Incidence and risk factors for clinical failure of uterine leiomyoma embolization

Objective: To estimate the incidence of clinical failure after uterine fibroid embolization (UFE) and identify possible risk factors. Methods: One hundred seventy-six consecutive women undergoing UFE were followed prospectively for a median of 48 (range 12-84) months to estimate the occurrence of clinical failure, defined as persistence or recurrence of fibroid symptoms, and any subsequent invasive treatment. Cumulative failure and re-intervention rates were estimated by survival analysis and log-rank tests according to baseline patient characteristics. Multivariable Cox proportional hazards analysis was performed to adjust for confounders. Results: Overall, there were 18 failures at a median of 36 (range 3-84) months. The cumulative failure rate increased steadily over time, 3% at 1 year, 7% at 3 years, 14% at 5 years, and 18% at 7 years. Of the 18 failures, 11 had re-intervention, including 6 hysterectomies, 4 myomectomies and 1 repeat UFE, at a median of 56 (range 15-84) months. The cumulative re-intervention rate was 0 at 1 year, 3% at 3 years, 7% at 5 years, and 15% at 7 years. Women aged ≤40 years had a higher failure risk (HR 5.89, 95% CI:2.50-20.02, P=.023) compared with older women. A history of previous myomectomy was also associated with an increased failure risk (HR 3.79, 95% CI:2.07-13.23, P=.037) Conclusions: The 7-year cumulative rates of clinical failure and re-intervention after UFE were 18% (95% CI:8.2-27.8) and 15% (95% CI:5.2-24.8), respectively. The failure risk was higher for younger patients and for those with a prior myomectomy.