Study objective: To determine the complication-related hysterectomy rate after uterine artery embolization (UAE) for symptomatic uterine leiomyomas.
Design: Prospective, multicenter, nonrandomized, single-arm clinical trial (Canadian Task Force classification II-2).
Setting: Eight Ontario University-affiliated teaching and community hospitals.
Patients: Five hundred fifty-five women.
Intervention: Polyvinyl alcohol particles were delivered through a catheter into uterine arteries under fluoroscopic guidance.
Measurements and main results: Prospective follow-up investigations consisted of telephone interviews, ultrasound examinations, and reviews of pathology and surgery reports. Median follow-up was 8.1 months, and all but five patients had complete 3-month follow-up. At 3 months, eight women (1.5%, 95% CI 0.6-2.8) underwent complication-related hysterectomy. Half of the surgeries were performed at institutions other than where UAE had been performed. Indications for hysterectomies were infections (2), postembolization pain (4), vaginal bleeding (1), and prolapsed leiomyoma (1).
Conclusions: The 3-month complication rate resulting in hysterectomy after UAE in a large cohort of women was low. Hysterectomy after UAE is an important measure of safety and a key outcome measure of this new therapy.