Click to edit Footer title style Randomized Trial of Bead Block TM vs Embosphere TM for UAE for...
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Transcript of Click to edit Footer title style Randomized Trial of Bead Block TM vs Embosphere TM for UAE for...
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Randomized Trial of Bead BlockTM vs EmbosphereTM for
UAE for Fibroids
Robert L Worthington-Kirsch, MD,
FSIR, FCIRSE, RVT, RPVI
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Disclosures
This study is supported by an unrestricted grant from Biocompatibles and Terumo
Dr Worthington-Kirsch is an active consultant to Biocompatibles, Terumo, Biosphere Medical, and Vascular Solutions
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Background
UAE has been established as mainstream therapy for fibroid diseaseEmbolic choice evolving
Calibrated hydrogel spheres preferredTris-acryl/gelatin most commonly usedPVA hydrogel is an emerging alternative
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PVA Hydrogel Spheres
Very similar to soft contact lensesPVA has been used as implanted biomaterial since the 1940sVery different properties than non-hydrogel PVA preparations
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Study Rationale
Clinical experience suggests that BB as effective as ES for UAE
Requires proper technique
Randomized trial needed to confirm or disprove anecdotal experience
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Study Design
Non-inferiority22 patients per arm gives desired power
PRCT (Level I data)Patients not informed about embolic usedMRI grader blinded for embolic used
Reviewed/approved by FDA
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Admission Criteria
Similar to other UAE studiesWomen ages 30-50Symptomatic fibroids without other uterine diseaseUterus >250cc, <24 weeks
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Study DesignMRIs on designated magnet
Pre-UAE, 3-7 days post-UAE, 3 months, 6 months
Best protocol for each embolicBB – start with 700-900
ES – start with 500-700, unless Ovarian A seen
Terumo Progreat microcatheter
Consistent defined embolization endpoints
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Embolization Endpoints
New filling of Ovarian A or cross-uterine collateralsRetrograde flow around catheter tip“Plumping” of artery with injectionNo further filling of ascending branch
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Outcome Measures
MRI fibroid perfusion“immediate”, 3 months, 6 months
Uterine/dominant fibroid sizeUFS-QOL
3 months, 6 months, 1 year
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Study to Date2 cohorts
Site 1 – 22 patientsComplete follow-up data set 1 technical failure (anatomic basis)
Site 2 – 22 + 2 patients1 withdrawal from initial 22Follow-up complete except for 12 month QOLs
22 analyzable patients in each arm
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Study to Date
No serious complications
All UAEs clinically successful per patients
Including technical failure3 “failures” to discuss in more detail
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Study to Date – Follow Up1 Week post-UAE (MRI only) – 43/44 (97%, 1 ES)
3 Mo post-UAEMRI – 36/44 (82%, 5 ES, 3 BB)
QOL – 39/44 (88%, 3 ES, 2 BB)
6 Mo post-UAEMRI – 37/44 (84%, 4 ES, 3 BB)
QOL – 43/44 (97%, 1 BB)
12 Mo post UAE (QOL only) – 21/21
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MRI GradingPre-UAE perfusion scored at 10
Global fibroid burden, not just dominant fibroid
Follow-up perfusion scored 1-101 – Complete infarction all visible fibroids
1-2 - “Success” (10% or less residual perfusion)
3-4 – “Partial Success” (11-30% residual perfusion)
5 or higher - “Failure” (>30% residual perfusion)
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UFS-QOL Grading
Symptom Score, QOL Score. QOL Subscales
Change of 10 points or greater significant
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Treatment Failures?
Patient # 2-003Embosphere
Complete infarction at 1 week and 3 months
Significant reperfusion (4) at 6 months
SS 94>44>0
QOL 86>89>96
Will symptoms recur?
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Treatment Failures?
Patient # 2-016Bead Block
Almost complete infarction (2) on all f/u MRIs
SS 41>69>66 (worsening)
QOL 66>50>52 (borderline improvement)
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Treatment Failures?
Patient # 2-013Embosphere
Perfusion score 3 @ 1 week, then 2
SS 47>25>31
QOL 53>56>51
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Treatment Failures?
General consensus in literature is that UAE failure rate is ~10%.
3 Failures out of 44 patients is not unexpected.
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Data Supports Noninferiority
UFS - QOLSymptom Severity Student T Sig (=95%)
Baseline .3075 Y
3 Month .2406 Y
6 Month .1289 Y
Overall QOL
Baseline to Baseline .8235 Y
3 Mo BB vs ES .0005 N
3 Mo change .1950 Y
6 Mo BB vs ES .2002 Y
6 Mo change 37252 Y
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Spies – “How to Evaluate New Embolics”
Well–defined inclusion/exclusion criteriaAdequate sample size/power analysisRandomization by independent third partyDouble-blindingIdentical care and follow-up
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Spies – “How to Evaluate New Embolics”
Well–defined inclusion/exclusion criteriaAdequate sample size/power analysisRandomization by independent third partyDouble-blindingIdentical care and follow-up
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Well–defined inclusion/exclusion criteriaAdequate sample size/power analysisRandomization by independent third partyDouble-blindingIdentical care and follow-up
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Well–defined inclusion/exclusion criteriaAdequate sample size/power analysisRandomization by independent third partyDouble-blindingIdentical care and follow-up
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Well–defined inclusion/exclusion criteriaAdequate sample size/power analysisRandomization by independent third partyDouble-blindingIdentical care and follow-up
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Well–defined inclusion/exclusion criteriaAdequate sample size/power analysisRandomization by independent third partyDouble-blindingIdentical care and follow-up
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Intention to treat analysisBlinded imaging assessmentClear endpoint assessmentUFS-QOL, Enhanced MRIReporting
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Intention to treat analysisBlinded imaging assessmentClear endpoint assessmentUFS-QOL, Enhanced MRIReporting
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Intention to treat analysisBlinded imaging assessmentClear endpoint assessmentUFS-QOL, Enhanced MRIReporting
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Intention to treat analysisBlinded imaging assessmentClear endpoint assessmentUFS-QOL, Enhanced MRIReporting
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Intention to treat analysisBlinded imaging assessmentClear endpoint assessmentUFS-QOL, Enhanced MRIReporting
Click to edit Footer title style
Spies – “How to Evaluate New Embolics”
Intention to treat analysisBlinded imaging assessmentClear endpoint assessmentUFS-QOL, Enhanced MRIReporting