Acute Ischemic Stroke: Overcoming Barriers by …img.medscape.com/images/853/753/853753_slide.pdf · Acute Ischemic Stroke: ... • CT misses 60%-90% of acute ischemic strokes in

Acute Ischemic Stroke: Overcoming

Barriers by Improving Systems of Care

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Current Tools for the Diagnosis and

Treatment of Acute Ischemic Stroke

Andy Jagoda, MD, FACEP

Professor and Chair of Emergency Medicine

Mount Sinai School of Medicine

New York, NY

Objectives

• Discuss clinical evaluations and the use of

stroke scale tools in decision-making

• Discuss neuro-imaging tools in the

assessment of patients with TIA and acute

stroke

• Discuss care map / protocol tools in

facilitating quality stroke care




CT Insensitive for StrokeCT is often normal for gross signs of

infarction for the first 6-12 hours, though

subtle, early changes are seen in up to 67%Latchaw RE, et al. Stroke. 2009;40:3646-3678.

Clinical DiagnosisStroke Assessment Tools

Stroke Mimic in about 3% of

Patients Treated with tPAWinkler DT, et al. Stroke. 2009;40:1522-1525.

Scott PA, Silbergleit R. Ann Emerg Med. 2003;42:611-618.

Symptom onset: Date Time

GCS E= M= V

BP / BS: If BS < 60 treat urgently and reassess

Has there been loss of consciousness or syncope? Y (-1) □ N (0) □

Has there been seizure activity? Y (-1) □ N (0) □

Asymmetric facial weakness Y (+1) □ N (0) □

Asymmetric arm weakness Y (+1) □ N (0) □

Asymmetric leg weakness Y (+1) □ N (0) □

Speech disturbance Y (+1) □ N (0) □

Visual field defect Y (+1) □ N (0) □

Total Score _____ (-2 to +5)

Provisional diagnosis: □ Stroke □ Non-stroke (specify) ___________________

* Stroke is likely if total scores are > 0. Scores of ≤ 0 have a low possibility of stroke

but not completely excluded.

Nor AM, et al. Lancet Neurol. 2005;4:727-734.

ROSIER Scale: Stroke Recognition Tool

TIA: ABCD2 Assessment Tool

• 20% to 50% of strokes

preceded by a TIA

• 75% resolve in <15

minutes; 97% <3 hours

• New definition: event lasting

less than 1 hour and not

associated with changes on

neuroimaging

• ABCD2 for risk stratification

Predictor Points

Age > 60 y 1

Blood Pressure >140/90 mm Hg 1

Clinical features (maximum 2)

Unilateral weakness (2)

Speech difficulty without

weakness (1)

2

Duration (maximum 2)

>60 min (2)

10-59 min (1)

<10 min (0)

2

Diabetes 1

Maximum total score 7

Bhatt A, Jani V. ISRN Neurol. 2011; 2011: 518621.




NIH Stroke Scale Score

• 11 Domains

– 1-5 minor

– 6-20 moderate

– >20 severe

• Stroke scales help quantify the deficit, facilitate

communication, identify location, provide prognosis, direct

testing

• Severe strokes are associated with increased risk of sICH

• “Minor” strokes are a relative contraindication for tPA

– Studies suggest that patients with minor or rapidly improving

deficits may benefit from treatment**

** Smith EE, et al. Stroke. 2005;36:2497-2499.

Posterior Circulation Strokes

• CT misses 60%-90% of acute ischemic strokes in the

brainstem or cerebellum

• MRI with diffusion-weighted imaging is more reliable than

CT, but is still misses 15%-20% of patients with posterior

circulation stroke in the early period

• HINTS is reported to be up to 99% sensitive when

performed by an experienced clinician

• www.emcrit/misc/posterior-stroke-video/

Newman-Toker DE, et al. Acad Emerg Med. 2013;20:986-996.

Kattah JC, et al. Stroke. 2009;40:3504-3510.

Non-Contrast CT

• Sensitive

• Available

• Fast

• Findings on CT

related to: – Size of infarct

– Severity of ischemia

– Time of onset

• Hypodensity or mass

effect associated with

8x increase risk of sICH

Miller DJ, et al. Neurohospitalist. 2011 Jul;1(3):138–147.




Alberta Stroke Program Early CT

Score (ASPECTS)

• 10 points quantitative topographic

CT score

• Defined scan protocol

• Developed to provide a reliable

grading system

• Early ischemic change predict

outcome and risk• Focal parenchymal hypodensity

• Cortical swelling with sulcal effacement /

loss of gray white differentiation

• Hyperdense MCA sign

• Scoring is limited to MCA strokes

• www.aspectsinstroke.com

www.aspectsinstroke.com

MRI – DWI • 88%-100% sensitivity

• Better than CT (Level IA)

• Takes 6 minutes

• Visible minutes after infarct

• Better than CT for distinguishing acute vs chronic lesions

• Better than CT for small CVAs, posterior fossa

MRI – Gradient Echo

• Blood dependent on age

and pulsing sequences

used

• As accurate as CT for

acute hemorrhage

• Micro-hemorrhages

• Relevance?

Jauch EC, et al. Stroke. 2013;44:870-947.

Vascular Imaging

• Digital Subtraction Angiography Gold standard

Risks, time-consuming

• CT w/o contrast + CTA Equivalent to DSA (Level IB evidence)

• MRI (DWI, FLAIR, GRE/SWI +/- PWI) +/- MRA Equivalent to DSA (Level IB evidence)

American Society of Neuroradiology, the American College of Radiology, and the Society of

NeuroInterventional Surgery, 2013




Imaging in Acute Ischemic Stroke

• P’s of acute stroke imaging:

Parenchyma (brain), Pipes (vasculature),

Perfusion (blood flow), and Penumbra

(at-risk tissue).

• Multimodal imaging

– Sequence studies: Image, angiography

perfusion, diffusion

– Enhances the sensitivity of

emergent neuroimaging for

acute ischemic processes

– Identifies patients who may

benefit from endovascular

interventions

Sa de Camargo EC, Koroshetz WJ. NeuroRx. 2005 Apr; 2(2): 265–276.

Does the Penumbra Matter?

Downloaded from http://radiologyassistant.nl/data/bin/w440/a50979784dd693_MR10.jpg

Indications/Contraindications

• Contraindications:

– Current intracranial

bleeding/SAH

– Active internal bleeding

– Head or spine surgery or

severe TBI within 3 months

– History of serious intracranial

conditions

i.e., AVM, neoplasm,

aneurysm

– Bleeding diathesis

– Current uncontrolled

hypertension

• Relative Contraindications:

– Minor or rapidly improving

symptoms

– Pregnancy

– Seizure at onset

– Major surgery or serious

trauma within previous 14 days

– Recent GI or urinary tract

hemorrhage within 21 days

– Recent AMI within previous 3

months

Alteplase [package insert]. Genentech. South San Francisco, CA. 2015.




ACEP Clinical Policy – 2015

Is IV r-tPA safe and effective for patients with acute ischemic

stroke if given within 3 hours of symptom onset?

• Level A Recommendation – none

• Level B Recommendation – with a goal to improve functional

outcomes, IV r-tPA should be offered and may be given to selected

patients with AIS within 3 hours of symptom onset at institutions. where

systems are in place to safely administer the medication. The

increased risk of sICH should be considered when deciding whether to

administer IV r-tPA to patients with AIS.

• Level C Recommendation – when feasible, shared decision-making

between the patient (and/or their surrogate) and a member of the

health care team should include a discussion of potential benefits and

harms prior to the decision whether to administer IV r-tPA for AIS.

Ann Emerg Med. 2015. In Press.

ACEP Clinical Policy – 2015

Is IV r-tPA safe and effective for patients with acute ischemic

stroke treated between 3-4.5 hours of symptom onset?

• Level A Recommendation – none

• Level B Recommendation – despite the known risk of sICH and the

variability in the degree of benefit in functional outcomes, IV r-tPA may

be offered and may be given to carefully selected patients with AIS within

3-4.5 hours after symptom onset at institutions where systems are in

place to safely administer the medication

• Level C Recommendation – when feasible, shared decision-making

between the patient (and/or their surrogate) and a member of the health

care team should include a discussion of potential benefits and harms

prior to the decision whether to administer IV r-tPA for AIS.

Ann Emerg Med. 2015. In Press.

Tools: Guidelines / Protocols

• AHA/ASA Get With The Guidelines: Stroke program

registry of 58,353 tPA treated patients

• Faster onset to treatment time in 15 minute increments

led to:

– Reduced in-hospital mortality (OR=0.96; 95% CI: 0.95, 0.98*)

– Symptomatic intracranial bleeding (OR=0.96; 95% CI: 0.95, 0.98*)

– Increase of independent ambulation at discharge

(OR=1.04; 95% CI: 1.03, 1.05*)

– Discharge to home (OR=1.03; 95% CI: 1.02, 1.04*)

• Conclusion: Rapidity or treatment significantly

influences outcomes with IV t-PA in AIS

Schwamm LH, et al. Circ Cardiovasc Qual Outcomes. 2013;6:543-549.




Conclusions

• Stroke scales are helpful in identifying stroke, determining

severity and prognosis

• The history and physical findings direct type of

neuroimaging

• CT, MRI equivalent for detecting hemorrhage

• Micro-hemorrhages seen on MRI may predict

hemorrhagic response to tPA

• MRI clearly superior for detecting acute stroke

• Multiple options for vascular imaging

• Unclear relevance of penumbra

• MRI findings in TIA may predict recurrence/CVA

• Protocols are useful tools for safety and efficiency

New Concepts for

Improving Time to Reperfusion

Edward C. Jauch, MD, MS, FAHA, FACEP

Professor and Director, Division of Emergency Medicine

Professor, Department of Neurosciences

Associate Vice Chair, Research, Department of Medicine

Medical University of South Carolina

Professor, Department of Bioengineering

Clemson University

Clemson, SC

Objectives

Attendees will be able to discuss:

• Mechanisms for coordinating stroke care to

improve door-to-needle/door-to-groin

• Experiences of individual hospital systems of

care

• Lessons from Get With The Guidelines (GWTG)

efforts and Target Stroke




Lessons Learned Over 20 Years

• Reperfusion is critical

– Minimize delay to reperfusion

– Maximize penumbral salvageability by:

Collateral flow

Physiologic optimization

• Time to reperfusion – Predicts clinical outcomes

– Significant tolerance-heterogeneity in populations

– Should drive all system development

Stroke Care in 2015

Changing Landscape for

Acute Ischemic Stroke

• New guidelines and policies imminent– Guideline update July 2015

• Measured national goals– Door to Needle (DTN) Time < 60 min

(soon even lower?)

– Computed Tomography (CT) to Thrombectomy Time < 90 min*

– Treatment rates by percent eligible for intravenous (IV) and intra-arterial (IA)

• New US Food and Drug Administration (FDA) product label




Stroke Care in 2015

• It is simple

– Do it fast

– Do it safely

– Do it as a team

• Detection: Early recognition

• Dispatch: Early EMS activation

• Delivery: Transport & management

• Door: ED triage

• Data: ED evaluation & management

• Decision: Neurology input, therapy selection

• Drug: Thrombolytic & future agents

• Disposition: Admission or transfer

Stroke Chain of Survival

NINDS Recommendations and ACLS

Guidelines

Jauch EC, et al. Circulation. 2010;122:S818-828.Olsen TS, et al. Cerebrovasc Dis. 2003;16:311-337.

NINDS National Symposium on Acute Stroke, 2003.NINDS: National Institute of Neurological Disorders and Stroke

ACLS: Advanced cardiovascular life support

Time

(mins)

Door-to-MD 10

Door-to-Stroke team

notification

15

Door-to-CT scan 25

Door-to-Drug 60*

Door-to-Admission 180

*80% Compliance




NINDS Recommendations and ACLS Guidelines

Jauch EC, et al. Circulation. 2010;122:S818-828.

Olsen TS, et al. Cerebrovasc Dis. 2003;16:311-337.NINDS National Symposium on Acute Stroke, 2003.

NINDS: National Institute of Neurological Disorders and Stroke

ACLS: Advanced cardiovascular life support

†NIH Stroke Scale or Canadian Neurologic Scale

No Hemorrhage Hemorrhage

Immediate general assessment and stabilization

• Assess ABCs, vitals

• Provide O2 if hypoxicemic

• Obtain IV access and blood samples

• Check glucose, treat if indicated

• Perform neurologic screening assessment

• Activate stroke team

• Order emergent CT scan of brain

• Obtain 12-lead ECG

Critical EMS assessments and actions

• Support ABCs, give O2 if needed

• Perform prehospital stroke assessment

• Establish time when patient was last known

normal

• Note: Therapies may be available beyond

3 hrs from onset

• Transport; consider triage to a center with a

stroke unit, if appropriate: Consider bringing a

witness, family member, or caregiver

• Alert hospital

• Check glucose, if possible

Immediate neurologic assessment by stroke

team or designee

• Review patient history

• Establish symptom onset

• Perform neurologic examination†

Suspected

Stroke

Does CT scan show any hemorrhage?

Probable AIS, consider fibrinolytic

therapy

• Check for fibrinolytic exclusions

• Repeat neurologic exam: are deficits

rapidly improving to normal?

Consult neurologist or neurosurgeon;

consider transfer if not available

Patient remains candidate

for fibrinolytic therapy?

Yes

Review risks/benefits with patient

and family: If acceptable:

• Give tPA

• No anticoagulants or antiplatelet

treatment for 24 hours

No

Administer aspirin • Begin stroke pathway

• Admit to stroke unit, if available

• Monitor BP, treat if indicated

• Monitor neurologic status: emergent

CT if deterioration

• Monitor blood glucose: treat if needed

• Initiate supportive therapy: treat

comorbidities

10 mins from ED arrival

25 mins from arrival



Learn From Finland –Where There is a Will…

PSC: primary stroke center; CSC: comprehensive stroke center; ED: emergency department;

EMS: emergency medical services; EMR: electronic medical record; tPA: tissue plasminogen activator

Meretoja A, et al. Neurology. 2012;79:306-313.

• Funnel all to a well-resourced institution– No PSC or CSC, all go to Helsinki University Hospital

– 24/7 neurology presence in ED

– Proximate CT

• Act on encode– EMS talks to neurologist

– Clinical history from EMR

– Premix tPA

– Bolus while in CT

Learn From Industry –Toyota Value Stream Analysis

Ford AL, et al. Stroke. 2012;43:3395-3398.

Patient Arrival

Trauma Bay

Neuro MD: Brief Hx/Begins NIHSS

RN: IV, STAT CBC/INR/PPT

Tech: Vitals, ECG

Head CT

Trauma Bay

Neuro MD: Completes NIHSS,

obtains witness for time of onset,

calls Chief Resident to make

decision

RN: BP med administration.

Calculates dose and prepares

tPA

tPA delivery

Pre-VSA Acute Stroke

Protocol

Post-VSA Acute Stroke

Protocol

Patient Arrival

Head CT

Trauma Bay

ED and Neuro MD: Time of

onset/NIHSS

RN: IV, POC INR, STAT

CBC/PTT, BP Med

administration

Tech: Vitals, ECG

Pharmacist: Calculates dose

and prepares tPA

Social Worker: Obtains witness

for time of onset

Neuro MD: Calls Chief Resident

to make decision

tPA delivery

Protocol Metrics and Outcomes Pre- and Post-VSA

Pre-VSA*

N=132

Post-

VSA*

N=87

P-value

Door-to-needle

time (mins)

60 [47-73] 39 [28-

56]

<0.0001

Patients with DNT

<60 mins (%)

52% 78% <0.0001

Onset-to-needle

time (mins)

131

[105-165]

111

[80-158]

0.016

Door-to-CT time

(mins)

16 [10-22] 1 [0-4] <0.0001

Door-to-CBC

time (mins)

22 [16-29] 24

[17-34]

0.13

Door-to-PTT time

(mins)

34 [29-42] 40

[31-47]

0.14

Symptomatic ICH 3.0% 3.4% 1.0

Favorable

discharge location

76% 83% 0.24

90-d mRS 0 to 2 49% 43% 0.34

Length of hospital

stay, d

4 [3-7] 3 [2-6] 0.056

Stroke mimic 6.8% 11.5% 0.33

*Jan 1, 2009 – Feb 28, 2011 †Mar 1, 2011 – Mar 1, 2012




Maximize Resources, Predefined Roles,

Parallel Processing

Pharmacist

Calculate rtPA

dose

Prepare rtPA

Neurology

resident

ED

resident

Nurse

#1

Nurse

#2

CT

tech

Social

worker

ED

tech

Admitting

Code Stroke

Patient ID

Registration

Room assign

CT scan IV placement

Monitor hook-up

Vital sign monitoring

Blood glucose

Lab draw

Weight estimate

NIHSS

Neuro Exam

History

Meds/allergies

Order rtPA

ID witness

Time of onset

Emergent

transport of

bloods to lab

Decision

Bolus & Infuse rtPA

Target: Stroke - Strategies

• National quality initiative (QI) to increase rates of DTN < 60 mins – 1030 GWTG-Stroke Hospitals

– Pre 2003-2009 / Post 2010-2013

• Interventions

Fonarow GC, et al. JAMA. 2014;311:1632-1640.

EMS prehospital notification

Stroke tools and tool kits

Rapid triage protocol and

stroke team notification

Single call activation system

Direct transfer to CT scanner

Rapid CT and interpretation

Rapid laboratory testing / POC

Mix rtPA ahead of time

Rapid access & rtPA initiation

Team-based approach

Prompt data feedback

Target: Stroke

Study Period Adjusted OR

(95% CI)

P

Value

tPA DTN time, median (IQR), min 77 (60-98) 67 (51-87) <.001

tPA DTN time ≤60 min, % (95%CI) 26.5 (26.0-27.1) 41.3 (40.8-41.7) <.001

End of Each Period 29.6 (27.8-31.5) 53.3 (51.5-55.2) <.001

Improvement in tPA DTN time ≤

60 min, % per year (95% CI)

1.36 (1.04-1.67) 6.20 (5.58-6.78) <.001

In-hospital all-cause mortality, % 9.93 8.25 0.89 (0.83-0.94) <.001

Discharge to home, % 37.6 42.7 1.14 (1.09-1.19) <.001

Independent ambulatory status, % 42.2 45.4 1.03 (0.97-1.10) .31

Symptomatic intracranial

hemorrhage within 36 h, %

5.68 4.68 0.83 (0.76-0.91) <.001

Fonarow GC, et al. JAMA. 2014;311:1632-1640.

Postintervention

(n=43,850)

Preintervention

(n=27,319)




What Are Other Patient-Centered

Outcome of These Systems?

• Triage to most appropriate hospital

– PSC more likely to have a plan and administer tPA

• Increased EMS prehospital activation

– Decreases Door to MD, CT, and Needle times

• Decreases Onset to Needle Time

– 30’ decrease increases relative favorable outcome 10%

• Decreases Onset to Reperfusion Time

– 30’ decrease increases absolute favorable outcome 10%

Monitoring Stroke Center Quality

• Comparison of Performance Achievement Award (PAA)

Recognition With Primary Stroke Center Certification for Acute

Ischemic Stroke Care

• 1356 hospitals in GWTG-Stroke from 2010 to 2012 reviewed

• After adjustment PSC and PAA improved measure adherence

“While both PSC certification and GWTG-Stroke PAA recognition

identified hospitals providing higher conformity with care measures

for patients hospitalized with acute ischemic stroke, PAA recognition

was a more robust identifier of hospitals with better performance.”

Fonarow GC, et al. J Am Heart Assoc. 2013 Oct 14;2(5):e000451.

In-patient Stroke

• Review of in-patient stroke cases from 2006 to

2012 in GWTG-Stroke

• After adjustment and in comparison to

community-onset ischemic stroke, inpatient

strokes were:

– Less likely discharged home (odds ratio [OR] 0.37)

– Less likely ambulatory at discharge (OR 0.42)

– In-hospital mortality also higher (OR 2.72)

Cumbler E, et al. Stroke. 2014 Jan;45(1):231-8. Epub 2013 Nov 19.




Timing Is Critical – IMS I & II

30 minutes = 10%!

IMS: Interventional Management of Stroke Studies

Image used with permission. Khatri P, et al. Neurology, 2009;73:1066-1072.

Team Member Roles in Parallel

Intra-arterial Therapy (IAT) Workflow

Mehta BP, et al. J Am Heart Assoc. 2014;3:e000963.

Disposition: Early Stroke Care

• Begin Acute Stroke Pathway

• ICU / Stroke Unit admission now

– 24 hrs for tPA

– Q 15’ X 6 hours, Q 1ox18 hours

• Facilitate medical or surgical measures to improve outcome after stroke

– Optimize blood pressure, glucose, temp

• Begin to prevent subacute complications

• Plan for long-term therapies to prevent recurrent stroke

• Start efforts to restore neurological function

Summers D, et al. Stroke. 2009;40:2911-2944.

Jauch EC, et al. Stroke. 2013;44:870-947.




Disposition (Care Transition)

Hyperacute

patient -

ischemic

stroke

Transfer to

Stroke Unit

Transfer to

Floor

Hyperacute

patient -

large

ischemic

stroke

Transfer to

Endo-

vascular

Suite

Transfer to

NICU

Transfer to

NICU

Transfer to

OR for

surgery

Hyperacute

patient with

ICH/SAH

•ED Care

DX and RX

•Advanced

imaging

•Possible IV

tPA

•Continue evaluation

•Monitoring for progression and bleeding

•Begin

prevention

measures

•Prepare for

rehab

•ED Care

DX and RX

•Advanced

imaging

•Possible IV

tPA

• IV tPA

•Endo-

vascular Tx

•Anesthesia

support

•Ongoing

care

•Monitor for

compli-

cations

•ED Dx and CareBegin imaging

•Control/ reverse bleeding

•Post-op care

•Monitor for

compli-

cations

•Hematoma

removal

•Aneurysm

clipping

•Hemicran-

iectomy

Conclusions

• “Time is Brain” is more than just a saying—every

minute counts

• Stroke systems of care must be organized to

maximize efficiency and effectiveness

• Application of best practice can reduce time to

reperfusion in every hospital setting

Endovascular Strategies to

Complement r-tPA: Assessing the Evidence

Philip B. Gorelick, MD, MPH

Professor, Translational Science & Molecular Medicine

Michigan State College of Human Medicine

Medical Director, Mercy Health Hauenstein Neurosciences

Grand Rapids, MI




Objectives

• In relation to endovascular strategies to complement tPA,

learners will be able to discuss:

1. Set-up time (work processes) for tPA versus endovascular

intervention

2. MR CLEAN, ESCAPE, SWIFT PRIME, EXTEND-IA,

& REVASCAT

3. Prior endovascular trial data SYNTHESIS, SYNTHESIS

Expansion, IMS III, & MR RESCUE

4. The next steps for intravenous (IV) & intra-arterial (IA)

reperfusion

Process Time for IV tPA &

Endovascular Therapy

Need to Eliminate Redundancies and Need

for Speed to Groin Puncture and

Reperfusion

More Efficient (“LEAN”) Systems

Hospital Strategies & Door-to-Needle Time

• 304 AHA Get with the Guideline-Stroke Hospitals

• 5460 patients receiving tPA within 3 hours

• Median door-to-needle time: 72 minutes

• Rapid triage: 8.1 minutes

• Single-call activation system: 4.3 minutes

• Tissue plasminogen activator (tPA) stored in ED:

3.5 minutes

• Each strategy shortened door-to-needle time by 1.3

minutes (adjusted mean difference)

• Total minutes saved if all strategies used: – 14 minutes

Xian Y, et al. Stroke. 2014;45:1387-1395.




Process Touch Points/Times of Interest in

Acute Ischemic Stroke (AIS) Therapy

Stroke onset to:

1. Study randomization

2. CT head study

3. Start of IV alteplase therapy

4. Groin puncture

5. CT head study to 1st reperfusion

6. 1st reperfusion

Goyal M, et al. N Engl J Med. 2015;372:1019-1030.

What the New Trials Accomplished: Reduction in Median

Time from Stroke Onset to Reperfusion

• IMS III: Mean time from onset to IA end/reperfusion: 325 (5 hours, 25 minutes): range: 180-418

• MR CLEAN: (stroke onset to groin puncture: 260 minutes)

• SWIFT PRIME: (stroke onset to first stent deployment: 252 minutes)

• ESCAPE: 241 minutes

• EXTEND-IA: 248 minutes

• REVASCAT: 355 minutes

Berkhemer OA, et al. N Engl J Med. 2015;372:11-20. Campbell BC, et al. N Engl J Med. 2015;372:1009-1018.

Goyal M, et al. N Engl J Med. 2015;372:1019-1030. Jovin TG, et al. N Engl J Med. 2015;372:2296-2306.

Saver JL, et al. N Engl J Med. 2015;372:2285-2295.

Approaches to Set-up

Scenario #1:

A. Treat acute ischemic stroke with IV tPA in field in mobile stroke

unit to soften or dissolve clot & pre-notification by EMS to ED

B. Transfer from ED door to CT/CTA machine or MRI/MRA next to or

in angiography suite

C. If appropriate, ICA or MCA thrombosis neuro-thrombectomy

procedure

Scenario #2:

A. Pre-notification by EMS ED door to CT/CTA machine

& mix tPA

B. If appropriate findings, give tPA in CT room

C. Transfer next door to angiography suite & start angiography

procedure if appropriate lesion neuro-thrombectomy

procedure




5 Neurothrombectomy Studies Published in

the New England Journal of Medicine – 2015

MR CLEAN: Multicenter Randomized Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands

Berkhemer OA, et al. N Engl J Med. 2015;372:11-20.

EXTEND IA: Extending the Time for Thrombolysis in Emergency Deficits—Intra-Arterial

Campbell BC, et al. N Engl J Med. 2015;372:1009-1018.

ESCAPE: Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times

Goyal M, et al. N Engl J Med. 2015;372:1019-1030.

SWIFT PRIME: Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment

Saver J, et al. N Engl J Med. 2015;372: 2285-2295.

REVASCAT: Randomized Trial of Revascularization with Solitaire FR Device versus Best Medical Therapy in the Treatment of Acute Stroke Due to An Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptomatic Onset Jovin T, et al. N Engl J Med. 2015;372:2296-2306.

Key Study Features of 5 Trials*

*All features are recorded as medians unless otherwise specified

Feature MR CLEAN EXTEND-IA ESCAPE SWIFT PRIME

REVASCAT

1. Age (years) 65.8 70.2 71 66.3 65.7

2. Atrial fibrillation 28.3% 31% 37% 39% 34%

3. Systolic BP (mm Hg) 146 --- 147 --- 142

4. NIHSS Score 17 13 16 17 17

5. ASPECTS 9 9 9 9 7

6. Site1. Intra ICA2. ICA/M13. M1

0.4%25.3%66.1%

31%---51%

---27.6%68.1% (M1 or M2)

16%---77%

0%25.5%64.7%

7. Stroke onset to start IV tPA (minutes)

85 145 110 117 117.5


Goyal M, et al. N Engl J Med. 2015;372:1019-1030. Saver JL, et al. N Engl J Med. 2015;372:2285-2295.

Jovin TG, et al. N Engl J Med. 2015;372:2296-2306.

ASPECTS: Alberta Stroke Program Early CT score, NIHSS: National Institutes of Health Stroke Scale

Comparison of 4 AIS Mechanical

Thrombectomy Trials

Study Character MR CLEAN SWIFT PRIME EXTEND IA ESCAPE

IV-tPA vs IV tPA + Endovascular

Yes (~90%)

Yes Yes Yes

Time Window 6 hours 6 hours 8 hours (IV alteplase within 4.5 hrs)

12 hours

# of Patients N=500 N=196 N=70 N=314

Primary Device Stentreivers in 81.5% (IA thrombolysis allowed)

Solitaire Solitaire Solitaire

Primary Endpoint Ordinal Rankin(shift)

Rankin shift Reperfusion at 24 hrs w/o sICH <72 hrs

NIHSS 0-2 orRankin 0-2 at 90 days

Trial Status Completed Efficacy met, trial stopped

Efficacy met, trial stopped

Efficacy met, trial stopped


Goyal M, et al. N Engl J Med. 2015;372:1019-1030. Saver JL, et al. N Engl J Med. 2015;372:2285-2295.




REVASCAT

Characteristic REVASCAT

IV-tPA vs IV tPA +

Endovascular

Yes: 68.0% in thrombectomy group &

77.7% in control group

Time Window 8 hours

# of Patients N= 206

Primary Device Solitaire

Primary Endpoint modified Rankin scale (shift analysis)

Trial Status Terminated (loss of equipoise based on

reported trials)

Jovin T, et al. N Engl J Med. 2015;372:2296-2306.

Comparison of 4 AIS Mechanical

Thrombectomy Trials

IAT= intra-arterial therapy

Fiorella DJ, et al. J Neurointervent Surg. 2015;7:314-315.

Trial TherapyArm

Good Outcome (mRS = 0-2) at 90 days (%)

P-value (95% CI)

MR CLEAN IATMedical

3319

(5.9, 21.2)

ESCAPE IAT Medical

5329

<.001

EXTEND IA IATMedical

7140

.01

SWIFTPRIME

IATMedical

6036

<.001

Relationship Between Flow Grade

and Achievement of mRS 0-2

Study IAT Flow:

TICI 2b3

IAT

mRS= 0-2

Control

mRS= 0-2

SWIFT PRIME 88% 60% 36%

EXTEND IA 86% 71% 40%

ESCAPE 72% 53% 29%

REVASCAT 66% 44% 28%

MR CLEAN 59% 33% 19%IAT= intra-arterial thrombectomy; mRS= modified Rankin Scale;

TICI= thrombolysis in cerebral infarction

Conclusion: Achieving good outcome

is proportionate to reperfusion

Grotta JC, Hacke W. Stroke. 2015;46:1447-1452.




2015 AHA/ASA Focused Update of the 2013 Guidelines for Early

Management of Patients with AIS Regarding Endovascular Therapy

1. Patients eligible for IV r-tPA should receive it even if endovascular treatments are being considered (Class I; level of evidence A)

2. Endovascular therapy with a stent retriever is indicated according to the following criteria (Class I, level of evidence A):

A. Pre-stroke mRS score 0 to 1

B. AIS receiving r-tPA within 4.5 hours of onset according to guidelines from

professional medical societies

C. Causative occlusion of internal carotid artery or MCA (M1)

D. Age: ≥ 18 years

E. NIHSS score of ≥ 6

F. ASPECTS of ≥ 6

G. Treatment can be initiated (groin puncture)

within 6 hours of symptom onset

Powers WJ, et al. Stroke. 2015 [epub ahead of print].

H. If contraindication to IV tPA, stent retrievers within 6 hours is reasonable

(Class IIa, LOE C)

I. Stent retrievers may be reasonable for M2, M3, ACA, vertebral, basilar, PCA

(Class IIb, LOE C)

J. Stent retrievers may be reasonable for those <18 yrs. & within 6 hours

(Class IIb, LOE C)

K. Stent retrievers may be reasonable for prestroke mRS>1, ASPECTS <6,

NIHSS <6 & occluded ICA or M1 (Class IIb, LOE B-R)

L. Salvage intra-arterial tPA may be reasonable (Class IIb, LOE B-R)

M. Initial treatment with intra-arterial fibrinolysis is beneficial in selected

patients of <6 hours with MCA occlusion (Class I, LOE B-R)

N. It might be reasonable to favor conscious sedation over general anesthesia

(Class IIb, LOE C)

Powers WJ, et al. Stroke. 2015 [epub ahead of print].

2015 AHA/ASA Focused Update of the 2013 Guidelines for Early

Management of Patients with AIS Regarding Endovascular Therapy

SYNTHESIS*, SYNTHESIS

Expansion, IMS III, & MR

RESCUE

*A Pilot Study




3 Negative Endovascular Trials in AIS in 2013

Broderick JP, et al. N Engl J Med. 2013;368:893-903. Kidwell CS, et al. N Engl J Med. 2013;368:2434-2435.

Ciccone A, et al. N Engl J Med. 2013;368:904-913.

Study Study Question Comment

Interventional Management of Stroke III (IMS-III):

Is endovascular therapy after administration of IV tPA in moderate-to-severe AIS more effective (and safe) compared to IV tPA alone within 3 hours after symptom onset?

Primary EndpointmRS ≤ 2:Endovascular 40.8%IV tPA 38.7% (P=.70)Predefined EndpointsNIHSS 8-19 or ≥ 20 (P=.27)

Mechanical Retrieval and REcanalization of Stroke Clots Using Embolectomy (MR RESCUE)

1. Does presence of substantial penumbral tissue predict patients most likely to respond to mechanical embolectomy?

2. Do embolectomy patients have improved functional outcome compared to randomized controls?

Up to 8 hours of stroke onset.

P= not significant for either question (penumbra or embolectomy)

SYNTHESIS Expansion

AIS patients within 4.5 hours randomized to endovascular therapy (IA thrombolysis with tPA, mechanical clot disruption or retrieval or a combination of approaches vs IV tPA)

For mRS (0,1), P=.16

Lessons From 3 Negative Trials

• Too slow to treat

• Need for better neurothrombectomy

devices

• Make sure target lesion (clot) is present

• Take into account collaterals

Next Steps for Intravenous (IV)

and Intra-arterial (IA)

Reperfusion Therapies

Emphasis on Maximizing Pre-hospital Processes




Maximizing Pre-hospital

Processes

1. Delivery of tPA in the field

(mobile unit teleneurology/

teleradiology, point-of-care

lab & CT scanner)*

2. Real time monitoring &

tracking by app of mobile

stroke unit to hospital

3. Bypass to Comprehensive

Stroke Centers if high NIHSS

4. From ED door to CTA or

angiography suite

*If no mobile stroke unit, tele-

neurology can be deployed in ambulance

Slide courtesy James Grotta, MD

Conclusions

1. Highly efficient work flow processes are needed in the

field, in transfer to the ED, and from the ED door to the

CT/CTA/MRI/MRA and angiography suites

2. IV tPA plus endovascular neuro-thrombectomy are the

standard of care for appropriate intracranial occlusions

in acute ischemic stroke

3. Emphasis on maximizing pre-hospital processes is a

current focus of attention to reduce treatment times

Current Status of Stroke Systems of

Care and Telestroke Care

Lee H. Schwamm, MD, FAHA, FANA

Executive Vice Chair of Neurology

C Miller Fisher Endowed Chair and Director of Stroke Services

Director MGH TeleHealth

Massachusetts General Hospital,

Professor of Neurology, Harvard Medical School

Boston, MA

Getting the Right Patients to the Right Places in the Right Amount of Time




Site of

strokePatient history, vitals, CT scan

Triage decision:ED physician/

neurologist confirmsstroke diagnosis

Negative CT Positive CT ICH

EMS transfer

Prehospitaltriage

Self-present

Stroke center

Hospital

Acute Stroke Triage To Improve

Access To IV tPA

A New Era Dawns

65Smith EE, Schwamm LH. Stroke. 2015;46:1462-1467.

Acute Stroke Ready Hospital

BLS transport

ALS transport

Air transport

Mobile Stroke Unit Rx Onsite

Basic Receiving Hospital

Stroke center-Primary

Stroke center-Comprehensive

Factors:

• tPA candidate?

• EVT candidate?

• Distance

• Run Times

• Designation Tiers

• Availability of Services

• Diversion Status

• Medical Control

• ABC stable

• Dispatch Criteria

• Public vs. Private EMS

• Patient Preference

Regional Prehospital

TriageAlgorithms:based on

stroke duration and

patient severity

2015: Pre-Hospital Triage Pathways

for Acute Stroke




How Must We Change in Light of the

Compelling EVT Evidence of Benefit?

• Who are the right patients?

– How can we detect them reliably?

• What are the right places?

• How soon is the right amount of time?

• How should we accomplish this?

"Sy says — When having a stroke, get to

the hospital as soon as possible — within

the first 6 hours. Ask for a T.P.A”

http://www.theatlantic.com/health/archive/2009/12/about-my-father/32221/

Most Patients Don’t Come with a Note Pinned to

their Chest that says “Get me a thrombectomy!”

Penumbra(at risk)

Core(irreversibly

damaged)

Major Strokes:

How to Define?




By Imaging Criteria? Preserved Parenchyma &

Good Collaterals if CTA Available and Reliable

70

Collaterals: From Rags ………………………………………………………to Riches

for

undergoo MRI-DWI

o CT

o Vessel Imaging

o Perfusion Imaging

o Removing Shoes

Clinical Criteria: Basically, It’s a Bad Stroke

• NIHSS: PPV 86.4% for NIHSS ≥9; 84.4% for NIHSS ≥71

• sNIHSS is a valid short form for prehospital use

• The Los Angeles Motor Scale (LAMS) for LVO, 5 versus

2 points, had sensitivity 81%, specificity 89%

• Cincinnati Prehospital Stroke Severity Scale to identify

stroke patients with NIHSS ≥15 (sensitivity 92%) or with

LVO (sensitivity 83%)2

• Rapid Arterial oCclusion Evaluation (RACE) scale to

detect LVO had sensitivity 85%, specificity 68%, PPV

42%, NPV 94%

1. Heldner MR, et al. Stroke. 2013 Apr;44(4):1153-7.

2. Katz BS, et al. Stroke. 2015 Jun;46(6):1508-12.






– First Stop vs Transfer





The Joint Commission Made 24/7 Availability of Mechanical

Thrombectomy a Requirement for CSC Designation

Basic Care:

Assessment, identification, stabilization & transfer

Acute Stroke Ready Hospitals:

IV tPA, CT scanner, 24x7 rapid access to stroke and

imaging expertise on site or via TeleStroke support

Primary Stroke Center: (JACHO, ASA, State)

Stroke Director & dedicated coordinator, Stroke

Service/Unit, continuum of inpatient care

Comprehensive Stroke Center

Neurosurgeon & Neuroendovascular on site,

All PSC functions plus endovascular thrombectomy

and full spectrum of hemorrhagic stroke care

Goal :

~150-200

Goal :

~1200-1500

Goal :

~1200-1500

Goal :

~1800-2500Alberts MJ, et al. Stroke. 2011; 42: 2651-2665

EVT for Stroke: High Impact,

Low Frequency, Widely Dispersed

Menon BK, et al. Stroke. 2015;46:989-995.

13%

16%

21% 20% 21%

26% 26%27% 27%

29%

23%

0.69% 0.80% 0.86% 0.83% 0.96% 1.62% 1.60% 1.83% 1.89%2.02%

1.91%

0%

5%

10%

15%

20%

25%

30%

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Year

Proportion of GWTG hospitals providing endovascular therapy

Proportion of patients at GWTG hospitals RECEIVING endovascular therapy

Pe

rce

nta

ge

(%

)




Time Waits for No Man: Pick

Someone Training for Success

0

10

20

30

40

50

60

70

80

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Median Door To Needle Time for tPA

National Benchmark=60 Min

(unpublished data, MGH Stroke Service)

Hypothetical Triage of AIS Patients <4.5 hr who EMS

Considers Potentially Eligible for IV tPA +/- EVT

1st Entry MSU Basic ASRH PSC CSC

Mimic? Opp cost Not Good* ? ? Opp Cost

V. Mild sx Opp cost Not Good* OK Ideal Opp Cost

Mod sx Ideal Not Good* Ideal Ideal Opp Cost

Severe sx Ideal Not Good* OK OK Ideal

Mod-Sev HS Ideal Not Good* OK OK Ideal

Admission MSU Basic ASRH PSC CSC

Benign Mimic - ? OK? Prob Ideal Opp Cost

V. Mild sx - Not Good Maybe Ideal Opp Cost

Mod sx - Not Good Not Good Ideal Maybe

Severe sx - Not Good Not Good Maybe Ideal

Mod-Sev HS - Not Good Not Good Maybe Ideal

* Unless airway compromise or unstable in BLS care

Potential for Inequitable Access to

Regional Advanced Centers

Carr BG, et al. Ann Emerg Med. 2009;54:261-269. Smith EE, Schwamm LH. Stroke. 2015;46:1462-1467.







– 6 vs 8 vs 12 hours?

– Is time relevant if imaging is favorable?




Drip and Ship: Turning tPA Treatment

Online in Community Hospitals

Sheth KN, et al. Stroke. 2015;46:732-739.

Pick Your First Dance Partner Carefully

Hard to get out of...

Herrin J, et al. Arch Intern Med. 2011;171:1879-1886. Prabhakaran S, et al. Stroke. 2011;42:1626-1630.

Median DIDO for PPCI:

64 (43,104) min

Goal <30 min

For EVT in Stroke: Median hospital-to-hospital distance was 14.7 (IQR 8.5–21.9) miles and median transfer

time was 104 (IQR 80 –135) min. Odds of treatment decrease by 2.5% for every min of transfer time.

Easy to get into...









• How should we accomplish this?– What changes to the stroke system of care?

– Focus on STEEEP, the 6 IOM domains of quality Safe

Timely

Effective

Efficient

Equitable

Patient-centered

An Educated Consumer is our Best

Customer, …In Any Language!

https://massclearinghouse.ehs.state.ma.us/mm5/merchant.mvc

Primary

Stroke Centers

Comp

Stroke

Centers

Acute Stroke Ready

Hospitals

Basic Receiving Hospitals

Field Response and Triage

Paradigm for

Regionalization

of Stroke Care

Limited ?

Advanced




Going Beyond the mRS: The

ICHOM Stroke Standard Set

http://www.ichom.org/medical-conditions/stroke/

Why Telemedicine for Acute Stroke?

• Cost effective sustainable way to staff a low frequency,

high impact event

• Level playing field for smaller hospitals with limited

neurology coverage

• Standardize care across a network or state

• Support development of stroke centers in community with

high quality at lower cost setting

• Evaluate and treat more patients with tPA to reduce

disability and save money

• Transfer appropriate cases for advanced treatments like

thrombectomy




INSTINCT: Barriers to tPA Use Survey

TeleStroke Addresses

Each of These Barriers

Meurer WJ, et al. BMC Emerg Med. 2011;11:5.

TeleStroke is Spreading Across

Europe and the US

Müller-Barna P, et al. Curr Opin Neurol. 2012;25:5-10.

Silva GS, et al. Stroke. 2012;43:2078-2085.

TeleStroke is Cost Effective

• Payer

– Short-term increase in costs w/break- even at 90 days

• Health Care System

– Greater value per health care $ spent

Nelson RE, et al. Neurology. 2011;77:1590-1598.

1




Caring for the Region: A 4 to 1 Multiplier

0

50

100

150

200

250

2005 2006 2007 2008 2009 2010 2011 2012 2013

MGH Thrombolysis Volume Trends over Time (n=1357)

IV tPA @MGH

IV tPA via TS

IAT@ MGH

Total


MGH

TeleStroke

Program


Calendar Year 2013 Snapshot:

Efficient, Effective Stroke Care

93(unpublished data, MGH Stroke Service)




Scorecard

Specificity Delay, Risk

Smith EE, Schwamm LH. Stroke. 2015;46:1462-1467.

Really Radical Redesign?

Volunteers Giving IV tPA at the Minute Clinic!

Documents

Acute Ischemic Stroke: Overcoming Barriers by …img.medscape.com/images/853/753/853753_slide.pdf · Acute Ischemic Stroke: ... • CT misses 60%-90% of acute ischemic strokes in