Incidence and risk factors for clinical failure of uterine leiomyoma embolization.

OBJECTIVE To estimate the incidence of clinical failure after uterine leiomyoma embolization and identify possible risk factors. METHODS One hundred seventy-six consecutive women undergoing uterine leiomyoma embolization were followed prospectively for a median of 48 months (range 12-84 months) to estimate the occurrence of clinical failure, defined as persistence or recurrence of leiomyoma symptoms, and any subsequent invasive treatment. Cumulative failure and reintervention 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 months (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 reintervention, including six hysterectomies, four myomectomies, and one repeat uterine leiomyoma embolization, at a median of 56 months (range 15-84 months). The cumulative reintervention rate was 0 at 1 year, 3% at 3 years, 7% at 5 years, and 15% at 7 years. Women aged 40 years or younger had a higher failure risk (hazard ratio [HR] 5.89, 95% confidence interval [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). CONCLUSION The 7-year cumulative rates of clinical failure and reintervention after uterine leiomyoma embolization 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. LEVEL OF EVIDENCE III.