Interventional procedure consultation document

Uterine artery embolisation for treating adenomyosis

Treating adenomyosis by blocking the blood supply to affected parts of the uterus

Adenomyosis is a condition where some of the lining tissue of the uterus grows into its outer muscular layer: this can cause heavy and painful menstrual periods.

Uterine artery embolisation involves injecting small particles into the blood vessels that take blood to the uterus, via arteries in the groin. The aim is to block the blood supply to the adenomyosis so that it shrinks which may then relieve the symptoms.

The National Institute for Health and Care Excellence (NICE) is examining uterine artery embolisation for treating adenomyosis 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 treating adenomyosis.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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

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, advance equality of opportunity, 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: 27 August 2013

Target date for publication of guidance: December 2013

1                      Provisional recommendations

1.1                  Current evidence on uterine artery embolisation for treating adenomyosis 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, consent and audit.

1.2                  During the consent process patients should be informed, in particular, that symptoms may not be relieved, that symptoms may return and that further procedures may be needed. Patients contemplating pregnancy should be informed that the effects of the procedure on fertility 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 uterine artery embolisation compared with other procedures to treat adenomyosis, particularly for patients wishing to maintain or improve their fertility.

 

2                      Indications and current treatments

2.1                  Adenomyosis is a benign condition characterised by presence of ectopic endometrial glands and stroma within the myometrium. Adenomyosis frequently occurs coincidentally with fibroids. Adenomyosis may cause no symptoms but some women with adenomyosis experience heavy, prolonged menstrual bleeding with severe cramps, pelvic pain and discomfort.

2.2                  Treatment for symptomatic adenomyosis includes anti-inflammatory medications, hormone therapy or endometrial ablation. For severe symptoms that do not respond adequately, hysterectomy has been the conventional surgical treatment.  Uterine artery embolisation may be an alternative option for patients who do not wish to have hysterectomy and/or who wish to preserve their fertility.

 

3                      The procedure

3.1                  The aim of uterine artery embolisation for treating adenomyosis is to block the blood supply to the adenomyosis causing it to shrink. The intended benefits of the procedure are that it offers a less invasive alternative to hysterectomy and fertility may be preserved.

3.2                  With the patient under 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 both uterine arteries until cessation of blood flow is achieved.

3.3                  Various embolisation agents can be used for this procedure.

 

4                      Efficacy

This section describes efficacy 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.

4.1                  In a case series of 54 patients with adenomyosis, 78% (42/54) of whom presented with menorrhagia, resolution of menorrhagia was reported in 26% (10/39) of patients at mean follow-up of 5 years. In a case series of 40 patients (90% [36/40] presenting with menorrhagia), symptoms had resolved in 78% (28/36) of patients at median follow-up of 40 months.

4.2                  In a case series of 27 patients, complete resolution of dysmenorrhoea was reported in 38% (7/18), 57% (9/16), 36% (4/11) and 64% (7/11) of patients at 6, 12, 24 and 36 months respectively.

4.3                  In the case series of 54 patients with adenomyosis, 43% (23/54) presented with bulk-related symptoms. Complete resolution of these symptoms was reported in 35% (8/23) of patients at mean follow-up of 5 years. In the case series of 27 patients, complete resolution of bulk-related symptoms was reported in 38% (7/18), 31% (5/16), 46%(5/11) and 55% (6/11) of patients at 6, 12, 24 and 36 months respectively.

4.4                  In a case series of 15 patients, a significant improvement in quality of life was reported at mean follow-up of 8 months in the following domains: ability to perform activities of daily life, ability to socialise outside the home, overall energy level, pain or cramping during menstruation (p<0.001), and pain during sexual intercourse (p=0.02).

4.5                  In the case series of 54 patients with adenomyosis, 5 patients became pregnant (3 delivered successfully and 2 opted for abortion).

4.6                  In a case series of 18 patients with adenomyosis, 44% (8/18) of patients had subsequent treatments because of treatment failure or recurrent symptoms. Twenty-eight per cent (5/18) of patients underwent hysterectomy (4 months after the procedure in 1 patient because of treatment failure, and between 9 and 27 months after the procedure in 4 patients because of recurrent symptoms). Eleven per cent (2/18) of patients needed additional medication treatment and 6% (1/18) of patients needed endometrial balloon thermocoagulation because of recurrent symptoms (timing unclear).

4.7                  The specialist advisers listed key efficacy outcomes to be quality of life, symptom resolution and need for further treatment.

 

5                      Safety

This section describes 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.

5.1                  Severe cramping pain (4 days after the procedure; treated successfully by analgesia) was reported in 1 patient in the case series of 18 patients.

5.2                  Worsening of symptoms was reported in 82% (9/11) of patients in the case series of 27 patients at 3 years follow-up. Three patients opted for hormonal therapy to help with symptom relief and none chose hysterectomy.

5.3                  Amenorrhoea was reported in 4% (2/54) of patients (aged 41 and 44 years) immediately after the procedure in the case series of 54 patients.

5.4                  Transient increased vaginal discharge was reported in 8% (3/40) of patients in a case series of 40 patients (timing unclear).

5.5                  The specialist advisers noted that adverse events from uterine artery embolisation used for adenomyosis are unlikely to differ significantly from those occurring when the procedure is used for fibroids. They include post-embolisation syndrome and non-target embolisation.

 

6                      Committee comments

6.1                  In assessing safety, the Committee was mindful of its previous evaluations of the large volume of evidence on uterine artery embolisation for the treatment of fibroids. It considered that the safety profile of uterine artery embolisation was unlikely to be different when used for adenomyosis (and patients with both adenomyosis and fibroids dominated the published evidence).

 

7                      Further information

7.1            For related NICE guidance, see NICE website.

7.2           Patient commentaries were received after the Committee had met to consider the evidence on the procedure. These commentaries will be considered alongside the consultation comments and updated literature search.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

July 2013

_{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.}