Leiomyoma Infarction after Uterine Artery Embolization: A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres

doi:10.1016/j.jvir.2007.08.034

Journal of Vascular and Interventional Radiology

Volume 19, Issue 1, January 2008, Pages 58-65

https://doi.org/10.1016/j.jvir.2007.08.034 Get rights and content

Purpose

To determine the degree of leiomyoma infarction after uterine artery embolization (UAE) performed with tris-acryl gelatin microspheres or polyvinyl alcohol (PVA) microspheres.

Materials and Methods

Patients determined to be candidates and scheduled for UAE were randomized prospectively to receive tris-acryl gelatin microspheres or PVA microspheres. The manufacturers’ recommended technique was used for both products during the UAE procedures (including the recently described refined protocol for PVA microspheres). All patients underwent magnetic resonance (MR) imaging of the pelvis with contrast agent enhancement before and after the UAE procedure. On the postprocedural MR study, the degree of tumor infarction was assessed on postcontrast images. These findings were classified as follows: 100% infarction, 90%–99% infarction, 50%–89% infarction, and less than 50% infarction. Treatment failure was defined by enhancement of more than 10% of a patient’s entire tumor burden.

Results

A total of 53 patients were enrolled in this study. Twenty-seven (mean age, 44.9 years) received PVA microspheres and 26 (mean age, 45.1 years) received tris-acryl gelatin microspheres. There were no significant differences in the preprocedural uterine volume, dominant tumor volume, location of dominant tumor, and presenting symptoms between populations. In the PVA microsphere group, treatment failure was seen in eight patients (29.6%). In the tris-acryl gelatin microsphere group, treatment failure was seen in one patient (3.8%), which was a significant difference between groups (P ≤ .025).

Conclusions

There was a significantly greater degree of tumor infarction in patients treated with tris-acryl gelatin microspheres during UAE than in patients who received PVA microspheres administered in accordance with a newly refined protocol. Given the known risk of recurrence in patients with persistent tumor enhancement after UAE, it is concluded that tris-acryl gelatin microspheres should be the preferred agent for UAE at this time.

Section snippets

Study Design

This was a prospective, randomized study that received approval from our institutional review board before study initiation. All patients were first seen within our outpatient interventional radiology office, where they were evaluated for the UAE procedure. As part of our routine UAE protocol, all patients were evaluated with pelvic MR imaging before it was determined whether they were candidates for the procedure. The uterus was measured on this study and volume was calculated according to the

Results

During the study period, a consecutive group of 64 patients were evaluated for participation in this study over a 6-month period of time. A total of 53 patients were successfully enrolled in the study. Eleven patients were not enrolled in the study for reasons that included the presence of adenomyosis without fibroid tumors (n = 3), claustrophobia precluding MR imaging (n = 4), and a desire to not participate in a research study (n = 4). One of these patients signed the research consent but

Discussion

The choice of an embolic agent for use during UAE is one that has been under scrutiny of late. This issue did not exist when UAE was first introduced. Particulate PVA was the initial agent used for this procedure, and its success in addressing the symptoms of a patient with uterine leiomyomas and decreasing uterine and tumor volume has been well documented (14, 15, 16, 17, 18). For several years, there was a uniform approach to UAE by most interventional radiologists because there was virtual

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This study aimed to investigate whether uterine artery embolization offers a better quality of life than myomectomy in premenopausal women diagnosed with leiomyomas of the uterus.
A literature search was performed using the electronic databases of PubMed and Cochrane Central Register of Controlled Trials from inception to January 2023.
Randomized controlled trials comparing uterine artery embolization with myomectomy in women of premenopausal age suffering from uterine leiomyomas were considered.
The primary outcome was quality of life. The secondary outcomes were reintervention rate and timing, successful pregnancy, stillbirth and miscarriage, cesarean delivery on delivery, and perioperative morbidity. Moreover, time-to-event and standard pairwise meta-analyses were performed, as appropriate. The certainty of the evidence was assessed in line with the Grading of Recommendations, Assessment, Development, and Evaluations methodology.
A total of 6 randomized controlled trials met our inclusion criteria. The meta-analysis suggested little to no difference in terms of quality of life between uterine artery embolization and myomectomy (standard mean difference, 0.05; 95% confidence interval, −0.38 to 0.48; I²=92%; very low certainty of evidence). Sensitivity analysis, including randomized controlled trials, which included solely myomectomy procedures in the control arm, demonstrated better quality of life for women treated with myomectomy (standard mean difference, −0.32; 95% confidence interval, −0.49 to −0.15; I²=15%). Concerning reintervention, myomectomy was likely associated with a decreased risk of future reintervention (risk ratio, 0.32; 95% confidence interval, 0.15–0.69; I²=60%; low certainty of evidence) and a more prolonged time interval since a potential reintervention because of recurrence than uterine artery embolization (hazard ratio, 0.41; 95% confidence interval, 0.22–0.77; I²=77%; low certainty of evidence). No difference was found between the 2 interventions concerning severe perioperative adverse events (relative risk, 4.13; 95% confidence interval, 0.44–39.20; I²=0%; low certainty of evidence).
Uterine artery embolization is likely associated with increased reintervention rates and less time to reintervention compared with myomectomy in premenopausal women diagnosed with uterine leiomyomas. Evidence suggests no difference between the 2 interventions regarding perioperative morbidity. Uterine artery embolization may exert no effect on quality of life and successful pregnancy; however, the evidence is very uncertain.
Uterine Myomas: Endovascular Treatment
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Uterine fibroids embolization is a safe and effective organ sparing treatment for fibroid-related symptoms based on a broad range of published evidence including randomized-controlled trials. Indication to treatment is usually the presence of symptomatic uterine fibroids. In this review, a systematic search of journal articles relevant to the treatment of symptomatic uterine fibroids was conducted, with a special focus on the indication to treatment, technique, procedural outcomes and pain control. All clinical trials published in English language, representing original research, and reporting clinical outcomes associated with interventions for the management of symptomatic uterine fibroids were considered.
Uterine Fibroid Embolization
2020, Image-Guided Interventions: Expert Radiology Series, Third Edition
Uterine fibroid embolization (UFE) is now recognized as an effective therapy for uterine fibroids. There is extensive data from clinical trials, including numerous randomized trials, that demonstrate the effectiveness and safety of UFE in a broad range of patients. The procedure technique is well established and the potential adverse events are well known. The procedure is now routinely done safely in both hospital and outpatient settings.
Transradial and Transfemoral Uterine Fibroid Embolization Comparative Study: Technical and Clinical Outcomes
2020, Journal of Vascular and Interventional Radiology
To compare clinical and technical outcomes of transradial (TRA) uterine artery embolization (UAE) with those of the transfemoral (TFA) approach.
Consecutive patients who underwent UAE with TRA and TFA in an academic hospital between May 2014 and June 2018 were included in this study. The ability to perform the procedure as planned, complication rates, and reduction in uterine volume, fibroid enhancement, and symptomatic improvement were compared using descriptive statistics, Student t-test, and chi-square test.
There were 91 patients in the TFA group and 91 patients in the TRA group, with 1 crossover to TFA due to vasospasm (1 of 91; 1%). The tallest patient in the TRA UAE group was 178 cm and 4 patients taller than 178 cm in the TFA UAE group. Larger particles (900–1,200 μm) were more often used in the TFA group than in the TRA group (P < .001). There were similar low rates of minor access site complications. In the TFA group (6 of 91, 7%), 5 patients had groin hematomas, and 2 patients had groin pain compared to the TRA group (5 of 91, 5%): in which 4 patients had transient focal occlusion of the radial artery and 1 patient had focal pain, all of which resolved with conservative management. There were similar rates of uterine volume reduction in 40% ± 17% in the TFA versus 36% ± 16% in the TRA group (P = .22) and no residual enhancement in 49 of 58 [84%] in the TFA group versus 66 of 77 [86%] in the TRA group (P = .84). There were similar reductions in modifying symptoms (60 of 64 [94%] in the TRA group; and 37 of 40 [93%] in the TFA group; P = NS) was noted at follow-up.
Transradial UAE in women up to 178 cm tall and transfemoral UAE have similar technical and clinical outcomes, with low rates of access site complications.
Comparison of microsphere penetration with LC Bead LUMI™ versus other commercial microspheres
2018, Journal of the Mechanical Behavior of Biomedical Materials
Citation Excerpt :
For instance, in Table 4 it is clear from the comparison of the products tested by both Lewis 2006 and Forster 2010 that the modulus of Contour SE seems significantly lower than the other embolic microspheres tested, which may raise questions about this products behaviour in vivo. Indeed, the clinical literature reported of the difficulties experienced with the use of this product with inadequate devascularisation as a result of its softness, lack of shape recovery and more distal migration (Spies et al., 2005; Siskin et al., 2008). For LC Bead LUMI™, the increase in density of the product due to the attachment of the iodine to the structure means that the mechanical properties are increased and the compressive modulus is significantly higher than any of the currently-available embolic microspheres (Table 3).
The purpose of this study was to evaluate LC Bead LUMI™ (40–90 µm and 70–150 µm) in order to determine if their increased resistance to compression influences microsphere penetration and distribution compared to more compressible commercial microspheres. LC Bead LUMI™ 40–90 µm and 70–150 µm, LC BeadM1^® 70–150 µm, Embozene™ 40 µm and Embozene™ 100 µm size and distributions were measured using optical microscopy. Penetration in vitro was evaluated using an established ‘plate model’, consisting of a calibrated tapered gap between a glass plate and plastic housing to allow visual observation of microsphere penetration depth. Behaviour in vivo was assessed using a rabbit renal embolization model with histopathologic confirmation of vessel penetration depth. Penetration behaviour in vitro was reproducible and commensurate with the measured microsphere size, the smaller the microsphere the deeper the penetration. Comparison of the microsphere diameter measured on the 2D plate model versus the corresponding average microsphere size measured by histopathology in the kidney showed no significant differences (p = > 0.05 Mann-Whitney, demonstrating good in vitro - in vivo predictive capabilities of the plate model) confirming predictable performance for LC Bead LUMI™ (40–90 µm and 70–150 µm) based on microsphere size, their increased rigidity having no bearing on their depth of penetration and distribution. An assessment of a LC Bead LUMI™ (40–90 µm and 70–150 µm) has shown that despite having greater resistance to compression, these microspheres behave in a predictable manner within in vitro and in vivo models comparable with more compressible microspheres of similar sizes.
Leiomyoma Infarction after Uterine Artery Embolization: Influence of Embolic Agent and Leiomyoma Size and Location on Outcome
2017, Journal of Vascular and Interventional Radiology
To study the factors that might impact infarction of individual uterine leiomyomas and total tumor burden after uterine artery embolization (UAE).
This retrospective study included 91 patients (mean age, 44 y [range, 34–54 y]) who underwent UAE with tris-acryl gelatin microspheres (TAGMs) or nonspherical polyvinyl alcohol (PVA) particles. Twenty-one patients were treated with PVA (23%) and 70 were treated with TAGMs (77%). A total of 356 uterine leiomyomas were assessed, with a median uterine volume of 533 cm³ (range, 321–848 cm³). A reader masked to demographic and technical details reviewed contrast-enhanced magnetic resonance images before and 3 months after UAE to estimate the extent of tumor infarction.
There was no significant difference in global or individual tumor infarction rate between embolizations with TAGMs and PVA particles (P = .73 and P = .3, respectively). Global infarction was not affected by age (P = .53), race (P = .12), number of leiomyomas (P = .72), or uterine volume (P = .74). Leiomyoma size did not influence individual tumor infarction (P = .41). Leiomyoma location was the sole factor that influenced individual tumor infarction rates, with pedunculated serosal tumors significantly less likely to show complete infarction than transmural tumors (odds ratio, 0.24; P = .01).
Nonspherical PVA particles and TAGMs produce similar rates of uterine leiomyoma infarction. Complete infarction of individual tumors is less likely in serosal and pedunculated serosal tumors.

View all citing articles on Scopus

¹: G.P.S. has received research grants from Boston Scientific Corporation and Biosphere Medical Corporation.

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Clinical studyLeiomyoma Infarction after Uterine Artery Embolization: A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres

Purpose

Materials and Methods

Results

Conclusions

Section snippets

Study Design

Results

Discussion

J Vasc Interv Radiol

J Vasc Interv Radiol

J Vasc Interv Radiol

J Vasc Interv Radiol

Obstet Gynecol

Br J Obstet Gynaecol

Fertil Steril

J Vasc Interv Radiol

J Vasc Interv Radiol

J Vasc Interv Radiol

Am J Obstet Gynecol

J Vasc Interv Radiol

J Vasc Interv Radiol

J Vasc Interv Radiol

Trisacryl gelatin microspheres for therapeutic embolization: IDevelopment and in-vitro evaluation

AJNR Am J Neuroradiol

Collagen-coated acrylic microspheres for embolotherapy: in vivo and in vitro characteristics

AJNR Am J Neuroradiol

Clinical study
Leiomyoma Infarction after Uterine Artery Embolization: A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres