PURPOSE: To assess the safety and effectiveness of tris-acryl gelatin microspheres (Embospheres) in the treatment of leiomyomata by uterine artery embolization. MATERIALS AND METHODS: This was a Phase I study of 30 patients with symptomatic leiomyomata. Each patient underwent ultrasound imaging and completed questionnaires regarding symptoms and health status at baseline and 3 and 6 months after treatment. Bilateral embolization was performed with use of tris-acryl gelatin microspheres. Summary statistics were used to characterize the demographic and procedure data. Paired t-tests were used to assess change in the severity of menstrual bleeding and health-related quality of life. RESULTS: Bilateral embolization was technically successful in all patients. Three months after treatment, menstrual bleeding was markedly improved as assessed by menorrhagia questionnaire (P <.0001) and menstrual calendar (P <.0001). Pelvic pain and discomfort was improved in 92% of cases. Physical component summary scores of the SF-12 also increased from baseline at 3 months (P =.02) and at 6 months (P =.01). Minor complications occurred in nine patients; there were no major complications. CONCLUSION: Although limited, this initial experience suggests that tris-acryl gelatin microspheres are an effective and safe embolic agent for the treatment of uterine leiomyomata.
PURPOSE: To assess the safety and effectiveness of tris-acryl gelatin microspheres (Embospheres) in the treatment of leiomyomata by uterine artery embolization. MATERIALS AND METHODS: This was a Phase I study of 30 patients with symptomatic leiomyomata. Each patient underwent ultrasound imaging and completed questionnaires regarding symptoms and health status at baseline and 3 and 6 months after treatment. Bilateral embolization was performed with use of tris-acryl gelatin microspheres. Summary statistics were used to characterize the demographic and procedure data. Paired t-tests were used to assess change in the severity of menstrual bleeding and health-related quality of life. RESULTS: Bilateral embolization was technically successful in all patients. Three months after treatment, menstrual bleeding was markedly improved as assessed by menorrhagia questionnaire (P <.0001) and menstrual calendar (P <.0001). Pelvic pain and discomfort was improved in 92% of cases. Physical component summary scores of the SF-12 also increased from baseline at 3 months (P =.02) and at 6 months (P =.01). Minor complications occurred in nine patients; there were no major complications. CONCLUSION: Although limited, this initial experience suggests that tris-acryl gelatin microspheres are an effective and safe embolic agent for the treatment of uterine leiomyomata.
Authors: Bassel Mohammad Nijres; Anas S Taqatqa; Lamya Mubayed; Gregory J Jutzy; Ra-Id Abdulla; Karim A Diab; Hoang H Nguyen; Brieann A Muller; Cyndi R Sosnowski; Joshua J Murphy; Joseph Vettukattil; Vishal R Kaley; Darcy N Marckini; Bennett P Samuel; Khaled Abdelhady; Sawsan Awad Journal: Pediatr Cardiol Date: 2018-08-13 Impact factor: 1.655