neurointerventional treatment of acute stroke in 2015 at abbott northwestern hospital

Neurointerventional Treatment of Acute Stroke in 2015 at

ANW

Yasha Kayan, MDJosser E. Delgado, MD

Abbott Northwestern HospitalInnovation Summit 2015

2

Acute Ischemic Stroke Treatment

Ischemic Stroke

IV-tPA

IA~21%

~6%

• IV-tPA– large & small vessel

occlusions – Within 4.5 hours from

onset

• Intra-arterial– Mechanical

Thrombectomy & IA-tPA– IV-tPA candidates &

non-candidates– large vessel occlusions

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Hyper-dense Clot Sign

Hyperdense MCA Clot

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>8mm = 0% recanalization

Riedel et al. Stroke 2011,42:1775-1777

Large Clot Size Decreases Probability of Recanalization from IV-tPA

Why is IV-tPA not enough?

Clot Length (mm)

Prob

abili

ty o

f Rec

anal

izatio

n

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Acute Ischemic Stroke: ELVOs

• Acute ischemic stroke from an emergent large vessel occlusion (ELVO) is a major medical emergency that could lead to death or significant disability among survivors if untreated

66

Large Vessels of the Brain

• Main Vessels Treated with Thrombectomy – MCA – M1

& M2– ACA (A1)– ICA– Basilar– PCA

M1

M2

ICA

Basilar

A1PCA

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Thrombectomy Locations

MCA

ICA

Posterior

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

M1

ICA Terminus

Basilar

M2

PCA

M3

ANW thrombectomy locations 2012-July2015 N=126

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Symptoms of Large Vessel Occlusions

Peter Vanacker, Mohamed Faouzi, Ashraf Eskandari, et al. EJMINT Original Article, 2014: 1444000227 (30th October 2014)

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Cortical Signs

RIGHT BRAIN: LEFT BRAIN:

- Right gaze preference - Left gaze preference

- Neglect - Aphasia

• If present, think LARGE VESSEL stroke

1010

Neuro IR Angio Suite

1111

Thrombectomy Arterial Access

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Mechanical ThrombectomyProcedural Overview

Device Selection and Preparation:

Wire and catheter passed from femoral artery, over the aortic arch, through the internal carotid artery, to the middle cerebral artery (MCA) and through the clot.

(Clot in MCA in illustration)

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Positioning and Deployment of stent in the clot:Guide catheter removed and stent catheter

advanced over the wire through the clot.

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Positioning and Deployment of stent in the clot:

Catheter pulled back, stent deployed into clot.

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Deployment of stent in the clot:Stent embedded in clot –

traps the clot within device mesh.

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Stent and clot removal:Stent with embedded clot pulled back into guide catheter.

Entire system removed from femoral artery.View of clot after retrieval:

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Penumbra Device (ADAPT Technique)

Direct Aspiration by large catheter at the site of thrombus

Rapid and Painless Clot Extraction

Intact Clot Extraction may reduce distal emboli

Spiotta, et al. JNIS, 1/14

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“Solumbra” Aspiration + Stent-Retriever Technique for Thrombectomy

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Evidence for Mechanical Thrombectomy in 2013

• 3 randomized trials comparing IV-tPA to intra-arterial therapy published in NEJM in 2013 found no difference in clinical outcomes:

IMS III SYNTHESIS EXPANSION MR RESCUE

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)

Primary Intervention: MERCI IA-tPA and clot

fragmentation MERCI

LVO (ICA, M1): 33% 34% 81%Successful

recanalization(TICI 2b/3):

44% Not reported 27%

Good clinical outcome (mRS 0-2): 43% 42% 13%

Symptomatic ICH: 6% 6% 5%

Death (90 days): 19% 8% 19%


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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)


fragmentation MERCI






Death (90 days): 19% 8% 19%


Outdatedtechnology

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Thrombectomy Devices

2004 2007 2010

MERCI

Penumbra (original)

Solitaire

Trevo

2013

Penumbra5MAX ACE

2012 – “stent-retrievers”

2013 – large bore

aspiration

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)


fragmentation MERCI






Death (90 days): 19% 8% 19%


Most ptsDID NOT HAVE

large vesselocclusions

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)


fragmentation MERCI






Death (90 days): 19% 8% 19%


Successfulrecanalization

ratesWERE LOW

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)


fragmentation MERCI






Death (90 days): 19% 8% 19%


But also… no differencein risk profile

compared to iv-tPA

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• Recent advances in endovascular thrombectomy devices have led to – higher rates of successful recanalization– marked reduction in thrombectomy procedures

times

Translates into improved clinical outcomes

Recent Advances in Treatment

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MR CLEAN Trial - 2015

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MR CLEAN: What Was Different?

• Confirmation of large vessel occlusion (ELVO) was required– ELVOs confirmed by CTA– Imaging confirmation was not required in IMS3

• Specific measures taken to minimize selection bias– 100% of interventional stroke centers in Netherlands

participated

• Majority of procedures with modern technology

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MR CLEAN Trial Design

• Prospective RCT comparing Best Medical Management vs Best Medical Management + IA therapy

• Key inclusion criteria

– Anterior circulation ELVO confirmed by CTA– IA treatment initiated within 6 hours from

onset• Primary Outcome: mRS score at 90 days (blinded assessment)

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Intervention Improves Outcomes

MR CLEAN Results

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acOR 2.16 (95% CI: 1.39 to 3.38)acOR > 1 indicates higher odds of acheiving functional independence in favor of intervention

Intervention Control0%

10%

20%

30%

40%32.6%

19.1%

mRS ≤ 2 at 90 Days

Intervention Improves Outcomes

MR CLEAN Results

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Intervention Control

Mortality within 7 days 11.6% 12.4%

Mortality within 30 days 18.9% 18.4%

Symptomatic ICH 7.8% 6.4%

“There was no difference in the occurrence of serious adverse events between the groups during the 90 day

follow-up. (p=0.31)”

MR CLEAN Investigators, A Randomized Trial of Intra-Arterial Treatment for Acute Ischemic Stroke, NEJM 2014

Intervention Is Safe

MR CLEAN Results

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Intervention Benefits a

Broad Population

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)

MR CLEAN(N=500)


fragmentation... MERCI Stent-Trievers

LVO (ICA, M1): 33% 34% 81% 86%Successful


44% Not reported 27% 59%Good clinical

outcome (mRS 0-2):

43% 42% 13% 33%Symptomatic

ICH: 6% 6% 5% 8%

Death (90 days): 19% 8% 19% 21%


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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)

MR CLEAN(N=500)






outcome (mRS 0-2):


ICH: 6% 6% 5% 8%

Death (90 days): 19% 8% 19% 21%


Moderntechnology

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)

MR CLEAN(N=500)






outcome (mRS 0-2):


ICH: 6% 6% 5% 8%

Death (90 days): 19% 8% 19% 21%


Whenapplied

to ELVOs

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)

MR CLEAN(N=500)






outcome (mRS 0-2):


ICH: 6% 6% 5% 8%

Death (90 days): 19% 8% 19% 21%


Leads tohigher

successfulrecanalization

rates

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)

MR CLEAN(N=500)






outcome (mRS 0-2):


ICH: 6% 6% 5% 8%

Death (90 days): 19% 8% 19% 21%


With a lowrisk profile

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TICI 2b/3rate

mRS 0-2 at 90 days

Death rate

MR CLEAN 59% 32.6% v. 19.1% 21% v 22%

ESCAPE 72% 53% v. 29% 10% v. 19%

EXTEND-IA 86% 71% v. 40% 9% v. 20%

SWIFT PRIME 88% 60% v. 36% 9% v. 12%

REVASCAT 66% 44% v 28% 18% v 16%

5 Total Major Thrombectomy Trials Published in NEJM in 2015

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IV-tPA + Endovascular Treatment

In 2015:Now standard of care for

acute ischemic stroke due tolarge vessel occlusions

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Thrombectomy Patient Algorithm

ANW Thrombectomy Standardized Algorithm- Minimize risks• Thrombectomy is a high risk procedure- Maximize speed• Time is brain

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Thrombectomy Risk Considerations

Intra-Procedural Complications

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Futile Recanalization

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Post-Procedural Symptomatic Intracranial Hemorrhage

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Thrombectomy Patient Algorithm

5 Guiding Principles1. Always administer IV-tPA to ALL eligible patients2. Define stroke severity required to intervene3. Target proximal intracranial large-vessel

occlusions only: ICA terminus, M1, proximal M2, basilar

4. Simplify imaging used to assess infarct core5. Patient age and baseline condition matter

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ANW Mechanical ThrombectomyAnterior Circulation Strokes

Administer IV-tPA when appropriate

NIHSS ≥6 or global aphasia

Contact ANW Stroke Neurologist via OneCallNIR calculates NCCT ASPECTS*

ASPECTS ≥6 & Age ≤85

Not optimal candidate for

thrombectomy, may consider on an individual basis

LKW ≤6 hrs

No

Yes

LKW >6 hours or unknown

Transfer for emergent

thrombectomy

Obtain emergent CTA head / neck(on-site if possible)

NIR calculates CTA ASPECTS*CTA ASPECTS

≥6

CTA ASPECTS <6

*Imaging expires after 90 minutes

Case Examples

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60 y/o man, driving

• Driving alone in car, wife following in another vehicle

• Suddenly unable to control right leg and right arm• Markedly accelerates, wife unable to keep up• Finally able to stop car, daughter and EMS note

unable to move right side or talk• Transferred via EMS to OSH• NIHSS = 23 at OSH prior to tPA

5050

The patient was taken to OSH and iv-tPA was administered. NCCT a favorable ASPECTS (10) with a hyperdense left MCA sign.

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Successful mechanical thrombectomy of an embolus to the M1 segment of the left middle cerebral artery with the 5 Max ACE aspiration catheter

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• Regains ability to speak within an hour• First word was his wife’s name (she was thrilled!)• MRI shows area of ischemia in left corona radiata• Discharged to CKRI with minor coordination and

speech issues• CEA one week later and discharged to home with

minor deficits

Results

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Acute ischemia within the left corona radiata extending into the left basal ganglia.

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47 y/o man, coughing

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Abbott’s Thrombectomy Experience

– July 1st 2011 to December 31st, 2014107 mechanical thrombectomies (2-3 per month)– 49% women, 51% men– Mean age: 67.5 years (33 – 93 years)– Mean admission NIHSS: 16.5 (3 - 28)– History of atrial fibrillation: 43%– Mean distance from presenting ED to Abbott for

transfers: 51 miles (13 - 314 miles)

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Successful recanalization (TICI 2b/3):86%

Mean time from symptom onset to reperfusion: 321 minutes

(5 hours 21 minutes)

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• Intra-procedural complications: 6.5%– Embolus to previously-uninvolved vascular territory:

3.7% (ACA territory)– Vessel perforation: 1.9%– Catheter rupture/retention: 0.9%

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– Symptomatic intracranial hemorrhage: 6.5%• SAH: 3.7%

– 75% received either IA-tPA or glycoprotein IIb/IIIa inhibitor intra-procedurally

• ICH: 2.8%– Futile recanalization: 4.7%

• Requiring hemicraniectomy: 2.8%• Resulting in death: 1.9%• 60% ICA terminus occlusions• 60% reperfused >5 hours from symptom onset

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• Mean Neuro-ICU LOS: 3.5 days (0 – 19 days)• Mean hospital LOS: 6.9 days (1 – 22 days)• In-hospital mortality: 21.5%

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• Discharge disposition:– Home: 23%– Rehabilitation facility: 38%– Skilled nursing facility: 16%– Expired/hospice: 23%

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• Clinical outcome at 90-days available in 104 patients– 97%, 3 pts pending 90-day follow-up

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All Patients:

TICI 0-2a(15%):

TICI 2b/3 (85%):

p-value:

mRS 0-2: 41% 6% 48% 0.002

mRS 3: 12% 12% 12% 1

mRS 4-6: 47% 81% 41% 0.05

8x

2x

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IMS III(N=629)

SYNTHESIS(N=362)

MR RESCUE(N=118)

MR CLEAN(N=500)

Abbott (N=119)


fragmentation MERCI Stent-Trievers ADAPT/ Solumbra

LVO (ICA, M1): 33% 34% 81% 86% 87%Successful


44% Not reported 27% 59% 86%Good clinical

outcome (mRS 0-2):

43% 42% 13% 33% 44%

Symptomatic ICH: 6% 6% 5% 8% 8%

Death (90 days): 19% 8% 19% 21% 23%


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2015

2014

2013

2012

0 50 100 150 200 250 300 350 400

180

154

151

176

28

74

106

122

43

52

56

64

Onset to ED Arrival ED Arrival to Arterial Puncture Arterial Puncture to Reperfusion

Standardizedalgorithm

implemented

Optimizing Delivery of Neurointerventional Stroke Care

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2014 20150%

5%

10%

15%20%

25%

30%

35%

40%

45%50%

MRS 0-2 Death

Optimizing Delivery of Neurointerventional Stroke Care

0

50

100

150

200

250

Door to Puncture Good Outcome

Mortality

Door to Puncture Time

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Conclusions

• Endovascular thrombectomy is a safe, highly effective procedure that saves lives and reduces disability when:

– Early treatment with IV-tPA for patients that qualify– Patients are carefully selected to identify proximal occlusions– Treatment is extremely fast

• For every four patients treated, one more patient is independent at long term follow up

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Conclusions

• Coordinated neurovascular team effort• Advent of new devices has led to

– decreased procedure times– high rates of successful recanalization– lower rates of intra-procedural complications

• Achieving TICI 2b/3 recanalization is requisite but does not guarantee a good clinical outcome

• Integrating systems of care & standardizing patient selection to decrease time to recanalization is imperative to maximize good clinical outcomes

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Conclusions

• Each 5 minutes of delay eliminated benefit for one person out of every 100 treated with thrombectomy

• TIME IS BRAIN

neurointerventional treatment of acute stroke in 2015 at abbott northwestern hospital

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