This bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.
Aetna Clinical Policy Bulletin Number 0050: Varicose Veins. Last reviewed Jan 6, 2017. http://www.aetna.com/0050.html.
Almeida JI, Javier JJ, Mackay EG, Baustista C, Cher DJ, Probestle TM. Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg: Venous and Lym Dis. 2017;1-9.
American Academy of Dermatology. Guidelines of care for sclerotherapy treatment of varicose and telangiectatic leg veins. http://www.aadassociation.org/Guidelines/sclero.html. Accessed on May 3, 2005.
American College of Phlebology. Practice Guidelines-Superficial Venous Disease. Last reviewed Jan 6, 2017. http://www.phlebology.org/wp-content/uploads/2016/02/SuperficialVenousDiseaseGuidelinesPMS313-02.03.16.pdf.
Anthem Medical Policy Number SURG.00037: Treatment of Varicose Veins (Lower Extremities). Last reviewed Jan 6, 2017. https://www.anthem.com/053323.htm.
Bánhidy F, Ács N, Puhó EH, Czeizel AE. Varicose veins of lower extremities in pregnant women and birth outcomes. Cent Eur J Public Health. 2010;18(3):161–168.
Biemans AA, Kockaert M, Akkersdijk GP, et al. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013;58(3):727-734.
Blue Cross Blue of Massachusetts Medical Policy Number 238: Treatment of Varicose Veins/Venous Insufficiency. Last reviewed Jan 6 2017. http://www.bluecrossma.com/238.pdf.
Boersma D, van Eekeren RRJP, Werson DAB, van der Waal RIF, Reijnen MMJP, de Vries JPPM. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013;45(3):299-303.
Bootun R, Lane TRA, Dharmarajah B, et. al. Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: the multicentre Venefit™ versus ClariVein® for varicose veins trial. Phlebology. 2016;31(1):61-65.
Brittenden J, Cotton SC, Elders A, et. al. A randomized trial comparing treatments for varicose veins. N Engl J Med. 2014;371:1218-1227.
Carugo D, Ankrett DN, O'Byrne V, Wright DDI, Lewis AL, Hill M, Zhang X. The role of clinically-relevant parameters on the cohesiveness of sclerosing foams in a biomimetic vein model. J Mater Sci Mater Med. 2015:26(11):258.
Carugo D, Ankrett DN, Zhao X, et al. Benefits of polidocanol endovenous microfoam (Varithena®) compared with physician-compounded foams. Phlebology. 2016;31(4):283-295.
CGS Administrators, LLC Local Coverage Determination (LCD) L34082: Varicose Veins of the Lower Extremity, Treatment of. Last accessed 07/12/2017.
Cigna Medical Coverage Policy Number 0234: Varicose Veins Treatment. Last reviewed Jan 6, 2017. https://cigna.com/0234.pdf.
Davies HO, Popplewell M, Darvall K, Bate G, Bradbury AW. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology. 2016;31(4):234-240.
Deijen CL, Schreve MA, Bosma J, et. al. Clarivein mechanochemical ablation of the great and small saphenous vein: Early treatment outcomes of two hospitals. Phlebology. 2015:1-6.
Delaney CL, Russell DA, Iannos J, Spark JI. Is endovenous laser ablation possible while taking warfarin? Phebology. 2012;27(5):231-234.
Demody M, Schul MW, O’Donnell TF. Thromboembolic complications of endovenous thermal ablation and foam sclerotherapy in the treatment of great saphenous vein insufficiency. Phlebology. 2015;30(5):357-364.
Elias, S. Emerging endovenous therapies. Endovascular Today. March 2014:42-46.
FDA 510(k) Clarivein approval. http://www.accessdata.fda.gov/cdrh_docs/pdf7/k071468.pdf
Feied C. Varicose veins and spider veins. http://www.emedicine.com/derm/topic475.htm. Accessed on March 26, 2006.
First Coast Service Options, Inc. Local Coverage Determination (LCD) L33762: Treatment of varicose veins of the lower extremity. Last accessed 07/12/2017.
Gibson K, Kabnick L, Varithena® on behalf of the 013 Investigator Group. A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. Phlebology. 2016 Mar 7. pii: 0268355516637300. [Epub ahead of print].
Gloviczki P, Comerota AJ, Dalsing MC, et al. 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. J Vasc Surg. 2011;53:2S-48S.
Handbook of Venous and Lymphatic Disorders. Fourth Edition. Guidelines of the American Venous Forum (AVF). Emerging endovenous technology for chronic venous disease: Mechanical occlusion chemically assisted ablation (MOCA), cyanoacrylate embolization (CAE), and V block assisted sclerotherapy (VBAS). January 2017.
Kim PS, Bishawi M, Draughn D, et. al. Mechanochemical ablation for symptomatic great saphenous vein reflux: a two-year follow-up. Phlebology. 2016:1-6.
King JT, O'Byrne M, Vasquez M, Wright D for the VANISH-1 Investigator Group. Treatment of truncal incompetence and varicose veins with a single administration of a new polidocanol endovenous microfoam preparation improves symptoms and appearance. Eur J Vasc Endovasc Surg. 2015:50(6):784-793.
Kugler NW, Brown KR. An update on the currently available nonthermal ablative options in the management of superficial venous disease. J Vasc Surg: Venous and Lym Dis. 2017;5(3):422-429.
Lal BK, Mallick R, Wright D. Improvement in patient-reported outcomes of varicose veins following treatment with polidocanol endovenous microfoam. Phlebology. 2017: 268355516678512.
Lane T, Bootun R, Dharmarajah B, et. al. A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins – Final results of the Venefit versus Clarivein for varicose veins trial. Phlebology. 2016:1-10.
Laser Ablation Versus Mechanochemical Ablation Trial (LAMA). NCT02627846. https://clinicaltrials.gov/ct2/show/NCT02627846.
Mallick R, Lal BK, Daugherty C. Relationship between patient-reported symptoms, limitations in daily activities, and psychological impact in varicose veins. J Vasc Surg Venous Lymphat Disord. 2017; 5: 224-237.
Manfrini S, Vincenzo G, Danielsson G, et al. Endovenous management of saphenous vein reflux. Endovenous Reflux Management Study Group. J Vasc Surg. 2000;32:330-42.
Merchant RF, Pichot O, Myers K. Four-year follow-up on endovascular radiofrequency obliteration of great saphenous reflux. Dermatology Surgery. 2005;31:129-134.
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins (MARADONA). NCT01936168. https://clinicaltrials.gov/ct2/show/NCT01936168?term=NCT01936168&rank=1.
Morrison N, Gibson K, Vasquez M, et al. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017. 2017;5(3):321-330.
Noridian Healthcare Solutions, LLC Local Coverage Determination (LCD) L34010: Treatment of Varicose Veins of the Lower Extremities. Last accessed 07/12/2017.
Novitas Solutions, Inc. Local Coverage Determination (LCD) DL34924: Treatment of Varicose Veins of the Lower Extremities. Last accessed 07/12/2017.
Özen Y, Çekmecelioglu D, Sarikaya S. Mechano-chemical endovenous ablation of great saphenous vein insufficiency: two-year results. Damar Cer Derg. 2014;23(3):176-179.
Palmetto GBA Local Coverage Determination (LCD) L33454: Varicose Veins of the Lower Extremities. Last accessed 07/12/2017.
Parsons M. Sclerotherapy basics. Dermatology Clinics. 22(4). W.B. Saunders Company.
Pletnicks J. Sclerotherapy. The Doctor’s Medical Library. http://www.medical-library.net/specialties/_sclerotherapy.html. Accessed on May 3, 2005.
Primary Insufficiency of the Great Saphenous Vein (GSV) With a Diameter >/= 12 mm, Antero-lateral Branches, or GSV Insufficiency Below the Knee (MOCA-XL). NCT02345018. https://www.clinicaltrials.gov/ct2/show/NCT02345018?term=mechanochemical&rank=2.
Proebstle TM, Alm J, Dimitri S, et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015;3(1):2-7.
Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011;98:1079-1087.
Riesenman PJ, de Fritas DJ, Konigsberg SG, Kasirajan K. Noninterruption of warfarin therapy is safe and does not compromise outcome in patients undergoing endovenous laser therapy (EVLT). Vasc Endovascular Surgery. 2011;45(6):524-526.
Sadick N. Advances in the treatment of varicose veins: ambulatory phlebectomy, foam sclerotherapy, endovascular laser and radiofrequency closure. Dermatologic Clinics. 23(3). W.B. Saunders Company.
Schultz C. Laser Treatment of Vascular Lesions. Dermatology Clinics. 23(4). W.B. Saunders Company.
Teruya T, Ballard J. New approaches for the treatment of varicose veins. Surgical Clinics of North America. 85(5). W.B. Saunders Company.
The American Academy of Cosmetic Surgery (2003). 2003 Guidelines for sclerotherapy. http://www.cosmeticsurgery.org. Accessed on March 21, 2006.
Theivacumar NS, Gough MJ. Influence of warfarin on the success of endovenous laser ablation (EVLA) of the great saphenous vein (GSV). Eur J Vasc Endovasc Surg. 2009;38(4):506-510.
Theivacumar NS, Dellagrammaticas D, Darwood RJ, Mavor AI, Gough MJ. Fate of the great saphenous vein following endovenous laser ablation: does re-canalisation mean recurrence? Eur J Vasc Endovasc Surg. 2008;36:211-5.
Thibault P. Sclerotherapy and ultrasound-guided sclerotherapy: The Vein Book. London U. Elsevier Academic Press; 2007:189-199.
Todd KL, Wright DI and the VANISH-2 Investigator. Group. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). J Vasc Surg Venous Lymphat Disord. 2015:3(3):258-264 e251.
Todd KL III, Wright DI, Gibson K, et al. 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. 2014;29(9):608-618.
Trelles M. The 800-nm diode laser in the treatment of leg veins: Assessment at 6 months. Journal of American Academy of Dermatology. 54(2).
UnitedHealthcare Medical Policy Number 2017T0447R: Surgical and ablative procedures for venous insufficiency and varicose veins. Last reviewed Jan 7, 2017. https://www.unitedhealthcareonline.com/Surgical_Ablative_Venous_Insuff_Varicose_Veins.pdf.
U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims; Last reviewed Aug 5, 2017. www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM.
van Eekeren RRJP, Boersma D, Konijn, V, de Vries JPPM, Reijnen MMJP. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013;57(2):445-450.
Van Rij AM, Andre M, Jones GT, Hill G, Jiang P. Neovascularization and recurrent varicose veins: more histologic and ultrasound evidence. Department of Surgery, Dunadin School of Medicine, University of Otago, New Zealand. J Vasc Surg. 2004;40:298-302.
Van Rij AM, Jiang P, Solomon O, Ross CA, Hill G. Recurrence after varicose vein surgery: A prospective long-term clinical study with duplex ultrasound scanning and air plethysmography. Department of Surgery, Dunadin School of Medicine, University of Otago, New Zealand. J Vasc Surg. 2003;38:935-43.
Varicose Veins, Essentials of Diagnosis. McGraw-Hill's Access Medicine. Chapter 36, Veins & Lyphatics, The Veins, Disease of the Venous Sytem. http://www.acessmedicine.com. Accessed on April 8, 2009.
Vascular Insights website. Accessed Jan 7, 2017. http://clarivein.com/clarivein-ous/for-physicians/clarivein-advantage/.
Vasquez M, Gasparis AP on behalf of the Varithena® 017 Investigator Group (2016). A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2016 Mar 7. pii: 0268355516637300. [Epub ahead of print].
Vun SV, Rashid ST, Blest NC, Spark JI. Lower pain and faster treatment with mechanico-chemical endovenous ablation using ClariVein®. Phlebology. 2014:1-5.
Wisconsin Physicians Service Insurance Corporation Local Coverage Determination (LCD L34536: Treatment of Varicose Veins of the Lower Extremities. Last accessed 07/12/2017.
Witte ME, Zeebregts CJ, de Borst GJ, Reijnen MMPJ, Boersma D. Mechanochemical endovenous ablation of saphenous veins using the ClariVein: A systematic review. Phlebology. 2017 Jan 1:268355517702068. doi: 10.1177/0268355517702068. [Epub ahead of print].
Witte WE, Holewijn S, van Eekeren RR, de Vries JP, Zeebregts CJ, Reijnen MMPJ. Midterm outcome of mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency. J Endovasc Ther. 2016:1-7.