Neuroform Stenting in Acutely Ruptured Aneurysms

Michael Horowitz, M.D.
Pittsburgh, PA
Thanks to my co-authors
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Tudor Jovin, M.D.
Ajith Thomas, M.D.
Nirov Vora, M.D.
Rishi Gupta, M.D.
Amin Kassam, M.D.
Elad Levy, M.D.
Yacov Gologorski, M.D.
Narenda Panapitiya, B.S.
Elizabeth Crago, R.N., B.S.N.
Allison Hricik, M.S.
Kimberly Lee, R.N., B.S.N
Matthew Gallek, R.N., B.S.N.
UPMC Experience
 2004- April 2007
 415 aneurysms treated endovascularly
 March 2004 – March 2007
 130 aneurysms treated with Neuroform (31%)

41 aneurysms treated acutely following SAH
Demographics
 41 ruptured aneurysms treated with Neuroform
 Male
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16
Female
24
Size
3-32mm (mean 7.5)
Murphy’s tits 46%
98% treated within 24 hours of ictus (40/41)
2% treated within 48 hours of ictus (1/41)
6 patients with multiple aneurysms (15%)
1 patient with multiple aneurysms had two treated at same
procedure
Aneurysm Size
Size (mm)
N
%
1-10 mm
30
73%
11-25 mm
10
24%
>25 mm
1
3%
Hunt and Hess
Hunt and Hess Score
N
%
1
6
15%
2
3
8%
3
13
32%
4
16
40%
5
2
5%
Aneurysm Location
Aneurysm Location
N
%
Basilar Apex
9
22%
Posterior Communicating
9
22%
Middle Cerebral Bifurcation 4
10%
Vertebral Confluence
4
10%
Posterior Inferior Cerebellar
4
10%
Internal Carotid Bifurcation
2
5%
Ophthalmic
2
5%
Anterior Communicating
1
2%
Anterior Cerebral A1
1
2%
PericallosalCallosomarginal
1
2%
Anterior Choroidal
1
2%
Superior Cerebellar
1
2%
Basilar Trunk
1
2%
Superior Hypophyseal
1
2%
Anticoagulation
 97.5% of patients received anticoagulation with some form of
anticoagulant and/or antiplatelet during and/or after the procedure
 Heparin
3000-8000 units (mean 5151U; median 5000U)
 Integrilin
15 mg IV bolus
 Integ(post) 120 micrograms/kg
 Plavix
600 mg load; 75 mg/day
 ASA
81-325 mg/day
Anticoagulation
Heparin
during
procedu
Integrilin
during
procedu
Integrilin
post
procedu
Heparin post
procedu
Plavix post
procedu
Aspirin post
procedu
Heparin +
Antiplat
N = 40
N = 32
N=1
N = 24
N = 22
N = 32
N = 35
97.5%
78%
2.4%
59%
54%
78%
88%
Intraprocedural Events
 12% risk of aneurysm rupture (5/41)
 5% (2/5) risk during diagnostic angio (no anticoag)
 7% (3/5) risk during coil insertion (heparin+/- Integrilin)
 10% (4/40) thromboembolic events during procedure
 1 (2.3%) clinically significant stroke from TE event
Procedural Rupture Rates
 Cloft et al. published meta-analysis of intraprocedural
aneurysm perforation
 Perforation significantly higher in ruptured vs.
unruptured patients (4.1% vs. 0.5%)
Procedural Rupture Rates
 Ross et al. reviewed their 3 year history of endovascular
embolizations
 Aneurysm rupture/perforation rate significantly higher in ruptured
vs. unruptured (9% vs. 0%)
 Ng et al. published their complications during the coiling
of 81 ruptured and 63 unruptured aneurysms
 Procedure related rupture significantly higher in ruptured vs.
unruptured (16% vs. 1.3%)
 Ricolfi et al. published their complications during the
coiling of 91 ruptured aneurysms
 Procedure related rupture was 4.4%
Study
Ours
Intraprocedural
Aneurysm
Perforation/Rupture
(Ruptured aneurysms)
7%
Ross et al.
9%
Ng et al.
16%
Ricolfi et al.
4.4%
Post Procedure Hemorrhage and Stroke
 5% procedural or post procedural non-aneurysmal
hemorrhages (2/40)
 1 PCA perforation
 1 diffuse multifocal hemorrhage
 12.5%(5/40) ischemic strokes
 5%(2/5) had hemorrhagic conversion
 7.5%(3/5) had bland infarcts
Combined Stroke Rate
(Procedural and Post-procedural)
 3 aneurysms perforations plus
 1 PCA perforation plus
 1 diffuse multifocal hemorrhage plus
 5 ischemic strokes
 10 strokes total (25%; 10/40)
Thromboembolic Events
 Symptomatic TE rate in largest series of ruptured
aneurysms without use of a stent ranges from 4.7% 14.5% with an average of 8.5%.
 Ross et al. noted TE risk in ruptured and unruptured
aneurysms was 11.3% vs. 2.6%
Ischemic Strokes and Relationship to
Medications
 33% (2/6) ischemic strokes occurred in patients
who had not received Integrilin during procedure.
Both were bland.
 Both patients either did not receive heparin during
procedure or had it reversed with no subsequent
medications
 50% (3/6) of ischemic stroke patients received
heparin and antiplatelet meds during and after
procedure.
 1/3 bland
 2/3 hemorrhagic
Stroke Patients
Patient
HH
GOS
MRS
Aneurysm
An Size
Stent Loc
Stroke Etiol
Stroke Type
Anticoag Regimen
1
2
1
6
BA
10
BA-L PCA
PCA perf
Hem
H/Int/H/Pl/ASA
2
4
4
3
R fus MCA
20
R M1-M2
Non st M2 occl
Isch/bland
None
3
1
4
3
L SCA
7
BA-L SCA
Thal/Occ lobe
Isch/Hem
H/Int/H/Pl/ASA
4
3
1
6
BA
8
BA-L PCA
Bil PCA str
Isch/bland
H/Int/H/Pl/ASA
5
1
3
4
VA trunk fusi
8
R VA
Diffuse hem
Hem
H/Int/Pl/ASA
6
5
1
6
ICA Bif
32
R ICA- R
MCA
MCA stroke
Isch/Bland
H
7
1
4 (3m)
3 (3m)
BA
10
BA- R PCA
L PCA
L PCA OL
Isch/hem
H/Int/H/Pl/ASA
8
4
1
6
P comm
7
ICA
An Rupture
Hem
H/ASA
9
4
1
6
Vert Confl
9
Vert-BA
An Rupture
Hem
H
10
3
NA
NA
Vert-PICA
7
Vert
An Rupture
Hem
H/ASA
Patients Without Strokes
 75% of patients (30) were stroke free
 93% (28/30) received combinations of heparin,
Integrilin, ASA and Plavix
 7% received heparin during the procedure and ASA
afterwards
 1 patient only received ASA after the procedure
Ventriculostomy
Ventriculostomy
N
Not placed
7 (17.5%)
Placed
33 (82.5%)
Placed Pre-Procedure
Placed During
Procedure
Placed Post Procedure
Replaced During
Procedure
22 (67%)
1 (3%)
10 (30%)
2 (6%)
Ventriculostomy Hemorrhages
 24% incidence of blood along tract
 0% symptomatic
 6% incidence of hematoma
 20 cc asymptomatic
 45 cc symptomatic
 No surgical evacuations needed
Ventriculostomy Placement Timing and
Hemorrhage
 Blood along tract in:
 27% (6/22) of pre-coiling placed ventriculostomies
 20% (2/10) of post-coiling placed ventriculostomies
 0% (0/1) of intra-procedurally placed ventriculostomies
 0% (0/2) of ventriculostomies placed down existing
tracts intaprocedurally
 Hematoma cases occurred in 1 pre and 1 post placed
ventriculostomy. Asymptomatic case was placed post.
Ventriculostomy Hemorrhages
Hematoma
Clinically
Significant
Patient
Tract blood
HH
GOS
MRS
Anticoagulation
1
X
No
H,I,H,P,A
2
X
No
H,I,H,P,A
3
X
No
H,I,H,P
4
X
No
H,I,H, A
4
X
No
H,I
5
X
No
H,I,
6
X
No
H,I,H,P,A
7
X
No
H,I,H,P,A
P,A
8
45 cc
Yes
2
4
3
H,I,H, A
9
20 cc
No
4
1
6
H,I
A
Ventriculostomy Related Hemorrhages
 27% (9/33) risk of catheter related hemorrage 3%
(1/33) risk of symptomatic hemorrhage
 Others
-meta-analysis shows risk of clinically sig. hematomas
0.5% - 12.5%
Maniker et al. noted 33% risk of hemorrhage
2.5% symptomatic
Extracranial Hemorrhagic
Complications
 10% (4/40) incidence of significant extracranial
hemorrhagic complications
 None treated surgically
 35% incidence of trachestomy (14/40)
 1 epsiode of bleeding from trach site
 33% incidence of GT (13/40)
 No bleeding from GT site
Extracranial Hemorrhagic Complications
Patient
Groin
Hematom
Retroperiton
Hematom
GI Bleeding
Anticoag
Stroke
Ventric
Bleeding
1
X
X
X
H,I,H,P,A
No
No
2
X
H,I
No
20cc clot
No
No
No
No
3
4
X
H, I
X
A
H,I,H,P,A
Immediate Angiographic Outcomes
Immediate Angiographic Results
N
%
Category 1 (no post coiling opacification of aneurysm
11
27%
Category 2 (slight opacification within coil mass interstices; dense coil
pack in all quadrants)
27
66%
Category 3 (residual fundal or neck opacification)
3
7%
Complete Coiling (Category 1)
Interstitial Filling. Near Complete.
Dense Coil with Stagnant Contrast In
Interstices (Category 2)
Incomplete Coiling with Contrast in
Fundus and Incomplete Aneurysm
Packing (Category 3)
Findings and Interpretations
 Intraop Ruptures/Perforations
 3/4 died but these 3 were in high risk patients who had
other negative prognostic factors that may have lead to
poor outcomes for other reasons if approached
exovascularly



Perforation was in 10 mm BA HH2
1 rupture was in 9 mm vert confluence HH4
1 rupture was in P comm HH4
Findings and Interpretations
 The presence of multiple anticoagulants may have
made hemorrhagic conversion of the 5 ischemic
infarcts more likely
 3 bland
 #1
No meds
 #2
H/Int/H/Pl/ASA
 #3
H
 2 hemorrhagic conversions
 #1
H/Int/H/Pl/ASA
 #2
H/Int/H/Pl/ASA
 Incidence of device
related
ischemic strokes was low (12%;
Findings
and
Interpretations
5 cases) and overall outcomes were good. Outcomes in
stroke patients may not have been any different even if
strokes had been avoided due to the nature of the initial
insult or the aneurysms location (making exovascular
therapy difficult)
 1 patient with ischemic stroke died but presented HH 5 so would
likely have not survived the initial SAH with or without a
complication
 3 patients with ischemic strokes had GOS 4 and MRS 3 at follow-up

These 3 presented with aneurysms that are difficult to treat exovascularly
in the setting of SAH making GOS and MRS outcomes acceptable



10 mm BA
GOS4, MRS3
7 mm SCA
GOS4, MRS3
20 mm fusiform MCA; HH4 GOS4, MRS3
Findings and Interpretations
 No elevation of hemorrhage rate in our series despite
anticoagulation with heparin and antiplatelet in 100% of
our patients with ventriculostomy insertion before, during,
or after the procedure
 Ventriculostomy insertion in this series showed 25% incidence of
blood on CT and 3% incidence of clinically significant hemorrhage
 Accepted published literature for ventriculostomy hemorrhagic
complication rate is 33% incidence of blood on CT and 2.5%
clinically significant hematoma (Maniker A, et al. Neurosurgery
59[ONS Suppl 4]:ONS-419-ONS-425, 2006)
Findings and Interpretations
 No clinically significant extracranial hemorrhagic
complications in terms of GI bleeds, retroperitoneal
bleeds, groin hematomas, tracheostomy site bleeds, Gtube site bleeds, or shunt bleeds
 7 identified episodes
 No surgical intervention required
Findings and Interpretations
 Immediate post-coiling angiographic results were
good thus justifying use of stent
 93% complete or near-complete occlusion
 No re-hemorrhage
 Does this mean we should use stents in all aneurysms?
 I believe it does, but to justify this medicolegally and
financially a large scale review on safety and efficacy is
needed.
Justification for Use of Stents in Acutely
Ruptured Aneurysms
 Ultimate goal must be total occlusion
 Incomplete occlusion significantly increases risk of delayed
hemorrhage
 In ISAT, 7/10 patients who rebled within 30 days were judged to have
incomplete aneurysm occlusion
 In the ISAT f/u, 6/8 patients who rebled over a year after coiling
showed incomplete occlusion on 6 month f/u DSA
 Sluzewski et al. showed that all 5/393 patients who rebled after
coiling of ruptured aneurysms had subtotal occlusion or evidence of
recurrence
 2143 patients randomized to clipping or coiling
 In the coiling group, 7/10 patients who rebled within
30 days were judged to have incomplete aneurysm
occlusion
 1 year outcomes for 1063 patients allocated to
endovascular treatment
 In the coiling group, 6/8 patients who rebled over a
year after coiling showed incomplete occlusion on 6
month f/u DSA
 1001 patients with a mean of 4 years f/u
 Degree of aneurysm occlusion was strongly
associated with risk of rerupture P<0.0001
 The risk of re-rupture of aneurysms with <70%
occlusion approximated the risk of re-rupture in
historically untreated aneurysms
Summary Important Findings
 Anticoagulation needs surrounding stenting may not increase

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


consequences of intracranial hemorrhage following SAH
Anticoagulation may not increase risk of or clinical significance of
ventriculostomy related hemorrhages
Ventriculostomy insertion before or after coiling and stenting may not
matter in terms of complications
Non-cranial hemorrhage rates may not be exacerbated by use of
anticoagulation surrounding stenting
Anticoagulation may increase risk of hemorrhagic conversion of ischemic
infarcts
Stents may significantly improve early coiling angiographic results in
ruptured aneurysms (and as an extension unruptured aneurysms as well)
Strokes are not uncommon during stenting and coiling in ruptured
aneurysms
Strokes during coiling and stenting of ruptured aneurysms and the effects
of such events may be an even trade off with the expected complications of
exovascular therapy for poor grade, difficult to clip lesions (posterior
circulation, wide necked, HH 4-5)
Stents vs. Balloon Remodeling
 Balloon remodeling is another option to aid in the
treatment of wide neck aneurysms
 However, this technique carries its own significant risk
 118 patients undergoing 126 endovascular treatment
sessions
 12.5% risk of aneurysm perforation or rupture
 8/11 (72%) occurred during use of balloon remodeling
device
 681 consecutive patients presenting with a
ruptured aneurysm treated via endovascular
approach
 The use of a temporary supporting balloon was the
only significant risk factor for procedural
complications
 20% of patients treated with balloon remodeling
suffered procedure related death or disability
 499 patients randomized to endovascular treatment
with bare platinum coils or the HydroCoil
 Greater trend towards procedural adverse events with
use of assist devices
 the use of balloons/other assist devices conferred greater
risk than stents

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30% in control group
24% in HydroCoil group
Critical Question At This Time
 Does it matter that we prove that coils with stents are
the ideal therapy combination?
 How much longer will we be using coils as primary
therapy?
 Key question is neck control and inflow control in
ruptured and unruptured aneurysms.
Who is betting on coils?