To prospectively evaluate the safety and effectiveness of polyvinyl alcohol (PVA) microspheres in patients undergoing uterine artery embolization (UAE) to treat uterine fibroid tumors and to compare the long-term changes in health-related quality of life (QOL) after UAE with the changes seen after myomectomy.MATERIALS AND METHODS:
One hundred forty-six patients with uterine myomas were enrolled into this multicenter study, with 77 patients undergoing UAE with PVA and 69 patients undergoing myomectomy. Six-month follow-up was completed for the myomectomy, whereas 2-year follow-up was completed for the UAE group. Outcomes were assessed with the Uterine Fibroid QOL Questionnaire and based on adverse event incidence, time to return to normal activity, and changes in tumor symptom scores, QOL scores, and menorrhagia bleeding scores. For the UAE cohort, changes in total uterine volume and dominant tumor size on magnetic resonance (MR) imaging were assessed.RESULTS:
In the UAE cohort, 88.3% of patients experienced a reduction of tumor-related symptoms (increase ≥5 points from baseline measurement) at 6 months, with 75.4% of patients in the myomectomy group experiencing similar improvement. Median QOL questionnaire scores at 6 months were found to be significantly higher in patients treated with UAE (P = .041), with sustained improvement seen at 12 and 24 months. Both procedures resulted in significant reductions in 6-month menorrhagia bleeding scores, with sustained improvement in the UAE cohort at 12 and 24 months. MR imaging at 6 months revealed significant uterine and tumor volume reductions after UAE (P < .05). At least one adverse event occurred in 42% of patients in the myomectomy group, compared with 26% in the UAE group (P < .05).CONCLUSIONS:
UAE performed with PVA microspheres was associated with greater sustained improvements in symptom severity and health-related QOL and with fewer complications compared with myomectomy. Six-month MR imaging data demonstrated significant reductions in uterine and tumor volumes, although the degree of tissue infarction after UAE was not assessed with contrast medium–enhanced MR imaging.