Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional...
Transcript of Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional...
![Page 1: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/1.jpg)
1
Therapeutic options:
Interventional Neuroradiology
Jan Gralla MD MSc
Inselspital – University of Bern – [email protected]
![Page 2: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/2.jpg)
2
Current protocol of interventional treatment
Which occlusions ?
Which device ?
Protection device ?
Influence of training ?
Time window ?
![Page 3: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/3.jpg)
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
![Page 4: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/4.jpg)
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.
![Page 5: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/5.jpg)
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
![Page 6: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/6.jpg)
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
![Page 7: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/7.jpg)
7Galimanis A et al. Stroke 2012, 43: 1053-1057
Occlusion site and outcome
NIHSS
mRS
![Page 8: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/8.jpg)
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
![Page 9: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/9.jpg)
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
![Page 10: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/10.jpg)
10
Limitations of IVT
Riedel et al. Stroke. 2010 41:1659-1664.
![Page 11: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/11.jpg)
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
![Page 12: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/12.jpg)
12
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
![Page 13: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/13.jpg)
13
Devices
![Page 14: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/14.jpg)
14
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
![Page 15: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/15.jpg)
15
Interventional stroke treatment techniques
Intraarterial thrombolysis
Approaches and Techniques
![Page 16: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/16.jpg)
16
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
![Page 17: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/17.jpg)
17
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
![Page 18: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/18.jpg)
18
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Approaches and Techniques
![Page 19: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/19.jpg)
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
![Page 20: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/20.jpg)
20
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
![Page 21: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/21.jpg)
21
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
![Page 22: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/22.jpg)
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
![Page 23: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/23.jpg)
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
![Page 24: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/24.jpg)
24
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
![Page 25: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/25.jpg)
25
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
![Page 26: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/26.jpg)
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
![Page 27: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/27.jpg)
27
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
![Page 28: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/28.jpg)
28
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
Stent retrieval
![Page 29: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/29.jpg)
29
Approaches and Techniques
Interventional stroke treatment techniques
Intraarterial thrombolysis
Proximal thrombectomy
Distal thrombectomy
Stent recanalization
Stent retrieval
![Page 30: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/30.jpg)
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
![Page 31: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/31.jpg)
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
……
![Page 32: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/32.jpg)
![Page 33: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/33.jpg)
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
![Page 34: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/34.jpg)
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
![Page 35: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/35.jpg)
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.
![Page 36: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/36.jpg)
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.
![Page 37: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/37.jpg)
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.
![Page 38: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/38.jpg)
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.
![Page 39: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/39.jpg)
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.
![Page 40: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/40.jpg)
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.
![Page 41: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/41.jpg)
41
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
first line device: stent retrievers
![Page 42: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/42.jpg)
42
Time Window for Interventional Treatment
![Page 43: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/43.jpg)
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
![Page 44: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/44.jpg)
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
![Page 45: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/45.jpg)
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
![Page 46: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/46.jpg)
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
![Page 47: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/47.jpg)
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
![Page 48: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/48.jpg)
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%
![Page 49: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/49.jpg)
49
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
first line device: stent retrievers
time window?
![Page 50: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/50.jpg)
50
Balloon Occlusion Catheter
![Page 51: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/51.jpg)
51
Balloon occlusion and flow reversal
![Page 52: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/52.jpg)
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)
![Page 53: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/53.jpg)
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.
![Page 54: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/54.jpg)
54
Developing Stroke Intervention
proximal vessel occlusion (M1, BA, ICA)
first line device: stent retrievers
time window?
balloon occlusion catheters
![Page 55: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/55.jpg)
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
![Page 56: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/56.jpg)
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)
![Page 57: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/57.jpg)
57
Training
![Page 58: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/58.jpg)
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
![Page 59: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/59.jpg)
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
![Page 60: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/60.jpg)
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
![Page 61: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/61.jpg)
61
x5 x2
x2 x2
Brinjikji et al. AJNR 2011, 32:1065-70
![Page 62: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/62.jpg)
62
Stroke Centers in Switzerland
![Page 63: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/63.jpg)
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
![Page 64: Therapeutic options: Interventional Neuroradiology · Therapeutic options: Interventional Neuroradiology ... VB 16 (11%) PCA 2 (1%) SCA 1 (1%) ... 39 54 65 83 96 118 134 158 185 189](https://reader031.fdocuments.us/reader031/viewer/2022022610/5b97351409d3f206218c452f/html5/thumbnails/64.jpg)
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