The National Institute for Clinical Excellence is examining radiofrequency ablation of 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 radiofrequency ablation of 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 recommendation 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: 27 May 2003
Target date for publication of guidance: 24 September 2003

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

Provisional recommendation

Current evidence of the safety and efficacy of radiofrequency ablation of varicose veins appears adequate to support the use of this procedure as an alternative to sapheno-femoral ligation and stripping, provided that the normal arrangements are in place for consent, audit and clinical governance.

The procedure

Indications

Outline of the procedure

Radiofrequency ablation of varicose veins involves heating the wall of the vein using a bipolar generator and catheters with sheathable electrodes.

Efficacy

Evidence indicated that radiofrequency treatment resulted in immediate occlusion of 90-100% of long saphenous veins. In one study, patients who received radiofrequency ablation had less pain compared with those who had standard surgery (stripping), and required less analgesia.

In general, the evidence showed that fewer than 5% of patients continued to have symptoms such as leg pain, leg fatigue, oedema and noticeable varicose veins after the procedure. There were high patient satisfaction rates.

Safety

One study showed similar postoperative complication rates of approximately 50% in the radiofrequency ablation and stripping arms, including minor complications. Other studies showed that skin burns occurred in 2 to 7% of patients who had radiofrequency ablation. Paraesthesiae occurred in 0-15% of patients, and were more common in patients whose treatment was below the knee. Clinical phlebitis occurred in 2-3% of patients, deep vein thrombosis occurred in 1% and pulmonary embolism was uncommon, occurring in fewer than 1%.

Specialist Advisors reported similar complications to those above.

Other comments

The Committee noted that there were no long-term follow-up data; treated veins may undergo late re-canalisation.