Top

CardioVascular and Interventional Radiology

Published in:

01-06-2011 | Clinical Investigation

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

Authors: Robert L. Worthington-Kirsch, Gary P. Siskin, Paul Hegener, Richard Chesnick

Published in: CardioVascular and Interventional Radiology | Issue 3/2011

Abstract

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).

Spies JB, Allison S, Flick P et al (2004) Polyvinyl alcohol particles and Tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a randomized comparative study. J Vasc Interv Radiol 15:793–800PubMed

Spies JB, Allison S, Flick P et al (2005) Spherical polyvinyl alcohol versus Tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a limited randomized comparative study. J Vasc Interv Radiol 16:1431–1437PubMed

Siskin GP, Beck A, Schuster M et al (2008) Leiomyoma infarction after uterine artery embolization: a prospective randomized study comparing Tris-acryl gelatin microspheres versus polyvinyl alcohol microspheres. J Vasc Interv Radiol 19:58–65PubMedCrossRef

Galvez JA, McCarthy S, Weinreb J et al (2008) Comparison of MRI outcomes of uterine artery embolization for uterine leiomyomas using Tris-acryl gelatin microspheres, polyvinyl alcohol spheres, and polyvinyl alcohol particles. J Comput Assist Tomogr 32:356–361PubMedCrossRef

http://www.fda/gov/ohrms/dockets/ac/06/transcripts/4217t2.pdf

Pelage J, Guaou Guaou N, Jha R et al (2004) Long-term imaging outcome after embolization for uterine fibroid tumors. Radiology 230:803–809PubMedCrossRef

Spies JB (2009) What evidence should we demand before accepting a new embolic material for uterine artery embolization? J Vasc Interv Radiol 20:567–570PubMedCrossRef

Spies J, Coyne K, Guaou Guaou N et al (2002) The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 99:290–300PubMedCrossRef

Kroencke TJ, Scheurig C, Lampmann LE et al (2008) Acrylamido polyvinyl alcohol microspheres for uterine artery embolization: 12-month clinical and MR imaging results. J Vasc Interv Radiol 19:47–57PubMedCrossRef

10.

Seron A, Pelage JP, Counord JL et al (2005) Rigidity and elasticity of Embosphere, Bead Block and Contour SE (abstract 89). Presented at Cardiovascular and Interventional Radiological Society of Europe

11.

Worthington-Kirsch RL (2005) Uterine artery embolization for fibroid disease. In: Van Sonnenberg E, McMullen W, Solbiati L (eds) Tumor ablation: principles and practice. Springer, New York, pp 414–417

12.

Waltman AC, Courey AD, Athanasoulis C et al (1973) Technique for left gastric artery catheterization. Radiology 109:732PubMed

13.

Cramer SF, Patel D (1990) The frequency of uterine leiomyomas. Am J Clin Pathol 94:435–438PubMed

14.

Schwartz SM (2001) Epidemiology of uterine leiomyomata. Clin Obstet Gynecol 44:316–326PubMedCrossRef

15.

Namur J, Wassef M, Pelage JP et al (2005) Arterial location of three sizes of Embosphere and Bead Block in sheep uterus models (abstract 47.7.5). Presented at Cardiovascular and Interventional Radiological Society of Europe

16.

Stampfl S, Belleman N, Stampfl U et al (2009) Arterial distribution characteristics of Embozene particles, and comparison with other spherical embolic agents in the porcine acute embolization model. J Vasc Interv Radiol 20:1597–1607PubMedCrossRef

17.

Sampson JA (1912) The blood supply of uterine myomata. Surg Gynecol Obstet 14:215–234

18.

Spies JB, Benenati JF, Worthington-Kirsch RL (2001) Initial experience with use of Tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata. J Vasc Interv Radiol 12:1059–1063PubMedCrossRef

19.

Spies JB, Cooper JM, Worthington-Kirsch RL et al (2004) Outcome of uterine embolization and hysterectomy for leiomyomas: results of a multicenter study. Am J Obstet Gynecol 191:22–31PubMedCrossRef

20.

Chrisman HB, Dhand S, Rajeswaran S et al (2010) Prospective evaluation of the embolic agent bead block in the treatment of uterine leiomyomas with uterine artery embolization: a phase II study. J Vasc Interv Radiol 21:484–489PubMedCrossRef

21.

Abramowitz SA, Israel GM, McCarthy SM et al (2009) Comparison of four embolic materials at uterine artery embolization by using postprocedural MR imaging enhancement. Radiology 250:482–487PubMedCrossRef

22.

Spies JB, Myers ER, Worthington-Kirsch R et al (2005) The FIBROID Registry: symptoms and quality-of-life status 1 year after therapy. Obstet Gynecol 106:1309–1318PubMedCrossRef

23.

Goodwin SC, Spies JB, Worthington-Kirsch R et al (2008) Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry. Obstet Gynecol 111:22–33PubMedCrossRef

Title: 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
Authors: Robert L. Worthington-Kirsch
Gary P. Siskin
Paul Hegener
Richard Chesnick
Publication date: 01-06-2011
Publisher: Springer-Verlag
Published in: CardioVascular and Interventional Radiology / Issue 3/2011
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-010-0049-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Objective

Design, Setting, Participants

Intervention

Main Outcome Measures

Results

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Design, Setting, Participants

Intervention

Main Outcome Measures

Results

Please log in to get access to this content

Other articles of this Issue 3/2011

Initial Experience with Computed Tomography and Fluoroscopically Guided Placement of Push-Type Gastrostomy Tubes Using a Rupture-Free Balloon Catheter

Endovascular Stent Treatment for Symptomatic Benign Iliofemoral Venous Occlusive Disease: Long-Term Results 1987–2009

Bone Marrow Nails Created by Percutaneous Osteoplasty for Long Bone Fracture: Comparisons Among Acrylic Cement Alone, Acrylic-Cement–Filled Bare Metallic Stent, and Acrylic-Cement–Filled Covered Metallic Stent

Experimental Study of Poly-l-Lactic Acid Biodegradable Stents in Normal Canine Bile Ducts

Reply to the Article Entitled “Emergency Renal Ablation for Life-Threatening Hemorrhage from Multiple Capsular Branches During Renal Artery Stenting” by Aytekin et al.

Initial Experience of Uterine Fibroid Embolization Using Porous Gelatin Sponge Particles