8Spheres conformal microspheres as embolic agents for symptomatic uterine leiomyoma therapy in uterine artery embolization (UAE): A prospective clinical trial.

Abstract

To evaluate the treatment efficacy of uterine artery embolization (UAE) using 8Spheres conformal microspheres for symptomatic uterine leiomyoma. In this prospective observational study, 15 patients were enrolled and underwent UAE by 2 experienced interventionalists from September 1, 2018, to September 1, 2019. All patients underwent menstrual bleeding scores, the symptom severity domain of the Uterine Fibroid Symptom and Quality of Life questionnaire scores (with lower scores indicating mild symptoms), pelvic contrast-enhanced magnetic resonance imaging, ovarian reserve tests (estradiol, prolactin, testosterone, follicle-stimulating, luteinizing, and progesterone), and other appropriate preoperative examinations within 1 week before UAE. During follow-up, menstrual bleeding scores and the symptom severity domain of the Uterine Fibroid Symptom and Quality of Life questionnaire scores were recorded at 1, 3, 6, and 12 months after UAE to assess the efficacy of symptomatic uterine leiomyoma. Pelvic contrast-enhanced magnetic resonance imaging was performed 6 months after the interventional therapy. Biomarkers of ovarian reserve function were reviewed at 6 and 12 months after treatment. All 15 patients successfully underwent UAE, without severe adverse effects. Six patients experienced abdominal pain, nausea, or vomiting, all of which improved significantly after symptomatic treatment. The menstrual bleeding scores declined from baseline (350.2 ± 61.9 mL) to (131.8 ± 42.7 mL), (140.3 ± 42.4 mL), (68.0 ± 22.8 mL), and (64.43 ± 17.0 mL) at 1, 3, 6, and 12 months, respectively. The symptom severity domain scores at 1, 3, 6, and 12 months postoperatively were significantly lower and statistically significant compared to the preoperative scores. The uterus and dominant leiomyoma volumes decreased from baseline (340.0 ± 35.8 cm3), (100.6 ± 24.3 cm3) to (266.6 ± 30.9 cm3), (56.1 ± 17.3 cm3) at 6 months after UAE, respectively. Moreover, the ratio of leiomyoma volumes and uterus decreased from (27.4 ± 4.5%) to (18.7 ± 3.9%). At the same time, there was no significant effect on changes in the biomarkers of ovarian reserve levels. Only the changes in testosterone levels before and after UAE were statistically significant (P < .05). 8Spheres conformal microspheres are ideal embolic agents for UAE therapy. This study showed that 8Spheres conformal microsphere embolization for symptomatic uterine leiomyoma could effectively relieve heavy menstrual bleeding, improve the symptom severity of patients, reduce the volume of leiomyoma, and have no significant effect on ovarian reserve function.