DESCRIPTION
Percutaneous transluminal angioplasty (PTA) is a procedure used to restore blood flow by opening arteries that have become stenosed (narrowed) or occluded (blocked) with an accumulation of fatty deposits. The goal of percutaneous transluminal angioplasty of the aortic arch vessels and coarctation of the aorta is the restoration of arterial blood flow by enlarging the lumen of a vessel stenosed or occluded by arteriosclerotic plaques or disease processes.
A stent is a tiny stainless steel cage that is inserted into the artery after angioplasty has been performed to help maintain patency of the artery. It may reduce the rate of restenosis. The individual may need to be on blood thinning medication to help prevent blood clots when stents are used.
POLICY
Percutaneous transluminal angioplasty with stenting of the carotid arteries is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Percutaneous transluminal angioplasty with or without stenting for the treatment of coarctation of the aorta is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Percutaneous transluminal angioplasty with or without stenting of the carotid arteries when not at high risk for adverse events from carotid enterectomy and for other conditions/diseases is considered investigational.
Percutaneous transluminal angioplasty with or without stenting for the treatment of coarctation of the aorta for other conditions/diseases is considered investigational.
Any stenting system and embolic protection device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
Percutaneous transluminal angioplasty with or without stenting for the treatment of brachiocephalic and subclavian arteries is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Percutaneous transluminal angioplasty with or without stenting for the treatment of vertebral arteries is considered investigational.
Policies with similar titles: Percutaneous Transluminal Angioplasty of Intracranial Atherosclerotic Stenoses With or Without Stenting
MEDICAL APPROPRIATENESS
Percutaneous transluminal angioplasty with stenting of the carotid arteries is considered medically appropriate if all of the following criteria are met:
With neurological symptoms and greater than or equal to 50% stenosis of the common or internal carotid artery by ultrasound or angiogram or without neurological symptoms and greater than or equal to 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and
High risk for adverse events from carotid endarterectomy (e.g., congestive heart failure, abnormal stress test, need for open-heart surgery, severe pulmonary disease, contralateral carotid occlusion, contralateral laryngeal nerve palsy, previous radical neck surgery or radiation therapy to the neck, recurrent stenosis after endarterectomy, age greater than 80 years); and
Reference vessel diameter within the range of 4.0 (millimeters) mm to 9.0 mm at the target lesion.
Percutaneous transluminal angioplasty with or without stenting for the treatment of coarctation of the aorta is considered medically appropriate if any of the following criteria are met:
Angiographic evidence of significant discrete coarctation; or
Coarctation pressure gradient greater than or equal to 20 mm HG; or
Systemic hypertension not controlled by medical treatment; or
Inability to tolerate surgical correction; or
Recurrent coarctation following prior attempted surgery; or
Recurrent coarctation following surgical palliation of hypoplastic left heart syndrome, including surgical repair of the aortic arch.
Percutaneous transluminal angioplasty with or without stenting for the treatment of brachiocephalic and subclavian arteries is considered medically appropriate if any of the following criteria are met:
Stenosis greater than 50% and the symptomatic individual is experiencing the following:
Myocardial ischemic symptoms when there is a patent ipsilateral internal mammary to coronary bypass; or
Ischemic symptoms in the ipsilateral arm; and
There is greater than 10 mm Hg systolic pressure differential; and
ADDITIONAL INFORMATION
Carotid endarterectomy continues to be the gold standard for treatment of atherosclerotic occlusions of the carotid arteries.
No evidence of long-term efficacy is available from published studies regarding percutaneous transluminal angioplasty with or without stenting of the carotid arteries without high risk for carotid enterectomy, vertebral arteries, or for coarctation of the aorta for other conditions/diseases.
Percutaneous transluminal angioplasty with or without stenting of the carotid arteries without high risk for carotid enterectomy, vertebral arteries and for coarctation of the aorta for other conditions/diseases does not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
American Heart Association. (1998). Carotid stenting and angioplasty. Retrieved May 31, 2002 from http://216.185.112.5/presenter.jhtml?identifier=9185.
American Heart Association. (2005, January). Carotid artery stenosis. Retrieved January 21, 2005 from http://www.americanheart.org/presenter.jhtml?identifier=4497.
American Heart Association. Coarctation of the aorta (CoA). Retrieved May 31, 2002 from http://216.185.112.5/presenter.jhtml?identifier=1667.
Ballotta, E., Da Giau, G., Abbruzzese, E., Mion, E., Manara, R., & Baracchini, C. (2002). Subclavian carotid transposition for symptomatic subclavian artery stenosis or occlusion. A comparison with the endovascular procedure. International Angiology, 21 (2), 138-144. Abstract retrieved April 7, 2006 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2004). Extracranial carotid angioplasty / stenting (7.01.68). Retrieved January 19, 2005 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2004). Percutaneous transluminal angioplasty of intracranial atherosclerotic stenoses with or without stenting. (2.01.54). Retrieved January 19, 2005 from BlueWeb.
Brountazos, E. N., Peterson, B., Binkert, C., Panagiotou, I., & Kaufman, J. A. (2004). Primary stenting of subclavian and innominate artery occlusive disease: A single center's experience. Cardiovascular and Interventional Radiology, 27 (6), 616-623. Abstract retrieved April 7, 2006 from PubMed database.
Brown, M. M., Rogers, J., & Bland, J. M. (2001). Endovascular versus surgical treatment in patients with carotid stenosis in the carotid and vertebral artery transluminal angioplasty study (CAVATAS): A randomized trial. Lancet, 357 (9270), 1729-1737.
Cloud, G. C., Crawley, F., Clifton, A., McCabe, D. J., Brown, M. M., & Markus, H. S. (2003). Vertebral artery origin angioplasty and primary stenting: Safety and restenosis rates in a prospective series. Journal of Neurology, Neurosurgery and Psychiatry, 74 (5), 586-590. Abstract retrieved April 4, 2006 from PubMed database.
Complete Guide to Medicare Coverage Issues [Computer software]. (2005, November). Percutaneous Transluminal Angioplasty (PTA) (NCD 20.7, p. 2-8, 2-10). St. Anthony Publishing.
Complete Guide to Medicare Coverage Issues. (2005, March). Decision Memorandum for Carotid Artery Stenting (CAG-00085R). Retrieved April 6, 2005 from http://www.cms.hhs.gov/mcd/viewnca.asp?from=basket&nca_id=157&basket=nca:00085R:157:Carotid+Artery+Stenting:Closed:1st+Recon:4.
Corno, A. F., Botta, U., Hurni, M., Payot, M., Sekarski, N., Tozzi, P., et al. (2001). Surgery for aortic coarctation: A 30 years experience. European Journal of Cardio-thoracic Surgery, 20 (6), 1202-1206. Abstract retrieved May 31, 2002 from PubMed database.
Coward LJ, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for vertebral artery stenosis. The Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD000516. DOI: 10.1002/14651858.CD000516.pub2.
Coward LJ, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. The Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD000515. DOI: 10.1002/14651858.CD000515.pub2.
Crawley, F., Brown, M. M. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis (Cochrane Review). In: The Cochrane Library, Issue 2, 2002. Oxford: Update Software.
Cundy, J. B. (2002). Carotid artery stenosis and endarterectomy. AORN Journal, 75 (2), 314-324. Abstract retrieved May 28, 2002 from PubMed database.
De Vries, J. P., Jager, L. C., Van den Berg, J. C., Overtoom, T. T., Ackerstaff, R. G., Van de Pavoordt, E. D., et al. (2005). Durability of percutaneous transluminal angioplasty for obstructive lesions of proximal subclavian artery: Long-term results. Journal of Vascular Surgery, 41 (1), 19-23. Abstract retrieved June 28, 2006 from PubMed database.
Fawzy, M. E., Awad, M., Hassan, W., Kadhi, Y. A., Shoukri, M., & Fadley, F. (2004). Long-term outcome (up to 15 years) of balloon angioplasty of discrete native coarctation of the aorta in adolescents and adults. Journal of the American College of Cardiology, 43 (6), 1062-1067.
Golledge, J., Mitchell, A., Greenhalgh, R. M., & Davies, A. H. (2000). Systematic comparison of the early outcome of angioplasty and endarterectomy for symptomatic carotid artery disease. Stroke, 31 (6), 1439-1443. Abstract retrieved August 2, 2000 from PubMed database.
Gonzalez, A., Gil-Peralta, A., Gonzalez-Marcos, J. R., & Mayol, A. (2002). Angioplasty and stenting for total symptomatic atherosclerotic occlusion of the subclavian or innominate arteries. Cerebrovascular Diseases, 13 (2), 107-113. Abstract retrieved March 31, 2003 from PubMed database.
Hadjipetrou, P., Cox, S., Piemonte, T., & Eisenhauer, A. (1999). Percutaneous revascularization of atherosclerotic obstruction of aortic arch vessels. Journal of the American College of Cardiology, 33 (5), 1238-1245. Abstract retrieved August 1, 2000 from PubMed database.
Hamdan, M. A., Maheshwari, S., Fahey, J. T., & Hellenbrand, W. E. (2001). Endovascular stents for coarctation of the aorta: Initial results and intermediate-term follow-up. Journal of the American College of Cardiology, 38 (5), 1524-1527. Abstract retrieved June 5, 2002 from PubMed database.
Harada, K. (2004). Therapeutic strategy and outcome of stenting for subclavian and innominate artery occlusive disease. No Shinkei Geka. Neurological Surgery, 32 (2), 151-158. Abstract retrieved April 4, 2006 from PubMed database.
Hauth, E. A., Gissler, H. M., Drescher, R., Jansen, C., Jaeger, H. J., & Mathias, K. D. (2004). Angioplasty or stenting of extra- and intracranial vertebral artery stenoses. Cardiovascular and Interventional Radiology, 27 (1), 51-57. Abstract retrieved April 7, 2006 from PubMed database.
Health Technology Assessment Information Service. TARGET database. (2004, October). Carotid stenting with embolic protection for carotid artery stenosis. Retrieved January 20, 2005 from ECRI HTAIS.
Hernandez-Gonzalez, M., Solorio, S., Conde-Carmona, I., Rangel-Abundis, A., Ledesma, M., Munayer, J., et al. (2003). Intraluminal aortoplasty vs. surgical aortic resection in congenital aortic coarctation. A clinical random study in pediatric patients. Archives of Medical Research, 34 (4), 305-310.
Hijazi, Z. M., Fahey, J. T., Kleinman, C. S., & Hellenbrand, W. E. (1991). Balloon angioplasty for recurrent coarctation of aorta. Circulation, 84 (3), 1150-1156.
Huttl, K., Nemes, B., Simonffy, A., Entz, L., & Berezi, V. (2002). Angioplasty of the innominate artery in 89 patients: Experience over 19 years. Cardiovascular and Interventional Radiology, 25 (2), 109-114. Abstract retrieved April 5, 2006 from PubMed database.
Internet Stroke Center. (2005). Stroke scale & clinical assessment tools: Modified Rankin Scale. Retrieved January 20, 2004 from http://www.strokecenter.org/trials/scales/rankin.html.
Janssens, E., Leclerc, X., Gautier, C., Godefroy, O., Koussa, M., Henon, H., et al. (2004). Percutaneous transluminal angioplasty of proximal vertebral artery stenosis: Long-term clinical follow-up of 16 consecutive patients. Neuroradiology, 46 (1), 81-84. Abstract retrieved April 7, 2006 from PubMed database.
Jenkins, J. S., White, C. J., Ramee, S. R., Collins, T. J., Chilakamarri, V. K., McKinley, K. L., et al. (2001). Vertebral artery stenting. Catheterization and Cardiovascular Interventions, 54 (1), 6-7. Abstract retrieved April 4, 2006 from PubMed database.
Koerselman, J., de Vries, H., Jaarsma, W., Muyldermans, L., Ernst, J. M., & Plokker, H. W. (2000). Balloon angioplasty of coarctation of the aorta: A safe alternative for surgery in adults: Immediate and mid-term results. Catheter Cardiovascular Intervention, 50 (1), 28-33. Abstract retrieved August 4, 2000 from PubMed database.
Marshall, A. C., Perry, S. B., Keane, J. F., & Lock, J. E. (2000). Early results and medium-term follow-up of stent implantation for mild residual or recurrent aortic coarctation. American Heart Journal, 139 (6), 1054-1060.
Mukherjee, D., Roffi, M., Kapadia, S. R., Bhatt, D. L., Bajzer, C., Ziada, K. M., et al. (2001). Percutaneous intervention for symptomatic vertebral artery stenosis using coronary stents. Journal of Invasive Cardiology, 13 (5), 363-366. Abstract retrieved April 4, 2006 from PubMed database.
Patel, H. T., Madani, A., Paris, Y.M., Warner, K. G., & Hijazi, Z. M. (2001). Balloon angioplasty of native coarctation of the aorta in infants and neonates: Is it worth the hassle? Pediatric Cardiology, 22 (1), 53-57. Abstract retrieved May 31, 2002 from PubMed database.
Peterson, B. G., Resnick, S. A., Morasch, M. D., Hassoun, H. T., & Eskandari, M. K. (2006). Aortic arch vessel stenting: A single-center experience using cerebral protection. Archives of Surgery, 141 (6), 560-563. Abstract retrieved June 28, 2006 from PubMed database.
Piotin, M., Spelle, L., Martin, J., Weill, A., Rancurel, G., Ross, I. B., et al. (2000). Percutaneous transluminal angioplasty and stenting of the proximal vertebral artery for symptomatic stenosis. American Journal of Neuradiology, 21 (4), 727-731. Abstract retrieved April 4, 2006 from PubMed database.
Przewlocki, T., Kablak-Ziembicka, A., Pieniazek, P., Musialek, P., Kadzielski, A., Zalewski, J., et al. (2006). Determinants of immediate and long-term results of subclavian and innominate artery angioplasty. Catheterization and Cardiovascular Interventions, 67 (4), 519-526. Abstract retrieved April 4, 2006 from PubMed database.
Qureshi, A. I., Suri, M. F., New, G., Wadsworth, D. C., Dulin, J., & Hopkins, L. N. (2002). Multicenter study of the feasibility and safety of using the memotherm carotid arterial stent for extracranial carotid artery stenosis. Journal of Neurosurgery, 96 (5), 830-836. Abstract retrieved May 28, 2002 from PubMed database.
Rao, P. S., Singh, G. K., Balfour, I. C., Jureidini, S. B., & Fiore, A. C. (1999). Balloon angioplasty of long-segment aortic coarctation in the neonate. Journal of Invasive Cardiology, 11 (12), 734-738.
Saba, S. E., Nimri, M., Shamaileh, Q., Al-Hakim, F., Krayyem, M., Abu-Ata, I., et al. (2000). Balloon coarctation angioplasty: Follow-up of 103 patients. Journal of Invasive Cardiology, 12 (8), 402-406. Abstract retrieved September 26, 2000 from PubMed database.
Spence, D., & Eliasziw, M. (2001). Endarterectomy or angioplasty for treatment of carotid stenosis? The Lancet, 357 (9270), 1722-1723.
Spies, J. B., Bakal, C. W., Burke, D. R., Cardella, J. F., Drooz, A., Edwards, M. E., et al. (2003). Angioplasty standard of practice. Journal of Vascular Interventional Radiology, 14 (9 Pt 2), S219-S221.
Spies, J. B., Bakal, C. W., Burke, D. R., Husted, J. W., McClean, G. K., Palestrant, A. M., et al. (2003). Guidelines for percutaneous transluminal angioplasty. Journal of Vascular Interventional Radiology, 14 (9 Pt 2), S209-S217.
Thanopoulos, B. D., Hadjinikolaou, L., Konstadopoulou, G. N., Tsaousis, G. S., Triposkiadis, F., & Spirou, P. (2000). Stent treatment for coarctation of the aorta: Intermediate term follow up and technical considerations. Heart, 84, 65-70.
The Technology Evaluation Center (2005, February). Angioplasty and stenting of the cervical carotid artery with distal embolic protection of the cerebral circulation (Vol. 19, No. 15). Chicago: BlueCross BlueShield Association.
U. S. Food and Drug Administration. (2004, August). Center for Devices and Radiological Health. Pre-market approval decisions for August 2004. Retrieved January 28, 2005 from http://www.fda.gov/cdrh/pdf4/p040012a.pdf.
Walhout, R. J., Lekkerkerker, J. C., Ernst, S. M., Hutter, P. A., Plokker. T. H., & Meijboom, E. J. (2002). Angioplasty for coarctation in different aged patients. American Heart Journal, 144 (1), 180-186.
Walhout, R. J., Lekkerkerker, J. C., Oron, G. H., Bennink, G. B., & Meijboom, E. J. (2004). Comparison of surgical repair with balloon angioplasty for native coarctation in patients from 3 months to 16 years of age. European Journal of Cardio-Thoracic Surgery, 25 (5), 722-727.
Yadav, J. S., Wholey, M. H., Kuntz, R. E., Fayad, P., Katzen, B. T., Mishkel, G. J., et al. (2004). Protected carotid-artery stenting versus endarterectomy in high-risk patient. The New England Journal of Medicine, 351 (15), 1493-1501.
Yetman, A. T., Nykanen, D., McCrindle, B. W., Sunnegardh, J., Adatia, I., Freedom, R. M., et al. (1997). Balloon angioplasty of recurrent coarctation: A 12-year review. Journal of the American College of Cardiology, 30 (3), 811-816.
Zoghbi, J., Serraf, A., Mohammadi, S., Belli, E., Gayet, F. L., Aupecie, B., et al. (2004). Is surgical intervention still indicated in recurrent aortic arch obstruction? The Journal of Thoracic and Cardiovascular Surgery, 127 (1), 203-212.
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EFFECTIVE DATE |
12/9/2006 |
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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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