Interventional procedure consultation document

Magnetic resonance image-guided transcutaneous focused ultrasound for uterine fibroids

Image-guided ultrasound treatment for uterine fibroids

Uterine fibroids are non-cancerous (benign) growths that occur in the womb. They can cause heavy menstruation and reproductive problems. This procedure uses magnetic resonance imaging (MRI) to locate the fibroids and direct high-intensity ultrasound energy to destroy fibroid tissue, with the aim of reducing symptoms.

The National Institute for Health and Clinical Excellence (NICE) is examining magnetic resonance image-guided transcutaneous focused ultrasound for uterine fibroids and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’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 magnetic resonance image-guided transcutaneous focused ultrasound for uterine 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 provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 19 May

Target date for publication of guidance: September 2011

1   Provisional recommendations

1.1   Current evidence on the safety of magnetic resonance image (MRI)-guided transcutaneous focused ultrasound for uterine fibroids shows that there are well-recognised potential complications. The evidence on efficacy in terms of reducing the size of fibroids and relieving symptoms in the short term is adequate, although further treatment may be required. The evidence on efficacy in the long term is inadequate. Therefore, when the procedure is offered with the intention of short-term symptom relief (for example in patients close to the menopause), it may be used with normal arrangements for clinical governance, consent and audit. When the procedure is offered with the intention of longer-term symptom relief (for example in younger women who wish to avoid further treatment), it should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to offer MRI-guided transcutaneous focused ultrasound for uterine fibroids to patients with the intention of achieving longer-term symptom relief should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure’s long-term efficacy, the risk of skin burns and the possible need for further procedures. They should provide them with clear written information. In addition, the use of NICE’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 MRI‑guided transcutaneous focused ultrasound for uterine fibroids when the procedure is offered to patients with the intention of achieving longer term symptom relief (see section 3.1).

1.3   Patient selection should be carried out by a multidisciplinary team, including a gynaecologist and an imaging specialist.

1.4   Clinicians should inform all patients about the risk of skin burns as a result of the procedure. They should also inform them about the possible need for further procedures.

1.5   NICE encourages further research into the efficacy of MRI-guided transcutaneous focused ultrasoundfor uterine fibroids. Research studies should report long-term outcomes, especially in comparison with other procedures, and the incidence of subsequent pregnancy in patients who choose this procedure because they wish to maintain or improve their fertility.

2   The procedure

2.1  Indications and current treatments

2.1.1   Uterine fibroids are benign tumours of the uterine wall. Fibroids may be asymptomatic or cause symptoms including abnormal uterine bleeding, urinary incontinence, pelvic pressure, or pain. They may be associated with subfertility and miscarriage.

2.1.2   For symptomatic fibroids, treatment options include hysterectomy, myomectomy, uterine artery embolisation and endometrial ablation techniques.

2.2   Outline of the procedure

2.2.1   MRI guidance enables thermal mapping to monitor tissue heating during transcutaneous focused ultrasound treatment for uterine fibroids. In addition, the patient is under conscious sedation and able to communicate with the operator about any adverse symptoms such as burning sensations or pain. A catheter is inserted to keep the bladder empty during the procedure. The focussed ultrasound is first used at low power to target the centre of the fibroid, and then at higher power to ablate part of the fibroid.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/343/overview

2.3   Efficacy

2.3.1   A non-randomised comparative study of 192 patients treated by MRI-guided transcutaneous focused ultrasoundor abdominal hysterectomy reported improvements in all 8 Short Form-36 quality of life domains for both treatment groups, although scores at 6 months were better for patients who had a hysterectomy (significant for 5 of 8 domains with p values from 0.004 to 0.05).

2.3.2   A case series of 359 patients reported a significantly greater reduction from baseline in symptom severity score (0 – 100; higher scores worse) at 3 months in patients with a non-perfused volume (NPV) ratio (defined as NPV of all treated fibroids divided by the volume of all fibroids, treated and untreated) greater than 20% versus those with an NPV ratio of 20% or less (31 points versus 24 points, p < 0.001).

2.3.3   A case series of 80 patients reported that 8 (10%) had a hysterectomy within 12 months.

2.3.4   A case series of 51 women who conceived after the procedure (total of 54 pregnancies at a mean 8 months after treatment) reported that 41% (22/54) of pregnancies resulted in deliveries; miscarriage occurred in 26% (14/54) and 13% (7/54) were electively terminated.

2.3.5   The Specialist Advisers listed key efficacy outcomes as quality of life, symptom improvement, avoidance of further surgery, and subsequent fertility.

2.4   Safety

2.4.1   Sciatic nerve palsy was reported in 1 of 109 patients (1%) treated by the procedure in the non-randomised comparative study of 192 patients. The case series of 80 patients reported mild temporary sciatica in 1 patient (1%).

2.4.2   A full-thickness burn in the lower abdomen was described in a case report (treated by elliptical excision of the burned area and direct closure). The case series of 287 patients reported skin burns in 7% (10/144) of patients treated in 2003–5 compared with 1% (2/143) of patients treated in 2005–6 (p = 0.04).

2.4.3   The Specialist Advisers listed adverse events reported in the literature as skin burns and reversible nerve injury. They considered theoretical adverse events to include damage to the bladder or bowel.

2.5   Other comments

2.5.1   The Committee was informed that some women choose this procedure for their fibroids because they wish to preserve their fertility. The evidence on preservation of fertility is very limited in quantity and quality, and this consideration underlies the recommendation in 1.5.

3   Further information

3.1   This guidance requires that clinicians undertaking the procedure with the intention of achieving longer-term symptom relief make special arrangements for audit. NICE 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.

3.2   This guidance is a review of ‘Magnetic resonance image-guided transcutaneous focused ultrasound for uterine fibroids’ NICE interventional procedures guidance 231 (2007).

3.3   For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

April 2011

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}