Purpose: To evaluate safety and mid term efficacy (> or = 1 year follow-up) of uterine fibroid embolization (UFE) using spherical particles (Embosphere) in a study applying criteria identical to those submitted to the FDA for initial material approval.
Materials and methods: Twenty of the first 26 consecutive patients referred for potential UFE were enrolled in the study. Pre-interventional MRI was used to assess morphologic contraindication to UFE. The embolization procedures were performed from a unilateral femoral approach using 4F selective catheters in straight vessels, > 2 mm in diameter, and micro-catheters in smaller and tortuous arteries. The endpoint of the "flow guided" embolization was defined by reaching the angiographic "pruned tree" appearance and sluggish flow in the main stem of the uterine artery. Assessment of morphologic mid term success was done by MRI 10 days, 3 months, 6 months, 9 months and 1 year after UFE. The clinical mid term success was assessed by having questionnaires completed for menstrual bleeding, retention of clinical (symptomatic) benefit and quality of life.
Results: Technical success was 100 %, with 8 minor (2 post-interventional collapses, 2 hematomas, 4 relevant post-embolizations syndromes, 1 spontaneous expulsion of a submucous myoma) and 3 major complications (1 hysterectomy because of vaginal bleeding for 5 weeks, 1 transient amenorrhea and 1 spontaneous expulsion of myoma with transient bleeding requiring admission). In 17 of 19 patients, MRI showed total fibroid devascularization throughout the entire follow-up. The average shrinkage of the dominant fibroid was 71.3 % at one year. The menstrual bleeding record in the cohort group fell from an average of 501.6 before treatment to 76.2 points at one year. At the same time, the clinical symptoms significantly improved. The patient satisfaction with the applied therapy was > 95 % at 1 year. One patient with residual fibroid perfusion underwent a second procedure, which achieved complete devascularization and adequate clinical success at one year. The second patient with incomplete devascularization had a persistent clinical benefit.
Conclusion: Under controlled study conditions, flow guided UFE with spherical particles achieves high overall success and patient satisfaction. MRI provides exact morphologic description of the fibroid for the initial evaluation and for post-procedural follow-up.