Angioplasty and Stenting for Intracranial Arterial Disease (Atherosclerosis and Aneurysms)
Aneurysms are caused by a weakness in the artery wall, causing dilatation or ballooning of the vessels. Thinning of the vessel and the pressure of continuous blood flow may cause the aneurysm to enlarge and rupture and/or hemorrhage. Intracranial aneurysms have been treated by surgical ligation and clipping; however, some aneurysms are located in areas that are difficult to access. Detachable coil embolization procedures have been introduced as a minimally invasive alternative for these hard to reach areas. Stent-assisted coiling and the use of flow-diverting stents are proposed as an alternative to endovascular coiling in individuals whose anatomy is not amenable to simple coiling.
Atherosclerotic stenosis is a potentially life threatening disorder which can lead to an ischemic stroke.
It is estimated that intracranial atherosclerosis 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. Medical treatment typically includes either anticoagulant therapy (e.g., warfarin) or antiplatelet therapy (e.g., clopidogrel. Percutaneous transluminal angioplasty (PTA) has been investigated for the prophylaxis or treatment of symptomatic atherosclerotic stenosis of intracranial arteries. PTA (e.g. Neurolink System®, Wingspan™ Stent System) involves inserting an inflatable balloon catheter into a narrow or stenosed vessel to dilate and recanalize the vessel. These devices have been approved through the FDA Humanitarian Device Exemption process.
Note: This policy does not address the use of endovascular mechanical embolectomy for acute ischemic stroke or rescue endovascular therapies, including intra-arterial vasodilator infusion and intracranial percutaneous transluminal angiography, in delayed cerebral ischemia after aneurysmal hemorrhage.
Intracranial percutaneous transluminal angioplasty with stent placement as part of the endovascular treatment of intracranial aneurysm is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Intracranial percutaneous transluminal angioplasty with or without stenting in the treatment of atherosclerotic cerebrovascular disease is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Intracranial percutaneous transluminal angioplasty with stent placement (e.g., stent-assisted coiling or flow-diverting stent) is considered medically appropriate if ALL of the following criteria are met:
Diagnosed intracranial aneurysm
Surgical treatment is not appropriate
Standard endovascular techniques do not allow for complete isolation of the aneurysm (e.g., wide-neck aneurysm [4 mm or more] or sack-to-neck ratio less than 2:1)
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
In 2011, the Pipeline® Embolization Device, an intracranial aneurysm flow diverter, was approved by FDA through the premarket approval process for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery. Three stents have received FDA approval through the humanitarian device exemption (HDE) program for treatment of intracranial aneurysms for use with embolic coils. They are the Neuroform™ Microdelivery Stent System, the Enterprise® Vascular Reconstruction Device and Delivery System, and the Low-Profile Visualized intraluminal Support Device™.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4: 2018). Endovascular procedures for intracranial arterial disease (atherosclerosis and aneurysms) (2.01.54). Retrieved July 27, 2018 from BlueWeb. (137 articles and/or guidelines reviewed)
Briganti, F., Leone, G., Marseglia, M., Mariniello, G., Caranci, F., Brunetti, A., et al. (2015). Endovascular treatment of cerebral aneurysms using flow-diverter devices: a systemic review. Journal of Neuroradiology, 2015, Aug. 27, pii:1971400915602803. [Epub ahead of print]. Abstract retrieved October 15, 2015 from PubMed database.
Centers for Medicare & Medicaid Services. CMS.gov. (2013, March) NCD for percutaneous transluminal angioplasty (PTA) (20.7). Retrieved October 15, 2015 from http://www.cms.gov.
Ding, D., Starke, R., Crowley, R., & Liu, K. (2013). Role of stenting for intracranial atherosclerosis in the post -SAMMPRIS era. Biomedical Research International. Doi: 10.1155/2013/304320. Epub 2013 Nov 20. (Level 3 evidence)
Hong, Y., Wang, Y., Deng, Z., Wu, Q., & Zhang, J. (2014). Stent-assisted coiling versus coiling in treatment of intracranial aneurysm: a systematic review and meta-analysis. PLOS One, 9 (1), e82311. (Level 2 evidence)
National Institute for Health and Clinical Excellence (NICE). (2012, July). Endovascular stent insertion for intracranial atherosclerotic disease, IPG 429. Retrieved February 11, 2013 from http://www.nice.org.
National Institute for Health and Clinical Excellence (NICE). (2012, May). Pipeline embolisation device for the treatment of complex intracranial aneurysms. Retrieved April 29, 2014 from http://www.nice.org.
Patzig, M., Forbrig, R., Ertl, L., Brückmann, H., & Fesl, G. (2017). Intracranial aneurysms treated by flow-diverting stents: long-term follow-up with contrast-enhanced magnetic resonance angiography. Cardiovascular and Interventional Radiology, 2017 Jul 6. Doi: 10.1007/s00270-017-1732-z. [Epub ahead of print]. Abstract retrieved July 31, 2017 from PubMed database.
U. S. Food and Drug Administration. (2002, August). Center for Devices and Radiological Health. NEUROLINK® system - H010004. Retrieved February 11, 2013 from http://www.accessdata.fda.gov
U. S. Food and Drug Administration. (2005, August). Center for Devices and Radiological Health. Wingspan™stent system with Gateway™ PTA balloon catheter - H050001. Retrieved February 11, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2005, August). Center for Devices and Radiological Health. Cordis Enterprise™ vascular reconstruction device and delivery system - H060001. Retrieved April 29, 2014 from http://www.accessdata.fda.gov.
U.S. Food and Drug Administration. (2002, September). Center for Devices and Radiological Health. Neuroform microdelivery stent system - H020002. Retrieved April 29, 2014 from http://www.accessdata.fda.gov.
U.S. Food and Drug Administration. (2011. April). Center for Devices and Radiological Health. Pipeline embolization device. Retrieved April 29, 2014 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc., Medical Technology Directory. (2013, July; last update search June 2017). Neuroform microdelivery stent system for intracranial aneurysms. Retrieved July 31, 2017 from www.hayesinc.com/subscribers. (107 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc., Medical Technology Directory. (2017). Flow diverter devices for intracranial aneurysms: a review of reviews. Retrieved July 31, 2017 from www.Hayesinc.com/subscribers (43 articles and/or guidelines reviewed)
Yang, S., Hampton, T., Kandasamy, N., Hart, J., Ashmore, J., Walsh, D., et al. (2017). Outcome study of the pipeline embolization device for treatment of intracranial aneurysms at a single UK institution. British Journal of Neurosurgery, 2017 Jul 27:1-7. Doi: 10.1080/02688697.2017.1354121. [Epub ahead of print]. Abstract retrieved July 31, 2017 from PubMed database.Zhou, G., Su, M., Yin, Y., & Li, M. (2017). Complications associated with the use of flow-diverting devices for cerebral aneurysms: a systematic review and meta-analysis. Neurosurgical Focus, 42 (6), E17. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 8/12/2006
MOST RECENT REVIEW DATE: 9/13/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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