Initial experience of uterine fibroid embolization using porous gelatin sponge particles.
ABSTRACT The purpose of this study was to prospectively assess the safety and effectiveness of uterine artery embolization (UAE) using porous gelatin particle (PGP; Gelpart; Asuterasu, Tokyo, Japan) for symptomatic uterine fibroids. Twenty-five consecutive premenopausal women underwent UAE with PGP. The angiographic end point of embolization was near stasis of the ascending uterine artery. Pelvic magnetic resonance imaging (MRI) was obtained before and after the procedure. Complications were assessed. The outcomes of technique, infarction rates of all fibroid tissue after UAE with contrast-enhanced MRI, change in symptoms and quality of life using serial Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaires, and additional interventions were evaluated. Bilateral UAE was successfully performed in all patients. Enhanced MRI 1 week after UAE showed that 100% infarction of all fibroid tissue was achieved in 65% (15 of 23) of patients; 90-99% infarction was achieved in 35% (8 of 23) of patients. Mean follow-up was 12 months (range 1-20). Symptom and QOL scores at baseline were 47.2 and 61.7, respectively. Both scores significantly improved to 26.3 (P<0.001) and 82.4 (P<0.001) at 4 months and to 20.4 (P<0.001) and 77.6 (P<0.001) at 1 year, respectively. No additional gynecologic interventions were performed in any patient. There were no major complications. Minor complications occurred in two patients. UAE using PGP is a safe and effective procedure and shows that outcomes after UAE, as measured with enhanced MRI and UFS-QOL questionnaires, seem comparable with those of UAE using other embolic agents. PGP is a promising embolic agent used for UAE to treat symptomatic uterine fibroids. Further comparative study between PGP and other established embolic agents is required.
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ABSTRACT: 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. 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. 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. The use of spherical PVA particles in the manner described herein results in an unacceptably high rate of failed tumor infarction in UAE.Journal of Vascular and Interventional Radiology 12/2005; 16(11):1431-7. · 2.00 Impact Factor
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ABSTRACT: The efficacy and safety of uterine-artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. We conducted a randomized trial comparing uterine-artery embolization and surgery in women with symptomatic uterine fibroids. The primary outcome was quality of life at 1 year of follow-up, as measured by the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Patients were randomly assigned in a 2:1 ratio to undergo either uterine-artery embolization or surgery, with 106 patients undergoing embolization and 51 undergoing surgery (43 hysterectomies and 8 myomectomies). There were no significant differences between groups in any of the eight components of the SF-36 scores at 1 year. The embolization group had a shorter median duration of hospitalization than the surgical group (1 day vs. 5 days, P<0.001) and a shorter time before returning to work (P<0.001). At 1 year, symptom scores were better in the surgical group (P=0.03). During the first year of follow-up, there were 13 major adverse events in the embolization group (12%) and 10 in the surgical group (20%) (P=0.22), mostly related to the intervention. Ten patients in the embolization group (9%) required repeated embolization or hysterectomy for inadequate symptom control. After the first year of follow-up, 14 women in the embolization group (13%) required hospitalization, 3 of them for major adverse events and 11 for reintervention for treatment failure. In women with symptomatic fibroids, the faster recovery after embolization must be weighed against the need for further treatment in a minority of patients. (ISRCTN.org number, ISRCTN23023665 [controlled-trials.com].)New England Journal of Medicine 02/2007; 356(4):360-70. · 51.66 Impact Factor
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ABSTRACT: To evaluate the midterm results of limited embolization of the uterine arteries in the management of symptomatic uterine fibroids and to evaluate the efficacy and safety of limited uterine artery embolization (UAE) with use of calibrated tris-acryl gelatin microspheres in the management of symptomatic uterine fibroids. Twenty women (mean age, 43 years) with symptomatic uterine fibroids underwent bilateral embolization of the uterine arteries with use of calibrated microspheres. Devascularization of the fibroids was achieved and the main uterine artery was left patent in all women. Embolization was offered as an alternative to surgery in all women who had been treated unsuccessfully with medical therapy. All procedures were technically successful. Microspheres 700-900 micro m in diameter were used in 14 women (70%). After a mean follow-up duration of 30.2 months (range, 24-48 mo), all women reported improvement in their symptoms, with 85% reporting complete resolution of menorrhagia at the most recent follow-up. One woman with multiple fibroids required a second embolization procedure because of persisting symptoms at 6 months. She is currently symptom-free after 48 months. In two women with submucosal fibroids, expulsion of necrotic fibroids occurred 2 and 7 months after the procedure, respectively. All women resumed normal menstruation after the procedure. One woman had a successful full-term pregnancy after embolization. Early experience with UAE with use of calibrated tris-acryl gelatin microspheres indicates that it is safe and efficacious in controlling menorrhagia.Journal of Vascular and Interventional Radiology 02/2003; 14(1):15-20. · 2.00 Impact Factor