UAE: Does the choice of embolic matter?

1
UAE Does the choice of embolic matter?

• John C. Lipman, MD, FSIR
• Atlanta Interventional Institute
• Marietta, Georgia

2
In Conclusion

• Yes

3
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
  recurrence.
• Technical goal of UAE is to infarct all the
  fibroids.

4
Causes For UAE Failure

• 1. Technique issues
• 2. Collateral supply
• 3. Choice of embolic

5
Perfusion of fibroids after UAE predictor of
outcome

• DeSouza (Rad 2002 (2) 222 367-74) perfusion of
  myometrium dominant fibroids pre post UAE
  (1mo/4mo).
• Pelage (SIR 05 abstract)
• -79 women with MRI _at_ 24, 6m,12m, 24m.
• -Those completely infarcted _at_ 24 stayed
  infarcted.
• -This group had significant clinical improvement
  vs. incompletely infarcted group.
• -No difference in uterine dominant volume
  reduction between groups.

6
No Symptom Recurrence Complete Fibroid Infarction
3 Months
1 Year
2 Years
3 years
Baseline
7
Early Recurrence Incomplete Fibroid
InfarctionRecurrent symptoms at 2.5 years
post-embolization (Radiology 2004230803-9).
Pre
3 mo
1 year
2 years
3 years
4 years
8
Late RecurrenceOld and New Fibroids
46 months
26 Months
4 Months
Baseline
9
Currently materials in use in United States and
Europe

• 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)

10
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.

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Embosphere Microspheres

• First embolic to win FDA clearance specifically
  for uterine 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.

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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.

13
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 LeiomyomasResults of a
Randomized Comparative Study. J Vasc Intervent
Radiol 200415793-800.
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TAGM vs. PVA

• Statistically significant TAGM more cc used
  (9.4 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).

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ResultsProcedure 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 (gt1) 31 28 35 0.45
Frequency of OA flow (gt2) 14 9 20 0.14
Frequency of catheter occlusion 15 4 28 0.001
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ResultsShort-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
Total PCA (mg) 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
Symptom Score Wk 1 26.6 (16.4) 27.1 (15.9) 26.1 (15.9) 0.77
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Results3 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
Freq. Of Amenorrhea 2 2 0.74
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ResultsImaging 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

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Contour SE

• Marketed as a Embospheres-like sphere made of
  PVA. 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.

20
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
  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,
  Plt0.001).

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sPVA 90 uninfarcted
Pre
Post
22
Embosphere 30 uninfarcted
Pre
Post
23
sPVA vs. PVA

• Levin SIR 05 presentation
• -23 pts. 500-700 sPVA and 23 350-500 PVA.
• -Similar baseline ut. volumes, or size of
  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)

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sPVA

• Siskin, SIR05 presentation
• -124 pts but only 69 had MRI.
• -500-700m sPVA to complete stasis.
• -100 infarction in only 35/69 (51).

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Initial Conclusions

• Short term imaging outcome shows frequent 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).

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Refined Protocol for sPVA

• Unpublished data Pelage, SIR 05 presentation
  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.

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Bead Block

• Similar to spherical PVA.
• No clinical studies demonstrating its
  effectiveness compared to other materials.
• Terumo IR Survey 312 IR professionals polled _at_
  SIR 2005, 72 said that Bead Block is superior to
  other embolics (26 same, 2 inferior).

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Bead Block (cont)

• 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
  90-100 infarction).
• Given concerns regarding spherical PVA, careful
  assessment of the extent of fibroid infarction
  with contrast-enhanced MRI essential.

29
Gelfoam

• Essentially no published data on its
  effectiveness.
• Abstract by Katsumori et al SIR 05 in long-term
  outcomes. 85 pts (17 lost to f/u, similar symptom
  control, somewhat less failure _at_ 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.

30
Embogold

• Essentially the same as Embospheres but with
  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.

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Conclusions

• In early years of UAE, there was little data to
  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 contrast-enhanced MRI
  to insure complete fibroid infarction.