The National Institute for Clinical Excellence is examining transilluminated powered phlebectomy 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 transilluminated powered phlebectomy 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 transilluminated powered phlebectomy for varicose veins includes small numbers of patients and is of limited quality. It 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 transilluminated powered phlebectomy 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.

Transilluminated powered phlebectomy is used to treat varicose veins, which affect 25-33% of women and 10-15% of men. Varicose veins are a sign of underlying venous insufficiency.

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.

Transilluminated powered phlebectomy is intended as an alternative to hook phlebectomy for symptomatic varicose veins in the leg, and as an adjunct to surgical removal of the saphenous vein.

Under anaesthetic, an endoscopic transilluminator is inserted underneath the skin to illuminate the vein clusters to be resected. A suction device with guarded blades (resector device) is then introduced via another incision at the other end of the varicose vein, and the varicosities are cut and removed by suction. Once removal of the veins is complete, a second anaesthetic is injected to minimise bruising, pain and haematoma formation.

The resector device can also be inserted through the first incision, minimising the number of incisions made during the procedure.

The main efficacy outcomes identified in the studies were reduced pain and cosmetic satisfaction. Comparative data suggested that transilluminated powered phlebectomy resulted in similar or less pain, at 6 weeks, and greater cosmetic satisfaction compared to hook phlebectomy. The evidence reported in the non-comparative studies supported these findings. The available studies reported short-term results only.

The evidence also indicated that fewer incisions were required for transilluminated powered phlebectomy than with hook phlebectomy (mean 6 versus 17 incisions in one study). There was also some evidence to suggest that the number of incisions reduced with surgeon experience. For more details refer to the Overview (see Appendix A).

One Specialist Advisor commented that the cosmetic advantages of the procedure can be negligible because of damage to the subcutaneous fat. It was noted by one Advisor that this procedure might be more effective for the treatment of multiple and recurrent varicosities, which can be difficult to treat by hook phlebectomy.

The comparative data indicated that transilluminated powered phlebectomy had fewer complications than hook phlebectomy. Common complications reported in the studies included haematomas, bruising and paraesthesia.

One case of deep vein thrombosis, in a study of 114 patients (0.9%), was also reported as a complication of the procedure. For more details refer to the Overview (see Appendix A).

The Specialist Advisors listed the main potential complications as haematoma, pain and bruising. Neuropraxia, causing sensory disturbance, was also listed by one Advisor as a potential complication, although it was considered that the incidence of this would be low.

The Advisory Committee noted that although the evidence suggested the procedure is effective, the evidence was too limited to be conclusive. A particular weakness was that there were no data on the number of different veins treated during the procedure in each patient.

The Committee was concerned about the lack of long-term follow-up data and the Specialist Advisors' anxiety about potential complications.

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

• Interventional Procedure Overview of Transilluminated Powered Phlebectomy for Varicose Veins, April 2003