The National Institute for Clinical Excellence is examining uterine artery embolisation for the treatment of fibroids and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. 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 uterine artery embolisation for the treatment of fibroids.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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: 22 June 2004

Target date for publication of guidance: August 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 uterine artery embolisation (UAE) suggests that it is safe enough for routine use and that there is symptomatic benefit in a proportion of patients in the short term. However, evidence of the degree, frequency and durability of the procedure's benefits is not currently adequate to support its use without special arrangements for consent and for audit or research.

Clinicians wishing to undertake uterine artery embolisation should take the following actions.

• Ensure that patients understand the uncertainty about the degree, frequency and durability of the procedure's benefits and 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 uterine artery embolisation. Data should be submitted to the British Society of Interventional Radiology registry (www.bsir.org).

Patient selection should be made with the involvement of a multidisciplinary team which should include a gynaecologist and an interventional radiologist.

Further research will be useful in reducing the current uncertainty and should use validated outcome measures and longer follow-up than existing research. The Institute may review the procedure upon publication of further evidence.

Uterine artery embolisation (UAE) is used to treat uterine fibroids, also known as uterine leiomyomas or uterine myomas, which are benign tumours of the uterus. Symptoms caused by fibroids include abnormal bleeding, pelvic pressure and pain, and reproductive problems.

Fibroids are common and are the most frequent reason for a woman to have a hysterectomy or myomectomy.

UAE is performed under conscious sedation. Both uterine arteries are blocked with particles injected via the femoral and uterine arteries. This causes the fibroids to shrink, but is believed to have no permanent effect on the rest of the uterus. Patients are in hospital for 24-36 hours, and are advised to rest for 1-2 weeks. The procedure is performed by an interventional radiologist.

This procedure was the subject of a systematic review commissioned by the Institute and completed in March 2004. The evidence from the studies included in the review indicated that following UAE there was a reduction in mean fibroid volume of between 40-75%. Reductions in fibroid volume, however, were not found to be associated with changes in symptoms. Improvement in symptoms were reported in 62% (8/13) to 95% (19/20) of women who received UAE, with 73-90% of women in a case series of 400 women reporting symptom improvement. However, follow-up was short and in the majority of studies it was limited to 6 months. For more details, refer to the sources of evidence (see Appendix).

In three studies including a total of 604 women, 24 women (4%) reported pregnancies following UAE. For more details, refer to the sources of evidence (see Appendix).

There was a large variation in the reported rate of complications in the studies included in the systematic review. Complication rates in the larger studies ranged from 5% (30/555) to 13% (21/167). Pain was the most common complication following UAE. Other complications included infection, fever, the need for a hysterectomy and the late expulsion of the fibroid. There was one death reported in a small study of 21 patients. For more details, refer to the sources of evidence (see Appendix).

Ovarian dysfunction was also reported, particularly in older women. The rate of ovarian dysfunction was reported in five studies and ranged from 2.5% (2/80) to 14% (9/66) of patients. In a further study of 555 patients, amenorrhoea following UAE was reported in 3% of women younger than age 40 years and in 41% of women aged 50 years and older.

UAE is an alternative to hysterectomy for fibroids, which allows a woman to retain her uterus.

Although ovarian dysfunction is a complication of UAE, it can also complicate other treatments for fibroids.

The technique has been used for several years to treat obstetric haemorrhage, before being used to treat fibroids.

The following documents, which summarise the evidence, were considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Coleman P. Systematic review of the efficacy and safety of uterine artery embolisation in the treatment of fibroids [report on the internet]. Sheffield: Review Body for Interventional Procedures; 2004. Commissioned by the National Institute for Clinical Excellence.

Available from: www.nice.org.uk/ip020systematicreview

• Interventional procedure overview of uterine artery embolisation for fibroids, November 2002

Available from: www.nice.org.uk/ip020overview