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UFE Evidence - A Critical Review of the Clinical Data

Updated: Feb 3, 2019


Uterine fibroid embolization (UFE) is clinically proven, safe, and effective. Dr. Michael Lalezarian reviews the UFE evidence that informs his practice.


Uterine fibroid embolization (UFE) works by occluding the blood vessels that feed the fibroid tissue.

Uterine fibroid embolization (UFE, also called uterine artery embolization) came about in the 1990s as a minimally invasive alternative method to medications or surgery in the treatment of symptomatic fibroids. Medication options include hormone modulators¹ that help to shrink the abnormal tissue of fibroids, however like contraceptive medications, they are not without side effects and may not be ideal for long term use. In the opposite spectrum, total hysterectomies (removing the entire uterus) offer permanent resolution of fibroids and the associated symptoms, but this is a major irreversible surgery. Myomectomies (focused surgical removal of fibroids) and UFE are the current interventional options that bridge the gap between medication management and all-out surgery to provide symptom resolution without the major side effects. However, myomectomy and UFE still offer very different benefits and risks, and to say that they have equivalent uses and efficacies does not tell the entire story.² In our practice, our goal is to provide the best quality care that is right for you, so stay with us as we review the data that tells us when UFE is the right option or, of equal importance, when it may be the wrong option.



Early Data and Early Understanding


In 2014, about 20 years after UFE started being implemented in the United States, a group of physicians in association with the Cochrane group (an independent community aimed to provide evidence-based recommendations) took a look at the data.³ Their review found 7 studies of reasonable quality that sought to compare UFE to myomectomy, hysterectomy, or both - focusing on patient satisfaction rates, risk of adverse events, and need for re-intervention. What they found was favorable for UFE, but details often get lost in translation. Patient satisfaction rates were equivalent within the first 24 months of the procedure, regardless of UFE or surgery, and the risk for major adverse events was also similar. However, there were more minor complications within 5 years of intervention following UFE compared to surgery, and UFE was associated with a higher rate of requiring re-intervention. This data is not especially encouraging, but it is important to recognize that many of these trials occurred in the early implementation of UFE.


The EMMY study was a large trial performed in the Netherlands between 2002-2004 comparing UFE to hysterectomy only. Their 5-year follow up data was included in the Cochrane review, but they later published a 10-year follow up,⁴ where they showed that the highest risk for re-intervention is within the first 2 years of the original UFE. This suggests that when UFE is done well in the appropriate patient, there is a much higher likelihood of success, and data from more recent interventions is beginning to confirm this.⁵ Notably, preservation of fertility in UFE versus myomectomy has not been well studied. There was 1 study evaluated by the Cochrane review that analyzed fertility in a small subgroup and demonstrated that UFE may be associated with less favorable fertility outcomes. However, it is important to note that the study was neither designed nor powered to assess this, so it remains unclear whether myomectomy or UFE had better preservation of fertility.



Advancements in Time, Technique, and Evidence


UFE benefits from being a relatively new modality in a volatile time in medicine. Early trials and data are expectedly underwhelming because the technology and techniques used in UFE will only improve over time, and evaluating newer data should begin to show trends toward improved outcomes. Unfortunately, these studies take time and are only in their early phases. The FEMME study is a large multi-center trial in the United Kingdom designed to compare UFE and myomectomy,⁶ and COMPARE-UF registry is a massive database in the United States that was recently started to provide comparative effectiveness data regarding uterine fibroid treatment.⁷ Both of these studies intend on evaluating the usual outcomes of short and long term success, in both quality of life and adverse outcomes, but they are also designed to look into pregnancy outcomes for those patients who wish to remain fertile.


At this time fertility remains the key question to differentiate the treatment options, as our understanding continues to be limited. Due to the uncertainty in fertility preservation with UFE, the American College of Obstetricians and Gynecologists advises that women who wish to get pregnant in the future do NOT undergo UFE, and a more recent systematic review supports this ongoing recommendation.⁸ Still, we’re beginning to see data that demonstrates improving pregnancy outcomes after UFE. Dr. Bruce McLucas, the early pioneer for UFE in the United States, recently published data that predicts a nearly 50% in women after UFE, which is equivalent to pregnancy rates after myomectomy.⁹


As more data rolls in from the FEMME study, COMPARE-UF registry, and other independent trials, we’re optimistic that UFE will be increasingly recognized as a safe and effective treatment option with established fertility preserving benefit. It may not be appropriate for every woman, but we look forward to providing accurate and useful information to help them make the right decision for whatever their symptoms and long term plans.


If you're considering fibroid treatment, we recommend that you familiarize yourself with all of your options.



About the Author


Dr. Michael Lalezarian is a practicing interventional radiologist with the Fibroid Specialists of University Vascular in Los Angeles, CA. In addition to patient care, Dr. Lalezarian teaches and supervises medical students, residents, and fellows as a full time teaching Professor in the Department of Radiology at UCLA. He is regarded as an expert in uterine fibroid embolization. You can view Dr. Lalezarian's full bio here.


This blog post was written with research and editorial assistance from OnChart™.



References


[1] Faustino F, Martinho M, Reis J, Águas F. Update on medical treatment of uterine fibroids. Eur J Obstet Gynecol Reprod Biol. 2017;216:61-68.

[2] Young M, Mikhail LN. Uterine, Fibroid Embolization. [Updated 2018 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-.

[3] Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2014;(12):CD005073.

[4] De bruijn AM, Ankum WM, Reekers JA, et al. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 10-year outcomes from the randomized EMMY trial. Am J Obstet Gynecol. 2016;215(6):745.e1-745.e12.

[5] Salehi M, Jalilian N, Salehi A, Ayazi M. Clinical Efficacy and Complications of Uterine Artery Embolization in Symptomatic Uterine Fibroids. Glob J Health Sci. 2015;8(7):245-50.

[6] Mcpherson K, Manyonda I, Lumsden MA, et al. A randomised trial of treating fibroids with either embolisation or myomectomy to measure the effect on quality of life among women wishing to avoid hysterectomy (the FEMME study): study protocol for a randomised controlled trial. Trials. 2014;15:468.

[7] Stewart EA, Lytle BL, Thomas L, et al. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018;219(1):95.e1-95.e10.

[8] Karlsen K, Hrobjartsson A, Korsholm M, Mogensen O, Humaidan P, Ravn P. Fertility after uterine artery embolization of fibroids: a systematic review. Arch Gynecol Obstet. 2018;297(1):13-25.

[9] Mclucas B, Voorhees WD, Elliott S. Fertility after uterine artery embolization: a review. Minim Invasive Ther Allied Technol. 2016;25(1):1-7.



Medical Disclaimer


The Materials available on the FibroidSpecialists.org blog are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients.

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The Fibroid Specialists of University Vascular are leading providers of uterine fibroid embolization (UFE), the least invasive treatment option for women suffering from uterine fibroids. Our physicians have devoted their expertise to helping women overcome fibroids without hysterectomy or major surgery. 

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