Deep vein valve reconstruction refers to several surgical techniques aiming to restore the function of valves which have stopped working properly in the deep veins of the legs.

The National Institute for Health and Clinical Excellence is examining lower limb deep vein valve reconstruction for chronic deep venous incompetence and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about lower limb deep vein valve reconstruction for chronic deep venous incompetence.

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

• comments on the preliminary recommendations
  
• the identification of factual inaccuracies
  
• additional relevant evidence.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

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

Closing date for comments: 27 February 2007
Target date for publication of guidance: May 2007

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 lower limb deep vein valve reconstruction for chronic deep venous incompetence does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to use lower limb deep vein valve reconstruction for chronic deep venous incompetence should take the following actions.

? Inform the clinical governance leads in their Trusts.

? Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]

? Audit and review clinical outcomes of all patients having lower limb deep vein valve reconstruction for chronic deep venous incompetence (see section 3.1).

Further research on the procedure would be useful. The Institute may review the procedure upon publication of further evidence.

Chronic deep venous incompetence in the lower limbs may be caused by primary incompetence of the venous valves or by damage to the valves as a result of deep vein thrombosis. Reflux or obstruction in deep veins of the legs interferes with venous return (venous insufficiency) and causes high pressure in the veins of the lower leg (venous hypertension). Chronic deep venous incompetence causes a range of symptoms and signs in the legs, including pain, swelling, lipodermatosclerosis and recurrent ulcers.

Chronic deep venous incompetence is usually treated conservatively, with graduated compression stockings. Ulcers are treated by compression bandaging. If symptoms persist and ulcers fail to respond to conservative treatments, surgery may be considered.

One randomised controlled trial comparing a combination of valvuloplasty and superficial venous surgery with superficial venous surgery alone reported that a significantly higher proportion of patients who had valvuloplasty (86% [54/63] compared with 64% [40/62] respectively [p < 0.05])="" showed="" no="" further="" increase="" in="" disease="" severity="" during="" follow-up.="" a="" second="" randomised="" controlled="" trial="" of="" 44="" patients="" found="" that="" those="" receiving="" valvuloplasty="" reported="" a="" significantly="" better="" quality="" of="" life="" than="" patients="" receiving="" superficial="" venous="" surgery="" alone="" at="" 10-year="" follow-up="" (p="">< 0.05).="" one="" case="" series="" of="" 169="" legs="" reported="" that="" 64%="" and="" 47%="" of="" patients="" with="" primary="" and="" secondary="" valvular="" incompetence="" respectively="" had="" no="" recurrence="" of="" ulcer="" at="" 2="" years="" (absolute="" numbers="" were="" not="" provided="" in="" the="" paper).="" a="" second="" case="" series="" of="" 141="" legs="" reported="" that="" 90%="" (76/84)="" of="" ulcers="" healed="" within="" 3="" months="" of="" valvuloplasty="" and="" 17%="" (13/76)="" recurred="" during="" the="" follow-up="" period="" (1-42="">

Two randomised controlled trials reported that 82% (9/11) and 71% (45/63) of valves treated by valvuloplasty were competent, as assessed by duplex ultrasound scanning, after 2 years and 7-8 years respectively. A non-randomised controlled trial reported that 94% (16/17) of valves were competent after valvuloplasty compared with 29% (4/14) of valves in patients treated with superficial venous surgery alone, at a mean follow-up of 25 months (p <>

One randomised controlled trial reported that the mean ambulatory venous pressure in 35 legs followed up for 10 years was significantly lower after valvuloplasty with superficial venous surgery than after superficial venous surgery alone (44 mm Hg versus 62 mm Hg, p < 0.05).="" the="" mean="" refilling="" time="" was="" also="" significantly="" longer="" (16="" seconds="" versus="" 12="" seconds,="" p="">< 0.05).="" the="" studies="" used="" a="" variety="" of="" methods="" for="" undertaking="" valvuloplasty="" although="" the="" most="" common="" was="" internal="" valvuloplasty.="" for="" more="" details,="" refer="" to="" the="" sources="" of="" evidence="" (see="">

The safety evidence in this overview relates to five case series, including a total of 612 legs. Four case series reported deep vein thrombosis rates of 4% (5/141), 7% (8/107), 12% (21/169) and 13% (11/85) after deep venous valve reconstruction/repair. A single case of pulmonary embolism was reported in the case series of 141 legs (< 1%).="">

Four case series reported rates of wound infection between 1% (2/141) and 7% (12/169). For more details, refer to the sources of evidence (see appendix).

The Specialist Advisers stated that the main potential adverse effects of the procedure are deep vein thrombosis, pulmonary embolism and bleeding.

It was noted that there was more published evidence about the efficacy of the procedure in patients with primary vein incompetence than in patients with secondary venous incompetence following deep vein thrombosis.

This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

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

• 'Interventional procedure overview of lower limb deep vein valve reconstruction for chronic deep venous incompetence', October 2006.