Surgery Section - Percutaneous Venous Transluminal Angioplasty and Stenting

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Percutaneous Transluminal Angioplasty (PTA) of the Veins

PTA of the veins is a procedure that is an alternative to open vascular surgery in order to restore blood flow through narrowed veins. Techniques used to restore blood flow include balloon angioplasty, laser angioplasty, and stent placement.  PTA may also be used in coronary, pulmonary, peripheral, intracranial, renal, and aortic stenoses which are addressed in separate policies.

Intravascular Stents

Intravascular stents are used as an adjunct to angioplasty, to prevent vessel wall collapse. They can be placed via transluminal catheters or placed with catheters during open vascular procedures. There are several types of stents that are approved by the U.S. Food and Drug Administration (FDA) for the creation of intrahepatic shunt connections between the portal venous system and hepatic vein. Drug-eluting stents are intended to prevent restenosis by reducing the growth of neointimal tissue. A number of different drugs are being evaluated for this use, including paclitaxel and sirolimus. These stents are coated with a mixture of synthetic polymers blended with the drug. A second coat of drug-free polymers is then added to serve as a diffusion barrier, thus allowing the gradual release of drug to the precise site of interest while avoiding systemic side effects.  There are currently no stents with FDA approval for use in veins other than intrahepatic shunts or for improvement of outflow for arteriovenous (A-V) access grafts in hemodialysis patients.

Note: This policy addresses percutaneous angioplasty and stenting of venous vessels only.  This policy does not address percutaneous angioplasty and stenting of carotid or intracranial vessels which are addressed in separate policies (see Cross References below).

Policy/Criteria

1. Percutaneous transluminal angioplasty, with or without stenting, may be considered medically necessary for the treatment of venous vascular stenoses in the following instances:
   1. Stenotic lesions of arteriovenous dialysis fistulas and grafts, and ipsilateral venous stenosis in the outflow of a functioning dialysis fistula and graft
   2. Superior vena cava in patients with malignant superior vena cava syndrome, when standard treatments (radiation and/or chemotherapy) have failed
   3. May-Thurner Syndrome (iliac compression syndrome)
2. The use of an endoprosthesis for creation of intrahepatic shunt connections between the portal venous system and hepatic vein may be considered medically necessary.
3. Percutaneous transluminal angioplasty, with or without stenting, is considered investigational for all other venous indications, including but not limited to:
   1. Deep vein thrombosis
   2. Axillary-subclavian venous thrombosis (Paget-Schroetter Syndrome)

Scientific Background

The following discussion focuses on the investigational indications noted in 3A and 3B above and the new medically necessary indication noted in 1C above.

Deep Vein Thrombosis (DVT)

There are several objectives of treatment for venous thromboembolism, namely (1,2):

• Prevention of pulmonary embolism,
• Restoration of unobstructed blood flow through the thrombosed vein,
• Preservation of venous valve function, and
• Prevention of recurrent thrombosis.

As discussed by Hoffman and colleagues (3), the current standard of treatment for achieving these goals is anticoagulant therapy.  Specifically, intravenous unfractionated heparin is administered to achieve a therapeutic partial thromboplastin time (PTT). Warfarin is then started and the heparin continued until the INR (International Normalized Ratio) has reached a therapeutic level.  While this treatment is typically delivered in an inpatient setting, more recently, some patients with acute venous thrombosis have been safely and effectively managed as outpatients with therapeutic doses of low-molecular-weight heparin and warfarin.  After completion of an initial course of anticoagulation therapy, patients with venous thromboembolism require continuing therapy to prevent recurrence. Some patients will require long-term anticoagulation, depending on their risk for recurrence, whereas other patients may be able to either discontinue therapy or continue with a reduced target INR.

Anticoagulation therapy is the standard against which percutaneous transluminal angioplasty, with or without stenting, must be compared in order to evaluate the safety, efficacy, and final health outcomes of the latter procedure in the treatment of DVT.  A search of the MEDLINE database through June 23, 2005 identified two small, nonrandomized preliminary studies investigating thrombolysis followed by angioplasty and stenting. (1,2) However, the search failed to identify any randomized controlled clinical trials in which PTA with or without stenting was compared to standard medical management of DVT.  Furthermore, no practice guidelines were identified which specifically recommend angioplasty, with or without stenting, as a treatment of DVT.  Finally, no venous stents have received FDA approval.

Based on a paucity of data from well-designed clinical trials and the lack of FDA approval for venous stents, it is not possible to reach scientific conclusions concerning the safety, efficacy, and final health outcomes of angioplasty, with or without stenting, for the treatment of deep vein thrombosis.

Axillary-Subclavian Venous Thrombosis (Paget-Schroetter Syndrome)

Effort vein thrombosis, or Paget-Schroetter syndrome, occurs as a result of mechanical trauma to the subclavian vein at the thoracic outlet, and the natural history of the disorder is typically one of chronic venous obstruction with development of a painful, swollen extremity.  Typical management of this condition involves thrombolysis and surgical decompression after a variable interval of oral anticoagulation.  PTA and stenting of the subclavian vein has been investigated, but the role of stent placement in this region is controversial as there are reports of stent fracture in this region. (4,5)

Although there are small case series reporting short-term outcomes of PTA and stenting in patients with axillary-subclavian venous thrombosis, a search of the MEDLINE database failed to identify studies comparing PTA and stenting with thrombolysis and/or decompression, which are considered first-line treatments.  (4-10) There are no evidence-based practice guidelines which recommend PTA and stenting as a treatment of axillary-subclavian venous thrombosis, and finally, there are no FDA approved stents for use in the subclavian vein.  Thus it is not possible to draw scientific conclusions concerning the efficacy of PTA and stenting in the treatment of axillary-subclavian venous thrombosis.

May-Thurner Syndrome (Iliac Vein Compression Syndrome)

May-Thurner syndrome or iliac vein compression syndrome is deep vein thrombosis resulting from the chronic compression of the vein against the caudal lumbar vertebrae by the overlying right common iliac artery. (12)  Inadequately treated, May-Thurner syndrome may result in recurrent deep vein thrombosis or postthrombotic syndrome or both, characterized by chronic swelling and pain in the affected extremity.  Some patients also develop varicosities and stasis ulcers.  Although this syndrome involves an anatomic variant that is found in up to 22% of the general population, the syndrome itself is relatively uncommon, usually occurring in women in their twenties to fifties.  Most patients tend to be asymptomatic until some other clinical event occurs, such as trauma, surgery, pregnancy, or a major illness involving prolonged bedrest.

Treatment has historically involved anticoagulation therapy and thrombectomy, however, this treatment option does not address the underlying mechanical compression, and rethrombosis has been reported in up 73% of patients with a venous spur. (13)  Different surgical procedures have been advocated, including vein-patch angioplasty with excision of intraluminal bands, division of the right common iliac artery and relocation behind the left common iliac vein or vena cava, and contralateral saphenous vein graft bypass to the ipsilateral common femoral vein with creation of a temporary arteriovenous fistula.   Reported success rates range from 40% to 95%.  Endovascular management has been suggested as a less-invasive front-line treatment for May-Thurner syndrome. 

Ideally, randomized controlled trials comparing endovascular treatment with surgical intervention are needed to determine the long-term safety and efficacy of stenting.  However, the published literature on endovascular treatment of May-Thurner syndrome consists of single case reports or small, uncontrolled case series, none of which involved comparisons to surgical intervention. (12-18) The two largest case series involving 22 and 39 patients were retrospective analyses rather than prospective controlled trials. (15, 16)  The one-year patency rate for all patients is consistently 91.3% to 93%.  Given the rare occurrence of May Thurner syndrome it is not expected that well-designed, randomized trials are possible.  The small studies that are available consistently report excellent outcomes with stenting which are consistently better than the outcomes reported from small case series of open surgical repair.  Given these three conditions it is determined that the technology evaluation criteria are met for stenting for May-Thurner syndrome.

An updated search of the literature through January 2009 did not return any new clinical trial data for the investigational indications listed in the policy.  The available evidence supports the criteria as written.

References

1. AbuRahma AF, Perkins SE, Wulu JT, Ng  HK.  Iliofemoral deep vein thrombosis: conventional therapy versus lysis and percutaneous transluminal angioplasty and stenting.  Ann Surg 2001;233(6):752-60
2. Cho YP, Ahn JH, Choi SJ  et al.  Endovascular management of iliofemoral deep venous thrombosis due to iliac vein compression syndrome in patients with protein C and/or S deficiency.  J Korean Med Sci 2004;19(5):729-34
3. Hoffman R, Benz Jr EJ, Shattil SJ et al.  Hematology: Basic Principles and Practice, 4th ed. Copyright © 2005 Elsevier
4. Braunwald: Heart Disease: A Textbook of Cardiovascular Medicine, 6th ed., Copyright © 2001 W. B. Saunders Company p. 1498
5. Urschel HC, Patel AN.  Paget-Schroetter syndrome therapy: failure of intravenous stents.  Ann Thorac Surg  2003;75:1693-6
6. Beygui RE, Olcott C 4th, Dalman RL.  Subclavian vein thrombosis: outcome analysis based on etiology and modality of treatment.  Ann Vasc Surg  1997;11(3):247-55
7. Rutherford RB, Hurlbert SN.  Primary subclavian-axillary vein thrombosis: consensus and commentary.  Cardiovasc Surg  1996;4(4):420-3
8. Wisselink W, Money SR, Becker MO et al.  Comparison of operative reconstruction and percutaneous balloon dilatation for central venous obstruction.  Am J Surg  1993;166(2):200-4
9. Rutherford RB. Primary subclavian-axillary vein thrombosis: the relative roles of thrombolysis, percutaneous angioplasty, stents, and surgery. Semin Vasc Surg  1998;11(2):91-5
10. Kreienberg PB, Chang BB, Darling III CD et al.  Long-term results in patients treated with thrombolysis, thoracic inlet decompression, and subclavian vein stenting for Paget-Schroetter syndrome.  J Vasc Surg  2001;33(2):S100-5
11. ASA Physical Status Classification System.  www.asahq.org/clinical/physicalstatus.htm (Verified 3/28/06)
12. Grunwald MR, Goldberg MJ, Hofmann LV.  Endovascular management of May-Thurner syndrome.  AJR Am J Roentgenol 2004;183(5):1523-4
13. Lamont JP, Pearl GJ, Patetsios P et al.  Prospective evaluation of endoluminal venous stents in the treatment of the May-Thurner syndrome.  Ann Vasc Surg 2002;16(1):61-4
14. Patel NH, Stookey KR, Ketcham DB, Cragg AH.  Endovascular management of acute extensive iliofemoral deep venous thrombosis caused by May-Thurner syndrome.  J Vasc Interv Radiol 2000;11(10):1297-302
15. O'Sullivan GJ, Semba CP, Bittner CA et al.  Endovascular management of iliac vein compression (May-Thurner) syndrome.  J Vasc Interv Radiol 2000;11(7):823-36
16. Kwak HS, Han YM, Lee YS et al.  Stents in common iliac vein obstruction with acute ipsilateral deep venous thrombosis: early and late results.  J Vasc Interv Radiol 2005;16(6):815-22
17. 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):22-6
18. Heijmen RH, Bollen TL, Duyndam DA et al.  Endovascular venous stenting in May-Thurner syndrome.  J Cardiovasc Surg (Torino) 2001;42(1):83-7

Cross References

Carotid Angioplasty/Stenting, Regence Medical Policy Manual, Surgery, Policy No. 93

Percutaneous Transluminal Angioplasty of Intracranial Atherosclerotic Stenoses With or Without Stenting, Regence Medical Policy Manual, Medical Policy, Surgery, Policy No. 141

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