Clinical studyComparison of Clinical Outcomes of Tris-acryl Microspheres Versus Polyvinyl Alcohol Microspheres for Uterine Artery Embolization for Leiomyomas: Results of a Randomized Trial
Section snippets
Study Design
A prospective, double-blinded, randomized controlled trial was conducted in accordance with the Declaration of Helsinki, with approval obtained from the institutional review board. A signed informed consent form was obtained from each patient. Sixty patients were randomly assigned at a 1:1 ratio to the treatment groups to receive tris-acryl microspheres (500–700-μm Embosphere particles; BioSphere, Roissy, France) or PVA microspheres (500–700-μm Contour SE particles; Boston Scientific, Natick,
Patient Demographics and Clinical Findings
During the period from February 2006 to November 2009, 457 patients with uterine leiomyomas were managed in the authors' institution. A total of 290 underwent surgery, 61 did not meet study inclusion criteria, and 46 chose not to participate. Sixty patients were recruited into the study, with 30 patients randomly allocated into each of the two groups to receive the allocated intervention. After the embolization procedure, one patient in the PVA microsphere group and three patients in the
Discussion
The aim of uterine leiomyoma embolization is infarction of tumors (7). Pathologic studies of leiomyomas successfully embolized and devascularized tumors typically show hyaline necrosis or coagulative necrosis of the tumor (8, 9). However, failure of complete devascularization of tumors may affect long-term clinical outcome and lead to persistent or recurrent symptoms (10, 11). MR imaging can be used to assess the degree of posttreatment residual intratumoral arterial perfusion, which may
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2018, World NeurosurgeryCitation Excerpt :Other desirable properties of Embospheres include pliability for ease of surgical handling, biodegradability, immunologic inactivity, and nontoxicity.18 In a randomized controlled trial comparing Embospheres and PVA microspheres for embolization of uterine leiomyomas, Yu et al.9 reported that Embospheres had greater clinical success and decreased rates of postembolization fever, indicating a decreased inflammatory response. The ability of the microspheres to achieve embolization of the tumor bed well beyond the feeding pedicle where they are administered was clear throughout this series, especially in case 1.
Polymeric materials for embolic and chemoembolic applications
2016, Journal of Controlled ReleaseCitation Excerpt :Furthermore, the trisacryl gelatin MSs treated patients had superior outcomes, level of infarction and quality of life score, both for short term and long term measures. Similar results were determined in subsequent, larger prospective studies [38,90,91]. The theory remains that the material properties, high compressibility, of PVA compared with trisacryl gelatin serves to produce early redistribution and recanalization as a result of particle deformation assuming a smaller profile after embolization [89,92], allowing more distal passage when injected, but also partial revascularization of portions of the fibroid tumor tissue [89].
None of the authors have identified a conflict of interest.