The National Institute for Clinical Excellence is examining subfascial endoscopic perforator vein surgery 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 subfascial endoscopic perforator vein surgery.

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 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: 27 January 2004

Target date for publication of guidance: April 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 subfascial endoscopic perforator vein surgery (SEPS) does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake SEPS should:

• inform the clinical governance leads in their Trusts.
• ensure that patients 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.
• audit and review clinical outcomes of all patients having SEPS. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. The Institute may review the procedure upon publication of further evidence.

The procedure is used for patients with either healed or active ulcers (CEAP¹ classifications 5 or 6) caused by chronic venous insufficiency where conservative management has failed. Deep venous occlusion and/or infected ulcers are usually contraindications to SEPS.

SEPS has also been used for patients with post-thrombotic valvular incompetence, but there is now evidence that this particular group of patients may have poorer outcomes following SEPS, compared with patients with primary valvular incompetence.

SEPS is a minimally invasive alternative to open subfascial perforator vein surgery.

Preoperative evaluation is performed by duplex scanning of the superficial, deep and perforator venous systems to diagnose both valvular incompetence and obstruction. At operation the limb is exsanguinated and two endoscopic ports are placed in the subfascial space in the calf at sites remote from the area of venous ulceration. A space-maker balloon is introduced and inflated in this subfascial space to improve access. Carbon dioxide is then insufflated to facilitate dissection. The incompetent perforating veins are clipped and divided with endoscopic scissors or, alternatively, coagulated and divided with an ultrasonic coagulator (harmonic scalpel).

One randomised controlled trial (RCT), two non-randomised comparative studies and two uncontrolled studies were reviewed. The studies showed great potential for bias: there were large losses to follow-up, considerable discrepancies in length of follow-up between SEPS and open procedure groups, and uncertainties about patient selection. The studies that compared SEPS with open procedures found ulcer-healing to be 85% (17/20 patients) to 90% (18/20 patients) in the SEPS groups and 100% (18/18 and 19/19 patients) in the open procedure groups. Ulcer recurrence rates in these studies were 12% (2/17 patients) to 28% (5/18 patients) in the SEPS groups and 22% (4/18 patients) to 68% (13/19 patients) in the open procedure groups. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered the efficacy of this procedure to be unproven. They also noted that the indications for SEPS are not well established.

The results of the RCT showed a considerably lower wound infection rate in the SEPS group of 0% (0/20 patients), compared with the open procedure group's rate of 53% (10/19 patients). This trial was closed early because the high rate of wound infection in the open procedure group made it unethical to continue. One of the non-randomised comparative studies also found the wound complication rate to be lower in the SEPS group (2/27 patients) when compared with the open procedure group (13/29 patients). For more details, refer to the sources of evidence (see Appendix).

Other reported complications of the SEPS procedure included nerve injury and deep vein thrombosis (DVT). The reported incidence of nerve injury ranged from 0% (0/20 patients) to 7% (2/30 patients); and DVT ranged from 0% (0/27 patients) to 14% (21/146 limbs). The study that reported 14% incidence of DVT originally had a total of 254 patients, of which data from only 130 patients (146 limbs) were analysed due to high loss to follow-up. In this study, DVTs occurred in 2 patients directly after surgery and in an additional 19 patients during the follow-up period. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted safety concerns similar to those reported in the studies: wound infection, nerve injury, DVT and haematoma.

The Advisory Committee commented that the indications for this procedure are uncertain, and that careful patient selection is particularly important.

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

• Interventional Procedure Overview of subfascial endoscopic perforator vein surgery, November 2002

Available from: www.nice.org.uk/ip088overview