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 non‑invasive 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 26 July 2011

Target date for publication of guidance: October 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 of efficacy in the short term is adequate, although further treatment may be required and the effect on subsequent pregnancy uncertain. The procedure may be used with normal arrangements for clinical governance and audit.

1.2   During the consent process clinicians should inform patients that symptom relief may not be achieved; that symptoms may return; and that further procedures may therefore be required. They should also inform patients about the risk of skin burns. Patients contemplating pregnancy should be informed that the effects of the procedure on fertility and on pregnancy are uncertain.

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

1.4   NICE encourages further research into the efficacy of MRI-guided transcutaneous focused ultrasound for uterine fibroids. Research studies should report long-term outcomes including the need for further treatment. Data on the incidence and outcomes of subsequent pregnancy in patients who choose this procedure because they wish to maintain or improve their fertility are particularly important.

2   The procedure

2.1   Indications and current treatments

2.1.1   Uterine fibroids are benign tumours of the uterine wall. Fibroids can be asymptomatic or cause symptoms including abnormal uterine bleeding, urinary incontinence, pelvic pressure, or pain. They can 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-guided transcutaneous focused ultrasound for uterine fibroids is carried out with the patient lying prone inside an MR scanner, using imaging and thermal mapping guidance. The patient is usually under intravenous conscious sedation and is able to communicate with the operator about adverse symptoms such as burning sensations or pain. A catheter is inserted to keep the bladder empty during the procedure.

2.2.2   The head of the ultrasound device is placed in contact with the skin of the patient’s lower abdomen. Low power ultrasound is first used to target the centre of the fibroid, followed (after the aiming of the ultrasound has been confirmed) by high power pulses to ablate part of the fibroid. The patient may have to lie still for up to 3 hours. After treatment, imaging is used to evaluate the volume of the fibroid ablated, as a marker of treatment efficacy.  

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 in the group of patients who were treated by 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 130 patients reported that 88% (78/89) of patients had symptom relief at 12-month follow-up.

2.3.4   Case series of 130 and 80 patients reported that 5% (7/130) and 10% (8/80) of patients respectively had a hysterectomy within 12 months.

2.3.5   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.

2.3.6   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   Spontaneous vaginal expulsion of treated fibroid tissue requiring hysteroscopic removal was documented in a case report.

2.4.4   Bowel perforation following treatment by the procedure was reported in a patient (submitted as an adverse event report to the US Food and Drug Administration [FDA] Manufacturer and User Facility Device Experience [MAUDE] database). Surgical management was required, confirming perforation in 3 bowel sites.

2.4.5   The Specialist Advisers stated that adverse event reported in the literature included reversible nerve injury. They considered a theoretical adverse event of damage to the bladder.

2.5   Other comments

2.5.1   The Committee was informed that many women wish to avoid more invasive interventions for symptomatic fibroids, even if this choice carries an increased chance of requiring further treatments. Some women choose this procedure because they wish to preserve their fertility: the lack of evidence on subsequent fertility underlies the recommendation in 1.4.

2.5.2   The Committee noted that there is continuing evolution and development of the techniques used in this procedure.

3    Further information

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

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

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

June 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.