Embolization of uterine leiomyomas with polyzene F-coated hydrogel microspheres: initial experience.

Purpose: To evaluate effectiveness and safety of Polyzene F-coated hydrogel microspheres for uterine artery embolization (UAE) in women with symptomatic uterine leiomyomas.

Materials And Methods: Between August 2006 and August 2008, 86 nonconsecutive premenopausal women (mean age, 43.9 years; median, 44 y; range, 28-54 y) were treated with UAE. Calibrated microspheres of 500, 700, and 900 μm, alone or in combination, were used as embolic agents. Change in uterine and tumor volume and tumor infarction rate during follow-up were assessed with magnetic resonance imaging. Clinical follow-up was evaluated by the Uterine Fibroid Severity and Quality Of Life (UFS-QOL) questionnaire at baseline, 3 months, and last follow-up in November 2008.

Results: At 3 months, mean volume reductions of the dominant leiomyoma and uterus were 45% and 42%, respectively, and complete infarction of the dominant leiomyoma was achieved in 69 patients (80%). Complete infarction of the overall tumor burden was achieved in 52 patients (60%). Infarction rates of the dominant tumor and overall tumor burden were more than 90% in 81 patients (94%) and 79 patients (91%), respectively. During follow-up, permanent amenorrhea developed in seven women (8.1%). Four women (4.7%) had additional therapy after UAE; three had a hysterectomy and one had a second embolization. The UFS-QOL showed significant improvement in symptom severity and quality of life after 3 months that continued to improve at last follow-up (mean, 12.8 months).

Conclusions: In this preliminary study, Polyzene F-coated hydrogel microspheres for UAE resulted in good dominant and overall tumor infarction in most patients, with corresponding improvement of symptoms. Determining optimal sizing of the material and comparing outcomes versus those of other embolic agents requires additional study.