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Guidelines for the management of varicose veins

P Gloviczki and M L Gloviczki Phlebology 2012 27: 2 DOI: 10.1258/phleb.2012.012S28 The online version of this article can be found at: http://phl.sagepub.com/content/27/suppl_1/2

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Review article

Guidelines for the management of varicose veins

P Gloviczki* and M L Gloviczki
*Division of Vascular and Endovascular Surgery, Mayo Clinic; Rochester, MN, USA

Abstract
Recently published evidence-based guidelines of the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) include recommendations for evaluation, classication, outcome assessment and therapy of patients with varicose veins and more advanced chronic venous insufciency (CVI). The need for such guidelines has been evident since imaging techniques and minimally invasive technologies have progressed by leaps and bounds and radiofrequency ablation, laser and sclerotherapy have largely replaced classical open surgery of saphenous stripping. This report reviews the most important guidelines recommended by the SVS/AVF Venous Guideline Committee. It is obvious, however, that some of the technology that is recommended in North America is either not available or not affordable in some parts of the world for patients with varicose veins and CVI. The readers are urged therefore to also consult the guidelines of their national societies, recent publications of the National Institute for Clinical Excellence and the Venous Forum of the Royal Society of Medicine. Venous specialists should also keep in mind that scientic evidence should always be combined with the physicians clinical experience and the patients preference when the best treatment is selected for an individual patient. Keywords: varicose veins; guidelines; chronic venous insufciency; laser; radiofrequency; foam; stripping

Introduction
The management of varicose veins has rapidly progressed in the last two decades and open surgical treatment using the classical high ligation and saphenous stripping is rarely performed today. In 2012, minimally invasive outpatient interventions are available, including radiofrequency (RF) and laser ablations, foam and liquid sclerotherapy, miniphlebectomy and powered phlebectomy to treat patients with unsightly or symptomatic varicose veins. While most venous experts agree that effective operation in patients with simple varicose veins and saphenous vein incompetence should include ablation of the incompetent great saphenous vein (GSV), in some parts of the world
Correspondence: P Gloviczki MD, Division of Vascular and Endovascular Surgery, 200 First Street SW, Mayo Clinic, Rochester, MN 55905, USA. Email: gloviczki.peter@mayo.edu Accepted 14 January 2012

preservation of the saphenous vein using the CHIVA technique or performing the ASVAL procedure is preferred.

Clinical presentation
Varicose veins of the lower limbs are dilated subcutaneous veins that are . 3 mm in diameter measured in the upright position. These veins can be asymptomatic and cause cosmetic problems only or they can present with pain, aching, heaviness of the leg, muscle cramps, ankle swelling or itching. Symptoms are usually more prominent at the end of the day or after prolonged sitting or standing and they are relieved by elevating the legs or by wearing elastic stockings. Thrombophlebitis and bleeding are the most frequent complications of simple varicose veins, but varicosity can also lead to deep vein thrombosis or contribute to more advanced chronic venous insufciency (CVI), that includes oedema, skin changes, such as

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P Gloviczki and M L Gloviczki. Guidelines for the management of varicose veins

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eczema, dermatitis, pigmentation, induration, lipodermatosclerosis and venous ulcerations.

Guidelines for management

The Venous Forum of the Royal Society of Medicine recently published recommendations for referral and treatment of lower-limb CVI including varicose veins in the National Health Service (NHS) of the UK.1 The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) also reported in 2011 new clinical practice guidelines for the care of patients with varicose veins and more advanced forms of chronic venous disease (CVD).2 Recommendations of the North American Joint Venous Guideline Committee are based on the Grading of Recommendations Assessment, Development and Evaluation system, as reported by Guyatt et al. 3 The recommendation is strong (GRADE 1) if the benets clearly outweigh risks, burden and costs. The suggestion is weak (GRADE 2) if the benets are closely balanced with risks and burden. The level of scientic evidence to support the guideline can be of high (A), medium (B), or of low or very low (C) quality. This document briey reviews the most important guidelines on evaluation, classication and treatment of varicose veins as they were presented in detail by the North American Joint Committee on Venous Guidelines.2 The readers are also urged to consult national guidelines, published by the Venous Forum of the Royal Society of Medicine,1 by the German Society of Phlebology,4 by Wittens et al. 5 for the Dutch vascular societies and by Nicolaides et al.6 for the International Union of Angiology. For a complete list of references, the readers are referred to the SVS/AVF Guidelines, published in the Journal of Vascular Surgery 2 and to the recommendations for referral and treatment of CVI in the NHS, published in Phlebology.1

both infrainguinal venous obstruction and reux (valvular incompetence). In patients with varicose veins, the test should focus on evaluation of reux in the supercial and deep venous system, and, selectively, it should investigate the perforating veins. Reux is evaluated with the patient in standing position, with weight on the opposite leg. Reux can be elicited in two ways: a Valsalva manoeuvre or compression and release of the limb distal to the point of examination. The Valsalva manoeuvre is more appropriate for evaluation of reux in the common femoral, femoral and proximal GSV while compression and release are preferred more distally on the limb. Compression can be performed manually or with a pneumatic cuff. The recommended cut-off value for abnormally reversed venous ow (reux) in the saphenous, tibial, perforating and deep femoral veins is 500 ms and for the femoral and popliteal vein it is one second (Figures 1, 2a and 2b). Perforating veins are evaluated selectively, usually in those with healed or active venous ulcers (CEAP [clinical, aetiological, anatomical and pathological elements] class C5 C6) or in those with recurrent varicose veins after previous interventions. The SVS/AVF Guidelines dene pathologic perforating veins as those with outward ow of 500 ms, with a diameter of . 3.5 mm, located beneath a healed or open venous ulcer (CEAP class C5 C6). While some guidelines recommend rst the use of hand-held Doppler evaluation of patients with simple varicose veins,5 the SVS/AVF Committee strongly recommended the use of duplex scanning before any intervention is performed.

Evaluation
(1) Evaluation of patients with varicose veins should include duplex ultrasound scanning of the deep and supercial veins. Recommendation: GRADE 1 (strong), level of evidence: A (high quality) Taking a thorough history and performing a physical exam should be followed by duplex scanning as the rst diagnostic test for patients with varicose veins. Duplex scanning is excellent to investigate

Figure 1 Duplex scanning of the great saphenous vein conrms valvular incompetence with a reux duration of 7.13 seconds

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P Gloviczki and M L Gloviczki. Guidelines for the management of varicose veins

Figure 2 (a) Incompetent saphenofemoral junction before treatment, with dilation (arrow) and gross reux of the great saphenous vein. (b) Postoperative duplex scanning after radiofrequency ablation shows thrombosis (arrow) of the great saphenous vein (GSV). The tip of the thrombus is at 4 mm from the common femoral vein (CFV)

Aetiology can be congenital (Ec), primary (Ep) or secondary (Es), usually due to post-thrombotic syndrome. The anatomic classication separates supercial venous disease (As), perforator disease (Ap), or involvement of deep veins (Ad). Pathophysiology of the disease can be reux (Pr), obstruction (Po), or both. The basic CEAP classication is a simplied version, suitable for ofce use while the comprehensive CEAP classication is used for research. The main purpose of using the CEAP classication in patients with CVD in addition to describing severity is to distinguish primary venous disease from congenital varicosity and, most importantly, from secondary, post-thrombotic venous disease. Evaluation and treatment of these conditions are distinctly different. The CEAP classication is not suitable to follow outcome since it contains too many static elements, especially in classes C4 and C5 and is not sensitive enough for the assessment of improvement following therapy. To assess the outcome of treatment, the SVS/AVF committee recommended the use of the revised Venous Clinical Severity Score (VCSS), that is based on assessment of nine clinical signs or symptoms of CVD, including pain, presence of varicose veins, oedema, signs of CVI and venous ulcers.8 Compliance with compression therapy is also assessed. The VCSS correlates well with the CEAP score and with ultrasonographic assessment of venous valvular incompetence or obstruction. In addition to the VCSS, a disease-specic validated quality-of-life instrument is recommended to evaluate improvement in quality of life (QOL).

Classication and outcome assessment

(2) The CEAP classication should be used to describe the severity of CVD and the revised Venous Clinical Severity Score should be used to assess treatment outcome. Recommendation: GRADE 1 (strong), level of evidence: B (medium quality) The CEAP classication is based on clinical signs of venous disease (C), aetiology (E), anatomy (A) and the underlying pathophysiology (P).7 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), oedema (C3), skin changes, such as pigmentation or eczema (C4a) or lipodermatosclerosis or atrophie blanche (C4b) and healed (C5) or active (C6) ulcer. The presence or absence of symptoms is also recorded (S, symptomatic; A, asymptomatic).
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Treatment
(3) Compression therapy is suggested for patients with symptomatic varicose veins. Recommendation: GRADE 2 (weak), level of evidence: C (low to very low quality) A large meta-analysis of compression hosiery for simple varicose veins (C2) by Palfreyman and Michaels9 analysed data of 11 randomized controlled trials (RCTs) or systematic reviews, 12 nonrandomized studies and two guidelines. Although compression improved symptoms, it did not decrease progression nor did it prevent recurrence of varicose veins after treatment. Admittedly, these studies included a high number of noncompliant patients. The level of compression for patients with class C2 disease is also disputed. A meta-analysis by Amsler and Blattler10 of 11 RCTs suggested that in

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P Gloviczki and M L Gloviczki. Guidelines for the management of varicose veins

Review article

healthy patients, in those with C1 to C3 disease, and in those after varicose vein surgery, medium compression stockings ( . 20 mmHg) may add no benet over that obtained with a compression between 10 and 15 mmHg. Until further data on appropriate pressure of elastic garments are available, for patients with simple varicose veins (class C2), the SVS/AVF Guideline Committee suggested graded prescription stockings with an ankle pressure of 20 30 mmHg. To avoid skin breakdowns or necrosis after incorrectly measured or applied garments, the Committee recommended that only those with the necessary skills and training prescribe stockings for patients with venous disease. (4) The guidelines recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation. Recommendation: GRADE 1 (strong), level of evidence: B (medium quality) The need for a period of compression treatment before any intervention for simple varicose veins (class C2 patients) has been surrounded by a lot of controversy. Although third-party payers often require a trial of compression stockings, there is no scientic evidence to support such a policy when saphenous ablation to treat supercial reux is both more efcacious and cost-effective. For obvious cost considerations uncomplicated simple varicose veins are not offered interventional treatment by the NHS according to the UK guidelines.1 The efcacy of saphenous ablation versus compression alone was conrmed in a RCT by Michaels et al. 11 The REACTIV trial randomized 246 patients with simple varicose veins (class C2) to conservative management or surgery. In the rst two years after treatment, surgery provided more symptomatic relief and improvements in QOL than conservative management with compression hosiery and lifestyle modications in patients with uncomplicated varicose veins. Surgery was signicantly more costeffective than both sclerotherapy and conservative management.12 Based on available current evidence, the Guideline Committee recommended against compression therapy being considered as the sole primary treatment of symptomatic varicose veins (class C2) or those with complications (bleeding, thrombophlebitis) or with more advanced disease (C3 C6), if the patients are otherwise candidates for saphenous vein ablation.

(5) Compression therapy should be used as the primary treatment to aid healing of venous ulceration. Recommendation: GRADE 1 (strong), level of evidence: B (medium quality) Compression therapy continues to be the standard of care for patients with advanced CVD and venous ulcers (class C3 C6). Compression therapy improves calf muscle pump function and decreases reux in vein segments in patients with CVI. In patients with venous ulcers, the ESCHAR trial conrmed that graded compression is effective as the primary treatment to aid healing of venous ulceration and as adjuvant therapy to interventions to prevent recurrence of venous ulcers.13,14 (6) To decrease recurrence of venous ulcers, compression therapy should be supplemented with ablation of the incompetent supercial veins. Recommendation: GRADE 1 (strong), level of evidence: A (high quality) The ESCHAR study13,14 randomized 500 patients with leg ulcers to either compression treatment alone or compression in combination with supercial venous surgery. The 12-month ulcer recurrence rates were signicantly reduced in the compression with surgery group versus those with compression alone (12% vs. 28%, P , 0.0001). The difference in ulcer recurrence rates persisted between the two groups at four years. (7) For treatment of the incompetent GSV, endovenous thermal ablation (radiofrequency, RF, or endovenous laser therapy, EVLT) is recommended over high ligation and stripping of the saphenous vein. Recommendation: GRADE 1 (strong), level of evidence: B (medium quality) Currently used and sufciently tested endovenous thermal techniques to ablate the saphenous veins include RF and EVLT. Progress in this technology has been remarkable and for a few years several generations of devices have been available for clinical use. Data on long-term efcacy are usually available for rst-generation devices. Short-term data, however, support better performance of the latest technology. Four RCTs compared results of RF with surgery.15 19 RF treatment in these studies resulted in faster return to work and normal activities, higher patient satisfaction, less pain and better short-term QOL scores, with high-quality evidence conrming early efcacy and safety. Results at two years were similar in both groups.
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P Gloviczki and M L Gloviczki. Guidelines for the management of varicose veins

Seven RCTs20 26 compared results of EVLT of the GSV with open high ligation, division and saphenous stripping. An RCT by Rasmussen et al.20 found that both treatments were equally safe and efcient in eliminating saphenous reux, alleviating symptoms and signs of varicose veins, and improving QOL. The recurrence rate of varicose veins at two years was 33% following high ligation and 26% after endovenous laser ablation (EVLA) (P NS).27 Four RCTs compared RF ablation (RFA) to EVLA.28 30 Moderate evidence suggests that early results (pain, bruising) are better with RF than with the 980-nm EVLA. The Committee, however, did not support one endovenous ablation technique versus another but recommended both endovenous thermal ablation techniques over open surgery for those patients who have suitable saphenous anatomy for thermal ablation, like non-aneurismal saphenofemoral junction, sufcient distance ( , 1 cm after tumescent anaesthesia) between the vein and the skin (Grade 1B). The Guidelines of the Venous Forum of the Royal Society of Medicine and the German Society of Phlebology also recommend ultrasound-guided foam sclerotherapy (UGSF) as a minimally invasive technique of sufcient evidence to use over surgery.1,4 When selecting the different types of treatment that are available and affordable in different parts of the world for patients with varicose veins and CVI, the readers can also consult recent publications of the National Institute for Clinical Excellence1 and the Royal Society of Medicine Venous Forum (Venous Intervention Project)31 as well as other recent recommendations of the American Venous Forum32 and other societies. (8) Phlebectomy or sclerotherapy is recommended to treat varicose tributaries. Recommendation: GRADE 1 (strong), level of evidence: B (medium quality) Surgical phlebectomy for branch varicosity has been practiced with success for decades, performed either through small skin incision or through stab wounds. The efcacy of phlebectomy has been emphasized in a study by Pittaluga et al. 33 In a welldocumented study, these authors followed patients for a mean of four years after phlebectomy alone, performed without saphenous ligation or stripping: no or minimal saphenous reux ( , 500 ms) was found in 66.3% of 303 limbs, symptoms improved in 78% and varicose veins recurred in only 11.5%.
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For treatment of varicose tributaries the SVS/AVF Committee recommended phlebectomy as well as sclerotherapy using liquid or foam. Liquid has shown efcacy in treating reticular veins and telangiectasia while foam had better results when used for varicose veins. The second European Consensus Meeting on Foam Sclerotherapy reported that foam was an effective, safe and minimally invasive treatment for varicose veins with a low rate of complications and recommended the use of either STS (Sotradecol) or polidocanol for foam sclerotherapy.34 (9) Foam sclerotherapy is suggested as an option to treat the incompetent saphenous vein. Recommendation: Grade 2 (weak), evidence: C (low to very low quality). Foam sclerotherapy has been used with increasing frequency to treat the incompetent saphenous vein. In 1411 limbs, Coleridge-Smith35 used 1% polidocanol, 1% sotradecol and 3% STS in the form of foam to treat incompetent saphenous trunks. At six months follow-up, the GSV was occluded in 88% and the small saphenous vein in 82% of the treated limbs. The efcacy of liquid and foam sclerotherapy, surgery and thermal ablations were studied in a large meta-analysis by Murad et al. 36 The authors examined data from 8207 patients, reported in 38 comparative studies that included 29 RCTs. Surgery was found to be associated only with nonsignicant reduction in varicose vein recurrence, compared with sclerotherapy, laser therapy or RFA. Studies of laser therapy, RFA and foam sclerotherapy, however, demonstrated short-term effectiveness and safety. This study concluded that that short-term studies support the efcacy of thermal ablations as well as foam and liquid sclerotherapy and that these techniques are associated with less early disability and pain. Since long-term results of foam sclerotherapy of the GSV are not available, evidence for durability of foam for saphenous ablation was judged by the SVS/AVF Committee as being of low or very low quality. As mentioned previously, UGSF for treatment of the incompetent saphenous vein is much more popular in Europe than in the USA and supporting evidence on both its efcacy and safety is steadily increasing.37,38 A recent RCT by Rasmussen et al. 39 that was published following the SVS/AVF Guideline publication compared RF and EVLT with UGFS and surgical stripping in 580 legs with GSV reux. At one year, GSV recanalization with reux was present in 16.3% of patients treated by foam

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P Gloviczki and M L Gloviczki. Guidelines for the management of varicose veins

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versus 4.8% treated with laser or surgery or 5.8% treated by RF (P , 0.001). One patient developed a pulmonary embolus after foam sclerotherapy and one had deep vein thrombosis after surgical stripping. Although technical failure was highest after foam treatment, the study also found that RF and foam were associated with a faster recovery and less postoperative pain than EVLT or stripping. (10) The committee recommended against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C2). Recommendation: Grade 1 (strong), evidence: B (medium quality), but suggested treatment of pathological perforating veins (outward ow duration . 500 ms, vein diameter . 3.5 mm) located underneath healed or active ulcers (CEAP class C5 C6). Recommendation: Grade 2 (weak), evidence: B (medium quality).

Conclusions
The SVS/AVF venous guidelines and the recommendations of the Venous Forum of the Royal Society of Medicine should be considered by venous specialists in the care of patients with varicose veins and more advanced forms of CVI. Appropriately selected patients will greatly benet from the treatment of varicose veins and CVI. The new, minimally invasive treatment options are offered as outpatient procedures; they are performed in an ofce setting under local anaesthesia, with signicantly less complications than classical surgical procedures and permit early return to work with the associated costsavings for the society. Scientic evidence on the efcacy of therapy, however, should always be combined with the physicians clinical experience and the patients preference to select the best possible treatment for each patient.

The use of selective perforator ablation with subfascial endoscopic perforator surgery (SEPS) or with endothermal ablations has been a matter of controversy, but evidence is medium quality now for not doing these procedures in patients with simple varicose veins (CEAP class C2). In a RCT, Kianifard et al. 40 analysed the benets of adding perforator ablation to surgery in patients with class C2 disease. At one year after treatment there were no differences between the two groups with respect to pain, mobility, varicose vein recurrence or QOL scores. Therefore, in class C2 patients no additional clinical benet could be observed when SEPS was added to high ligation and stripping. In patients with advanced CVI, current data provide moderate evidence that large ( . 3.5 mm), high-volume, incompetent pathological perforators (reux . 500 ms), located in the affected area of the limb, with outward ow on duplex scanning in patients with class C5 or C6 disease can be treated by experienced interventionists, unless the deep veins are obstructed. These data are supported by results of the North American SEPS registry (NA-SEPS),41 by the only RCT on this topic, the Dutch SEPS study,42 and by two meta-analyses of perforator ablations.43,44 The committee also reviewed early results of percutaneous ablation techniques (RF, EVLT, sclerotherapy)45 and concluded that these minimally invasive techniques can be suggested as an alternative therapy for SEPS for perforator treatment, although mid- or long-term results are not available. This, of course, was a weak recommendation with a low or very low level of evidence (GRADE 2C).

References
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