BlueCross BlueShield of Tennessee Medical Policy Manual

Varicose Vein Treatments for the Lower Extremities

DESCRIPTION

Varicose veins are enlarged, dilated, and tortuous vessels and a common clinical manifestation of chronic venous insufficiency. These veins can be found anywhere on the body but occur most often in the lower extremities. Symptoms range from pain, burning, and itching to edema, skin discolorations, and ulcerations.

During the past decade, new venous terminology has been developed and adopted by vascular societies around the world. The main superficial veins of the lower extremities are the great saphenous veins (GVS) and small saphenous vein (SSV). All previous names used to describe these vessels (greater, long, and lesser) should be abandoned. There are posterior and anterior accessory saphenous veins in the calf and the thigh. The intersaphenous vein (formerly the vein of Giacomini), which runs in the posterior thigh, connects the SSV with the GSV. The deep system includes the popliteal, femoral, anterior, posterior tibial and peroneal veins. Perforator veins, not considered part of the superficial system, connect the superficial veins to the deep veins where they drain.

One way valves are located in both the superficial system and the perforator veins, which aid the return of venous blood. Typically varicosities are related to incompetence of these valves which lead to increased pressure in the superficial venous system and result in an accumulation of blood and expansion or bulging of the veins.

Telangiectasias (i.e. spider veins, spider bursts, web veins, thread veins, dilated venules) are permanently dilated blood vessels that create fine, thread-like veins. Usually, they are limited to the dermis and are small (≤1 mm in diameter). The treatment of telangiectasias is most commonly performed for cosmetic improvement.

The treatment of varicose veins depends on the severity of the problem. Asymptomatic varicose veins and those with moderate symptoms are treated with conservative measures such as exercise, elevation of leg(s), supportive stockings, the avoidance of tight clothing, and prolonged standing.

A variety of treatment modalities are available to treat varicose veins/venous insufficiency, including surgical approaches, thermal ablation, and sclerotherapy. The application of each of these treatment options is influenced by the severity of the symptoms, type of vein, source of venous reflux, and the use of other (prior or concurrent) treatments. Surgical techniques include ligation (tying off a vein), stripping (removing a long segment of vein with a special instrument), ambulatory phlebectomy (removal of a vein through tiny incisions also called stab avulsion or hook phlebectomy), endoluminal radiofrequency ablation (e.g., VNUS® Closure™ System), endoluminal laser ablation (e.g., EVLT™ procedure kit). Radiofrequency energy and/or laser therapy is designed to damage the intimal wall of the vessel, resulting in fibrosis and ultimate obliteration of the vein.

Sclerotherapy is a less invasive procedure involving the injection of a sclerosant agent; liquid, foam, or more recently, microfoam directly into the vein resulting in changes to the lining of the vein wall. If successful the vein is occluded and no longer able to serve as conduit for venous blood flow. The success of the treatment depends on accurate injection of the vessel, an adequate volume and concentration of sclerosant agent. Historically, larger veins were not considered to be good candidates for sclerotherapy due to dilution of the agent in the blood volume of the larger veins and potential migration of the compounded foam into the larger vasculature. Technical improvements in sclerotherapy have included the use of ultrasound to target refluxing vessels, and the development of a proprietary microfoam sclerosant (i.e. Varithena ®) that is dispersed from a canister with a controlled density and more consistent bubble size.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

2013 FDA approval of microfoam sclerotherapy (i.e. Varithena ®) indications are for the ‘treatment of incompetent great saphenous veins (GVS), accessory saphenous veins and visible varicosities of the GVS system’.

The CEAP classification, developed by the American Venous Forum, is a method commonly used to document the severity of chronic venous disease and is based on clinical presentation (C) - defined below in class 1-6; etiology (E) - congenital, primary, secondary; anatomy (A) - superficial, perforator, deep; and pathophysiology (P) - reflux or obstruction, basic or advanced:

SOURCES

American Academy of Cosmetic Surgery. (2003). Guidelines for sclerotherapy. Retrieved May 2, 2012 from http://www.cosmeticsurgery.org/media/2003_sclerotherapy_guidelines.pdf.

American College of Phlebology. (2011) Practice guidelines, superficial venous disease. Retrieved November 12, 2015 from http://phlebology.org/resources.

American College of Phlebology. (2012) Practice guidelines, varicose vein surgery. Retrieved March 26, 2014 from http://phlebology.org/resources/Varicose-Vein-Rx-Guidelines.pdf.

American College of Radiology. (2012). ACR appropriateness criteria-treatment of lower extremity venous insufficiency. Retrieved September 21, 2015 from http://www.guideline.gov/. (NCG#009661)

American Society of Dermatologic Surgeons. (2014). Sclerotherapy for spider veins. Retrieved March 20, 2014 from https://www.asds.net/PrintTemplate.aspx.

American Venous Forum. (2013) Relevant Venous Anatomy Fellows Venous Course 2013. Retrieved November 12, 2015: www.veinforum.org/UserFiles/file/RelevantVenousAnatomy.pdf.

Biemans, A., Kockaert, M., Akkersdijk, G., van den Bos, R., Maeseneer, M., Cuypers, P., et. al., (2013) Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. Journal of Vascular Surgery. 2013;58:727-34. (Level 1 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2015). Treatment of varicose veins/venous insufficiency. (7.01.124). Retrieved November 13, 2015 from BlueWeb. (60 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee network physicians. June - July 2012.

Brittenden, J. Cotton, S., Elders, A., Ramsay, C., Norrie, J., Burr, J., et. al. (2014, September) A randomized trial comparing treatments for varicose veins. The New England Journal of Medicine. 2014; 371: 1218-1227.

Bush, R., Bush, P., Flanagan, J., Gueldner, T., Koziarski, J., McMullen, K., et al. 92014). Factors associated with recurrence of varicose veins after thermal ablation: results of the recurrent veins after thermal ablation study. The Scientific World Journal, 2014 (505843).

Centers for Medicare & Medicaid Services. LCD for Wisconsin Physicians Service Insurance Corporation. (2015, October). (LCD L34536) Treatment of varicose veins of the lower extremities. Retrieved November 18,, 2015 from http://www.cms.gov.

Chwala, M., Szczeklik, W., Szczeklik, M., Aleksiejew-Kleszczynski, T., Hagielska-Chwala, M. (2015) Varicose veins of lower extremities, hemodynamics and treatment methods. Advances in Clinical and Experimental Medicine 2015, 24, 1, 5-14. (Literature Review)

Delgado-Beltran, A. (2013, October) Crossectomy and foam sclerotherapy of the great saphenous vein versus stripping of great saphenous vein and varicectomy in the treatment of the legs ulcers. Hindawi Publishing Corporation. Vol. 2013, Article ID 734859, 5 pages (Level 2 evidence)

Dietzek, C. (2007, September) Sclerotherapy: Introduction to solutions and techniques. Perspectives in Vascular Surgery and Endovascular Therapy Volume 19 Number 3, 2007 317-324. (Level 5 evidence)

ECRI Institute. Health Technology Information Service. Windows on Medical Technology. (2006, August). Endovenous radio-frequency ablation (VNUS Closure® System) for the treatment of varicose veins. Retrieved August 9, 2007 from ECRI Institute. (59 articles and/or guidelines reviewed)

ECRI Institute. Health Technology Information Service. Windows on Medical Technology. (2004, December). Endovenous laser ablation of the greater saphenous vein. Retrieved August 9, 2007 from ECRI Institute. (58 articles and/or guidelines reviewed)

Galeandro, A., Quistelli, G., Scicchitano, P., Gesualdo, M., Zito, A., Caputo, P., et al. (2012). Doppler ultrasound venous mapping of the lower limbs. Vascular Health and Risk Management, 2012 (8), 59 - 64. (Level 3 evidence - Independent)

Glovicki, P., Comerota, A., Dalsing, M., Eklof, B., Gillespie, D., Glovicki, M., et al. (2011). The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society of Vascular Surgery and the American Venous Forum. Journal of Vascular Surgery, 53 (5), 2s-48s. (Level 1 evidence - Independent)

Grover, G., Tanase, A., Elstone A., and Ashley, S. (2014) Chronic venous leg ulcers: Effects of foam sclerotherapy on healing and recurrence. Phlebology OnLine. 0(0) 1-8. (Level 4 evidence)

International Accreditation Commission. (2012). IAC standards and guidelines for vascular testing accreditation. Retrieved March 20, 2014 from http://intersocietal.org/vascular/standards/IACVascularTestingStandards2013.pdf.

Kalodiki, E., Lattimer, C., Azzam, M., Shawish, E., Bountouroglou, D., Geroulakos, G., et. al., (2012) Long-term results of a randomized controlled trial on ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation vs standard surgery for varicose veins. Journal of Vascular Surgery. 2012;55:451-7. (Level 2 evidence)

King, J.T. O’Byrne, M. Vasquez, M., Wright, D., et al., (2015) Treatment of truncal incompetence and varicose veins with a single administration of a new polidocanol endovenous microfoam preparation improves symptoms and appearance. European Journal of Vascular and Endovascular Surgery. DOI: http://dx.doi.org/10.1016/j.ejvs.2015.06.111 (Level 2 evidence)

Kundu,S., Grassi, C., Khilnani, N., Fanelli, F., Kalva, S., Ahmed, A., et al. (2010). Multi-disciplinary quality improvement guidelines for the treatment of lower extremity superficial venous insufficiency with ambulatory phlebectomy from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology and Canadian Interventional Radiology Association. Journal of Vascular Interventional Radiology, 21 (1), 1-13.

Meissner, M. (2012). What is the medical rationale for the treatment of varicose veins? Phlebology, 27 (10), 27-33.

Michaels, J. A., Campbell, W. B., Brazier, J. E., Macintyre, J. B., Palfreyman, S., Ratcliffe, J., et al. (2006). Randomized clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial). Health Technology Assessment, 10 (13), 1-196. (Level 1 evidence - Independent)

Murad, M.., Coto-Yglesias, F., Zumaeta-Garcia, M., Elamin, M., Duggirala, M., Erwin, P., et al. (2011) A systematic review and meta-analysis of the treatments of varicose veins. Journal of Vascular Surgery, 53 (16S) 49S-65S. (Level 1 evidence - Independent)

National Institute for Health and Clinical Excellence. (2013, July). Varicose veins in the legs: the diagnosis and management of varicose veins. Retrieved September 8, 2015 from http://www.nice.org.

Nesbitt, C., Coyne, p., Badri, H., Bhattacharya, V & Stansby, G. (2011) Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for the great saphenous vein varices (2011). Cochrane Database of Systematic Reviews 2011, Issue 10. Art. No. CD005624. DOI: 10.1002/14651858.pub2 (Level 1 evidence - Independent)

O’Donnell Jr, T., Passman, M., D, Marston, W., Ennis, W., Dalsing, M., Kistner, R., et.al., (2014) Management of venous leg ulcers: Clinical practice guidelines of the society for vascular surgery and the american venous forum. Journal of Vascular Surgery. 60:3S-59S.

O’Donnell, T. (2008) The present status of surgery of the superficial venous system in the management of venous ulcer and the evidence for the role of perforator interruption. Journal of Vascular Surgery 2008; 48: 1044-52. (Level 5 evidence)

Sarvananthan, T., Shepard, A., Willenberg, T., Davies A. (2012) Neurological complications of sclerotherapy for varicose veins. Journal of Vascular Surgery. 2012;55:243-51 (Level 5 evidence)

Schul, M. Schloerke, B., and Gomes, G. (2015) The refluxing anterior accessory saphenous vein demonstrates similar clinical severity when compared to the refluxing great saphenous vein.

Society for Vascular Surgery / American Venous Forum (SVS/AVF) (2014) Management of venous leg ulcers: clinical practice guidelines of the society for vascular surgery and the american venous forum. Retrieved September 8, 2015 from: http://dx.doi.org/10.1016/j.jvs.2014.04.049.

Society of Interventional Radiology. (2003). Position Statement: Endovenous Ablation. Retrieved November 3, 2009 from http://www.scvir.org/clinical/cpg/SIR_venous_ablation_statement_final_Dec03.pdf.

Stucker, M., Kobus, S., Altmeyer, P., & Reich-Schupke, S. (2010). Review of published information on foam sclerotherapy. Dermatologic Surgery, 36 (S2), 983-992. (Level 1 evidence - Industry sponsored)

Tisi, P.V., Beverley C., Rees A. Injection sclerotherapy for varicose veins. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.:CD001732. DOI:10.1002/14651858.CD001732.pub2. (Level 1 evidence - Independent)

Todd, K., and Wright, DI. (2013)  The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology. September 18, 2015 from: http://phl.sagepub.com/content/early/2014/03/17/0268355513497709 (Level 2 evidence)

U. S. Food and Drug Administration. (1999. October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K990723. Retrieved August 11, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K990723.pdf.

U. S. Food and Drug Administration. (2003. June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K030700. Retrieved August 11, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/K030700.pdf.

U. S. Food and Drug Administration. Center for Drug Evaluation and Research. (2005). Asclera®(polidocanol). Retrieved May 2, 2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf.

U. S. Food and Drug Administration. Center for Drug Evaluation and Research. (2013). 505(b)(1) Varithena® (microfoam polidocanol). Retrieved September 8, 2015 http://www.accessdata.fda.gov.

Vascular Society of Great Britain and Ireland. (2013, May) Commissioning guide: varicose veins. Retrieved November 12, 2013 from: www.nice.org.uk/accredittation

Vasquez, M., Rabe, E., McLafferty, R., Shortell, C., Marston, W., Gillespie, D., et al. (2010). Revision of the venous clinical severity score: Venous outcomes consensus statement: Special communication of the American Venous Forum Ad Hoc Outcomes Working Group. Journal of Vascular Surgery, 52 (5), 1387-1396.

Williamsson, C., Danielsson, P., and Smith, L. (2014) Catheter-directed foam sclerotherapy for chronic venous leg ulcers. Phlebology. Vol. 29(10) 688-693 (Level 3 evidence)

Winifred S. Hayes, Inc. Medical Technology Directory. (2009, February, last updated March 16, 2012). Endovenous laser therapy for varicose veins due to great saphenous vein reflux. Retrieved October 9, 2009 from www.Hayesinc.com/subscribers. (47 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2009, March, last updated March 19, 2012). Endovenous laser therapy for varicose veins due to small saphenous vein reflux. Retrieved October 9, 2009 from www.Hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)

Wong, M. (2015) Should foam made with physiologic gases be the standard in sclerotherapy? Phlebology. Vol. 30(9) 580–586. (Level 4 evidence)

ORIGINAL EFFECTIVE DATE:  10/1998

MOST RECENT REVIEW DATE:  4/15/2016

ID_BA

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.

This document has been classified as public information.