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1
Therapeutic options:
Interventional Neuroradiology
Jan Gralla MD MSc
Inselspital – University of Bern – [email protected]
2
Current protocol of interventional treatment
Which occlusions ?
Which device ?
Protection device ?
Influence of training ?
Time window ?
3
Outcome: 3 months mRS
0 No symptoms at all
1 No significant disability despite symptoms
2 Slight disability
3 Moderate disability
4 Moderate severe disability
5 Severe disability
6 Death
Primary clinical endpoint
4
40%
48%25%
20%0% 40% 60% 80%
R-proUK
N = 121
Placebo
N = 59
35% 25%
27%
100%
MCA-Verschlüsse (M1/M2), 6-Stunden Zeitfenster, NNT = 7
15% Differenz in gutem Outcome
PROACT II Studie
del Zoppo et al. Stroke 1998, Jan;29(1):4-11.
5
Favourable Outcome: 3 months mRS
Individual independent predictors:
• Younger age P<0.0001
• Low NIHSS at presentation P<0.0001
• Peripheral occlusion P<0.0001
• Good piale collaterals P<0.002
• Absence of DM II P<0.002
Therapeutic independent predictors:
• Recanalisation P<0.0001
• Time to recanalisation P<0.0001
• Complications – sICH
Galimanis A et al. Stroke 2012, 43: 1053-1057
Predictors of Outcome
6
5 10 15 20 250
0.2
0.4
0.6
0.8
1.0 226 occlusions
•171 central
•29 peripheral
•26 no occl.
Specificity
Sensitivity
30 35NIHSS on
admission
PPV: 91%
NIHSS and occlusion site
Fischer U et al. Stroke. 2005; 36:2121-5
7Galimanis A et al. Stroke 2012, 43: 1053-1057
Occlusion site and outcome
NIHSS
mRS
8
Time to treatment with intravenous
alteplase and outcome in strokeAn updated pooled analysis of ECASS, ATLANTIS, NINDS, and
EPITHET trials
Lees KR et al. Lancet 2010; 375: 1695-703
9
NNT
0-90 Min. 4.5
90-180 Min 9
180-270 Min 14.1
Time to treatment with intravenous
alteplase and outcome in strokeAn updated pooled analysis of ECASS, ATLANTIS, NINDS, and
EPITHET trials
Lees KR et al. Lancet 2010; 375: 1695-703
10
Limitations of IVT
Riedel et al. Stroke. 2010 41:1659-1664.
11Riedel et al. Stroke. 2011 42:1775-1777.
- 138 stroke patients with
MCA occlusion and IVT
- recanalisation in 62
patients
- correlation of recanalisation
and thrombus burden
Limitations of IVT
12
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
13
Devices
14
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
15
Interventional stroke treatment techniques
Intraarterial thrombolysis
Approaches and Techniques
16
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
17
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
18
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Approaches and Techniques
19
Proximal Thrombectomy: Device Overview
Device
Vasco +35
AspiBALT
5.1F
DACConcentric
038: 3.9F
044: 4.3F
057: 5.2F
Penumbra
SystemPenumbra
026: 2.8F
032: 3.4F
041: 4.1F
054: 5.0F
20
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
21
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
22
Distal Thrombectomy: Device Overview
DeviceDelivery system
Min IDSizes (mm)
Merci
X TypeConcentric
0.017“ 1.5-3x7
Merci
L Type
V TypeConcentric
0.021“
L:
2x2.5
2.5x4.5
2.7x4.5
V:
2x5
up to
3x7
23
Distal Thrombectomy: Device Overview
DeviceDelivery system
Min IDSizes (mm)
CatchBALT
0.0236“Vasco+ 21
4x18
Phenox
pCRPhenox
0.021-0.027“
1-2-10
2-4-20
3-5-20
Phenox
CRCPhenox
0.027“2-4-22
3-5-22
24
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
25
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
26
Device:
• Initial passage of the microwire and stent between the thrombus and vessel wall
• Compression of the thrombus to the contralateral vessel wall
• Preservation of side branches (perforating arteries)
Stent Recanalization
Brekenfeld/Gralla et al. AJNR 2009; Brekenfeld/Gralla et al. Stroke 2009; Mordasini/Gralla et al. NRJ 2012
27
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
28
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
Stent retrieval
29
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
Stent retrieval
30
Stent Retrieval: Device Overview
DeviceDelivery system
Min IDSizes (mm)
Solitaire FRCovidien
0.021“4x15/4x20
6x20/6x30
Trevo proConcentric
0.021“ 4x20
ReviveCodman
0.021“ 4.5x22
AperioAcandis
0.027“ 4.5x40
CaptureCovidien
0.027“3x30
5x30
31
Stent Retrieval: Device Overview
DeviceDelivery system
Min IDSizes (mm)
Capture LPCovidien
0.0165“3x30
5x30
BonnetPhenox
0.021“5x35
5x23
pREsetPhenox
0.021“ 4x20
……
33
Castano et al. Initial experience in 20 acute stroke patients
within an 8-hours time window
successful recanalization in 90% of cases
mean procedural time 50 minutes
and favourable clinical outcome was attained in 45%
Castano C et al, Stroke 2010; 41:1836-1840.
Clinical Results
34
Castano et al. Initial experience in 20 acute stroke patients
within an 8-hours time window
successful recanalization in 90% of cases
mean procedural time 50 minutes
and favourable clinical outcome was attained in 45%
Other small case series:
recanalization rates (88%-91%)
fast procedural times (42-55min)
favourable clinical outcome (42%-54%)
Castano C et al, Stroke 2010; 41:1836-1840.
Clinical Results
35
retrospective study in 6 European sites
141 acute stroke patients in a 8-hour time window
anterior and posterior circulation
independend „core lab“ (n=124)
Stent-Retriever
Dávalos A al. Stroke. 2012 Jul 31.
36
• Mean age: 66.3 [20-89]
• Female gender: 62 (44%)
• mean NIHSS score: 18 [1-32]
• 141 stroke patients
Stent-Retriever
IVT: 74 administered (52%)
failed IV-tPA: 46 (32%)
bridging: 28 (20%)
No IVT administered: 67 (48%)
contraindication: 56 (40%)
direct IAT: 11 (8%)
Dávalos A al. Stroke. 2012 Jul 31.
37
Occlusion site - CoreLab
Localisation N (%)
ICA 6 (4%)
Carotid T 33 (23%)
M1 66 (46%)
M2 19 (13%)
VB 16 (11%)
PCA 2 (1%)
SCA 1 (1%)
• N= 143 occlusion sites over 138 patients analyzed*
*: 2 patients not evaluable: Angiopplasty/ stent proxy carotid. Not clear distal clot removal performed Stent left ICA origin. Stenosis 70%. No intracranial occlusion treated.
1 patient not evaluated due to missing imaging (pt 10-035).
Dávalos A al. Stroke. 2012 Jul 31.
38
Technical Parameter Outcome
Balloon Guide Catheter Use 74%
Technical Success 138/141 (97.8%)
Time from Groin Puncture to Revascularization- Median (min.)- Minimum - Maximum
45 min.14 min – 4 hr 03 min
Mean Number of Passes 1.8 (range 1-7)
Recanalization Success with 2 passes- All series (N = 141)- IV-tPA series (N= 74)
77%85%
Rescue Therapy Required 7 (4.9%)
Procedural Characteristics
Dávalos A al. Stroke. 2012 Jul 31.
39
Patient Outcome at 90 days
mRS N (%)
0 27 (19%)
1 25 (18%)
2 25 (18%)
3 13 (9%)
4 17 (12%)
5 4 (3%)
6 26 (18%)
mRS ≤ 2: 55%
Morbidity (mRS>2): 34/141 (24%)
Mortality : 29/141 (20.5%)3 patients lost to Follow-up considered as worst outcome
Dávalos A al. Stroke. 2012 Jul 31.
40
retrospective study in 6 European sites
141 acute stroke patients in a 8-hour time window
anterior and posterior circulation
independend „core lab“ (n=124)
mean procedural time: 45 min
recanalization rate: 85%
favourable clinical outcome: 55%
sICH rate: 4%
Stent-Retriever
Dávalos A al. Stroke. 2012 Jul 31.
Dávalos A, Mendes-Pereira V, Chapot R, Bonafé A,
Andersson T, Gralla J, the Soliaire Study group.
Retrospective multicenter study of Solitaire Fr for
revascularisation in the treatment of acute ischemic stroke.
41
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
first line device: stent retrievers
42
Time Window for Interventional Treatment
43
IV-Lysis
NINDSS II (NNT =8 )
IV-Lysis
ECASS III (NNT = 14)
IA-Lysis
PROACT II (NNT = 7)
IA Thrombectomy (Merci,
Solitaire, Penumbra etc.)
2hSymptom
onset
4h 6h 8h
Therapeutic time window
44
Randomized controlled trial (RCT) to compare IV rtPA and MT
IV and IA approach superior to standard IV tPA alone (<3h after
stroke onset)?
Thrombectomy devices were approved during the study period:
MERCI (cleared in 2004)
Penumbra (cleared 2007)
Solitaire stent-retriever (cleared March 2012)
Interventional Management of Stroke Trial
IMS III
45
Randomized controlled trial (RCT) to compare IV rtPA and MT
IV and IA approach superior to standard IV tPA alone (<3h after
stroke onset)?
Thrombectomy devices were approved during the study period:
MERCI (cleared in 2004)
Penumbra (cleared 2007)
Solitaire stent-retriever (cleared March 2012)
Enrolment of 587 of the aimed 900 patients enrolment was
suspended in April 2012 because of equipoise (10% difference)
Interventional Management of Stroke Trial
IMS III
46
Due to this late clearance, the results of the trial cannot be
considered to reflect the clinical results of stent retrievers
Interventional Management of Stroke Trial
IMS III
47
Prospective multicenter randomized controlled trial (FDA)
comparing the efficacy and safety of the Solitaire FR with the
Merci device
113 ischemic stroke patients within 8 hours of symptom onset
Trial halted, significantly better results for the Solitaire group
Solitaire FR with the Intention for Thrombectomy
SWIFT
48
Prospective multicenter randomized controlled trial (FDA)
comparing the efficacy and safety of the Solitaire FR with the
Merci device
113 ischemic stroke patients within 8 hours of symptom onset
Trial halted, significantly better results for the Solitaire group
Solitaire FR with the Intention for Thrombectomy
SWIFT
Solitaire FR Merci retriever
Successful recanalization 83.3% 48.1%
Good clinical outcome 58.2% 33.3%
sICH 2% 11%
Mortality 17% 38%
49
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
first line device: stent retrievers
time window?
50
Balloon Occlusion Catheter
51
Balloon occlusion and flow reversal
52
Recovery
45 |
Inflate the balloon of the BGC and stop the BGC
continuous flush.
Retrieve the SolitaireTM FR device and the MC as
a unit into the BGC under constant aspiration
8 Continue to aspirate
until there is a good
flow reversal
Confidential | For Internal Use Only | No Distribution
Correlation between collateral infarction and
Balloon guide catheter use (24hrs)
53
Correlation between collateral infarction and
Balloon guide catheter use (24hrs)
Core Lab controlled
P=0.0009 by Fisher`s exact test
N cases
(N=124)
N Infarct % Infarct
With BGC 96 6 6.2%
Without BGC 28 9 32%
Dávalos A al. Stroke. 2012 Jul 31.
54
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
first line device: stent retrievers
time window?
balloon occlusion catheters
55
STAR Trial (Covidien)
Internationale, Core-Lab kontrollierte, prospektive Multizenter-Studie mit
Solitaire FR („single-arm“)
Global Principal Investigators:
Jan Gralla / Vitor Mendes Pereira
Steering Committee:
Antoni Davalos, Gerhard Schroth,
René Chapot, Thomas Liebig,
Alain Bonafé,Vitor Mendes Pereira,
Jan Gralla
56
Fist emrollement:1/200:
October 2010
Enrolling centre: 14
Switzerland, Germany, France, Spain
Austria, Canada, Australia
Patient emrollement completet:
200 patients until10/2012
200. Enrollement 31.05.2012
1 3 3 3 5 7 1219
25
39
5465
8396
118
134
158
185
189200
0
50
100
150
200
250
Oct
No
v
Dec Jan
Feb
Mar
Ap
r
May Jun
Jul
Au
g
Sep
Oct
No
v
Dec Jan
Feb
Mar
Ap
r
May
Nb
of
pat
ien
ts
Cumulative Enrollment
STAR Trial (Covidien)
57
Training
58
125 patients treated with the Penumbra device
• 11.2% symptomatic ICH
• 12.8% device related complications
• vasospasm (4), re-occlusion (3) anemia
(1), SAH and perforation (4), dissection (3),
embolism (2)
Stroke. 2008 Apr;39(4):1205-12. Stroke. 2009 Aug;40(8):2761-8.
164 patients treated with the Merci device
• 9.8% symptomatic ICH
• 2.4% serious device related complications
50 patients treated with the Solitaire FR device
• 2% of sICH (ECASS definition)
• 5p (10%) symptomatic complications
• of which 4p new infarct
• SAH and perforation (2p)
Stroke. 2011, 42:1929-1935
59
Shift in complications
2% in the natural course of stroke
sICH: 10% after IAT (Proact II)
might require decompressive craniectomy
delayed complication
observe a shift towards intra-procedural
complications
60
• evaluated outcomes of unruptured intracranial aneurysms
• morbidity and mortality
• based on the ICD codes (discharge in long-term facility)
• 5219 clipping cases and 5405 coiling cases
• mean age ~55 years
Brinjikji et al. AJNR 2011, 32:1065-70
61
x5 x2
x2 x2
Brinjikji et al. AJNR 2011, 32:1065-70
62
Stroke Centers in Switzerland
63
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
first line device: stent retrievers
time window?
balloon occlusion catheters
few dedicated high-volume centres
64
Conclusion
• Endovascular techniques have extended the time window
of stroke treatment
• Current first line device - when applicable - are the stent
retrievers
• Mechanical approaches have shown efficacy in proximal
vessel occlusions – within the time window of 0-4.5 hours
• The prove of superiority over IV-tPA is missing
• Due to the risk of periprocedural complications dedicated
neurointerventional training is required
• Centralization to high volume stroke centers are likely to
improve clinical results