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A retrospective cohort study comparing a novel, spherical, resorbable particle against five established embolic
D Maclean1, G Vigneswaran1, T Bryant1
1Department of Interventional Radiology, University Hospital Southampton, Tremona Road, Southampton SO16 7AX, UK.
Aim:
To evaluate the effectiveness of a novel, resorbable, spherical embolic agent compared with other established agents, by studying percentage fibroid infarction (the best indicator of long-term symptom improvement) in patients undergoing uterine fibroid embolisation (UFE).
Materials And Methods:
This retrospective cohort study examined six different embolic agents used for fibroid embolisation, including a new gelatin-based, fully resorbable, spherical agent. The primary effectiveness outcomes were magnetic resonance imaging (MRI)-determined dominant fibroid infarct percentage (DF%) and all fibroid percentage infarct (AF%) at 3 months post-embolisation. MRI-determined uterine artery patency rate was the secondary outcome. Chi-squared test (χ2), relative risk (RR) calculation (primary outcomes), and analysis of variance (ANOVA) (secondary outcome) were the statistical tests employed.
Results:
One hundred and twenty patients were treated with six embolic agents (20 consecutive patients per group, overall mean age 44.8±6.4, initial uterine volume 570±472 ml, dominant fibroid volume 249±324 ml). Fibroid infarctrates were similar between the cohorts with no significant difference between the new gelatin-based resorbable particle and other embolics in either DF% (χ2=3.92, p=0.56) or AF% (χ2=2.83, p=0.73). Complete DF% RR=1.07 (0.90-1.27) and AF% RR=1.09 (0.85-1.41) suggest non-inferiority of the resorbable particle (d=0.67, p<0.05). A favourable uterine artery patency rate was demonstrated for the resorbable particle compared with gelatin slurry (82.5% versus 27.5%, p<0.001 after Bonferroni adjustment).
Conclusions:
This new gelatin-based, fully resorbable particle is an effective embolic agent for fibroid embolisation and achieves an infarct rate non-inferior to established embolics.
