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Not long ago, women with uterine fibroids had to choose between hysterectomy and abdominal myomectomy to alleviate their symptoms. Then came minimally invasive surgeries such as laparoscopic myomectomy and hysteroscopic myoma resection, although even now these surgeries are offered by a limited number of skilled gynecologic surgeons. And despite their substantially shorter recovery times, these procedures are still surgeries, with inherent complications. On top of that, long-term outcomes data are limited.
Enter the next generation of fibroid treatments: uterine artery embolization (UAE), focused ultrasound with magnetic resonance imaging (MRI) guidance, and selective progesterone receptor modulators—though the last option is still in the pipeline. Gynecologists will be seeing advertisements and promotional materials for these interventions in the near and not-so-distant future.
Uterine artery embolization: In the right hands, a worthwhile strategy
Myers ER, Goodwin S, Landow W, et al. Prospective data collection of a new procedure by a specialty society: the FIBROID Registry. Obstet Gynecol. 2005;106:44–51.
Worthington-Kirsch R, Spies JB, Myers ER, et al. The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes. Obstet Gynecol. 2005;106:52–59.
Congratulations are in order. When the Society of Interventional Radiology created the Fibroid Registry in 2000, it was looking for early data on UAE to share with patients. In its short but impressive life, the registry has collected more data about UAE than we have about “tried-and-true” surgeries.
In the United States, UAE was first used to treat fibroids in 1997. Although numerous studies since then have reported on its safety and effectiveness, many gynecologists continue to question the suitability of UAE for symptomatic women.
The Web-based registry was established with Duke Clinical Research Institute to track short- and long-term outcomes after UAE in various settings.
What we know from the registry
The Fibroid Registry enrolled its first patient in December 2000, and collected data from 72 sites on 3,319 UAE procedures through December 2002. The reports by Myers et al and Worthington-Kirsch and colleagues contain patient demographics, procedural details, and 30-day outcomes.
The registry defined adverse events as any unexpected event that necessitated an unscheduled office or emergency room visit or unanticipated therapy (medical or surgical). Major complications required increased care or additional hospitalization or had permanent adverse sequelae. Minor complications required medical management or no therapy.
Thirty-day outcomes were available for approximately 91% of patients.
A low complication rate
Complications were uncommon during the first 30 days after UAE, with a 1.1% incidence of additional surgery. In fact, complication rates and recovery times compared favorably with myomectomy and abdominal hysterectomy for large fibroids.
The UAE procedure averaged 56 minutes, with 96.2% technical success and a return to normal activities in about 2 weeks.
Other findings:
- 26% of patients had an adverse event, but only 4% had a major event, most commonly emergency care or hospital readmission for pain management (2.1%) or possible infection (<1%).
- 31 women required another procedure within 30 days, including 3 myomectomies, 9 dilatation and curettage procedures for sloughing leiomyomata, 5 hysteroscopic resections, and 3 hysterectomies for unrecorded indications.
- 1 patient was hospitalized for pain 10 days after UAE and underwent exploratory laparotomy with bilateral oophorectomy.
- The most common minor adverse events were hot flushes (5.7%) and pain requiring additional therapy (9.6%).
Predictors of adverse outcomes:
- current or recent smoking (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.007–1.293),
- African-American race (OR 1.129, 95% CI 1.019–1.251),
- prior procedures (OR 1.23, 95% CI 1.02–1.38), and
- duration of procedure (OR 1.004, 95% CI 1.001–1.006).
Interestingly, short-term outcomes did not differ among centers, nor did procedure times, length of stay, and incidence of adverse events during the first 30 days.
What to tell patients
I inform patients with symptomatic fibroids about all available treatments—including the option of doing nothing at all. Most have no interest in UAE, and are distressed by the thought of their bodies reabsorbing dead tissue.
However, I have had several patients whose operative risks were very high. For example, 1 woman was morbidly obese (>250 lb, which required her UAE treatment at a special facility equipped to perform fluoroscopy in morbidly obese patients), hypertensive, diabetic, and hemiparetic after a stroke. She was also a Jehovah’s Witness. Obviously, nonsurgical intervention was to her benefit. Her bleeding stopped almost immediately.