A retrospective cohort study comparing a novel, spherical, resorbable particle against five established embolic agents for uterine fibroid embolisation
A retrospective cohort study comparing a novel, spherical, resorbable particle against five established embolic agents for uterine fibroid embolisation
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 (χ
2), 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% (χ
2=3.92, p=0.56) or AF% (χ
2=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.
452-457
Maclean, D
3f429b47-ac02-4568-af31-6b9d5927371a
Vigneswaran, Ganesh
4e3865ad-1a15-4a27-b810-55348e7baceb
Bryant, Timothy
05bd12ef-e864-450e-96f5-addcc60c173d
Modi, Sachin
caef086a-dda5-418a-ada8-fc042e6e0b18
Hacking, N
b6287f0b-1b80-49a6-a01a-f52f9da671c8
1 June 2021
Maclean, D
3f429b47-ac02-4568-af31-6b9d5927371a
Vigneswaran, Ganesh
4e3865ad-1a15-4a27-b810-55348e7baceb
Bryant, Timothy
05bd12ef-e864-450e-96f5-addcc60c173d
Modi, Sachin
caef086a-dda5-418a-ada8-fc042e6e0b18
Hacking, N
b6287f0b-1b80-49a6-a01a-f52f9da671c8
Maclean, D, Vigneswaran, Ganesh, Bryant, Timothy, Modi, Sachin and Hacking, N
(2021)
A retrospective cohort study comparing a novel, spherical, resorbable particle against five established embolic agents for uterine fibroid embolisation.
Clinical Radiology, 76 (6), .
(doi:10.1016/j.crad.2021.01.012).
Abstract
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 (χ
2), 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% (χ
2=3.92, p=0.56) or AF% (χ
2=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.
More information
Accepted/In Press date: 18 January 2021
e-pub ahead of print date: 23 February 2021
Published date: 1 June 2021
Identifiers
Local EPrints ID: 448757
URI: http://eprints.soton.ac.uk/id/eprint/448757
ISSN: 0009-9260
PURE UUID: c5057915-f488-43b4-85be-85be006665de
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Date deposited: 05 May 2021 16:30
Last modified: 17 Mar 2024 06:29
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Author:
D Maclean
Author:
Timothy Bryant
Author:
Sachin Modi
Author:
N Hacking
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