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vi Varicose veins in the legs KCE Reports 164C THERAPEUTIC PROCEDURES Compression and medication The review of the literature produces the following findings in relation to compression and medication. • A systematic review concluded that a number of low quality studies indicated a possible effectiveness of compression on the pain and symptoms associated with varicose veins. • A Cochrane review analysed the impact of so-called “veno-active medications” (rutosides (e.g. Venoruton ® ), calcium dobesilate (Doxium ® , not available in Belgium), plants) on chronic venal insufficiency. There are insufficient data to recommend the use of this medication. Furthermore a study comparing calcium dobesilate with placebo in patients with chronic venous insufficiency indicated that there was no significant difference between the groups for the main outcomes (quality of life, oedema and symptoms after three months treatment). Thermal ablation by endovenous laser treatment and by radio frequency The studies in relation to thermal ablation are limited in scope and have a maximum follow-up period of two years. The studies on endovenous laser treatment do not show any significant difference (percentage of relapse) between these techniques and conventional surgery. The percentage of clinical relapse (CEAP-classification) after one year is approximately 10%. Neither do studies in relation to radio frequency ablation show how this technique would be superior with regard to clinical effectiveness in the short term (maximum 20 months), compared to endovenous laser therapy and conventional surgery. The results with regard to the satisfaction of the patients and the evaluation of their quality of life are better with these two techniques than with conventional surgery. Some authors furthermore state a quicker return to ordinary activities after an intervention using laser or radio frequency (2 or 3 days) than after conventional surgery (about ten days). Chemical ablation: sclerotherapy with injection of liquid or foam Clinical trials on sclerotherapy are larger in size (> 30 patients). The follow-up is short term for foam sclerotherapy (maximum 2 years), but may last ten years for liquid injections. These trials generally analyse the results in terms of the Doppler ultrasound image, but give little information in relation to clinical results (symptoms, relapse). The effectiveness of sclerotherapy after a few months (based on the percentage of occlusion on the Doppler ultrasound) is comparable to that of conventional surgery. In the long term (follow-up for a maximum of ten years) the percentage of relapse of the varicose veins is lower with surgery (approximately 40%), than with liquid sclerotherapy (approximately 50%). The average length of the inability to work is shorter after sclerotherapy (2 days) than after conventional surgery (8 days). Foam sclerotherapy appears more effective than liquid sclerotherapy, but the authors base their conclusions solely on the level of venous occlusion during the examination with Doppler ultrasound.
KCE Reports 164C Varicose veins in legs vii Side effects of conventional surgery and of endovenous treatments Pain, bruising and hematoma occur with all these interventions. However, trials have shown that these side effects and post-operative infections are more frequent after conventional surgery (between 2 and 5%) than after the other techniques (generally < 1%). Some complications particularly appear to occur more frequently after specific procedures, such as pigmentation after laser (3% in a prospective trial) or after foam sclerotherapy (1-10 %). The aim of the studies does not generally allow the accurate determination of the incidence of serious complications. A systematic literature review estimates the frequency for laser therapy at less than 1% (nerve damage, deep vein thrombosis and pulmonary embolism). For sclerotherapy, a French register (12,173 sessions) reports an incidence of deep vein thrombosis from 0.09% to 0.2% after foam sclerotherapy (versus < 0.1% with liquid). A number of cases of cerebrovascular accident (CVA) and transient ischaemic attack (TIA) were described after sclerotherapy, especially when using foam. Diverse anaesthesia techniques depending on the trials The review of the literature did not identify any clinical trial that was specifically aimed at the anaesthesia techniques for interventions on varicose veins in the legs. Therefore there is no data to associate one or other anaesthesia technique to clinical results. Local tumescent-anaesthesia is a technique that is being used more in the context of endovenous procedures. In this technique a large quantity of diluted local anaesthetic is injected to prevent swelling of the tissue. This technique not only has an anaesthetic effect but also protects the tissues around the vein and makes surgery easier. The analysis of the techniques used in therapeutic clinical examinations may be summarised as follows: • General anaesthesia and spinal anaesthesia are the most commonly used techniques in trials on varicose veins in legs (conventional surgery, laser ablation or radio frequency); • Thermal ablation techniques (laser, radio frequency) are also carried out under local tumescent anaesthesia. • Sclerotherapy has the advantage that it can be carried out without anaesthesia.
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118. Advantages, disadvantages and
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