Blue Advantage Administrators of Arkansas Coverage Policy for Walmart

Coverage Policy#:	761
Category:	Surgery
Initiated:	January 2010
Last Review:	February 12, 2025
Last Revision:	February 12, 2025

BlueAdvantage National Accounts
Coverage Policy for Participants and Beneficiaries enrolled in Walmart Associates' Health and Welfare Medical Plan
(Developed by BlueAdvantage Administrators and Adopted by the Walmart Plan as Plan Coverage Criteria)

Treatment of Varicose Veins/Venous Insufficiency

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:

1. Identification by preoperative Doppler ultrasonography of the valvular incompetence;

2. Control of the most proximal point of reflux, traditionally by suture ligation of the incompetent saphenofemoral or saphenopopliteal junction;

3. Removal of the superficial vein from circulation, for example by stripping of the greater and/or lesser saphenous veins;

4. Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab avulsion (phlebectomy) or injection sclerotherapy.

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. Varithena™ (previously known as Varisolve, BTG Plc, London) is a proprietary microfoam sclerosant that is dispersed from a canister with a controlled density and more consistent bubble size.

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

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 to seal 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.

Coding

There is no specific CPT code for transilluminated powered phlebectomy. Providers might elect to use CPT codes describing stab phlebectomy (37765 or 37766) or unlisted vascular surgery procedure (37799).

Mechanochemical ablation should be reported with the unlisted vascular surgery procedure code 37799.

There is no specific CPT for microfoam sclerotherapy. Providers might elect to use CPT codes describing sclerotherapy (36468-36471) or the unlisted vascular surgery procedure code 37799. Use of codes 36475-36476 would be inappropriate as the procedure is not ablation therapy.

Policy/
Coverage:

GREATER OR LESSOR SAPHENOUS VEINS

Treatment of the greater or lesser saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, or microfoam sclerotherapy may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:

There is demonstrated saphenous reflux as shown by duplex demonstrating > 500 msec of reverse flow and CEAP [Clinical, Etiology, Anatomy, Pathophysiology] class C2 or greater; AND

2. There is documentation of one or more of the following indications:

Ulceration secondary to venous stasis; OR
Recurrent superficial thrombophlebitis OR
Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity; OR
Persistent pain, swelling, itching, burning, or other symptoms are associated with saphenous reflux, AND the symptoms significantly interfere with activities of daily living, AND conservative management including compression therapy for at least 3 months has not improved the symptoms.

Treatment of greater or lesser saphenous veins by surgery, endovenous radiofrequency or laser ablation, or microfoam sclerotherapy that do not meet the criteria described above is considered cosmetic and not medically necessary.

ACCESSORY SAPHENOUS VEINS

Treatment of accessory saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation, or microfoam sclerotherapy may be considered medically necessary for symptomatic varicose veins/venous insufficiency when the following criteria have been met:

Incompetence of the accessory saphenous vein is isolated, OR the great or small saphenous veins had been previously eliminated (at least 3 months); AND

2. There is demonstrated accessory saphenous reflux as shown by duplex demonstrating > 500 msec of reverse flow; AND

3. There is documentation of one or more of the following indications:

Ulceration secondary to venous stasis; OR
Recurrent superficial thrombophlebitis; OR
Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity; OR
Persistent pain, swelling, itching, burning, or other symptoms are associated with saphenous reflux, AND the symptoms significantly interfere with activities of daily living, AND conservative management including compression therapy for at least 3 months has not improved the symptoms.

Treatment of accessory saphenous veins by surgery or endovenous radiofrequency or laser ablation, microfoam sclerotherapy, that do not meet the criteria described above is considered cosmetic and not medically necessary.

SYMPTOMATIC VARICOSE TRIBUTARIES

The following treatments are considered medically necessary as a component of the treatment of symptomatic varicose tributaries when performed either at the same time or following prior medically necessary treatment (surgical, radiofrequency or laser) of the saphenous veins (none of these techniques has been shown to be superior to another):

Stab avulsion
Hook phlebectomy
Sclerotherapy
Transilluminated powered phlebectomy

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.

PERFORATOR VEINS

Surgical ligation (including subfascial endoscopic perforator surgery) or endovenous radiofrequency or laser ablation of incompetent perforator veins may be considered medically necessary as a treatment of leg ulcers associated with chronic venous insufficiency when the following conditions have been met:

There is demonstrated perforator reflux; AND
The superficial saphenous veins (great, small, or accessory saphenous and symptomatic varicose tributaries) have been previously eliminated; AND
Ulcers have not resolved following combined superficial vein treatment and compression therapy for at least 3 months; AND
The venous insufficiency is not secondary to deep venous thromboembolism.

Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is not medically necessary.

TELANGIECTASIA

Treatment of telangiectasia such as spider veins, angiomata, and hemangiomata is considered cosmetic and not medically necessary.

OTHER

Techniques for conditions not specifically listed above are investigational, including, but not limited to:

Sclerotherapy techniques, other than microfoam sclerotherapy, of great, small, or accessory saphenous veins
Sclerotherapy of perforator veins
Sclerotherapy of isolated tributary veins without prior or concurrent treatment of saphenous veins
Stab avulsion, hook phlebectomy, or transilluminated powered phlebectomy of perforator, great or small saphenous, or accessory saphenous veins
Endovenous radiofrequency or laser ablation of tributary veins
Endovenous cryoablation of any vein
Mechanochemical ablation of any vein
Cyanoacrylate adhesive of any vein

Investigational and not medically necessary services are Plan exclusions.

Policy Guidelines:

The standard classification of venous disease is the CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) classification system. The following is the Clinical portion of the CEAP (Lurie et al, 2020)

Clinical Classification

C0 No visible or palpable signs of venous disease

C1 Telangiectasies or reticular veins

C2 Varicose veins

C2r Recurrent varicose veins

C3 Edema

C4 Changes in skin and subcutaneous tissue secondary to Chronic Venous Disease.

C4a Pigmentation and eczema

C4b Lipodermatosclerosis and atrophie blanche

C4c Corona phlebectatica

C5 Healed venous ulcer

C6 Active venous ulcer

S Symptomatic (Symptoms including ache, pain, tightness, skin irritation, heaviness, muscle cramps, as well as other complaints attributable to venous dysfunction)

A Asymptomatic

It should be noted that the bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of the saphenous vein, as opposed to the varicose tributaries. When ultrasound guidance is used to guide sclerotherapy of the varicose tributaries, it would be considered either not medically necessary or incidental to the injection procedure.

An accessory saphenous vein, defined as an anterior vein which communicates to the saphenofemoral junction, may be ablated at the time of ablation of the ipsilateral greater saphenous vein.

An anterior vein which is a tributary of the greater saphenous vein and which does not communicate to the saphenofemoral junction is not considered an anterior accessory saphenous vein and treatment of this type of vein should be addressed under treatment of symptomatic varicose tributaries.

Rationale:

This policy has been updated periodically using the MEDLINE database. The most recent update was performed through April 05, 2024. Following is a summary of key studies to date.

CONVENTIONAL 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).

A Cochrane review by Knight Nee Shingler et al assessed compression stockings as an initial treatment for varicose veins in patients without venous ulceration (Knight Nee Shingler, 2021). This is the second update of a review first published in 2011. Thirteen studies involving 1021 participants with varicose veins without healed or active venous ulceration (CEAP [Clinical, Etiology, Anatomy, Pathophysiology] class C2 to C4) were selected. Compression ranged from 10 to 50 mmHg among studies. Studies could not be pooled for analysis due to heterogeneity in outcomes and method of assessment leading to a low or very low certainty of evidence. Using compression stockings compared to no treatment or placebo stockings led to subjective improvement in symptoms but this finding could be biased because the change in symptoms was not compared to the control arm in all studies. Studies that compared different compression stockings also found subjective improvement in symptoms from baseline to the end of the study, but the change in symptoms was not always compared between groups. The authors were unable to make conclusions about the optimal stocking pressure or length of stocking exposure from the included studies. Reviewers concluded that there was insufficient high-quality evidence to determine whether compression stockings were effective as the sole and initial treatment of varicose veins in patients without venous ulceration, or whether any type of stocking was superior to another 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 (1996) 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. At 1 year, reflux was detected in 9% of patients, rising to 26% at 2 years. Rutgers and Kitslaar (1994) reported on the results of a trial that randomized 181 limbs to undergo either ligation and stripping or ligation combined with sclerotherapy. At 2 years, Doppler ultrasound demonstrated reflux in approximately 10% of patients after ligation and stripping, increasing to 15% at 3 years.

ENDOVENOUS THERMAL ABLATION (LASER OR RADIOFREQUENCY)

Farah et al conducted a systematic review and meta-analysis that informed the 2022 multiorganization guideline on management of varicose veins (Farah, 2022). The review addressed 3 key questions related to treatment: whether there is a benefit of surgical stripping versus endovenous ablation, whether there is a benefit of thermal versus nonthermal ablation techniques, and whether ablation of incompetent perforator veins improves outcomes. Multiple outcomes of interest were assessed at various time points for each question. For the first key question, an analysis of 30 RCTs and 16 observational studies found few studies that reported the outcomes of interest at each time point (between 1 month and 5 years), but anatomic closure was better with surgical stripping compared to endovenous ablation techniques. Analysis for the second question included 16 RCTs and 11 observational studies, few of which included the outcomes of interest at the time points of interest. Overall, endovenous laser ablation resulted in higher rates of anatomical closure at 1 year and 5 years versus nonthermal ablation techniques.

An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus ligation/stripping for saphenous vein varices (Nesbitt et al, 2014).

A Cochrane review by Whing et al (2021) compared interventions for great saphenous vein incompetence. The review included 24 RCTs (N=5135) and the duration of follow-up for included trials ranged from 5 weeks to 8 years. When comparing endovenous laser ablation to ligation and stripping, pooled data from 6 RCTs (n=1051) suggest that technical success may be better with endovenous laser ablation up to 5 years (odds ratio [OR], 2.31, 95% confidence interval [CI],1.27 to 4.23; low-certainty evidence), but not at 5 years and beyond based on data from 5 RCTs (n=874). The risk of recurrence is similar between treatments within 3 years and at 5 years based on data from 7 RCTs each (n=1459 and n=1267, respectively).When comparing radiofrequency ablation (RFA) to ligation and stripping, data from 2 RCTs (n=318)suggest that there is no significant difference in the rate of technical success up to 5 years; data from 1 RCT (n=289) with duration over 5 years also suggest no significant difference between treatments. Based on data from 4 RCTs (n=546), there is no significant difference in the risk of recurrence up to 3 years; but based on 1 trial (n=289), a possible long-term benefit for RFA is observed (OR, 0.41, 95% CI, 0.22 to 0.75; low-certainty evidence). When comparing endovenous laser ablation with RFA, technical success is comparable up to 5 years and over 5 years. Based on data from 1 study (n=291), there is no significant difference in the risk of recurrence between treatments at 3 years, but a benefit for RFA over endovenous laser ablation may be seen at 5 years (OR, 2.77, 95% CI, 1.52 to 5.06).

A 2016 Cochrane review compared endovenous laser ablation or RFA to surgical repair for short saphenous veins with reflux at the saphenopopliteal junction (Paravastu et al, 2016). Three RCTs identified compared endovenous laser ablation with surgery.

Randomized Controlled Trials

In 2014, Brittenden et al reported a multicenter randomized trial that compared foam sclerotherapy, EVLA, and surgical treatment in 798 patients. The study was funded by U.K.’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. Six months after 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 2012 RELACS study randomized 400 patients to endovenous laser ablation performed by a surgeon at 1 site or to ligation and stripping performed by a different surgeon at a second location (Rass, 2012). At 2-year follow-up, there were no significant differences between the groups for clinically recurrent varicose veins, medical condition on the Homburg Varicose Vein Severity Score, or disease-related QOL. Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous laser treatment (17.8% vs 1.3%). The follow-up rate at 5 years was 81% (Rass, 2015). Same-site recurrences were more frequent in the endovenous laser ablation group (18% with endovenous laser ablation 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 endovenous laser ablation, p=0.002). Overall, there was no significant difference in recurrence rates between the groups. There were also no significant differences between groups in disease severity or QOL at 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 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. At 5 years, health-related quality of life and CEAP classification improved in all groups with no significant differences among them (van der Velden et al, 2015). Grade I neovascularization was higher in the conventional surgery group (27%vs.3%, p<.001), while grade II neovascularization did not differ significantly between surgical (17%) and endovenous laser ablation (13%) groups.

Wallace et al (2018) published the five-year outcomes of an RCT (HELP-1 trial) comparing surgery and endovenous laser ablation (EVLA) as treatments for symptomatic great saphenous varicose veins.16, Data from 218 patients were available at 5-year follow-up. The clinical recurrence rate was 34.4% for the surgery group and 20.9% for EVLA (p=0.010). Patients’ QOL, assessed using EuroQol Five Dimensions (EQ-5D) and AVVQ, was significantly improved from baseline for both surgery (EQ-5D: 0.859 to 1.0, p=0.002; AVVQ: 13.69 to 4.59, p<0.001) and EVLA (EQ-5D: 0.808 to 1.0, p=0.002; AVVQ: 12.73 to 3.35, p<0.001). Technical success assessed by duplex ultrasound examination was 85.4% for surgery and 93.2% for EVLA (p=0.074).

A systematic review by Alozai et al (2021) identified 16studies that evaluated treatment modalities for anterior accessory saphenous vein incompetence. All included studies were of moderate to poor quality. The pooled anatomic success rates were 91.8% after endovenous laser ablation andRFA (n=11 studies), 93.6% after CAC (n=3 studies), and 79.8% after sclerotherapy (n=2 studies).

Endovenous Radiofrequency Ablation (RFA)

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. 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. 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.

SCLEROTHERAPY

A Cochrane review by Whing et al (2021) that compared interventions for great saphenous vein incompetence was introduced above. Based on pooled data from 4 RCTs (n=954), ultrasound-guided foam sclerotherapy was inferior to ligation and stripping for technical success up to 5 years (OR, 0.32, 95% CI, 0.11 to 0.94; low-certainty evidence), and beyond 5 years based on 3 RCTs (n=525)(OR, 0.09, 95% CI, 0.03 to 0.30; moderate-certainty evidence). There was no significant difference between treatments for recurrence up to 3 years based on 3 RCTs (n=822) and beyond 5 years based on 3 RCTs (n=639). Similarly, technical success was improved with endovenous laser ablation over ultrasound-guided foam sclerotherapy up to 5 years based on data from 3 RCTs (n=588) (OR, 6.13, 95% CI, 0.98 to 38.27; low-certainty evidence), and beyond 5 years based on data from 3 RCTs (n=534) (OR, 6.47, 95% CI, 2.60 to 16.10; low-certainty evidence). There was no significant difference between endovenous laser ablation and ultrasound-guided foam sclerotherapy for recurrence up to 3 years based on data from 2 RCTs (n=443), and at 5 years based on data from 2RCTs (n=418).

Hamann et al (2017) conducted a meta-analysis of RCTs that had 5-year follow-up. The meta-analysis

(3 RCTs, 10 follow-up studies) included 611 legs treated with endovenous laser ablation, 549 treated with high ligation and stripping, 121 with sclerotherapy, and 114 with high ligation and endovenous laser ablation.

In the 2013 MAGNA trial (previously described), 223 consecutive patients (240 legs) with great saphenous vein reflux were randomized to EVLA, ligation and stripping, or physician compounded foam sclerotherapy (1 cc aethoxysclerol 3%: 3 cc air). (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. At 5-year follow-up, obliteration or absence of the great saphenous vein was observed in only 23% of patients treated with sclerotherapy compared with 85% of patients who underwent conventional surgery and 77% of patients who underwent EVLA (van der Velden, 2015).

Vahaaho et al (2018) published a study looking at the 5-year follow-up of patients with symptomatic great saphenous vein (GSV) insufficiency. Between 2008 and 2010, 166 individuals were randomized to receive open surgery, EVLA, or ultrasound-guided foam sclerotherapy (UGFS). 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 UGFS (p<0.001). For patients with no additional treatment during follow-up, occlusion rates for open surgery, EVLA, and UGFS were 96%, 89%, and 41%, respectively. The study was limited by the lack of blinding and by non-standardized foam application.

Hamel-Desnos et al (2023) conducted a randomized trial of endovenous laser ablation versus physician-compounded foam sclerotherapy (0.5 mL polidocanol at concentrations ranging from 1% to 3% depending on vessel diameter; 2 mL air) in 161patients with isolated small saphenous vein incompetence. Tributary vein treatments were not allowed for the first 6 months after the procedure. After the first 6 months, 33% of patients who received sclerotherapy and 19% of patients who received endovenous laser ablation received tributary treatment. The primary endpoint, absence of reflux in the treated segment at 3years, was achieved in 86% of patients who received endovenous laser ablation versus 56% of patients who received sclerotherapy (risk ratio, 1.59; 95% CI, 1.26 to 2.01). Rates of partial and total failure were higher in the sclerotherapy group than the endovenous laser ablation group. Limitations include the pragmatic design that allowed clinicians to treat patients according to their normal practice except for the study intervention and a lack of blinding.

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. Lam et al (2018) reported eight year follow-up with 53% of the patients in the original trial. All measures of treatment success (eg, symptomatic GSV reflux, saphenofemoral junction failure, and recurrent reflux in the GSV) were lower in the physician-compounded sclerotherapy group compared to the ligation and stripping group.

Microfoam Sclerotherapy

In 2013, Varithena™ microfoam was approved under a new drug application for the treatment of varicose veins. Efficacy data were from 2 randomized, blinded, multicenter studies (FDA, 2013). One evaluated Varithena™ at 0.5%, 1.0%, and 2.0% polidocanol and the second evaluated Varithena™ at 0.5% and 1.0% polidocanol compared with endovenous placebo or a subtherapeutic dose of polidocanol foam. The primary end point was improvement in symptoms at week 8, as measured by the Varicose Vein Symptoms Questionnaire. The improvement in symptoms was greater in the pooled Varithena™ treatment group (p<0.001) and in each of the individual dose-concentration groups compared with vehicle alone. Secondary and tertiary end points (appearance, duplex ultrasound response, quality of life) were also significantly better for the Varithena™ groups compared with controls. This second study, called VANISH-2, was published in 2014 (Todd, 2013). 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% group, and 1.8% of the placebo group. Analysis of data from both studies showed a dose response from 0.5% to 2.0% for improvement in appearance and from 0.5% to 1.0% for Duplex responders. The 1.0% dose of Varithena™ was selected for the FDA approval. Safety analysis found deep vein thrombosis detected by ultrasound in 2.8% of Varithena™-treated patients with 1% of patients having proximal symptomatic thrombi; these were treated with anticoagulants. There was no signal of an increase in neurological adverse events, and there were no adverse cardiac or cardiopulmonary effects following treatment with Varithena™ injectable foam. Rates of occlusion with Varithena™ are similar to those reported for EVLA or stripping. A randomized trial comparing EVLA and stripping with this new preparation of foam sclerotherapy is needed to evaluate its comparative effectiveness. Evaluation out to 5 years is continuing.

Vasquez et al (2017) reported on a double-blinded RCT that evaluated the addition of polidocanol

microfoam to endovenous thermal ablation. 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 0.5% (n=39) or 1% (n=40) polidocanol. 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 did not achieve statistical significance. At 6 month follow-up, the percent of patients who achieved a clinically meaningful change was significantly higher for both the physician (70.9% vs 42.1%, p=0.001) and patient ratings (67% vs 50%, p=0.034). The proportion of patients who received additional treatment for residual varicosities between week 8 and month 6 was modestly improved (13.9% for the polidicanol vs 23.7% for placebo, p=0.037).

Deak (2018) reported a retrospective review of 250 patients with symptomatic chronic venous insufficiency who were treated with polidocanol microfoam in a community practice.

MECHANOCHEMICAL ABLATION

In 2017, Lane et al reported on results from an RCT of 170 patients that compared ClariVein with RFA. Maximum visual analog scale (VAS) pain scores (out of 100) during the procedure were significantly lower in the mechanochemical ablation group (median, 15 mm) than in the RFA group (median, 34 mm; p=0.003). Average VAS pain scores during the procedure were also significantly lower in the mechanochemical ablation group (median, 10 mm) than in the RFA group (median, 19.5 mm; p=0.003). Occlusion rates, clinical severity scores, disease-specific QOL, and generic QOL scores were similar between the groups at 1 and 6 months. However, only 71% of patients were available for follow-up at 6 months, limiting the evaluation of closure rates at this time point.

Lam et al (2016) reported interim results of a dose finding randomized study, reporting greater closure with use of 2% or 3% polidocanol (liquid) compared with 1% polidocanol (microfoam). Systematic reviews have included both of the 2 trials described above and within-subject comparisons.

Vahaaho et al (2019) reported an RCT that compared mechanochemical ablation (MOCA) with endovenous thermal ablation (EVLA or RFA). Liquid sclerosant at a concentration of 1.5% was used. Out of 132 patients enrolled, seven patients were later excluded and 117 (88.6%) attended the one-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 (Lam et al [2016]) reported interim results of a dose-finding study, finding greater closure with use of polidocanol 2% or 3% (liquid) than with polidocanol 1% (microfoam). Therefore, it is uncertain whether the concentration of sclerosant in the study by Vahaaho et al (2019) was optimal

Sun et al (2017) included the two trials described above and 11 reports from prospective observational within-subject comparisons. They found MOCA to be effective in the short-term with minimal complications, but lack of standardization precluded comparison with other techniques. Potential sources of bias in the studies included patient self-selection and lack of blinding, combined with subjective patient-reported outcomes measures. Overall, the quality of evidence was rated as low or very low.

Three percent policocanol was tested in the Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation (MARADONA) noninferiority trial reported by Holewijn et al (2019). Athough the study was powered for 400 participants, only 213 patients were randomized before reimbursement for the procedure was suspended. Pain scores in the 14 days after the procedure were slightly lower, but hyperpigmentation was higher.

Another RCT reported by Mohamed et al (2020) is the ongoing Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein) in the Management of Superficial Venous Insufficiency (LAMA). Patients (n=150) were randomized to MOCA with 1.5% sodium tetradecyl sulfate or to EVLA. Anatomic success (occlusion) rates were lower in the MOCA group 77% compared to the EVLA group (91%) with no significant difference between the 2 treatments in intraprocedural pain scores. In contrast to the difference in anatomical occlusion rates, clinical severity and quality of life scores were not significantly different between the groups at 1 year follow-up. Follow-up is continuing to evaluate durability of the treatments.

In comparison, Witte et al (2017) rated 13 studies with 10 cohorts (1521 veins) according to the MINORS study rating score. The trials by Bootun/Lane and Lam (described above) were rated as good quality. All studies were considered to have end points appropriate to the aim of the study, unbiased assessment of the study end point, and a follow-up period appropriate to the aim of the study. Limitations of some of the studies were nonconsecutive enrollment, retrospective design, and loss to follow-up of greater than 5%. None of the studies were designed to compare success with endothermal ablation. In the available cohort studies, short-term anatomic success was reported for 87% to 92% of the veins.

Several prospective series and cohort studies have been reported (Bishawi, 2013; Elias and Raines, 2012; Boersma, 2013). A prospective cohort study that had 5 year follow-up was reported by Thierens et al (2019).

CYANOACRYLATE ADHESIVE

The VenaSeal™ pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients that compared VenaSeal™ versus RFA for the treatment of venous reflux (U.S. Food and Drug Administration, 2015; Morrison et al, 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 mean time to return to work in a prospective cohort of 50 patients was 0.2 days (Gibson, 2017). Longer term follow-up is needed to permit conclusions on the durability of this procedure.

Eroglu et al (2017) reported closure rates of 94.1% at 30 months in a prospective cohort of 159 patients. Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida et al (2015). Thirty-three-month follow-up was reported in 467 veins out of a series of 795 veins (58.7%) treated at 1 institution in Germany (Zierau, 2015). An inflammatory reddening of the skin was observed at approximately 1 week after treatment in 11.7% of cases. No permanent skin responses were observed. Of the 467 veins reexamined, the sealing rate was 97.7%. This series is limited by the high loss to follow-up. For the cyanoacrylate and RFA groups, the complete occlusion rates were 97.2% and 97.0%, respectively, although subsequent treatments were allowed. Freedom from recanalization, which may be more representative of treatment success, was also similar between the two groups (p=0.08) (Morrison et al, 2017). Twenty-four month results were reported by Gibson et al (2018), which included 171 patients (87 from CAC and 84 from RFA) (Gibson et al, 2018). The complete closure rates for cyanoacrylate and RFA were 95.3% and 94.0% (p=0.0034), respectively. Recanalization-free survival at 24 months was non-inferior in the cyanoacrylate group compared to the RFA group (94.6% vs 97.8%, p< 0.001 for non-inferiority). 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). 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 two 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 (2018) in an RCT with 525 patients. Periprocedural outcomes showed a shorter intervention time, less pain, and shorter return to work with CAC compared to endovenous thermal ablation (see Table 8). There was no signficant difference in occlusion rates between the three treatments at 6, 12, and 24 month follow-up.

Alhewy et al (2024) conducted an RCT at 2 centers in Egypt comparing VenaSeal CAC with RFA in 248 patients with venous reflux, with follow-up extending to 2 years post procedure. The primary outcome was complete closure of the target great saphenous vein at the 3-month visit, although results for this outcome were not reported by the authors. Authors reported that at the 1-month follow-up, all veins treated with CAC remained occluded, while 154 out of 158 (97%) veins treated with RFA remained occluded. At 24 months, 122 out of 128 (95%) veins treated with CAC and 146 out of 158 (93%) veins treated with RFA remained occluded. At month 24, there were 6 recanalizations in the CAC group and 12 in the RFA group, with recanalization-free survival in the CAC group found to be non-inferior to that of the RFA group (95.3% vs. 92.4%, respectively; p<.0001 for 10% noninferiority). The CAC group experienced fewer complications, with only 2 cases of paresthesia and 18 cases of bruises reported, whereas the RFA group encountered 18 cases of bruises, 2 cases of skin burns, and 2 cases of access site hematoma. Periprocedural outcomes showed a potentially shorter intervention time with CAC vs RFA.

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 (2008, 2011) reported 2 and 5 year outcomes from a randomized trial that compared cryostripping with EVLA. 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.

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 (Tisi, 2006; Leopardi, 2009; El-Sheikha et al, 2014; Michaels, 2006).

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).

Cochrane review of 28 studies by de Avlia Oliveira et al (2021) concluded that there is low certainty evidence that sclerotherapy is effective and safe compared to placebo for treating cosmetic appearance, persistent symptoms, and quality of life concerns related to varicose veins. Evidence was limited or lacking for comparisons of foam with liquid sclerotherapy or other substances, and between concentrations of foam. Sclerotherapy and phlebectomy are considered appropriate in the absence of reflux of the saphenous system (eg, post- or adjunctive treatment to other procedures such as surgery).

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. (2006) that compared TIPP (n=29) with a multiple stab incision procedure (n=33).

PERFORATOR REFLUX

Giannopoulos et al (2022) performed a systematic review of percutaneous treatments for pathologic perforating veins. Thirty-five studies met the inclusion criteria (5 double-arm studies and 28 single-arm studies). Endovenous laser ablation (with or without microphlebectomy and/or sclerotherapy) was successful within the first 2 weeks after the procedure in 95% of patients. Success rates for RFA (with or without microphlebectomy) were 91% (95% CI, 75% to 99%). Ultrasound-guided sclerotherapy had a success rate of 70% after multiple sessions (95% CI, 53% to 84%). After 12 months of follow-up, occlusion rates were 89%, 77%, and 83% in the 3 groups, respectively. Limitations of the review include heterogeneity of the interventions in the included studies, including adjuvant therapy that could be provided at the investigator's discretion. Ho et al (2022) published a systematic review to compare interventions for incompetent perforator veins, including open ligation, SEPS, endovascular laser ablation, ultrasound-guided sclerotherapy, and RFA. A total of 81 studies (N=7010) were identified, and the overall quality of evidence was low to intermediate. Results demonstrated that in the short term (=1 year), efficacy rates for wound healing were 99.9% for ultrasound-guided sclerotherapy, 72.2% for open ligation, and96.0% for SEPS. For short-term freedom from wound recurrence, the pooled estimate for SEPS was 91.0%; wound recurrence rates were not reported for other interventions.

A systematic literature review published in 2008 by O’Donnell indicates insufficient evidence for the role of incompetent perforator vein surgery. 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 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 (Blomgren, 2005; O’Donnell, 2008). 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.

Lawrence et al (2020) reported a multicenter retrospective review of 832 consecutive patients who met criteria and were treated for venous leg ulcers in the U.S. Of the 832 patients, 187 were managed with compression alone (75% ulcer healing) and 528 received superficial vein treatment after failure of a mean of 23 months of compression. Of the 528, 344 also underwent ablation of an average of 1.8 perforator veins. Techniques included radiofrequency, laser, and sclerotherapy. The ulcer healing rate was 17% higher inpatients treated for perforator reflux (68%) in comparison with superficial vein treatment alone (51%; hazard ratio 1.619; 95% CI 1.271to 2.063), even though the ulcers were larger at baseline. Perforator vein treatment did not affect recurrence rates in ulcers that had healed. Larger ulcers were associated with reflux in more than 1 level, and deep vein stenting was performed in 95 patients, some in combination with superficial vein treatment and some in combination with both superficial and perforator vein treatment. The ulcer healing rate in patients who underwent all 3 procedures was 87% at 36 months with an ulcer recurrence of 26% at 24 months.

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. 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. Van Gent et al (2015) reported 10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for venous leg ulcers. 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 than in 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.

A 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).

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 (Hirsh, 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, 2008 & 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 OF EVIDENCE

Saphenous Veins

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive

endovenous thermal ablation (radiofrequency or laser), the evidence includes randomized controlled trials

(RCTs) and systematic reviews of controlled trials. The relevant outcomes are symptoms, change in disease status, morbid events, quality of life (QOL), and treatment-related morbidity (TRM). There are a number of large RCTs and systematic reviews of RCTs assessing endovenous thermal ablation of the saphenous veins. Comparison with the standard of ligation and stripping at 2- to 5-year follow-up has supported the use of both endovenous laser ablation and radiofrequency ablation (RFA). Evidence has suggested that ligation and stripping lead to more neovascularization, while thermal ablation leads to more recanalization, resulting in similar clinical outcomes for endovenous thermal ablation and surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive MOCA, the evidence includes RCTs with 6 mo to 2 yr results that compared MOCA to thermal ablation, a prospective cohort with follow-up out to 5 years, and retrospective case series. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and TRM. MOCA is a combination of liquid sclerotherapy with mechanical abrasion. A potential advantage of this procedure compared with

thermal ablation is that MOCA does not require tumescent anesthesia and may result in less pain during the procedure. Results to date have been mixed regarding a reduction in intraprocedural pain compared to thermal ablation procedures. Occlusion rates at 6 mos to 2 year from RCTs indicate lower anatomic success rates compared to thermal ablation, but a difference in clinical outcomes at these early time points has not been observed. Experience with other endoluminal ablation procedures suggests that lower anatomic success in the short term is associated with recanalization and clinical recurrence between 2 to 5 years. The possibility of later clinical recurrence is supported by a prospective cohort study with 5-year follow-up following treatment with MOCA. However, there have been improvements in technique since the cohort study was begun, and clinical progression is frequently observed with venous

disease. Because of these limitations of the single arm studies, longer follow-up in the more recently conducted RCTs is needed to establish the efficacy and durability of this procedure compared with the criterion standard of thermal ablation. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive MOCA, the evidence includes two RCTs and case series. The relevant outcomes are symptoms, change in disease status, morbid events, QOL, and TRM. MOCA is a combination of liquid sclerotherapy with mechanical abrasion. Potential advantages of this procedure compared with thermal ablation are that MOCA does not require multiple needle sticks with tumescent anesthesia and may result in less pain during the procedure. The evidence on MOCA includes an RCT that compared MOCA to thermal ablation with 1 year results, an RCT with short-term results that compared mechanochemical ablation with RFA, and case series with follow-up out to three years. The short-term results of one RCT suggested that intraprocedural pain is slightly lower with MOCA than with RFA. However, the second RCT showed lower occlusion rates than thermal ablation. MOCA has been assessed in relatively few patients and for short durations. Longer follow-up in RCTs with a larger number of patients is needed to evaluate the efficacy and durability of this procedure compared with established procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive CAC, the evidence includes two RCTs and a prospective cohort. The relevant outcomes are symptoms, change in disease status, morbid events, QOL, and TRM. Evidence includes a multicenter noninferiority trial with follow-up through 36 months, an RCT with follow-up through 24 months, and a prospective cohort with 30 month follow up. The short-term efficacy of VenaSeal CAC has been shown to be noninferior to RFA at up to 36 months. At 24 and 36 months the study had greater than 20% loss to follow-up, but loss to follow-up was similar in the two groups at the long-term follow-up and is not expected to influence the comparative results. A second RCT (n=525) with the same active CAC ingredient (N-butyl cyanoacrylate) that is currently available outside of the US found no significant differences in vein closure between CAC and thermal ablation controls at 24 month follow-up. The CAC procedure and return to work were shorter and pain scores were lower compared to thermal ablation, although the subjective pain scores may have been influenced by differing expectations in this study. A

prospective cohort reported high closure rates at 30 months. Overall, results indicate that outcomes from CAC are at least as good as thermal ablation techniques, the current standard of care. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have varicose veins/venous insufficiency and saphenous vein reflux who receive

cryoablation, the evidence includes RCTs and multicenter series. The relevant outcomes are symptoms, change in disease status, morbid events, QOL, and TRM. Results from a recent RCT of cryoablation have indicated that this therapy is inferior to conventional stripping. Studies showing a benefit on health outcomes are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

Varicose Tributary Veins

For individuals who have varicose tributary veins who receive ablation (stab avulsion, sclerotherapy, or phlebectomy) of tributary veins, the evidence includes RCTs and systematic reviews of RCTs. The relevant outcomes are symptoms, change in disease status, morbid events, QOL, and TRM. The literature has shown that sclerotherapy is effective for treating tributary veins following occlusion of the saphenofemoral or saphenopopliteal junction and saphenous veins. No studies have been identified comparing RFA 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 evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Perforator Veins

For individuals who have perforator vein reflux who receive ablation (eg, subfascial endoscopic perforator surgery) of perforator veins, the evidence includes RCTs and systematic reviews of RCTs. The relevant outcomes are symptoms, change in disease status, morbid events, QOL, and TRM. The literature has indicated that the routine ligation or ablation of incompetent perforator veins is not 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 (ie, ulcers), treatment of perforator vein reflux may be as beneficial as an alternative (eg, deep vein valve replacement). Comparative studies are needed to determine the most effective method of ligating or ablating incompetent perforator veins. Subfascial endoscopic perforator surgery 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 compared with surgical interventions. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Ongoing and Unpublished Clinical Trials

A search of online site ClinicalTrials.gov registry identified several currently unpublished trials that might influence this policy.

Clinical Input Received Through Academic Medical Centers and Specialty Medical Societies

2015 Input: In response to requests, input was received from 4 physician specialty societies while this policy was under review in 2015. There was no agreement on the need to treat varicose tributaries to improve functional outcomes in the absence of saphenous vein disease. Input was also mixed on the use of mechanochemical ablation or use of cyanoacrylate adhesive.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American Venous Forum et alIn 2020, in response to published reports of potentially inappropriate application of venous procedures, the American Venous Forum, Society for Vascular Surgery, American Vein and Lymphatic Society, and the Society of Interventional Radiology published appropriate use criteria for the treatment of chronic lower extremity venous disease (Masuda et al, 2020). Appropriate use criteria were developed using the RAND/UCLA method incorporating best available evidence and expert opinion. Appropriate use criteria were determined for various scenarios (eg, symptomatic, asymptomatic, CEAP [Clinical, Etiology, Anatomy and Pathophysiology] class, axial reflux, saphenofemoral junction reflux) for the following:

Saphenous vein ablation

Great saphenous vein
Small saphenous vein
Accessory great saphenous vein

Non-truncal varicose veins
Diseased tributaries associated with saphenous ablation
Perforator Veins
Iliac Vein or inferior vena cava stenting as a first line treatment
Duplex ultrasound
Timing and Reimbursement.

Treatment of saphenous veins for asymptomatic CEAP class 1 and 2, or symptomatic class 1, was considered to be rarely appropriate or never appropriate, and treatment of symptomatic CEAP class 2,3, and 4-6 without reflux was rated as never appropriate. Based on the 2011 Guidelines from the Society for Vascular Surgery and American Venous Forum (see below), treatment of perforator veins for asymptomatic or symptomatic CEAP class 1 and 2was considered to be rarely appropriate or never appropriate. Perforator vein treatment was rated as appropriate for CEAP classes 4-6, and may be appropriate for CEAP class 3. Except for a recommendation to use endovenous procedures for perforator vein ablation, techniques used to treat veins in these scenarios were not evaluated.

Society for Vascular Surgery and American Venous ForumThe 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).

The Society for Vascular Surgery, the American Vein and Lymphatic Society (AVLS), and the American Venous Forum published a joint clinical practice guideline in 2022 on management of lower extremity varicose veins (Gloviczki, 2023). The guideline will be published in sections; the first part (published in 2022) focuses on duplex scanning and treatment of superficial truncal reflex. Superficial truncal veins are defined as the great saphenous vein, small saphenous vein, anterior accessory great saphenous vein, and posterior accessory great saphenous vein. A summary of the guideline recommendations is provided below. The second part of the guideline was published in 2023 and focuses on the management of varicose vein patients with compression, treatment with drugs and nutritional supplements, evaluation and treatment of varicose tributaries, superficial venous aneurysms, and management of complications of varicose veins and their treatment (Gloviczki, 2024).

Summary of Recommended Treatment of Superficial Truncal Reflex:

Symptomatic varicose veins and axial reflux

Reflux in the great or small saphenous vein - superficial venous intervention preferred over long-term compression stockings (Grade 1B; Strength of Recommendation – Strong; Quality of Evidence – Moderate)
Reflux in the anterior accessory or posterior accessory great saphenous vein - superficial venous intervention preferred over long-term compression stockings (Grade 2C; Strength of Recommendation - Weak; Quality of Evidence - Low)
Reflux in the superficial truncal vein - compression therapy suggested for primary treatment (Grade 2C; Strength of Recommendation - Weak; Quality of Evidence - Low)
Reflux in the great saphenous vein - endovenous ablation preferred over high ligation and stripping (Ligation and stripping can be performed if endovenous ablation is not feasible) (Grade 1B; Strength of Recommendation - Strong; Quality of Evidence - Moderate)
Reflux in the small saphenous vein - endovenous ablation preferred over high ligation and stripping (Ligation and stripping can be performed if endovenous ablation is not feasible.) (Grade 1C; Strength of Recommendation - Strong; Quality of Evidence - Low)
Reflux in the anterior accessory or posterior accessory great saphenous vein - endovenous ablation (with phlebectomy if needed) over ligation and stripping (Ligation and stripping can be performed if endovenous ablation is not feasible.) (Grade 2C; Strength of Recommendation - Weak; Quality of Evidence - Low)
Patients who place a high priority on long-term outcomes (quality of life and recurrence) - laser ablation, radiofrequency ablation, or ligation and stripping over ultrasound-guided foam sclerotherapy (Grade 2C or 2B; Strength of Recommendation - Weak; Quality of Evidence - Moderate or Low)

Symptomatic axial reflux

Reflux in the great saphenous vein - thermal and nonthermal ablation recommended (Grade 1B; Strength of Recommendation - Strong; Quality of Evidence - Moderate)
Reflux in the small saphenous vein - thermal and nonthermal ablation recommended (Grade 1C; Strength of Recommendation - Strong; Quality of Evidence - Low)
Reflux in the anterior accessory or posterior accessory great saphenous vein - either thermal or nonthermal ablation suggested (Grade 2C; Strength of Recommendation - Weak; Quality of Evidence - Low)

Varicose veins (CEAP class C2)

Reflux in the great or small saphenous vein - recommend against concomitant initial ablation and treatment of incompetent perforating veins (Grade 1C; Strength of Recommendation - Strong; Quality of Evidence - Low)
Reflux in the anterior accessory or posterior accessory great saphenous vein - recommend against concomitant initial ablation and treatment of incompetent perforating veins (Grade 2C; Strength of Recommendation - Weak; Quality of Evidence - Low)
Persistent or recurrent symptoms after previous complete ablation - treatment of perforating vein incompetence suggested (Grade 2C; Strength of Recommendation - Weak; Quality of Evidence - Low)

Symptomatic reflux and associated varicosities

Reflux in the great or small saphenous vein - ablation and concomitant phlebectomy or ultrasound-guided foam sclerotherapy recommended (Grade 1C; Strength of Recommendation - Strong; Quality of Evidence - Low)
Reflux in the anterior accessory or posterior accessory great saphenous vein - ablation and concomitant phlebectomy or ultrasound-guided foam sclerotherapy suggested (Grade 2C; Strength of Recommendation - Weak; Quality of Evidence – Low)

American Vein and Lymphatic Society

In 2015, the American Vein and Lymphatic Society (AVL, previously named the American College of Phlebology) published guidelines on the treatment of superficial vein disease. AVL gave a Grade 1 recommendation based on high quality evidence that compression is an effective method for the management of symptoms, but when patients have a correctable source of reflux definitive treatment should be offered unless contraindicated. AVL recommends against a requirement for compression therapy when a definitive treatment is available. AVL gave a strong recommendation based on moderate quality evidence that endovenous thermal ablation is the preferred treatment for saphenous and accessory saphenous vein incompetence, and gave a weak recommendation based on moderate quality evidence that mechanochemical ablation may also be used to treat venous reflux.

In 2017, AVL published guidelines on the treatment of refluxing accessory saphenous veins (Gibson et al, 2017). The College gave a Grade 1 recommendation based on level C evidence that patients with symptomatic incompetence of the accessory saphenous veins be treated with endovenous thermal ablation or sclerotherapy to reduce symptomatology. The guidelines noted that although accessory

saphenous veins may drain into the great saphenous vein before it drains into the common femoral vein, they can also empty directly into the common femoral vein.

National Institute for Health and Care Excellence

NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in 2013. The guidance states that:

“1.1 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose veins is adequate. The evidence on safety is adequate, and provided that patients are warned of the small but significant risks of foam embolization (see section 1.2), this procedure may be used with normal arrangements for clinical governance, consent and audit.

1.2 During the consent process, clinicians should inform patients that there are reports of temporary chest tightness, dry cough, headaches and visual disturbance, and rare but significant complications including myocardial infarction, seizures, transient ischemic attacks and stroke.”

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.

In 2016, NICE revised its guidance on endovenous mechanochemical ablation, concluding that "Current evidence on the safety and efficacy of endovenous mechanochemical ablation for varicose veins appears adequate to support the use of this procedure...."

U.S. Preventive Services Task Force Recommendations

Not applicable.

Regulatory Status

In 2015, the VenaSeal® Closure System (Sapheon, a part of Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval 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.

Varithena™ (formerly known as Varisolve®, BTG Plc, London) is a sclerosant microfoam made with a proprietary gas mix. It was approved by FDA in 2013 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 have received specific U.S. Food and Drug Administration (FDA) marketing clearance for the endovenous treatment of superficial vein reflux:

In 1999, the VNUS® Closure™ System, a radiofrequency device, was cleared by the FDA through the 510(k) process for “endovascular coagulation of blood vessels in patients with superficial vein reflux.” In 2005, the VNUS RFS™ and RFSFlex™ devices were cleared by the FDA for “use in vessel and tissue coagulation including treatment of incompetent (ie, refluxing) perforator and tributary veins.” In 2008, the modified VNUS® ClosureFast™ Intravascular Catheter was cleared by the FDA through the 510(k) process. FDA product code: GEI.
In 2002, the Diomed 810 nm surgical laser and EVLT™ (endovenous laser therapy) procedure kit were cleared by the FDA through the 510(k) process “…for use in the endovascular coagulation of the great saphenous vein of the thigh in patients with superficial vein reflux.” FDA product code: GEX.
In 2005, a modified Erbe Erbokryo® cryosurgical unit (Erbe USA) was approved by the FDA for marketing. A variety of clinical indications are listed, including cryostripping of varicose veins of the lower limbs. FDA product code: GEH.
In 2003, the Trivex® system (InaVein), a device for transilluminated powered phlebectomy, was cleared by FDA through the 510(k) process for “ambulatory phlebectomy procedures for the resection and ablation of varicose veins.” FDA product code: DNQ.
In 2008, the ClariVein® Infusion Catheter (Vascular Insights) was cleared by the FDA through the 510(k) process (K071468) for mechanochemical ablation. FDA determined that this device was substantially equivalent to 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

CPT/HCPCS:

36465	Injection of non compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; single incompetent extremity truncal vein (eg, great saphenous vein, accessory saphenous vein)
36466	Injection of non compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; multiple incompetent truncal veins (eg, great saphenous vein, accessory saphenous vein), same leg
36468	Injection(s) of sclerosant for spider veins (telangiectasia), limb or trunk
36470	Injection of sclerosant; single incompetent vein (other than telangiectasia)
36471	Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg
36473	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated
36474	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
36475	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated
36476	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
36478	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated
36479	Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
36482	Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; first vein treated
36483	Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)
37500	Vascular endoscopy, surgical, with ligation of perforator veins, subfascial (SEPS)
37700	Ligation and division of long saphenous vein at saphenofemoral junction, or distal interruptions
37718	Ligation, division, and stripping, short saphenous vein
37722	Ligation, division, and stripping, long (greater) saphenous veins from saphenofemoral junction to knee or below
37735	Ligation and division and complete stripping of long or short saphenous veins with radical excision of ulcer and skin graft and/or interruption of communicating veins of lower leg, with excision of deep fascia
37760	Ligation of perforator veins, subfascial, radical (Linton type), including skin graft, when performed, open,1 leg
37761	Ligation of perforator vein(s), subfascial, open, including ultrasound guidance, when performed, 1 leg
37765	Stab phlebectomy of varicose veins, 1 extremity; 10 20 stab incisions
37766	Stab phlebectomy of varicose veins, 1 extremity; more than 20 incisions
37780	Ligation and division of short saphenous vein at saphenopopliteal junction (separate procedure)
37785	Ligation, division, and/or excision of varicose vein cluster(s), 1 leg
37799	Unlisted procedure, vascular surgery
S2202	Echosclerotherapy

ICD9:

ICD10:

I83.001	Varicose veins of unsp lower extremity with ulcer of thigh
I83.002	Varicose veins of unsp lower extremity with ulcer of calf
I83.003	Varicose veins of unsp lower extremity with ulcer of ankle
I83.004	Varicos vn unsp lower extremity w ulcer of heel and midfoot
I83.005	Varicos vn unsp lower extremity w ulcer oth part of foot
I83.008	Varicos vn unsp low extrm w ulcer oth part of lower leg
I83.009	Varicose veins of unsp lower extremity w ulcer of unsp site
I83.011	Varicose veins of right lower extremity with ulcer of thigh
I83.012	Varicose veins of right lower extremity with ulcer of calf
I83.013	Varicose veins of right lower extremity with ulcer of ankle
I83.014	Varicose veins of r low extrem w ulcer of heel and midfoot
I83.015	Varicose veins of r low extrem w ulcer oth part of foot
I83.018	Varicose veins of r low extrem w ulcer oth part of lower leg
I83.019	Varicose veins of right lower extremity w ulcer of unsp site
I83.021	Varicose veins of left lower extremity with ulcer of thigh
I83.022	Varicose veins of left lower extremity with ulcer of calf
I83.023	Varicose veins of left lower extremity with ulcer of ankle
I83.024	Varicose veins of l low extrem w ulcer of heel and midfoot
I83.025	Varicose veins of l low extrem w ulcer oth part of foot
I83.028	Varicose veins of l low extrem w ulcer oth part of lower leg
I83.029	Varicose veins of left lower extremity w ulcer of unsp site
I83.10	Varicose veins of unsp lower extremity with inflammation
I83.11	Varicose veins of right lower extremity with inflammation
I83.12	Varicose veins of left lower extremity with inflammation
I83.201	Varicos vn unsp low extrm w ulc of thigh and inflammation
I83.202	Varicos vn unsp low extrm w ulc of calf and inflammation
I83.203	Varicos vn unsp low extrm w ulc of ankle and inflammation
I83.204	Varicos vn unsp low extrm w ulc of heel and midft and inflam
I83.205	Varicos vn unsp low extrm w ulc oth part of foot and inflam
I83.208	Varicos vn unsp low extrm w ulc oth prt low extrm and inflam
I83.209	Varicos vn unsp low extrm w ulc of unsp site and inflam
I83.211	Varicos vn of r low extrem w ulc of thigh and inflammation
I83.212	Varicos vn of r low extrem w ulc of calf and inflammation
I83.213	Varicos vn of r low extrem w ulc of ankle and inflammation
I83.214	Varicos vn of r low extrem w ulc of heel & midft and inflam
I83.215	Varicos vn of r low extrem w ulc oth part of foot and inflam
I83.218	Varicos vn of r low extrem w ulc oth prt low extrm & inflam
I83.219	Varicos vn of r low extrem w ulc of unsp site and inflam
I83.221	Varicos vn of l low extrem w ulc of thigh and inflammation
I83.222	Varicos vn of l low extrem w ulc of calf and inflammation
I83.223	Varicos vn of l low extrem w ulc of ankle and inflammation
I83.224	Varicos vn of l low extrem w ulc of heel & midft and inflam
I83.225	Varicos vn of l low extrem w ulc oth part of foot and inflam
I83.228	Varicos vn of l low extrem w ulc oth prt low extrm & inflam
I83.229	Varicos vn of l low extrem w ulc of unsp site and inflam
I83.811	Varicose veins of right lower extremity with pain
I83.812	Varicose veins of left lower extremity with pain
I83.813	Varicose veins of bilateral lower extremities with pain
I83.819	Varicose veins of unspecified lower extremity with pain
I83.891	Varicose veins of r low extrem with other complications
I83.892	Varicose veins of l low extrem with other complications
I83.893	Varicose veins of bi low extrem w oth complications
I83.899	Varicos vn unsp lower extremity with other complications
I87.2	Venous insufficiency (chronic) (peripheral)

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