The National Institute for Clinical Excellence is examining endovenous laser treatment for varicose veins and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about endovenous laser treatment for varicose veins.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 23 September 2003

Target date for publication of guidance: November 2003

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of endovenous laser treatment for varicose veins does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake endovenous laser treatment for varicose veins should inform the clinical governance leads in their trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

Endovenous laser treatment is used to treat varicose veins, which affect 10-15% of men and 25-33% of women. Varicose veins are a sign of underlying venous insufficiency. Saphenous vein insufficiency is the most common form of venous insufficiency in people presenting with symptoms.

People with venous insufficiency may have symptoms of fatigue, heaviness, aching, burning, throbbing, itching and cramps in the legs. Chronic venous insufficiency can lead to skin discolouration, inflammatory dermatitis, recurrent or chronic cellulitis, cutaneous infarction and ulceration.

Endovenous laser treatment is a minimally invasive alternative to surgical stripping of the saphenous vein, which is the most common treatment option for varicose veins.

Under ultrasound guidance and local anaesthesia, a catheter is placed into the greater saphenous vein. A laser fibre is passed through it and positioned below the saphenofemoral junction. An anaesthetic agent is then injected, and the fibre is slowly withdrawn while energy from a diode laser is applied in short pulses. This is repeated along the entire length of the vein until the greater saphenous vein is closed from the saphenofemoral junction to the point of access.

The evidence on efficacy was based on five case series. In these studies, the mean follow-up ranged from 1 to 6 months. Saphenous vein closure rates at 6 months were between 95 and 100%. To date, there is no published evidence available on long-term outcomes.

Limited evidence also suggested that endovenous laser treatment of varicose veins could reduce pain and oedema. For more details refer to the Overview (see Appendix A).

Opinion varied among the Specialist Advisors as to the efficacy of the procedure. One Advisor felt that efficacy had not been established. A second stated that short-term results were favourable but that medium- and long-term results were still unknown, while a third Advisor commented that durability of the procedure had been established, at least in the medium term.

The most common complications reported in the studies were pain and bruising. Other more serious complications such as paraesthesia, burns and scarring were also reported although less frequently. There was one reported case of deep vein thrombosis (DVT) in a patient with a history of multiple DVTs. For more details refer to the Overview (see Appendix A).

The Specialist Advisors listed the main potential complications as sensory loss, skin burns, perforation of deep veins, and pulmonary embolism or DVT. One Advisor stated that endovenous laser treatment had fewer complications than standard surgical treatment, while another Advisor believed that the complication rate was unknown.

The Advisory Committee noted that, while the procedure may be effective in terms of occluding the vein, this may not result in the improvement of symptoms.

The Committee was also concerned about the lack of evidence on long-term failure rates due to recanalisation.

Few studies reported on patient-orientated outcomes.

The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.

• Interventional Procedure Overview of Endovenous Laser Treatment for Varicose Veins, April 2003