Transcript UAE: Stasis vs. Pruning

UAE: Does the choice of
embolic matter?
John C. Lipman, MD, FSIR
Atlanta Interventional Institute
Marietta, Georgia
In Conclusion
•Yes
Why does embolic choice matter?
• Successful long-term outcome is defined by:
– Symptom control
– No recurrent growth of fibroids.
• Imaging documentation by contrast-enhanced MRI.
– Absence of re-interventions
• Fibroids need to completely infarct to avoid
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recurrence.
Technical goal of UAE is to infarct all the fibroids.
Causes For UAE Failure
• 1. Technique issues
• 2. Collateral supply
• 3. Choice of embolic
Perfusion of fibroids after UAE:
predictor of outcome
• DeSouza (Rad 2002 (2); 222: 367-74): perfusion of
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myometrium & dominant fibroids pre & post UAE
(1mo/4mo).
Pelage (SIR ’05 abstract)
-79 women with MRI @ 24’, 6m,12m, 24m.
-Those completely infarcted @ 24’ stayed infarcted.
-This group had significant clinical improvement vs.
incompletely infarcted group.
-No difference in uterine & dominant volume reduction
between groups.
No Symptom Recurrence
Complete Fibroid Infarction
Baseline
3 Months
1 Year
2 Years
3 years
Early Recurrence
Incomplete Fibroid Infarction
Recurrent symptoms at 2.5 years post-embolization (Radiology
2004;230:803-9).
Pre
3 mo
1 year
2 years
3 years
4 years
Late Recurrence
Old and New Fibroids
Baseline
4 Months
26 Months
46 months
Currently materials in use in United
States and Europe
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Particle PVA (Contour, other brands)
Tris-acryl Gelatin Microspheres (Embospheres)
Tris-acryl Gelatin Microspheres AU (Embogold)
Spherical PVA (Contour SE)
Spherical PVA hydrogel (Bead Block)
Gelatin sponge (Gelfoam)
Particle PVA (Contour, others)
• Longest use of any product.
• Relatively inexpensive.
• Hard to inject, can easily clog
microcatheters.
• Initial experience in UAE all based on
particle PVA.
• Early suspicions that PVA caused more
pain than necessary.
Embosphere® Microspheres
• First embolic to win FDA clearance specifically for uterine
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embolization.
Easy to inject.
Demonstrated effective in randomized comparison to
particle PVA.
More expensive than particle PVA.
Allows easier control over endpoint (more gradual
occlusion).
Believed to cause less pain than PVA (anecdotal). Papers
by Ryu, Spies showed no difference.
Imaging Outcome after TAGM
• Banovac (Spies) JVIR ’02; 13: 681-7.
• -61 fibroids, 23 pts.
• -Pre & 3-4 month post MRI.
• -54/61 (89%) & 21/23 dominant (91%)
were completely devascularized.
PVA Particles vs Embospheres
• Randomized comparison study of
embolics*.
• 100 subjects (54 TAGM, 46 PVA)
• Outcome measures:
– Short-term pain (VAS scale), recovery
– Symptom, quality of life change 3 months
– Imaging outcome at 3 months.
*Spies JB, et al. Polyvinyl Alcohol Particles and Tris-acryl gelatin Microspheres for Uterine
Artery Embolization for Leiomyomas:Results of a Randomized Comparative Study. J Vasc
Intervent Radiol 2004;15;793-800.
TAGM vs. PVA
• Statistically significant : TAGM more cc used (9.4
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vs 3 cc), PVA higher cath occlusion (28% vs
4%). TAGM had higher symptom score change
(started off worse). PVA had more complete
infarction of dominant fibroid (95% vs 82%).
Equivalent: Spasm rate, pain scores 1wk & 3m,
narcotic requirements, symptom scores 1wk &
3m. Qof L total score. Amenorrhea rate.
Trend: More uninfarcted nondominant fibroids
with PVA (20% vs. 8%).
Results
Procedure Details
Mean (SD)
Total
TAGM
PVA
P-value
Fluoro time (min)
16.8 (7.0)
17.9 (5.5)
15.5 (8.3)
0.09
Embolic vol. (cc)
6.4 cc (5.4)
9.4 (5.7)
3.0 (1.6)
0.0001
Frequency of spasm
(>1)
31%
28%
35%
0.45
Frequency of OA
flow (>2)
14%
9%
20%
0.14
Frequency of
catheter occlusion
15%
4%
28%
0.001
Results
Short-term Outcomes
Mean (SD)
Total
TAGM
PVA
P-value
Max VAS
3.0 (2.6)
3.0 (2.5)
3.1 (2.7)
0.87
Max VAS week 1
4.9 (2.5)
4.9 (2.6)
4.9 (2.3)
0.99
PCA dose attempts
70.6 (65.8)
70.4 (63.3)
70.8 (69.4)
0.98
PCA doses given
28.8 (16.0)
29.8 (17.7)
27.6 (13.8)
0.50
46.7 (34)
49 (35)
44 (34)
0.55
Percocet (N)
10.7 (11.4)
10.3 (12.6)
11.1 (10.0)
0.75
Max Temp
37.4 (0.5)
37.4 (0.5)
37.5 (0.4)
0.28
26.6 (16.4)
27.1 (15.9)
26.1 (15.9)
0.77
Total PCA (mg)
Symptom Score Wk 1
Results
3 Months
Mean (SD)
TAGM
PVA
P-Value
Bleeding Score Change
3.2 (1.9)
3.3 (1.5)
0.77
Pain Score Change
3.3(2.0)
3.4 (1.4)
0.77
UFS-QoL Symptom Score
21.3 (14.8)
23.4 (18.5)
0.55
UFS-QoL Symptom Score
Change
-39.2 (24.3)
-26.8 (24.9)
0.02
UFS-QoL Total Score
81.9 (15.7)
80.9 (18.8)
0.80
UFS-QoL Total Score Change
36.0 (25.5)
23.1 (23.4)
0.02
2%
2%
0.74
Freq. Of Amenorrhea
Results
Imaging Outcome
TAGM
PVA
P-value
Uterine Volume change
35%
31%
0.20
Fibroid Volume change
56%
42%
0.01
Uninfarcted area in dominant
fibroids %
18%
5%
0.02
Uninfarcted area in other
fibroids %
8%
20%
0.13
Contour SE
• Marketed as a Embospheres-like sphere made of PVA.
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Easy to inject.
Specific-label approval by FDA for uterine embolization.
Questions have arisen about effectiveness
Repeated study for sPVA vs Embospheres*
– Randomized to either embolic
– Patient, research nurse blinded to embolic
– Review of pre and post embo MRIs blinded to
embolic.
* Spies JB, et al. Spherical Polyvinyl Alcohol versus Tris-acryl Gelatin Microspheres for
Uterine Artery Embolization for Leiomyomas: Results of a Limited Randomized Comparative
Study. J Vasc Intervent Radiol, in press.
Results
• 36 patients enrolled: 17 with Contour SE and 19 with
Embospheres.
– Enrollment stopped based on initial findings.
• No difference in short-term measures.
• Embospheres advantage quality of life scores at 3
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months. (91.9 vs 78.1, p= 0.02).
Among 19 patients with imaging follow-up, Contour less
likely to infarct all fibroids (1 of 14 for Contour vs 6 of 11
for Embospheres, P= 0.02).
Contour SE had greater percent unifarcted (mean 48%
for Contour SE vs 5% for Embospheres, P<0.001).
sPVA 90% uninfarcted
Pre
Post
Embosphere 30% uninfarcted
Pre
Post
sPVA vs. PVA
• Levin SIR ’05 presentation:
• -23 pts. 500-700 sPVA and 23 350-500 PVA.
• -Similar baseline ut. volumes, # or size of
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fibroids.
-?embo light or stasis.
-sPVA: 3.7 x more likely to have persistently
enhancing fibroids than PVA.
-(Ut. size avg. decrease of 16% sPVA & 28%
PVA)
sPVA
• Siskin, SIR’05 presentation:
• -124 pts but only 69 had MRI.
• -500-700m sPVA to complete stasis.
• -100% infarction in only 35/69 (51%).
Initial Conclusions
• Short term imaging outcome shows frequent
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poor results from sPVA.
Difference statistically significant (Spies data),
although still a small sample.
Likely mechanism is redistribution after
embolization.
Primary Contour size was 500-700. Larger size
embolic may be more effective, although no
published data to support (Pelage unpublished
data).
Refined Protocol for sPVA
• Unpublished data Pelage, SIR ’05 presentation
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that followed Levin:
-2 groups of 23 pts.
-Grp 1: sPVA, 500-700m, “embo light”
-Grp 2: sPVA, 700-900m & up, embo to stasis
(Increase UA viz 510 cardiac beats & leave
catheter in place for 5’ & re-check)
-19/23 (83%) complete fibroid infarction in grp
2 vs. only 2/23 (9%) in grp 1.
Bead Block
• Similar to spherical PVA.
• No clinical studies demonstrating its
effectiveness compared to other materials.
• Terumo IR Survey: 312 IR professionals
polled @ SIR 2005, 72% said that Bead
Block is superior to other embolics (26%
same, 2% inferior).
Bead Block
(con’t)
• No published studies on its effectiveness.
– (Kroencke ISET ’05 presentation: 42 pts, 500-700m
up to 6cc then upsize, “embo light” initially then
extended study to increase infarction rate by
changing to near stasis and upsizing. 74% had 90100% infarction).
• Given concerns regarding spherical PVA, careful
assessment of the extent of fibroid infarction
with contrast-enhanced MRI essential.
Gelfoam
• Essentially no published data on its effectiveness.
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– Abstract by Katsumori et al SIR ‘05 in long-term
outcomes. 85 pts (17 lost to f/u, similar symptom
control, somewhat less failure @ 5 yr (11.5 vs. 20%).
No data to support contention that since it is temporary
agent it is better for patients interested in pregnancy (2
pts pregnant, both miscarried).
– May be as likely or more to result in uterine artery
occlusion than other materials.
Needs further study.
Embogold
• Essentially the same as Embospheres but with
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elemental gold added.
Likely same effectiveness profile as
Embospheres.
Associated with recurrent pain, low grade fevers
and rash in higher than expected number of UAE
patients.
No longer recommended by manufacturer for
UAE.
Should not be used for UAE.
Conclusions
• In early years of UAE, there was little data to
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suggest that the embolic type impacted
outcome.
Recent experience with newer embolics suggests
that embolic characteristics do impact
effectiveness through incomplete fibroid
infarction.
Prior to acceptance of new embolics, need
quality imaging data with follow-up contrastenhanced MRI to insure complete fibroid
infarction.