1. Bilateral uterine artery embolization (UAE) was associated with high clinical efficacy in patients with uterine fibroids.
2. Major complications were rare but included endometrial ischemia, endometritis, and permanent amenorrhea.
Original Date of Publication: October 1999
This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials, 2e (The Classics Series).
Study Rundown: Uterine fibroids are the most common benign pelvic tumor in women, affecting up to 40% of females over the age of 35 in the United States. Historically, definitive management of patients with symptomatic uterine fibroids consisted of surgical intervention with hysterectomy. UAE, which employs an endovascular approach, was developed to provide a uterus-sparing option for patients who either prefer a less invasive approach or are not eligible for surgery. The purpose of this early retrospective study was to evaluate the effectiveness of UAE in the treatment of uterine fibroids.
The retrospective review included 60 consecutive patients that were referred for UAE with polyvinyl alcohol (PVA) particles for treatment of symptomatic fibroids. The primary outcome of interest was clinical and symptomatic improvement post-UAE. Secondary outcomes included post-procedural complications and sonographic evaluation of residual fibroid volume at follow-up. At the conclusion of the trial, 59 of 60 patients underwent successful bilateral UAE. The majority of patients reported either moderate or marked clinical improvement of their previous symptoms by 2 years follow-up. Furthermore, there was an approximately 50% reduction of dominant fibroid volume in this cohort on ultrasound follow-up. There were two cases of treatment failure resulting in hysterectomy. One case demonstrated permanent amenorrhea post UAE. The results of this trial provided evidence for the use of UAE as an effective, minimally invasive treatment modality for symptomatic fibroids. However, the study is limited by a small sample size and lack of a comparison group to myomectomy or hysterectomy. Additional randomized trials have since demonstrated similar efficacy compared to surgical intervention.
Please click to read study in JVIR
In-Depth [retrospective cohort]: This was a retrospective review of 60 consecutive patients (mean age: 43.5; range 27-66) that underwent UAE for symptomatic fibroids at a single institution in the United States. No patients were excluded from the study. With the exception of one patient, all underwent bilateral UAE with permanent PVA. Each patient underwent routine clinical and ultrasound follow-up at regular intervals at 6 weeks, then at 2, 6, 12, 18, and 24 months. The primary outcome of interest was symptomatic improvement as determined by patient-reported abnormal bleeding and pain Likert scale. Secondary outcomes of interest included rates of complications as well as dominant fibroid volume post-procedure. After a mean follow up of 10.2 months, 47 of 54 (87%) patients and 41 of 45 (91%) patients reported either moderate or marked improvement in abnormal bleeding and pain, respectively. Additionally, 92% of patients demonstrated reduction in the dominant fibroid volume with an average volume reduction of 48.8% (range: -522% to 100%). Two patients required an additional embolization procedure due to recanalization; treatment failure occurred in one patient that required hysterectomy. Common post-procedure complications were abdominal pain (100%), fever (34%), and post-embolization syndrome (10%). Significant complications were rare but included moderate groin hematoma (n = 1), permanent amenorrhea (n = 1), and delayed infection resulting in hysterectomy (n = 1). There was no specific report of patient disposition post-procedure, but 22 patients (37%) required same-day hospital admission for pain management. Univariable analysis demonstrated that patients with large fibroid volume reduction on ultrasound (p < 0.001) or with a previous history of myomectomy (p < 0.02) were less likely to undergo hysterectomy post-UAE. Additionally, younger patients were more likely to experience treatment failure (p < 0.02).
Goodwin SC, McLucas B, Lee M, Chen G, Perrella R, Vedantham S, et al. Uterine Artery Embolization for the Treatment of Uterine Leiomyomata Midterm Results. J Vasc Interv Radiol. 1999 Oct;10(9):1159–65.
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