The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization

Abstract

To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings. Examining the FIBROID Registry, a multicenter prospective voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied the frequency of adverse events and predictors of adverse events within 30 days of the procedure. We also report on the technical aspects of the procedure, including details of periprocedural care, technique, and short-term recovery. All adverse events were recorded and classified using standard definitions, both in terms of type and severity. Summary statistics were used to describe the data set, and univariate and multivariate analyses were used to determine which factors might influence the incidence of adverse events. Of the 3,160 patients enrolled at 72 contributing sites, major in-hospital complications occurred in 0.66%, and postdischarge major events occurred in 4.8% within the first 30 days. The most common adverse event after discharge was inadequate pain relief requiring additional hospital treatment (2.4%). Thirty-one patients required additional surgical intervention within 30 days after treatment, 3 of whom required hysterectomy (0.1%). There were no deaths. Multivariate analysis showed modest increased odds for an adverse event for African Americans, smokers, and those with prior leiomyoma procedures. There were no differences in outcome based on the practice site experience, practice type, or any procedure-related factors. Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting. II-3.