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

Abstract

PURPOSE:

To determine the long-term outcome of uterine fibroid therapy (UFE) using tris-acryl gelatin microspheres (TAGM).

MATERIALS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: James B Spies, Curt Cornell, Robert Worthington-Kirsch, John C Lipman, James F Benenati
• Journal: Journal 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
• PMID: 17327552 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Acrylic Resins
• trisacryl gelatin microspheres
• Gelatin

Topics

• 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