The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes.
OBJECTIVE
To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings.


METHODS
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.


RESULTS
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.


CONCLUSIONS
Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting.


METHODS
II-3.
Image Guided Surgery Associates, Philadelphia, Pennsylvania, USA.
Robert
R
Worthington-Kirsch
James B
JB
Spies
Evan R
ER
Myers
Jyotsna
J
Mulgund
Matthew
M
Mauro
Gaylene
G
Pron
Eric D
ED
Peterson
Scott
S
Goodwin
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007889:Leiomyoma / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011336:Probability; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*