Spherical polyvinyl alcohol versus tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a limited randomized comparative study.

摘要

PURPOSE: To compare the outcomes of uterine artery embolization (UAE) for leiomyomas with use of tris-acryl gelatin microspheres (TAGM) versus spherical polyvinyl alcohol (PVA) particles. MATERIALS AND METHODS: Patients undergoing UAE were randomly assigned to receive TAGMs or PVA. Embolization was performed in a standardized manner. Outcome data were collected at 3 months after embolization, including assessment of clinical symptoms, scores from a fibroid tumor-specific symptom and quality of life (QOL) questionnaire, and findings on contrast material-enhanced magnetic resonance (MR) imaging, including the degree of tumor infarction and volume reduction. Data were analyzed with use of t tests, the Mann-Whitney U test, and chi2 tests as appropriate. RESULTS: Thirty-six patients were treated. There were no differences in the two treatment groups at baseline. Clinical follow-up was obtained in 35 patients. Among the clinical outcome measures, QOL score improvement was greater for UAE with TAGMs compared with PVA (49.0 vs 27.9; P = .02), but no other differences were noted. Of the 25 patients in whom 3-month MR imaging follow-up was completed, those treated with TAGM were significantly more likely to have complete infarction of all leiomyomas (six patients vs one patient; P = .02), were more likely to have at least 90% tumor infarction (eight patients vs four patients; P = .03), and had a lower mean percent of residual perfused fibroid tumor tissue (9.6% vs 44.3%; P = .004) compared with patients treated with PVA. Based on these differences between the embolic agents, enrollment in this study was terminated. CONCLUSION: The use of spherical PVA particles in the manner described herein results in an unacceptably high rate of failed tumor infarction in UAE.