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Midterm Results of Uterine Artery Embolization Using Narrow-Size Calibrated Embozene Microspheres

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Abstract

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).

Conclusion

Uterine 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.

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Acknowledgment

Financial disclosure: Research grant from CeloNova Biosciences, Newnan, GA, USA.

Conflict of Interest

U.S, S.S. and G.M.R. have received a research grant from and G.M.R. has served as a consultant to CeloNova Biosciences.

Author information

Authors and Affiliations

  1. Department of Diagnostic and Interventional Radiology, University of Heidelberg, Heidelberg, Germany

    Ulrike Stampfl, Boris Radeleff, Christof Sommer, Angelika Dahlke, Nadine Bellemann & Hans-Ulrich Kauczor

  2. Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany

    Sibylle Stampfl

  3. Clinics for Diagnostic and Interventional Radiology, Klinikum Stuttgart, Kriegsbergstr. 60, 70174, Stuttgart, Germany

    Goetz M. Richter

Authors
  1. Ulrike Stampfl
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  2. Boris Radeleff
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Correspondence to Goetz M. Richter.

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Stampfl, U., Radeleff, B., Sommer, C. et al. Midterm Results of Uterine Artery Embolization Using Narrow-Size Calibrated Embozene Microspheres. Cardiovasc Intervent Radiol 34, 295–305 (2011). https://doi.org/10.1007/s00270-010-9986-8

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  • DOI: https://doi.org/10.1007/s00270-010-9986-8

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