20131224UAE Final Evidence Report

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Evidence Summary Report for HB/WHSSC
prioritisation panels
Title: Uterine Artery Embolisation (UAE) for symptomatic fibroids
Uterine fibroids are benign tumours which can be symptomatic or asymptomatic;
symptoms include heavy and prolonged bleeding, pain, pressure effects and
subfertility. Presenting symptoms are dependent on the location of the fibroids.
Submucosal fibroids are usually responsible for abnormal uterine bleeding though
intramural fibroids can encroach of endometrial cavity and produce menorrhagia. Large
intramural or subserosal fibroids give rise to mass effect on adjacent organs
corresponding symptoms such as urinary frequency, urgency and or constipation.
Submucous fibroids and intramural fibroids distorting the uterine cavity can contribute
to subfertility.
Treatment for fibroids ranges through medical treatments to surgical interventions.
Uterine artery embolisation (UAE) is a less invasive alternative to hysterectomy and
myomectomy for the treatment of symptomatic fibroids. The intervention blocks the
blood supply to the uterus and thus shrinks the fibroids reducing their effects. As with
myomectomy, UAE offers preservation of the uterus. The procedure is performed by an
interventional radiologist.
Aneurin Bevan currently offers UAE for the treatment of symptomatic fibroids having
significant impact on quality of life but wish to formalise the pathway in relation to this
procedure to minimise variation in practice and optimise outcomes for patients. UAE
may be a more appropriate choice than hysterectomy or myomectomy for some
patients; data on clinical and cost effectiveness are sought to help define appropriate
patient selection.
Requested by: Aneurin Bevan Health Board
Date: 19 September 2013
Evidence summary
Does it work?
Considerations for the
panel
Clinical effectiveness
A recent Cochrane systematic review found that:
 Patient satisfaction rate was similar between UAE and
surgical groups.
Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not
used in a misleading context. Acknowledgement to Public Health Wales NHS Trust to be stated. Copyright in the typographical
arrangement, design and layout belongs to Public Health Wales NHS Trust.
This document is representative of the view of the Public Health Wales Health Intelligence Division. Every effort has been made
to ensure it is accurate and complete, however omissions and inaccuracies may occur. It was collated after due consideration of
the available evidence. Healthcare professionals may choose to take this document into consideration when exercising their
professional judgement, however, the document does not override the individual responsibility of healthcare professionals to
make decisions appropriate to the circumstances of individuals and communities.

Trials comparing UAE with surgery (hysterectomy or
myomectomy) reported a reduction in total length of
hospital stay and quicker resumption to daily
activities with UAE
 The odds of further surgical intervention within five
years were significantly higher with UAE, reducing
cost-effectiveness versus hysterectomy (see also
below).
 Limited very low level data suggests that women
wishing to have children who undergo myomectomy
will have higher pregnancy and live birth rates
compared with those undergoing UAE
The FEMME trial may elucidate relative roles of UAE and
myomectomy in those wishing to retain fertility (reporting
date 2019)
Women in ABHB are not
referred for UAE treatment
for infertility; some wish to
retain fertility but improve
quality of life/heavy
menstrual bleeding/
pressure symptoms
Health gain
The health gain associated with UAE for symptomatic
fibroids accrues in the quality of life of the woman treated.
The procedure is not as successful as hysterectomy in
relieving symptoms. Joint Royal College of
Radiologists/Royal College of Obstetricians and
Gynaecologists guidance notes that around 80% of women
will have either complete or significant relief of symptoms.
At one year approximately 10% of UAE patients require
either hysterectomy or repeat embolisation for symptom
control. There is a higher probability of re-intervention in
women below 40 years of age.
Complications of UAE can occur up to four years after
intervention; complications range from post-procedure pain
through to premature ovarian failure.
Level of health gain will
vary depending on the age
of the patient
55 UAE cases undertaken in
ABHB over 2010-13 being
examined for complication
and follow-up rates
Does it add value to society?
Priority status
NICE guidance on heavy menstrual bleeding (HMB) (2007)
notes that hysterectomy, myomectomy and UAE should all
be considered where surgery for fibroid related heavy
menstrual bleeding is felt necessary. A joint guideline from
the Royal College of Radiologists (RCR) and Royal College of
Obstetricians and Gynaecologists (RCOG) and quality
improvement guidelines from Cardiovascular and
Interventional Radiological Society of Europe (CIRSE) and
Society of Interventional Radiology (SIR) are in agreement
with NICE that UAE should be considered alongside
myomectomy and hysterectomy.
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Internal audit of treatment
for fibroids currently being
conducted to ascertain
whether women who
underwent
hysterectomy/myomectomy
were offered UAE.
The NICE guidance on HMB notes that hysterectomy should
not be used as a first-line treatment for HMB alone. This is
highlighted in a Public Health Wales INNU document
discussing hysterectomy in HMB. The INNU document notes
that
For hysterectomy a patient must have documented
evidence of heavy bleeding due to fibroids greater than 3cm
and the following must apply:
 Other symptoms (e.g. pressure) are present
 There is evidence of severe impact on quality of life
 Other pharmaceutical options have failed
 Patient has been offered myomectomy and / or
uterine ablation (unless medically contra-indicated)
Population and individual impact
Limited data was found in regard to the prevalence of
fibroids with wide ranges quoted in the literature, from
5.4% to 77.0%, depending on the method of diagnosis
used. Observational evidence indicates that the incidence of
fibroids increases after puberty to menopause, reducing
thereafter. The true prevalence is difficult to ascertain as
many women are asymptomatic and are not assessed. Data
from post-mortem examinations showed 50% of women
having these tumours.
Health inequities/Equality Impact Assessment
Fibroids is a condition that only affects women and the
incidence of fibroids in black women is three times greater
than that in white women. The data collected in relation to
the effectiveness of the intervention indicates that women
who are closer to menopause report better scores in
symptom relief and quality of life and are at lower risk of
recurrence and the requirement of re-intervention than
women younger women.
Is it a reasonable cost to the public?
Affordability
No articles discussing affordability were identified by the
Evidence Service
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Cost effectiveness
Appropriate patient selection affects the cost-effectiveness
of UAE.
UAE is cost-effective in an
appropriate patient group.
As quality of life is the important outcome of treatment a
cost-utility analysis is an appropriate methodology for
assessment of value.
A recent UK based cost-utility analysis has found that
whether UAE is cost effective or not versus hysterectomy
will depend on the age of the patient and the quality of life
value assigned by a woman to retaining a uterus. The
model used suggested that in a woman aged 35,
hysterectomy may be more cost-effective due to recurrence
and risk of re-intervention with UAE.
Is it the best way of delivering the service?
Alternative services/interventions
Hysterectomy and myomectomy are alternatives to uterine
artery embolisation for symptomatic fibroids. Other newer,
less common interventions include magnetic resonance
imaging (MRI)-guided focussed ultrasound, laparoscopic or
transcutaneous diathermy and laparoscopic or vaginal
occlusion of uterine vessels. These latter interventions are
not offered within Aneurin Bevan Health Board and have not
been the focus of this report.
NICE interventional procedure guidance notes that patient
selection for UAE should be carried out by a
multidisciplinary team including a gynaecologist and an
interventional radiologist.
Possible parameters for optimising patient selection for UAE
versus other interventions include age, MRI findings, size,
number and location of fibroids, fertility preferences and
known contraindications.
Workforce implications
A joint guideline from the Royal College of Radiologists
(RCR) and Royal College of Obstetricians and
Gynaecologists (RCOG) notes:
 Following the procedure the patient is jointly in the
care of the radiologist and the gynaecologist but
patients should have rapid access to a named
individual who will be in a position to discuss
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When UAE was introduced
in AB MRI imaging was
used. Currently ultrasound
is used because of capacity
issues/ MRI waiting times.
anxieties and identify potentially serious
complications.
 Lead consultant for follow-up and after-care should be
formally agreed.
 Routine clinical follow-up is advised at one, six and
12 months
 GPs should be educated and informed about UAE
Geography
Information not requested.
Supporting evidence
Evidence review detail
Does it work?
Clinical effectiveness
A recent Cochrane review has examined the data pertaining
to uterine artery embolisation for symptomatic uterine
fibroids (1). This has critically appraised the data available in
the primary literature to November 2011. The systematic
review included 6 small randomised controlled trials (Table
1). Three trials compared UAE with abdominal
hysterectomy, two compared UAE with myomectomy and
one trial compared UAE with surgery (43 hysterectomies and
8 myomectomies). No studies were blinded therefore there
is high risk of bias for subjective outcomes such as
satisfaction rates and a moderate risk of bias for
complications and reintervention. FUME had a risk of
attrition bias as it did not include an intention to treat
analysis.
Table 1: Trials included in 2012 version of Cochrane
review
No. of
Follow Pregnancy
participants up
outcomes
REST 2011
157
5 yrs
Y (not
UAE v
included in
hysterectomy(43/51)
analyses or myomectomy
selection
(8/51)
bias)
EMMY 2010
177
5yrs
N
UAE v hysterectomy
Ruuskanen 2010
57
2 yrs
N
UAE v hysterectomy
Mara 2008
121
24.9
Live birth
UAE v myomectomy
months and impact
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1. Gupta JK et al. Uterine
artery embolization for
symptomatic uterine
fibroids. Cochrane
Database Syst Rev 2012.
Systematic review
Pinto 2003
UAE v hysterectomy
FUME 2012
UAE v myomectomy
57
164
(mean) on fertility
(short
duration of
follow-up)
6
N
months
1 yr
N
Meta - analysis outcomes
 Moderately good evidence that there is no significant
difference between UAE and surgery in patient
satisfaction rates and two years (OR 0.69, 0.40 to
1.21, 516 women, 5 trials) or at five years (OR 0.90,
95% CI 0.45 to 1.80, 295 women, 2 trials).
Satisfaction rates were measured by asking women
whether they would undergo the same treatment
again (4 trials) or whether they obtained symptom
relief (1 trial). Analyses were also stratified data by
the specific type of surgery (myomectomy or
hysterectomy) and these also yielded no significant
differences in reported patient satisfaction.

Very low level evidence suggesting that myomectomy
may be associated with better fertility outcomes than
UAE, but this analysis was restricted to the limited
cohort of women (n=66) who tried to conceive in one
study of UAE versus myomectomy (live birth: OR
0.33, 95% CI 0.11 to 1.00; pregnancy: OR 0.29, 95%
CI 0.10 to 0.85).

Compared to surgery, UAE was associated with a
significantly reduced
o length of the procedure: for hysterectomy (MD 16.40 minutes, 95% CI -26.04 to -6.76, 156
women, 1 trial: EMMY 2010) for myomectomy
(MD -49.70 minutes, 95% CI -58.76 to -40.64,
121 women)
o length of hospital stay (between 1.6 and 5.38
days shorter for hysterectomy and between 0.56 and 4.97 days shorter for myomectomy)
o time to resumption of routine activities (MD 24.28 days, 95% CI -27.59 to -20.98, 343
women).Difference less marked in analysis of
myomectomy data alone (MD -10.20 days, 95%
CI -13.60, to-6.80, 121 women).

Moderately good evidence of no significant difference
between surgery and UAE in the rate of major
complications within one year (OR 0.54, 95% CI 0.29
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to 1.01, 6 trials, 671 women) or major complications
within five years (OR 0.71, CI 0.32 to 1.58, 1 trial,
144 women).

UAE was associated with
o higher rates of minor complications within 1 year
(OR 2.13, CI 1.43 to 3.17,550 women, 5 trials,
I2=28%,) and at 5 years (OR 2.55,CI 1.26 to
5.19, 144 women, 1 trial) than surgery.
o more unscheduled readmissions within 4-6
weeks after discharge when compared with
surgery (OR 2.48, 95% CI 1.40 to 4.40, 338
women, 3 trials, I2=0%)
o increased surgical reintervention rate within two
years (OR 5.09, 95%CI 2.82 to 9.18, 5 trials,
608 women, I2=21%) and at five years (OR
5.79, 95% CI 2.65 to 12.65,289 women, 2
trials, I2=65%).

Very low level evidence that there is no significant
difference within two years of follow-up in terms of
fibroid recurrence rate when comparing myomectomy
to UAE (OR 1.32, 95% CI 0.38 to 4.57, 120 women).
Health gain
The health gain associated with UAE for symptomatic
fibroids accrues in the quality of life of the woman treated.
The procedure is not as successful as hysterectomy in
relieving symptoms. RCR/RCOG guidance (2) notes around
80% will have either complete or significant relief of
symptoms but that at one year approximately 10% of UAE
patients require either hysterectomy or repeat embolisation
for symptom control. The probability of requiring further
treatment (repeat UAE, exploration of uterine cavity,
myomectomy or hysterectomy) is higher the younger the
patient; 25% below 40 and 10% between 40 and 50- years
old (data from REST, HOPEFUL cohort study)
There are two registries of non-randomised data, the
FIBROID registry which collated prospective data from UAE
procedures carried out in the USA (3) and the UK Uterine
Artery Embolisation for Fibroids Registry (4). FIBROID used
a validated disease specific Quality of Life instrument (UFSQOL) to assess effectiveness and collected data on
reinterventions and adverse events in 2112 women over a
12 month period (20% loss to follow up); data collection
ended in March 2004. The UK registry involved 59 centres
and 1387 procedures between 2003 and 2006. This also
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2. Royal College of
Radiologists / Royal College
of Obstetricians and
Gynaecologists. Clinical
recommendations on the
use of uterine artery
embolisation in the
management of fibroids.
2009.
Guideline
3. AHRQ. The FIBROID
Registry 2004. Registry
4. British Society for
Interventional Radiology.
UK Uterine Artery
Embolisation for Fibroids
Registry 2003-2008.
Registry
used the UFS-QOL instrument; only 48% of patients were
followed up to 12 months. Both are severely limited in their
ability to measure long-term outcomes. NICE Interventional
Procedure Guidance 367 on uterine artery embolisation for
fibroids highlights some data from both registries and RCTs
(5). They note that the FIBROID register reported a reintervention rate of 15% during a 3 year follow-up (10%
hysterectomy, 3% myomectomy and 2% repeat UAE) whilst
the EMMY trial reported that 28% of UAE treated patients
required hysterectomy at 5-year follow-up.
The HOPEFUL cohort study (6) was a multicentre
retrospective study comparing the experiences of two
representative cohorts of women who received one of two
alternative treatments for symptomatic fibroids
(hysterectomy, N = 459; UAE, N = 649). In this study more
women in the hysterectomy cohort reported relief from
fibroid symptoms (89% versus 80% UAE, p < 0.0001) and
feeling better (81% versus 74% UAE, p < 0.0001), but only
70% (compared with 86% UAE, p = 0.007) would
recommend their treatment to a friend. The authors
reported that UAE women had up to a 23% (95% CI 19 to
27%) likelihood of requiring further treatment. This study
also noted the need for good communication with patients
about the process of fibroid reduction following the
intervention and management of expectations with regard to
fertility.
Complications
The temporal profile for complications arising as a result of
UAE is very different from those undergoing hysterectomy or
myomectomy. Whereas the first 30 postoperative days
capture almost all surgical complications, this is not the case
with UAE where complications can occur up to four years
later.
Complications of UAE include post-procedure pain, postembolisation syndrome, infection premature ovarian failure
secondary amenorrhoea due to endometrial atrophy or
intrauterine adhesions, recurrence and unknown effects on
conception and pregnancy. Many consider that postembolisation syndrome is an expected aspect of recovery
and rather than a complication unless unplanned medical
therapy or prolonged hospitalization is required.
THE RCR/RCOG guideline notes that in patient undergoing
UAE, complications lead to hysterectomy in up to 2.9% of
cases and premature ovarian failure may occur in 1-2% of
cases though the latter is largely confined to those over 45
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5. NICE. Uterine artery
embolisation for fibroids
2010
Interventional
Procedure Guidance
6. Hirst A et al. A multicentre retrospective cohort
study comparing the
efficacy, safety and costeffectiveness of
hysterectomy and uterine
artery embolisation for the
treatment of symptomatic
uterine fibroids. The
HOPEFUL study. Health
Technol Assess 2008
Cohort
or approaching menopause. They also note that passage of
fibroid material may require assistance in 6% of patients
and that endometritis occurs in 0.5% of cases. These
guidelines note that MRI should be considered early in
assessment of complications such as sepsis and expulsion
since valuable information regarding tissue viability, fluid
collections and partially expelled fragments can be gleaned
from MRI.
Does it add value to society?
Priority status
NICE guidance on heavy menstrual bleeding (HMB) was
published in 2007 (7). At that time where was insufficient
evidence on long term complications and recurrence rates of
UAE to make recommendations related to these issues. Its
recommendations with regard to UAE were based mainly on
case-series and cohort data. Their recommendations in
relation to UAE and myomectomy state








For women with large fibroids and HMB, and other
significant symptoms such as dysmenorrhoea or
pressure symptoms, referral for consideration of
surgery or uterine artery embolisation (UAE) as firstline treatment can be recommended. [D (GPP)]
UAE, myomectomy or hysterectomy should be
considered in cases of HMB where large fibroids
(greater than 3 cm in diameter) are present and
bleeding is having a severe impact on a woman’s
quality of life. [C]
When surgery for fibroid-related HMB is felt necessary
then UAE, myomectomy and hysterectomy must all be
considered, discussed and documented. [D (GPP)]
Myomectomy is recommended for women with HMB
associated with uterine fibroids and who want to retain
their uterus. [D]
UAE is recommended for women with HMB associated
with uterine fibroids and who want to retain their
uterus and/or avoid surgery. [B]
Prior to scheduling of UAE or myomectomy, the uterus
and fibroid(s) should be assessed by ultrasound.
If further information about fibroid position, size,
number and vascularity is required, MRI should be
considered. [D(GPP)]
Pre-treatment before hysterectomy and myomectomy
with a gonadotrophin-releasing hormone analogue for
3 to 4 months should be considered where uterine
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7. NICE. Heavy menstrual
bleeding 2007.
Guideline

fibroids are causing an enlarged or distorted uterus.
[A]
If a woman is being treated with gonadotrophinreleasing hormone analogue and UAE is then planned,
the gonadotrophin-releasing hormone analogue should
be stopped as soon as UAE has been scheduled.
[D(GPP)] [Note: RCR/RCOG says not be given within
the preceding two months prior to procedure]
The guideline also states:
 Hysterectomy should not be used as a first-line
treatment solely for HMB. Hysterectomy should be
considered only when:
o other treatment options have failed, are
contraindicated or are declined by the woman
o there is a wish for amenorrhoea
o the woman (who has been fully informed)
requests it
o the woman no longer wishes to retain her uterus
and fertility. [C]
A joint guideline from the Royal College of Radiologists
(RCR) and Royal College of Obstetricians and Gynaecologists
(RCOG) (2) and quality improvement guidelines from
Cardiovascular and Interventional Radiological Society of
Europe (CIRSE) and Society of Interventional Radiology
(SIR) (8) are in agreement with NICE that UAE should be
considered alongside myomectomy and hysterectomy.
This is also highlighted in a Public Health Wales INNU
evidence statement discussing hysterectomy in HMB (9).
The statement highlights that:
For hysterectomy a patient must have documented evidence
of heavy bleeding due to fibroids greater than 3cm and the
following must apply:
 Other symptoms (e.g. pressure) are present
 There is evidence of severe impact on quality of life
 Other pharmaceutical options have failed
 Patient has been offered myomectomy and / or uterine
ablation (unless medically contra-indicated)
8. RSE and SIR Standards
of Practice Committees.
Quality improvement
guidelines for uterine
artery embolization for
symptomatic leiomyomata
2009. J Vasc Interv Radiol
Guideline
9. Public Health Wales.
INNU- Hysterectomy in
Heavy Menstrual Bleeding
2012. Evidence
Statement
Population and individual impact
Limited data was found in regard to the prevalence of
fibroids. BMJ Clinical Evidence summarised the evidence in
relation to interventions for fibroids in 2009 (10). The
background section includes available data on prevalence.
Clinical Evidence notes that wide ranges are quoted in the
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10. Lethaby A, Vollenhoven
C. Fibroids, BMJ Clinical
Evidence 2009. Secondary
Evidence Synthesis
literature, from 5.4% to 77.0%, depending on the method of
diagnosis used. Observational evidence indicates that the
incidence of fibroids increases after puberty to menopause,
reducing thereafter. The true prevalence is difficult to
ascertain as many women are asymptomatic and are not
assessed. Data from post-mortem examinations showed
50% of women having these tumours.
Health inequities/Equality Impact Assessment
Fibroids is a condition that only affects women and the
incidence of fibroids in black women is three times greater
than that in white women. The data collected in relation to
the effectiveness of the intervention indicates that women
who are closer to menopause report better scores in
symptom relief and quality of life and are at lower risk of
recurrence and the requirement of re-intervention than
younger women.
Is it a reasonable cost to the public?
Affordability
No articles discussing affordability were identified by the
Evidence Service
Cost effectiveness
NICE guidance on heavy menstrual bleeding (2007) noted
that UAE was less costly than surgery at 12 months and was
cost-effective from the perspective of the health service (7).
This was based on a cost-minimisation analysis of short
term data from the REST trial. UAE had a mean cost of
£1,685.36 (95% CI £1,465.72 to £1905.00) compared with
surgery at a mean cost of £2.566.87 (95% CI £2,263.73 to
£2,870.01). This analysis was conducted prior to 5-year
outcomes from clinical trials being available.
2009 RCR/RCOG clinical recommendations noted that cost
effectiveness may reduce longer term with need for
additional treatment. This is also commented upon in the
2012 Cochrane review (1) which highlights that the increase
in the surgical re-intervention rate may balance out the
initial cost advantage of UAE (re-interventions within 2
years: OR 5.09, 95% CI 2.82 to 9.18, 608 women, 5 trials;
within 5 years: OR 5.79, 95%CI 2.65 to 12.65, 289 women,
2 trials, (REST 2011; EMMY 2010).
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The Cochrane review also comments that the 23% chance of
requiring further treatment for fibroids after UAE at 4.6
years in the HOPEFUL cohort study was similar to the
findings of their analyses. The authors of the cost-utility
analysis conducted alongside HOPEFUL indicated that UAE is
less expensive than hysterectomy even after further
treatments for unresolved or recurrent symptoms are taken
into account, with little difference in QALYs between the two
treatments. However the determining factor on the
economics appears to be the age of the patient. HOPEFUL
investigators report that younger women are exposed to the
risk of recurrent fibroids and subsequent additional
procedures over a longer period and consequently UAE may
no longer be cost-effective, although this would depend on
the quality of life value placed by an individual woman on
uterine preservation. The discussion notes:
“In the base-case analysis, UAE was associated with lower
QALYs than hysterectomy; however, the size of the
difference in QALYs in the two groups was small. When
considering UAE in younger women (35 years old), UAE
became slightly more costly than hysterectomy over time
when additional procedures were taken into account.”
Other cost analyses are available from the US and Hong
Kong (11)(12). These are likely to be less generalisable to
the UK.
11. Beinfeld MT et al .Costeffectiveness of uterine
artery embolization and
hysterectomy for uterine
fibroids. Radiology 2004
Cost Effectiveness
Is it the best way of delivering the service?
12. You JH et al. Uterine
artery embolization,
hysterectomy, or
myomectomy for
symptomatic uterine
fibroids: a cost-utility
analysis. Fertility and
Sterility 2009
Cost Utility
Alternative services/interventions
Hysterectomy and myomectomy are alternatives to uterine
artery embolisation for symptomatic fibroids. Other newer,
less common interventions include magnetic resonance
imaging (MRI)-guided focussed ultrasound, laparoscopic or
transcutaneous diathermy and laparoscopic or vaginal
occlusion of uterine vessels. These latter interventions are
not offered within Aneurin Bevan Health Board and have not
been the focus of this report.
Patient Selection
NICE Interventional procedure guidance 367 on uterine
artery embolisation for fibroids (5) notes that patient
selection should be carried out by a multidisciplinary team,
including a gynaecologist and an interventional radiologist.
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NICE guidance on heavy menstrual bleeding notes that
appropriate treatment should be planned based on size,
number and location of the fibroids. Both that guideline and
the RCR/RCOG guideline note that further research is
required to elucidate the association between size, number
of and site of uterine fibroids and symptoms/symptom
resolution to help with patient selection. The RCR/RCOG
guideline notes that large fibroids should not be considered
a contraindication. The UK registry report (4) notes that
increased age and increased number of fibroids were the
only variables shown in their analysis to be significant
predictors of improvement in UFS-QOL scores. Increased
age at the time of intervention was also shown to predict an
improved symptom score on a five point scale (much better,
better, unchanged, worse, much worse). The registry report
states that with UAE the whole uterus is treated whereas
large numbers of fibroids can make myomectomy more
difficult.
Data on recurrence rate of fibroids after UAE is sparse but
the time course to symptoms will depend on age and the
onset of menopause.
The literature identified stated that the presence of fibroids
should be confirmed by technically adequate imaging and
add that the likelihood of the fibroids being the cause of
main symptoms should be assessed; other possible causes
such as endometriosis and adenomyosis should be detected
as symptoms could be attributable to these conditions and
symptoms may not resolve following UAE if that is the case.
According to RCR/RCOG accurate pre-treatment diagnosis
with MRI is preferred, good quality ultrasound being the
minimum imaging requirement. The guideline also notes
that MRI alters management in as many as 22% with 19%
not undergoing UAE. MRI is more likely to recognise
adenomyosis if present. RCR/RCOG authors report that
although UAE in the presence of adenomyosis is less
efficacious but may still be considered when fibroids and
adenomyosis co-exist.
Contraindications
Some contraindications listed in the secondary literature
are:
 Viable pregnancy

Current or recent infection because of likelihood of
abscess formation and related septic complications
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
Women who are unwilling to have a hysterectomy in
any circumstances

Significant doubt about the diagnosis of benign
pathology which is of particular concern in peri- and
postmenopausal women

Relative contraindications;
o
narrow-stalked pedunculated subserous fibroids
(attachment point<50% of diameter) might
detach and cause significant complications post
embolisation requiring surgical intervention
Submucosal pendunculated fibroids may be
expelled transcervically and may require surgical
intervention in the event of arrested passage.
o Coagulopathy, sever contrast material allergy
o Renal impairment
o Immunocompromise
o Previous pelvic irradiation or surgery
o Chronic endometritis,
Patients contemplating a subsequent pregnancy
A recent Cochrane review on surgical treatment for fibroids
causing subfertility (13) (last assessed as up to date in
2012) concluded:
“There is currently insufficient evidence from randomised
controlled trials to evaluate the role of myomectomy to
improve fertility”
NICE guidance on heavy menstrual bleeding (7) notes
“Women should be informed that UAE or myomectomy will
potentially allow them to retain their fertility. [C]”
RCR/RCOG guideline (2) states
“Women who desire pregnancy but experience subfertility or
recurrent miscarriage due to fibroids who are unsuitable for
hysteroscopic resection or myomectomy, or in whom
myomectomy has failed can be offered UAE as a safe
effective alternative. What effect UAE has on IVF has not
Version: 1 (FINAL)
14
13. Metwally M et al.
Surgical treatment of
fibroids for subfertility.
Cochrane Database Syst
Rev 2012.
Systematic Review
been determined. Patients must be made aware of the
potential complications of the procedure including the risk of
ovarian damage “
The Cochrane review (1) noted very low level evidence
suggesting that myomectomy may be associated with better
fertility outcomes than UAE.
“Mara 2008 was the only study which specifically looked at
the impact of UAE versus myomectomy on fertility, an
important parameter as both are uterine-sparing
procedures. The findings for live birth were of borderline
statistical significance, favouring myomectomy, and there
were significantly more pregnancies in the myomectomy
group. Not all the women in the study were trying to
conceive: 26 after UAE and 40 after myomectomy. The
pregnancy rate after UAE was 50%, delivery rate 19% and
miscarriage rate 53%, while these percentages were 78%,
48% and 23%, respectively, after myomectomy. The
differences in all these parameters were statistically
significant (P < 0.05).”
A consensus statement (2011) developed by a group of
Australasian subspecialists in reproductive endocrinology
and infertility (the ACCEPT group) on the evidence
concerning the impact and management of fibroids in
infertility(14) notes:
“Subserosal fibroids do not appear to impact on fertility
outcomes. Intramural (IM) fibroids may be associated with
reduced fertility and an increased miscarriage rate (MR);
however, there is insufficient evidence to inform whether
myomectomy for IM fibroids improves fertility outcomes.
Submucosal fibroids are associated with reduced fertility
and an increased MR, and myomectomy for submucosal
fibroids appears likely to improve fertility outcomes. The
relative effect of multiple or different sized fibroids on
fertility outcomes is uncertain, as is the relative usefulness
of myomectomy in these situations. It is recommended that
fibroids with suspected cavity involvement are defined by
magnetic resonance imaging, sonohysterography or
hysteroscopy because modalities such as transvaginal
ultrasound and hysterosalpingography lack appropriate
sensitivity and specificity. Medical management of fibroids
delays efforts to conceive and is not recommended for the
management of infertility associated with fibroids. Newer
treatments such as uterine artery embolisation,
radiofrequency ablation, bilateral uterine artery ligation,
magnetic resonance-guided focussed ultrasound surgery
and fibroid myolysis require further investigation prior to
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15
14. Kroon B et al.
Australasian CREI
Consensus Expert Panel on
Trial evidence (ACCEPT)
group. Fibroids in
infertility-consensus
statement from ACCEPT.
Aust N Z J Obstet Gynaecol
2011. Consensus
Statement
their establishment in the routine management of fibroidassociated infertility.”
Fibroids can be a cause of subfertility but their treatment
can also have an impact on fertility. For myomectomy
concerns include fibroid recurrence, adhesion formation and
the increased possibility of uterine rupture in pregnancy and
during delivery. Ovarian failure due to impairment of ovarian
blood flow, theoretical risk of adverse effect on placental
blood flow and infection leading to fallopian tube damage
and infertility are some concerns associated with UAE.
Outcomes from the FEMME trial (15), due to be reported in
mid 2019 will hopefully clarify the position of myomectomy
and UAE for women with symptomatic fibroids wishing to
retain their womb. It will report on the relative clinical and
cost effectiveness of the two procedures. 650 women having
symptoms and who have MRI confirmed fibroids will be
recruited from over 30 UK hospitals by gynaecologists and
interventional radiologists and will be randomised in a 1:1
ratio to myomectomy or embolisation. The primary outcome
of quality of life will be assessed by use of a disease specific
questionnaire at two years. Effectiveness will also be
assessed at 6 months and 1 and 4 years after treatment.
Secondary outcomes include effect on menstrual bleeding,
pregnancy outcomes, further treatment and adverse events.
Information about the surgical technique, healthcare
resources, complications, repeat surgeries, conceptions and
pregnancy outcomes will be collected throughout the study.
A subset of up to 400 women will also be asked to give
blood before and afterwards to measure their reproductive
hormone levels to gauge their fertility potential.
Workforce implications
The joint guideline from the Royal College of Radiologists
(RCR) and Royal College of Obstetricians and Gynaecologists
(RCOG) (2) notes:
 Following the procedure the patient is jointly in the
care of the radiologist and the gynaecologist but
patients should have rapid access to a named
individual who will be in a position to discuss anxieties
and identify potentially serious complications.
 Lead consultant for follow-up and after-care should be
formally agreed.
 Routine clinical follow-up is advised at one, six and 12
months
 GPs should be educated and informed about UAE
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16
15. Mc Pherson K et al.
FEMME trial: Randomised
trial of treating fibroids
with either embolisation or
myoMectomy to measure
the Effect on quality of life,
In progress.
Randomised controlled
trial
Geography
No information requested
Methods:
Information
sources/Databases
Trip Database, NHS Evidence, PubMed Clinical Queries (2011 to date),
controlled trials register
Limits (language, date)
English, focus secondary sources
Search terms
[uterine artery (embolisation or embolization)] or UAE
Search Date
2 October 2013
References
1. Gupta JK et al. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst
Rev 2012, Issue 5. Art. No.: CD005073. DOI: 10.1002/14651858.CD005073.pub3. Available at:
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD005073.pub3/pdf
2.
Royal College of Radiologists, Royal College of Obstetricians and Gynaecologists. Clinical
recommendations on the use of uterine artery embolisation in the management of fibroids. 2nd ed.
London: The Royal College of Radiologists; 2009. Available at:
https://www.rcr.ac.uk/docs/radiology/pdf/BFCR(09)1_Embolisation.pdf
3. Agency for Healthcare Research and Quality. The FIBROID Registry.[Online] 2005. Available at:
http://archive.ahrq.gov/research/fibroid/
4. British Society for Interventional Radiology. UK Uterine Artery Embolisation for Fibroids Registry
2003-2008. London: BSIR. Available at:
http://www.drpaulcrowe.com/media/2ba54602372e41f6aae4816b1960f735.pdf
5. National Institute for Health and Clinical Excellence. Uterine artery embolisation for fibroids. IPG 367.
London: NICE; 2010. Available at: http://www.nice.org.uk/nicemedia/live/11025/51706/51706.pdf
6.
Hirst A et al. A multi-centre retrospective cohort study comparing the efficacy, safety and costeffectiveness of hysterectomy and uterine artery embolisation for the treatment of symptomatic
uterine fibroids. The HOPEFUL study. Health Technol Assess 2008; 12(5). Available at:
http://www.hta.ac.uk/execsumm/summ1205.shtml
7. National Collaborating Centre for Women’s and Children’s Health. Heavy menstrual bleeding.
Commissioned by NICE. London: RCOG; 2007. Available at:
http://www.nice.org.uk/nicemedia/live/11002/30401/30401.pdf
8. Hovsepian DM et al. Quality improvement guidelines for uterine artery embolization for symptomatic
leiomyomata. J Vasc Interv Radiol. 2009 20(7 Suppl):S193-9. Available at:
http://www.sirweb.org/medical-professionals/GR_PDFs/UFE_Grand_Rounds.pdf
9. Public Health Wales. INNU. Hysterectomy in heavy menstrual bleeding. [Online] 2012. Available at:
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http://howis.wales.nhs.uk/sitesplus/888/page/48750
10. Lethaby A, Vollenhoven B. Fibroids. BMJ Clinical Evidence;2009 Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217738/pdf/2011-0814.pdf
11. Beinfeld MT et al. Cost-effectiveness of uterine artery embolization and hysterectomy for uterine
fibroids. Radiology 2004; 230(1): 207-213. Available
at:http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?AccessionNumber=22004000128
12. You JH, Sahota DS, Yuen PM. Uterine artery embolization, hysterectomy, or myomectomy for
symptomatic uterine fibroids: a cost-utility analysis. Fertility and Sterility 2009; 91(2): 580-588.
Available at: http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?AccessionNumber=22009100736
13. Metwally M, Cheong YC, Horne AW. Surgical treatment of fibroids for subfertility. Cochrane Database
Syst Rev 2012, Issue 11. Art. No.: CD003857. DOI: 10.1002/14651858.CD003857.pub3. Available
at: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003857.pub3/abstract
14. Kroon B et al. Fibroids in infertility-consensus statement from ACCEPT (Australasian CREI Consensus
Expert Panel on Trial evidence). Aust N Z J Obstet Gynaecol. 2011;51(4):289-95. Available at:
http://www.ncbi.nlm.nih.gov/pubmed/21806566
15. Mc Pherson K et al. FEMME trial: Randomised trial of treating fibroids with either embolisation or
myoMectomy to measure the effect on quality of life. HTA 08/53/22. In progress (estimated
publication date 2018). Available at: http://www.hta.ac.uk/2378
Compiled by: Eleri Tyler
Email: eleri.tyler@wales.nhs.uk
Review date: None allocated
Version no. 1
Version: 1 (FINAL)
Evidence Service Team, Public Health Wales
Tel: 01495 332343
Updated: n/a
Quality status: Pending approval
18
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