The veins of the leg are designed to return blood from the leg upwards towards the heart. Blood is under the force of gravity and, left to itself, would flow downwards. Valves within the veins normally prevent blood from flowing downwards (i.e. backwards), however, if these valves become leaky, pressure within the veins increases. This high pressure causes swelling, thickening and damage to skin, which may break down to form ulcers. Venous leg ulcers are associated with pain and mobility restrictions that affect quality of life.
Compression of legs with bandages or medical stockings helps to move the blood upwards, and reduces pressure in the veins and tissues. This treatment has been shown to improve ulcer healing. Compression is unpopular because it can be uncomfortable, and only provides a benefit while the bandages or hosiery are worn. Even with compression treatment, healing of venous ulcers may still take a long time, and ulcers often come back.
Traditionally, surgery for venous disease involves removing the veins from the leg. The blood is then diverted through the remaining healthy veins. This reduces the pressure in the veins and helps prevent ulcers that have healed from coming back. Generally, this surgery is performed under a general anaesthetic and involves a period of recovery. Some people, particularly the elderly, are less suitable for general anaesthetic and may be at risk of age-related complications or a prolonged and difficult recovery. Newer 'keyhole' surgical techniques destroy the veins with heat, and require only local anaesthesia. These treatments have been shown to be as effective as surgery in the treatment of varicose veins in the absence of ulcers, and result in less pain than traditional surgery. Since a general anaesthetic can be avoided, there is also a reduced risk associated with the anaesthetic procedure, and the recovery period is shorter.
The purpose of this review was to compare the effectiveness of these new, minimally invasive surgical techniques with compression therapy for the management of venous leg ulcers. We wanted to see how well the different treatments work in terms of ulcer healing and recurrence rates. However, despite extensive searching of the literature, we could find no high quality evidence that could provide any answers to the question, so further evidence is needed in this area before any conclusions can be drawn.
The review identified no randomised controlled trials on the effects on ulcer healing, recurrence or quality of life, of superficial endovenous thermal ablation in people with active or healed venous leg ulcers. Adequately-powered, high quality randomised controlled trials comparing endovenous thermal ablative interventions with compression therapy are urgently required to explore this new treatment strategy. These should measure and report outcomes that include time to ulcer healing, ulcer recurrence, quality of life and cost-effectiveness.
Venous leg ulcers represent the worst extreme within the spectrum of chronic venous disease. Affecting up to 3% of the adult population, this typically chronic, recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The current mainstay of treatment for venous leg ulcers is compression therapy, which has been shown to enhance ulcer healing rates. Open surgery on the veins in the leg has been shown to reduce ulcer recurrence rates, but it is an unpopular option and many patients are unsuitable. The efficacy of the newer, minimally-invasive endovenous thermal techniques has been established in uncomplicated superficial venous disease, and these techniques are now beginning to be used in the management of venous ulceration, though the evidence for this treatment is currently unclear. It is hypothesised that, when used with compression, ablation may further reduce pressures in the leg veins, resulting in improved rates of healing. Furthermore, since long-term patient concordance with compression is relatively poor, it may prove more popular, effective and cost-effective to provide a single intervention to reduce recurrence, rather than life-long treatment with compression.
To determine the effects of superficial endovenous thermal ablation on the healing, recurrence and quality of life of people with active or healed venous ulcers.
In August 2013 we searched Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions on the language of publication but there was a date restriction based on the fact that superficial endovenous thermal ablation is a comparatively new medical technology.
Randomised clinical trials comparing endovenous thermal ablative techniques with compression therapy alone for venous leg ulcers were eligible for inclusion. Trials had to report on at least one objective measure of ulcer healing (primary outcome) such as proportion of ulcers healed at a given time point, time to complete healing, change in ulcer size, proportion of ulcers recurring over a given time period, or at a specific point, and ulcer-free days. Secondary outcomes sought included patient-reported quality of life, economic data and adverse events.
Details of potentially eligible studies were extracted and summarised using a data extraction table. Data extraction and validity assessment were performed independently by two review authors, and any disagreements resolved by consensus or by arbitration of a third review author.
No eligible randomised controlled trials were identified. 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.