Br J Surg. Mechanochemical endovenous ablation of saphenous veins using the ClariVein: a systematic review. J Vasc Surg Venous Lymphat Disord. Vein anatomy clarified in position statement. Br J Surg. Removed requirement for medication from medically necessary criteria. The use of specific product names is illustrative only. GRADE 1B, We recommend (non-visible) symptomatic tributary veins be treated by ultrasound guided liquid sclerotherapy or foam chemical ablation. Eklöf B, Rutherford RB, Bergan JJ, et al. However, there is a lack of clinical evidence to sufficiently demonstrate the clinical efficacy for vessels other than the saphenous vein. Key recommendations included: O’Donnell and colleagues (2014) published clinical practice guidelines for the management of venous leg ulcers. MPTAC review. Michaels JA, Brazier JE, Campbell WB, et al. Controlled studies have shown that sclerotherapy/echosclerotherapy of the underlying refluxing great or small saphenous veins is associated with a higher rate of recurrence compared to ligation and stripping (Belcaro, 2003). Updated Scope, Rationale and References sections. A total of 225 subjects had 295 GSVs treated with RFA. Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Liu ZX, Guo PM, Zhang LL, et al. 0000002340 00000 n 2006; 31(1):93-100. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. 2017; 36(3):281-288. Results of duplex ultrasound and other clinical measures supported the findings. A systematic review evaluated the ClariVein’s anatomical, technical and clinical success by analyzing pooled data from 13 studies comprising 1521 veins (GSV and SSV). Conservative treatment consisted of lifestyle changes (that is, exercise, management of weight and diet, leg elevation), and the use of compression hosiery. In a randomized study of 25 individuals, those receiving sclerosant reported a higher obliteration rate compared with those receiving normal saline at 12 weeks follow-up. 2019; 27(4):352-358. The level of available evidence to support the evaluation or treatment was stated to be of high (A), medium (B), or low or very low (C) quality. Updated Rationale and References sections. Eroglu E, Yasim A. Phlebology. Duplication of the great saphenous vein: a definition problem and implications for therapy. %PDF-1.4 %���� Five-year results from the prospective European multicenter cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Phlebology. 2020; 8(3):472-481. Vascular. The procedure takes less than half an hour on average and is considered a minimally invasive office procedure. Endovenous laser ablation of the saphenous vein utilizes a small laser fiber that is inserted through a small incision in the skin into the vein. Available data indicated that 3 of 65 subjects (5%) in the surgical group and 53 of 107 (50%) subjects in the conservative treatment group self-reported dissatisfaction of their initial treatment. When services are Cosmetic and Not Medically Necessary: Injections of sclerosant for spider veins (telangiectasia); limb or trunk, Unlisted special dermatological service or procedure [when specified as tunable dye or pulsed dye laser treatment]. J Vasc Surg Venous Lymphat Disord. A total of 92.4% of the treated limbs were reported to be pain free at the 5-year follow-up visit. The medical record should reflect that these veins are incompetent, and note their size, presence or absence of tortuosity, and depth relationship to the skin, i.e. 2018; 378:2105-2114. Recurrent varicose veins were observed in 24 and 25 legs during the 5 years in the laser and stripping groups, respectively. Catheter ablation: A technique involving the application of either radiofrequency or laser energy through an endovenous catheter for the purpose of ablating varicose vein tissue of the GSV or SSV; this does not include the “closure” or ablation of a vein using the injection of a sclerosing agent through a hollow catheter. Only 3 of these 20 RCTS (Morrison, 2015, Morrison, 2017, Gibson, 2018, described above) looked at cyanoacrylate adhesion and then only in comparison to RFA. Darwood RJ, Theivacumar N, Dellagrammaticas D, et al. J Cardiovasc Surg. d0 ?�� 2017; 39:267-275. J Am Acad Dermatol. Forty subjects (17%) had repeat UGFS. References updated. Wallace T, El-Sheikha J, Nandhra S, et al. Due to large incompatibilities between trials and different time point measurements for outcomes, the evidence is lacking in robustness. Further noted, was: For RFA and EVLA a straight segment of GSV of approximately 15-20 cm immediately distal to the saphenofemoral junction, as well as a GSV diameter larger than 3 mm at the intended cannulation site (at the knee), were needed to ensure suitability. A Cochrane review (Nesbitt, 2014) compared endovenous ablation (radiofrequency and laser) and foam sclerotherapy to ligation and stripping for GSV varices. Varicose veins: Treatment. Quality of life outcomes were also similar between treatment groups. The evidence regarding this techniques, in particular the study published by Belcaro and colleagues (2003), suffers from flaws in study design, including a failure to address specific information in regard to participant selection criteria, no description of the randomization process, and a failure to include appropriate comparator groups, including standard surgical treatment consisting of vein stripping and ligation. A randomized trial of cryo stripping versus conventional stripping of the great saphenous vein. Of the 114 legs with recurrent GSV reflux disease, 83 (73%) were considered suitable to receive endovenous therapy. Updated Coding section with 10/01/2009 ICD-9 changes; removed ICD-9 diagnosis code 453.8 (no longer applicable). Venous insufficiency: An abnormal circulatory condition marked by decreased return of venous blood from the legs to the trunk of the body. Tributary vein: A superficial vein branch that flows into larger veins. N Engl J Med. Comparisons of Ablation and Sclerotherapy to Surgical Ligation and Stripping. Therefore, these techniques are considered primarily cosmetic in nature. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. Available at: Vasquez MA, Rabe E, McLafferty RB, et al. endstream endobj 22 0 obj <> endobj 23 0 obj <> endobj 24 0 obj <>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>> endobj 25 0 obj <> endobj 26 0 obj <> endobj 27 0 obj <> endobj 28 0 obj <> endobj 29 0 obj [/ICCBased 36 0 R] endobj 30 0 obj <> endobj 31 0 obj <> endobj 32 0 obj <>stream We recommend compression as the primary therapeutic modality for healing venous ulcers (GRADE 1B). Lifestyle changes (weight loss, exercise, periodic limb elevation, rehabilitation of the ankle joint, avoidance of a standing position and a sitting position with lowered limbs). Lurie F, Passman M, Meisner M, et al. 50385 1644.66 9/15/2017 8. This was addressed in one small study of 18 participants (Bush, 2007) and a case report of 2 individuals (Theivacumar, 2007). J Vasc Surg Venous Lymphat Disord. 50430 549.44000000000005 9/15/2017 3. 50386 1644.66 9/15/2017 8. Br J Surg. During follow-up at 2-12 months, recanalization of coil-embolized veins occurred in 9 of the 12 initially occluded veins. Outcome assessments occurred at baseline, 6 weeks and 6 months following treatment. Consensus for sclerotherapy. 2020; 35(2):84-91. 158 Likes, 3 Comments - Kelly Groover (@_kellyy_marie) on Instagram: âLast weekend staffing as a pharmacy resident is bitter sweet. Ovalı C, Sevin MB. Veins carry deoxygenated and nutrient depleted blood back to the heart and lungs. J Vasc Surg 2004; 39(3):583-589. 2009; 16(4):500-505. In 2020, Kolluri and colleagues conducted a network meta-analysis of RCTs comparing 6-month outcomes reported in 20 heterogeneous RCTs evaluating cyanoacrylate adhesion, EVLA, RFA, mechanochemical ablation, sclerotherapy and surgery for the management of chronic venous insufficiency. Sclerotherapy as the sole treatment of symptomatic varicose tributaries of the GSV is not indicated in the presence of saphenofemoral or saphenopopliteal junctional reflux. 50365. Preliminary results. McDonagh B, Huntley DE, Rosenfeld R, et al. Risk of venous thromboembolism following surgical treatment of superficial venous incompetence. When used in conjunction with a balloon catheter (for example, KAVS procedure). Theivacumar NS, Darwood RJ, Gough MJ. These averages included physicians whose practice patterns deviated significantly from the mean with 3.3% of beneficiaries undergoing 6 to 10 ablations, and 0.3% undergoing 11 or more ablations (Mann, 2019). Ecchymosis at day 3 was significantly lower in the VenaSeal group; 67.6% of those treated with cyanoacrylate had no ecchymosis compared with 48.2% of individuals treated with RFA (p<0.01). Lim SY, Tan JX, D'Cruz RT, et al. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. 2014; 371(13):1218-1227. Chwala and colleagues (2015) reported that therapeutic management of chronic venous disease can be based on conservative (medical) or invasive methods. In 2013, Varithena microfoam (polidocanol injectable foam) was FDA approved under a new drug application as a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the GSV system above and below the knee (Varithena prescribing information, 2016). Bishawi M, Bernstein R, Boter M, et al. However, their tolerance may be problematic, especially in the summer. 2019; 7(2):210-216. Individual response to each injection can vary and it may require more than one injection to obliterate a vessel. Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. Saphenous vein: A vein that serves as the principal blood vessel returning blood from the surface of the leg back to the trunk. Medical Policy & Technology Assessment Committee (MPTAC) review. Perspect Vasc Surg Endovasc Ther. Phlebology. The authors concluded, “comprehensive follow-up for other methods to 5 years is required to establish the optimal treatment for varicose veins.”. Eur J Vasc Endovasc Surg. In summary, they concluded that this procedure requires randomized controlled studies (RCTs) and long-term follow-up to properly assess health outcomes. Acute infections at puncture sites (infection should be treated first). Phlebology. Bellam Premnath K, Joy B, Raghavendra VA, et al. This causes the formerly small veins located just below the skin to become engorged with blood. In the surgical arm of the study, subjects received the same lifestyle advice but also underwent surgical treatment. Subfascial: Below the fascia; fascia is a strong connective tissue that performs a number of functions, including surrounding and providing structural support within the body. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery. An anterior accessory vein (AASV) is often mistaken for a duplication of the GSV, but the AASV is usually smaller and does not drain the same cutaneous territory as the GSV. Wang JC, Li Y, Li GY, et al. Endoluminal Radiofrequency Ablation (VNUS Closure, now known as the Venefit Procedure) System: Also known as radiofrequency endovenous occlusion, endoluminal RF ablation is typically performed by using a thin catheter inserted into the saphenous vein through a small opening in the skin. 2019; 28(1):6-14. Recommendations/suggestions (2A or better) made by the American Vein and Lymphatic Society consist of the following: Treatment of Circumflex Veins and Other Non Truncal Veins. 2015; 24(1):5-14. Int Angiol. J Vasc Surg. Casana R, Tolva VS, Odero A, et a. The clinical, etiology, anatomy, pathological (CEAP) classification is to be used for patients with CVD (GRADE 1A) and the revised Venous Clinical Severity Score is to be used to assess treatment outcome (GRADE 1B). accessible or not accessible by phlebectomy. Endoluminal RF ablation of the saphenous vein is based on the principle of treating reflux disease by control of the point of reflux and isolation of the refluxing saphenous vein from circulation. Scores on the Aberdeen Varicose Vein Questionnaire (AAVQ) were significantly better among recipients of laser ablation or surgery compared to those who received therapy with foam sclerotherapy (p<0.00 for both comparisons). 2019; 7(3):344-348. 2009; 49(2):403-409. At 3 months’ follow-up, there were no complications reported and the GSV remained occluded in all cases. Government Agency, Medical Society and Other Authoritative Publications: ClariVeinClosure ProcedureCoil EmbolizaitonCOMPASSEndoluminal CryoablationEndosaphenous Radiofrequency or Laser Ablation for Primary Venous InsufficiencyEVLTLaser Ablation for Primary Venous InsufficiencyMechanochemical AblationMOCAOne-Shot ScleroembolizationPhotoDermPhotothermal sclerosisPrimary Venous InsufficiencyRadiofrequency Ablation for Primary Venous InsufficiencySpider VeinsSubfascial Endoscopic Perforating Vein Surgery (SEPS)Telangiectatic Dermal VeinsTrans-Illuminated Powered Phlebectomy (TIPP)TRIVEX SystemVaricose VeinsVasculiteVein CoilingVeinLaseVenefitVarithenaVNUS Closure Catheter Systems. Study limitations include lack of blinding and limited follow-up of 2 years. 50380. Introduction of destructive agent into peripheral vein, open approach. Anti-embolism hose (also called elastic stockings or compression stockings): A type of stocking worn to prevent the formation of blood clots in the legs (thromboses); assisting in the return flow of the blood to the heart, and prevention of pooling in the veins; there are three support grades of prescription hose; mild to severe support (15-20, 20-30, 30-40 mmHg) which are generally used to assist with a medical condition and light support (8-15 mmHg) that may be used as a preventive measure. J Vasc Surg Venous Lymphat Disord. The frequency of procedure related complications was lower in the laser group (1%) than in the surgery group (p<0.001); but similar in the foam group (6%) and the surgery group (7%). A comparison of concomitant tributary laser ablation and foam sclerotherapy in patients undergoing truncal endovenous laser ablation for lower limb varicose veins. Phlebology. Surgery consisted of proximal ligation and stripping (of only the GSV) and concurrent phlebectomies. [Product Information], West Conshohocken, PA Biocompatibles Inc. June 2016. A total of 328 (73%) of the legs were considered suitable for at least one of the endovenous procedures. Treatment of varicose veins normalize venous hemodynamics and remove visible varices in order to relieve symptoms, prevent recurrence and minimize the complications (Pavlović, 2015). 2020; 8(4):505-525. The 2020 appropriate use criteria for chronic lower extremity venous disease of the American Venous Forum, the Society for Vascular Surgery, the American Vein and Lymphatic Society, and the Society of Interventional Radiology. No long-term device- or procedure-related serious adverse events occurred in either group between the 36- and 60-month follow-ups. Applicable to Commercial HMO members in California: When a medical policy states a procedure or treatment is investigational, PMGs should not approve or deny the request. Vascular. MPTAC review. The ablations were successful and without complications. Five subjects were lost to follow-up. PhotoDerm, VeinLase and Vasculite are laser devices primarily used in treating telangiectatic and reticular veins and other skin related applications. Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomized controlled trial. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. VenaSeal Closure System. Participants were randomized to receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam 1.0% or placebo. All RCT’s were independently reviewed and 11 fulfilled the predefined criteria. 2018; 6(4):477-484. We recommend patients should be evaluated using the CEAP classification and the Venous Clinical Severity Score (VCSS). 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