The National Institute for Clinical Excellence is examining magnetic resonance (MR) image-guided percutaneous laser ablation for uterine fibroids 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 magnetic resonance (MR) image-guided percutaneous laser ablation for uterine fibroids.

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: 2 September 2003

Target date for publication of guidance: 26 November 2003

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

There is only limited use of magnetic resonance (MR) image-guided percutaneous laser ablation for uterine fibroids. Data on outcomes are insufficient to support its use without special arrangements for consent and for audit or research. Clinicians wishing to undertake MR image-guided percutaneous laser ablation for uterine fibroids should inform the clinical governance leads in their trusts. They should ensure that women offered the procedure understand the uncertainty about its safety and efficacy, and 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.

This procedure is used to treat uterine fibroids (also known as uterine leiomyomas or uterine myomas). Uterine fibroids are the most common pelvic tumours in women, and they are the most common indication for hysterectomy. Only 20-30% of uterine fibroids are symptomatic, resulting in symptoms such as excessive menstrual bleeding, pelvic discomfort and pain.

Hysterectomy or other surgery is the standard treatment for uterine fibroids causing troublesome symptoms. However, in the past decade, there has been increased interest in minimally invasive surgical techniques.

Under image guidance (normally MRI), needles are inserted into the centre of the targeted uterine fibroid through an area of skin that has been anaesthetised. Bare laser fibres are inserted down the centre of each of the needles into the targeted fibroid. Laser energy is then used to destroy the fibroid.

A thermal mapping sequence is used to depict the extent of the heated tissue in the target area as the procedure is carried out.

A catheter is placed in the bladder before the start of the procedure and women receive intravenous sedation and analgesia throughout.

The evidence for efficacy was based on four reports published by one UK study group. Some women were included in more than one report. Limited evidence suggested that the procedure resulted in a short-term (3-month) reduction of fibroid volume of around 30%. For more details refer to the Overview (see Appendix A).

The main comment from the Specialist Advisors related to the relatively new nature of the procedure. One Advisor commented on patient selection, stating that the procedure might only be appropriate for fibroids of a certain size, and that it might not be of benefit for women with larger or multiple fibroids.

Adverse events were reported in a minority of patients. Potential complications included urinary tract infections, skin burns and vaginal bleeding. These events were relatively minor and of a transitory nature. For more details refer to the Overview (see Appendix A).

The Specialist Advisors listed the potential adverse effects as infection, burns, uterine damage and bowel or bladder damage.

This is a very specialised procedure and currently only one centre in the UK undertakes it. As such, the evidence available to the Advisory Committee was limited.

The following source of evidence was considered by the Interventional Procedures Advisory Committee.

• Interventional Procedure Overview of Magnetic Resonance (MR) Image-Guided Percutaneous Laser Ablation of Uterine Fibroids, April 2003