Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata.
OBJECTIVE
To assess the safety and effectiveness of tris-acryl gelatin microspheres (Embospheres) in the treatment of leiomyomata by uterine artery embolization.


METHODS
This was a Phase I study of 30 patients with symptomatic leiomyomata. Each patient underwent ultrasound imaging and completed questionnaires regarding symptoms and health status at baseline and 3 and 6 months after treatment. Bilateral embolization was performed with use of tris-acryl gelatin microspheres. Summary statistics were used to characterize the demographic and procedure data. Paired t-tests were used to assess change in the severity of menstrual bleeding and health-related quality of life.


RESULTS
Bilateral embolization was technically successful in all patients. Three months after treatment, menstrual bleeding was markedly improved as assessed by menorrhagia questionnaire (P <.0001) and menstrual calendar (P <.0001). Pelvic pain and discomfort was improved in 92% of cases. Physical component summary scores of the SF-12 also increased from baseline at 3 months (P =.02) and at 6 months (P =.01). Minor complications occurred in nine patients; there were no major complications.


CONCLUSIONS
Although limited, this initial experience suggests that tris-acryl gelatin microspheres are an effective and safe embolic agent for the treatment of uterine leiomyomata.
Spies
J B
JB
Department of Radiology, Georgetown University Hospital, Washington, DC 20007-2197, USA. spiesj@gunet.georgetown.edu
Benenati
J F
JF
Worthington-Kirsch
R L
RL
Pelage
J P
JP
D000328:Adult; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005780:Gelatin; D006801:Humans; D007889:Leiomyoma / Q000098:blood supply / Q000628:therapy*; D008863:Microspheres; D008875:Middle Aged; D018579:Patient Selection; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000098:blood supply / Q000628:therapy*
D005780:Gelatin