Abstract
Uterine artery embolization (UAE) is a safe and effective organ sparing treatment for fibroid-related symptoms based on a broad range of published evidence including randomized-controlled trials. Indication for treatment by means of UAE are symptomatic uterine fibroids. UAE is an alternative to surgical and medical treatment for uterine fibroids as well as treatment by MRgFUS. This consensus paper covers the structural prerequisites, the criteria for technical and clinical success, contraindications, side effects and complications as well as the role of UAE treatment in women wishing to conceive and gives guidance on radiation safety measures and clinical follow-up.
Key words: uterus, embolization, leiomyoma, uterine artery embolization
Key Points
The therapeutic aim of UAE for fibroids is the improvement (alleviation) or disappearance of fibroid-related symptoms.
The indication for UAE treatment is based on a gynecological examination incl. ultrasound performed by a specialist.
UAE is an alternative to surgical or medical therapy of fibroids as well as fibroid treatment by means of MRgFUS, independently of the size and number of fibroids (leiomyoma) or previous surgery.
The decision to offer UAE should be based on the wish of the patient and having regard to treatment alternatives, their success rates, limitations and side effects.
For women with uterine fibroids who wish to conceive the role of UAE as a treatment options is still not clarified based on the current state of knowledge.
Citation Format
Kröncke T, David M. Uterine Artery Embolization (UAE) for Fibroid Treatment – Results of the 7th Radiological Gynecological Expert Meeting. Geburtsh Frauenheilk 2019. doi:10.1055/a-0893-4807
Introduction
Uterine artery embolization (UAE) is an organ-preserving, established, safe, and effective method in the spectrum of procedures for treating fibroid-related symptoms.
The aim of UAE is the reduction or elimination of fibroid-related symptoms, not the removal of the fibroid. At the same time the size of the fibroid is reduced.
There is consensus between the disciplines of gynecology and interventional radiology that the determination of the required treatment for uterine fibroids should be based on an examination and counseling by a gynecologist. Comprehensive counseling regarding treatment options for symptomatic uterine fibroids encompasses not only medication-based and surgical options but also UAE. The decision for or against an alternative therapy should be made under consideration of the patientʼs wishes and with knowledge of other treatment options, their chances of success, limitations, typical side effects and possible complications (informed decision).
In Germany, Austria and Switzerland, UAE treatment represents a treatment option for patients with fibroid-related symptoms and allows further treatment individualization for uterine fibroids.
Aim of the Consensus Meeting
The intention of the consensus meeting was to evaluate UAE. After taking into account the current literature, internationally published recommendations ** and their own experience, and after extensive discussion, the participants in the meeting of radiological-gynecological experts came to a consensus between the two disciplines.
The panel of experts was aware that this was an assessment of the possibilities and limitations of a radiological treatment method held in conjunction with gynecology specialists who do not perform the procedure themselves but have experience with the diagnosis and treatment of disorders of female reproductive organs.
The group of experts composed of 12 radiologists and 9 gynecologists which met on January 12, 2019 in Berlin for the 7th radiological-gynecological consensus meeting included radiologists and gynecologists from Switzerland and Austria. After an extensive – and at times controversial – discussion, the group came to a consensus regarding the following recommendations.
The consensus paper is supported by the gynecologists and radiologists listed at the end of the article.
The paper reflects the current state of knowledge.
Structural Prerequisites and Quality Assurance for Performing UAE
UAE should be performed only at clinics possessing the requisite gynecological and radiological knowledge regarding all fibroid treatment methods and possessing the necessary radiological expertise for performing UAE and regarding adequate and structured pain management after the intervention, the management of side effects, and the non-surgical and surgical treatment of fibroids.
Particularly due to the necessity for postinterventional pain management, UAE should be performed on an inpatient basis at a suitable clinic.
Prior to introducing UAE, theoretical and practical training at a center with extensive UAE experience is recommended. In addition to the legally required documentation, the calculated key radiation exposure figures (dose area product, fluoroscopy time) for UAE should be critically reviewed and optimized for quality assurance.
Participation in suitable quality assurance as defined by the professional associations is recommended.
Examinations Required Prior to UAE
A gynecological examination incl. ultrasound performed by a specialist must be performed prior to treatment decisions. If ultrasound does not allow definitive diagnosis, MRI examination is indicated.
Prior to fibroid embolization, the indication for hysteroscopy and fractionated curettage must be examined. Unremarkable cytological smear findings of the uterine cervix must have been obtained within the previous 12 months.
Pregnancy test results as well as the following laboratory results must be available: creatinine, coagulation status, thyroid values (in the case of a history of thyroid disease), blood count, and CRP. Acute inflammation must be ruled out in the case history and clinically.
According to the current state of knowledge, it is not necessary to remove an implanted IUD prior to UAE.
Within the context of the informed consent discussion prior to UAE, the patient should be informed of the lack of preinterventional histological confirmation of the presumed uterine fibroids, as is the case with all other organ-preserving fibroid therapies.
The total risk of an undetected uterine malignancy (including uterine sarcoma) in patients undergoing surgery for a presumed fibroid is specified between 0.09 and 0.18% in the current literature. Symptoms 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 should therefore 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 the size of the leiomyoma(s), an insufficient embolization result and the presence of a uterine sarcoma must be considered in the differential diagnosis.
Indications for UAE
A symptomatic uterine fibroid is an indication for uterine artery embolization. UAE represents an alternative to surgical and medication-based procedures and to fibroid treatment with focused ultrasound regardless of the size and number of fibroids or previous surgeries. Treatment should be selected based on the objective of the treatment as well as the wishes of the patient.
Success Criteria for UAE
UAE treatment success is primarily defined as improvement or complete elimination of the (fibroid-related) symptoms specified by the patient and to a lesser extent as a reduction in the volume of the dominant fibroid or the entire uterus after treatment.
Medication-based Treatment ***
According to the current state of knowledge, the administration of ulipristal acetate does not play a role in the indication for UAE or the performing of the procedure and does not affect the results.
Contraindications for UAE
Anatomical
Relative
Isolated, submucosal fibroids type 0 and I of the FIGO classification (Fédération Internationale de Gynécologie et dʼObstétrique) that are accessible for hysteroscopic ablation
Isolated pedunculated subserosal fibroids
Supply of the fibroid(s) via an ovarian artery; the benefits and risks of additive embolization of the relevant ovarian artery should be considered.
Clinical
Absolute
Primarily Malignancy
Pregnancy
Acute genital infection
Clinically manifest hyperthyroidism/acute thyroiditis in hyperthyroidism and planned or ongoing radioiodine therapy if iodine-containing contrast agents are used
Relative
Documented allergic reaction to contrast agents containing iodine
Postmenopausal patient
Allergy to local anesthesia
Latent hyperthyroidism
Renal insufficiency
Desire to become pregnant
UAE in Patients Wishing to Become Pregnant
UAE is to be considered at most a last resort in patients wishing to become pregnant.
UAE in Patients with a Latent Desire for Children
For patients with a symptomatic uterine fibroid and a latent desire for children, the role of UAE as a treatment option is still not sufficiently defined in the current literature.
Pregnancy after UAE is possible. In addition to miscarriage, placental problems and peripartal hemorrhage may be more common after fibroid embolization (insufficient reliable data).
Prior to UAE, the preservation of fertility and a latent desire for children should be discussed with every patient on an interdisciplinary basis in connection with age, previous interventions, prior pregnancies, and imaging findings.
Before a hysterectomy is performed in a patient with extensive uterine fibroid disease who wishes to become pregnant, the possibility of performing UAE should be investigated.
Pregnancy after UAE
A minimum wait time of approximately 6 months between fibroid treatment with UAE and conception is recommended.
Special Case: Preoperative Uterine Artery Embolization (PUAE)
PUAE, embolization as preparation immediately before surgical myoma enucleation, can be considered and offered in individual cases for patients who absolutely want to preserve their uterus but in whom a significantly increased bleeding risk can already be assumed preoperatively and/or in whom the risk of the ultimate need for a hysterectomy is estimated to be very high “for technical reasons” (e.g. very large fibroid and/or multiple fibroids, large fibroid that is difficult to remove, fibroid with unfavorable location).
Radiation Protection
Radiation protection is particularly important in UAE. Pulsed fluoroscopy should be used. Serial angiography and oblique projections should be kept to a minimum. A scan frequency of 1 frame/second is typically sufficient. Under normal conditions, the average dose area product should be less than 50 Gy × cm 2 (corresponding to 5000 cGy × cm 2 or 5000 µGy × m 2 ) for pulsed systems. The radiation exposure in this case would correspond approximately to 2 to 3 abdominal CT scans.
Side Effects
The following are described as relevant side effects and complications of UAE: post-embolization syndrome, amenorrhea as a consequence of disruption or failure of ovarian function, pain, discharge, angiography-related complications (e.g. groin hematoma), vaginal discharge of fibroid material, hot flashes, endometritis/myometritis, deep vein thrombosis/pulmonary embolus.
Uterine discharge can be normal in the first weeks after UAE. In the case of abnormal vaginal discharge, the patient should be diagnosed and treated for infection. Menorrhagia, cramping of the lower abdomen, discharge of tissue components can occur in the case of submucosal fibroids in particular. Depending on the clinical symptoms and the findings of diagnostic imaging, hysteroscopic myomectomy or vaginal myomectomy as in a fibroid in statu nascendi (fibroid expulsion) may be indicated. Hysterectomy is not indicated a priori. In cases of doubt, the center in which the UAE procedure was performed should be contacted.
Post-treatment Examination After UAE
Post-treatment examination by a specialist is recommended approx. 6 months after UAE.
Imaging procedures are useful (e.g., sonography in conjunction with Doppler sonography, MRI). Further diagnostic workup is required if the therapy is unsuccessful (no improvement of symptoms and/or size progression of the fibroid) or there are abnormalities on the imaging (increase in the size of the fibroid(s) or uterus) and/or there is a lack of devascularization of the fibroid(s).
Outlook
These recommendations regarding uterine artery embolization in the case of fibroid-related symptoms are to be revised again in 2021 based on the available data and experience.
The participants of the consensus meeting recommend the preparation of an interdisciplinary guideline on all aspects of the diagnosis and treatment of uterine fibroids.
Appendix
Authors for correspondence
Prof. Dr. med. Thomas Kröncke, MBA
Universitätsklinikum Augsburg
Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Stenglinstraße 2
86156 Augsburg
Prof. Dr. med. Matthias David
Charité – Universitätsmedizin Berlin
Klinik für Gynäkologie
Campus Virchow-Klinikum
Augustenburger Platz 1
13353 Berlin
Participants of the consensus meeting 2019
Priv.-Doz. Dr. med. Ralf Adamus/Nürnberg
Dr. med. Michael Bartsch/Hamburg
Prof. Dr. med. Christoph A. Binkert/Winterthur (CH)
Prof. Dr. med. Michael Bohlmann/Mannheim
Dr. med. Alexander Burges/Munich
Prof. Dr. med. Matthias David/Berlin
Dr. med. Matthias M. Dufner/Heidelberg
Prof. Dr. med. Dr. phil. Andreas D. Ebert/Berlin
Dr. med. Thomas Hess/Winterthur (CH)
Priv.-Doz. Dr. med. Hans-Christian Kolberg/Bottrop
Prof. Dr. med. Thomas Kröncke/Augsburg
Dr. med. Matthias Matzko/Dachau
Prof. Dr. med. Thomas Pfammatter/Zürich (CH)
Dr. med. Gernot Rott/Duisburg
Dr. med. Renana Schinker/Hamburg
Prof. Dr. med. Jalid Sehouli/Berlin
Priv.-Doz. Dr. med. Dirk Schnapauff/Berlin
Priv.-Doz. Dr. med. Christof-M. Sommer/Heidelberg
Dr. med. Frederik F. Strobl/Munich
Prof. Dr. med. Dierk Vorwerk/Ingolstadt
Priv.-Doz. Dr. med. Peter Waldenberger/Salzburg (AT)
Participating professional societies and professional organizations
BVF, Berufsverband der Frauenärzte [Professional Association of Gynecologists]
DeGIR, Deutsche Gesellschaft für Interventionelle Radiologie und minimal-invasive Therapie [German Society for Interventional Radiology and Minimally Invasive Therapy]
DGGG, Deutsche Gesellschaft für Gynäkologie und Geburtshilfe [German Society of Gynecology and Obstetrics]
DRG, Deutsche Röntgengesellschaft [German Radiological Society]
NOGGO, Nordostdeutsche Gesellschaft für Gynäkologische Onkologie [Northeastern German Society of Gynecological Oncology]
ÖGIR, Österreichische Gesellschaft für interventionelle Radiologie und minimal-invasive Therapie [Austrian Society of Interventional Radiology and Minimally Invasive Therapy]
SSVIR, Swiss Society of Vascular and Interventional Radiology
Reference to selected relevant publications
Borah BJ. Comparative effectiveness of uterine leiomyoma procedures using a large insurance claims database. Obstet Gynecol 2017; 130: 1047 – 1056
Czuczwar P et al. Comparison of the influence of three fibroid treatment options: supracervical hysterectomy, ulipristal acetate and uterine artery embolization on ovarian reserve – an observational study. J Ovarian Research 2018; 11: 45. doi:10.1186/s13048-018-0420-1
Davis MR et al. Reintervention rates after myomectomy, endometrial ablation, and uterine artery embolization for patients with uterine fibroids. J Womenʼs Health 2018; 27: 1204 – 1214
Karlsen K et al. Fertility after uterine artery embolization of fibroids: a systematic review. Arch Gynecol Obstet 2018; 297: 13 – 25
Keung JJ et al. Uterine artery embolization: A review of current concepts. Best Pract Res Clin Obstet Gynaecol 2018; 46: 66 – 73
Kohi MP, Spies JB. Updates on uterine artery embolization. Semin Intervent Radiol 2018; 35: 48 – 55
Sandberg EM et al. Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: a systematic review and meta-analysis. Fertil Steril 2018; 109: 698 – 707
Kovacsik HV et al. Evaluation of changes in sexual function related to uterine fibroid embolization (UFE): Results of the EFUZEN study. Cardiovasc Intervent Radiol 2017; 40: 1169 – 1175
Published simultaneously.
Published simultaneously in RöFo – Fortschritte auf dem Gebiet der Röntgenstrahlen und der bildgebenden Verfahren: Fortschr Röntgenstr 2019. doi:10.1055/a-0884-3168
Conflict of Interest/Interessenkonflikt The authors declare that they have no conflict of interest./Die Autoren geben an, dass kein Interessenkonflikt besteht.
For the participants of the consensus meeting 2019 listed in alphabetical order at the end of the article.
The appendix contains references to selected relevant publications.
The use of GnRH analogs in fibroid treatment is no longer clinically relevant and the available data regarding the interaction with UAE is unclear.
Für die am Ende des Artikels in alphabetischer Reihenfolge aufgeführten Teilnehmerinnen und Teilnehmer des Konsensustreffens 2019.
Im Anhang finden sich Literaturhinweise auf ausgewählte relevante Publikationen.
Die Anwendung von GnRH-Analoga in der Myomtherapie ist klinisch nicht mehr relevant und die Datenlage zur Interaktion mit der UAE unsicher.