therapeutic options: interventional neuroradiology · therapeutic options: interventional...

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Therapeutic options:

Interventional Neuroradiology

Jan Gralla MD MSc

Inselspital – University of Bern – [email protected]

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Current protocol of interventional treatment

Which occlusions ?

Which device ?

Protection device ?

Influence of training ?

Time window ?

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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

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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.

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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

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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

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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

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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

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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

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Developing Stroke Intervention

proximal vessel occlusion (M1, BA, ICA)

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Devices

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Approaches and Techniques

Interventional stroke treatment techniques

Intraarterial thrombolysis

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Proximal thrombectomy

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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

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Distal thrombectomy

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Distal thrombectomy

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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

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Distal Thrombectomy: Device Overview


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

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Distal thrombectomy

Stent recanalization

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Distal thrombectomy


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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

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Distal thrombectomy


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Distal thrombectomy


Stent retrieval

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Distal thrombectomy


Stent retrieval

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Stent Retrieval: Device Overview


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

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Stent Retrieval: Device Overview


Min IDSizes (mm)

Capture LPCovidien

0.0165“3x30

5x30

BonnetPhenox

0.021“5x35

5x23

pREsetPhenox

0.021“ 4x20

……

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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

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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

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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.

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• 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%)


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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).


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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


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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


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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, 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.

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first line device: stent retrievers

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Time Window for Interventional Treatment

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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

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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

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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)


IMS III

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Due to this late clearance, the results of the trial cannot be

considered to reflect the clinical results of stent retrievers


IMS III

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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

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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%

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time window?

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Balloon Occlusion Catheter

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Balloon occlusion and flow reversal

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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)

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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%


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time window?

balloon occlusion catheters

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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

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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)

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Training

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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

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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

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• 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

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x5 x2

x2 x2

Brinjikji et al. AJNR 2011, 32:1065-70

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Stroke Centers in Switzerland

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time window?

balloon occlusion catheters

few dedicated high-volume centres

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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

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Thank you

Jan Gralla MD MSc

Inselspital – Universität Bern – [email protected]

therapeutic options: interventional neuroradiology · therapeutic options: interventional...

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