Research Article
Hiraku Yodono, Yoko Saito a
Abstract
Background: We performed uterine fibroid embolization (UFE) in four patients to assess the safety and efficacy of bland embolization using DC Bead®. They were the first patients in the world who underwent UFE procedure by using DC Bead®. Methods: Four patients with uterine fibroids were enrolled and super selective embolization with DC Bead® was performed in a Japanese clinical trial. Efficacy, success rate of embolization in the target vessel (embolic performance) and operability were evaluated. To evaluate the safety, adverse events and device deficiency occurring within 30 days after the embolization were collected. Results: Patient’s age range was 34 to 48 years old, Uterine fibroid size range was 40 to 108 mm (maximum length of diameter). Multiple tumors were found in all cases. DC Bead® size range was 100-300 μm to 500-700 μm. In the evaluation of embolic performance, three cases were completely embolized (100% disappearance of target vessel and staining on DSA) and one case was highly embolized (80% or more disappearance of target vessel, stained on DSA). In the evaluation of operability, all cases were evaluated as very easy to use. At 3,6,12 months after embolization, shrinkage in all uterine fibroids could be seen. The largest reduction rate was 59% in size (the mean was 43%). Post embolization syndrome was observed in all patients. However, the degree of these was mild or moderate (grade 1 or 2 of CTCAE version 4.0). There was no serious adverse event. Conclusions: Uterine fibroid embolization using DC Bead® was safely and successfully performed. DC Bead® will be a useful embolic material for uterine fibroid embolization.