BlueCross BlueShield of Tennessee Medical Policy Manual

Varicose Vein Treatments for the Lower Extremities

DESCRIPTION

Varicose veins are enlarged, dilated, 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 painful 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 discouraged. 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 mild to 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 severe symptoms of 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, hook phlebectomy or transilluminated powered 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 chemical 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 chemicals 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.

Emerging techniques and technologies that use mechanochemical ablation (e.g., ClariVein® Infusion Catheter), cryoablation (e.g., Erbe Erbokryo®), surgical adhesive (e.g., VenaSeal™ Closure System), microwave ablation, or steam injection have not been proven to be superior and/or have no long term studies that address the issues of recurrence, healing, neovascularization, thrombus formation, thrombophlebitis, wound infection, or transient neurologic effects.

Note: Liquid sclerosing agents (e.g. Asclera®) can be foamed at the bedside with CO2 or room air, this does not constitute an ‘off-label’ use of the product. While the literature refers to this as physician-compounded; BCBST’s Administrative Services policy Compounded Drug Products would only apply if components other than CO2 or room air were added to the manufacturer’s product.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

2013 FDA approval of microfoam sclerotherapy (i.e. Varithena®) indications for use 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

Almeida, J., Javier, J., MacKay, E., Bautista, C. Cher, D. and Proebstle, T. (2015, July) Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 30(6):397-404. Abstract retrieved November 17, 2016 from PubMed database.

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

American College of Phlebology. (2012) Practice guidelines, varicose vein surgery. Retrieved March 26, 2014 from http://phlebology.org.

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).

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)

Bishawi, M., Bernstein, R., Boter, M., Draughn, D., Gould, C., Hamilton, C., et. al. (2014, July) Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report. Phlebology. (6): 397-400.Abstract retrieved November 16, 2016 from PubMed database.

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2017). Treatment of varicose veins/venous insufficiency. (7.01.124). Retrieved January 19, 2018 from BlueWeb. (54 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. (Level 1 evidence)

Bush, R., Bush, P., Flanagan, J., Gueldner, T., Koziarski, J., McMullen, K., et al. (2014). Factors associated with recurrence of varicose veins after thermal ablation: results of the recurrent veins after thermal ablation study. The Scientific World Journal, 2014 (Level 3 evidence)

Chan, Y., Ting, A., Yiu, W., and Cheng, S. (2012) Cyanoacrylate superglue to treat varicose veins: truly office based and minimally invasive? European Society for Vascular Surgery. .2012.11.005. (Level 5 evidence)

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. (Level 5 evidence)

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. (Level 2 evidence)

Disselhoff, B.,  der Kinderen, D., Kelder, J., and Moll, F. (2011, August) Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins. British Journal of Surgery. 98(8)1107-11. Abstract retrieved November 16, 2016 from PubMed database.

Elias, S. and Raines, J. (2012) P Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology 2012;27:67–72. (Level 3 evidence – industry sponsored)

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)

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. Vol. 50, Issue 6, pages 784-793. (Level 3 evidence)

Milleret, R., Huot, L., Nicolini, P., Creton, D., Roux, A., Decullier, E., et. al. (2013, January) Great saphenous vein ablation with steam injection: results of a multicentre study. European Society for Vascular Surgery.2013.01.027. (Level 3 evidence)

Morrison, N., Gibson, K., McEnroe, S., Goldman, M., King, T., Weiss, R., et. al., (2015) Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose) Journal of Vascular Surgery. 2015;61:985-94. (Level 3 evidence - industry sponsored)

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: diagnosis and management. Retrieved November 15, 2016 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. (Level 1 evidence - Independent)

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. Phlebology OnLine. 0(0) 1–6 (level 4 evidence)

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 for Vascular Surgery / American Venous Forum (SVS/AVF) (2011) The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. Retrieved January 19, 2018 from http://www.jvascsurg.org.

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. Retrieved September 18, 2015 from: http://phl.sagepub.com. (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.

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.

U. S. Food and Drug Administration. (2005, July). Center for Devices and Radiological Health.510(k) Premarket Notification Database. K051509 (Erbe Erbokryo®). Retrieved November 16, 2016 from: http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2008, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071468 (ClariVein®). Retrieved November, 16, 2016 from: http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2015, February). Center for Devices and Radiological Health. Premarket Approval Notification Database. P140018 (VenaSeal®). Retrieved November, 16, 2016 from: http://www.accessdata.fda.gov.

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.

Van den Bos, R., Malskat, W., Maeseneer, M., de Roos, K., Groeneweg, D., Kockaert, M., et al. (2014, August) Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. British Journal of Surgery 101(9), 1077-83. Abstract retrieved January 19, 2018 from PubMed database.

Van der Velden, S., Biemans, A., Maeseneer, G., Kockaert, P., Cuypers, P., Hollestein, L., et. al. (2015) Five-year results of a clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patient with great saphenous varicose veins. British Journal of Surgery. 2012; 102:1184-1194. (Level 1 evidence)

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 (2017, October) Endovenous radiofrequency ablation versus conventional surgery for symptomatic varicose veins: a review of reviews. Retrieved January 19, 2018 from www.hayesinc.com (56 articles and/or guidelines reviewed)

Wisconsin Physicians Service Insurance Corporation. (2015, December). Local Coverage Determination: LCD  Treatment of varicose veins of the lower extremities (L34536). Retrieved November 15, 2016 from: http://www.cms.gov.

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

Yamaki, T., Hamahata, A., Soejima, K., Kono, T., Nozaki, M., and Sakurai, H. (2012) Prospective randomised comparative study of visual foam sclerotherapy alone or in combination with ultrasound-guided foam sclerotherapy for treatment of superficial venous insufficiency: preliminary report. European Journal of Vascular and Endovascular Surgery. 43; 343-347. (Level 2 evidence)

Yang, L., Wang, X., Su, W.,  Zhang, Y.,  and Wang, Y. (2013, August) Randomized clinical trial of endovenous microwave ablation combined with high ligation versus conventional surgery for varicose veins. European Society for Vascular Surgery. Volume 46 Issue 4 p. 473-479. (Level 2 evidence)

ORIGINAL EFFECTIVE DATE:  10/1998

MOST RECENT REVIEW DATE:  2/8/2018

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.