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Comparison of the efficacy of the embolic agents acrylamido polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: a prospective randomized controlled trial.
MedLine Citation:
PMID:  21127866     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres (a-PVAM) as an embolic agent for uterine artery embolization (UAE) compared with Tris-acryl gelatin microspheres (TAGM).
DESIGN, SETTING, PARTICIPANTS: Prospective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas.
INTERVENTION: UAE procedure was performed with either of the two embolic agents. Either 700-900-μm a-PVAM or 500-700-μm TAGM was used.
MAIN OUTCOME MEASURES: Changes in leiomyoma perfusion, overall uterine volume, and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week, 3 months, and 6 months after UAE by a reader blinded to the embolic agent used. Changes in Uterine Fibroid Symptoms and Quality of Life questionnaire scores were measured at 3, 6, and 12 months after UAE.
RESULTS: Forty-six patients were randomized and treated under the study protocol (a-PVAM n = 22, TAGM n = 24). There were no procedure-related complications. Two patients were excluded from analysis (one technical failure of the procedure, one withdrawal from study). Successful (>90%) leiomyoma devascularization was observed in 81% of subjects at 1 week after UAE, 97% at 3 months after UAE, and 95% at 6 months after UAE. No significant differences were observed in 14 of 15 outcome measurements, consistent with noninferiority. TAGM was slightly superior to a-PVAM on one comparison (overall quality of life at 3 months after UAE).
Authors:
Robert L Worthington-Kirsch; Gary P Siskin; Paul Hegener; Richard Chesnick
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Publication Detail:
Type:  Journal Article     Date:  2010-12-03
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  34     ISSN:  1432-086X     ISO Abbreviation:  Cardiovasc Intervent Radiol     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  493-501     Citation Subset:  IM    
Affiliation:
Image Guided Surgery Associates, PC, c/o Peripheral Vascular Institute of Philadelphia, 4220 Market Street, 2nd Floor, Philadelphia, PA, 19104, USA, rkirsch@vascularcenters.com.
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