Percutaneous Transluminal Angioplasty of Intracranial Atherosclerotic Stenoses With or Without Stenting
DESCRIPTION
Percutaneous transluminal angioplasty (PTA) involves inserting a balloon catheter into a narrow or occluded vessel to recanalize and dilate the vessel by inflating the balloon. The intent of PTA is to improve blood flow through the diseased section of the vessel so the vessel patency is increased and embolization is decreased. Technical difficulties in catheter and stent designs, along with the risk of embolism, have resulted in a slow and cautious approach towards intracranial PTA.
POLICY
Percutaneous transluminal angioplasty for the treatment of intracranial stenoses with or without stenting is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Policies with similar titles: Percutaneous Transluminal Angioplasty of the Aortic Arch Vessels with or without stenting (Brachiocephalic, Carotid, Subclavian & Vertebral Arteries) and of Coarctation of the Aorta
ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of percutaneous transluminal angioplasty for the treatment of intracranial stenoses compared to alternative treatments.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2007). Percutaneous transluminal angioplasty of intracranial atherosclerotic stenoses with or without stenting (2.01.54). Retrieved January 15, 2008 from BlueWeb. (8 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2007, November). Percutaneous transluminal angioplasty (PTA) (NCD 20.7, p. 2-8 - 2-11). St. Anthony Publishing.
Gupta, R., Schumacher, H. C., Mangla, S., Myers, P. M., Duong, H., Khandji, A. G., et al. (2003). Urgent endovascular revascularization for symptomatic intracranial atherosclerotic stenosis. Neurology, 61 (12), 1729-1735. (Level 4 Evidence)
Hacein-Bay, L., & Varekas, P. N. (2006). Intracranial angioplasty and stenting for cerebrovascular disease. Neurologic Clinics, 24 (4), 697-713.
Higashida, R. T., Meyers, P. M., Connors, J. J. III, Sacks, D., Strother, C. M., Barr, J., et al. (2005, October). Intracranial angioplasty & 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, 16 (10), 1281-1285.
Jiang, W. J., Xu, X. T., Du, B., Dong, K. H., Jin, M., Wang, Q. H., et al. (2007). Comparison of elective stenting of severe vs moderate intracranial atherosclerotic stenosis. Neurology, 68 (6), 420-426. (Level 3 Evidence)
Komotar, R., Mocco, J., Wilson, D. A., Connolly, E. S., Lavine, S. D., & Meyers, P. M. (2005). Current endovascular treatment options for intracranial carotid artery atherosclerosis. Neurosurgical Focus, 18 (1), e5.
SSYLVIA Study Investigators. (2004). Stenting of symptomatic atherosclerotic lesions in the vertebral or intracranial arteries (SSYLVIA): Study results. Stroke, 35 (6), 1388-1392. (Level 1 Evidence)
Suh, D. C., Kim, S. J., Lee, D. H., Kim, W., Choi, C. G., Lee, J. (2005). Outcome of endovascular treatment in symptomatic intracranial vascular stenosis. Korean Journal of Radiology, 6 (1), 1-7. (Level 4 Evidence)
Terada, T. T., Tsuura, M., Matsumoto, H., Masuo, O., Yamaga, H., & Itakura, T. (2005). Diffusion-weighted imaging abnormalities after stenting for intracranial atherosclerotic disease. AJNR American Journal of Neuroradiology, 26 (2), 385-389. (Level 4 Evidence)
U. S. Food and Drug Administration. (2002, August). Center for Devices and Radiological Health. Humanitarian use devices. Retrieved February 1, 2008 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm.
U. S. Food and Drug Administration. (2002, August). Center for Devices and Radiological Health. NEUROLINK® System - H010004. Retrieved January 15, 2008 from http://www.fda.gov/cdrh/pdf/H010004b.pdf.
U. S. Food and Drug Administration. (2005, August). Center for Devices and Radiological Health. Wingspan stent system with Gateway PTA balloon catheter - H050001. Retrieved January 15, 2008 from http://www.fda.gov/cdrh/ode/H050001sum.html.
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EFFECTIVE DATE |
2/28/2008 |
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ID_BT
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