and Reinhart T. Grundmann2
(1)
Department of Vascular Medicine, University Heart and Vascular Center at University Clinics Hamburg–Eppendorf, Hamburg, Germany
(2)
Former Medical Director, Community Hospital Altoetting-Burghausen, Burghausen, Germany
14.1 Guideline Recommendations
14.1.1 NICE
The NICE guidelines recommend (NICE National Institute for Health and Care Excellence 2013):
In some people varicose veins are asymptomatic or cause only mild symptoms, but in others they cause pain, aching or itching and can have a significant effect on their quality of life. Varicose veins may become more severe over time and can lead to complications such as changes in skin pigmentation, bleeding or venous ulceration. It is not known which people will develop more severe disease but it is estimated that 3–6% of people who have varicose veins in their lifetime will develop venous ulcers.
Referral to a vascular service
Refer people to a vascular service if they have any of the following:
Symptomatic primary or symptomatic recurrent varicose veins.
Lower-limb skin changes, such as pigmentation or eczema, thought to be caused by chronic venous insufficiency.
Superficial vein thrombosis (characterised by the appearance of hard, painful veins) and suspected venous incompetence.
A venous leg ulcer (a break in the skin below the knee that has not healed within 2 weeks).
A healed venous leg ulcer.
Assessment
Use duplex ultrasound to confirm the diagnosis of varicose veins and the extent of truncal reflux, and to plan treatment for people with suspected primary or recurrent varicose veins.
Interventional treatment
For people with confirmed varicose veins and truncal reflux:
Offer endothermal ablation and endovenous laser treatment of the long saphenous vein.
If endothermal ablation is unsuitable, offer ultrasound-guided foam sclerotherapy.
If ultrasound-guided foam sclerotherapy is unsuitable, offer surgery.
If incompetent varicose tributaries are to be treated, consider treating them at the same time.
14.1.2 Society for Vascular Surgery (SVS) and the American Venous Forum (AVF)
Varicose veins of the lower limbs are dilated subcutaneous veins that are > 3 mm in diameter measured in the upright position (Gloviczki et al. 2011).
Duplex scanning: we recommend that in patients with chronic venous disease, a complete history and detailed physical examination are complemented by duplex scanning of the deep and superficial veins. (Grade of recommendation 1/Level of Evidence: A)
Plethysmography: we recommend that venous plethysmography be used for the noninvasive evaluation of the venous system in patients with advanced chronic venous disease if duplex scanning does not provide definitive information on pathophysiology (CEAP class C3-C6). (Grade 1/Level of Evidence: B)
Classification: we recommend that the CEAP classification be used for patients with chronic venous disease. The basic CEAP classification is used for clinical practice, and the full CEAP classification system is used for clinical research. (Grade 1/Level of Evidence: A)
Outcome assessment: We recommend that the revised Venous Clinical Severity Score is used for assessment of clinical outcome after therapy for varicose veins and more advanced chronic venous disease. (Grade 1/Level of Evidence: B). We recommend that a quality-of-life assessment is performed with a disease-specific instrument to evaluate patient-reported outcome and the severity of chronic venous disease. (Grade 1/Level of Evidence: B)
Compression therapy: We suggest compression therapy using moderate pressure (20–30 mm Hg) for patients with symptomatic varicose veins. (Grade 2/Level of Evidence: C). We recommend compression as the primary therapeutic modality for healing venous ulcers. (Grade 1/Level of Evidence: B). We recommend against compression therapy as the primary treatment of symptomatic varicose veins in patients who are candidates for saphenous vein ablation. (Grade 1/Level of Evidence: B).
Open venous surgery: For treatment of the incompetent great saphenous vein, we suggest high ligation and inversion stripping of the saphenous vein to the level of the knee. (Grade 2/Level of Evidence: B). To reduce hematoma formation, pain, and swelling, we recommend postoperative compression. The recommended period of compression in C2 patients is 1 week. (Grade 1/Level of Evidence: B). For treatment of small saphenous vein incompetence, we recommend high ligation of the vein at the knee crease, about 3–5 cm distal to the saphenopopliteal junction, with selective invagination stripping of the incompetent portion of the vein. (Grade 1/Level of Evidence: B). To decrease recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy. (Grade 1/Level of Evidence: A).
Endovenous thermal ablation: Endovenous thermal ablations (laser and radiofrequency ablations) are safe and effective, and we recommend them for treatment of saphenous incompetence. (Grade 1/Level of Evidence: B). Because of reduced convalescence and less pain and morbidity, we recommend endovenous thermal ablation of the incompetent saphenous vein over open surgery. (Grade 1/Level of Evidence: B).
Sclerotherapy of varicose veins: We recommend liquid or foam sclerotherapy for telangiectasia, reticular veins, and varicose veins. (Grade 1/Level of Evidence: B). For treatment of the incompetent saphenous vein, we recommend endovenous thermal ablation over chemical ablation with foam. (Grade 1/Level of Evidence: B)
Treatment of perforating veins: We recommend against selective treatment of incompetent perforating veins in patients with simple varicose veins (CEAP class C2). (Grade 1/Level of Evidence: B). We suggest treatment of “pathologic” perforating veins that includes those with an outward flow duration of ≥500 ms, with a diameter of ≥3.5 mm, located beneath a healed or open venous ulcer (CEAP class C5-C6). (Grade 2/Level of Evidence: B)
14.1.3 European Society for Vascular Surgery (ESVS)
The clinical practice guidelines recommend among others (Wittens et al. 2015):
Recommendation 1: Use of the Clinical Etiological Anatomical Pathophysiological (CEAP) classification is recommended as a standardized, descriptive classification tool to assess disease severity in patients with chronic venous disease for research and audit. (Class I/Level of Evidence: B)
Recommendation 4: Disease severity and burden of disease should be reliably assessed by generic tools in the form of the physical component of the SF-36 and the EuroQol-5D, respectively. (Class IIa/Level of Evidence: B)
Recommendation 9 (Duplex ultrasound examination): To define venous incompetence the following cut off values are recommended: retrograde flow lasting more than 0.5 s in the superficial venous system, the deep femoral vein, and the calf veins, more than 1 s in the common femoral vein, the femoral vein, and the popliteal vein, and more than 0.35 s in perforating veins. (Class I/Level of Evidence: B)
Recommendation 11: Duplex ultrasound is recommended as the primary diagnostic tool of choice in suspected chronic venous disease, to reliably evaluate the specific venous anatomy and to identify the source and pattern of reflux. (Class I/Level of Evidence: A)
Recommendation 14: Plethysmography may be considered for the assessment of quantitative parameters related to venous function (Class IIb/Level of Evidence: C)
Recommendation 16: Phlebography may be considered in cases where other diagnostic tools are inconclusive (mainly in the diagnosis of abdominal/pelvic vein diseases). (Class IIb/Level of Evidence: B)
Recommendation 23: Elastic stockings are recommended as an effective treatment modality for symptoms and signs of chronic venous disease. (Class I/Level of Evidence: B)
Recommendation 39: Foam sclerotherapy is recommended as a second choice treatment of varicose veins (C2) and for more advanced stages of chronic venous disease (C3-C6) in patients with saphenous vein incompetence, not eligible for surgery or endovenous ablation. (Class I/Level of Evidence: A)
Recommendation 40: Foam sclerotherapy should be considered as primary treatment in patients with recurrent varicose veins, and in elderly and frail patients with venous ulcers. (Class IIa/Level of Evidence: B)
Recommendation 41: Liquid sclerotherapy should be considered for treating telangiectasias and reticular veins (C1). (Class IIa/Level of Evidence: B)
Recommendation 42: Transcutaneous laser may be indicated for treatment of telangiectasias, only when sclerotherapy is not applicable. (Class IIb/Level of Evidence: C)
Recommendation 43: For the treatment of great saphenous vein reflux in patients with symptoms and signs of chronic venous disease, endovenous thermal ablation techniques are recommended in preference to surgery. (Class I/Level of Evidence: A)
Recommendation 44: For the treatment of great saphenous vein reflux in patients with symptoms and signs of chronic venous disease, endovenous thermal ablation techniques are recommended in preference to foam sclerotherapy. (Class I/Level of Evidence: A)
Recommendation 45: For the treatment of small saphenous vein reflux in patients with symptoms and signs of chronic venous disease, endovenous thermal ablation techniques should be considered. Access to the small saphenous vein should be gained no lower than mid-calf. (Class IIa/Level of Evidence: B)
Recommendation 46: For non-complicated varicose veins (C2, C3), surgical treatment is recommended instead of conservative management, to improve symptoms, cosmetics, and quality of life. (Class I/Level of Evidence: B)
Recommendation 47: In cases in which surgical treatment of the refluxing saphenous vein is performed, high ligation and stripping is recommended instead of high ligation only. (Class I/Level of Evidence: A)
Recommendation 48: Surgical stripping of the [great] saphenous vein without high ligation leaving a 2 cm stump may be considered. (Class IIb/Level of Evidence: B)
Recommendation 49: If high ligation is performed, oversewing the great saphenous vein stump, interposition of a polytetrafluoroethylene patch, or closure of the cribriform fascia may be considered, in order to reduce the effect of neovascularization at the saphenofemoral junction. (Class IIb/Level of Evidence: B)
Recommendation 51: When performing endovenous thermal ablation of a refluxing saphenous trunk, adding concomitant phlebectomies should be considered. (Class IIa/Level of Evidence: B)
Recommendation 52: To treat tributary varicose veins, ambulatory phlebectomy should be considered. (Class IIa/Level of Evidence: C)
14.1.4 European Guidelines for Sclerotherapy
This guideline was drafted on behalf of 23 European Phlebological Societies (Rabe et al. 2014).
Indications
We recommend sclerotherapy for all types of veins, in particular:
Incompetent saphenous veins (GRADE 1A)
Tributary varicose veins (GRADE 1B)
Incompetent perforating veins (GRADE 1B)
Reticular varicose veins (GRADE 1A)
Telangiectasias (spider veins) (GRADE 1A)
Residual and recurrent varicose veins after previous interventions (GRADE 1B)
Varicose veins of pelvic origin (GRADE 1B)
Varicose veins (refluxing veins) in proximity of leg ulcers (GRADE 1B)
Venous malformations (GRADE 1B).
We recommend liquid sclerotherapy as the method of choice for ablation of telangiectasias and reticular varicose veins (C1) (GRADE 1A). Foam sclerotherapy of C1 varicose veins is an alternative method (GRADE 2B).
We recommend foam sclerotherapy over liquid sclerotherapy for the treatment of saphenous veins (GRADE 1A), venous malformations (GRADE 2B) and recurrent varices after previous treatment, accessory saphenous varices, nonsaphenous varices and incompetent perforating veins (GRADE 1C).
Contraindications
Absolute contraindications:
Known allergy to the sclerosant
Acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Local infection in the area of sclerotherapy or severe generalized infection
Long-lasting immobility and confinement to bed
For foam sclerotherapy in addition: Known symptomatic right-to-left shunt (e.g. symptomatic patent foramen ovale).
Relative contraindications (individual benefit–risk assessment mandatory):
Pregnancy
Breast feeding (interrupt breast feeding for 2–3 days)
Severe peripheral arterial occlusive disease
Poor general health
Strong predisposition to allergies
High thromboembolic risk (e.g. history of thromboembolic events, known severe thrombophilia, hypercoagulable state and active cancer)
Acute superficial venous thrombosis
For foam sclerotherapy in addition: Neurological disturbances, including migraine, following previous foam sclerotherapy.
14.2 Results
14.2.1 Sclerotherapy
Systematic review
Jia et al. (2007) reviewed the safety and efficacy of foam sclerotherapy. Sixty-nine studies were included. The median rates of serious adverse events, including pulmonary embolism and deep vein thrombosis, were less than 1%. The median rate of visual disturbance was 1.4%, headache 4.2%, thrombophlebitis 4.7%, matting/skin staining/pigmentation 17.8% and pain at the site of injection 25.6%. The median rate of complete occlusion of treated veins was 87.0% and for recurrence or development of new veins it was 8.1%. Meta-analysis for complete occlusion suggested that foam sclerotherapy is less effective than surgery (relative risk (RR) 0.86) but more effective than liquid sclerotherapy (RR 1.39), although there was substantial heterogeneity between studies. Foam sclerotherapy appeared to be efficacious for both main trunk and minor vein disease. Foam sclerotherapy is conducted as an outpatient procedure, does not require general anaesthesia and, compared with surgery, results in an earlier return to normal activities. However, several treatment sessions may be required.
Studies
The Board of the French Society of Phlebology sponsored a prospective multicenter registry in 22 phlebology clinics to report their activity and complications (Guex et al. 2005). During a median of 8 (±3.1) weeks, 12.173 sessions of sclerotherapy were carried out, 5.434 with liquid sclerosants, 6.395 with foam, and 344 using both. Foam sclerosants were less frequently used than liquid for treatment of reticular and spider veins (2.293 vs 3.631). But foam was used significantly more in the treatment of great saphenous veins (1.533 vs 261) and small saphenous veins (492 vs 109). Ultrasound guidance was used in 4.088 sessions (33.9%). Injections of saphenous veins represented 17% of sclerotherapy sessions in this registry. Forty-nine incidents or accidents were reported (0.4%). Visual disturbances were the most frequently recorded adverse events. They were observed either with liquid (n = 4) or with foam (n = 16). This complication occurred almost always when air was injected (19 of 20 times). All cases spontaneously regressed, without long-term effects. In addition, one femoral vein thrombosis and one case of distal muscular vein thrombosis were noted. Pulmonary emboli, skin necrosis, muscular necrosis, or arterial injection were not seen. The results demonstrate that sclerotherapy is a very safe procedure, and that the risks of complications are extremely low.
Long-term incidence of adverse events with polidocanol was registered in the French Polidocanol Study (Guex et al. 2010). Between April 2004 and April 2008, 1.605 patients (6.444 treatment sessions) who had received at least one polidocanol injection were surveyed. A total of 3.357 patient years were covered. Most of the sessions were performed with sclerosants in foamed formulation (n = 4.403); the rest (n = 2.041) was performed with liquid sclerosants. Thirty-seven patients (total of 51 sessions) showed an adverse event that could be attributed to a treatment session with polidocanol. The global rate of incidence of adverse events related to polidocanol was 0.8% (per session) and 0.02 per patient year. The five reactions observed after injection with polidocanol liquid were one cramp, two inflammatory reactions, one pigmentation, and one visual disturbance. The total rate of adverse events with liquid polidocanol was 0.25%. Most common adverse reactions directly related to polidocanol foam were 13 visual disturbances. Only one such event could be seen after treatment with the liquid. There were seven cases of headaches (including migraines), and eight muscular vein thromboses with polidocanol foam. The total incidence of adverse events with foamed polidocanol was 1.07%. These results demonstrate that sclerotherapy with polidocanol is safe, especially in the long term. The authors assumed that ultrasound-guided foam sclerotherapy (UGFS) is a reference method in the treatment of incompetent saphenous trunks. The use of liquid, with an incidence of side effects lower than 0.4%, perfectly fits for the treatment of benign lesions such as small varices, reticular veins, or telangiectasias, whereas foamed polidocanol injected under ultrasound guidance used in the treatment of large varicose veins presents fewer side effects than surgery, with which it competes.
Between April 2004 and May 2007, 351 patients (479 limbs) were treated with UGFS by Darvall et al. (2014). The median volume of foam injected was 10 (range 2–16) ml. One hundred legs (20.9%) had ‘tidy up’ injections at 4 weeks. After a minimum of 5 years, attempts were made to contact all patients, and a follow-up appointment was sent along with a questionnaire booklet. This included both quality-of-life instruments, a questionnaire regarding fulfilment of expectations since UGFS, and some questions regarding overall satisfaction with treatment. A total of 285 patients (391 limbs) attended for review, giving an 81.2% response rate, at a median of 71 months after treatment. The majority of patients were highly satisfied with their treatment, and 82.0% gave a score of between 8 and 10 (highly satisfied); only 3.3% were dissatisfied. Some 91.0% of patients would recommend the treatment to others. The estimated cumulative proportion of patients requiring retreatment at 5 years was 15.3%. The results emphasize the cost-effectiveness of UGFS.
King et al. (2015) determined in a multicenter study if a single administration of ≤15 mL of pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena [polidocanol injectable foam]) could alleviate symptoms and improve appearance of varicose veins in a typical population of patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the great saphenous vein (GSV) system. Two hundred seventy-nine patients were treated with either placebo (n = 56) or PEM 0.125% (n = 57), 0.5% (n = 51), 1% (n = 52), or 2% (n = 63). At Week 8, VVSymQ (Varicose Veins Symptoms Questionnaire) scores for the pooled PEM group (0.5% + 1% + 2%; p < .0001) and individual dose concentrations (p < .001) were significantly superior to placebo. The study demonstrated the benefit of treatment with PEM in the improvement of symptoms and appearance of varicose veins in patients with an incompetent GSV and/or accessory saphenous veins and visible varicosities. Significant improvements in disease-specific quality of life also were demonstrated. There was a low rate of deep venous thrombi, no pulmonary emboli, and no cerebrovascular or neurological events. This ultrasound-guided technique requires no tumescent anesthesia. Patients are ambulatory immediately after the procedure. Efficacy can be achieved in a single treatment. However, the recommendation is to limit the amount of PEM to 15 mL per session. Therefore, patients with more extensive disease might need more than one treatment.
Shadid et al. (2012) compared in a multicentre randomized controlled non-inferiority trial the effectiveness and costs of ultrasound-guided foam sclerotherapy (UGFS) and surgery for treatment of the incompetent great saphenous vein (GSV). Two hundred thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11.3% and 9.0%. At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35.0%) than in the surgery group (21.0%). Mean (s. d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824 (141) for stripping. The study supports the broader use of UGFS due to the non-inferiority concerning recurrent clinical symptoms and its cost-effectiveness.
14.2.2 Endovenous Thermal Ablation
14.2.2.1 Meta-analyses and Systematic Reviews
For their guidelines, the Society for Vascular Surgery (SVS) partnered with the American Venous Forum (AVF) commissioned Murad et al. (2011) to conduct a systematic review and meta-analysis to summarize the best-available evidence about the benefits and harms of the different treatments of varicose veins. Thirty-nine eligible studies (30 were randomized trials) enrolling 8285 participants were found. Surgery appeared to have low- to moderate-quality evidence demonstrating less recurrence and better long-term results. Compared with surgery, however, liquid or foam sclerotherapy and endoluminal thermal ablation therapies (laser and radiofrequency) were associated with faster return to work, shorter duration of disability, and less pain. The evidence on quality of life was sparse and inconclusive. Data on outcomes of DVT and PE were sparse and poorly reported. In conclusion, very low quality evidence suggested that the available treatments for varicose veins (surgery, sclerotherapy, foam therapy, laser endoluminal ablation and radiofrequency endoluminal ablation) appear to be safe with rare side effects. Surgery is the only treatment with long-term effectiveness data. Table 14.1 summarizes the reported frequency of local complications associated with surgery, liquid sclerotherapy, laser ablation, radiofrequency ablation, and foam therapy.
Table 14.1
Commonly reported adverse events with surgery, liquid sclerotherapy, laser ablation, radiofrequency ablation, and foam therapy for varicose veins
Surgery |
Wound infection 3–6%/Sural or saphenous nerve injury, 10–23%/Hematoma, 31%/superficial phlebitis, 0–12% |
Sclerotherapy |
Skin staining or necrosis, 3%/Superficial phlebitis, 22–27% |
Laser ablation |
Purpura/bruising, 11–23%/Erythema, 33%/Hyperpigmentation, 57%/Hypopigmentation, 2%/Blistering/sloughing, 7%/Scaring, 13%/Telangiectatic matting, 28%/Edema, 15%/Paresthesia, 1–2%/Superficial phlebitis 6% |
Radiofrequency ablation |
Saphenous nerve paresthesia, 13%/Superficial phlebitis, 0–20%/Hematoma, 7%/Thermal skin injury, 7%/Paresthesia, <1%/Leg edema, <1% |
Foam therapy |
Contusion, bruising, hematoma, 61%/Skin pigmentation, 51%/Headache, 11% |
In addition, a Cochrane review (Nesbitt et al. 2014) determined whether endovenous ablation (radiofrequency and laser) and foam sclerotherapy have any advantages or disadvantages in comparison with open surgical saphenofemoral ligation and stripping of great saphenous vein varices. All randomized controlled trials (RCTs) of ultrasound-guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA), endovenous laser therapy (EVLT) and open surgery or high ligation and stripping (HL/S) were considered for inclusion (last search January 2014). Thirteen studies with a combined total of 3081 randomized patients were included in this analysis. Clinical trial evidence suggested that UGFS, EVLT and RFA are at least as effective as surgery in the treatment of great saphenous varicose veins. Due to large incompatibilities between trials and different time point measurements for outcomes, the evidence is lacking in robustness.
14.2.2.2 Venous Leg Ulcers
Venous leg ulcers represent the worst extreme within the spectrum of chronic venous disease. Samuel et al. (2013a) determined the effects of superficial endovenous thermal ablation on the healing, recurrence and quality of life of people with active or healed venous ulcers. This Cochrane review identified no eligible RCTs. There is an absence of evidence regarding the effects of superficial endovenous thermal ablation on ulcer healing, recurrence or quality of life of people with venous leg ulcer disease. Adequately-powered, high quality RCTs comparing endovenous thermal ablative interventions with compression therapy are urgently required to explore this treatment strategy. There is evidence from two systematic reviews and meta-analyses that healing outcomes (including time to healing) are better when patients with leg ulcers receive compression compared with no compression (O’Meara et al. (2012); Mauck et al. (2014a)).
Mauck et al. (2014b) also summarized the evidence regarding the efficacy of surgical interventions compared with conservative management alone (compression) on ulcer healing and recurrence in patients with lower extremity ulceration due to venous disease. Seven studies compared open surgical procedures on the venous system (with or without compression) with compression alone on ulcer healing outcomes, representing 572 limbs in the surgical group and 571 limbs in the compression group. The pooled risk ratio (RR) was 1.06, demonstrating that ulcer healing outcomes are only slightly better in the surgery group. There was no difference in ulcer healing outcomes when only RCTs were included. Surgical intervention resulted in less ulcer recurrence. However, when only RCTs were included, there was a trend toward surgical intervention resulting in less ulcer recurrence, but this was no longer statistically significant. The current evidence does not definitively support the superiority of open or endovascular surgical interventions compared with compression alone with respect to ulcer healing and ulcer recurrence outcomes in patients with lower extremity venous ulcers.
14.2.2.3 Randomized Studies with Endovenous Laser Therapy
EVLT vs. open surgery
Patients with symptomatic varicose veins due to GSV insufficiency were randomized to HL/S (100 limbs) or EVLT (104 limbs) by Christenson et al. (2010). Major complications, such as deep vein thrombosis or wound infection were not observed in either group. HL/S limbs had significantly more postoperative hematomas than EVLT limbs, and EVLT patients reported more bruising. At 1 year follow-up, two GSVs in the EVLT group reopened and three partially reopened. No open GSVs occurred in HL/S limbs. Ninety-eight percent of the limbs in both groups were free of symptoms. Improvement in quality of life was similar after HL/S and EVLT. At 2 years after treatment, however, two GSVs were completely reopened and five were partially reopened after EVLT, which was significantly higher than after HL/S. Three of these patients required a reintervention due to recurrent symptoms.
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