Medical Policy: 07.01.32
Original Effective Date: July 2006
Reviewed: June 2016
Revised: July 2014
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.
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).
Percutaneous transluminal angioplasty (PTA) has been approached cautiously for use in the intracranial circulation, due to technical difficulties in 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 veins, and the increased use of stents have lead to further research on PTA as minimally invasive treatment of this difficult-to-treat population. The majority of published research studies of intracranial PTA have focused on the vertebrobasilar circulation.
In a trial sponsored by the Medical University of South Carolina, Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS), investigators planned to determine whether intracranial stenting with intensive medical therapy is superior to the medical therapy alone for preventing second stroke in high-risk patients with symptomatic stenosis of a major intracranial artery. Recent research has suggested a benefit in prevention of recurring stroke by aggressively treating risk factors such as hypertension, elevated LDL, and diabetes. It has been hypothesized that combining intracranial stenting with aggressive medical management will significantly decrease the incidence of a second stroke. In April 2011, the SAMMPRIS trial was halted due to the high risk of stroke and death in the stenting group according to the U.S. National Institutes of Health.
Intracranial stents are also being utilized in the treatment of 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 grew, stenting was also used in smaller berry aneurysms as an approach to decrease the rate of retreatment needed in patients who receive coiling. A randomized trial has demonstrated that treatment of ruptured intracranial aneurysms with coiling leads to improved short-term outcome compared with surgical clipping; however, patients who receive coiling have a need for more repeat/follow-up procedures.
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 subarachnoid hemorrhage (SAH). Balloon angioplasty 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.
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
- 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 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 2013, the American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Peripheral Vascular Disease, and Council on Clinical Cardiology issued Guidelines for the Early Management of Patients with Acute Ischemic Stroke which contain two new recommendations that concur with the other specialty medical society guidance regarding extracranial and intracranial artery angioplasty and stenting as a treatment of acute ischemic stroke as follows:
- The usefulness of emergent intracranial angioplasty and/or stenting is not well established. These procedures should be used in the setting of clinical trials (Class IIb; Level of Evidence C);
- The usefulness of emergent angioplasty and/or stenting of the extracranial carotid or vertebral arteries in unselected patients is not well established (Class IIb; Level of Evidence C).
Intracranial stent placement as part of the endovascular treatment of an intracranial aneurysm may be considered as medically necessary when surgical treatment is not feasible and standard endovascular techniques cannot provide complete isolation of the aneurysm due to its anatomy (e.g., wide-neck aneurysm (4 mm or more) or sack-to-neck ratio less than 2:1.
Intracranial stent placement is considered investigational in the treatment of intracranial aneurysms except as noted above.
Intracranial percutaneous angioplasty, with or without stenting, for the treatment of atherosclerotic stenosis or cerebral vasospasm following aneurysmal subarachnoid hemorrhage is considered investigational.
PTA of the intracranial cerebrovascular artery with the Neurolink® Stent & Delivery Catheter and Neurolink® Balloon Dilatation Catheter System is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
Individuals who have intracranial lesions that are highly calcified or otherwise could prevent access or appropriate expansion of the stent
Individuals in whom anticoagulant and/or antiplatelet therapy is contraindicated
PTA of the intracranial cerebrovascular artery with the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
- Individuals who have a lesion that prevents effective angioplasty
- Individuals in whom antiplatelet and or coagulation therapy is contraindicated
- For Wingspan™ Stent System, treatment of a stroke with an onset of symptoms within seven days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)
There is preliminary evidence that balloon angioplasty, with or without stenting, may be effective in treating symptomatic patients with intra-cranial stenosis, available data are mainly from retrospective case series. Randomized controlled studies are needed to ascertain the effectiveness of this technology compared to best medical care in preventing stroke in patients with intra-cranial stenosis that is symptomatic or asymptomatic. The clinical benefit of balloon angioplasty, with or without stenting has not been firmly established. There is insufficient evidence at this time to permit conclusions on net health outcome. Therefore, intracranial percutaneous angioplasty, with or without stenting for the treatment of atherosclerotic stenosis is considered investigational.
There is some preliminary evidence from retrospective case series studies that balloon angioplasty may be beneficial in treating cerebral vasospasm following aneurysmal subarchnoid hemorrhage (SAH), its effectiveness in the prevention and treatment of this condition needs to be verified by prospective, randomized, controlled trials. There is insufficient evidence at this time to permit conclusions on net health outcome. Therefore, intracranial percutaneous angioplasty, with or without stenting for the treatment of cerebral vasospasm following aneurysmal subarchnoid hemorrhage (SAH) is considered investigational.
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
- 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.
- ECRIExternal Site. 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.
ECRIExternal Site. 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
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
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.