Background: Data are limited regarding comparison between nonspherical polyvinyl alcohol (PVA) particles and tris-acryl gelatin microspheres (TAGM) in uterine artery embolization (UAE). Purpose: To compare pain after UAE with PVA versus TAGM for treatment of symptomatic fibroids. Materials and Methods: In this randomized clinical trial, participants were assigned to be administered nonspherical PVA (355-550 mm) or TAGM (500-700 mm). Both groups were administered fentanyl-based intravenous patient-controlled analgesia during the first 24 hours after UAE and rescue analgesics. Neutrophil-to-lymphocyte ratio was measured to assess inflammatory response. Contrast-enhanced MRI 1 day after UAE was used to evaluate dominant fibroid necrosis and ischemia of normal myometrium. Symptom severity score and health-related quality-of-life score were assessed before and 3 months after UAE. Variables measured over time were analyzed by using the generalized estimating equation method. Results: A total of 54 participants (mean age, 44 years ± 4 [standard deviation]) were evaluated (27 participants in each group). Although pain scores and fentanyl dose were not different during the first 24 hours, use of rescue analgesics was higher in the PVA group (33% vs 11%; P = .049). After embolization, symptom severity score and health-related quality-of-life score were not different between groups (symptom severity score: 16 [interquartile range, 6-22] for PVA vs 19 [interquartile range, 9-34] for TAGM, P = .45; health-related quality-of-life score: 93 [interquartile range, 80-97] for PVA vs 89 [interquartile range, 84-96] for TAGM, P = .41). Changes in neutrophil-to-lymphocyte ratio from before to 24 hours after UAE were greater in the PVA group (3.9 [interquartile range, 2.7-6.8] for PVA and 2.5 [interquartile range, 1.5-4.6] for TAGM; P = .02). Rates of complete dominant fibroid necrosis were not different between groups, but transient global uterine ischemia of normal myometrium was more frequent in the PVA group (44% vs 15%; P = .04). Conclusion: When used in uterine artery embolization, polyvinyl alcohol particles and tris-acryl gelatin microspheres resulted in similar pain scores and fentanyl dose. Polyvinyl alcohol resulted in a greater inflammatory response, higher rates of rescue analgesic use, and more frequent transient global uterine ischemia.
|Number of pages||8|
|Publication status||Published - 2021 Feb|
Bibliographical noteFunding Information:
This was a double-blind randomized clinical trial approved by our institutional review board and registered with ClinicalTri-als.gov (NCT03420248). Data are available from the corresponding author on request. This study was funded by Merit Medical (4–2016–1108), the manufacturer of both embolic agents. The authors had full control of the data and performed all analyses. Recruitment took place in a radiology clinic and informed consent was obtained. Inclusion criteria were women older than 19 years undergoing UAE for symptomatic fibroids. Exclusion criteria were concurrent adenomyosis, severe liver or kidney dysfunction, heart block greater than first degree, and uncontrolled hypertension.
© RSNA, 2020
All Science Journal Classification (ASJC) codes
- Radiology Nuclear Medicine and imaging