Cemal B. Sozener, MD, MEng, FACEP

Department of Emergency MedicineUniversity of Michigan Medical Center

October 22, 2015

Cemal B. Sozener, MD, MEng, FACEPFuture Landscapes of EMS for Stroke Care

Financial Disclosure: Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

▪ Study Group Chair - Karen Johnson, MD (UVA)▪ Sponsor NIH – NINDS U01 NS069498-01A1

Unlabeled/Unapproved Uses Disclosure: None

Discuss current prehospitalstroke care

Discuss development and implementation of stroke centers

Endovascular game change

EMS Bypass

Regionalization schemes

Future directions

Stroke is a major public health concern 795,000 new strokes each year in the US 5th leading cause of death in the US 2nd leading cause of death world-wide A leading cause of disability in the US Annual cost of long-term disability $74 Billion annually (2010 Dollars)

Any intervention making even modest improvements in morbidity can have a substantial effect on Functional outcomes Quality of life Need for long-term care Costs to the medical system

“Hello…

I need help. My mother is not able to speak. She’s drooling out of the side of her mouth…

I think she’s having a stroke…”

Womens-Health-Advice.comOHSU.edu

EMS Systems play a key role in optimizing stroke care

Call to dispatch is the first link to stroke chain of survival

AHA/ASA Policy Statement –Implementation Strategies for Emergency Medical Services Within Stroke Systems of Care Dispatch highest level of care

possible in the shortest time possible

Time from call receipt to dispatch of unit <90 seconds

EMSNews.com

Reginella et al, Predictors of Stroke During 911 Calls: Opportunities for Improving EMS Response, Prehospital Emergency Care 2006 EMS dispatchers correctly identified 80% of all stroke calls if the caller

mentioned “stroke, facial droop, weakness/fall, or communication problem”

Multiple investigators have shown that without ongoing stroke-specific training and feedback, dispatchers fail to identify significant percentage of potential stroke, even when callers use the word “stroke” while talking with dispatch

Ramanujam et al, Prehospital Transport Time Intervals For Acute Stroke Patients, J of Emerg Med 2009 Diagnostic concordance between dispatch and paramedics leads to shorter

scene and run times

Main causes of delayed presentation to the hospital following stroke: Lack of public awareness of stroke signs and symptoms Not understanding the urgency of immediate care Not activating EMS

Schwamm, et al, Temporal trends in patient characteristics and treatment with IV thrombolysis among acute ischemic stroke patients at GWTG –Stroke hospitals, Circulation 2013 Looked at 1,093,895 patients admitted for AIS from April 2003 through

December 2011 52.9% of all AIS patients brought to hospital by EMS 77.5% tPA eligible patients brought by EMS 81.8% tPA treated patients brought by EMS

www.cnbc.com

AHA/ASA Management of Acute Stroke Guidelines Send properly equipped and

staffed ambulance Arrival time < 8 minutes On-scene time < 15 minutes

barring extenuating circumstances

Travel time is equivalent to trauma or AMI calls

Hva.org

Licensing of emergency medical responders and oversight of EMS are governed at the state level Scope of practice varies widely from state to state National Registry of Emergency Medical Technicians (NREMT) attempts to

provide a degree of national certification 46 states currently use the NREMT certification National certification is not the same thing as state licensure

Tremendous variability in stroke training/education

Who are your pre-hospital personnel? Private EMS Hospital-based EMS Volunteer first responders Municipal (Fire)

What is the level of training of EMS in your system MFR – Medical First Responder EMT – Basic EMT – Specialist/Advanced Paramedic

Time <15 minutes

Rapid assessment Airway Breathing Circulation

Early stabilization O2 Sat >94% IVF for SBP<120mmHg, HOB flat BG measure/treat (<60) IV access

www.jems.com

Focused History From patient or

family/bystanders Any trauma Any seizure activity Pertinent past medical history Pertinent medication

(Anticoagulants, NOACs)

CRITICAL – Time of symptom onset/Last Normal▪ Be precise▪ Caution – wake up stroke

IMPORTANT – Phone number of contact

Bring a family member?

Neurological Evaluation

Important to have consistent use of a standardized prehospital stroke assessment scale

Prior to standardized scale use, 28-57% of stroke diagnoses made by EMS was not correct (Corry and Smith, Accuracy of Paramedic Diagnosis of Stroke and TIA, Neurology, 1996)

▪ CPSS▪ FAST▪ LAPSS

Cincinnati Prehospital Stroke Scale (CPSS)

Developed in 1997 by the Cincinnati Stroke Team Derived as a simplification of the NIHSS Can be taught in 10 minutes, performed in 1 minute

Evaluates for (normal or abnormal):▪ Facial palsy – smile/show teeth▪ Arm weakness/drift – extend both arms for 10 seconds, eyes closed▪ Speech abnormality – “The sky is blue in Cincinnati”

Cincinnati Prehospital Stroke Scale (CPSS)

Performance (Kothari, et al, Cincinnati Prehospital Stroke Scale, Reproducibility and Validity, Annals of EM, 1999)▪ Excellent EMS reproducibility

▪ (rI, 0.89, range 0.75 – 0.91 individual items)▪ No difference between EMT and paramedic

▪ Excellent correlation for total score between EMS and MD▪ (rI, 0.92, range 0.78 – 0.91 individual items, arm weakness most consistent)

▪ 66% sensitive all comers, 88% for anterior circulation▪ 10/13 patients missed has posterior circulation, 3 had mild symptoms, no tPA▪ Presence of single abnormality of CPSS identified all patient that were tPA candidates▪ Prior study had 100% sensitivity, 90% specificity (Kothari et al, Acad EM, 1997)

▪ 87% specific

▪ Easy, taught quickly, reproducible▪ Missed mild or atypical strokes and caution in posterior circ

FAST – Face, Arm, Speech Test

Developed 1999 in the UK (Harbison et al, Diagnostic Accuracy of Stroke Referrals from Primary Care, ER Physicians, and Ambulance Staff Using the FAST, Stroke, 2003)

Arm drift for 5 seconds

Assesses normal language during paramedic assessment

Los Angeles Prehospital Stroke Screen (LAPSS)

Developed in 1998

1 page instrument

Less than 3 minutes to complete

Designed to identify most common stroke patient as well as exclude likely stroke mimics

Excludes non-acute candidates

Instrument

4 history items▪ Age >45, no h/o seizure, symptoms

less than 24 hours, not bedridden/wheelchair

Blood glucose (60 – 400) 3 exam items looking for

unilateral motor weakness (face, grip, arm)

Los Angeles Prehospital Stroke Screen (LAPSS)

Performance (Kidwell, et al, Design and Retrospective Analysis of the LAPSS, Prehospital Em Care 1998)▪ 38/41 AIS patients correctly identified (Sensitivity 93%)

Prospective validation (Kidwell, et al, Identifying Stroke in the Field Prospective Validation of the LAPSS, Stroke, 2000)▪ 1298 EMS runs, 206 completed LAPSS▪ 3% had acute symptomatic cerebrovascular disease▪ Sensitivity 91% (95% CI, 76% - 98%)▪ Specificity 97% (95% CI, 93% - 99%)▪ PPV 86% (95% CI 70% - 95%)▪ NPV 98% (95% CI, 95% - 99%)

Los Angeles Motor Scale (LAMS)

Llanes, et al, Prehospital Em Care 2004. 8:1,46-50▪ Created by assigning points to the LAPSS motor components (0 – 5 / 10 bilat)

▪ Facial Strength – 0 = normal, 1 = droop▪ Arm strength – 0 = normal; 1 = drift; 2 = falls rapidly▪ Grip strength – 0 = normal; 1 = weak; 2 = no grip

▪ Allen et al, Stroke 2013. 44:A15▪ 21% of patients with LAMS 4-5 (2007 – 2012) received CSC specific intervention

Rapid Arterial Occlusion Evaluation Scale (RACE)

NP de la Ossa, et al, Stroke 2014. 45(1),87-91▪ Utilizes items of the NIHSS with highest predictive value of LVO

▪ Facial palsy – 0-2 (absent – mod/severe)▪ Arm motor function – 0-2 (normal – severe)▪ Leg motor function – 0-2 (normal – severe)▪ Head and gaze deviation – 0-1 (absent – present)▪ Aphasia (right)/ Agnosia (left) – 0-2▪ Total score 0 – 9

▪ Eval 357 patients; RACE ≥5 = 85% sensitivity, 68% specificity for detecting LVO

Patient is loaded Prehospital stroke assessment

completed Patient placed on monitor Vital signs recorded O2 initiated Glucose measured IV placed

www.annarbor.com

www.hendricks.org

www.southernminn.com

www.medicalnewstoday.com

Patient or family preference Regional hospitals’ stroke capabilities Certified stroke center Stroke unit

Hospital capacity Transport distance Transportation options Time from onset of symptoms Stroke severity

Warrencountyems.com

27

1999 - 2004 Treatment Rates

for Ischemic Stroke:

1%Schumacher C et al: Use of Thrombolysis in Acute Ischemic Stroke. Ann Emerg Med. 2007;50:99-107

Adeoye, et al 2011 Analyzed rates of tPA use 2005 – 2009 nationally Compared with treatment estimates 2001 - 2004 Medicare Provider and Analysis Review (MEDPAR) dataset Premier Hospital Database

▪ Private nationwide hospital database that allows pharmacy code cross-referencing

National estimates of recombinant tissue-type plasminogen activator (rtPA) use in the United

States.

Opeolu Adeoye et al. Stroke. 2011;42:1952-1955

Copyright © American Heart Association, Inc. All rights reserved.

tPA Rates Doubled

1.8-2.1%

3.4-5.2%

Why the increase? Joint Commission establishment of primary stroke center certification

(Dec 2003) ECASS III expansion of treatment window Various state-wide initiatives to standardize acute stroke care Expansion of telemedicine AHA’s aggressive GWTG-Stroke campaign (2003) 2005 higher reimbursement rates (DRG 559 – Acute Ischemic Stroke

with use of a Thrombolytic Agent)▪ Nearly doubled prior DRG▪ Increase in treatment rates began before this

Kleindorfer D: US Distribution of tPA Utilization. Stroke. 2009;40:3580-4

Retrospective analysis of MEDPAR database (Medicare discharges)

4,750 hospitals with 495,186 ischemic stroke admissions

64% of hospitals with no tPA treatments

Kleindorfer D: US Distribution of tPA Utilization. Stroke. 2009;40:3580-4

Concentrate treatment at specialized stroke centers Leverage their size Resources

▪ Professional▪ Physical

Ability to advance science▪ Research experience

Trauma experience AMI/STEMI care Appeals to our need for

order

Brain Attack Coalition recommended formation of stroke centers 2000 The Joint Commission and other organizations (state health departments,

Healthcare Facilities Accreditation Program) have since been certifying hospitals as different levels of stroke centers

Stroke system of care encompasses 4 different types of acute care facilities Non-stroke centers Acute stroke ready hospital (ASRH) Primary Stroke Center (PSC) Comprehensive Stroke Cetner (CSC)

Small facility Typically rural Minimal annual stroke

admissions

No advanced neuroimaging No thrombolytic capability Patients presenting with stroke

are transferred out

www.cockergroupreport.com

Typically smaller facility Rural or isolated suburban 2-3 of 5-10 small hospitals

Role: Stabilize, provide acute stroke

care, arrange transport to higher level of stroke care

Many have established telemedicine link to PSC or CSC

Should have prearranged written transfer protocols to more advanced facility

Certification began 7/2015

These hospitals care for the majority of stroke patients in the US not requiring advanced techniques or care

Stroke unit Lower death rates and improved

patient outcomes

Use of tPA more frequent Improved outcomes have been

demonstrated in US and international studies

Launched 12/2003

www.helios-kliniken.de

Care for the most complex and challenging stroke cases

Provide endovascular and surgical therapies

Formal Joint Commission certification program began 9/2012

NICU or ICU staffed by intensivists

Advanced neuroimaging Most elements available 24/7 Have improved outcomes

(mortality, d/c to home) www.lighthousenewsdaily.com

Admission to a stroke center was associated with a lower stroke mortality compared to admission to a non-designated hospital (Xian, 2011)

“Mrs. Smith is LAPSS positive…

…She has trouble with speech, can’t move the right side of her body, and has a facial droop…

…I think she is having a big stroke.

…Her last known normal was 40 minutes ago.”

www.mediccast.com

www.smalltwonman.wordpress.com

• This unit is one of only 2 ambulances on duty to cover the community

• Run to the CSC (80 min drive time) would put it out of service for 3 hours 10 minutes

• Run to the PSC (55 min drive time) would put it out of service for 2 hours 20 minutes

Multiple EMS units are on at the same time

Surrounded by 3 PSCs in a 20 mile radius and a CSC just a little further

Do you transport to the nearest PSC?

Do you transport to the CSC as the patient has a large stroke and they have more resources?

Traffic

Mlive.com

1995 2015201020052000

PROACT II MERCI PENUMBRA IMS III

SYNTHESIS

MR RESCUE

March 2012 –Covidien Solitaire FR

August 2012 –Stryker Trevo

1995 2015201020052000

PROACT II MERCI PENUMBRA IMS III

TREVO

SYNTHESIS

MR RESCUE SOLITAIRE

Multicenter Randomized CLinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands

Is IA treatment plus usual care more effective than usual care alone in patients with an established proximal artery occlusion in the anterior circulation when treated within six hours of symptom onset? IA = chemical thrombolysis, mechanical treatment, or both

Hypothesis - benefit because of: A short time window before IA (within 6 hours) Establishment of proximal occlusion with vascular imaging Use of retrievable stents

16 Dutch centers participated

Patients randomized to usual care + IA versus usual care alone

Eligible patients 18 or older (no upper limit) Occlusion of distal ICA, M1, M2, A1, or A2 established by CTA, MRA, or

DSA NIHSS ≥ 2 IA therapy had to be able to be started within six hours of symptom

onset Primary Outcome mRS at 90 days

Randomized 500 patients between December 2010 and March 2014

4 hours 20 minutes

196 of the 233 intervention patients ultimately received intra-arterial treatment 195 mechanical therapy

▪ 190 retrievable stent▪ 5 other devices

1 got chemical monotherapy 24 got mechanical + chemical therapy

mRS 0-2

33%

19%

March 12, 2015

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

Is rapid IA treatment plus usual care more effective than usual care alone in patients with an ICA or MCA occlusion selected on the basis of CT and CTA when using contemporary endovascular techniques? The use of retrievable stents was recommended

22 centers participated 11 Canada, 6 US, 3 SK, 1 Ireland, 1 UK

Patients randomized to usual care + IA versus usual care alone

Primary Outcome mRS at 90 days

Eligible patients 18 or older (no upper limit) Had been functioning independently in the community (Barthel index ≥

90) before stroke NIHSS > 5 Enrollment up to twelve hours from symptom onset

Multi-phase CTA was recommended Occlusion of carotid T, M1, or two M2s Small infarct core on CT (ASPECTS 6-10) Moderate-to-good collateral circulation (filling of 50% or more of MCA-pial

circulation on CTA when compared to other side)

Randomized 316 (of 400 intended) patients

Trial was stopped after an unplanned interim analysis due to the release of MR CLEAN results

Stroke onset to groin puncture 180 minutes

151 of the 165 (91.5%) intervention patients ultimately received IA treatment 130 (86%) retrievable stents

▪ 100/130 Solitaire FR stent

Some patients underwent groin puncture while tPA was still being infused

29%

54%

mRS 0-2

March 12, 2015

Extending the Time for Thrombolysis in Emergency Neurologic Deficits with Intra-Arterial Therapy

Is Solitaire FR thrombectomy plus IV tPA more effective than IV tPA alone in patients with a proximal arterial occlusion in the anterior circulation by CTA with evidence of salvageable tissue by CTP when treated within 6 hours of symptom onset?

10 centers participated 9 Australia, 1 New Zealand

Patients randomized to IV tPA + Solitaire FR thrombectomyversus IV tPA alone

Eligible patients 18 or older (no upper limit) Had received IV tPA within 4.5 hours mRS 0 or 1 prior to stroke No minimum NIHSS Occlusion of ICA, M1, or M2 by CTA Evidence of salvageable brain tissue and ischemic core of < 70 cc on

CTP and mismatch volume > 10cc▪ Used automated CTP formatting

Able to undergo groin puncture within 6 hours of stroke onset

Primary Outcomes Reperfusion at 24 hours by CTP Early neurologic improvement (≥8 point reduction on NIHSS at day 3,

or a score of 0/1 at day 3)

Secondary Outcome mRS at 90 days

Randomized 70 (of 100 intended) patients Trial was stopped early due to release of MR CLEAN results 27 of the 35 intervention patients ultimately received

Solitaire FR thrombectomy

3.5 hours

NNT 2.8 for endovascular therapy to achieve improvement of at least one point on the mRS compared to IV tPA alone

Patients eligible for IV tPA should receive even if endovascular treatment considered (Class I; Level A)

Patients should receive endovascular therapy with stent retriever if all criteria are met: (Class I; Level A) Prestroke mRS 0-1 AIS receive tPA within 4.5 hours occlusion of ICA or proximal MCA age ≥18 NIHSS ≥6 ASPECTS ≥6 can initiate treatment within 6 hours of symptom onset

If endovascular therapy is contemplated, a non-invasive intracranial vascular study is strongly recommended during the initial imaging evaluation of the acute stroke patient but should not delay IV tPA if indicated (Class I; Level A)

EMS Bypass N=0

∞[(EMSR)(Distance)(time) (Patient Condition)+(Normal)t-0

(Preferences) nl[Hosp Capabilities](diversion status)Exp(Hospital Cooperation)

SIN(Political Will Power)] Complex decision with several variables• Time since last normal• Distance to various hospitals• Patient condition• Capabilities of regional hospitals• Ambulance availability• Patient/family preference

Need a predetermined plan

Guiding principles for field triage of patients with suspected acute stroke.

Randall Higashida et al. Stroke. 2013;44:2961-2984

Copyright © American Heart Association, Inc. All rights reserved.

For patients within 6-8 hours from stroke onset If only 1 ASRH/PSC/CSC in the area = destination of choice If multiple stroke-capable hospitals within similar driving distance

▪ Patient preference▪ Stroke severity▪ Other hospital characteristics

Without compelling mitigating circumstances, EMS should not bypass the closest facility to go to a higher-level facility if diversion would add 15-20 minutes▪ Time windows may require modification for rural communities or other geographical

challenges

If multiple PSCs and CSCs all within roughly equal distances and transport times recommend transport to highest level facility because Type of stroke (ischemic or hemorrhagic) is unknown to EMS Even if patient stable now, may decompensate

Relatively small number of CSCs in comparison to ASRH and PSC CSCs would be overrun if every stroke bypassed to CSC Bypassing smaller stroke-capable facilities would decay the experience and

ability to treat at these smaller facilities False positives can overload the CSC Potential overuse of a scarce resource Issues with hospital/ER overcrowding Patients and families may be forced to be further away from home making it

logistically more difficult to visit

www.promortgagematters.com

AHA/ASA 2013 Policy Statement – Interactions within Stroke Systems of Care

Regardless of the triage protocol used, ongoing QI is imperative to evaluate protocol adherence and acceptability Will ensure patients continue to be transported to the appropriate facility Will identify need for triage protocol modifications

Triage protocols should be designed with cooperation of EMS leaders, local, regional and state agencies, medical authorities and local experts.

It is the responsibility of all regional stakeholders to provide feedback and work towards optimizing the prehospital phase of stroke care

Patient to the Stroke Team

Stroke Team to the Patient

Local physician delivery with support

Local delivery without support

Telemedicine / Telestroke

Cost-effective way to increase access to limited specialty expertise

Image interpretation Acute clinical support Post-tx management MD/Staff education Standardizing care Research enrollment

Rural Hospitals 50% of US hospitals with <100 beds are in rural

locations 137.5 million Americans live >60 miles from PSC Vascular neurologists are a rare commodity Geographic penalty – live in rural underserved

acute stroke care area, you will not have a chance to receive tPA

Telestroke allows breaking down of geographic barriers

Choi et al: Using telemedicine to facilitate thrombolytic therapy for patients with acute stroke. J Qual Pt Safety. 2006; 32:199-205

Telemedicine consult at 2 Houston community hospitals Compared rates of IV tPA use over 13 months pre and post Treatment rate increased from 0.8% to 4.3%

Silva GS et al, The Status of Telestroke in the US: A Survey of Currently Active Stroke Telemedicine Programs, Stroke. 2012;43:2078-2085 In 2012 56 telestroke programs in 27 States Deliver stroke service to >350 spoke hospitals

Allows patients in any geographical location access to a vascular neurologist

Can lead to increased rates of tPA use in rural or community hospitals (multiple studies)

Leads to more correct treatment decisions (98% vs 82%) than telephone consultation (Meyer et al, Efficacy of site-independent telemedicine in the STRokE DOC trial, Lancet Neuro. 2008;7:787-795

Cost-effectiveness (Neurology. 2011; 77:1590-1598) Significant upfront costs Telestroke networks appear cost-effective from long-term, societal perspective ICER $108,000/QALY over 90-day time horizon ICER $2,400/QALY over lifetime horizon

Reimbursement Easier in rural/medical underserved area Still being worked out

Legal Little precedent Most claims based on failure to treat/telestroke helps

“University, University…

…Alpha 115 is en route to your facility emergently with a 73yo female with dense right sided weakness, facial droop and speech disturbance concerning for a large stroke…

…Last normal 40 minutes ago. Will be at your facility in 7 minutes.”

www.nbcnews.com

Lin, et al, EMS Hospital Notification is Associated with Improved Eval and Treatment of AIS, Circ Cardiovasc Qual Outcomes, July 2012

371,988 AIS patients transported by EMS enrolled in GWTG – Stroke (2003 – 2011) Prenotification occurred in 67% More likely to be tPA treated (82.8% vs 79.2%) Shorter door to imaging time (26min vs 31min) Shorter door to needle time (141min vs 145min)

EMS prenotification independently associated with greater likelihood of▪ Door-to-imaging time ≤25 minutes▪ Door-to-needle time ≤60 minutes▪ Onset-to-needle time ≤120 minutes▪ tPA use within 3 hours

Lees et al: Time to treatment in 3670 patients. Lancet 2010;375:1695-703.

NNT = 5

NNT = 9NNT = 15

Telemedicine in the rig High-Quality –

Videoteleconferenceing (HQ-VTC)

Stroke and other disease states

iPhone in the Ambulance Demaerschalk et al, Reliability of

real-time video smartphone for assessing NIHSS in acute stroke patients. Stroke 2012; 43:3271-3277.

Reliable, easy to use, affordable and high MD satisfaction

HIPAA issues www.lifebot.info

Imaging in the ambulance Houston Cleveland Germany

Telestroke, point of care labs and thrombolytics in the ambulance

STEMO model Wendt et al, Improved prehospital

triage of patients with stroke in a specialized stroke ambulance, Stroke. 2015;46:740-745 Reduce rates of pt deliver to non

stroke unit hospital (10.1% to 3.9% Reduce deliver of pt with ICH without

neurosurgery (43% to 11.3%)

www.app.newmediawire.com

Ensure effective interaction and collaboration among agencies, services and key stakeholders

Promote use of an organized, standardized approach in each facility and component of the system

Identify performance measures (process and outcomes) and include mechanisms for evaluating effectiveness

Ensure decisions about protocols and patient care based on what is in the best interests of stroke patients

Should be customized by state, region or locality

Piperreport.com

“Primum non nocere”“First, do no harm”

Important Corollary inStroke Treatment:To do nothing…Is to do harm