Medical Policy: 02.01.54
Original Effective Date: August 2014
Reviewed: May 2021
Revised: May 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
This policy addresses miscellaneous treatments for varicose veins/venous insufficiency that may be considered not medically necessary or investigational.
The venous system of the lower extremities is separated into two main systems: the deep venous and the superficial venous system. The two systems are connected by perforator veins. The deep venous system comprises the popliteal and femoral veins; the superficial venous system comprises the great saphenous (GSV) and small saphenous (SSV) veins (formerly called the short or lesser saphenous vein). The GSV generally measures 3–4 mm in diameter in the upper thigh; the GSV meets the femoral vein at the saphenofemoral junction (SFJ). The SSV is not usually larger than 3 mm in diameter and connects with the deep veins at the saphenopopliteal junction (SPJ) in the knee area. The accessory saphenous vein (ASV) arises from the GSV and is considered a GSV tributary. Anatomically the ASV originates at the distal thigh, courses upwards outside the saphenous compartment parallel to the GSV, and drains into the femoral vein, GSV or tributary above or below the SFJ. Perforator veins are veins of the lower extremity that drain from the superficial veins to the deep veins. Varicose tributaries are veins that empty into a larger vein.
GSV reflux is the most common source of chronic venous insufficiency in up to 70% of individuals, followed by the SSV in 18- 20% and AASV lest commonly in 10%. Incompetence of the superficial venous system typically results from failure of valves at the SFJ and the SPJ with resulting pressure that is worse at the more distal area of the vein. Incompetence of the perforating veins also leads to increased pressure in the superficial venous system due to the pump mechanism of the calf.
Varicose veins vary in size from 3–10 mm, on average. Symptoms that have been associated with varicose veins of the lower extremities result from inadequate emptying of the vein (i.e., venous insufficiency) and include pain, cramping, aching, burning, throbbing, swelling and the feeling of heaviness or fatigue in the leg. Typically, symptoms are exacerbated by standing and warm weather. Saphenous varicose veins can ultimately result in intractable ulcerations and recurrent bleeding. Patients with larger varicosities (e.g., varicose veins greater than 3 mm in diameter) are more prone to thrombophlebitis and other complications than those with smaller varicosities. Chronic cellulitis may also be associated with varicosities.
Varicose veins of the upper extremity are rare and there are few reports in the published, peer-reviewed medical literature dealing with the management of upper extremity varicosities. Varicose veins may develop during pregnancy. Treatment is not medically necessary as most varicosities will spontaneously resolve within 4–6 months after delivery.
Telangiectases are permanently dilated blood vessels, also called spider veins that create fine red or blue lines on the skin. They are similar to varicose veins but are limited to the dermis and are not usually more than 3 mm in diameter. They are not typically associated with symptoms, and treatment is generally considered cosmetic in nature and not medically necessary (see medical policy 10.01.02 Cosmetic and Reconstructive Services).
The diagnosis of chronic venous disease is suggested by the presence of typical symptoms (leg pain, fatigue, heaviness) and physical examination findings. Venous duplex ultrasound examination confirms the diagnosis demonstrating the presence of venous reflux (>500 milliseconds for superficial or perforator veins; >1000 milliseconds for deep veins). The majority of symptomatic patients should undergo venous duplex ultrasonography to evaluate the nature and extent of venous reflux, which impacts the choice of treatment. Any combination of superficial, perforator or deep venous reflux, or deep venous obstruction can be present.
The CEAP classification is a method commonly used to document the severity of chronic venous disease and is based on clinical presentation (C), etiology (E), anatomy (A), and pathophysiology (P). Each classification can be further defined as follows:
|C - Clinical Classification||C0: No visible or palpable signs of venous disease C1: Telangiectases or reticular veins C2: Varicose veins C3: Edema C4a: Pigmentation and/or eczema C4b: Lipodermatosclerosis and/or atrophie blanche C5: Healed venous ulcer C6: Active venous ulcer CS: Symptoms, including ache, pain, tightness, skin irritation, heaviness, muscle cramps, as well as other complaints attributable to venous dysfunction CA: Asymptomatic|
|E - Etiology||Ec: Congenital
Ep: Primary Es: Secondary (post-thrombotic) En: No venous etiology identified
|A - Anatomy||As: Superficial veins Ap: Perforator veins Ad: Deep veins An: No venous location identified|
|P - Pathophysiology||Pr: Reflux Po: Obstruction Pr.o: Reflux and obstruction Pn: No venous pathophysiology identifiable|
Classification of disease starts with an initial assessment and is often not entirely completed until after surgery and histopathologic assessment. As a result, it is recommended that CEAP classification value be followed by the date of examination. Venous disease can be reclassified at any given time.
Conservative medical practices that may be used in the management of varicose veins include leg elevation, analgesia for symptom relief and avoidance of prolonged periods of standing. Compression therapy, the use of custom-fit compression stockings with pressure gradients, a mainstay of initial/conservative management, is routinely attempted prior to stripping, ligation, sclerotherapy or other, more invasive procedures. The amount of compression required for treatment of stasis dermatitis or ulceration is between 35 and 40 mm Hg, for varicose veins, for mild edema and leg fatigue the recommended pressure is 20 to 30 mm Hg. When conservative measures fail, treatment options rely on identifying and correcting the site of reflux and on redirecting the flow of blood through veins with properly functioning valves. No single method of treatment is universally employed in the literature; the intervention selected is generally dependent upon the competency of deep and perforating veins, and the site and degree of reflux. Surgery is commonly used to treat mainstem varicose veins.
Initial treatment may be referred to as primary treatment and secondary treatment may be referred to as retreatment. Many patients require a combination of techniques to correct symptoms associated with venous insufficiency, most of which can be performed in a single treatment session.
The following are miscellaneous treatments that may be utilized in the treatment of varicose veins/venous insufficiency:
Coil embolization, also known as coil occlusion, involves the use of a coil combined with a sclerosant to occlude the vein and is under investigation for treatment of lower extremity varicose veins. It is a technique generally reserved for larger diameter veins such as perforating veins; the coil is curled up into the vein and may involve the use of more than one coil. Evidence in the peer-reviewed published literature evaluating this method of treatment for lower extremity varicosities is very limited, additional clinical trials are necessary to develop strong conclusions regarding safety and efficacy. The evidence is insufficient in determining this technology improves net health outcome.
Cryoablation uses extreme cold to cause injury to the vessel. Cryostripping of the GSV has been suggested as an alternative approach to traditional ligation and stripping. During this procedure, a cryoprobe is passed through the GSV, the probe freeze attaches to the GSV and stripping is performed by pulling back the probe. Theoretically cryosurgery requires less time, has fewer complications and results in less hospital day. Results of cryotherapy procedures for treatment of varicose veins in the published scientific literature are mixed and do not lend strong support to improved clinical outcomes when compared to more conventional methods of varicose vein treatment. Further studies are needed to demonstrate safety, efficacy and the clinical utility of cryostripping. The evidence is insufficient in determining this technology improves net health outcomes.
Sclerotherapy is a non-surgical procedure used to eradicate varicose veins and/or improve the appearance of the leg. This involves injection of a sclerosant/foam directly into the vein resulting in changes to the lining of the vein wall. The vein is then considered sclerosed or thrombosed and no longer able to serve as a conduit for venous blood flow.
Echosclerotherapy utilizes duplex ultrasound to guide the injection of the sclerosing solution and to enhance the precision of saphenous vein sclerotherapy. The use of duplex-guided ultrasound for sclerotherapy of varicose veins of the lower extremities has not been shown to definitively increase the effectiveness or safety of this procedure. There is very little published medical literature on the use of echosclerotherapy, and no large long-term outcomes have been reported.
Minimally invasive methods for treatment of varicose veins continue to evolve. One method under current investigation is the endomechanical ablative approach to varicose vein treatment utilizing a percutaneous infusion catheter. The procedure is also referred to as mechanical occlusion chemically assisted ablation (MOCA), mechanic-chemical endovenous ablation (MCEA), and mechanically enhanced endovenous chemical ablation (MEECA).The approach involves the use of a special catheter (ClariVein) which combines two modalities of treatment for varicose veins: endovenous mechanical vein destruction with a rotating wire and the simultaneous infusion of an FDA approved liquid sclerosant, sodium tetradecyl sulfate to enhance venous occlusion. This mechanical-chemical ablative modality (endomechanical ablative approach) is described as minimally invasive and purported to accomplish great saphenous vein occlusion without the use of tumescent anesthesia.
Evidence in the published peer-reviewed medical literature evaluating endomechanical ablative approaches using rotating catheter is in the form few randomized controlled trials. Evidence in the peer-reviewed published scientific literature supporting long-term safety and efficacy of endomechanical ablative approaches to treatment of varicose veins is currently lacking. Randomized controlled trials comparing MOCA anatomical success to endothermal ablation are few. Evidence lends support to improved quality of life scores and clinical success in the short to mid-term, however anatomic success (occlusion rate) has been shown to deteriorate at one- to- three-year follow-up; additional well-designed studies are needed to support the long- term efficacy of this approach. The evidence is insufficient in determining this technology improves net health outcomes.
The KAVS procedure [catheter-assisted vein sclerotherapy] procedure involves an intravascular catheter with a balloon at the distal end to temporarily block the blood flow to that segment of the vein being targeted for sclerotherapy; this may also be referred to as endovenous catheter directed chemical ablation with balloon isolation. Evidence evaluating the safety and efficacy of endovenous catheter-directed chemical ablation in conjunction with balloon isolation as a treatment of varicose veins has not been published in the peer-reviewed literature. The evidence is insufficient in determining this technology improves net health outcomes.
VenoSeal Closure System uses cyanoacrylate embolization (CAE) and does not require tumescent anesthesia; a cyanoacrylate adhesive is injected into the vein via a catheter inserted through the skin under ultrasound, the vein is compressed, and the adhesive material changes into a solid to seal the varicose vein.
In 2020, Morrison et. al. published 60 - month results for 89 subjects; 47 from the cyanoacrylate embolization (CAE) group, 33 from the radiofrequency ablation (RFA) group, in addition to 9 roll-in CAE subjects. At 60 months CAE continued to demonstrate noninferiority to RFA, both CAE and RFA were effective in achieving complete target vein closure with no serious long-term device or procedure related adverse events. The primary author noted that all of his subjects had cyanoacrylate still visible at 60 months, suggesting it was a permanent implant. This study is limited by the lack of blinding as noted by the authors and the small number of subjects available at the final five- year outcome.
Evidence in the published peer-reviewed medical literature evaluating cyanoacrylate adhesive embolization (VenaSeal) includes randomized controlled trials (RCTs) and systematic reviews. Although there is a growing body of evidence evaluating cyanoacrylate adhesive embolization (VenaSeal) in the peer-reviewed literature at present there is insufficient evidence in the literature to firmly establish long-term safety and efficacy of cyanoacrylate adhesive (VenaSeal) for treatment of varicose veins. Outcomes extending beyond 36 months are limited and although the adhesive in theory breaks down over time, in at least one clinical trial it remained present at five years post procedure. Uncertainty remains regarding the comparative effectiveness of the VenaSeal System with other endovenous techniques due to the lack of well-designed comparative trials. Additional well-designed RCTs consisting of large sample populations, with long term outcomes that consistently demonstrate anatomic and clinical success are needed to firmly establish safety and efficacy. The evidence is insufficient in determining this technology improves net health outcomes.
Transilluminated Powered Phlebectomy (TIPP), which is similar to ambulatory phlebectomy, is another minimally invasive alternative to standard surgery for the treatment of symptomatic varicosities. Also known as the TriVex procedure, TIPP involves endoscopic resection and ablation of the superficial varicosity.
Subcutaneous transillumination and tumescent anesthesia help visualize and locate the varicosity, while subcutaneous vein ablation is performed using a powered resector to obliterate the vein. Tumescent anesthesia involves the infusion of large amounts of saline and lidocaine to reduce hemorrhage and of epinephrine to delay absorption of the lidocaine. During this procedure, the veins are marked with a marker, and a bright light is introduced into the leg through a small incision (2–3 cm) to enhance visualization of the veins. The power vein resector is then inserted to cut and remove the vein through suction.
Proponents of this method assert the illuminating light allows quicker and more accurate removal of the vein, leading to a more effective yet less traumatic procedure. TIPP is intended for patients who are suitable candidates for conventional ambulatory phlebectomy and may also be used as an adjunctive method to other varicose vein treatments (e.g., ligation and stripping). A reported advantage of TIPP is the need for fewer incisions and that cosmetic outcomes do not appear to be superior to conventional ligation/excision techniques.
Evidence evaluating TIPP for the treatment of varicose veins is primarily in the form of published reviews, few comparative trials (few involving randomized groups) and both retrospective and prospective case series involving small populations and evaluating short-term outcomes. Overall evidence in the published, peer-reviewed, scientific literature does not lead to strong conclusions that TIPP results in clinical outcomes (e.g., improved pain, less varicose vein recurrence) that are as good as treatment with standard conventional methods (i.e., hook phlebectomy). Furthermore, long-term safety and efficacy of the procedure has not been adequately demonstrated. The evidence is insufficient in determining this technology improves net health outcomes.
In 2015, the VenaSeal Closure System (Sapheon, part of Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (P140018) process for the permanent closure of clinically significant venous reflux through endovascular embolization with coaptation. The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent. FDA product code: PJQ.
In 2008, the ClariVein Infusion Catheter (Vascular Insights) was approved by the U.S. Food and Drug Administration (FDA) through the 510(k) process for mechanochemical ablation.
In 2005, a modified Erbe Erbokryo cryosurgical unit (Erbe USA) was approved by the U.S. Food and Drug Administration (FDA) through the 510(k) process. A variety of clinical indications are listed, including cryostripping of varicose veins of the lower limbs.
In 2005, the KAVS catheter was approved by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.
In 2003, the Trivex system (InaVein), a device for transilluminated powered phlebectomy, was cleared by the FDA through the 510(k) process for ambulatory phlebectomy procedures for the resection and ablation of varicose veins.
See related medical policy
Echosclerotherapy is considered not medically necessary for the treatment of varicose veins, because ultrasound-monitored or duplex-guided techniques for sclerotherapy injectable liquid or microfoam followed by compression of varicose veins i.e., echosclerotherapy has not been shown to definitively increase the effectiveness or safety of this procedure.
The following varicose vein treatments are considered investigational, because the evidence is insufficient to determine this technology improves net health outcomes (this list may not be all-inclusive):
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