preventing cerebral ischemia. Due to inaccessibility, surgical options for the posterior circulation are even more limited.

 

Percutaneous transluminal angioplasty (PTA) has been approached cautiously for use in intracranial circulation, due to technical difficulties in the catheter and stent design and the risk of embolism, which may result in devastating complications if occurring in the posterior fossa or brain stem. However, improvement in the ability to track catheterization, allowing catheterization of tortuous vessels, and the increased use of stents have created ongoing interest in percutaneous transluminal angioplasty as a minimally invasive treatment of this difficult-to treat population. Most published studies of intracranial percutaneous transluminal angioplasty have focused on vertebrobasilar circulation.

 

Outcomes

The outcomes of interest are stroke, death, function and quality of life (QOL). Treatment-related adverse effects, including vessel perforation, hemorrhage, or thrombus formation in a new site, are important safety outcomes. Evidence for both short-term (30 day) and long-term (out to 2-years) outcomes are needed.

 

Systematic Reviews

In 2020, Wang et. al. completed a Cochrane review that compared the safety and efficacy of endovascular therapy (ET) plus conventional medical treatment (CMT) with CMT alone for the management of intracranial atherosclerotic stenosis (ICAS). Intracranial atherosclerotic stenosis (ICAS) is an arterial narrowing in the brain that can cause stroke. Endovascular therapy and medical management may be used to prevent recurrent ischemic stroke caused by ICAS. However, there is no consensus on the best treatment for people with ICAS. The selection criteria included the following: Randomized controlled trials (RCTs) comparing ET plus CMT with CMT alone for the treatment of symptomatic ICAS. ET modalities included angioplasty alone, balloon-mounted stent, and angioplasty followed by placement of a self-expanding stent. CMT included antiplatelet therapy in addition to control of risk factors such as hypertension, hyperlipidemia, and diabetes. Two review authors independently screened trials to select potentially eligible RCTs and extracted data. Any disagreements were resolved by discussing and reaching consensus decisions with the full team. The risk of bias was assessed and applied the GRADE approach to assess the quality of the evidence. The primary outcome was death of any cause or non-fatal stroke of any type within three months of randomization. Secondary outcomes included any-cause death or non-fatal stroke of any type more than three months of randomization, ipsilateral stroke, type of recurrent event, death, restenosis, dependency, and health-related quality of life. Three RCTs were included with 632 participants who had symptomatic ICAS with an age range of 18 to 85 years. The included trials had high risks of performance bias and other potential sources of bias due to the impossibility of blinding of the endovascular intervention and early termination of the trials. Moreover, one trial had a high risk of attrition bias because of the high rate of loss of one-year follow-up and the high proportion of participants transferred from endovascular therapy to medical management. The quality of evidence ranged from low to moderate, downgraded for imprecision. Compared to CMT, ET probably results in a higher rate of 30-day death or stroke (risk ratio (RR) 3.07, 95% confidence interval (CI) 1.80 to 5.24; 3 RCTs, 632 participants, moderate-quality evidence), 30-day ipsilateral stroke (RR 3.54, 95% CI 1.98 to 6.33; 3 RCTs, 632 participants, moderate-quality evidence), 30-day ischemic stroke (RR 2.52, 95% CI 1.37 to 4.62; 3 RCTs, 632 participants, moderate-quality evidence), and 30-day hemorrhagic stroke (RR 15.53, 95% CI 2.10 to 115.16; 3 RCTs, 632 participants, low-quality evidence). ET was also likely associated with a worse outcome in one-year death or stroke (RR 1.69, 95% CI 1.21 to 2.36; 3 RCTs, 632 participants, moderate-quality evidence), one-year ipsilateral stroke (RR 2.28, 95% CI 1.52 to 3.42; 3 RCTs, 632 participants, moderate-quality evidence), one-year ischemic stroke (RR 2.07, 95% CI 1.37 to 3.13; 3 RCTs, 632 participants, moderate-quality evidence), and one-year hemorrhagic stroke (RR 10.13, 95% CI 1.31 to 78.51; 2 RCTs, 521 participants, low-quality evidence). There were no significant differences between ET and CMT in 30-day transient ischemic attacks (TIA) (RR 0.52, 95% CI 0.11 to 2.35, P = 0.39; 2 RCTs, 181 participants, moderate-quality evidence), 30-day death (RR 5.53, 95% CI 0.98 to 31.17, P = 0.05; 3 RCTs, 632 participants, low-quality evidence), one-year TIA (RR 0.82, 95% CI 0.32 to 2.12; 2 RCTs, 181 participants, moderate-quality evidence), one-year death (RR 1.20, 95% CI 0.50 to 2.86, P = 0.68; 3 RCTs, 632 participants, moderate-quality evidence), and one-year dependency (RR 1.90, 95% CI 0.91 to 3.97, P = 0.09; 3 RCTs, 613 participants, moderate-quality evidence). No data on restenosis and health-related quality of life for meta-analysis were available from the included trials. Two RCTs are ongoing. The authors concluded this systematic review provides moderate-quality evidence showing that ET, compared with CMT, in people with recent symptomatic severe intracranial atherosclerotic stenosis probably does not prevent recurrent stroke and appears to carry an increased hazard. The impact of delayed ET intervention (more than three weeks after a qualifying event) is unclear and may warrant further study.

 

Randomized Controlled Trials

The Vitesse Intracranial Stent Study for Ischemic Stroke Therapy (VISSIT) trial, a randomized controlled trial (RCT) comparing a balloon-expandable stent plus medical management with medical management alone among patients who had symptomatic intracranial stenosis of 70% or greater. Eligible patients had stenosis of 70% to 99% of the internal carotid, middle cerebral, intracranial vertebral, or basilar arteries with a TIA or stroke attributable to the territory of the target lesion within the prior 30 days. Enrollment was planned for up to 250 participants. However, an early unplanned analysis was conducted by the trial sponsor after the results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial were published. A total of 112 patients were enrolled from 2009 to 2012 and randomized to the balloon-expandable stent (Vitesse stent) plus medical management (stent group; n=59) or medical management alone (medical group; n=53). Medical management included clopidogrel (75 mg daily) for the first 3 months post enrollment and aspirin (81-325 mg/d) for the duration of the study, along with management of hypercholesterolemia and/or hypertension, if necessary. The trial used a primary composite endpoint that included any stroke in the same territory as the presenting event within 1 year of randomization and “hard TIA ” in the same territory as the presenting event from 2 days to 1 year after randomization. Among 29 patients who met 1 of the primary endpoints within 1 year of randomization, 8 (15.1%) patients were in the medical group, and 21 (36.2%) were in the stent group (risk difference, 21.1%; 95% CI, 5.4% to 36.8%; p=0.02). The rates of stroke within 30 days of randomization or TIA were 9.4% in the medical group and 24.1% in the stent group (risk difference, 14.7%; 95% CI, 1.2% to 28.2%; p=0.05). The 30-day all-cause mortality rate was 5.2% and 0% in the stent and the medical groups, respectively (risk difference, 5.2%; 95% CI, -0.5% to 10.9%; p=0.25). The authors concluded that results did not support the use of a balloon-expandable stent for patients with symptomatic intracranial stenosis.

 

The SAMMPRIS trial was a randomized controlled trial (RCT) comparing aggressive medical management alone with aggressive medical management plus stenting in patients who had symptomatic cerebrovascular disease and intracranial stenosis between 70% and 99%. This trial used the Wingspan stent system implanted by experienced neurointerventionalists credentialed to participate in the trial. The authors planned to enroll 750 patients based on power calculations. However, the trial was stopped early for futility after 451 patients had been randomized, due to an excess of the primary outcome (stroke or death) at 30 days in the stenting group. In the stenting group, the rate of stroke or death at 30 days was 14.7% (95% CI, 10.7% to 20.1%) compared with 5.8% (95% CI, 3.4% to 9.7%; p=0.002) in the medical management group. At the time of trial termination, mean follow-up was 11.9 months. Kaplan-Meier estimates of the primary outcome (stroke or death at 1 year) was 20.5% (95% CI, 15.2% to 26.0%) in the stenting group and 12.2% (95% CI, 8.4% to 17.6%; p=0.009) in the medical management group. These results represented an excess rate of early adverse events with stenting over what was expected together with a decreased rate of stroke and death in the medical management group compared with expected values.

 

The SAMMPRIS investigators, also published results from long-term subject follow-up. Primary endpoints (in addition to stroke or death within 30 days of enrollment) included ischemic stroke in the qualifying artery beyond 30 days after enrollment or stroke or death within 30 days after a revascularization procedure of the qualifying lesion. During a median follow-up of 32.4 months, 34 (15%) of 227 patients in the best medical management group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event, with a significantly higher cumulative probability of a primary endpoint in the stenting group than in the best medical management group (p=0.025). Compared with the best medical management group, subjects in the stenting group had higher rates of any stroke (59/224 [26%] vs 42/227 [19%], p=0.047) and major hemorrhage (29/224 [13%] vs 10/227 [4%], p<0.001). The authors concluded the benefits of aggressive medical management over percutaneous angioplasty and stenting among patients with intracranial stenosis persist over long-term follow-up.

 

Post-Market Surveillance

In 2019, Alexander et. al. reported results from the Wingspan Stent System Post Market Surveillance (WEAVE) post-marketing surveillance study. WEAVE was an FDA-mandated, prospective, single-arm study evaluating the rate of stroke and death within 72 hours post-stenting in patients who met the FDA on-label usage criteria. One hundred fifty-two consecutive patients were enrolled at 24 hospitals. The study was designed to enroll 389 patients but was stopped early when the second, predetermined interim data analysis indicated that the safety benchmarks were met. The primary outcome included 2 nonfatal strokes and 2 deaths from strokes for a total of 4 patients (2.6%) with an event of stroke, bleed, or death.

 

Summary of Evidence

The strongest evidence on the efficacy of endovascular treatment for symptomatic intracranial stenosis is from the SAMMPRIS and VISSIT RCTs. The SAMMPRIS trial was stopped early due to harms because the rate of stroke or death at 30 days following treatment was higher in the endovascular arm, which received percutaneous angioplasty with stenting. Follow-up of the SAMMPRIS subjects has demonstrated no long-term benefit from endovascular therapy. The VISSIT RCT similarly found no benefit with endovascular treatment. These studies support the conclusion that outcomes of endovascular treatment are worse than medical therapy in patients with symptomatic intracranial stenosis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

Stent-Assisted Endovascular Treatment of Intracranial Aneurysms

Clinical Content and Therapy Purpose

The purpose of endovascular interventions in patients with intracranial aneurysm is to remove the aneurysm from the circulation and prevent possible rupture (or if the aneurysm had already ruptured, to stop bleeding and prevent re-rupture) or to divert blood flow away from an aneurysm.

 

Populations

The population of interest is patients with intracranial aneurysms. Treatment decisions depend on patient and aneurysm characteristics. Small (< 7 mm) asymptomatic aneurysms can generally be observed. Larger and asymptomatic aneurysms may be considered for treatment according to anatomical location and morphological characteristics of the aneurysm and relative risks for specific treatments.

 

Interventions

Self-expanding stents have FDA approval through the humanitarian device exemption program for the endovascular treatment of intracranial aneurysms.

 

Intracranial stents are being used to treat cerebral aneurysms. Stent-assisted coiling began as an approach to treat fusiform or wide-neck aneurysms in which other surgical or endovascular treatment strategies may not be feasible. As experience has grown, stenting has also been used in smaller berry aneurysms as an approach to decrease the rate of retreatment needed in patients who receive coiling.

 

Comparators

Small asymptomatic aneurysms can generally be observed without surgery. Surgical clipping of intracranial aneurysms has been used since the 1960s, but the feasibility of clipping for aneurysms depends on the aneurysm location.

 

Outcomes

The Executive Summary of an FDA meeting of the Neurological Devices Advisory Panel in 2018 states the primary safety outcomes for regulatory review have traditionally been focused on neurological deaths and major ipsilateral strokes (defined as an increase of ≥ 4 points in the National Institutes of Health Stroke Scale score during the stroke event) and the percentage of patients who had a disabling stroke (defined as a modified Rankin Scale score ≥ 3 assessed at a minimum of 90 days post-stroke event) within 6 months to 1 year of treatment. The FDA is considering an additional outcome to assess functional independence defined as the change in the modified Rankin Scale score at 1- year post-treatment compared to pre-procedure. The FDA has traditionally used a composite efficacy outcome defined as the percentage of patients demonstrating a Raymond I classification for complete occlusion (i.e., 100% aneurysmal occlusion) without retreatment of the target aneurysm or significant parent artery stenosis (≥ 50%) evaluated within 1- year post-procedure.

 

Self-Expanding Stent-Assisted Coiling and Flow Diverting Stents for Intracranial Aneurysms

For individuals who have intracranial aneurysm(s) who received endovascular coiling with intracranial stent placement or intracranial placement of a flow-diverting stent, the evidence includes randomized controlled trials (RCTs), nonrandomized comparative studies and single-arm studies. The available nonrandomized comparative studies report occlusion rates for stent-assisted coiling that are similar to or higher than coiling alone and recurrence rates that may be lower than coiling alone. For stent-assisted coiling with self-expanding stents, there is also some evidence that adverse event rates are relatively high, and one nonrandomized comparative trial reported that mortality is higher with stent-assisted coiling than with coiling alone. For placement of flow-diverting stents, a RCT and registry study have compared flow diversion with standard management (observation, coil embolization or parent vessel occlusion) in patients for whom flow diversion was considered a promising treatment. The RCT was stopped early after crossing a predefined safety boundary with 16% of patients treated with flow diversion were dead or dependent at three months or later. Flow diversion was also not as effective as the investigators had hypothesized. A nonrandomized study comparing the flow-diverting stents with endovascular coiling for intracranial aneurysms demonstrated higher rates of aneurysm obliteration in those treatment with the Pipeline endovascular device than those treatment with coiling, with similar rates of good clinical outcomes. The evidence does not provide high certainty whether stent-assisted coiling or placement of a flow-diverting stent improves outcomes for patients with intracranial aneurysms because the risk-benefit ration cannot be adequately defined. However, clinical input indicated strong support of the use of stent-assisted coiling for treatment of aneurysms that are not amendable to surgery or simple coiling. Similarly, clinical input indicated general support for the use of flow-diverting stents for certain types of aneurysms when surgical treatment is not appropriate.

 

Angioplasty and Stenting of Intra-Cranial Arteries for the Treatment of Cerebral Vasospasms after Aneurysmal Subarachnoid Hemorrhage

Aneurysmal subarachnoid hemorrhage (SAH) is a common form of stroke.  Frequently, a significant number of patients with this condition develop angiographical or clinical vasospasm with devastating consequences.  The pathogenesis of cerebral vasospasm following SAH remains unclear despite extensive research.  Due to the lack of a clear etiology, medical treatment is still largely limited to hypertensive-hypervolemic-hemodilution (triple-H) therapy, and calcium channel blockers (e.g., nimodipine).  Cerebral vasospasm that has become refractory to maximal medical therapy can be treated with intra-arterial infusion of vasodilators (e.g. papaverine).  Moreover, recent advent in the field of interventional neurology and the development of minimally invasive techniques has resulted in expansion of potential therapeutic approaches for cerebral vasospasm secondary to aneurysmal SAH.  Balloon angioplasty and stenting is being investigated as a treatment option in patients with vasospasm following aneurysmal SAH; however, its effectiveness for this indication has yet to be established and  additional prospective randomized controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in net health outcomes.

 

Practice Guidelines and Position Statements

American Heart Association and American Stroke Association

In 2018, the American Heart Association and the American Stroke Association published joint guidelines on the early management of patients with acute ischemic stroke (updated in 2019). These guidelines included several recommendations relevant to the use of endovascular therapies for acute stroke which included the following:

  • Coil embolization may be superior to surgical clipping with respect to procedural morbidity and mortality, length of stay, and hospital costs, so it may be reasonable to choose endovascular therapy over surgical clipping in the treatment of select unruptured intracranial aneurysms, particularly in cases for which surgical morbidity is high, such as at the basilar apex and in the elderly.
  • Endovascular treatment of unruptured intracranial aneurysms is recommended to be performed at high-volume centers.

 

Regulatory Status

The Neurolink® system, marketed by the Guidant Corporation, 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 a stenosis greater than or equal to 50% and that are accessible to the stent system.

 

The Wingspan™ Stent System with Gateway™ PTA Balloon Catheter, marketed by Boston Scientific, received HDE approval from the FDA in 2005 to treat refractory intracranial atherosclerotic disease resulting in 50 percent or greater narrowing in the intracranial arteries. Following analysis of data from the SAMMPRIS study, the original HDE clinical study and other clinical studies performed after the stent’s HDE approval, the FDA revised the use and labeling for the Wingspan™ stent in August 2012. The new labeling approves the use of Wingspan™ stent for a very select group of patients who are between 22 and 80 years of age and meet all of the following criteria: Have had two or more strokes despite aggressive medical management;

  • Their most recent stroke occurred more than seven days prior to Wingspan™ placement and
  • Have 70-99% stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and
  • Have made good recovery from previous stroke with a modified Rankin score of 3 or less prior to Wingspan™ treatment.

 

The Wingspan™ Stent System should not be used for the treatment of TIAs or treatment of stroke with onset of symptoms within seven days or less of treatment.

 

In 2007, based on a series of approximately 30 patients with 6-month follow-up, the Enterprise™ Vascular Reconstruction Device and Delivery (Cordis Neurovascular) was approved by the FDA through the humanitarian device exemption process (H060001) for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms.

 

In 2014, the Low-Profile Visualized Intraluminal Support Device (LVIS™ and LVIS™ Jr.; MicroVention) was approved by the FDA through the humanitarian device exemption process (H130005) for use with embolic coils for the treatment of unruptured, wide-neck (neck, ≥ 4 mm or dome-to-neck ratio, < 2), intracranial, saccular aneurysms arising from a parent vessel with a diameter of 2.5 mm or greater and 4.5 mm or smaller. In 2018, the LVIS™ and LVIS™ Jr. were approved through the PMA process (P170013).

 

In 2011, the Pipeline® Embolization Device (Covidien/eV3 Neurovascular), an intracranial aneurysm flow-diverter, was approved by the FDA through the premarket approval process (P100018) for the endovascular treatment of adults (≥ 22 years) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. .

 

In 2002, the Neuroform Microdelivery Stent System received HDE approval from the FDA for use with embolic coils for treatment of wide-neck intracranial aneurysms that cannot be treated by surgical clipping. Similarly, in 2007, the Enterprise Vascular Reconstruction Device and Delivery System received HDE approval from the FDA for use with embolic coils for treatment of wide-neck, intracranial, saccular or fusiform aneurysms.

 

In 2019, the Neuroform Atlas Stent System (Stryker) was approved by the FDA through the PMA process (P190031) based on the pivotal ATLAS study including 201 patients with up to 12 months of follow-up. The approved indication is "for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients greater than or equal to 18 years of age with saccular wide-necked (neck width greater or equal to 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.0 mm and less than or equal to 4.5 mm." 

 

In 2018, Surpass Streamline Flow Diverter (Stryker Neurovascular) was approved by the FDA through the premarket approval process (P170024) for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.3 mm. The approval was based on 1- year results of the Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT) study. The SCENT study is continuing follow-up to 5 years post-procedure as a post-approval study.

 

Prior Approval:

Not applicable

 

Policy:

See Related Medical Policy 

  • 10.01.14 Humanitarian Use Devices

 

Intracranial stent placement may be considered as medically necessary as part of the endovascular treatment of an intracranial aneurysm for patients when ALL of the following criteria are met:

  • When surgical treatment is not appropriate; and
  • Standard endovascular techniques do not allow for complete isolation of the aneurysm due to its anatomy e.g., wide-neck aneurysm (≥ 4 mm) or sack-to-neck ratio less than 2:1.

 

Intracranial flow-diverting stents with U.S. Food and Drug Administration (FDA) approval (see Regulatory Status information above) for the treatment of intracranial aneurysms may be considered medically necessary as part of the endovascular treatment of intracranial aneurysms for patients meeting ALL of the following criteria:

  • Not amendable to surgical treatment or standard endovascular therapy; and
  • The treatment is for large or giant wide-necked aneurysm with a size of ≥ 10 mm and has a neck diameter ≥ 4 mm in the internal carotid artery from the petrous to the superior hypophyseal segments.

 

Intracranial stent placement is considered investigational in the treatment of intracranial aneurysms except as indicated above.

 

Intracranial percutaneous transluminal angioplasty with or without stenting stenting including but not limited to the use of the Neurolink System or Wingspan Stent System is considered investigational for the treatment of intracranial atherosclerotic disease (stenosis), because studies support and conclude that outcomes of endovascular treatment are worse than medical therapy in patients with symptomatic intracranial stenosis and therefore, the evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

 

Intracranial percutaneous angioplasty, with or without stenting, for the treatment of cerebral vasospasm following aneurysmal subarachnoid hemorrhage is considered investigational, because the evidence is insufficient to determine that the technology results in improved net health outcomes.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 61630 Balloon angioplasty, intracranial (eg, atherosclerotic stenosis), percutaneous
  • 61635 Transcatheter placement of intravascular stent(s), intracranial (eg,atherosclerotic stenosis), including balloon angioplasty, if performed.
  • 61640 Balloon dilatation of intracranial vasospasm, percutaneous; initial vessel
  • 61641 Balloon dilatation of intracranial vasospasm, percutaneous; each additional vessel in same vascular family
  • 61642 Balloon dilatation of intracranial vasospasm, percutaneous; each additional vessel in different vascular family

 

Selected References:

  • American Society for Interventional and Therapeutic Neuroradiology. Angioplasty and stenting of extracranial brachiocephalic stenoses. AJNR Am J Neuroradiol. 2001 Sep;22(8 Suppl):S31-3.
  • FDA Summary of Safety and Probable Benefit. Neurolink®  System. 2002
  • FDA Summary of Safety and Probable Benefit. WingspanTM Stent System with GatewayTM PTA Balloon Catheter. 2004
  • Hartmann M, Bose A, Berez S et al. Wingspan stent in intracranial atherosclerotic disease. Neuroradiology 2004; 46:S80.
  • Coward LJ, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for vertebral artery stenosis. Cochrane Database Syst Rev 2005; 2:CD000516.
  • Institute for Clinical Systems Improvement Technology Assessment Report (ICSI) Carotid, Vertebral and Intracranial Artery Angioplasty and Stenting. TA #93 June 2006.
  • Cruz-Flores S, Diamond AL.  Angioplasty for intracranial artery stenosis.  Cochrane Database Syst Rev. 2006 Jul 19;3:CD004133. Abstract viewed on line.
  • Coward LJ, McCabe DJ, et al.  Long-term outcome after angioplasty and stenting for symptomatic vertebral artery stenosis compared with medical treatment in the Carotid And Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomized trial.  Stroke. 2007 May;38(5):1526-30.
  • ECRI. NIH stroke study on stenting versus medical therapy halted. Plymouth Meeting (PA):ECRI Health Technology Information Service; 2011 April 15. (ECRI Health Technology Forecast).
  • Higashida RT, Meyers PM, Connors JJ, et al. Intracranial Angioplasty and Stenting for Cerebral Atherosclerosis: A Position Statement of the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, and the American Society of Neuroradiology. Journal of Vascular and Interventional Radiology. 2009 July;20(7 Suppl): S312-316.
  • Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003.
  • National Institute for Health and Clinical Excellence (NICE). Endovascular stent insertion for intracranial atherosclerotic disease. Interventional procedure guidance 429.
  • ECRI. FDA narrows indication for brain arterial stent. Plymouth Meeting (PA): Health Technology Assessment Info Service. 24 August 2012. [Health Technology Forecast News Brief].
  • Qureshi AI, Al-Senani FM, Husain S, et al. Intracranial angioplasty and stent placement after stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS) trial: present state and future considerations. J Neuroimaging. 2012 Jan;22(1):1-13.
  • Bodily KD, Cloft HJ, Lanzino G, et al. Stent-assisted coiling in acutely ruptured intracranial aneurysms: a qualitative, systematic review of the literature. AJNR Am J Neuroradiol 2011;32(7):1232-6.
  • Shapiro M, Becske T, Sahlein D, et al. Stent-support aneurysm coiling: a literature survey of treatment and follow-up. AJNR Am J Neuroradiol 2012;33(1):159-63.
  • Yang PF, Huang QH, Zhao WY, et al. Safety and efficacy of stent placement for treatment of intracranial aneurysms: a systematic review. Chin Med J. 2012 May;125(10):1817-23. 
  • ECRI. Emerging Technology Evidence Report. Flow Diverting Stent (Pipeline Embolization Device) for Treating Unruptured Large and Giant Wide-Necked Intracranial Aneurysms, July 2013.
  • Philip M. Meyers, H. Christian Schumacher, Randall T. Higashida, Stanley L. Barnwell, Mark A. Creager, Rishi Gupta, Cameron G. McDougall, Dilip K. Pandey, David Sacks and Lawrence R. Wechsler. Circulation Journal of American Heart Association: Indications for the Performance of Intracranial Endovascular Neurointerventional Procedures: A Scientific Statement from the American Heart Association Council on Cardiovascular Radiology and Intervention, Stroke Council, Council on Cardiovascular Surgery and Anesthesia, Interdisciplinary Council on Peripheral Vascular Disease and Interdisciplinary Council on Quality of Care and Outcomes Research. 2009; 119:2235-2249
  • Beom Jin Choi M.D., Tae Hong Lee M.D., Jae II Lee M.D., Jun Kyeung Ko M.D., Hwa Seung Park M.D., Chang Hwa Choi M.D., Journal of Korean Neurosurgical Society 49: 157-162, 2011 Safety and Efficacy of Transluminal Balloon Angioplasty Using a Compliant Balloon for Severe Cerebral Vasospasm after Aneurysmal Subarachnoid Hemorrhage.
  • Velat GJ, Kimball MM, Mocco JD, Hoh BL, Vasospasm After aneurysmal Subarachnoid Hemorrhage: Review of Randomized contolled trials and meta analyses in the Literature. World Neurosurg, 2011 Nov; 76(5):446-54.doi: 10.1016/j.wneu.2011.02.030.  
  • Higashida RT, Meyers PM, Connors JJ 3rd, Sacks D, Strother CM, Barr JD, Wojak JC, Duckwiler GR. Intracranial angioplasty and stenting for cerebral atherosclerosis: a position statement of the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, and the American Society of Neuroradiology. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S312-6 
  • Jaunch E., Saver J., Adams H., et al. Guidelines for the Early Management of Patients with Acute Ischemic Stroke. American Heart Association/ Stroke Council,. Stroke, 2013 Jan, 44:  870-947, doi: 10.1161/STR.0b013e318284056a
  • Letsup H, Lynn M, Cotsonis G, et. al., Does the Shunting Versus Aggressive Medical Thearpy Trial Support Stenting for Subgroups with Intracranial Stenosis? Stroke. 2015; 46:  3282-3284   Published online before print September 17, 2015,  doi: 10.1161/STROKEAHA.115.009846 
  • Waters MF, Hoh BL, Lynn MJ, et al. Factors Associated With Recurrent Ischemic Stroke in the Medical Group of the SAMMPRIS Trial. JAMA Neurol 2016; 73:308
  • Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med 2011; 365:993.
  • Zaidat OO, Fitzsimmons BF, Woodward BK, et al. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA 2015; 313:1240.
  • Bai WX, et al. Wingspan stenting can effectively prevent long-term strokes for patients with severe symptomatic atherosclerotic basilar stenosis. Interv Neuroradiol 2016 June;22(3):318-324.
  • Derdeyn  CP, Fiorella  D, Lynn  MJ,  et al.  Impact of operator and site experience on outcomes after angioplasty and stenting in the SAMMPRIS trial.  J Neurointerv Surg. 2013;5(6):528–533.
  • 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
  • Center for Medicare & Medicaid Services. Decision Memo for Intracranial Stenting and Angioplasty (CAG-00085R5). 2008; 
  • Baptista-Sincos, Altun, G., Pulathan, Z., & Hemsinli, D. (2018). True Aneurysms of the Extracranial Carotid Artery : An Evaluation of Two "Giant Aneurysms" and the Current Literature. Journal of Korean Neurosurgical Society, 61(2), 282–286. doi:10.3340/jkns.2017.0404.003
  • He, Y., Li, T., Bai, W., Zhu, L., Wang, M., & Zhang, Y. (2019). Cerebrovascular Drug-Eluting Stent versus Bare-Metal Stent in the Treatment of Vertebral Artery Stenosis: A Non-Inferiority Randomized Clinical Trial. Journal of stroke, 21(1), 101–104. doi:10.5853/jos.2018.00479
  • Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. Mar 2018;49(3):e46-e110. PMID 29367334
  • Alexander MJ, Zauner A, Chaloupka JC et al. WEAVE Trial: Final Results in 152 On-Label Patients. Stroke. 2019 Apr;50(4). PMID 31125298
  • Xin WQ, Xin QQ, Yuan Y et al. Comparison of Flow Diversion and Coiling for the Treatment of Unruptured Intracranial Aneurysms. World Neurosurg. 2019 Aug;128:464-472. PMID 31132489
  • Food and Drug Administration. FDA Executive Summary General Issues: Meeting to Discuss the Evaluation of Safety and Effectiveness of Endovascular Medical Devices Intended to Treat Intracranial Aneurysms
  • Jankowitz BT, Hanel R, Jadhav AP, et al. Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort. J Neurointerv Surg. Aug 2019; 11(8): 801-806. PMID 30670625
  • Fiorella D, Boulos A, Turk AS, et al. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. J Neurointerv Surg. Apr 2019; 11(4): 357-361. PMID 30297543
  • Kiselev R, Orlov K, Dubovoy A, et al. Flow diversion versus parent artery occlusion with bypass in the treatment of complex intracranial aneurysms: Immediate and short-term outcomes of the randomized trial. Clin Neurol Neurosurg. Sep 2018; 172: 183-189. PMID 30053620
  • Xin WQ, Xin QQ, Yuan Y, et al. Comparison of Flow Diversion and Coiling for the Treatment of Unruptured Intracranial Aneurysms. World Neurosurg. Aug 2019; 128: 464-472. PMID 31132489
  • Thompson BG, Brown RD, Amin-Hanjani S, et al. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. Aug 2015; 46(8): 2368-400. PMID 26089327

 

Policy History:

  • June 2021 - Annual Review, Policy Revised
  • June 2020 - Annual Review, Policy Revised
  • June 2019 - Annual Review, Policy Revised
  • June 2018 - Annual Review, Policy Renewed
  • June 2017 - Annual Review, Policy Revised
  • June 2016 - Annual Review, Policy Renewed
  • June 2015 - Annual Review, Policy Renewed
  • July 2014 - Annual Review, Policy Revised
  • September 2013 - Annual Review, Policy Revised
  • October 2012 - Annual Review, Policy Renewed
  • October 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.