BETHESDA, MD. — Follow-up data for women who underwent uterine artery embolization for the treatment of fibroids show that 73% still reported improved symptoms 5 years later.
Of 182 women who completed 5-year follow-up, 25 had undergone hysterectomies, 6 had undergone myomectomies, and 3 had undergone repeat embolizations. None of the hysterectomies were performed due to complications of embolization, and at least four were due to a condition other than recurrent fibroids. The failure rate after 5 years was 20%.
“The women most likely to go on to subsequent intervention were those with single, very large fibroids,” James Spies, M.D., the study's lead investigator, said in an interview. On the other hand, the women with large numbers of smaller fibroids were less likely to fail.
The initial cohort included 200 women: 95% completed follow-up at 1 year, 80% at 2 years, 91% at 3 years, 89% at four years, and 91% at 5 years. Three patients died during the 5-year follow-up—two from unrelated cancer and one from heart disease.
Dr. Spies, professor of radiology at Georgetown University, Washington, and his associates presented data on the 5-year follow-up in a poster presentation at an international congress on uterine leiomyoma research sponsored by the National Institutes of Health.
Dr. Spies and his colleagues also presented a poster on 1-year follow-up data on 1,701 women of the 3,166 who initially registered with the Fibroid Registry for Outcomes Data (FIBROID).
The registry is a collaborative effort of the Society of Interventional Radiology Foundation, the Duke Clinical Research Institute, the Food and Drug Administration, and corporate supporters, including Biosphere, a company that produces the particles used in uterine artery embolization. Dr. Spies, a member of the medical advisory board for Biosphere, said the company had no input into the gathering of data or analysis of the registry.
Overall, the women demonstrated a significant improvement in symptoms. Compared with baseline scores, 90% showed an improvement of greater than 10% on symptom scores on the Health-Related Quality of Life scale at both 6 months and 1 year.
After 1 year, the mean HRQoL score was 86.5, and the mean symptom score on the Uterine Fibroid Symptom Quality of Life scale was 19.2; both represented significant improvements from baseline and were in the range of scores for normal subjects.
“There was a striking and marked improvement in both symptom and quality of life scores, there is stable improvement between 6 and 12 months, there were relatively few complications and hospitalizations, and in general most patients were satisfied with the outcome,” said Dr. Spies, a member of the Steering Committee of FIBROID.
Most women reported a dramatic improvement in sexual function, although some reported no significant change, and 6%–7% reported a decrease.
This angiogram shows fibroids as they appeared before uterine artery embolization was performed.
Normal branches (white arrows) and uterine arteries (black) are open after the procedure is completed. Photos courtesy Dr. James Spies