Uterine Artery Embolization for Treatment of Leiomyomata Long-Term Outcomes From the FIBROID Registry Scott C. Goodwin, MD, James B. Spies, MD, Robert Worthington-Kirsch, MD, Eric Peterson, MD, MPH, Gaylene Pron, PhD, Shuang Li, MS, and Evan R. Myers, MD, MPH, for the Fibroid Registry for Outcomes Data (FIBROID) Registry Steering Committee and Core Site Investigators* 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 embo- lization 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 aca- demic 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 ra- diology practice. (Obstet Gynecol 2008;111:22–33) LEVEL OF EVIDENCE: III U terine leiomyomata are a major public health care problem, occurring in at least half of Amer- ican reproductive-age women. 1 Leiomyomata may cause pain, abnormal bleeding, pressure, and other symptoms related to uterine enlargement and fertility problems. Symptomatic leiomyomata lead to 30 – 40% of all hysterectomies in the United States, and to 150,000 –200,000 hysterectomies annually. 2 More than 25% of women in the United States will have a hysterectomy by the time they are 60 years old. It is the second most frequently performed surgical proce- dure after cesarean delivery for women of reproduc- tive age in the United States. 3 Uterine artery embolization, as a less invasive alternative to hysterectomy for the treatment of symp- tomatic leiomyomata, was first reported in 1995. 4 The procedure is also known as uterine fibroid emboliza- tion. Since then, the procedure has grown in popular- ity, and currently approximately 25,000 uterine artery * For a list of the Fibroid Registry for Outcomes Data (FIBROID) Registry Steering Committee and Core Site Investigators, see the appendix online at www.greenjournal.org/cgi/content/full/111/1/22/DC1. From the Department of Radiological Sciences, School of Medicine at the University of California at Irvine, Irvine, California; Department of Radiology, Georgetown University Medical Center, Washington, DC; Image Guided Surgery Associates, Philadelphia, Pennsylvania; Department of Medicine, Duke University Medical Center, Durham, North Carolina; Department of Public Health Sciences, University of Toronto, Ontario, Canada; Duke Clinical Research Institute, Durham, North Carolina; and Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina. Funded by the Society for Interventional Radiology Foundation through unre- stricted grants from Biosphere Medical, Inc. (Rockland, MA) and Boston Scientific Corporation (Natick, MA). Corresponding author: Scott C. Goodwin, MD, UC Irvine Medical Center, 101 The City Drive South, Route 140, Orange, California 92868; e-mail: s.goodwin@uci.edu. Financial Disclosure Dr. Goodwin is a former consultant with Boston Scientific, Inc. (Rockland, MA) and Biosphere Medical (Natick, MA). Dr. Worthington-Kirsch received research support and served as a consultant to Biosphere Medical and Boston Scientific. The other authors have no potential conflicts of interest to disclose. © 2007 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. ISSN: 0029-7844/07 22 VOL. 111, NO. 1, JANUARY 2008 OBSTETRICS & GYNECOLOGY