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Uterine Artery Embolization for Treatment of Leiomyomata

Long-Term Outcomes From the FIBROID Registry

From the ¹Department of Radiological Sciences, School of Medicine at the University of California at Irvine, Irvine, California; ²Department of Radiology, Georgetown University Medical Center, Washington, DC; ³Image Guided Surgery Associates, Philadelphia, Pennsylvania; ⁴Department of Medicine, Duke University Medical Center, Durham, North Carolina; ⁵Department of Public Health Sciences, University of Toronto, Ontario, Canada; ⁶Duke Clinical Research Institute, Durham, North Carolina; and ⁷Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.

OBJECTIVE: To assess long-term clinical outcomes of uterine artery embolization across a wide variety of practice settings in a large patient cohort.

METHODS: The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization was a 3-year, single-arm, prospective, multi-center longitudinal study of the short- and long-term outcomes of uterine artery embolization for leiomyomata. Two thousand one hundred twelve patients with symptomatic leiomyomata were eligible for long-term follow-up at 27 sites representing a geographically diverse set of practices, including academic centers, community hospitals, and closed-panel health maintenance organizations. At 36 months after treatment, 1,916 patients remained in the study, and of these, 1,278 patients completed the survey. The primary measures of outcome were the symptom and health-related quality-of-life scores from the Uterine Fibroid Symptom and Quality of Life questionnaire.

RESULTS: Mean symptom scores improved 41.41 points (P<.001), and the quality of life scores improved 41.47 points (P<.001), both moving into the normal range for this questionnaire. The improvements were independent of practice setting. During the 3 years of the study, Kaplan-Meier estimates of hysterectomy, myomectomy, or repeat uterine artery embolization were 9.79%, 2.82%, and 1.83% of the patients, respectively.

CONCLUSION: Uterine artery embolization results in a durable improvement in quality of life. These results are achievable when the procedure is performed in any experienced community or academic interventional radiology practice.

LEVEL OF EVIDENCE: III

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