Evidence-based medicine is the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients.¹⁴ Guidelines for the care of patients with varicose veins, as recommended in this report, are based on scientific evidence. The need for adopting evidence-based guidelines and reporting standards for venous diseases has long been recognized by international experts¹⁵ and by leaders of the SVS¹⁶ and AVF.^{17, 18, 19, 20} To define current guidelines, members of the Venous Guideline Committee reviewed the relevant literature, including previously published consensus documents and guidelines,^{21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31} meta-analyses,^{6, 7, 8, 9, 10, 11, 12, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42} the AVF reports on the Venous Summit at the 2006 and 2009 Pacific Vascular Symposiums^{13, 43, 44, 45, 46} and considered the recommendations published in the third edition of the Handbook of Venous Disorders, Guidelines of the American Venous Forum.⁴⁷

The guidelines in this publication are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system, as it was described by Guyatt et al (Table I).⁴⁸ For each guideline, the letter A, B, or C marks the level of current evidence. The grade of recommendation of a guideline can be strong (1) or weak (2), depending on the risk and burden of a particular diagnostic test or a therapeutic procedure to the patient vs the expected benefit. The words “we recommend” are used for GRADE 1—strong recommendations—if the benefits clearly outweigh risks and burdens, or vice versa; the words “we suggest” are used for GRADE 2—weak recommendations—when the benefits are closely balanced with risks and burdens.

In this document, the updated terminology for superficial, perforating, and deep veins of the leg and pelvis are used.^{49, 50} Definitions of varicose and spider veins as well as other manifestations of CVD follow recommendations of the CEAP classification and the recent update on venous terminology of the International Committee of the AVF.^{51, 52}

Varicose veins of the lower limbs are dilated subcutaneous veins that are ≥3 mm in diameter measured in the upright position.⁵³ Synonyms include varix, varices, and varicosities. Varicosity can involve the main axial superficial veins—the great saphenous vein (GSV) or the small saphenous vein (SSV)—or any other superficial vein tributaries of the lower limbs.

Most varicose veins are due to primary venous disease. The most frequent cause is likely an intrinsic morphologic or biochemical abnormality in the vein wall, although the etiology can also be multifactorial. Labropoulos et al⁵⁴ proposed that the origin of venous reflux in patients with primary varicose veins can be local or multifocal structural weakness of the vein wall and that this can occur together or independently of proximal saphenous vein valvular incompetence. Varicosities can also develop as a result of secondary causes, such as previous deep vein thrombosis (DVT), deep venous obstruction, superficial thrombophlebitis, or arteriovenous fistula. Varicose veins may also be congenital and present as a venous malformation.

Varicosities are manifestations of CVD.^{51, 52} CVD includes various medical conditions of long duration, all involving morphologic and functional abnormalities of the venous system manifested by symptoms or signs (or both), indicating the need for investigation and care. The term chronic venous disorder is reserved for the full spectrum of venous abnormalities and includes dilated intradermal veins and venules between 1 and 3 mm in diameter (spider veins, reticular veins, telangiectasia; CEAP class C₁).

Varicose veins can progress to a more advanced form of chronic venous dysfunction such as chronic venous insufficiency (CVI).^{55, 56} In CVI, increased ambulatory venous hypertension initiates a series of changes in the subcutaneous tissue and the skin: activation of the endothelial cells, extravasation of macromolecules and red blood cells, diapedesis of leukocytes, tissue edema, and chronic inflammatory changes most frequently noted at and above the ankles.^{41, 53} Limb swelling, pigmentation, lipodermatosclerosis, eczema, or venous ulcerations can develop in these patients.

In the adult Western population, the prevalence of varicose veins is >20% (range, 21.8%-29.4%), and about 5% (range, 3.6%-8.6%) have venous edema, skin changes or venous ulcerations. Active venous ulcers are present in up to 0.5%, and between 0.6% and 1.4% have healed ulcers.⁵⁷ On the basis of estimates of the San Diego epidemiologic study, more than 11 million men and 22 million women between the ages of 40 and 80 years in the United States have varicose veins, and >2 million adults have advanced CVD, with skin changes or ulcers.¹ The incidence of postthrombotic venous ulcers has not changed in the past 2 decades for women, and it recently increased in men.⁵⁸ In the United States each year, at least 20,556 patients receive a new diagnosis of venous ulcers.³

The Bonn Vein Study,⁵⁹ which enrolled 3072 randomly selected participants (1722 women and 1350 men), aged from 18 to 79 years, found symptoms of CVD in 49.1% of men and in 62.1% of women. Also reported were varicose veins without edema or skin changes in 14.3% (12.4% men, 15.8% women), edema in 13.4% (11.6% men, 14.9% women), skin changes in 2.9% (3.1% men, 2.7% women), and healed or active ulceration in 0.6% or 0.1%, respectively. A French cross-sectional survey found varicose veins in 23.7% of men and 46.3% of women.⁶⁰

The National Venous Screening Program, under the auspices of the AVF, screened 2234 Americans for venous disease.⁶¹ The participants' mean age was 60 years, 77% were women, and 80% were white. The CEAP clinical classification of C₀ to C₆ was 29%, 29%, 23%, 10%, 9%, 1.5%, and 0.5%, respectively. Reflux or obstruction was noted in 37% and 5% of participants, respectively.

Progression of primary varicosity to severe CVI and venous ulcer is not rare: in the North American subfascial endoscopic perforator surgery (SEPS) registry, more patients with advanced CVI had primary venous disease than post-thrombotic syndrome (70% vs 30%).⁶² Bauer⁶³ had already observed in 1948 that 58% of his patients with advanced CVD, studied with phlebography, never had a previous DVT.

Varicose veins and venous ulcers can be a great financial burden to patients and to society. Varicose veins and associated complications may lead to chronic pain, disability, decreased quality of life (QOL), loss of working days, and early retirement. In the United States, the direct medical cost of CVD has been estimated to be between $150 million and $1 billion annually.^{3, 4} In the United Kingdom, 2% of the national health care budget per year (US $1 billion) is spent on the management of leg ulcers.¹

Venous ulcer is an under-recognized and undertreated disease. A recently published supplement of the Journal of Vascular Surgery details the noble goal of the Pacific Vascular Symposium 6 (PVS6) to lead a call to action to formulate a doable and achievable plan to reduce the incidence of venous ulcers in the United States by 50% in 10 years.⁶⁴

Superficial veins of the lower limbs are those located between the deep fascia, covering the muscles of the limb, and the skin. The main superficial veins are the GSV and the SSV. All previous names used to describe these vessels (greater, long, lesser) should be abandoned. The GSV originates from the medial superficial veins of the dorsum of the foot and ascends in front of the medial malleolus along the medial border of the tibia, next to the saphenous nerve (Fig 1). There are posterior and anterior accessory saphenous veins in the calf and the thigh. The saphenofemoral junction (SFJ) is the confluence of superficial inguinal veins, comprising the GSV and the superficial circumflex iliac, superficial epigastric, and external pudendal veins. The GSV in the thigh lies in the saphenous subcompartment of the superficial compartment, between the saphenous fascia and the deep fascia.

Fig 1

Medial superficial and perforating veins of the lower limb.

(Used with permission of Mayo Foundation for Medical Education and Research.)

The SSV is the most important posterior superficial vein of the leg (Fig 2). It originates from the lateral side of the foot and drains blood into the popliteal vein, joining it usually just proximal to the knee crease. The intersaphenous vein (vein of Giacomini), which runs in the posterior thigh, connects the SSV with the GSV.⁶⁵

Fig 2

Posterior superficial and perforating veins of the leg.

(Used with permission of Mayo Foundation for Medical Education and Research.)

Deep veins accompany the main arteries of the limb and pelvis. The deep veins of the calf (anterior, posterior tibial, and peroneal veins) are paired structures, and the popliteal and femoral veins may also be paired. The gastrocnemius and soleal veins are important deep tributaries. The old term superficial femoral vein has been replaced by the new term femoral vein.⁵² The femoral vein connects the popliteal to the common femoral vein.

The pelvic veins include the external, internal, and common iliac veins, which drain into the inferior vena cava (IVC). Large gonadal veins drain into the IVC on the right and the left renal vein on the left.

Perforating veins connect the superficial to the deep venous system (Fig 1). They pass through the deep fascia that separates the superficial compartment from the deep. Communicating veins connect veins within the same system. The most important leg perforating veins are the medial calf perforators.⁶⁶ The posterior tibial perforating veins (Cockett perforators in the old nomenclature) connect the posterior accessory GSV of the calf (the posterior arch vein in the old nomenclature) with the posterior tibial veins and form the lower, middle, and upper groups. They are located just behind the medial malleolus (lower), at 7 to 9 cm (middle) and at 10 to 12 cm (upper) from the lower edge of the malleolus. The distance between these perforators and the medial edge of the tibia is 2 to 4 cm.⁶⁶ (Fig 1). Paratibial perforators connect the main GSV trunk with the posterior tibial veins. In the distal thigh, perforators of the femoral canal usually connect directly the GSV to the femoral vein.

A thorough medical history is essential in the patient's evaluation and may establish the diagnosis of primary, secondary, or congenital varicosities. Questions to patients who present with varicose veins should address previous DVT or thrombophlebitis, established thrombophilia, medication history (particularly birth control pills), smoking, pregnancies, and a family history of varicosity or thrombotic disorders. Premenopausal women with varicose veins should also be questioned for symptoms of pelvic congestion syndrome (pelvic pain, aching, or heaviness; dyspareunia). Advanced age is the most important risk factor for varicose veins and for CVI. A positive family history, female sex, and multiparity are also risk factors for varicose veins, and a positive family history and obesity are risk factors for CVI.⁵⁷

The technique of venous duplex scanning has been described in detail previously by several authors.^{80, 83, 84, 85, 86, 87, 88} The pulsed-wave Doppler of 4 to 7-MHz linear array tranducers are used most frequently for the deeper veins, with the higher-frequency probes used more to assess the superficial veins. Evaluation of reflux in the deep and superficial veins with duplex scanning should be performed with the patient upright, with the leg rotated outward, heel on the ground, and weight taken on the opposite limb.⁵ The supine position gives both false-positive and false-negative results of reflux.⁸⁴

The examination is started below the inguinal ligament, and the veins are examined in 3- to 5-cm intervals. For a complete examination, all deep veins of the leg are examined, including the common femoral, femoral, deep femoral, popliteal, peroneal, soleal, gastrocnemial, anterior, and posterior tibial veins. The superficial veins are then evaluated, including the GSV, the SSV, the accessory saphenous veins, and the perforating veins.

The four components that should be included in a complete duplex scanning examination for CVD are (1) visibility, (2) compressibility, (3) venous flow, including measurement of the duration of reflux, and (4) augmentation. Asymmetry in flow velocity, lack of respiratory variations in venous flow, and waveform patterns at rest and during flow augmentation in the common femoral veins indicate proximal obstruction. Reflux can be elicited in two ways: increased intra-abdominal pressure using a Valsalva maneuver for the common femoral vein or the SFJ, or by manual compression and release of the limb distal to the point of examination. The first is more appropriate for evaluation of reflux in the common femoral vein and at the SFJ, whereas compression and release is the preferred technique more distally on the limb.⁸⁴ The advantage of a distal cuff deflation was emphasized by van Bemmelen et al.⁸⁵

The cutoff value for abnormally reversed venous flow (reflux) in the saphenous, tibial, and deep femoral veins has been 500 ms.⁸¹ International consensus documents previously recommended 0.5 seconds as a cutoff value for all veins to use for lower limb venous incompetence.^{5, 22, 86} This value is, however, longer, 1 second, for the femoral and popliteal veins.⁸¹ For the perforating veins, cutoff values of both 350 ms and 500 ms have been suggested.^{5, 81} The Committee recommends 500 ms as the cutoff value for saphenous, tibial, deep femoral, and perforating vein incompetence, and 1 second for femoral and popliteal vein incompetence.

Perforating veins have been evaluated in patients with advanced disease, usually in those with healed or active venous ulcers (CEAP class C₅-C₆) or in those with recurrent varicose veins after previous interventions. The diameter of clinically relevant “pathologic” perforators (eg, beneath healed or open venous ulcer) may predict valve incompetence. In a study by Labrapoulos et al,⁸⁷ a perforator vein diameter >3.9 mm had a high specificity (96%) but a low sensitivity (73%) to predict incompetence, given that almost one-third of the incompetent perforators had a diameter of <3.9 mm.^{87, 88} Sandri et al,⁸⁹ however, found that a perforator diameter of ≥3.5 mm was associated with reflux in >90% of cases. The SVS/AVF Guideline Committee definition of “pathologic” perforating veins includes those with outward flow of ≥500 ms, with a diameter of ≥3.5 mm, located beneath a healed or open venous ulcer (CEAP class C₅-C₆).^{5, 81, 88, 89}

Plethysmography (air or strain-gauge) is used for the noninvasive evaluation of calf muscle pump function, global venous reflux, and venous outflow obstruction.^{86, 94, 95, 96} Strain-gauge plethysmography is usually performed with a modified protocol of Struckmann, validated previously by comparison with simultaneously recorded ambulatory venous pressure measurements.^{97, 98, 99, 100} Strain-gauge or air plethysmography consists of exercise venous plethysmography, measurement of passive refill and drainage, and outflow plethysmography. Plethysmography quantifies venous reflux and obstruction and has been used to monitor venous functional changes and assess physiologic outcome of surgical treatments.⁹⁵ For more details of these examinations, the reader is referred to original articles^{94, 96, 97} and a recent relevant book chapter.¹⁰⁰

The use of plethysmography is less frequently indicated in patients with CEAP C₂ disease (simple varicose veins), but these studies provide information on venous function in patients with CVI, and they are complementary examination to duplex scanning. Examples for use in patients may include those with suspected outflow obstruction but normal duplex findings or those suspected of having venous disease due to calf muscle pump dysfunction, but no reflux or obstruction was noted on duplex scanning. Air plethysmography remains one of the few noninvasive techniques that can quantify reflux reliably^{98, 99} although other parameters have been reported to be variably useful. The Guideline Committee encourages using air plethysmography as “best practice” in the evaluation of patients with advance CVD if duplex scanning does not provide definitive diagnosis on pathophysiology (CEAP C₃-C₆).

Ascending or descending contrast venography for varicosities or other forms of CVD is performed selectively in patients with deep venous obstruction, in patients with post-thrombotic syndrome, and if endovenous or open surgical treatment is planned. It can be used with direct venous pressure measurements to evaluate patients with varicose veins and associated iliac vein obstruction (May-Thurner syndrome). Contrast venography is routinely used in CVD to perform endovenous procedures, such as angioplasty or venous stenting or open venous reconstructions.

Patients with simple varicose veins rarely require imaging studies more sophisticated than duplex ultrasonography. The techniques of CT and MR imaging have progressed tremendously in the past decade, and they provide excellent three-dimensional imaging of the venous system. MR and CT are both suitable to identify pelvic venous obstruction or iliac vein stenosis in patients with lower limb varicosity when a proximal obstruction or iliac vein compression (May-Thurner syndrome) is suspected.¹⁰¹ They are suitable to establish left renal vein compression (nutcracker syndrome),¹⁰² gonadal vein incompetence, and pelvic venous congestion syndrome. MR imaging with gadolinium is especially useful in evaluating patients with vascular malformations, including those with congenital varicose veins.

The cornerstone for management of CVD is the proper diagnosis and accurate classification of the underlying venous problem, which create the base for correctly directed treatment. The clinical and laboratory evaluation of the patient with varicose veins or more advanced CVD should be completed by establishing the clinical class of the disease. The CEAP classification was developed by the AVF in 1994 and later revised in 2004.^{76, 77} The classification is based on clinical signs of venous disease (C), etiology (E), anatomy (A), and the underlying pathophysiology (P).

Clinical class includes the full spectrum of venous disorders, from no signs of visible venous disease (C₀) to telangiectasia or reticular veins (C₁), varicose veins (C₂), edema (C₃), skin changes, such as pigmentation or eczema (C4_a) or lipodermatosclerosis or atrophie blanche (C_4b), and healed (C₅) or active (C₆) ulcer. The presence or absence of symptoms is also recorded as S (symptomatic) or A (asymptomatic).

Etiology can be congenital (E_c), primary (E_p), or secondary (E_s).

The anatomic classification separates superficial venous disease (A_s) from involvement of the perforators (A_p) or deep veins (A_d). Failure to identify an anatomic location is also coded (A_n).

Pathophysiology of the disease can be reflux (P_r), obstruction (P_o), or both. Failure to identify venous pathophysiology is also noted (P_n). Table II includes the full CEAP classification, and Table III lists the venous segments that can be involved in the disease.

The basic CEAP classification is a simplified version, suitable and easy for office use, and does not have the details of the comprehensive CEAP classification, which functions more as a research tool. As discussed in more detail by Meissner et al,¹³ for a patient with primary, symptomatic varicose veins and full saphenous and perforator incompetence (anatomic segments 2, 3, and 18 in Table III) with a small healed venous ulcer and skin pigmentation, the comprehensive CEAP classification would be C_2,4a,_5,SE_pA_s,p,P_r2,3,18.

Using the basic CEAP, the same patient would be classified as C_5,SE_pA_s,pP_r. In the basic CEAP classification, only the highest score is used to denote the clinical class and only the main anatomic groups (s, p, and d) are noted.

The revised format of the classification⁷⁷ includes two elements in addition to the C-E-A-P findings: the date of the examination and the level of the diagnostic evaluation:

• Level 1: History, physical examination, Doppler examination (handheld)

• Level 2: Noninvasive—duplex scan, plethysmography

• Level 3: Invasive or complex evaluation—contrast venography, venous pressure measurements, IVUS, CT venography, MR venography

The accuracy of the diagnosis increases with the addition of imaging and invasive testing. Recording the date and method used to confirm the clinical impression can be added in parentheses after the CEAP recording as follows:

• Full form: C_{2,4a,5, S} E_p A_{s, p} P_r2,3,18 (Level 2, Feb 8, 2010)

• Basic form: C_{5, S} E_pA_{s p}P_r (Level 2; Feb 8, 2010)

The main purpose of using the CEAP classification in patients with CVD is to distinguish primary venous disease from congenital varicosity and, most importantly, from secondary, post-thrombotic venous insufficiency.⁵³ Evaluation and treatment of the three conditions are distinctly different.

Generic QOL measures allow comparison with population norms and other disease states and provide a measure of any ill effects of treatment. Generic and disease-specific QOL measures are usually complementary and should be used together. Of the generic QOL instruments the Short Form 36-Item Health Survey (SF-36) has been used with success for assessment of global well-being of patients with varicose veins.^{105, 106}

Disease-specific QOL measurements are sensitive to the beneficial effects of treatment. Different disease-specific, patient-generated QOL tools and patient-reported outcomes (PROs) have been popular in venous disease reporting.^{107, 108} The most frequently used validated venous disease–specific instruments include the Venous Insufficiency Epidemiologic and Economic Study of Quality-of-Life (VEINES-QOL/Sym) questionnaire scale, the Chronic Venous Insufficiency Questionnaire (CIVIQ), the Aberdeen Varicose Vein Questionnaire (AVVQ), and the Charing Cross Venous Ulceration Questionnaire (CXVUQ).^{2, 109, 110, 111, 112, 113}

The VEINES instrument consists of 35 items in two categories that generate two summary scores.¹⁰⁹ The VEINES-QOL questionnaire comprises 25 items that study the effect of disease on QOL, and the VEINES symptom questionnaire (VEINES-Sym) has 10 items that measure symptoms. The focus of VEINES is on physical symptoms rather than psychologic and social aspects.

The CIVIQ 2 is a revision of an instrument developed to measure physical, psychologic, social, and pain factors.¹¹³ The revised version gives equal weight to each category, with 20 questions that provide a global score.³ CIVIQ has been used in studies^{3, 4} and proved to be a valid QOL measurement.

The AVVQ is a 13-question survey addressing all elements of varicose vein disease. Physical symptoms and social issues, including pain, ankle edema, ulcers, compression therapy use, and effect on daily activities, are examined in addition to cosmesis issues. The questionnaire is scored from 0 (no effect from varicose veins) to 100 (severe effect).^{114, 115}

The CXVUQ was developed to provide a QOL measure for patients with venous ulcers. It provides a consistent measure of patient-reported QOL in venous ulcers regardless of the treatment selected. Combining it with a generic measurement instrument may provide valuable information on the progression of ulcers and on the available treatment measures.³

Clinical outcome studies evaluate the results of procedures on patient-focused outcomes, including symptom improvement, recurrence of varicosity, healing or recurrence of skin ulcers, improvement in the chronic, progressive symptoms of CVD, improved QOL, and cosmetic improvement.¹²⁴

To report improvement in symptoms of CVD, we recommend the use of the revised VCSS in daily clinical practice.⁷⁸ For research and publications to report outcomes, one of the validated, disease-specific QOL instruments should be added, such as VEINES-QOL/Sym questionnaire scale, CIVIQ-2, the AVVQ, or the CXVUQ score in patients with advanced venous disease.^{2, 3, 109, 110, 111, 112, 113} A validated Likert pain scale can also be used, although most QOL questionnaires assess pain and discomfort.

We recommend using the basic CEAP clinical classification along with the revised VCSS in routine clinical practice. The revised VCSS is the best currently available instrument to quantify improvement and assess changes in the severity of CVD during follow-up (short-term, <1 year, midterm, 1-3 years, long term, >3 years; Table IV).¹⁰⁸ For research purposes, the complete CEAP classification should be used in addition to evaluation of QOL after treatment to help to assess the patient's perception of the burden of the disease. A general QOL instrument, such as the SF-36, and one of the disease-specific QOL instruments (eg, VEINES, CIVIQ, Aberdeen) should both be used for this purpose.

Patency of an ablated vein and the length of the patent or obstructed segment of the vein, as confirmed with duplex scanning, should be reported when assessing anatomic success. Postprocedural duplex scanning ≤1 month, at 1 year, at 1 to 3 years, and >3 years is important to define periprocedural, early, midterm, and late failures. Timing of the study is important because saphenous patency after ablation on a periprocedural duplex image (<3 days) indicates technical failure, whereas late patency after early occlusion suggests recanalization. The type of recurrence on late duplex scanning should also be documented, because recanalization of a previously occluded axial vein should be distinguished from neovascularization, which implies the presence of multiple small tortuous connections between the saphenous stump or the femoral vein and a residual saphenous vein or its tributaries.¹²⁴

Most patients who seek treatment for varicose veins have symptoms of aching, throbbing, feeling of a heavy leg, fatigue, cramps, pruritus, restless leg, ankle swelling, and tenderness or pain along bulging varicose veins. Some will have history of thrombophlebitis or bleeding from superficial varicose veins or have signs of more advanced CVD, such as edema, skin changes, including lipodermatosclerosis, eczema, pigmentation, atrophie blanche, corona phlebectatica, and healed or active ulceration. Less frequently, the veins are of cosmetic concern only.

A separate Cochrane review of 17 randomized controlled trials (RCTs) found that horse chestnut seed extract (aescin) was effective to decrease edema, pain, and itching.¹²⁹

The effect of pentoxifylline on ulcer healing was investigated in an RCT by Dale et al.¹³³ In a double-blind, placebo-controlled trial, complete healing of venous ulcers was observed in 64% of patients receiving pentoxifylline and in 53% of the patients receiving placebo. However, the difference was not statistically significant.

In another RCT, Falanga et al¹³⁴ investigated the effect of pentoxifylline on ulcer healing in 133 patients. Patients who were given 800 mg of pentoxifylline three times a day healed faster than those receiving placebo (P = .043). The median time to complete healing was 100, 83, and 71 days for placebo, pentoxifylline (400 mg), and pentoxifylline (800 mg) three times a day, respectively. A higher dose of pentoxifylline (800 mg three times a day) was more effective than the lower dose, although the higher dose had more significant gastrointestinal upset. The study concluded that pentoxifylline is effective in accelerating healing of leg ulcers.

In a more recent RCT, evidence to add pentoxifylline to a regimen of high-compression therapy to increase the chances of wound healing was of moderate quality.¹³⁵ Pentoxifylline increased the proportion of ulcer healing compared with placebo, although this finding was only statistically significant (P = .046) when a secondary adjusted analysis was conducted. Pentoxifylline in an oral dose of 400 mg three times daily is suggested to patients with venous ulcers in addition to local care, compression garment, or intermittent compression pump (ICP) in the venous guidelines of the American College of Chest Physicians (ACCP; GRADE 2B).¹³⁶

Reported case series of patients treated with elastic stockings frequently included the whole spectrum of patients with CVD (CEAP class C₀-C₆). Treatment with 30 to 40 mm Hg compression stockings in 112 patients (82% with varicose veins, 52% with edema, and 7% with healed or active ulcers) resulted in marked improvement in pain, swelling, skin pigmentation, activity, and well-being at 16 months after initiation of therapy, with compliance of 70%.¹⁴⁰

A large systematic review of compression hosiery for uncomplicated simple varicose veins was recently published by Palfreyman and Michaels.³⁴ They analyzed data of 11 prospective RCTs or systematic reviews, 12 nonrandomized studies, and 2 guidelines. Although compression improved symptoms, the study concluded that evidence is lacking to support compression garments to decrease progression or to prevent recurrence of varicose veins after treatment. However, these results could have been confounded by the high number of noncompliant patients included in these studies.³⁴

The level of compression for patients with class C₂ disease is also disputed. A meta-analysis by Amsler and Blattler¹⁴¹ of 11 RCTs suggested that in healthy patients, in those with C₁ to C₃ disease, and in those after varicose vein surgery, medium compression stockings (>20 mm Hg) may add no benefit over that obtained with a compression of between 10 and 15 mm Hg.

Until further data on appropriate tension of elastic garments are available, for patients with simple varicose veins (class C₂), the SVS/AVF Guideline Committee suggests graded prescription stockings with an ankle pressure of 20 to 30 mm Hg (GRADE 2C). The most common length recommended is knee-high stockings, although thigh-high stockings and pantyhose are also available and may be appropriate for many patients. Skin breakdown and frank necrosis after incorrectly measured or applied garments have been reported.¹⁴² The Committee recommends that only those with the necessary skills and training prescribe stockings for patients with venous disease.

The efficacy of conservative vs surgical treatment for varicose veins was studied in an RCT by Michaels et al.¹⁴³ The Randomised Clinical Trial, Observational Study and Assessment of Cost-Effectiveness of the Treatment of Varicose Veins (REACTIV) trial randomized 246 patients with simple varicose veins (class C₂) to conservative management or surgery. Conservative treatment included lifestyle advice relating to exercise, leg elevation, management of weight and diet, and the use of compression hosiery. In the surgical arm, patients received the same lifestyle advice but also underwent high ligation, stripping, and phlebectomies. In the first 2 years after treatment, there was a significant QOL benefit for surgery of 0.083 quality-adjusted life-years (QALY; 95% CI, 0.005-0.16 QALY) based on the SF-6D score (derived from scores on six domains of the SF-36) and 0.13 QALY (95% CI, 0.016-0.25 QALY) based on the EQ-5D score (a five-dimension descriptive system of health-related QOL). Considerable benefits were also seen in symptomatic and anatomic measures. The authors concluded that surgery provides more symptomatic relief and improvements in QOL than conservative management with compression hosiery and lifestyle modifications in patients with uncomplicated varicose veins.

The cost-effectiveness of conservative vs surgical therapy or sclerotherapy in patients with varicose veins was also studied in the REACTIV trial.¹⁴⁴ Cost-effectiveness analysis showed that surgery was significantly more cost-effective than both sclerotherapy and conservative management; sclerotherapy was less cost-effective than surgery but was still significantly more cost-effective than conservative treatment.

The need for a period of compression treatment before any intervention for simple varicose veins has been surrounded by controversy. Although third-party payers often require a trial of compression stockings, there is virtually no scientific evidence to support such a policy when saphenous ablation to treat superficial reflux is both more efficacious and cost-effective, a fact supported by data of the REACTIV trial. In addition, some patients, such as the obese or the elderly, may have difficulties applying an elastic stockings.¹³⁸ One study of predominantly elderly (mean age, 72 years) women with CVD found that 15% could not apply elastic stockings and 26% needed considerable help to do so.¹⁴⁵ On the basis of the available evidence, the Guideline Committee recommends against compression therapy being considered the primary treatment of symptomatic varicose veins (class C₂) in those patients who are candidates for saphenous vein ablation (GRADE 1B).

The term high ligation and division implies ligation and division of the GSV at its confluence with the common femoral vein, including ligation and division of all upper GSV tributaries.⁵¹ Partial or complete preservation of the upper GSV tributaries, when the GSV is ligated, stripped, or ablated, must therefore be clearly stated. The term stripping means removal of a long vein segment, usually of the saphenous vein, by means of a device.⁵¹

The SFJ is dissected through a 3- to 4-cm-long oblique incision made in the groin crease just lateral to the femoral artery. The cosmetic appearance of the scar of such an incision is excellent. The SFJ is dissected bluntly and sharply, minimizing injury to the surrounding lymphatic tissue to avoid lymphatic leak or lymphedema. The anterior wall of the common femoral vein is always visualized to ensure accurate ligation of the SFJ. All tributaries are ligated and divided, preferably to the secondary branches,¹⁷⁷ although firm evidence to support the need for this is not available. During dissection of the SFJ, the external pudendal artery is carefully preserved. Flush ligation of the saphenous vein is performed by double-ligating the vein with nonabsorbable suture close to the SFJ. It is important to avoid narrowing the femoral vein but equally important to minimize chances for a cul-de-sac in the saphenous vein stump.

To perform stripping, a flexible Codman stripper is often used for invagination stripping, without the removable acorn. The saphenous vein is tied to the tip of the stripper, and the vein is inverted into its lumen as the stripper is pulled down through a small incision made below the knee. Alternatively, an Oesch PIN stripper can be used.^{168, 169} Saphenous stripping below the knee is rarely performed today because of an increased incidence of reported saphenous nerve injury.¹⁶⁵ To decrease bleeding in the saphenous tunnel after stripping, we suggest that the perisaphenous space be infiltrated with tumescent anesthetic solution.

The operation is usually completed with a miniphlebectomy to remove the bulging varicose veins through a small stab wound. The incisions are then infiltrated with tumescent solutions, the groin incision is closed in layers with nonadsorbable sutures, and the stab wounds are closed with sterile adhesive strips. The extremity is bandaged with an elastic bandage to decrease the risk of bleeding and to decrease swelling and pain. The operation is an outpatient procedure.

Complete stripping of the SSV is rarely performed today because of possible injury to the sural nerve, but ligation of the SSV through a small transverse incision in the popliteal crease can be performed together with a limited invagination stripping of the vein to the mid calf, using the same technique described for GSV stripping. The safest technique to identify the SSV is intraoperative duplex scanning. There is no evidence that flush ligation is better than simple ligation of the vein when performed at a location closer to the skin, usually right in the knee crease. We recommend ligation of the SSV at this level, about 3 to 5 cm distal to the saphenopopliteal junction, since this can be performed through a very small skin incision and it avoids the need for deep dissection in the popliteal fossa, with the potential for associated wound complications or nerve injury.

To decrease hemorrhage within the saphenous tunnel and avoid any incision placed at the level of the knee, the technique of cryostripping has been suggested by some investigators.¹⁷⁹ Cryostripping is an alternative method to invagination stripping.¹⁸⁰ The technique is new in the United States and has not been fully evaluated.

For cryostripping, a cryosurgical system (Erbokryo CA, ERBE Elektromedizin GmbH, Tübingen, Germany), powered by liquid nitrogen, is used. After high ligation is completed, the cryoprobe is inserted into the saphenous vein and passed down to the level of the knee. As soon as the probe tip reaches the desired segment of the GSV, freezing is initiated. After the freezing cycle is maintained for a couple of seconds, the GSV is invaginated with an upward tug and is stripped toward the groin.

Ambulatory phlebectomy (stab or hook phlebectomy or miniphlebectomy) includes removal or avulsion of varicose veins through small stab wounds, made with a No. 11 Beaver blade or a 15° ophthalmologic blade, or through the puncture hole made with a larger, 19-gauge needle. Avulsion of the varicose veins is performed with hooks or forceps.^{172, 173} The most widely known hooks are Müller, Oesch, Tretbar, Ramelet, Varady, and Dortu-Martimbeau phlebectomy hooks.^{172, 173, 181} The veins are marked before surgery on the patient's skin with a marker, with the patient standing. The operation is usually performed under tumescent local anesthesia, using a solution of 445 mL of 0.9% saline, 50 mL of 1% lidocaine with 1:100,000 epinephrine, and 5 mL of 8.4% sodium bicarbonate.¹⁸¹

A rigid cannula with a light source can be used to inject the tumescent solution and also to transilluminate the subcutaneous tissues under the varicose veins.¹⁸² Injection of the tumescent solution can be performed using a large syringe or a Klein infiltration pump.^{181, 183} Digital compression is applied immediately, and infiltration of the wound with tumescent solution also provides good hemostasis. The skin incisions are usually approximated with sterile adhesive strips, and compression is applied to the extremity from foot to groin with an elastic compression bandage or compression stocking.

The CHIVA technique is a hemodynamic approach to varicose veins based on the principles of preserving the saphenous vein and venous drainage into the deep system.^{186, 190} The goal of CHIVA is to decrease the hydrostatic pressure in the saphenous veins and tributaries by the ligations placed in specific areas in the superficial venous system and to maintain the drainage function of the superficial veins, usually via a reversed flow.¹⁸⁶ It represents a systematic approach to varicose veins rather than a single operative procedure.

Several anatomic patterns of reflux have been identified, each requiring a somewhat different operative strategy based on the underlying anatomy, studied in utmost detail with duplex scanning.¹⁸⁸ A frequently used CHIVA technique presented in an RCT included proximal ligation of the incompetent saphenous vein; ligation, division, and avulsion of the incompetent varicose tributaries; and maintaining patency of the saphenous trunk, the competent saphenous tributaries, and saphenous venous drainage to the deep system through the so-called reentry perforators.¹⁹¹ A recently published RCT presented further details of the technique in six different types of varicosity.¹⁹²

Selective prophylaxis after risk assessment is warranted in patients who undergo venous surgery. The risk of DVT is increased in patients with thrombophilia, in those with a history of DVT or thrombophlebitis, and in obese patients. Similarly to the recently published ACCP guidelines,¹⁵⁹ we recommend, for patients who do not have additional thromboembolic risk factors, that surgeons not routinely use specific thromboprophylaxis other than early and frequent ambulation (GRADE 2B). For those with additional thromboembolic risk factors, we recommend thromboprophylaxis with low-molecular-weight heparin, low-dose unfractionated heparin, or fondaparinux (GRADE 1C).

HL/S of the GSV reduced the risk of reoperation by two-thirds at 5 years after surgery in a prospective randomized study reported by Dwerryhouse et al.¹⁹⁶ The authors randomized 133 legs of 100 patients to high ligation or HL/S. The need for reoperation was 6% in patients who underwent HL/S vs 20% in those patients who underwent high ligation alone (P > .02). The reason for this is that patients with only high ligation have recurrent reflux in the residual GSV, which causes new symptoms and increases the risk of reoperation.

In an RCT, Frings et al¹⁹⁷ found more neovascularization in patients who had the endothelium of the saphenous stump exposed vs those who had the saphenous stump oversewn with a running nonabsorbable polypropylene suture. (Neovascularization has been defined as the presence of multiple new small tortuous veins in anatomic proximity to a previous venous intervention.⁵¹) No conclusion could be reached, however, on the type of suture used to ligate the stump. Neoreflux was the same after ligature with absorbable suture vs nonabsorbable suture.

An RCT by Winterborn et al¹⁹⁸ observed no difference in varicose vein recurrence if a standard saphenofemoral ligation (transfixation and ligation using nonabsorbable suture, with exposed endothelium of the stump) or a flush saphenofemoral ligation (the stump was oversewn with a running polypropylene suture, with no endothelium exposed) was used. At 2 years, the recurrence rate was 33% in the standard group and 32% in the flush group (P = .90). Neovascularization was present in 22% in standard group and in 19% in the flush group (P = .57).

Another RCT on 389 limbs by van Rij et al¹⁹⁹ observed that placement of a polytetrafluoroethylene (PTFE) patch over the SFJ halved recurrence at 3 years compared with controls and that a synthetic patch was an effective mechanical suppressant of neovasculogenesis at the groin. These findings were not confirmed, however, in a smaller RCT by Winterborn and Earnshaw.²⁰⁰ This study randomized 40 legs to insertion or no insertion of a PTFE patch over the ligated SFJ. The overall complication rate was 35% (11 legs), with no statistically significant difference between the groups. By 2 years postoperatively, duplex imaging showed neovascularization had developed at the SFJ in 4 of 16 legs without a patch and in 5 of 16 legs with a patch (P = 1.0). We recommend double ligation of the SFJ with nonabsorbable suture (GRADE 1C), but we suggest against using a PTFE patch to cover the saphenous stump (GRADE 2C).

Using conventional stripping techniques, the incidence of saphenous nerve injury in one study was 7% in patients who had stripping to the knee and 39% in those who had stripping to the ankle.¹⁶⁵ Sural nerve injury occurred at a rate of 2% to 4%. Common peroneal nerve injury occurred in 4.7% in one series and in 6.7% in another series in those patients who underwent SSV ligation or stripping.²⁰⁷

Injury to the femoral vein or artery during high ligation of the saphenous vein is, fortunately, very rare. Consequences can be disastrous, because most are not recognized immediately,²⁰⁸ and a delay in treatment may result in massive DVT or even loss of the limb from the severe arterial injury.

An RCT by Menyhei et al¹⁷⁹ randomized 160 patients to high ligation, division, and cryostripping vs conventional stripping. No differences in QOL measures were noted by the SF-36 questionnaire at 6 months between the two groups. Bruising was more frequent after conventional stripping (P = .01), but there was no difference in pain score or complications. Two patients from the conventional stripping group and six from the cryostripping group were excluded from analysis because of incomplete stripping. Experience with this technique in the United States is limited, and at this time no recommendation is made.

High quality evidence indicates that superficial vein surgery reduces ulcer recurrence. The ESCHAR study,^{156, 157} as discussed earlier, randomized 500 patients with leg ulcers, who had isolated superficial venous reflux or mixed superficial and deep reflux, to compression treatment alone or to compression combined with superficial venous surgery. Compression consisted of multilayer compression bandaging, followed by class 2 below-knee stockings. Surgery included high ligation, division, and saphenous stripping. Rates of healing at 24 weeks were similar in both groups (65% vs 65%; hazard ratio, 0.84; 95% CI, 0.77-1.24; P = .85), but 12-month ulcer recurrence rates were reduced in the compression with surgery group (12% vs 28%; hazard ratio, −2.76; 95% CI, −1.78 to −4.27; P < .0001). The difference in ulcer recurrence rates between the two groups at 4 years was significant.¹⁵⁷

A limited number of studies, both retrospective and prospective, have been performed. Overall, reported complications after TIPP have varied considerably and include ecchymosis and hematoma in 4.9% to 95%, paresthesias and nerve injury in 9.5% to 39%, skin perforation in 1.2% to 5%, superficial phlebitis in 2.4% to 13%, swelling in 5% to 17.5%, hyperpigmentation in 1.2% to 3.3%, residual or recurrent varicose veins in 9.1% to 21.2%, and DVT in <1%.^{174, 210} In a comparison between TIPP and stab phlebectomy, TIPP revealed a difference in the number of incisions¹⁷⁴ and in the speed of the procedure.^{178, 179} However, there was no difference in bruising, cellulitis, and numbness at 1 to 2 weeks; nerve injury, residual veins, cosmesis score, and overall satisfaction at 6 weeks; and cosmesis or recurrence at 6 and 12 months. A learning curve to determine just how aggressive the surgeon can be during the procedure to eliminate all veins while minimizing bruising and other local complications has also been noted.^{211, 212} These reports, however, used an early-generation system, higher oscillation speeds (800-1200 rpm), and minimal tumescence.

With a newer-generation system and technical modifications incorporating a lower oscillation frequency (300-500 rpm), a dermal punch drainage technique, secondary tumescence with extensive flushing of residual hematoma and residual venous tissue fragments, and an additional tertiary subdermal tumescence phase, the results of powered phlebectomy have improved.²¹³ The largest series²¹⁴ using modified techniques included 339 patients with a mean operative time of 19.7 minutes, and >60% of cases involving 10 to 20 incisions. Discoloration of the skin was noted in eight patients (2.3%), excessive or hypertrophic scarring in two (0.6%), and cellulitis in one (0.3%). There were no significant hematomas and no recurrent varicose veins at 12 weeks in this series, and overall, 99.7% reported good outcomes and satisfaction.

Although no published data clearly show any statistically significant advantage of TIPP over conventional phlebectomy except for fewer incisions, most published literature represents earlier-generation systems and techniques. With the newer-generation system and modified technique and learning curve adjustments, TIPP has become less traumatic, which may decrease potential complications and improve outcomes over those previously reported. Until new trials are performed, any additional potential benefits of TIPP have yet to be substantiated.

Two RCTs^{188, 191} compared standard treatment (compression or high ligation, stripping, and phlebectomy) with CHIVA approaches with specific anatomic patterns of reflux (types I and III shunts). For the specific venous anatomy evaluated in these trials, such techniques were better than compression in preventing ulcer recurrence¹⁸⁸ and were at least equivalent to stripping of varicose veins.¹⁹¹

In a single-center RCT, Zamboni et al¹⁸⁸ used CHIVA or compression to treat 47 legs with venous ulcers. At a mean follow-up of 3 years, healing was 100% (median healing time, 31 days) in the surgical group and 96% (median healing time, 63 days) in the compression group (P < .02). The recurrence rate was 9% in the surgical group and 38% in the compression group (P < .05). The study excluded patients with post-thrombotic syndrome, deep vein reflux or obstruction, or excessive ulcers (>12 cm).

In a recent open-label, single-center RCT, Pares et al¹⁹² randomized 501 patients with primary varicose veins into three arms: CHIVA, stripping with clinic marking, and stripping with duplex marking. The primary end point was recurrence within 5 years, assessed clinically by independent observers. Clinical outcomes in the CHIVA group were better (44.3% cure, 24.6% improvement, 31.1% failure) than in the stripping with clinic marking (21.0% cure, 26.3% improvement, 52.7% failure) and stripping with duplex marking (29.3% cure, 22.8% improvement, 47.9% failure) groups. The OR between the stripping with clinic marking and CHIVA groups, of recurrence at 5 years of follow-up, was 2.64 (95% CI, 1.76-3.97; P < .001). The OR of recurrence at 5 years between the stripping with duplex marking and CHIVA group was 2.01 (95% CI, 1.34-3.00; P < .001).

Although the first two RCTs focused on a small group of patients with varicose veins, the trial of Pares et al¹⁹² deserves credit for including the full spectrum of patients with primary varicose veins. CHIVA is a complex approach, and a high level of training and experience is needed to attain the results presented in this RCT. However, the results achieved by a few outstanding interventionists does not support offering this procedure to all practitioners. Although CHIVA has called attention to the importance of directing surgical procedures toward the patient's venous anatomy and function, it still requires considerable education of venous interventionists willing to learn this approach.

Treatment of symptomatic recurrent varicose veins should be performed after careful evaluation of the patient with duplex scanning to assess the etiology, source, type, and extent of recurrent varicose veins. Sites of reflux at the SFJ or saphenopopliteal junction and at the sites of clinically important perforating veins should be searched. Duplex scanning is excellent in identifying residual saphenous stumps, but it has a sensitivity of 62% and a positive predictive value of only 26% to identify correctly the presence of neovascularization.²²⁴ Histologic examination is still the gold standard when trying to differentiate between different types of groin recurrences. If perineal or medial thigh varicosity suggests pelvic reflux, evaluation with transvaginal ultrasonography may be used, although the gonadal and pelvic veins are best evaluated with MR or contrast venography.^{225, 226}

To select the right patient for endovenous thermal ablation, thorough preprocedural duplex ultrasonography must be performed. The identification of all refluxing venous segments and their ablation during the procedure is the key to minimizing recurrence of varicose veins. Inappropriate vein size (<2 mm and >15 mm for RFA), a history of superficial thrombophlebitis resulting in a partially obstructed saphenous vein, and the uncommon occurrence of a tortuous GSV on duplex examination are potential contraindications. Patients with ropy varicose veins located immediately under the skin or those with aneurysmal dilations of the SFJ are probably better served with conventional high ligation, division, and stripping. Those with extensive deep venous occlusion should undergo superficial ablation selectively, because superficial veins in these patients may be important for venous outflow from the leg.

There are no absolute contraindications to EVLA, including vein diameter, although Lawrence et al²⁶² have recently suggested an association of central GSV diameter >8 mm with increased risk of extension of thrombus into the femoral vein. Other relative contraindications to endovenous saphenous vein ablation (EVLA or RFA) include uncorrectable coagulopathy, liver dysfunction limiting local anesthetic use, immobility, pregnancy, and breastfeeding.

The techniques of vein ablations using EVLA or RFA are similar. For GSV ablation, the patient is placed in the reverse Trendelenburg position first, and the GSV is accessed percutaneously under ultrasonographic guidance using a micropuncture needle inserted into the vein just distal to the knee. Treatment is usually limited to the above-the-knee segment of the vein to avoid injury to the saphenous nerve, which is close to the saphenous vein in the calf (Fig 1). A microguidewire is inserted in the vein, followed by placement of a 4F microsheath. With the help of a floppy guidewire, the sheath is exchanged for a 5F sheath, allowing placement of the laser fiber or for an 11-cm-long 7F sheath for placement of the RF catheter.

The laser fiber or RF probe is introduced through the sheath into the GSV and advanced proximally to the SFJ. The tip of the catheter is then positioned 1 cm distal to the confluence with the superficial epigastric vein or 2 cm distal to the SFJ. The patient is then placed in the Trendelenburg position and the vein emptied by elevation and compression by instillation of perivenous tumescent anesthesia with a diluted anesthetic solution (100-300 mL of the 500-mL solution of 445 mL of 0.9N saline, 50 mL of 1% lidocaine with 1:100,000 epinephrine, and 5 mL of 8.4% sodium bicarbonate)²³² into the saphenous subcompartment. The vein can be further compressed by applying negative pressure in the side port with a 20-mL syringe. Tumescent anesthesia enhances contact of the vein wall with the catheter or laser fiber for therapeutic effectiveness and provides analgesia and a heat sink around the treated vein, thereby decreasing heat-related injury to surrounding tissues, which is reflected in a lower incidence of skin burns and paresthesias.

The vein is then ablated in a retrograde fashion to just above the puncture site. The laser fiber is withdrawn at a rate of 1 to 2 mm/s for the first 10 cm and 2 to 3 mm/s for the remaining distance. For optimal treatment, 50 to 80 J/cm energy is delivered when using the 810-nm diode laser. With the RF catheter system, sequential heating of the vein is performed at 7-cm intervals, heating the vein to 120°C in each 20-second cycle. The first segment is treated twice. At the end of the procedure, the saphenous vein is reimaged to confirm successful obliteration and absence of thrombus protrusion into the femoral vein or, if the SSV was treated, into the popliteal vein. If a patent segment is identified, re-treatment is advisable.

Graduated compression stockings with an ankle pressure of 30 to 40 mm Hg or an elastic or nonelastic wrap is placed on the leg at the end of the procedure. Early ambulation is encouraged, and the patient leaves for home a few hours after the procedure. Recent evidence supports elastic compression for at least 1 week after superficial venous interventions.²⁰⁵ During this time, the patient is asked to have compression of the leg day and night. Although the risk of DVT, heat-induced thrombus extension, or PE is rare^{263, 264} and therefore the yield is low, we suggest postprocedural duplex scanning within 24 to 72 hours to exclude any thrombotic complication. Evidence to support this recommendation is of low quality (GRADE 2C).

Data to support the routine administration of thromboprophylaxis with heparin are not available. Selected patients with a history of thrombophlebitis, DVT, known thrombophilia, or obesity are candidates for thrombosis prophylaxis.¹⁵⁹ In one case series, age >50 years was a predictor of heat-induced thrombus extension into the femoral vein.²⁴⁶ Lawrence et al²⁶² reported 500 patients who underwent RFA, and 13 (2.6%) experienced thrombus bulging into the femoral vein or adherent to its wall, which was treated with low-molecular-weight heparin. All of these patients had thrombus retraction to the level of the SFJ in an average of 16 days. A significantly higher rate of proximal thrombus extension was noted in those patients with a history of DVT and in those with a GSV diameter of >8 mm (P < .02).

For high-risk patients, several interventionists use a single, preventive dose of low-molecular-weight heparin before or at the beginning of the procedure, although data on the effectiveness of such prophylaxis are not available.²⁴⁶ Performing the operation as an outpatient procedure under local or tumescent anesthesia permits early ambulation that decreases the risk of thromboembolic complications. In addition, the use of elastic compression and frequent leg elevation are also aimed at prevention of DVT or PE.

In an international endovascular working group registry that included 3696 procedures, bruising after EVLA was observed in 75%, paresthesia in 3%, thrombophlebitis in 1.87%, skin burns in 0.46%, and DVT or endovenous heat–induced thrombosis in 0.27%.²⁶³ Only one patient had a PE. In 509 patients treated with laser by Myers and Jolley,²⁶⁴ thromboembolic complications occurred in 3%. Knipp et al²⁶⁸ observed a DVT rate of 2.2% in patients who underwent EVLA with phlebectomy or perforator ligation and a thrombus extension rate into the femoral veins of 5.9%. When EVLA alone was performed, there was 0% true DVT but a high thrombus extension rate (7.8%) into the femoral vein. The risk-adjusted thrombosis prevention protocol in this study had no effect on thrombus extension rate into the femoral vein. Puggioni et al²⁴⁶ observed a 2.3% rate of thrombus extension into the femoral vein after EVLT.

Laser treatment of the SSV may result in sural nerve paresthesia, with an incidence of 1.3% in the series of Huisman et al.²⁶⁷ Superficial thrombophlebitis developed in 6 of 169 patients (3.5%) in this study, but serious complications did not occur.

Evidence to support the efficiency of higher-wavelength vs lower-wavelength laser fibers has been controversial. A prospective, randomized, single-center, single-surgeon trial evaluated lasers with 810- or 980-nm wavelengths.²⁴³ Thirty legs were treated for each group by a surgeon blinded for the type of laser. Patients in the 980-nm group showed less bruising than those in the 810-nm group (P < .005). Saphenous occlusion rates at 1 year, however, were identical, and no major complications occurred in either group. Studies by Proebstle et al²⁴⁰ and Pannier et al,²⁶⁹ however, suggest that laser light with longer wavelengths (1320-nm Nd:YAG laser, 1470-nm diode laser) may reduce adverse effects without compromising abolition of reflux.

Another recent development is the introduction of the ELVeS Radial Fiber, a fiber with a radial emitting laser tip (Biolitec AG, Jena, Germany), which may decrease the amount of energy required to occlude the vein, thus decreasing pain and adverse effects of thermal ablations. A RCT by Doganci and Demirkilic²⁷⁰ compared early occlusion rates of two different laser fibers. The immediate occlusion rate was 100% for both the 980-nm laser and bare-tip fiber and the 1470-nm laser with the radial fiber. Other clinical trials with such fibers are under way.

Serious complications from RFA, such as DVT or thermal skin injury, were not observed in a multicenter, nonrandomized study of RFA using the new-generation RF catheter system.²⁶⁰ Paresthesia occurred in 3.2%, thrombophlebitis in 0.8%, ecchymosis along the course of the GSV in 6.3%, and skin pigmentation in 2%. Lawrence et al²⁶² reported a 2.6% rate of thrombus extension into the femoral veins after 500 RF procedures. No femoral DVT occurred. The rate of proximal thrombus extension was significantly higher in patients with a history of DVT and in those with a GSV diameter of >8 mm (P < .02).

Four RCTs compared the results of RFA with those of high ligation, division, and stripping.^{195, 278, 280, 281, 282} Rautio et al²⁷⁸ from Finland reported results of a single-center randomized trial in 28 patients. Results at 3 years from the same study were reported later by Perälä et al.²⁸³ This study found significantly less pain with faster recovery and earlier return to work after RFA than after surgery (6.5 days vs 15.6 days). Perioperative costs were higher for RFA ($794 vs $360), but total societal costs were lower ($1401 vs $1926).

Lurie et al reported results of the Endovenous Radiofrequency Obliteration (Closure procedure) versus Ligation and Stripping (EVOLVeS) study at 4 months¹⁹⁵ and at 2 years.²⁵⁶ This international, multicenter, prospective study randomized 85 patients to RFA or HL/S. The RFA group had faster recovery, less postoperative pain, fewer adverse events, and superior QOL scores (P < .05). Clinical and hemodynamic outcomes of RFA were comparable to vein stripping at 2 years. The study found that at 2 years, 91.2% of limbs in the RFA group were free of superficial reflux vs 91.7% in the surgical group (P = NS).

Stötter et al²⁸¹ reported results of a single-center RCT from Germany comparing RFA with PIN stripping or cryostripping, with 20 patients in each of the 3 groups. At 1 year, RFA showed significantly better results in QOL and pain assessment, and the authors found significant superiority regarding return to routine activity and work.

Hinchcliffe et al²⁸² reported the results of a single-center trial comparing RFA with open surgery in 16 patients with bilateral recurrent GSV varicose veins after previous bilateral high ligation without stripping. One leg chosen at random was treated with RFA, the other with stripping, and both sides had phlebectomies. The time required to perform RFA was significantly shorter (25 vs 40 minutes), and pain and bruise scores were significantly lower for RFA than for stripping. Follow-up was 1 year. The authors concluded that RFA is the technique of choice to treat the incompetent GSV.

The Committee noted that these studies had short-term to medium-term follow-up, 1 year in two studies, 2 years in one study, and 3 years in the fourth study. RFA treatment resulted in faster return to work and normal activities, higher patient satisfaction, less pain, and better short-term QOL scores, with high-quality evidence confirming early efficacy and safety. The studies, however, did not report bias protection measures; therefore, the evidence of midterm efficacy is of low quality and no evidence is available on long-term efficacy.

Hypertonic saline is a weak hyperosmolar sclerosing agent that causes dehydration of endothelial cells through osmosis, which leads to endothelial cell death. The usual concentration is used in 23.4% sodium chloride. One formulation is manufactured as Sclerodex (Omega Laboratories Ltd, Montreal, Quebec, Canada). Burning pain is frequent during injection. Extravasation may cause skin ulcers and tissue necrosis, and osmotic agents are used for occlusion of small veins only.

Detergents destroy the endothelium by denaturation of the cell surface proteins. STS (as Sotradecol, Bioniche Pharma USA, Lake Forest, Ill; Fibro-Vein, STD Pharmaceutical Products Ltd, Hereford, UK; Tromboject, Omega Laboratories) is a long-chain fatty alcohol. A critical micellar concentration is needed to cause endothelial cell injury, and repeated treatments are frequently desirable. The solution is safe and painless when injected. When the solution is injected in higher concentration, extravasation may result in tissue necrosis. Hyperpigmentation, matting, and allergic reactions have been described. Foaming of this agent is easy and will result in longer exposure of the agent to the vein wall using a smaller amount of the solution.

Polidocanol (Asclera injection, Bioform Medical Inc, San Mateo, Calif), another detergent, was approved for use in the United States in 2010. This is the most commonly used sclerotherapy agent in the world; it is safe and painless when injected, with a low risk of tissue necrosis when used in a low concentration. It may cause hyperpigmentation, but has a very low rate of allergic or anaphylactic reaction.

Morrhuate sodium (Scleromate, Glenwood, LLC, Englewood, NJ) is a detergent that is used less frequently because of the relatively higher incidence of skin necrosis observed with extravasation and because of the higher risk of anaphylactic reactions.

The sclerosing chemicals need to be diluted before use, and the concentration of the solution should be the lowest when used for treatment of very small diameter veins, such as telangiectasia. Recommended concentrations of STS and polidocanol are listed in Table VIII.

Liquid sclerotherapy is performed using small tuberculin syringes and a 30- or 32-gauge needle. Treatment is usually started with larger varicose veins and ends with reticular veins and telangiectasia. The proximal part of the limb is treated first and the distal part second. Using loupes for magnification and transillumination (Veinlite, TransLite, Sugar Land, Tex; VeinViewer, Luminetx, Memphis, Tenn) helps intraluminal injection and avoids extravasation of the drug. The injection maximum of 1.0 mL of the chemical to one site is recommended, with not more than 10 to 20 injections performed per session. Severe pain during injection may signal extravasation, and further injection should be avoided.²⁹ Gauze pads are placed on the injection sites, and the patient is instructed to wear 30 to 40 mm Hg graduated compression stockings for 1 to 3 days after treatment of telangiectasia and reticular veins and at least 1 week after treatment of varicose and perforating veins.

Foam sclerotherapy of the saphenous vein is the least invasive of the endovenous ablation techniques. The European Consensus Meetings on Foam Sclerotherapy^{308, 309} reported that foam was an effective, safe, and minimally invasive endovenous treatment for varicose veins with a low rate of complications.

The most popular technique used today was developed by Tessari et al³¹² using a three-way stopcock connected with two syringes. Experts recommend a ratio of 1 part solution of STS or polidocanol to 4 or 5 parts of air.³¹³ Mixing the drug with air using the two syringes and pushing the mixture from one syringe into the other 20 times results in an approximate bubble size of <100 μm.

Coleridge-Smith³⁰⁶ advises to cannulate the veins in supine patients and then elevate the limb 30° to inject the foam. Ultrasonography is used to monitor the movement of foam in the veins. The saphenous trunk is injected first, followed by varicose and perforating veins if indicated. A maximum of 20 mL of foam is injected during one session. Bergan³¹³ recommends elevation of the limb for 10 to 15 minutes after injection to minimize the volume of foam that gets into the systemic circulation. The procedure is completed by placing a short stretch bandage or 30 to 40 mm Hg graduated compression stockings (or both) on the limb. Although most authors recommend 1 to 2 weeks of compression,^{313, 314} a recent RCT found no advantage to compression bandaging for >24 hours when thromboembolus-deterrent stockings were worn for the remainder of 14 days.³¹⁵

Severe complications after sclerotherapy, such as death, anaphylactic reaction, pulmonary emboli, stroke, and large areas of skin necrosis, are very rare (<0.01%).³¹⁶ Severe but rare complications also include thrombophlebitis, nerve damage (saphenous, sural), DVT, or inadvertent arterial injection of the solution.^{317, 318} Transient neurologic adverse effects such as visual disturbance, migraine-like headache, or confusional state may occur and are more frequent in patients with a patent foramen ovale.³¹⁹

Most complications are minor, and include matting, pigmentation, pain, allergy, and skin urticaria. The higher the concentration of the agent, the higher the likelihood of hyperpigmentation, a minor complication that can be observed in up to 30% of the cases.³²⁰ Between 70% and 95% of the pigmentations, however, resolve by 1 year after therapy.³¹⁷

The incidence of major neurologic events after foam injection is rare; instances of stroke were reported by Bush et al³²¹ and others.^{319, 322, 323} Immediate treatment with 100% oxygen and possibly hyperbaric oxygen therapy should be considered. Factors implicated in the risk of stroke after foam sclerotherapy include the use of air instead of carbon dioxide to prepare the foam, large bubble size, a patent foramen ovale, failure to elevate the limb after treatment, prolonged immobility after therapy, and an excessive amount of foam used during one session.^{319, 322, 323, 324} Standardization of the bubble size using commercially prepared microfoam and the replacement of air with carbon dioxide in the solution may decrease the risk of neurologic complications.³²⁵

A recent study Regan et al³²⁶ proposed that the composition and properties of the foam, including bubble size and gaseous components, may indeed contribute to the potential for microcirculatory obstruction and cerebral ischemia. The authors tested an ultralow nitrogen polidocanol endovenous microfoam with controlled bubble size and density and found that patients treated with foamed liquid sclerosants are commonly exposed to cerebrovascular gas bubbles. In a series of 60 high-risk patients with middle cerebral artery bubble emboli during or after treatment, however, there was no evidence of cerebral or cardiac microinfarction.

Although rare, allergic reactions and anaphylaxis after injection of a sclerosing solution can occur, and it is essential to have an emergency protocol, resuscitation equipment, oxygen, and drugs (diphenhydramine, epinephrine, cimetidine, steroids) available to prevent a major catastrophe.

Guex et al²⁹⁶ reported early and midterm complications in a prospective multicenter registry that included 12,173 sclerotherapy sessions, consisting of 5434 with liquid, 6395 with foam, and 344 using both. Ultrasonographic guidance was used in 4088 sessions (33.9%), and 49 incidents or accidents (0.4%) occurred, of which 12 were with liquid and 37 with foam. There were 20 cases of visual disturbances, in 19 cases, foam or air block was used; all resolved shortly, without any after effects. A femoral vein thrombosis was the only severe adverse event in this study, which also demonstrated that sclerotherapy is a safe technique.

A systematic review of foam sclerotherapy also found a low rate of major complications.¹⁰ In >9000 patients studied, the median rates of serious adverse events, including PE and DVT, were rare, <1%. The median rate of visual disturbance was 1.4%, headache occurred in 4.2%, thrombophlebitis in 4.7%, matting, skin staining, or pigmentation in 17.8%, and pain at the site of injection in 25.6%.

Morrison et al³²⁷ evaluated the safety of carbon dioxide in patients undergoing 1% polidocanol foam sclerotherapy and compared them with a historical control of patients who had air mixed with the sclerosing agent. The carbon dioxide–based foam group had 128 patients (115 women and 13 men). Visual disturbances were experienced by 3.1% (4 of 128) of the carbon dioxide group and in 8.2% (4 of 49) of the air group (P = .15). The incidence of chest tightness (3.1% vs 18%), dry cough (1.6% vs 16%), and dizziness (3.1% vs 12%) was significantly lower in the carbon dioxide group compared with the air group (P < .02). Nausea occurred in 2% of the carbon dioxide foam group and in 4% of the air foam group (P = .53). Overall, the proportion of patients describing adverse effects decreased from 39% (19 to 49) to 11% (14 to 128) as carbon dioxide replaced air for foam preparation (P < .001). The authors concluded that adverse effects decreased significantly if carbon dioxide rather than air was used to make the sclerosing foam for chemical ablation of superficial veins of the lower extremity.

A Cochrane review in 2004 examined results of surgery vs sclerotherapy for the treatment of varicose veins. Rigby et al³³⁵ reviewed 2306 references that included 61 comparative studies and 9 randomized trials. The study observed a trend that sclerotherapy was better at 1 year and surgery had a better outcome at 3 to 5 years. The meta-analysis concluded, however, that there was insufficient evidence to preferentially recommend sclerotherapy for treatment of varicose veins over surgical treatment.

Wright et al³²⁵ reported the effect of polidocanol microfoam and compared its use with surgery or sclerotherapy in the management of varicose veins. This European RCT found that 1% microfoam was inferior to surgery but superior to conventional sclerotherapy. Foam resulted in less pain and earlier returns to work than surgery.

In a systematic review on foam sclerotherapy, Jia et al¹⁰ analyzed data of 69 studies, including 10 RCTs. All patients underwent foam sclerotherapy for varicose veins, most frequently with use of polidocanol to ablate the GSV or SSV. The median rate of complete occlusion of treated veins was 87%. Meta-analysis for complete occlusion suggested that foam sclerotherapy was less effective than surgery (RR, 0.86; 95% CI, 0.67-1.10) but more effective than liquid sclerotherapy (RR, 1.39; 95% CI, 0.91-2.11), although there was substantial heterogeneity between studies. The authors concluded that there is currently insufficient evidence to allow a meaningful comparison of the effectiveness of this treatment with that of other minimally invasive therapies or surgery.

SEPS is performed under general or epidural anesthesia. The single or the double endoscopic port techniques can be used for dissection and division of medial calf perforators.^{62, 348, 349, 350} Most authors use balloon dissection and carbon dioxide insufflation with a pressure of 30 mm Hg and a pneumatic thigh tourniquet inflated to 300 mm Hg to avoid any bleeding in the surgical field.³⁵⁸ Division of the fascia of the deep posterior compartment with a paratibial fasciotomy is required to identify all important medial perforating veins. Occlusion of the perforators can be done with endoscopic clips, although most surgeons use an ultrasonic harmonic scalpel for division and transection of the perforators. The wounds are closed, the tourniquet is deflated, and the extremity is wrapped with an elastic bandage. The operation is an outpatient procedure, and patients are encouraged to ambulate 3 hours after the operation.

The ClosureRFS Stylet is a new intravascular ablation device (VNUS Medical Technologies, San Jose, Calif) available for RFA of the perforating vein. Intraluminal placement of the RF stylet is confirmed by ultrasonography and also by measuring impedance: values between 150 and 350 ohms indicate the intravascular location of the tip of the probe. Local anesthesia is used to infiltrate the tissues around the stylet before treatment, and the patient is then placed in the Trendelenburg position. Treatment is performed with a target temperature of 85°C. All four quadrants of the vein wall are treated for 1 minute each. The catheter is then withdrawn 1 or 2 mm, and a second treatment is performed. The treatment is finished with applying compression to the region of the treated perforating vein.

For laser treatment of perforating veins, a 16-gauge angiocatheter (for a 600-μm laser fiber) or a 21-gauge micropuncture needle (for a 400-μm laser fiber) can be used.³⁵⁷ Intraluminal placement of the access catheter is confirmed by ultrasonography and by aspiration of blood at or just below the fascial level. Once the fiber is positioned in the vein at or just below the level of the fascia, local anesthesia is infiltrated, and various methods of energy application are used. Elias³⁵⁷ recommends a pulsed technique with the generator set for 15 watts and a 4-second pulse interval. Each segment of vein is treated twice, thus giving 120 J to each segment. Three segments are usually treated. Proebstle and Herdemann³⁵⁹ also treat the perforating veins at three locations, each segment receiving between 60 and 100 J. The rest of the procedure is similar to RFA.

SEPS is safe and complications are rare. Death or PE has not been reported, and the North American SEPS registry had no patient with DVT ≤30 days of the procedure. Wound infection and saphenous neuralgia occurred in 6% each. In an RCT, Pierik et al³⁶⁰ observed a significantly higher rate of wound complications after open perforator ligation, using a modified Linton procedure, than after endoscopic perforator ligation (53% vs 0%; P < .001).

Complications after PAPS are rare, and in a review of published series, O'Donnell³⁵⁶ found evidence of tibial vein DVT in three series and foot drop and skin burn in one each. Masuda et al³⁵¹ treated 80 limbs with sclerotherapy of the perforating veins. There were no cases of DVT involving the deep vein adjacent to the perforator injected. One patient had skin complications with skin necrosis.

In an RCT, Kianifard et al³⁶¹ analyzed the benefits of adding SEPS to saphenofemoral ligation and stripping of the GSV in patients with class C₂ disease. The study allocated 38 to the SEPS group and 34 to the no-SEPS group. The two groups were similar with respect to pain, mobility, varicose vein recurrence, and QOL scores during the 1-year follow-up. A significantly higher proportion of patients in the no-SEPS group had incompetent perforating veins on duplex imaging at 1 year (25 of 32 vs 12 of 38; P < .001). This RCT concluded that at 1 year in class C₂ patients, no additional clinical benefit could be observed when SEPS was added to HL/S.

This finding was supported by a prospective study by van Neer et al³⁶² in 62 limbs with class C₂ disease, who had varicose veins distal to the knee and underwent HL/S of the GSV to the level of the knee. Clinical and ultrasonographic residual varicose veins at 6 months were not significantly related to the presence of preoperative incompetent perforating veins.

The appearance of varices in the region of the pubis, labia, perineum, or buttocks suggests a pelvic source of reflux. Several noninvasive diagnostic tests are available, including lower extremity, transabdominal, and transvaginal ultrasonography as well as CT and MR venography.³⁷² All have been reported to be useful in documenting pelvic venous reflux, although the selection of the most appropriate test largely depends on local institutional expertise. An ovarian vein diameter of >6 mm on ultrasonography has been reported to have a 96% positive-predictive value for pelvic varices.³⁷³ MR and CT venography criteria for pelvic venous varices include four or more tortuous parauterine veins, parauterine veins >4 mm in diameter, and an ovarian vein diameter >8 mm.³⁷⁴

Retrograde ovarian and internal iliac venography is the test of choice for the diagnosis of pelvic venous disorders, although it is most often reserved for patients in whom intervention is planned. Venographic criteria for pelvic congestion syndrome include one or more of the following: (1) an ovarian vein diameter of ≥6 mm, (2) contrast retention for ≥20 seconds, (3) congestion of the pelvic venous plexus and/or opacification of the ipsilateral (or contralateral) internal iliac vein, or (4) filling of vulvovaginal and thigh varicosities.³⁷⁵

Various nonsurgical and surgical approaches are available to treat pelvic congestion syndrome. Pharmacologic agents to suppress ovarian function, such as medroxyprogesterone or gonadotropin-releasing hormone, may offer short-term pain relief, but their long-term effectiveness has not been proven. Surgical approaches, including hysterectomy with unilateral or bilateral oophorectomy and ovarian vein ligation and excision, with interruption of as many collateral veins as possible, have been suggested for patients unresponsive to medical therapy.³⁷³

Percutaneous transcatheter embolization of refluxing ovarian and internal iliac vein tributaries with coils, plugs, or sclerotherapy, usually as combination treatment, has become the standard approach for management of both pelvic congestion syndrome and varices arising from a pelvic source.