Interventional procedure consultation document

Uterine artery embolisation for fibroids

Uterine fibroids are non-cancerous growths that occur in the womb. They often have no symptoms but they can cause heavy bleeding, pain, and sometimes make it difficult for a woman to conceive or to carry a pregnancy to term. Uterine artery embolisation involves injecting small particles into the blood vessels that take blood to the uterus, via the groin. The aim is to block the blood supply to the fibroids so that they shrink.

The National Institute for Health and Clinical Excellence (NICE) is examining uterine artery embolisation for 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 uterine artery embolisation for 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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).

NICE is committed to promoting through its guidance race and disability equality and 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 guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. 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: 27 July 2010

Target date for publication of guidance: November 2010

1   Provisional recommendations

1.1  Current evidence on uterine artery embolisation (UAE) for fibroids shows that the procedure is efficacious for symptom relief in the short and medium term for a substantial proportion of patients. There are no major safety concerns. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance and audit.

1.2  During the consent process patients should be informed, in particular, that symptom relief may not be achieved, that symptoms may return and that further procedures may therefore be required. 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 interventional radiologist.

1.4  NICE encourages further research into the effects of UAE compared with other procedures to treat fibroids, particularly for women wishing to maintain or improve their fertility.

2   The procedure

2.1  Indications and current treatments

2.1.1  Uterine fibroids, also known as uterine leiomyomas or uterine myomas, are benign tumours of smooth muscle cells and fibrous tissue that develop within the wall of the uterus. They are classified by their location relative to the layers of the uterus (subserous, intramural or submucous) and can be single or multiple.

2.1.2  Uterine fibroids are one of the most common gynaecological problems among women in the UK. They may be asymptomatic or can cause symptoms such as abnormal uterine bleeding, urinary incontinence, a feeling of pelvic pressure, or pain.  They may also be associated with reproductive problems such as infertility and miscarriage.

2.1.3  Asymptomatic fibroids require no treatment. Treatment for symptomatic fibroids includes hysterectomy and myomectomy.

2.2   Outline of the procedure

2.2.1  The aim of UAE for fibroids is to offer a less invasive alternative to hysterectomy or myomectomy, and a faster recovery time.

2.2.2  With the patient under conscious sedation and local anaesthesia, a catheter is inserted into the femoral artery (bilateral catheters are sometimes used). Fluoroscopic guidance is used to manipulate the catheter into the uterine artery. Small embolisation particles are injected through the catheter into the arteries supplying the fibroids, with the aim of causing thrombosis and consequent shrinkage of the fibroids.

2.2.3  Various embolisation agents can be used for this procedure.

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/IP20boverview

2.3   Efficacy

2.3.1  A register of 1387 patients reported that 84% and 83% of patients had an improvement in their symptoms after UAE at 6 and 24 months respectively. In a register of 2112 patients, mean symptom score (on a scale from 0–100; lower score indicates fewer symptoms) improved from 58.6 at baseline to 16.5 among 1218 patients at 3-year follow-up (p < 0.001).  

2.3.2  An RCT of 157 patients treated by UAE or surgery (hysterectomy or myomectomy) reported symptom improvement in both groups, but this improvement was significantly greater among patients treated by surgery than by UAE (p = 0.004 at 1 month, p = 0.03 at 12 months).

2.3.3  The register of 1387 patients reported a significant improvement in mean health-related quality of life scores (on a scale from 0–100) after UAE (79.5 after 6 months vs 44.1 at baseline, p < 0.001).

2.3.4  The register of 1387 patients reported a mean uterine volume reduction of 40% (n = 666) and a mean reduction in fibroid diameter of 2.2 cm (n = 847).

2.3.5  The register of 2112 patients reported a re-intervention rate of 15% during a 3-year follow-up (10% hysterectomy, 3% myomectomy and 2% repeat UAE).

2.3.6  An RCT of 177 patients treated by UAE or myomectomy reported that 24% (19/81) of UAE-treated patients had required hysterectomy at 2-year follow-up.

2.3.7  An RCT of 121 women treated by UAE or myomectomy reported that 50% (13/26) of women who tried to conceive after UAE became pregnant compared with 78% (31/40) of women after myomectomy at a mean follow-up of 25 months (p < 0.05). The rate of spontaneous abortion or missed miscarriage was 64% in the UAE group and 23% in the myomectomy group (p < 0.05).

2.3.8  The Specialist Advisers listed key efficacy outcomes as symptom improvement, quality of life and the need for further treatment.

2.4   Safety

2.4.1  Septic shock and multiple organ failure leading to death 25 days after UAE occurred in 1 patient in a case series of 21 patients, reported in a systematic review. Septicaemia and emergency myomectomy or hysterectomy were reported in 3% (17/649) of UAE-treated patients and less than 1% (2/459) of hysterectomy-treated patients in a non-randomised comparative study of 1108 patients. Uterine infection was reported in 2% (28/1387) of patients in one of the registers (there were significantly fewer infective complications after discharge in patients who received prophylactic antibiotics compared with those who did not; figures not provided).

2.4.2  Arterial dissection or perforation were reported in 2 patients, groin bleeding or pseudoaneurysm were reported in 2 patients and femoral artery occlusion was reported in 1 patient from the register of 1387 patients (events reported prior to discharge from hospital; clinical sequelae not described).

2.4.3  A severe vasovagal event requiring atropine was reported in 1 out of 106 UAE-treated patients in the RCT of 157 patients.

2.4.4  One case of bowel perforation treated by laparotomy was reported in the register of 1387 patients.

2.4.5  The Specialist Advisers listed adverse events reported in the literature as uterine infarction, bladder and vulval damage, ovarian damage, post-embolisation syndrome, pain, vaginal discharge and premature menopause.

3   Further information

3.1  This guidance is a review of ‘Uterine artery embolisation for fibroids’ NICE interventional procedures guidance 94 (2004).

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

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee
July 2010

_{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.}