Midterm Results of Uterine Artery Embolization Using Narrow-Size Calibrated Embozene Microspheres
- University of Heidelberg, Department of Diagnostic and Interventional Radiology (Germany)
- University of Heidelberg, Department of Neuroradiology (Germany)
Purpose: To evaluate safety and efficacy of uterine artery embolization using narrow-size-range polyphosphazene-coated hydrogel microspheres (Embozene, CeloNova Biosciences, Newnan, GA). Methods: Between May 2006 and September 2008, a total of 121 consecutive patients (mean {+-} SD age 42.1 {+-} 5.4 years, range 30.5-51.5 years) were enrolled onto this single-center study. The primary study endpoint was safety as assessed by the society of interventional radiology (SIR) classification. The secondary endpoint was efficacy, which was based on a 1-year magnetic resonance imaging study and relief of symptoms documented by the Medical Outcomes Study 36-Item Short-Form Health Survey questionnaire over a 2-year interval. Results: The mean {+-} SD diameter of the dominant fibroid was 6.4 {+-} 2.6 (range, 2.9-13.9) cm and the mean volume 137.2 {+-} 245.1 (range, 5.3-1184) ml. Most patients had multiple fibroids with 11% more than 10. A total of 240 of 242 interventions were completed as planned, a technical success rate of 99.2%. According to the SIR classification, one type A, eight type C, and one type D complication occurred. Total devascularization was noted in 96% (116 of 121) of dominant fibroids. Volume decrease was 4% at 2 weeks, 52% (P < 0.001) at 3 months, 78% (P < 0.001) at 6 months, and 91% at 12 months (P < 0.001). The latter difference was statistically significant (P = 0.007). A total of 92% had improved hypermenorrhea at 1 year and 94% at 2 years. Dysmenorrhea was improved in 96% at 1 year and in 95% at 2 years. The overall health status score was 60.4 {+-} 26.2 points at baseline and 96.9 {+-} 3.8 after 1 year (P = 0.0019).ConclusionUterine artery embolization with Embozene microspheres is a safe procedure. Its efficacy is demonstrated by high fibroid devascularization and volume reduction rates and significant improvements of clinical symptoms and quality-of-life scores during follow-up.
- OSTI ID:
- 21608707
- Journal Information:
- Cardiovascular and Interventional Radiology, Vol. 34, Issue 2; Other Information: DOI: 10.1007/s00270-010-9986-8; Copyright (c) 2011 Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
- Country of Publication:
- United States
- Language:
- English
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