On 10/16/2005, gynecology and radiology specialists met in Berlin for a consensus
meeting regarding the use of uterine artery embolization (UAE; fibroid embolization)
to treat fibroids [1]. The goal of this meeting was to summarize the current state of knowledge regarding
fibroid embolization, which was a new treatment option at that time, and to provide
recommendations regarding indication, implementation and follow-up from an interdisciplinary
radiological-gynecological standpoint. In 2010, representatives from Austria and Switzerland
participated in the discussion for the first time so that consensus recommendations
with the support of the professional societies can now be made across borders [2]. In 2013, the consensus meetings were expanded to include an interdisciplinary dialog
regarding the use of MR-guided focused ultrasound (MRgFUS [3]) in the treatment of fibroids and have since then been held every two years at the
IROS, the three-country meeting of the German, Austrian, and Swiss societies for interventional
radiology [4]
[5]
[6]
[7].
The current edition of RöFo [8]
[9] presents the results of the 3 rd consensus meeting “MRgFUS for fibroid treatment”
and 6th consensus meeting “UAE for fibroid treatment” which was held on January 14,
2017.
For the 3 rd consensus meeting “MRgFUS for fibroid treatment”, a selective search
of the literature including topics deemed relevant by the invited participants was
performed. Selected publications were included in the appendix of the consensus paper.
The effects of pretreatment with ulipristal acetate, the recommended interval between
MRgFUS and trying to conceive, the approach in the case of postinterventional discharge
of fibroid material from the vagina (fibroid expulsion), the necessity of follow-ups
after MRgFUS treatment, and the significance of volume reduction for symptom control
were discussed based on the current literature and the experiences of the consensus
participants with the method. Particular attention was given to the topic “treatment
of an undetected leiomyosarcoma”. The consensus participants agreed on the following
formulation: “...in the informed consent discussion prior to MRgFUS, the patient should
be made aware of the lack of preinterventional histological confirmation which all
other organ-preserving fibroid treatment methods have in common...”. In the case of
suspicion of a malignancy of the uterus, MRgFUS treatment is absolutely contraindicated.
Reference to the fact that the selective progesterone receptor modulator ulipristal
acetate can lead to better perfusion of fibroids so that the evaluation of the ability
to treat with MRgFUS as well as the treatment itself could be unfavorably affected
by the taking of ulipristal acetate was added.
With respect to “MRgFUS in patients desiring to have children”, the consensus participants
agreed on the basis of a lack of prospective study results that MRgFUS/HIFU treatment
cannot be recommended prior to a planned pregnancy. However, if a patient wants to
become pregnant after MRgFUS/HIFU treatment, a minimum interval of approximately 6
months between fibroid treatment with MRgFUS and conception is recommended.
The 6th consensus meeting “UAE for fibroid treatment” was also preceded by a selective
search of the literature. Two important publications were included in the appendix
of the consensus paper: The systematic review with a meta-analysis comparing UAE to
surgical methods by van den Kooij et al. (2011) and the “Cochrane Database Review”
by Gupta et al. (2014) including seven randomized controlled studies with 793 patients
[10]
[11]. The 10-year data of the EMMY study [12] published in 2016 is also referenced. Based on these publications and the extensive
experience of the consensus participants with fibroid embolization, the following
topics were discussed: UAE in the case of an intrauterine device (IUD), pretreatment
with ulipristal acetate, UAE and a desire to have children, management of “vaginal
fibroid discharge” as a result of UAE. The topic “embolization of an undetected uterine
sarcoma” was given special attention. The consensus participants agreed on the following
new recommendation: “The total risk of an undetected uterine malignancy (including
uterine sarcoma) in patients undergoing surgery for a fibroid is specified between
0.09 % and 0.18 % in the current literature. Clinical presentation and imaging do
not allow exclusion of a uterine sarcoma in particular. The decision for an organ-preserving,
medication-based, surgical, or interventional-radiological treatment option therefore
should include explanation of the risks of delayed diagnosis of a sarcoma. The spreading
of tumor cells after UAE has not been observed. In the case of a lack of response
to treatment or a lack of a reduction in size of the leiomyoma(s), an insufficient
embolization result and the presence of a uterine sarcoma must be considered as differential
diagnoses....” “UAE in women desiring to have children” was a controversial topic
of discussion. In a multi-step process, the majority of participants agreed to the
following formulation: “Pregnancy after UAE is possible. The risk of miscarriage may
be increased...” A minority of participants voted to include supplementary information
so that the following phrase was added as a minority opinion: “In addition to miscarriage,
abnormal placentation and peripartum bleeding may be more common after fibroid embolization
(insufficient reliable data)”.
As in the past, the participants of the expert meeting at this year's consensus meeting
were aware that the possibilities and limits of a radiological treatment method were
being discussed together with gynecology specialists who do not actually perform the
procedure. This approach has already proven effective. The consensus meetings are
used to formulate practical, patient-centric recommendations for performing UAE and
MRgFUS and thus follow a best practice approach. It must be noted that to date both
radiological treatment methods have been insufficiently included in relevant guidelines
in Germany, Switzerland, and Austria in comparison to other European countries. Already
in 2012, the Collège National des Gynécologues et Obstétriciens Français included
UAE as a treatment option in a revision of the national guidelines regarding the treatment
of uterine fibroids [13]. In the Netherlands in 2013, interdisciplinary guidelines regarding the treatment
of heavy menstrual bleeding that can be caused by fibroids were adopted jointly by
the Nederlandse Vereniging voor Radiologie and Nederlandse Vereniging voor Obstetrie
en Gynaecologie [14]. Both evidence-based guidelines were created on a disease-related and interdisciplinary
basis and with the participation of radiology specialists. This opportunity was missed
in the method-based S3 guidelines regarding hysterectomy in benign diseases published
in 2015 by the Deutsche Gesellschaft für Gynäkologie und Geburtshilfe (DGGG) [15]. Although guidelines regarding the indication for and methodology of a surgical
gynecological procedure were in the foreground here, it must be noted that hysterectomy
in benign diseases is indicated in 60 % of cases because of uterine fibroids. Therefore,
minimally invasive alternative methods are of particular importance in this regard.
Therefore, it is unfortunate that neither the Deutsche Röntgengesellschaft (DRG) nor
the Deutsche Gesellschaft für Interventionelle Radiologie (DeGIR) was included in
the guideline creation process.
The current consensus papers regarding uterine artery embolization and focused ultrasound
in fibroid treatment are published both in RöFo and in the “Zeitschrift für Geburtshilfe
und Frauenheilkunde” (GebFra). The DRG, DeGIR, and DGGG have supported both consensus
meetings logistically and financially due to which may be seen as a desire of the
societies to continue and improve the interdisciplinary dialog between radiology and
gynecology with respect to fibroid treatment.
Prof. Dr. Thomas Kröncke
Prof. Dr. Matthias David
Dr. Matthias Matzko
