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This guideline defines recommendations for quality care in women being treated with UAE for symptomatic uterine fibroids in Australia and New Zealand. The guideline has been developed according to the AGREE-II checklist for reporting of guidelines, with more detailed responses in Appendices S1 and S2. Recommendations have been made according to the available level of evidence with a focus on local data where applicable, and the types of recommendations are detailed in Table 1. Level I or II evidence. e. g. , systematic review, randomised controlled trial, prospective cohort study Level III or IV evidence. e. g. , case–control study, retrospective cohort study, case series Level V evidence. e. g. , case report or consensus of opinion of the authors Patients seeking and receiving treatment for uterine fibroids by embolisation, with comparison to alternative treatments including hysterectomy and myomectomy where relevant. Medical practitioners providing care for women with symptomatic uterine fibroids in Australia and New Zealand including general practitioners, gynaecologists, and interventional radiologists. This guideline can be used to inform clinical and governance decisions on standards of care. Data were derived from a search of MEDLINE, EMBASE, and Google Scholar from 1 January 1995 to 1 January 2022. Data collection was performed using the PICO format including the following search terms: women, uterine, fibroid, embolisation, UAE, UFE, hysterectomy, myomectomy, quality, bleeding, infection, and complications. Peer-reviewed evidence has been assessed according to study design with a preference for higher-level evidence were available including systematic reviews of prospective randomised controlled trials. However, evidence levels may include smaller cohort studies and case–control studies for emerging topics including pregnancy after UAE, or rarer topics such as complications. For some topics there exists a lack of evidence and case series or expert commentary may need to be considered. This guideline was developed through a modified version of the Delphi technique using an electronic process with a single facilitator combining responses. The contents of each of the 10 guideline topics were discussed in 4 rounds before a final guideline was reached. At the conclusion, a consensus was reached for 8 out of the 10 topics based on existing high-quality evidence. A statement of lack of consensus was discussed for the remaining 2 topics including the necessity of pre-operative MRI (with its local funding challenges in Australia) and pre-operative intra-uterine device removal, with the direction given for the need for more evidence. The guideline will be updated within 5 years of 1 January 2022, and will be updated according to the AGREE-CheckUp process. The contributors declare no funding was received for this guideline, and the authors declare no competing interests either financial or other. Leiomyomata, also known as fibroids, are a benign mesenchymal tumour of the uterus and are one of the most common diseases, affecting up to 70% of women in their lifetime. 1 Symptoms may include heavy menstrual bleeding, dysmenorrhoea, and mass effect. 1, 2 Adenomyosis is the presence of ectopic endometrial tissue in the myometrium, and often co-exists with leiomyomata. 3 Small fibroids in asymptomatic patients do not require active treatment. When symptomatic, treatment options vary based on the patient's disease burden and effect on the quality of life. Medical therapy includes non-hormonal medications or oral/injectable hormonal agents, and is effective in many patients with small fibroids. 4 Invasive or minimally invasive therapy may be required in those with large fibroids, diffuse disease, or those in which medical therapy has failed. Hysterectomy, myomectomy, and endometrial ablation are surgical options that have been performed as treatments for uterine fibroids for many years. Hysterectomy is the most definitive option for women when fertility is no longer a consideration but carries significant direct and indirect morbidity. 4 Myomectomy is another surgical option that may be performed via laparoscopic, hysteroscopic, or open surgical techniques. 4 It is offered to women who wish to conserve their uterus and preserve fertility. Endometrial ablation is a hysteroscopic, minimally invasive treatment for menorrhagia, but may not be feasible or effective if the endometrial cavity is distorted by fibroids. Uterine artery embolisation (UAE), also known as uterine fibroid embolisation, is a minimally invasive uterine-sparing alternative to traditional surgical techniques. 5-7 A recent systematic review concluded that there was a similar overall symptom improvement between UAE and surgery (75% surgery vs. 60% UAE, P > 0. 05), and that UAE resulted in shorter hospitalisation by 2. 9 days (P 5 cm, multifibroid disease, and/or adenomyosis. Although there was a high loss of follow-up, they reported 148 successful pregnancies and 109 live births including 74 at term. 22 Patients' levels of interest in future pregnancy should be thoroughly explored and considered on an individual basis, with informed consent including advice that the potential for future pregnancy after UAE is currently uncertain. For women who experience subfertility due to fibroids, desire pregnancy, and where surgery is a safe and feasible option, myomectomy may be preferred. In those who have had myomectomy previously or are poor surgical candidates, UAE may be performed with appropriate counselling regarding fertility. Only 1 randomised controlled trial on this topic has reported results, and prospective studies are now needed on this topic. 21 Recommendation: B The incidence of incidental uterine leiomyosarcoma increases with age, particularly over 50 years. 23, 24 Treatment of women where histology of fibroids is not assessed should include counselling that the risk of uterine leiomyosarcoma is 1 in 200 to 1 in 50023-25 and may be potentially undetected at the time of treatment; this may lead to a delayed diagnosis. This holds true for embolisation as it does for all non-surgical fibroid treatments. It is recommended that patients who are post-menopausal, or in whom fibroids continue to enlarge post-treatment, have dedicated surveillance with MRI. There may be a role for pre-procedure screening for malignancy using MRI with diffusion-weighted sequences and the use of lactate dehydrogenase isoenzyme levels. Tong et al. assessed the incidence of leiomyosarcoma within 1960 patients who underwent MRI screening pre-uterine fibroid resection, identifying 10 with leiomyosarcoma (0. 5%) with a sensitivity of 100% and specificity of 97%. However, there was a high false-positive rate in their study (59 patients or 3%). The incremental cost-effectiveness from MRI assessment was USD9326 per gained life-year based on their analysis. 24 Currently, MRI is not Medicare-funded for this indication in Australia and patients incur an out-of-pocket cost for this investigation. 12 Treatment of fibroids without MRI is the same consideration for all non-surgical treatments including hormonal agents for smaller fibroids. The balance in recommending MRI needs to be based on the available evidence, and include the sensitivity, cost, and leiomyosarcoma incidence. Recommendations must also consider women who would rather choose no treatment rather than hysterectomy, and thus where definitive histology is not possible. An 0. 3% incidence of leiomyosarcoma should not justify a “surgery first” approach, especially in pre-menopausal women. Given the level of evidence is low, and the high false-positive rate, the use of routine MRI may depend on individual patient circumstances (including age and economic situation) and could form a part of the pre-procedure counselling process. There was no consensus on the necessity of routine MRI from the authors. However, there was agreement that increased advocacy is needed towards expanding the Medicare Benefits Schedule to allow access for Australian women with fibroids in the future. Recommendation: C Embolisation may be performed as a day case or with hospital admission, depending on local circumstances and patient preferences. A regional local anaesthetic block to the superior hypogastric nerve may be considered to reduce the requirement for post-operative opioid analgesia, however, a recent randomised controlled trial of UAE day-procedures did not show any difference in the rate of readmission for pain, and its use may help to confine UAE procedures to a day-admission. 25 Intra-arterial lidocaine has also been reported to result in reduced post-procedure analgesic requirements. 26, 27 More data on efficacy for both these techniques are required before they can be recommended as a routine procedural adjunct. The role of antibiotic prophylaxis in minimising infectious complications after UAE is controversial. 28 The Royal College of Obstetricians and Gynaecologists and the Society of Interventional Radiology both recommend a single dose of periprocedural antibiotic prophylaxis targeted at skin flora28 and this is supported based on the available evidence and consensus. There was no consensus on the role of post-procedure prophylactic oral antibiotic use. Recommendation: C Immediate complications include access site (haematoma, pseudoaneurysm, and infection) or procedure-related (contrast allergy, non-target embolisation, and dissection). Later or delayed complications can include vaginal discharge (approximately 15%), expulsion per-vagina of fibroid tissue (10%), and infection (<1%). 17, 29 These are usually related to submucosal or transmural fibroids that need to be proactively and collaboratively managed with gynaecologists, including GnRHa pre-treatment, planned same day or delayed hysteroscopic resection, a contingency plan for unexpected endocavitary migration and cervical obstruction. Post-embolisation syndrome should be regarded as an expected sequela of treatment in most patients and is of variable severity. 17 Symptoms may include fever, abdominal pain, nausea, and vomiting. Interventional radiologists who perform UAE should be competent in the detection and management of procedural and post-procedural complications, and when it is appropriate to seek additional treatment including referral to a relevant gynaecologist. Recommendation: A Technical success should be expected in 90–100% of patients at completion of UAE. 7, 19 It may take months for uterine volume to reduce and it is anticipated that a volume of reduction of 40–60% is achievable, however, symptom improvement is often much sooner for women with heavy menstrual bleeding or dysmenorrhoea. 7, 19 It was estimated from the FIBROID registry that 14% of patients may need some form of additional uterine treatment again at 3 years29 and repeat UAE is an option in addition to surgical treatments. Overall patient satisfaction and monitoring of symptom improvement and complications remain the responsibility of the treating interventional radiologist. Planned follow-up within 3-months of the procedure should be arranged with the patient and the interventional radiologist should be available for contact in the event the patient, GP, or gynaecologist requires in the future. Recommendation: A UAE procedures should be performed by those who have undergone appropriate training and experience, ideally including credentialing from a relevant specialist college as well as local hospital accreditation for performing advanced embolisation procedures. In addition, training and credentialing should include competency in the use of microcatheters and advanced embolisation techniques with particulate embolic material. Procedures should be monitored by a local quality assurance program that may include logbook, appropriate follow-up, and quality improvement meetings. In Australia and New Zealand, interventional radiologists are the only specialist group who currently meet these criteria. 30 Recommendation: C Open access publishing facilitated by Monash University, as part of the Wiley - Monash University agreement via the Council of Australian University Librarians. Data sharing is not applicable to this article as no new data were created or analyzed in this study. Appendix S1. Summary of the AGREEII reporting checklist. Appendix S2. AGREEII reporting checklist. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
Clements et al. (Sun,) studied this question.