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 recommendation 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 Procedure 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 December 2003

Target date for publication of guidance: March 2004

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 appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance. Current evidence on the efficacy of this procedure is limited to case series with follow up no longer than two years. Further information will be useful and clinicians are encouraged to enter patients into a randomised controlled trial.

Endovenous laser treatment is used to treat varicose veins, which affect 20-30% of adults. Varicose veins are a sign of underlying venous insufficiency. Long 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, throbbing, itching and cramps in the legs. Chronic venous insufficiency can lead to skin discolouration, inflammatory dermatitis, cutaneous infarction and ulceration.

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

Under ultrasound guidance and local anaesthesia, a catheter is placed into the long 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 (810 or 940 nm wavelengths) is applied in short pulses. This is repeated along the entire length of the vein until the long saphenous vein is closed from the saphenofemoral junction to the point of access.

The evidence for efficacy was based on five case series. In these studies, the mean follow up ranged from 1 to 17 months. Saphenous vein closure rates were between 90% and 100%. One study reported a closure rate of 93.4% in patients followed up for 2 years (113/121 veins). For more details, refer to the sources of evidence (see Appendix).

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

The most common complications reported in the studies were pain and bruising. In a case series report of 423 patients, 90% (381) of patients reported feeling tightness along the limb and 24% (102) of patients experienced bruising; this resolved within one month after treatment. Phlebitis was also reported in a minority of patients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors listed the potential complications as sensory loss, skin burns and perforation of deep veins. One Advisor stated that endovenous laser treatment had fewer complications than standard surgical treatment, whereas 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 necessarily result in the improvement of symptoms. Few studies have reported on patient-orientated outcomes.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making it's provisional recommendations.

• Interventional Procedure Overview of Endovenous laser treatment for varicose veins, April 2003

Available from: www.nice.org.uk/ip209overview2