Long-term outcome from uterine fibroid embolization with tris-acryl gelatin microspheres: results of a multicenter study.

To determine the long-term outcome of uterine fibroid therapy (UFE) using tris-acryl gelatin microspheres (TAGM).
This was a multicenter prospective study of patients undergoing UFE with TAGM, and during this phase of the study, the clinical outcomes 3 years after treatment were assessed. Measures of outcome included the Ruta Menorrhagia Questionnaire, patient self-assessments of symptoms and impact on activities, patient satisfaction and health-related quality of life as measured by the SF-12. Long-term re-intervention rates were also assessed. The data were analyzed at each interval compared to baseline using appropriate statistical tests.
Of the 102 patients enrolled, 96 patients had complete baseline data and of these, 69 (72%) had known outcomes at 3 years after treatment. Sixty-one patients (64%) completed long-term follow-up without major intervention. An additional 8 patients (8.3%) underwent fibroid surgery (7 hysterectomies and 1 myomectomy). Among those without intervention, at 3 years after treatment, the mean Ruta Questionnaire Score was 19.3, compared to 47.9 at baseline and 24.5 at 3 months (P <.01). At baseline, 57% of patients had extremely heavy bleeding, while only 2% had that complaint at 36 months. At 36 months, much or moderate improvement in pelvic pain occurred in 83% of patients, pelvic discomfort in 83%, and urinary problems in 69% and 84% were moderately or very satisfied with their outcome.
Over the long-term, UFE using TAGM is effective and safe, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.
AuthorsJames B Spies, Curt Cornell, Robert Worthington-Kirsch, John C Lipman, James F Benenati
JournalJournal of vascular and interventional radiology : JVIR (J Vasc Interv Radiol) Vol. 18 Issue 2 Pg. 203-7 (Feb 2007) ISSN: 1051-0443 [Print] United States
PMID17327552 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Acrylic Resins
  • trisacryl gelatin microspheres
  • Gelatin
  • Acrylic Resins (therapeutic use)
  • Adult
  • Embolization, Therapeutic (methods)
  • Female
  • Follow-Up Studies
  • Gelatin (therapeutic use)
  • Humans
  • Hysterectomy (statistics & numerical data)
  • Leiomyoma (therapy)
  • Menorrhagia (therapy)
  • Middle Aged
  • Patient Satisfaction
  • Pelvic Pain (therapy)
  • Prospective Studies
  • Quality of Life
  • Surveys and Questionnaires
  • Treatment Outcome

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