| Coverage Policy Manual | |
| Policy #: | 2013015 |
| Category: | Surgery |
| Initiated: | April 2013 |
| Last Review: | August 2023 |
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| Treatment of Varicose Veins/Venous Insufficiency | |
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| Description: |
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.
The venous system of the lower extremities consists of the superficial veins (this includes the greater and lesser saphenous and accessory, or duplicate, veins that travel in parallel with the greater and lesser saphenous veins), the deep system (popliteal and femoral veins), and perforator veins that cross through the fascia and connect the deep and superficial systems. One-way valves are present within all veins to direct the return of blood up the lower limb. Since venous pressure in the deep system is generally greater than that of the superficial system, valve incompetence at any level may lead to backflow (venous reflux) with pooling of blood in superficial veins. Varicose veins with visible varicosities may be the only sign of venous reflux, although itching, heaviness, tension, and pain may also occur. Chronic venous insufficiency secondary to venous reflux can lead to thrombophlebitis, leg ulcerations, and hemorrhage. The CEAP classification considers the clinical, etiologic, anatomic, and pathologic (CEAP) characteristics of venous insufficiency, ranging from class 0 (no visible sign of disease) to class 6 (active ulceration).
Treatment of venous reflux/venous insufficiency is aimed at reducing abnormal pressure transmission from the deep to the superficial veins. Conservative medical treatment consists of elevation of the extremities, graded compression, and wound care when indicated. Conventional surgical treatment consists of identifying and correcting the site of reflux by ligation of the incompetent junction followed by stripping of the vein to redirect venous flow through veins with intact valves. While most venous reflux is secondary to incompetent valves at the saphenofemoral or saphenopopliteal junctions, reflux may also occur at incompetent valves in the perforator veins or in the deep venous system. The competence of any single valve is not static and may be pressure-dependent. For example, accessory saphenous veins may have independent saphenofemoral or saphenopopliteal junctions that become incompetent when the greater or lesser saphenous veins are eliminated and blood flow is diverted through the accessory veins.
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that travel in parallel with the greater or lesser saphenous veins. Tributaries are veins that empty into a larger vein. Treatment of venous reflux typically includes the following:
Minimally invasive alternatives to ligation and stripping have been investigated. These include sclerotherapy, transilluminated-powered phlebotomy, and thermal ablation using cryotherapy, high frequency radiowaves (200–300 kHz), or laser energy.
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an irritant solution (either a detergent, osmotic solution, or chemical irritant), ultimately resulting in the occlusion of the vessel. The success of the treatment depends on accurate injection of the vessel, an adequate injectate volume and concentration of sclerosant, and compression. Historically, larger veins and very tortuous veins were not considered to be good candidates for sclerotherapy due to technical limitations. Technical improvements in sclerotherapy have included the routine use of Duplex ultrasound to target refluxing vessels, luminal compression of the vein with anesthetics, and a foam/sclerosant injectate in place of liquid sclerosant. Foam sclerosants are produced by forcibly mixing a gas (e.g., air or carbon dioxide) with a liquid sclerosant (e.g., polidocanol or sodium tetradecyl sulfate). The foam is produced at the time of treatment and is considered an off-label use. A proprietary microfoam sclerosant (Varisolve, BTG PLC, London) with a controlled density and more consistent bubble sizes is being developed in Europe.
Endovenous Mechanochemical Ablation
Endovenous mechanochemical ablation utilizes both sclerotherapy and mechanical damage to the lumen. Following ultrasound imaging, a disposable catheter with a motor drive is inserted into the distal end of the target vein and advanced to the saphenofemoral junction. As the catheter is pulled back, a wire rotates at 3,500 rpm within the lumen of the vein, abrading the lumen. At the same time, a liquid sclerosant (sodium tetradecyl sulphate) is infused near the rotating wire. It is proposed that mechanical ablation allows for better efficacy of the sclerosant, without the need for the tumescent anesthesia used in radiofrequency (RF) ablation or endovenous laser ablation (EVLT).
Thermal Ablation
Radiofrequency ablation is performed by means of a specially designed catheter inserted through a small incision in the distal medial thigh to within 1–2 cm of the saphenofemoral junction. The catheter is slowly withdrawn, closing the vein. Laser ablation is performed similarly; a laser fiber is introduced into the greater saphenous vein under ultrasound guidance; the laser is activated and slowly removed along the course of the saphenous vein. Cryoablation uses extreme cold to cause injury to the vessel. The objective of endovenous techniques is to cause injury to the vessel, causing retraction and subsequent fibrotic occlusion of the vein. Technical developments since thermal ablation procedures were initially introduced include the use of perivenous tumescent anesthesia, which allows successful treatment of veins larger than 12 mm in diameter and helps to protect adjacent tissue from thermal damage during treatment of the lesser saphenous vein.
Cyanoacrylate Adhesive
A cyanoacrylate adhesive is a clear, free-flowing liquid that polymerizes in the vessel via an anionic mechanism (ie, polymerizes into a solid material on contact with body fluids or tissue). The adhesive is gradually injected along the length of the vein in conjunction with ultrasound and manual compression. The acute coaptation halts blood flow through the vein until the implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the treated vein. Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of indications, including gastrointestinal bleeding, embolization of brain arteriovenous malformations, and surgical incisions or other skin wounds.
Transilluminated Powered Phlebectomy
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook phlebectomy. This procedure uses 2 instruments: an illuminator, which also provides irrigation, and a resector, which has an oscillating tip and can perform suction. Following removal of the saphenous vein, the illuminator is introduced via a small incision in the skin and tumescence solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity. The resector is then inserted under the skin from the opposite direction, and the oscillating tip is placed directly beneath the illuminated veins to fragment and loosen the veins from the supporting tissue. Irrigation from the illuminator is used to clear the vein fragments and blood through aspiration and additional drainage holes. The illuminator and resector tips may then be repositioned, thereby reducing the number of incisions needed when compared with stab avulsion or hook phlebectomy. It has been proposed that TIPP might result in decreased operative time, decreased complications such as bruising, and faster recovery compared to the established procedures.
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems. Incompetent perforating veins were originally addressed with an open surgical procedure, called the Linton procedure, which involved a long medial calf incision to expose all posterior, medial, and paramedial perforators. While this procedure was associated with healing of ulcers, it was largely abandoned due to a high incidence of wound complications. The Linton procedure was subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin flap to provide access to incompetent perforator veins in the lower part of the leg. The modified Linton procedure may be occasionally utilized for the closure of incompetent perforator veins that cannot be reached by less invasive procedures. Subfascial endoscopic perforator surgery (SEPS) is a less-invasive surgical procedure for treatment of incompetent perforators and has been reported since the mid-1980s. Guided by Duplex ultrasound scanning, small incisions are made in the skin, and the perforating veins are clipped or divided by endoscopic scissors. The operation can be performed as an outpatient procedure. Endovenous ablation of incompetent perforator veins with sclerotherapy and RF has also been reported.
Other
Deep vein valve replacement is being investigated.
Outcomes of interest for venous interventions include healing and recurrence, recannulation of the vein, and neovascularization. Recannulation (recanalization) is the restoration of the lumen of a vein after it has been occluded; this occurs more frequently following treatment with endovenous techniques. Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently following vein stripping. Direct comparisons of durability for endovenous and surgical procedures are complicated by these different mechanisms of recurrence. Relevant safety outcomes include the incidence of paresthesia, thermal skin injury, thrombus formation, thrombophlebitis, wound infection, and transient neurologic effects.
Regulatory Status
In 2013, Varithena™ (formerly known as Varisolve®; BTG Plc, London), a sclerosant microfoam made with a proprietary gas mix, was approved by FDA under a new drug application for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee.
The following devices were cleared for marketing by FDA through the 501(k) process for the endovenous treatment of superficial vein reflux:
The ClariVein® Infusion Catheter (Vascular Insights) received marketing clearance through the 510(k) process in 2008 (K071468). It is used for mechanochemical ablation. Predicate devices were listed as the Trellis® Infusion System (K013635) and the Slip-Cath® Infusion Catheter (K882796). The system includes an infusion catheter, motor drive, stopcock and syringe and is intended for the infusion of physician-specified agents in the peripheral vasculature. FDA product code: KRA.
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.
Coding
Mechanochemical ablation should be reported with the unlisted vascular surgery procedure code 37799.
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Policy/ Coverage: |
Effective June 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Greater or Lesser Saphenous Veins
Treatment of the greater or lesser saphenous veins by surgery (ligation and stripping) or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
Accessory Saphenous Veins
Treatment of accessory saphenous veins by surgery (ligation and stripping) or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy meets member benefit certificate primary coverage criteria of effectiveness for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
Symptomatic Varicose Tributaries
The following treatments meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a component of the treatment of symptomatic varicose tributaries when performed either at the same time or following prior covered treatment (surgical, radiofrequency or laser) of the saphenous veins (none of these techniques has been shown to be superior to another):
Perforator Veins
Surgical ligation (including subfascial endoscopic perforator surgery) or endovenous radiofrequency or laser ablation of incompetent perforator veins meets member benefit certificate primary coverage criteria of effectiveness as a treatment of leg ulcers associated with chronic venous insufficiency when the following conditions have been met:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Treatment of greater or lesser saphenous veins by surgery or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy that do not meet the criteria described above is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Treatment of accessory saphenous veins by surgery or endovenous radiofrequency or laser ablation that do not meet the criteria described above is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above is considered investigational. Investigational services are specific contract exclusios in most member benefit certificates of coverage.
Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Telangiectasia
Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Other
Techniques for conditions not specifically listed above do not meet member benefit certificate primary coverage criteria and are investigational for members with contracts without primary coverage criteria, including, but not limited to:
NOTE: Ultrasound guidance (CPT code 76942) used to guide treatment of varicose veins/venous insufficiency is considered an integral part of the main procedure and is included in the description of most codes used for the billing of the procedures performed for the treatment of varicose veins/venous insufficiency and therefore is not separately reimbursable.
Effective Prior To June 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Greater or Lesser Saphenous Veins
Treatment of the greater or lesser saphenous veins by surgery (ligation and stripping) or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
Accessory Saphenous Veins
Treatment of accessory saphenous veins by surgery (ligation and stripping) or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy meets member benefit certificate primary coverage criteria of effectiveness for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
Symptomatic Varicose Tributaries
The following treatments meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a component of the treatment of symptomatic varicose tributaries when performed either at the same time or following prior covered treatment (surgical, radiofrequency or laser) of the saphenous veins (none of these techniques has been shown to be superior to another):
Perforator Veins
Surgical ligation (including subfascial endoscopic perforator surgery) or endovenous radiofrequency or laser ablation of incompetent perforator veins meets member benefit certificate primary coverage criteria of effectiveness as a treatment of leg ulcers associated with chronic venous insufficiency when the following conditions have been met:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Treatment of greater or lesser saphenous veins by surgery or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy that do not meet the criteria described above is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Treatment of accessory saphenous veins by surgery or endovenous radiofrequency or laser ablation that do not meet the criteria described above is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above is considered investigational. Investigational services are specific contract exclusios in most member benefit certificates of coverage.
Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Telangiectasia
Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Other
Techniques for conditions not specifically listed above do not meet member benefit certificate primary coverage criteria and are investigational for members with contracts without primary coverage criteria, including, but not limited to:
NOTE; Ultrasound guidance (CPT code 76942) used to guide treatment of varicose veins/venous insufficiency is considered not medically necessary. Not medically necessary services are specific contract exclusions in most member benefit certificates.
Effective Prior to December 2018
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Greater or Lesser Saphenous Veins
Treatment of the greater or lesser saphenous veins by surgery (ligation and stripping) or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
Accessory Saphenous Veins
Treatment of accessory saphenous veins by surgery (ligation and stripping) or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy meets member benefit certificate primary coverage criteria of effectiveness for symptomatic varicose veins/venous insufficiency when the following criteria have been met:
Symptomatic Varicose Tributaries
The following treatments meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a component of the treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment (surgical, radiofrequency or laser) of the saphenous veins (none of these techniques has been shown to be superior to another):
Perforator Veins
Surgical ligation (including subfascial endoscopic perforator surgery) or endovenous radiofrequency or laser ablation of incompetent perforator veins meets member benefit certificate primary coverage criteria of effectiveness as a treatment of leg ulcers associated with chronic venous insufficiency when the following conditions have been met:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Treatment of greater or lesser saphenous veins by surgery or endovenous radiofrequency or laser ablation, or microfoam sclerotherapy that do not meet the criteria described above is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Treatment of accessory saphenous veins by surgery or endovenous radiofrequency or laser ablation that do not meet the criteria described above is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, treatment of symptomatic varicose tributaries when performed either at the same time or following prior treatment of saphenous veins using any other techniques than noted above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Telangiectasia
Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata is considered cosmetic. Cosmetic services are specific contract exclusions in most member benefit certificates of coverage. For contracts without this exclusion, cosmetic services do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes or are considered not medically necessary for members with contracts without primary coverage criteria.
Other
Techniques for conditions not specifically listed above do not meet member benefit certificate primary coverage criteria and are investigational for members with contracts without primary coverage criteria, including, but not limited to:
NOTE; Ultrasound guidance (CPT code 76942) used to guide treatment of varicose veins/venous insufficiency is considered not medically necessary. Not medically necessary services are specific contract exclusions in most member benefit certificates.
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| Rationale: |
Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com.
This policy was created in 2013 to address the various modalities for the treatment of varicose veins/venous insufficiency. Sclerotherapy, radiofrequency ablation and laser ablation for the treatment of varicose veins were previously handled in separate policies. The following is a summary of the identified literature through March 2013.
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized, controlled trials (RCTs), with 47 different comparisons (O’Meara, 2009). The review was updated in 2012, and included 48 RCTs with 59 different comparisons (O’Meara, 2012). Most of the RCTs were small. Objective measures of healing were the time to complete healing, the proportion of ulcers healed within the trial period (typically 12 weeks), the change in ulcer size, and the rate of change in ulcer size. Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than without. Findings suggested that multi- component systems (bandages or stockings) were more effective than single-component compression. In addition, multi-component systems containing an elastic bandage appeared more effective than those composed mainly of inelastic constituents. Although these meta-analyses did not include time to healing, studies included in the review reported that the mean time to ulcer healing was approximately 2 months, while the median time to healing in other reports was 3 to 5 months.
A Cochrane review on compression stockings for the initial treatment of varicose veins in patients without venous ulceration was published in 2011 (Shingler, 2011). Included in the review were 7 studies involving 356 participants with varicose veins without healed or active venous ulceration (CEAP [clinical, etiology, anatomy, pathophysiology] classification C2 to C4). Six of the studies compared different types or pressures of stockings. Subjectively, participants’ symptoms improved, but results were not compared with a control arm. Due primarily to inadequate reporting, the methodologic quality of the included trials was unclear. Meta-analyses were not performed due to inadequate reporting and suspected heterogeneity. The authors concluded that there is insufficient high-quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in patients without venous ulceration, or whether any type of stocking is superior to any other type.
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers with superficial vein surgery and conservative compression treatments but a reduction in ulcer recurrence rate with surgery (Howard, 2008; O’Donnell, 2008). In general, recurrence rates after ligation and stripping are estimated at around 20%. Jones and colleagues reported on the results of a study that randomized 100 patients with varicose veins to undergo either ligation alone or ligation in conjunction with stripping (Jones, 1996). At 1 year, reflux was detected in 9% of patients, rising to 26% at 2 years. Rutgers and Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation and stripping or ligation combined with sclerotherapy (Rutgers, 1994). At 2 years, Doppler ultrasound demonstrated reflux in approximately 10% of patients after ligation and stripping, increasing to 15% at 3 years.
A 2011 Cochrane review compared endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus ligation/stripping for saphenous vein varices (Nesbitt, 2011). Included in the review were 13 reports from 5 studies with a combined total of 450 patients. Many of the comparisons between endovenous ablation and ligation/stripping failed to reach statistical significance. The authors concluded that current evidence suggests that endovenous radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) are at least as effective as surgery in the treatment of great saphenous varicose veins. No randomized trials comparing sclerotherapy with ligation/stripping met the study inclusion criteria, and there were thus insufficient data to comment on ultrasound-guided sclerotherapy.
Endovenous Radiofrequency Ablation
In 2008, Luebke and colleagues reported a meta-analysis of 8 studies that included a total of 224 patients who underwent RFA and 204 patients who underwent stripping (Luebke, 2008). There was no significant difference between RFA and surgery in immediate or complete greater saphenous vein occlusion, incomplete greater saphenous vein closure, freedom from reflux, recurrent varicose veins, recanalization, or neovascularization between the 2 treatments. There were significant reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours, 1 week, and 3 weeks with RFA. Quality-of-life results, including return to normal activity and return to work, favored RF over surgery. The authors noted that rates of recanalization, retreatment, occlusion, and reflux may alter with longer follow-up and that further RCTs with longer follow-up are needed.
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical registry in 2005 (Merchant, 2005). Thirty-four centers (1,006 patients, 1,222 limbs) participated in the registry, with 12 centers contributing 5-year data (406 limbs). The registry included data on the treatment of 52 lesser saphenous veins and 16 accessory saphenous veins. Follow-up at 1 week showed a 97% anatomical success rate and a decrease in pain in 50% (from 85% to 30%) of patients. An additional 162 failures were identified over the 5 years of follow-up; 129 veins were found to have recanalization, and 33 limbs had reflux in the groin. Logistic regression analysis (risk factors of gender, age, body mass index [BMI), vein diameter, and catheter pullback speed) showed that BMI was associated with long-term failure. The rate of pull-back speed of the catheter during treatment was associated with failure to occlude or recanalization.
Endovenous Laser Ablation
A systematic review of EVLA versus surgery was published in 2009 (Hoggan, 2009). Fifty-nine studies were included, with 7 studies that directly compared EVLA and surgery. Randomized and nonrandomized studies directly comparing outcomes for EVLA or surgery were included for the assessment of safety or effectiveness, while case series with a minimum patient population of 100 were included for the assessment of safety alone. For all studies, it was calculated that 5,759 patients (6,702 limbs) were treated with EVLA and 6,395 patients (7,727 limbs) underwent surgery. Few differences were apparent between treatments with respect to clinical effectiveness outcomes, although long-term follow-up was lacking. Nonclinical effectiveness outcomes generally favored EVLA over surgery in the first 2 months after treatment. The authors concluded that while EVLA offers short-term benefits and appears to be as clinically effective as surgery up to 12 months after treatment, clinical trials with a minimum of 3 years of follow-up are required to establish the enduring effectiveness of EVLA. Large clinical trials published subsequent to the systematic review are described below.
The 2012 RELACS study was a practical design that randomized 400 patients to EVLA performed by a surgeon at one site or to ligation and stripping performed by a different surgeon at a second location (Rass, 2012). Fifty-four patients withdrew from the study after receiving the randomization result (from an independent site), due primarily to preference for the other treatment. At 2-year follow-up, there was no significant difference between the groups for clinically recurrent varicose veins, medical condition on the Homburg Varicose Vein Severity Score, or disease-related quality of life. Saphenofemoral reflux was detected by ultrasonography more frequently after EVLT (17.8% vs. 1.3%). This study will follow patients for 5 years. Another trial compared EVLA with ligation and stripping in 200 limbs (100 in each group) (Christenson, 2010). At 1-year follow-up, 98% of the limbs were reported to be free of symptoms. At 2-year follow-up, the EVLA group had 2 veins completely reopened and 5 partially reopened, which was significantly greater than in the ligation and stripping group.
In 2009 Theivacumar et al. reported 2-year follow-up from 118 consecutive patients treated with either EVLA (69 limbs) or ligation and stripping (n=60 limbs) (Theivacumar, 2009). Sixty-eight of the patients agreed to be randomized to treatment; the remainder declined randomization but received one of the 2 treatments and agreed to follow-up. The rationale for the selection of treatment in the nonrandomized population was not described. Rates of clinical recurrence (7%) were similar in the 2 treatment groups at 2 years. Recanalization of the residual greater saphenous vein, reflux in the accessory greater saphenous vein, and reflux in incompetent perforator veins accounted for the majority of cases of clinical recurrence (6%) in both groups. Neovascularization was observed in only 1% of limbs treated with endoluminal ablation and 18% of limbs treated with ligation and stripping (2% were clinically significant at 2 years). Early neovascularization has been associated with clinical recurrence at 5 years.
Rasmussen et al. randomized 121 patients (137 legs) to EVLA (n=69) or to ligation and stripping (n=68) (Rasmussen, 2010). The incidence of clinical recurrence was found to increase gradually from 6 months onward. At 2-year follow-up, outcomes were similar between the 2 groups. In the EVLA group, there were 3 (4%) technical failures, 18 (26%) clinical recurrences, 6 (8%) cases of reflux into the anterior accessory saphenous vein, 2 (3%) cases of reflux in the groin, and 7 (10%) cases of reflux in perforator veins. In the ligation and stripping group, there were 2 (3%) technical failures, 25 (37%) recurrences, 3 (4%) cases of reflux in the accessory vein, 3 (4%) cases of reflux in the groin, and 15 (22%) cases of reflux in perforator veins.
Literature on isolated treatment of the anterior accessory saphenous vein is limited. In a 2009 study, outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory saphenous vein were compared with 33 matched controls undergoing EVLA of the greater saphenous vein (Theivacumar, 2009). In 21 of the patients (64%) in the accessory saphenous vein group, there had been no previous treatment of the greater saphenous vein. At 12-month follow-up, there was no evidence of reflux in these patients, and the treated accessory saphenous vein was not visible with ultrasound. The Aberdeen Varicose Vein Symptom Severity Score had improved in both groups, with no significant difference between the 2 groups. Patient satisfaction scores were also similar.
Endovenous Cryoablation
Klem and colleagues reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose veins (Klem, 2009). The percentage of patients with greater saphenous vein remaining was 44% in the endovenous cryoablation group and 15% in the conventional stripping group. The Aberdeen Varicose Vein Questionnaire also showed better results for conventional stripping (score of 11.7) in comparison with cryoablation (score of 8.0). There were no differences between the groups in Short-Form-36 (SF-36) subscores, and neural damage was the same (12%) in both groups.
Disselhoff and colleagues reported 2 and 5 year outcomes from a randomized trial that compared cryostripping with EVLA (FDA, 2013; Todd, 2014). Included were 120 patients with symptomatic uncomplicated varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux. At 10 days after treatment, EVLA had better results than cryostripping with respect to pain score over the first 10 days (2.9 vs. 4.4), resumption of normal activity (75% vs. 45%) and induration (15% vs. 52%). At 2-year follow-up, freedom from recurrent incompetence was observed in 77% of patients after EVLA and 66% of patients after cryostripping (not significantly different). At 5 years, 36.7% of patients were lost to follow-up; freedom from incompetence and neovascularization was found in 62% of patients treated with EVLA and 51% of patients treated with cryostripping (not significantly different). Neovascularization was more common after cryostripping, but incompetent tributaries were more common after EVLA. There was no significant difference between groups in the Venous Clinical Severity Score or Aberdeen Varicose Vein Severity Score at either 2 or 5 years.
Sclerotherapy
A comprehensive systematic review of sclerotherapy commissioned and funded by the U.K.’s National Institute for Health and Clinical Excellence (NICE) in 2006 reviewed 67 studies, including 9 RCTs, 1 registry report, 8 nonrandomized comparative studies, 43 case series, and 6 case reports (NICE, 2006; Jia, 2007). The report concluded that sclerotherapy “appears to be efficacious in occluding incompetent veins, including both main trunk and minor vein disease, however its longer-term efficacy in terms of recurrence or new varicosities is less certain,” and that “Estimates were based mainly on data from nonrandomized studies with a high dropout rate and no details of methods of follow-up, and as such may be prone to attrition bias.” More recent randomized trials using ultrasound-guided foam sclerotherapy of the greater saphenous vein (with or without ligation) showed high variability in success rates between centers (ranging from 25% to 100%) and a decline in success rates from 85% at 3-week follow-up to 53% at 2 years. (22, 23) Other studies indicate efficacy rates ranging from 12% to 76% for liquid sclerosant and from 57% to 84% for foam sclerosant (Hamel-Desnos, 2009).
A systematic review from 2008 found that foam sclerotherapy of varicose veins is associated with a higher recurrence rate in patients with saphenofemoral incompetence compared to the rates of endovenous laser therapy or RF obliteration, while a 2009 systematic review suggested that outcomes from sclerotherapy are worse than those of surgery (ligation and stripping) for saphenous vein reflux (Luebke, 2008; Leopardi, 2009). Although long-term sequelae have not been reported, transient adverse effects have been found in up to 8% of patients, including visual disturbance, migraine, shortness of breath, dizziness, and numbness (Coleridge, 2009). Bubbles appear in the right heart between 9 and 59 seconds after injection, and emboli have been detected in the middle cerebral artery following sclerotherapy of saphenous trunks and varices (Colerdige, 2009). Deep venous occlusion after ultrasound-guided sclerotherapy has also been reported; risk was found to be greater when treating veins 5 mm in diameter or greater (odds ratio [OR]: 3.7) and injecting 10 mL or more of foamed sclerosant (OR: 3.6) (Milleret, 2013).
A 2012 study was a non-inferiority trial of foam sclerotherapy versus ligation and stripping in 430 patients (Shadid, 2012). Analysis was per protocol. Forty patients (17%) had repeat sclerotherapy. At 2-years, the probability of clinical recurrence was similar in the 2 groups (11.3% sclerotherapy vs. 9.0% ligation and stripping), although reflux was significantly more frequent in the sclerotherapy group (35% vs. 21%). Thrombophlebitis occurred in 7.4% of patients after sclerotherapy. There were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and pulmonary embolis) that occurred within 1 week of treatment.
Blaise et al. reported 3-year follow-up from a multicenter double-blind randomized trial (143 patients) that compared treatment of the greater saphenous vein with either 1% or 3% polidocanol foam (Blaise, 2010). Additional treatment with foam sclerotherapy was carried out at 6 weeks, 3 and 6 months if required to abolish persistent venous reflux. There were 49 additional injections in the 1% polidocanol group and 29 additional injections in the 3% group. At 3-year follow-up, venous reflux was observed in 21% of patients in the 1% group and 22% of patients in the 3% polidocanol group.
Mechanochemical Ablation
In 2012, Elias and Raines reported an industry-sponsored safety and efficacy study of the ClariVein® system (Elias, 2012). Thirty greater saphenous veins in 29 patients were treated with this device. Greater saphenous veins with diameters greater than 12 mm were excluded. In this series 77% of veins were CEAP class 2 with 7% in class 3 (varicose veins and edema) and 16% in class 4a (varicose veins with skin changes). At 6-month follow-up 1 vein had recanalized, for a primary closure rate of 96.7%. No pain during the procedure or adverse events were reported. Controlled studies with longer follow-up are needed.
There are a number of large randomized trials on endovenous ablation of the saphenous veins. Comparison with ligation and stripping at 2-year follow-up supports use of both RF and EVLT. Evidence suggests that ligation and stripping may lead to neovascularization, while thermal ablation may lead to recanalization. Controlled studies with longer follow-up are needed to determine the long-term efficacy of these treatments with greater certainty. Two randomized controlled trials suggest that cryotherapy is not as effective as available alternatives. For sclerotherapy, there is high variability in success rates of the procedure and reports of serious adverse events. There is insufficient evidence to permit conclusions regarding the efficacy and safety of mechanochemical ablation.
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the gold standard for the treatment of saphenofemoral incompetence based on improved long-term recurrence rates, with sclerotherapy used primarily as an adjunct to treat varicose tributaries. A 2006 Cochrane Review, based primarily on RCTs from the 1980s, concluded that, “The evidence supports the current place of sclerotherapy in modern clinical practice, which is usually limited to treatment of recurrent varicose veins following surgery and thread veins” (Tisi, 2006). Sclerotherapy and phlebectomy are considered appropriate in the absence of reflux of the saphenous system, e.g., post- or adjunctive treatment to other procedures such as surgery (Leopardi, 2009).
A small proportion of patients may present with tributary varicosities in the absence of saphenous reflux. For example, of 1,009 patients recruited for an RCT, 64 patients were found to have minor varicose veins without reflux, 34 of whom agreed to be randomized to sclerotherapy or conservative treatment (Michaels, 2006). At baseline, 92% had symptoms of heaviness, 69% had cosmetic concerns, 53% reported itching, and 30% reported relief of symptoms through the use of compression hosiery. At 1-year follow-up, there was an improvement in clinicians’ assessment of the anatomical extent of varicose veins, with 85% of patients in the sclerotherapy group improved compared to 29% of patients in the conservative-therapy group. Symptoms of aching were better or eliminated in 69% of the sclerotherapy group and 28% of the group treated with conservative therapy. Cosmetic concerns were improved in 85% of the sclerotherapy patients and 14% of controls.
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of the saphenous vein, as opposed to the varicose tributaries. In 2012, Yamaki et al. reported a prospective randomized controlled trial that compared visual foam sclerotherapy vs. ultrasound-guided foam sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose tributary veins (Yamaki, 2012). A total of 51 limbs in 48 patients were treated with ultrasound-guided foam sclerotherapy plus visual foam sclerotherapy of the varicose tributaries, and 52 limbs in 49 patients were treated with foam sclerotherapy alone. At 6-month follow-up, complete occlusion was found in 23 limbs (45.1%) treated with ultrasound-guided and visual-guided foam sclerotherapy and in 22 limbs (42.3%) treated with visual sclerotherapy alone. Reflux was absent in 30 limbs (58.8%) treated with ultrasound and visual guidance and in 37 (71.2%) treated with visual guidance alone (not significantly different). The authors note that for the treatment of tributary veins in clinical practice, most patients receive direct injection of foam without ultrasound guidance.
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery (Luebke, 2008). Results showed a significant advantage of TIPP over the conventional treatment for number of incisions, mean cosmetic score, and duration of the procedure. However, TIPP also increased the incidence of hematoma and resulted in worse mean pain scores. Included in the meta-analysis was a randomized clinical trial by Chetter et al. that compared TIPP (n=29) with a multiple stab incision procedure (n=33) (Chetter, 2006). A single surgeon performed all but 2 of the procedures, and there was no difference in operating time. Patients treated with TIPP had an average of 5 incisions, compared with 20 for the multiple stab procedure. However, blinded evaluation revealed that bruising or discoloration was higher for the TIPP group at both 1 and 6 weeks after surgery. At 6 weeks after surgery, patients in the TIPP group showed no improvement in pain (-2 points on the Burford pain scale), while patients in the multiple stab incision group had a significant improvement in pain score compared with presurgical baseline (-20 points). At 6 weeks after surgery, quality-of-life measures had improved in the multiple-stab incision group but not in the TIPP group. Thus, although TIPP had the advantage of fewer surgical incisions, in this single-center study, it was associated with a more prolonged recovery due to more extensive bruising, prolonged pain, and reduced early postoperative quality of life. The current literature does not show an advantage of TIPP over conventional treatment.
Evidence indicates that both sclerotherapy and TIPP are as effective as stab phlebectomy in eliminating varicose tributaries. However, there is limited evidence that TIPP is associated with more pain, bruising, discoloration, and a longer recovery.
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of incompetent perforator vein surgery (O’Donnell, 2008). These conclusions were based on 4 RCTs published since 2000 that compared superficial vein surgery with conservative therapy in advanced chronic venous insufficiency (CEAP category C5/6). The 4 trials included 2 level I (large subject population) and 2 level II (small subject population) studies. Two of the trials combined surgical treatment of the incompetent perforator veins with concurrent or prior treatment of the superficial saphenous veins; the other 2 treated the greater saphenous vein alone. The 2 randomized studies in which the greater saphenous vein alone was treated (including the ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative therapy (Barwell, 2004; Gohel, 2007). A 2011 community hospital-based multicenter, double-blind, randomized trial found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and incompetent perforators (Nelzen, 2011).
Treatment of the great saphenous vein alone has been reported to improve perforator function. For example, one study showed that reversal of perforator vein incompetence (41% of 68 previously incompetent perforators) was more common than new perforator vein incompetence (22% of 183 previously competent perforators) following superficial vein surgery (Blomgren, 2005). O’Donnell discusses additional (lower quality) evidence to suggest deep venous valvular involvement rather than incompetent perforators in venous insufficiency (O’Donnell, 2008). Thus, although incompetence of perforator veins is frequently cited as an important etiologic factor in the pathogenesis of venous ulcer, current evidence does not support the routine ligation or ablation of perforator veins.
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004, Tenbrook and colleagues published a review of the literature of SEPS, which included 19 case series and one randomized trial (Tenbrook, 2004). In total, the reviewed studies included 1,031 patients with 1,140 treated limbs. The authors concluded that SEPS was associated with excellent results in terms of ulcer healing and prevention of recurrence. However, the authors also noted that randomized trials are required to define the relative contributions of compression therapy, superficial venous surgery, and SEPS in the management of severe venous disease. A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that “Its [SEPS] use should not be employed routinely and could only be justified in patients with persistent ulceration thought to be of venous origin, and in whom any superficial reflux has already been ablated and post-thrombotic changes excluded” (Luebke, 2009). The authors also state that “introduction of less invasive techniques for perforator vein ablation, such as ultrasound-guided sclerotherapy or radiofrequency ablation, may diminish the role of SEPS in the future."
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided foam sclerotherapy, microincision phlebectomy, or thermal ablation using a new short RF catheter for the treatment of symptomatic residual perforator vein incompetence (Hirsch, 2008). Ablation of incompetent perforator veins with laser or RFA had been shown to be technically feasible, although no studies had been identified that showed an improvement in clinical outcomes (e.g., ulcer healing or recurrence) (Disselhoff, 2011; Disselfoff, 2011; NICE, 2006; Leopardi, 2009). The 2011 literature update identified one study of EVLA for perforating veins in 33 patients with a CEAP classification of 4 (skin changes), 5 (healed ulcer), or 6 (active ulcer) (Hissink, 2010). All incompetent saphenous trunks were treated simultaneously (63% of limbs). At 3-month follow-up, occlusion was achieved in 78% of the perforating veins. Five patients (15%) had active ulcers at baseline; 4 of the 5 ulcers had healed by 6 weeks after EVLA. Evidence regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited, and there is a risk of deep venous occlusion (Myers, 2008).
Summary
Although randomized, controlled trials with longer follow-up are needed to evaluate long-term durability, and repeat treatments may be required, evidence indicates that endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-term clinical outcomes (e.g., pain and return to work) in comparison with surgery. In contrast, results from a recent randomized, controlled trial of cryoablation indicate that this therapy is inferior to conventional stripping. Sclerotherapy as the sole treatment of saphenofemoral or saphenopopliteal reflux has not been demonstrated to be as effective as available alternatives, and there is insufficient evidence on mechanochemical ablation.
The literature indicates that sclerotherapy of tributaries following occlusion of the saphenofemoral or saphenopopliteal junction and saphenous veins may be considered medically necessary. Evidence is insufficient to evaluate the health benefit of sclerotherapy as a sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous veins. No studies have been identified that compare radiofrequency or laser ablation of tributary veins with standard procedures (microphlebectomy and/or sclerotherapy). Transilluminated powered phlebectomy is effective at removing varicosities; outcomes are comparable to available alternatives such as stab avulsion and hook phlebectomy.
The literature indicates that the routine ligation/ablation of incompetent perforator veins is not medically necessary for the treatment of varicose veins/venous insufficiency at the time of superficial vein procedures. However, when combined superficial vein procedures and compression therapy have failed to improve symptoms (i.e., ulcers), treatment of perforator vein reflux may be as beneficial as any alternative (e.g., deep vein valve replacement). Therefore, treatment of incompetent perforator veins may be considered medically necessary in this specific situation.
Comparative studies are needed to determine the most effective method of ligating/ablating incompetent perforator veins. SEPS has been shown to be as effective as the Linton procedure with a reduction in adverse events. Although only one case series has been identified showing an improvement in health outcomes, endovenous ablation with specialized laser or radiofrequency probes has been shown to effectively ablate incompetent perforator veins with a potential decrease in morbidity in comparison with surgical interventions. For sclerotherapy, concerns have been raised about the risk of deep vein occlusion, and evidence is currently insufficient to evaluate the safety or efficacy of this treatment for incompetent perforator veins.
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum published clinical practice guidelines in 2011 (Gloviczki, 2011). The recommendations are rated as strong=1 or weak=2, based on a level of evidence that is either high quality=A, moderate quality=B, or low quality=C, and include the following:
Compression therapy for venous ulcerations and varicose veins: Compression therapy is recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B, strong recommendation, moderate quality evidence). To decrease the recurrence of venous ulcers, they recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A, strong recommendation, high-quality evidence). They recommend use of compression therapy for patients with symptomatic varicose veins (GRADE 2C, weak recommendation, low-quality evidence) but recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation (GRADE 1B, strong recommendation, moderate quality evidence).
Treatment of the incompetent great saphenous vein: Endovenous thermal ablation (radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B, strong recommendation, moderate quality evidence) or high ligation and stripping (GRADE 1B, strong recommendation, moderate quality evidence) due to reduced convalescence and less pain and morbidity. Cryostripping is a technique that is new in the United States, and it has not been fully evaluated.
Varicose tributaries: Phlebectomy or sclerotherapy are recommended to treat varicose tributaries (GRADE 1B, strong recommendation, moderate quality evidence). Transilluminated powered phlebectomy using lower oscillation speeds and extended tumescence is an alternative to traditional phlebectomy (GRADE 2C, weak recommendation, low-quality evidence).
Perforating vein incompetence: Selective treatment of perforating vein incompetence in patients with simple varicose veins is not recommended (CEAP class C2; GRADE 1B, strong recommendation, moderate quality evidence), but there is a GRADE 2B recommendation (weak recommendation, moderate quality evidence) for treatment of pathologic perforating veins (outward flow of >500 ms duration, with a diameter of >3.5 mm) located underneath healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery, sclerotherapy, or thermal ablations (GRADE 1C, weak recommendation, low-quality evidence).
In 2009, the American College of Radiology published appropriateness criteria for the treatment of lower-extremity venous insufficiency (Silberzweig, 2009). The following is a summary of treatment options:
Compression Stockings: Graduated compression stockings are routinely used to control venous insufficiency symptoms. They provide external support that can constrict dilated veins and restore competence to incompetent valves. Compression stockings are particularly helpful during pregnancy, and they are frequently used following venous ablation treatment.
Surgery: Great saphenous vein (GSV) stripping with branch ligation had historically been the primary treatment option for venous insufficiency. The GSV is ligated near the groin. Ligation alone can preserve the vein for subsequent harvesting in case of arterial bypass; however, ligation alone has proven unsatisfactory for preventing the occurrence of reflux, so it is often supplemented by vein stripping. Ambulatory phlebectomy is primarily used to treat surface varicose veins. It can be performed as an adjunct to endovenous ablation or stripping. This procedure involves making tiny punctures or incisions through which the varicose veins are removed. Other surgical methods to treat venous insufficiency have been described, including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by incompetent valves of the deep veins.
Injection Sclerotherapy: Injection sclerotherapy is a common treatment for telangiectasias and can be used to treat smaller varicose veins. The sclerotherapy solution can be in liquid form or can be injected as "foam" (mixed with a gas such as air). Sclerotherapy has not been shown to have long-term effectiveness for large veins, such as the GSV.
Endovenous Ablation: Endovenous ablation is a minimally invasive alternative to surgery. It is a percutaneous procedure that can be used to treat the GSV, small saphenous vein (SSV), and other superficial veins. Endovenous ablation uses RFA or laser energy (EVLA) applied inside the vein to cause occlusion. Small prospective trials comparing EVLA and RFA with conventional surgery in patients with GSV reflux have shown favorable results. One study demonstrated that EVLA is comparable to surgery in abolishing reflux and improving disease-specific quality of life and that it allows earlier return to normal activity. A recent systematic literature review comparing the safety and efficacy of EVLA and surgery involving saphenous ligation and stripping as treatments for varicose veins showed few differences in clinical effectiveness outcomes, although long-term follow-up was lacking. A meta-analysis suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity varicose veins. After 3 years, the estimated pooled success rates for treatment were 78% for surgical stripping, 77% for foam sclerotherapy, 84% for RFA, and 94% for laser therapy.
Adjunctive Treatments: Adjunctive treatments may be required to help eliminate venous insufficiency. Patients with venous insufficiency and associated venous occlusion or stenosis of the common iliac vein (e.g., May-Thurner syndrome) may require venous recanalization with angioplasty and stenting to achieve a patent conduit for venous return. Patients with pelvic venous insufficiency may require percutaneous embolization of the ovarian veins. Patients with deep venous thrombosis are typically treated with anticoagulation to reduce the risk of thrombus propagation, embolization, and post-thrombotic syndrome. One study suggested that endovenous ablation of the saphenous vein can be considered as a viable treatment alternative in patients with venous insufficiency and previous deep venous thrombosis.
Complications: All forms of lower-extremity venous insufficiency treatment are subject to recurrence. Additional risks of vein ligation and stripping surgery include: anesthetic risk, scarring, pain, bleeding, deep venous injury or thrombosis, nerve injury, and infection. Complications of the endovenous ablation procedure include bruising, swelling, transient numbness, and rarely deep venous thrombosis.
In 2003, the Society of Interventional Radiography (SIR) published a position statement (SIR, 2003) that considered endovenous ablation therapy, using either laser or radiofrequency devices under imaging guidance and monitoring, an effective treatment of extremity venous reflux and varicose veins under the following conditions:
2. A trial of conservative nonoperative treatment has failed. This would include mild exercise avoidance of prolonged immobility, periodic elevation of legs, and compressive stockings. And
3. The patient's anatomy is amenable to endovenous ablation.
In a joint statement published in 2007, the American Venous Forum and SIR recommended reporting standards for endovenous ablation for the treatment of venous insufficiency (Kundu, 2007). The document recommended that reporting in clinical studies should include the symptoms of venous disease, history of disease and prior treatment, the presence of major comorbidities, and any exclusion criteria. It was noted that potential candidates for endovenous ablation may include patients with reflux in an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch of the greater or smaller saphenous veins such as the anterior thigh circumflex vein, posterior thigh circumflex vein, or anterior accessory greater saphenous vein. The presence of reflux in these veins is important to document using duplex ultrasound imaging, and the ultrasound criteria used to define reflux should be indicated. It was also stated that in current practice, most vascular laboratories consider the presence of venous flow reversal for greater than 0.5 to 1.0 second with proximal compression, Valsalva maneuver, or distal compression and release to represent pathologic reflux.
In 2003 and 2004, the U.K.’s National Institute for Health and Clinical Excellence (NICE) published guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of the long saphenous vein (NICE, 2003; NICE, 2004). NICE concluded that the evidence on the safety and efficacy appeared adequate to support the use of these procedures provided that the normal arrangements were in place for consent, audit, and clinical governance. The evidence on efficacy at this time was limited to case series with limited follow-up. Clinicians were encouraged to collect longer-term follow up data.
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in 2009 (NICE, 2009). The guidance states that “…current evidence on ultrasound-guided foam sclerotherapy for varicose veins shows that it is efficacious in the short term. The evidence on safety includes systemic side effects in some patients. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit.” In addition, evidence of long-term efficacy is limited, and clinicians are encouraged to collect longer-term follow-up data.
NICE issued guidance on endovenous mechanochemical ablation in 2013, concluding that current evidence on the safety and efficacy of endovenous mechanochemical ablation for varicose veins is inadequate in quantity and quality (NICE, 2013). Therefore this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
2014 Update
A literature search conducted through February 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Endovenous Laser Ablation
In the 2013 MAGNA trial, 223 consecutive patients (240 legs) with great saphenous vein reflux were randomized to EVLA, ligation and stripping, or foam sclerotherapy (Biemans, 2013). At 1-year follow-up, the anatomic success rates were similar between EVLA and stripping (88.5% and 88.2%, respectively), which were superior to foam sclerotherapy (72.2%). Ten percent of the stripping group showed neovascularization. Health-related quality of life improved in all groups. The CEAP classification improved in all groups with no significant difference between the groups. Transient adverse events were reported in 11 patients after stripping, 7 after EVLA, and 5 after sclerotherapy.
Rasmussen et al randomized 121 patients (137 legs) to EVLA (n=69) or to ligation and stripping (n=68) (Rasmussen, 2010). The incidence of clinical recurrence was found to increase gradually from 6 months onward. At 2-year follow-up, outcomes were similar between the 2 groups. In the EVLA group, there were 3 (4%) technical failures, 18 (26%) clinical recurrences, 6 (8%) cases of reflux into the anterior accessory saphenous vein, 2 (3%) cases of reflux in the groin, and 7 (10%) cases of reflux in perforator veins. In the ligation and stripping group, there were 2 (3%) technical failures, 25 (37%) recurrences, 3 (4%) cases of reflux in the accessory vein, 3 (4%) cases of reflux in the groin, and 15 (22%) cases of reflux in perforator veins. Ninety-eight percent of patients were available for 5-year follow-up (Rasmussen, 2013). There was a trend toward greater recanalization following EVLA, but this was not associated with increased clinical recurrence (EVLA, 36%; stripping, 35%) or in the percentage of reoperations (EVLA, 38.6%; stripping, 37.7%).
Sclerotherapy
In the 2013 MAGNA trial (described above), 223 consecutive patients (240 legs) with great saphenous vein reflux were randomized to EVLA, ligation and stripping, or foam sclerotherapy (Biemans, 2013). At 1-year follow-up, the anatomic success rate of foam sclerotherapy (72.2%) was inferior to both EVLA and stripping (88.5% and 88.2%, respectively). Twenty-one patients in the sclerotherapy group had partial occlusion with reflux, though the clinical complaint was completely relieved. A 2012 study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430 patients. (31) Analysis was per protocol. Forty patients (17%) had repeat sclerotherapy. At 2 years, the probability of clinical recurrence was similar in the 2 groups (11.3% sclerotherapy vs 9.0% ligation and stripping), although reflux was significantly more frequent in the sclerotherapy group (35% vs 21%). Thrombophlebitis occurred in 7.4% of patients after sclerotherapy. There were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and pulmonary emboli) that occurred within 1 week of treatment.
The VANISH-2 study is an FDA-regulated 5-year randomized, double-blind multicenter trial that compares 0.5% or 1.0% polidocanol microfoam versus either endovenous placebo or a subtherapeutic dose of polidocanol foam(Todd, 2013). Patients with unsuccessful or incomplete treatment at the primary outcome assessment (week 8) could receive open-label foam sclerotherapy. At the 8-week assessment, there was elimination of reflux and/or occlusion of the previously incompetent vein in 85.6% of the combined 0.5% and 1.0% groups, 59.6% of patients in the 0.125% “subtherapeutic” group, and 1.8% of the placebo group. The improvement in the venous clinical severity score was significantly better in the 0.5% and 1.0% groups (-5.10) compared with placebo (-1.52), but was not reported for the 0.125% group. This is 1 of 2 pivotal Phase 3 studies undertaken to obtain marketing approval from FDA. Longer-term evaluation is in progress.
Mechanochemical Ablation
No RCT results were identified with mechanochemical ablation (MCA). Several prospective series and cohort studies have been reported. One study compared postoperative pain and early quality of life in 68 patients treated with either RFA or MCA of great saphenous veins (van Eekeren, 2013). Patients who did not want to be treated with MCA were offered treatment with RFA; this study design could potentially lead to selection bias. There was no significant difference between the groups in procedural pain. Compared with RFA, patients treated with MCA had a 14.3-mm reduction in pain measured on a 100-mm visual analog scale (VAS) measured over the first 3 postoperative days (6.2 vs 20.5) and a 13.8-mm reduction in pain (4.8 vs 18.6 mm) over the first 2 weeks. Patients treated with ClariVein also had an earlier return to normal activities (1.2 vs 2.4 days) and return to work (3.3 vs 5.6 days). There was a similar improvement in quality of life for the 2 groups when measured at 6 weeks.
A prospective multicenter series evaluated the efficacy of MCA of the great saphenous vein in 126 patients in a community setting (Bishawi, 2013). Veins were selected that were greater than 4 mm and less than 12 mm in diameter, with an average diameter of 7.3 mm. Closure rates were 100% at 1 week, 98% at 3 months, and 94% at 6 months. The venous clinical severity score decreased from a score of approximately 9 pretreatment to about 3 at 6 months.
Another prospective series evaluated MCA of the small saphenous vein in 50 consecutive patients (Boersma, 2013). Only patients with a vein diameter of 2.5 to 11 mm were included. The dose of sclerosant was increased after the first 15 patients. At the 6-week assessment, all treated veins were occluded and at 1-year follow-up, 94% remained occluded. The median VAS score for pain during the procedure was 2 of 10. There were no major complications. Controlled studies with a greater number of subjects and longer follow-up are needed.
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with RFA began in 2012 in Europe (Mueller, 2013). This trial will provide needed data on the comparative effectiveness of MCA, measured at a longer duration and in a larger population.
Other Treatments
Steam injection and microwave ablation for endovenous treatment of varicose veins were reported outside of the U.S (Milleret, 2013; Yang, 2013) These procedures have not been approved or cleared for marketing by FDA.
2015 Update
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Comparison of Endovenous Ablation with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus ligation/stripping for saphenous vein varices (Nesbitt, 2014). Included in the review were 13 randomized studies with a combined total of 3081 patients. The overall quality of the evidence was moderate. There was no significant difference between sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio (OR) 1.74, p=0.06) or for symptomatic recurrence (OR 1.28). For endovenous laser ablation (EVLA) versus surgery, there were no significant differences between the treatment groups for clinician noted or symptomatic recurrence, or for recanalization. Neovascularization and technical failure were reduced in the laser group (OR 0.05, p <0.0001 and OR 0.29, p=0.0009, respectively). For endovenous radiofrequency ablation (RFA) versus surgery, there were no significant differences between the groups in clinician noted recurrence, recanalization, neovascularization, or technical failure. The authors concluded that sclerotherapy, EVLA, and RFA are at least as effective as surgery in the treatment of great saphenous varicose veins.
Brittenden and colleagues reported a multicenter randomized trial that compared foam sclerotherapy, EVLA, and surgical treatment in 798 patients (Brittenden, 2014). The study was funded by the United Kingdom’s Health Technology Assessment Programme of the National Institute for Health Research. Veins greater than 15 mm were excluded from the study. At the 6-week follow-up visit, patients who were assigned to treatment with foam or laser had the option of treatment with foam for any residual varicosities; this was performed in 38% of patients in the foam group and 31% of patients in the EVLA group. At 6 months following treatment, mean disease-specific quality of life was slightly worse after sclerotherapy than after surgery (p=0.006), and there were more residual varicose veins, although the differences were small. Disease specific quality of life was similar for the laser and surgery groups. The frequency of procedural complications was similar for the foam sclerotherapy (6%) and surgery (7%) groups, but was lower in the laser group (1%). The rate of complications at 6 months (primarily lumpiness and skin staining), was highest for the sclerotherapy group.
El-Sheikha and colleagues reported a small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for varicose veins (El-Shelkha, 2014). Quality of life and clinical severity scores were similar between the groups by 1 year, with 16 of 24 patients (67%) in the sequential phlebectomy group receiving a secondary intervention.
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Kaplan-Meier 5 year follow-up analysis showed obliteration or absence of the great saphenous vein in 85% of patients who underwent conventional surgery and 77% of patients who underwent EVLA (not significantly different) (van der Velden, 2015). Grade I neovascularization was higher in the conventional surgery group (27% vs 3%, p<0.001), while grade II neovascularization was similar in the 2 groups (17% vs 13%).
Obliteration or absence of the greater saphenous vein was observed in only 23% of patients treated with sclerotherapy compared to 85% of patients who underwent conventional surgery and 77% of patients who underwent EVLA. Thirty-two percent of legs treated initially with sclerotherapy required 1 or more reinterventions during follow-up compared with 10% in the conventional surgery and EVLA groups. However, clinically relevant grade II neovascularization was higher in the conventional surgery and EVLA groups (17% and 13%, respectively), compared with the sclerotherapy group (4%). EuroQol-5D scores improved equally in all groups.
Subfascial Endoscopic Perforator Surgery
In 2015, Van Gent and colleagues reported 10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for venous leg ulcers (van Gent, 2015). Patients (196 legs) returned to the clinic on an annual basis and analysis was conducted with the last-observation carried-forward. The primary outcome, incidence ulcer-free, was significantly higher in the surgical group compared with the conservative treatment group (58.9% vs 39.6%, p=0.007). The number of incompetent perforator veins at follow-up was a risk factor for not being ulcer free (OR=18.5, p<0.001). The relatively high rate of recurrence of the surgically treated group may be due to limited/no stripping of the superficial veins at the time of SEPS.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed below:
Ongoing
NTR4613, Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial); an industry-sponsored or cosponsored trial; planned enrollment 160; completion date April 2020.
In 2015, NICE published a technology assessment on the clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation, and surgery for varicose veins (Brittenden, 2015). Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for varicose veins (described previously). Five-year trial results are currently being evaluated.
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2016 Cochrane review compared endovenous ablation with laser or RFA to surgical repair for short saphenous veins with reflux at the sapheno-popliteal junction (Paravastu, 2016). Three RCTs were identified that compared EVLA with surgery. There was moderate quality evidence that recanalization or persistence of reflux at six weeks occurred less frequently after EVLA than surgery (OR=0.07; 95% confidence interval [CI], 0.02 to 0.22), and low quality evidence that recurrence of reflux was less after EVLA at 1 year (OR=0.24; 95%
CI, 0.07 to 0.77).
The 2012 RELACS study randomized 400 patients to EVLA follow-up on rate at 5 years was 81% (Rass, 2015). Same-site recurrences were more frequent in the EVLA group (18% with EVLA vs 5% with surgery, p=0.002), but different-site recurrences were more frequent in the surgically treated group (50% with surgery vs 31% with EVLA, p=0.002). Overall, there was no significant difference in recurrence rates between the 2 groups. There were also no significant differences between the groups in disease severity or quality of life at 5 years.
In 2017, Lane and colleagues reported results of a multicenter RCT that evaluated efficacy and adverse effects of mechanochemical ablation (MOCA) compared to RFA of varicose veins (Lane, 2017). A total of 170 patients were randomized to MOCA or to RFA. Maximum visual analog scale (VAS) pain scores during the procedure were significantly lower in the MOCA group (median, 15 mm out of 100) compared to RFA (median, 3 mm; p=0.003). Average VAS pain scores during the procedure were also significantly lower in the MOCA group (median, 10 mm) compared to the RFA group (median, 19.5 mm; p=0.003). Occlusion rates, clinical severity scores, disease-specific, and generic QOL scores were similar between the groups at 1 and 6 months. Only 71% of patients were available for follow-up at 6-months, limiting the evaluation of closure rates at this time point.
2018 Update
This policy is being updated with a literature search through July 2018 to specifically address the treatment of varicose veins by endovenous ablation by transcatheter delivery of a chemical adhesive (e.g., cyanoacrylate). There was no new information identified that would prompt a change in the coverage intent. The key information is summarized below.
CYANOACRYLATE ADHESIVE
The VenaSeal pivotal study (VeClose), a multicenter noninferiority trial with 222 patients, compared VenaSeal with RFA for the treatment of venous reflux (FDA, 2018; Morrison, 2015). The primary end point (the proportion of patients with complete closure of the target great saphenous vein at 3 months measured by ultrasound) was noninferior to RFA, with a 99% closure rate for VenaSeal compared with 96% for RFA. The secondary end point (intraoperative pain) was similar for both groups (2.2 on a 10-point scale for VenaSeal vs 2.4 for RFA, p=0.11). Ecchymosis at day 3 was significantly lower in the cyanoacrylate group; 67.6% of patients treated with cyanoacrylate had no ecchymosis compared with 48.2% of patients following RFA (p<0.01). Scores on the AVVQ and Venous Clinical Severity Score improved to a similar extent in both groups. The mean time to return to work in a prospective cohort of 50 patients reported by Gibson and Ferris (2017) was 0.2 days (Gibson, 2017).
Eroglu et al reported closure rates of 94.1% at 30 months in a prospective cohort of 159 patients (Eroglu, 2017). Thirty-three-month follow-up was reported by Zierau for 467 (58.7%) of 795 veins treated at 1 institution in Germany (Zierau, 2017). An inflammatory reddening of the skin was observed at 1 week posttreatment in 11.7% of cases. No permanent skin responses were observed. Of the 467 veins reexamined, the sealing rate was 97.7%. This series had a high loss to follow-up.
Section Summary: Cyanoacrylate Adhesive
Evidence assessing cyanoacrylate adhesive for the treatment of varicose veins and venous insufficiency includes a multicenter noninferiority trial with 3 months of follow-up and case series with longer follow-up. The short-term efficacy of cyanoacrylate adhesive has been shown to be noninferior to RFA at 3 months. Longer follow-up in trials with a larger number of patients is needed to determine the durability of this treatment.
SCLEROTHERAPY
Physician-Compounded Sclerotherapy
A noninferiority trial by Shadid et al compared foam sclerotherapy with ligation and stripping in 430 patients (Shadid, 2012).The analysis was per protocol. Forty (17%) patients had repeat sclerotherapy. At 2 years, the probability of clinical recurrence was similar in both groups (11.3% sclerotherapy vs 9.0% ligation and stripping), although reflux was significantly more frequent in the sclerotherapy group (35% vs 21%). Thrombophlebitis occurred in 7.4% of patients after sclerotherapy. Two serious adverse events in the sclerotherapy group (deep venous thrombosis, pulmonary emboli) occurred within 1 week of treatment.
Microfoam Sclerotherapy
Vasquez et al reported on a double-blinded RCT that evaluated the addition of polidocanol microfoam to endovenous thermal ablation (Vasquez, 2017). A total of 117 patients who were candidates for both endovenous thermal ablation and treatment of visible varicosities received endovenous thermal ablation plus placebo (n=38) or polidocanol 0.5% (n=39) or 1% (n=40). At 8-week follow-up, physician-blinded vein appearance was significantly better with the combined polidocanol groups (p=0.001), but the improvement in patient ratings was not statistically significant. At 6-month follow-up, the percentages of patients who achieved a clinically meaningful change were significantly higher in both physician (70.9% vs 42.1%, p=0.001) and patient (67% vs 50%, p=0.034) ratings. The proportion of patients who received additional treatment for residual varicosities between week 8 and month 6 was modestly reduced (13.9% for the polidocanol vs 23.7% for placebo, p=0.037).
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Treatment of Saphenous Veins: Sclerotherapy
Vahaaho et al (2018) published a study looking at the 5-year follow-up of patients with symptomatic great saphenous vein (GSV) insufficiency (Vahaaho, 2018). Between 2008 and 2010, 166 individuals were randomized to receive open surgery, EVLA, or ultrasound-guided foam sclerotherapy. The GSV occlusion rate was 96% (95% CI: 91-100%) for open surgery, 89% (95% CI: 82-98%) for EVLA, and 51% (95% CI: 38-64%) for ultrasound-guided foam sclerotherapy (p<0.001). For patients with no additional treatment during follow-up, occlusion rates for open surgery, EVLA, and ultrasound-guided foam sclerotherapy were 96%, 89%, and 41%, respectively. The study was limited by the lack of blinding and by non-standardized foam application.
Treatment of Saphenous Veins: Mechanochemical Ablation
Vahaaho et al reported an RCT that compared MOCA with endovenous thermal ablation (EVLA or RFA) (Vahaaho, 2019). Liquid sclerosant at a concentration of 1.5% was used. Out of 132 patients enrolled, 7 patients were later excluded and 117 (88.6%) attended the 1-year follow-up evaluation. Occlusion of the great saphenous vein was observed in 45 of 55 (82%) of the MOCA group compared to 100% of the EVLA and RFA groups (p=0.002). Another randomized trial reported interim results of a dose-finding study, finding greater closure with use of polidocanol 2% or 3% (liquid) than with polidocanol 1% (microfoam) (Lam, 2016). Therefore, it is uncertain whether the concentration of sclerosant in the study by Vahaaho et al was optimal.
Treatment of Saphenous Veins: Cyanoacrylate Adhesive
The VenaSeal pivotal study (VeClose), a multicenter noninferiority trial with 222 patients, compared VenaSeal with RFA for the treatment of venous reflux (Gibson, 2017; Eroglu, 2017). The pivotal registration study for the VeClose study and follow-up through 36 months have been published (Gibson, 2017; Eroglu, 2017; Klem 2009; Morrison, 2018). The primary endpoint (the proportion of patients with complete closure of the target GSV at 3 months measured by ultrasound) was noninferior to RFA, with a 99% closure rate for VenaSeal compared with 96% for RFA. The secondary endpoint (intraoperative pain) was similar for both groups (2.2 on a 10-point scale for VenaSeal vs 2.4 for RFA, p=0.11). Ecchymosis at day 3 was significantly lower in the cyanoacrylate group; 67.6% of patients treated with cyanoacrylate had no ecchymosis compared with 48.2% of patients following RFA (p<0.01). Scores on the AVVQ and Venous Clinical Severity Score improved to a similar extent in both groups. The mean time to return to work in a prospective cohort of 50 patients reported by Gibson and Ferris (2017) was 0.2 days (Zierau, 2015).
For the CAC and RFA groups, the complete occlusion rates were 97.2% and 97.0%. Freedom from recanalization was also similar between the two groups (p=0.08) (Klem, 2009). Twenty-four month results were reported by Gibson et al (2018), which included 171 patients (87 from CAC and 84 from RFA) (Disselhoff, 2011). Thirty-six month results were reported by Morrison et al (2019), with follow-up on 146 (66%) patients (72 from CAC and 74 from RFA) (Morrison, 2018). Loss to follow-up was similar in the two groups. The complete closure rates for CAC and RFA were 94.4% and 91.9% (p=0.005 for non-inferiority), respectively. Recanalization-free survival through 36 months was not statistically different for the 2 groups. No significant device- or procedure-related adverse events were reported for either group.
VariClose CAC was compared with RFA and EVLA by Eroglu and Yasim in an RCT with 525 patients (Eroglu, 2018). Periprocedural outcomes showed a shorter intervention time, less pain, and shorter return to work with CAC compared to endovenous thermal ablation. There was no significant difference in occlusion rates between the three treatments at 6, 12, and 24 month follow-up.
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