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Title: Uterine Artery Embolisation

title: uterine artery embolisation (uae) for symptomatic fibroids uterine fibroids are benign tumours which can be symptomatic or
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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?
Clinical effectiveness
A recent Cochrane systematic review found that:
*
Patient satisfaction rate was similar between UAE and surgical
groups.
*
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 costeffectiveness 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)
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 reintervention in
women below 40 years of age.
Complications of UAE can occur up to four years after intervention;
complications range from postprocedure pain through to premature
ovarian failure.
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.
The NICE guidance on HMB notes that hysterectomy should not be used as
a firstline 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 contraindicated)
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
postmortem 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 reintervention than women
younger women.
Is it a reasonable cost to the public?
Affordability
No articles discussing affordability were identified by the Evidence
Service
Cost effectiveness
Appropriate patient selection affects the costeffectiveness of UAE.
As quality of life is the important outcome of treatment a
costutility analysis is an appropriate methodology for assessment of
value.
A recent UK based costutility 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 costeffective due to recurrence and risk of
reintervention 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
anxieties and identify potentially serious complications.
*
Lead consultant for followup and aftercare should be formally
agreed.
*
Routine clinical followup is advised at one, six and 12 months
*
GPs should be educated and informed about UAE
Geography
Information not requested.
Considerations for the panel
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
Level of health gain will vary depending on the age of the patient
55 UAE cases undertaken in ABHB over 201013 being examined for
complication and followup rates
Internal audit of treatment for fibroids currently being conducted to
ascertain whether women who underwent hysterectomy/myomectomy were
offered UAE.
UAE is costeffective in an appropriate patient group.
When UAE was introduced in AB MRI imaging was used. Currently
ultrasound is used because of capacity issues/ MRI waiting times.
Evidence review detail
Supporting evidence
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 participants
Follow up
Pregnancy outcomes
REST 2011
UAE v hysterectomy(43/51) or myomectomy (8/51)
157
5 yrs
Y (not included in analyses selection bias)
EMMY 2010
UAE v hysterectomy
177
5yrs
N
Ruuskanen 2010
UAE v hysterectomy
57
2 yrs
N
Mara 2008
UAE v myomectomy
121
24.9 months (mean)
Live birth and impact on fertility (short duration of followup)
Pinto 2003
UAE v hysterectomy
57
6 months
N
FUME 2012
UAE v myomectomy
164
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 (n66) 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
*
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)
*
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)
*
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, to6.80, 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 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
*
higher rates of minor complications within 1 year (OR 2.13, CI
1.43 to 3.17,550 women, 5 trials, I228%,) and at 5 years (OR
2.55,CI 1.26 to 5.19, 144 women, 1 trial) than surgery.
*
more unscheduled readmissions within 46 weeks after discharge
when compared with surgery (OR 2.48, 95% CI 1.40 to 4.40, 338
women, 3 trials, I20%)
*
increased surgical reintervention rate within two years (OR
5.09, 95%CI 2.82 to 9.18, 5 trials, 608 women, I221%) and at
five years (OR 5.79, 95% CI 2.65 to 12.65,289 women, 2 trials,
I265%).
*
Very low level evidence that there is no significant difference
within two years of followup 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 nonrandomised 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 used the UFSQOL instrument; only 48% of patients
were followed up to 12 months. Both are severely limited in their
ability to measure longterm 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 followup (10% hysterectomy, 3% myomectomy and 2% repeat UAE)
whilst the EMMY trial reported that 28% of UAE treated patients
required hysterectomy at 5year followup.
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 postprocedure 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 12% of cases though the latter
is largely confined to those over 45 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 caseseries 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 fibroidrelated 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)]
*
Pretreatment before hysterectomy and myomectomy with a
gonadotrophinreleasing hormone analogue for 3 to 4 months should
be considered where uterine 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 gonadotrophinreleasing
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 firstline treatment solely
for HMB. Hysterectomy should be considered only when:
*
other treatment options have failed, are contraindicated or
are declined by the woman
*
there is a wish for amenorrhoea
*
the woman (who has been fully informed) requests it
*
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 contraindicated)
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 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 postmortem 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 reintervention 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 costeffective from the
perspective of the health service (7). This was based on a
costminimisation 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 5year 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 reintervention rate may balance out
the initial cost advantage of UAE (reinterventions 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).
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 costutility 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
costeffective, although this would depend on the quality of life
value placed by an individual woman on uterine preservation. The
discussion notes:
“In the basecase 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.
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.
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.
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 UFSQOL 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 pretreatment 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 coexist.
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
*
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;
*
narrowstalked 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.
*
Coagulopathy, sever contrast material allergy
*
Renal impairment
*
Immunocompromise
*
Previous pelvic irradiation or surgery
*
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 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 uterinesparing 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 resonanceguided focussed ultrasound surgery and
fibroid myolysis require further investigation prior to 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 followup and aftercare should be formally
agreed.
*
Routine clinical followup is advised at one, six and 12 months
*
GPs should be educated and informed about UAE
Geography
No information requested
1. Gupta JK et al. Uterine artery embolization for symptomatic uterine
fibroids. Cochrane Database Syst Rev 2012.
Systematic review
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 20032008. Registry
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
7. NICE. Heavy menstrual bleeding 2007.
Guideline
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
10. Lethaby A, Vollenhoven C. Fibroids, BMJ Clinical Evidence 2009.
Secondary Evidence Synthesis
11. Beinfeld MT et al .Costeffectiveness of uterine artery
embolization and hysterectomy for uterine fibroids. Radiology 2004
Cost Effectiveness
12. You JH et al. Uterine artery embolization, hysterectomy, or
myomectomy for symptomatic uterine fibroids: a costutility analysis.
Fertility and Sterility 2009
Cost Utility
13. Metwally M et al. Surgical treatment of fibroids for subfertility.
Cochrane Database Syst Rev 2012.
Systematic Review
14. Kroon B et al. Australasian CREI Consensus Expert Panel on Trial
evidence (ACCEPT) group. Fibroids in infertilityconsensus statement
from ACCEPT. Aust N Z J Obstet Gynaecol
2011. Consensus Statement
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
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)1Embolisation.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 20032008. 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 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;
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):S1939. Available at:
http://www.sirweb.org/medicalprofessionals/GRPDFs/UFEGrandRounds.pdf
9.
Public Health Wales. INNU. Hysterectomy in heavy menstrual
bleeding. [Online] 2012. Available at:
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/20110814.pdf
11.
Beinfeld MT et al. Costeffectiveness of uterine artery
embolization and hysterectomy for uterine fibroids. Radiology
2004; 230(1): 207213. Available at:http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?AccessionNumber22004000128
12.
You JH, Sahota DS, Yuen PM. Uterine artery embolization,
hysterectomy, or myomectomy for symptomatic uterine fibroids: a
costutility analysis. Fertility and Sterility 2009; 91(2):
580588. Available at:
http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?AccessionNumber22009100736
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 infertilityconsensus statement from
ACCEPT (Australasian CREI Consensus Expert Panel on Trial
evidence). Aust N Z J Obstet Gynaecol. 2011;51(4):28995.
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
Evidence Service Team, Public Health Wales
Email: [email protected]
Tel: 01495 332343
Review date: None allocated
Updated: n/a
Version no. 1
Quality status: Pending approval
18
Version: 1 (FINAL)

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