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Clinical Policy Bulletin:
Balloon-Expandable Venous Stents
Number: 0531


Policy

  1. Aetna considers placement of balloon-expandable venous stents with or without initial thrombolysis or surgical thrombectomy medically necessary for any of the following indications:

    • Budd-Chiari syndrome (thrombotic obstruction of major hepatic veins); or
    • Chronic iliac vein occlusions; or
    • Ilio-femoral thrombosis secondary to iliac compression syndrome (compression of the left iliac vein between the right iliac artery and the fifth lumbar vertebra); or
    • Post-operative venous narrowing due to repair of sinus venosus atrial septal defect (ASD); or
    • Pulmonary artery stenosis and/or hypoplasia in a child; or
    • Salvage of thrombosed or stenotic arterio-venous dialysis access grafts; or
    • Superior or inferior vena caval stenosis in a child or adult; or
    • Symptomatic pelvic venous spurs (May-Thurner syndrome) -- left deep venous thrombosis or post-thrombotic leg swelling; or
    • Venous obstruction of the superior or inferior limb of an atrial baffle after Mustard or Senning repair of transposition of the great arteries.
       
  2. Aetna considers balloon-expandable venous stents experimental and investigational for all other indications because of insufficient evidence of effectiveness.



Background

Endovascular balloon dilation has been proven to be effective in a great majority of patients with stenoses or occlusions of major veins.  It is performed to re-establish venous flow and relieve symptomatic venous obstructions secondary to benign disease, malignant disease, and/or radiotherapy and has been associated with little morbidity and mortality.  The addition of balloon-expandable stents to the armamentarium has increased the overall success rate in a variety of clinical scenarios.  Stents have been found to be particularly useful in dilatable venous lesions whose intrinsic elasticity results in vessel recoil after balloon dilation alone.

In children, there have been numerous reports of successful balloon dilation with stent placement of systemic venous stenoses, especially in patients who have post-operative narrowing due to repair of sinus venosus atrial septal defect (ASD) or Mustard or Senning operation.  Balloon-expandable stents for superior vena caval stenosis, occurring in patients with sclerosing mediastinitis due to malignancy or other causes, is recommended as a preferred alternative to surgery, as operative repair is difficult and somewhat unrewarding.  In contrast to the success observed with systemic venous obstruction, the limited experience with pulmonary vein stenosis dilation has been almost uniformly futile.  Even when some initial successes were reported, stenosis recurred in virtually every instance.

Balloon-expandable stents have also been used successfully to treat superior or inferior vena caval stenosis in children and adults.  Stenting appears to provide excellent short- and intermediate-term relief of such large venous obstructions, which may be associated with the presence of indwelling central venous lines or mediastinal malignancy, either before or after radiation therapy.  Superior vena cava syndrome, mainly associated with malignant tumors, is usually resistant to any therapy.  Although mechanical dilation of narrowed lumen is ideal for relief of symptoms, conventional balloon angioplasty has not been effective.  Surgical intervention is not a good choice in patients with advanced malignant tumors.  Recently developed expandable metallic stents have been adopted to the superior vena cava syndrome with good results.

Budd-Chiari syndrome (BCS) is an uncommon form of portal hypertension caused by obstruction of the hepatic venous outflow.  Primary BCS requires different therapies depending on the stage of the disease.  The fulminant or chronic forms with irreversible hepatic damage require definitive treatment, such as orthotopic liver transplantation.  For the acute or subacute forms, characterized by reversible hepatic injury, a porto-systemic shunt represents the most effective treatment.  The patients at poor hepatic risk can be treated by balloon-expandable stents.  In both cases preliminary caval stenting is necessary if the syndrome is complicated by significant obstruction of the inferior vena cava.

Iliac vein compression syndrome is a clinical condition that occurs as a result of compression of the left iliac vein between the right iliac artery and the fifth lumbar vertebra.  Venous hypertension develops and patients usually have marked edema of the left leg, sometimes leading to recurrent episodes of left leg cellulitis.  Besides surgical repair, stenting has been shown to restore and maintain venous flow through the compressed area, relieving the leg edema.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
35476
Other HCPCS codes related to the CPB:
C1876 Stent, non-coated/non-covered, with delivery system
C1877 Stent, non-coated/non-covered, without delivery system
C2617 Stent, non-coronary, temporary, without delivery system
C2625 Stent, non-coronary, temporary, with delivery system
ICD-9 codes covered if selection criteria are met:
451.11 Phlebitis and thrombophlebitis of femoral vein (deep) (superficial) [ilio-femoral thrombosis secondary to iliac compression syndrome]
451.81 Phlebitis and thrombophlebitis of iliac vein [chronic occlusions]
453.0 Budd-Chiari syndrome
453.2 Embolism and thrombosis of vena cava [superior or inferior vena caval stenosis]
453.40 - 453.42 Venous embolism and thrombosis of deep vessels of lower extremity [left deep vein thrombosis or post-thrombotic leg swelling]
453.8 Venous embolism and thrombosis of other specified veins [chronic iliac vein occlusions]
459.2 Compression of vein [superior or inferior vena caval stenosis]
745.12 Corrected transposition of great vessels [status post Mustard or Senning repair]
747.3 Anomalies of pulmonary artery[stenosis and/or hypoplasia]
747.49 Other anomalies of great veins [congenital superior or inferior vena caval stenosis]
996.1 Mechanical complication of other vascular device, implant, and graft [involving dialysis catheter]
996.56 Mechanical complication of other specified device, implant, and graft, due to peritoneal dialysis catheter [thrombosed or stenotic arteriovenous dialysis access grafts]


The above policy is based on the following references:
  1. Allen HD, Beekman RH 3rd, Garson A Jr, et al. Pediatric therapeutic cardiac catheterization: A statement for healthcare professionals from the Council on Cardiovascular Disease in the Young, American Heart Association. Circulation. 1998;97(6):609-625.
  2. Ward CJB, Mullins CE, Nihill MR, et al. Use of intravascular stents in systemic venous and systemic venous baffle obstructions: Short-term follow-up results. Circulation. 1995;91:2948-2954.
  3. Chatelain P, Meier B, Friedli B. Stenting of superior vena cava and inferior vena cava for symptomatic narrowing after repeated atrial surgery for D-transposition of the great arteries. Br Heart J. 1991;66:466-468.
  4. Solomon N, Wholey MH, Jarmolowski CR. Intravascular stents in the management of superior vena cava syndrome. Cathet Cardiovasc Diagn. 1991;23:245-252.
  5. Dodds GA III, Harrison JK, O'Laughlin MP, et al. Relief of superior vena cava syndrome due to fibrosing mediastinitis using the Palmaz stent. Chest. 1994;106:315-318.
  6. Trerotola SO, Lund GB, Samphilipo MA, et al. Palmaz stent in the treatment of central venous stenosis: Safety and efficacy of redilation. Radiology. 1994;190:379-385.
  7. Binkert CA, Schoch E, Stuckmann G, et al. Treatment of pelvic venous spur (May-Thurner syndrome) with self-expanding metallic endoprostheses. Cardiovasc Intervent Radiol. 1998;21(1):22-26.
  8. Akesson H, Lindh M, Ivancev K, et al. Venous stents in chronic iliac vein occlusions. Eur J Vasc Endovasc Surg. 1997;13(3):334-336.
  9. Dyet JF, Gaines PA, Nicholson AA, et al. Treatment of chronic iliac artery occlusions by means of percutaneous endovascular stent placement. J Vasc Interv Radiol. 1997;8(3):349-353.
  10. Reyes R, Maynar M, Lopera J, et al. Treatment of chronic iliac artery occlusions with guide wire recanalization and primary stent placement. J Vasc Interv Radiol. 1997;8(6):1049-1055.
  11. Nazarian GK, Bjarnason H, Dietz CA Jr, et al. Iliofemoral venous stenoses: Effectiveness of treatment with metallic endovascular stents. Radiology. 1996;200(1):193-199.
  12. Nazarian GK, Austin WR, Wegryn SA, et al. Venous recanalization by metallic stents after failure of balloon angioplasty or surgery: Four-year experience. Cardiovasc Intervent Radiol. 1996;19(4):227-233.
  13. Rilinger N, Gorich J, Mickley V, et al. Endovascular stenting in patients with Iliac compression syndrome. Experience in three cases. Invest Radiol. 1996;31(11):729-733.
  14. Irving JD, Dondelinger RF, Reidy JF, et al. Gianturco self-expanding stents: Clinical experience in the vena cava and large veins. Cardiovasc Intervent Radiol. 1992;15(5):328-333.
  15. Sawada S, Fujiwara Y, Koyama T, et al. Application of expandable metallic stents to the venous system. Acta Radiol. 1992;33(2):156-159.
  16. Elson JD, Becker GJ, Wholey MH, et al. Vena caval and central venous stenoses: Management with Palmaz balloon-expandable intraluminal stents. J Vasc Interv Radiol. 1991;2(2):215-223.
  17. Pisani-Ceretti A, Intra M, Prestipino F, et al. Surgical and radiologic treatment of primary Budd-Chiari syndrome. World J Surg. 1998;22(1):48-53.
  18. Witte AM, Kool LJ, Veenendaal R, et al. Hepatic vein stenting for Budd-Chiari syndrome. Am J Gastroenterol. 1997;92(3):498-501.
  19. Akers DL, Jr., Creado B, Hewitt RL. Iliac vein compression syndrome: Case report and review of the literature. J Vasc Surg. 1996;24:477-481.
  20. Kogel H. Regarding ’Iliac vein compression syndrome: Case report and review of the literature’. J Vasc Surg. 1997;26(4):721-722.
  21. La Hei ER, Appleberg M, Roche J. Surgical thrombectomy and stent placement for iliac compression syndrome. Australas Radiol. 1997;41(3):243-246.
  22. Lumsden AB, Hughes JD, MacDonald MJ, et al. The thrombosed arteriovenous graft: An endovascular model for vascular surgeons. Cardiovasc Surg. 1997;5(4):401-407.
  23. Marston WA, Criado E, Jaques PF, et al. Prospective randomized comparison of surgical versus endovascular management of thrombosed dialysis access grafts. J Vasc Surg. 1997;26(3):373-380.
  24. Uflacker R, Rajagopalan PR, Vujic I, et al. Treatment of thrombosed dialysis access grafts: Randomized trial of surgical thrombectomy versus mechanical thrombectomy with the Amplatz device. J Vasc Interv Radiol. 1996;7(2):185-192.
  25. Okubo M, Benson LN. Intravascular and intracardiac stents used in congenital heart disease. Curr Opin Cardiol. 2001;16(2):84-91.
  26. National Institute for Clinical Excellence (NICE). Stent placement for vena caval obstruction. Interventional Procedure Guidance 79. London, UK: NICE; July 2004.
  27. National Institute for Clinical Excellence (NICE). Balloon angioplasty of pulmonary vein stenosis in infants. Interventional Procedure Guidance 75. London, UK: NICE; July 2004.
  28. Hood DB, Alexander JQ. Endovascular management of iliofemoral venous occlusive disease. Surg Clin North Am. 2004;84(5):1381-1396, viii.
  29. Rerksuppaphol S, Hardikar W, Smith AL, et al. Successful stenting for Budd-Chiari syndrome after pediatric liver transplantation: A case series and review of the literature. Pediatr Surg Int. 2004;20(2):87-90.
  30. Patel U, Bratby MJ, Brookes MJ, Lehmann ED. Angioplasty and/or stenting for arteriovenous fistulae and graft stenoses in haemodialysis patients (Protocol for Cochrane Review). Cochrane Database Syst Rev. 2005;(3):CD005424.
  31. Kim JY, Choi D, Guk Ko Y, et al. Percutaneous treatment of deep vein thrombosis in May-Thurner syndrome. Cardiovasc Intervent Radiol. 2006;29(4):571-575.
  32. Lou WS, Gu JP, He X, et al. Endovascular treatment for iliac vein compression syndrome: A comparison between the presence and absence of secondary thrombosis. Korean J Radiol. 2009;10(2):135-143.
  33. Chiriano J, Teruya TH, Zhang WW, et al. Treatment of superior mesenteric artery portal vein fistula with balloon-expandable stent graft. Ann Vasc Surg. 2009;23(1):99-102.
  34. Zilani G, Pereira EA, Baig F, et al. Venoplasty and stenting of a jugular foramen meningioma. Br J Neurosurg. 2009;23(5):557-560.
  35. Novotný J, Peregrin JH, Stríbrná J, Janousek R. Treatment of venous aortorenal bypass graft aneurysm using a stent-graft. Cardiovasc Intervent Radiol. 2010;33(1):177-181.
  36. Titus JM, Moise MA, Bena J, et al. Iliofemoral stenting for venous occlusive disease. J Vasc Surg. 2011;53(3):706-712.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna 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 Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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