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Aneurysm Coiling and
Flow Diverters
Italo Linfante MD, FAHA Director
Endovascular Neurosurgery
Baptist Neuroscience Center
Baptist Cardiac and Vascular Institute
Cerebral Aneurysms
TREATMENT
Traditional Surgery
Microsurgical
Clipping
Endovascular Embolization
Multicentric prospective RCT
comparing Endovascular
coiling and Neurosurgical
clipping for ruptured intra-
cerebral aneurysms.
Lancet. 2002;360:1267–1274
Funding agencies: UK Medical Research Council
Canadian Institute of Health Research
French Health Ministry
Stroke Association of the UK for
Neuropsychological assessments
ISAT ISAT was a randomized controlled trial of
patients with aSAH
2143 patients with ruptured intracranial
aneurysms randomly assigned to MC and
ET
95% of the aneurysms were < 10 mm in
size and 54% were < 5 mm in size.
Primary outcome at 1 year n=1528
Endovascular Neurosurgical
0
20
40
60
80
100
0-no symptoms
1-minor symptoms
2-some restriction
3-significant
restriction
4-partly dependent
5-fully dependent
6-dead
Pro
portio
n (%
)
Treatment allocation
p value for 0-2 vs 3-6=0.00082 2 for trend = 11.4
p=0.00075
Long-term ISAT
• Early survival advantage of endovascular maintained to 7 years and remained significant
• In SAH coiling results in absolute reduction in the risk of death or dependency of 7.4% compared to clipping
• Non significant increased risk of hemorrhage in endovascular group (0.2;0.1)
Lancet 2005 3-9;366:809-17
AJNR Procedural Complications of Coiling of
Ruptured Intracranial Aneurysms:
Incidence and Risk Factors in a
Consecutive Series of 681 Patients
W.J. van Rooija, M. Sluzewskia, G.N. Beuteb and P.C.
Nijssenc
Complications for Coiling of
Ruptured Aneurysms
Complications 40 of 681 patients 5.87%
Death in 18 patients 2.6%;
Disability in 22 patients 3.2%; 95% CI, 2.0% to
4.9%).
There were 8 procedural ruptures
The use of a temporary supporting balloon was
the only significant risk factor (OR, 5.1; 95% CI,
2.3 to 15.3%) for the occurrence of procedural
complications.
58 yo woman with SAH
Balloon assisted coil embolization
12 months f/u months angiography
73 year old with ICH and SAH (AP view 66 yo with right HP
)
3D
R MCA (M1)
R MCA (M2)
R MCA (M2)
Final (AP view)
Final ( unsubtracted AP view)
Unruptured Aneurysms
Hospital Mortality and Complications of
Electively Clipped or Coiled Unruptured
Intracranial Aneurysms
Amer Alshekhlee, Sonal Mehta, Randall C. Edgell, Nirav Vora, Eli Feen, Afshin
Stroke 2010, 41:1471-1476:
Clip vs Coil
National Inpatient Sample database for the years
2000 through 2006
3738 (34.3%) clipping 3498 (32.1%) coiling
Hospital mortality higher with clipping 60
(1.6%) vs 20 (0.57%) (p=0.001)
Hospital Stay: longer with clipping (4 vs 1 day;
p=0.0001), incurring a higher hospital charges
($42,070 vs $38,166; P=0.0001)
Clip vs Coil
Perioperative intracerebral hemorrhage and acute
ischemic stroke were higher in the clipped
population.
The rate of hospital use of coil embolization has
increased over the years (P = 0.0001)
61 yo man with headaches
Bioactive coils
3D 6 m follow-up angiograms
12 month f/u
Wide Neck Aneurysms
Neurostents Design
68 yo w fusiform left MCA aneurysm
3D
Stent assisted coil embolization
Before
1 year follow-up
First stent
Second stent
Reconstruction of the ICA with 2 stents
Final Post Coil Embolization
One Year F/U Angiography
Closed-Cell Stent for Coil Embolization of
Intracranial Aneurysms: Clinical and
Angiographic Results
Wakhloo AK, Linfante, Silva C, Dabus G,Segal E, Samaniego E,
Gounis M
Stent Assisted Coil
Embolization • 147 consecutive patients in 2 centers with 161 wide-neck
ruptured and unruptured
• Procedure-related mortality 2 patients (both
ruptured)(1.4%)
• Permanent neurological deficits 5 patients (3.4%),
respectively
• Follow-up angiography showed recanalization occurred in
12 aneurysms (10%), requiring retreatment in 7 (5.8%)
• Moderate in-stent stenosis 1 (0.8%), which remained
asymptomatic
Complications No (%)
Intraop. Thrombus* 7.4%
Intraop. Perforation
1.4%
TIA 2.2%
Minor Stroke 3.0%
Major Stroke 2.2%
Access Site 3.5%
Deaths^ 3.0%
0 2 4 6
Results: Montreal Shift
Although post-procedure shows many Class II
and III results (pts on ASA, Plavix, and Heparin)
– follow-up shows mostly Class I
16% 82%
Scale defined in: D Roy, G Milot, & J Raymond. Stroke 2001; 32:1998
Class III:
23% Class I: 48% Class II: 29%
2%
Flow Diversion
Flow Diversion
Disruption of the fluid momentum
transfer from the parent vessel into
into the aneurysmal sac
Endothelial growth
Particle Image Velocimetry
Side wall aneurysm – Shear-driven Flow (I)
Lieber, Nikolaidis, Wakhloo Ann Biomed Eng 1998
0
1( ) where: ( )
T
m
A
t dt V ndAT
Average hydrodynamic circulation
Convection Diffusion
+ 0
1
2
t
e e t-h (h-m) 2
t1 2s 2
t1
dh sp
- -
* f(t)=r1
1
0
1- 1 t t
e (h-m) 2
t2 2s 2
r2 s 2p
- -
-
dh e
÷ ÷
MATHEMATICAL MODEL
Use of Functional Angiography
s,m = Contrast injection related parameters.
r1 = Relative magnitude of contrast convected out of aneurysm.
t1 = Convection time constant.
r2 = Relative magnitude of contrast diffused out of aneurysm.
t2 = Diffusion time constant.
Lieber, Gounis, Chander, Wakhloo Crit. Rev Biomed Eng 2004
21days
90 days
180 days
Wakhloo et al Stroke 2007
Surpass ltd
Clinical Data
Pipeline
2009 2010 2011 2012 2013 2014 2015
Buenos Aires
Experience
n= 53 patients
12 month follow up
PITA
n=31 patients
6 month follow up
Budapest
Experience
n= 18 patients
6 month follow up
Australian Registry
n=54 patients
Up to 1 year follow up
Ankara
Experience
n=191 patients
Up to 24 months
follow up
Hong Kong
Experience
n=143 patients
Up to 18 months
follow up
PUFs n=108 patients
6 months follow up
IntrePED n=793 patients
12 to 24 month follow up
ASPIRe n=191 patients
7 Years of Publications on
Pipeline™
PUFs (Pipeline™ Embolization
Device for Uncoilable or Failed
Aneurysms) : Results from a Multicenter
Clinical Trial
Tibor Becske et al Radiology 2013;267:858-68
PUFs Aneurysm Characteristics: Size • Prospective, multi-center trial 108 patients
• Large or Giant & Wide-Necked
o ≥10 mm diameter
o ≥ 4 mm neck
|
Mean Size
(mm)
Range (mm)
Aneurysm 18.2 6.2* – 36.1
Neck 8.8 4.1 – 36.1
*One 6.2 mm aneurysm was treated but excluded from
efficacy analysis because <10 mm diameter. PUFs FDA Summary of Safety & Effectiveness Data (SSED)
Endpoints Independently Adjudicated
Core Radiology Lab
3 physicians
Adjudicated all
angiograms
Clinical Events
Committee
3 physicians
Adjudicated all SAEs
EFFECTIVENESS SAFETY
PUFs FDA Summary of Safety & Effectiveness Data (SSED)
PUFs Primary Safety
Endpoint Event Descriptions
Primary Safety Endpoint Event Descriptions* # %
Hemorrhage (parenchymal bleeds not SAH) 2 1.9%
>50% stenosis with major stroke 1 0.9%
Thrombosis with major stroke 2 1.9%
Probable neurologic death** 1 0.9%
Total 6 5.6%
* Safety events that did not result in a major stroke or neurologic death were not classified as primary safety endpoint events.
** Event was classified as probably neurologic death of unknown cause. No head CT or autopsy completed.
PUFs FDA Summary of Safety & Effectiveness Data (SSED)
PUFs Summary • Prospective, multi-center trial 108 patients
• Challenging aneurysm characteristics – 20% giant,
18.2 mm average size
• High rates of occlusion – 82% at 180 days, 86% at
1 year
• Complications – 5.6% rate of major
stroke/neurological death at 180 days
• Approval by the FDA in April 2011
PUFs FDA Summary of Safety & Effectiveness Data (SSED)
International Retrospective Study of the Pipeline
Embolization Device: A Multicenter Aneurysm
Treatment Study (IntrePED)
D Kelmes et al AJNR 2015
Neurological death
0
5
10
15
20
25
30
35
40
24 hr 30 hr 180 days Complete f/up
1.0%
2.9%
3.2% 3.8%
All Patients
Median follow-up 19 months
days
Posterior – 5 Ruptured – 6
Safety Outcome:
Ischemic Stroke
Total
incidence
52/793
(6.6%) Minor
15
(1.9%)
Major
37
(4.7%)
• Anterior location – 33/737 (4.5%) ; Posterior location – 4/56 (7%)
• Outcome of event Resolved – 26 (3.2) ; death – 11 (1.5%)
95% CI [3.3% - 6.4%]
Total M&M
• The overall M&M rate, consisting of major
ischemic stroke, hemorrhage, neurological
death, delayed rupture, stenosis and
permanent cranial neuropathy was 8.3%
(66/793).
Treatment Study % F/u &
Duration
Pts M&M Intracranial
Hemorrhages
Pipeline PUFs 96% /
1 year 107
5.6% 1.9%
Pipeline IntrePED 19.3 mo
median 793
8.3% 2.4%
Stent-Coiling Fiorella et al,
2009
62%
13 mo 284
8.1% 1.4%
Meta- analysis
Stent-Coiling
Shapiro et al,
2012
13 mo
avg
1517 pts (763 pts reported
M&M)
5.3% 2.2%
Safety profile compared to
stent assisted coiling
Clinical History
16 yr old woman developed generalized
tonic clonic seizure
She had associated transient diplopla
without headaches
No significant past medical history
Head CT demonstrated possible brain mass
MRI/MRA brain showed a 30mm LICA
fusiform aneurysm with bony erosion
First PED deployment
Initial Deployment in Distal Left ICA
Pipeline 5.0 x 35mm
Distal end dislodged while trying to free
proximal end to undo twist
Second PED (4.5mm x 35mm)
Third PED 4.5 x 20 mm
Final Angiogram
Immediate Clinical Followup
Occasional headaches after procedure treated
with steroids and tylenol
Partial left 6th nerve palsy with left eye
minimally crossing midline to the left
Small area of visual defect affecting the left
inferior aspect of field of view with
progressive improvement
No other neurological deficits
Clinical History
64 yr old woman with progressive
deterioration of her cognitive functions
On exam is deeply drowsy requiring
intubation
Head CT demonstrated possible brain mass
53 y/o man with a SAH
SCENT Trial
The Surpass intraCranial aneurysm
EmbolizatioN system pivotal Trial to
treat large or giant wide neck aneurysms
Surpass Deployment
Surpass Deployment
Surpass Deployed
Cone beam CT
Final Angiogram
Deployment
5.3mmx50mm
6 month follow-up Pre-Implant
Conclusions
The treatment of intracranial aneurysms is
Endovascular
Overall M&M is inferior to clipping
Undoubtedly, FD is a mayor advancement in
the treatment of large and giant aneurysms,
previously considered “untreatable”
Trials ongoing for small aneurysms