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Stroke 2006 Debate Stroke Care 2006: Stroke Care 2006: Clinical Consensus Clinical Consensus and Opportunities and Opportunities A Case Study to A Case Study to Challenge the Experts Challenge the Experts

Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

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Page 1: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Stroke Care 2006: Stroke Care 2006: Clinical Consensus Clinical Consensus and Opportunitiesand Opportunities

A Case Study to A Case Study to Challenge the ExpertsChallenge the Experts

Page 2: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Clinical Decision Making in Clinical Decision Making in Emergency Medicine:Emergency Medicine:An Evidence-Based An Evidence-Based

ConferenceConference

Ponte Vedra Beach, FLPonte Vedra Beach, FLJune 15-17, 2006June 15-17, 2006

Page 3: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Thank you to AstraZeneca Thank you to AstraZeneca for their support of this for their support of this

stroke educational meetingstroke educational meeting

Page 4: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

PanelistsPanelists

• Andy Jagoda, MD, FACEP (Moderator) Andy Jagoda, MD, FACEP (Moderator) Mount Sinai School of MedicineMount Sinai School of Medicine

• Thomas G. Brott, MDThomas G. Brott, MDMayo Clinic JacksonvilleMayo Clinic Jacksonville

• E. Bradshaw Bunney, MD, FACEPE. Bradshaw Bunney, MD, FACEPUniversity of Illinois at ChicagoUniversity of Illinois at Chicago

• J. Stephen Huff, MD, FACEP J. Stephen Huff, MD, FACEP University of VirginiaUniversity of Virginia

• Edward P. Sloan, MD, MPH, FACEP Edward P. Sloan, MD, MPH, FACEP University of Illinois at ChicagoUniversity of Illinois at Chicago

Page 5: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

DisclosuresDisclosures• Andy Jagoda, MD Andy Jagoda, MD

• AstraZenecaAstraZeneca• Thomas G. Brott, MDThomas G. Brott, MD

• NoneNone• E. Bradshaw Bunney, MDE. Bradshaw Bunney, MD

• AstraZeneca, Genentech consultantAstraZeneca, Genentech consultant• J. Stephen Huff, MDJ. Stephen Huff, MD

• NoneNone• Edward P. Sloan, MD, MPHEdward P. Sloan, MD, MPH

• NoneNone

Page 6: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Global ObjectivesGlobal Objectives

• Improve acute stroke patient care Improve acute stroke patient care • Minimize morbidity and mortalityMinimize morbidity and mortality• Expedite dispositionExpedite disposition• Optimize resource utilizationOptimize resource utilization• Enhance our job satisfactionEnhance our job satisfaction

Page 7: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Session ActivitiesSession Activities

• Present a relevant clinical casePresent a relevant clinical case• Poll the audience about carePoll the audience about care• Discuss the questionsDiscuss the questions• Understand areas of consensusUnderstand areas of consensus• Explore areas of uncertaintyExplore areas of uncertainty• Go forth and prosperGo forth and prosper

Page 8: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Case PresentationCase Presentation• 62 year-old professor has an 62 year-old professor has an

apparent stroke while teaching at the apparent stroke while teaching at the local community college.local community college.

• Contact to the local EMS base station Contact to the local EMS base station occurs within 15 minutes of the onset occurs within 15 minutes of the onset of symptoms.of symptoms.

• He arrives at the closest ED within 30 He arrives at the closest ED within 30 minutes of symptom onset.minutes of symptom onset.

Page 9: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Case PresentationCase Presentation• VS 178/80 RR 18 P 96 Temp 98.6VS 178/80 RR 18 P 96 Temp 98.6• Cardiopulmonary exam OKCardiopulmonary exam OK• Mental Status OKMental Status OK• Neurological ExamNeurological Exam

• Awake and alertAwake and alert• R facial weaknessR facial weakness• Slurred speechSlurred speech• Right visual field neglectRight visual field neglect• Unable to purposefully move RUE / RLEUnable to purposefully move RUE / RLE

Page 10: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: TIA ED VisitTIA ED Visit

• Had this patient presented to the ED two weeks earlier with dizziness and numbness in his R upper extremity, what would be your approach?

Page 11: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: TIA ED VisitTIA ED Visit

A. I admit all TIA patients regardless of the severity of the symptoms.

Page 12: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: TIA ED VisitTIA ED Visit

B. I only admit those patients who have clear motor weakness or visual symptoms (amaurosis fugax) because of a greater stroke risk.

Page 13: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: TIA ED VisitTIA ED Visit

C. I might consider sending this patient home, but only if I have completed a cranial CE and an evaluation of the carotids (Doppler, CTA, MRA).

Page 14: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: TIA ED VisitTIA ED Visit

D. I would send this patient home with aspirin therapy and arrange that a physician complete a TIA work-up as an outpatient.

Page 15: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: TIA ED VisitTIA ED Visit

E. I don’t really have an opinion on what to do with this TIA patient, and so would depend on my neurologist for a disposition decision.

Page 16: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: TIA ED VisitTIA ED Visit

A. I admit all TIA patients. B. I only admit those patients who

have clear motor weakness or visual symptoms.

C. Send home after a cranial CT and a carotid evaluation.

D. Send home, outpatient TIA workup.E. No opinion, ask the neurologist.

Page 17: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: EMS TriageEMS Triage

• Regarding EMS triage, should this patient be:

Page 18: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: EMS TriageEMS Triage

A. Transported to the closest hospital?

Page 19: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: EMS TriageEMS Triage

B.B. Diverted to the closest Diverted to the closest primary stroke center?primary stroke center?

Page 20: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: EMS TriageEMS Triage

C.C. Diverted to the closest Diverted to the closest tertiary center with 24/7 tertiary center with 24/7 interventional radiology?interventional radiology?

Page 21: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: EMS TriageEMS Triage

D. D. Diverted to the closest Diverted to the closest comprehensive stroke comprehensive stroke center?center?

Page 22: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: EMS TriageEMS Triage

E. E. Asked to finish his class first?Asked to finish his class first?

Page 23: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: EMS TriageEMS Triage

A. Closest hospital

B. Closest primary stroke center

C. Closest 24/7 IR tertiary center

D. Closest comprehensive stroke center

E. Asked to finish the class first

Page 24: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

• If this patient is transported to the closest ED of a hospital with no specific stroke team or protocol, which of the following best describes circumstances when transfer to a tertiary or stroke center should take place for this stroke patient?

Page 25: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

A.A. There are no indications for inter-hospital transfer to take place.

Page 26: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

B.B. The patient should be transferred after IV tPA is administered.

Page 27: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

C.C. Transfer should take place only if IV tPA is not indicated and CNS intra-arterial thrombolytic therapy or thrombus removal is likely.

Page 28: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

D.D. Transfer should take place Transfer should take place for all patients if the time for all patients if the time from symptom onset is from symptom onset is between three and ten hours between three and ten hours in order to allow advanced in order to allow advanced diagnostics to be provided diagnostics to be provided acutely.acutely.

Page 29: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

E.E. Transfer to a primary stroke Transfer to a primary stroke center should take place for center should take place for all stroke patients, regardless all stroke patients, regardless of the time of symptom of the time of symptom onset, whether IV tPA has onset, whether IV tPA has been provided, and whether been provided, and whether an acute clot intervention is an acute clot intervention is contemplatedcontemplated

Page 30: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

F. F. I have no idea when inter-I have no idea when inter-hospital transfer should take hospital transfer should take place for patients such as this place for patients such as this one.one.

Page 31: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Inter-hospital TransferInter-hospital Transfer

A. No indications B. After IV tPA is administered.C. IV tPA is not indicated and CNS

intra-arterial thrombolytic therapy or thrombus removal is likely

D.D. Symptoms 3-10 hours, diagnosticsSymptoms 3-10 hours, diagnosticsE.E. Transfer all stroke patientsTransfer all stroke patientsF.F. I have no ideaI have no idea

Page 32: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Cincinnati Prehospital Stroke Cincinnati Prehospital Stroke ScaleScale

One positive = possible stroke

Page 33: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

11 elements of a Primary Stroke Center11 elements of a Primary Stroke Center

JAMA 2000; 283:3102-3109JAMA 2000; 283:3102-3109

• EMS integrated into the acute stroke responseEMS integrated into the acute stroke response• Stroke team available 24 / 7 Stroke team available 24 / 7 • Written care protocols Written care protocols • ED integrated into the acute stroke teamED integrated into the acute stroke team• Stroke unitStroke unit• Neurosurgical services available within 2 hoursNeurosurgical services available within 2 hours• Commitment from the institution Commitment from the institution • Neuroimaging interpreted within 45 min of arrivalNeuroimaging interpreted within 45 min of arrival• Laboratory services with rapid turn around of testsLaboratory services with rapid turn around of tests• CQI program including a database or registryCQI program including a database or registry• Continuing education programContinuing education program

Page 34: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

NINDS Symposium 2002:NINDS Symposium 2002:Improving the Chain of Recovery for Acute Improving the Chain of Recovery for Acute

Stroke in Your CommunityStroke in Your Community

• ED – basicED – basic• Recognizes that not all EDs can provide Recognizes that not all EDs can provide

thrombolytic carethrombolytic care• Stabilization: ABC / BP / glucose / tempStabilization: ABC / BP / glucose / temp• Transfer protocolsTransfer protocols

• Primary Stroke CenterPrimary Stroke Center• Comprehensive Stroke CenterComprehensive Stroke Center

• Tertiary care centerTertiary care center• Advanced stroke expertise in neuroimaging, Advanced stroke expertise in neuroimaging,

neurosurgery, interventional neuro-radiologyneurosurgery, interventional neuro-radiology

Page 35: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Stroke CentersStroke Centers

• Improves outcomes?Improves outcomes?

Newell et al. clinical efficiency tools improve stroke Newell et al. clinical efficiency tools improve stroke management in a rural southern health system. management in a rural southern health system. Stroke 1998; 29:1092-1098Stroke 1998; 29:1092-1098

Wentworth et al. Implementation of an acute stroke Wentworth et al. Implementation of an acute stroke program decreases hospitalization cost and length of program decreases hospitalization cost and length of stay. Stroke 1996; 27:1040-1043.stay. Stroke 1996; 27:1040-1043.

Douglas et al. Do the brain attach coalition’s criteria Douglas et al. Do the brain attach coalition’s criteria for stroke centers improve care for ischemic stroke? for stroke centers improve care for ischemic stroke? Neurology 2005; 64: 422-427Neurology 2005; 64: 422-427

Implementation increased incidence of t-PA useImplementation increased incidence of t-PA use

Page 36: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

AHRQ #127: Acute StrokeAHRQ #127: Acute Stroke

• Are designated centers effective in Are designated centers effective in reducing stroke related disability and reducing stroke related disability and mortality?mortality?• No studies were identifiedNo studies were identified• Studies have shown that stroke teams Studies have shown that stroke teams

decrease the time to evaluationdecrease the time to evaluation• Lattimore et al showed that creation of Lattimore et al showed that creation of

stroke team increased tPA use from 1.5% stroke team increased tPA use from 1.5% to 10.5% of acute stroke patients seento 10.5% of acute stroke patients seen

Page 37: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

IV tPA Utilization IV tPA Utilization Cleveland Clinic Health SystemCleveland Clinic Health System

July 1997 - June 1998July 1997 - June 1998

70 pts treated with IV tPA:70 pts treated with IV tPA:

1.8%1.8% ischemic strokes ischemic strokes

11.1%11.1% of ischemic strokes of ischemic strokes arriving < 3 hrsarriving < 3 hrs

31% selected protocol 31% selected protocol deviationsdeviations

16% symptomatic 16% symptomatic intracranial hemorrhage intracranial hemorrhage

July 1999 - June 2000July 1999 - June 2000

5353 pts treated with IV tPA: pts treated with IV tPA: 2.4% ischemic strokes 2.4% ischemic strokes 23.4% of ischemic strokes 23.4% of ischemic strokes

arriving < 3 hrs (53/226) arriving < 3 hrs (53/226)

17% selected protocol 17% selected protocol deviationsdeviations

6.5% symptomatic 6.5% symptomatic intracranial hemorrhageintracranial hemorrhage

Katzan et al, Stroke 2003;34:799-800

Page 38: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

JCAHO Disease Specific Care JCAHO Disease Specific Care CertificationCertification

• Joint initiative between ASA and JCAHOJoint initiative between ASA and JCAHO• Voluntary participationVoluntary participation

• 94 accredited hospitals94 accredited hospitals• 36 site visits in progress36 site visits in progress• 718 applications pending718 applications pending

• Premise is that accreditation process will drive Premise is that accreditation process will drive quality measures and improve outcomesquality measures and improve outcomes

• No emergency medicine society has endorsed No emergency medicine society has endorsed this initiativethis initiative

• t-PA controversyt-PA controversy• OvercrowdingOvercrowding• Medical legal implicationsMedical legal implications

Page 39: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

• Which of the following describes your views regarding the use of the NIHSS in evaluating stroke severity and the indications for various stroke therapies?

Page 40: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

A.A. Every emergency physician should know how to calculate the NIHSS for patients such as this one, since it is the standard of care for determining stroke severity and the need for any and all stroke therapies.

Page 41: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

B.B. It is obvious how severe this It is obvious how severe this patient’s stroke is, and the patient’s stroke is, and the need for all potential stroke need for all potential stroke therapies can be determined therapies can be determined clinically without actually clinically without actually calculating the NIHSS.calculating the NIHSS.

Page 42: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

C.C. The NIHSS can be reliably The NIHSS can be reliably estimated by determining estimated by determining symptom severity in four symptom severity in four categories: motor, speech, categories: motor, speech, mental status, and mental status, and visual/neglect.visual/neglect.

Page 43: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

D.D. The NIHSS is a research tool The NIHSS is a research tool that can be calculated that can be calculated retrospectively as needed as retrospectively as needed as long as the neurological long as the neurological exam in the ED is exam in the ED is documented appropriately.documented appropriately.

Page 44: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

E.E. When I am considering IV When I am considering IV tPA, I just quickly calculate tPA, I just quickly calculate the NIHSS using Internet the NIHSS using Internet tools.tools.

Page 45: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

F.F. What does NIHSS stand for, What does NIHSS stand for, anyways?anyways?

Page 46: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of the NIHSSUse of the NIHSS

A. NIHSS is the standard of care B. Determine Rx clinically, no NIHSSC. Estimate NIHSS in 4 clinical areasD.D. Calculate retrospectively from examCalculate retrospectively from examE.E. Quickly calculate NIHSS with InternetQuickly calculate NIHSS with InternetF.F. What does NIHSS stand for?What does NIHSS stand for?

Page 47: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: PatientPatient NIHSSNIHSS

• What is the approximate NIHSS of What is the approximate NIHSS of this patient?this patient?

Awake and alertAwake and alert R facial weaknessR facial weakness Slurred speechSlurred speech Right visual field neglectRight visual field neglect Unable to purposefully move his Unable to purposefully move his

RUE / RLERUE / RLE

Page 48: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: PatientPatient NIHSSNIHSS

A. 0-5 B. 5-10C. 10-15D.D. 15-2015-20E.E. Greater than 20Greater than 20

Page 49: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of ScalesUse of Scales

• Regarding the use of stroke Regarding the use of stroke outcome scales such as the outcome scales such as the Modified Rankin Scale (MRS) or Modified Rankin Scale (MRS) or the Barthel Index (BI), which of the Barthel Index (BI), which of the following is your clinical the following is your clinical approach?approach?

Page 50: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of ScalesUse of Scales

A.A. I use these scales in I use these scales in assessing stroke patient assessing stroke patient severity in the ED.severity in the ED.

Page 51: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of ScalesUse of Scales

B.B. I understand the MRS and the I understand the MRS and the BI, and I use them to help in BI, and I use them to help in assessing the effectiveness assessing the effectiveness of new stroke therapies from of new stroke therapies from published clinical trialspublished clinical trials..

Page 52: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of ScalesUse of Scales

C.C. I do not have any idea how I do not have any idea how these outcome scales are these outcome scales are utilized, either in the ED or utilized, either in the ED or after hospital dispositionafter hospital disposition..

Page 53: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of ScalesUse of Scales

D.D. These scales correlate with These scales correlate with the NIHSS, making their use the NIHSS, making their use superfluous.superfluous.

Page 54: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of ScalesUse of Scales

E.E. I have not ever heard of these I have not ever heard of these scales, let alone use themscales, let alone use them!!

Page 55: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Use of ScalesUse of Scales

A. I use these scales in the EDB.B. Scales assess the effectiveness Scales assess the effectiveness

of new stroke therapiesof new stroke therapiesC.C. No idea how these outcome No idea how these outcome

scales are utilizedscales are utilizedD.D. Scales correlate with the NIHSS, Scales correlate with the NIHSS,

making their use superfluousmaking their use superfluousE.E. I have never heard of these I have never heard of these

stroke scalesstroke scales

Page 56: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The utility of clinical scalesThe utility of clinical scales

• Allow gross quantification of injury/pathologyAllow gross quantification of injury/pathology• Aid in communication to consultantsAid in communication to consultants• Can be used to track improvement or deterioration Can be used to track improvement or deterioration

in the acute treatment phasein the acute treatment phase• Can be used to track outcomeCan be used to track outcome• Can be useful research toolsCan be useful research tools

Adapted from slide set of Kama Guluma, MD

Page 57: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke Scale

Adapted from slide set of Kama Guluma, MD

Page 58: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIHSSThe NIHSS

1.1. Level of consciousnessLevel of consciousness2.2. Gaze Gaze 3.3. Visual fieldsVisual fields4.4. Facial strengthFacial strength5.5. Arm strengthArm strength6.6. Leg strengthLeg strength7.7. Limb ataxia (FNF, heel-down-shin)Limb ataxia (FNF, heel-down-shin)8.8. Sensation (pinch/pinprick)Sensation (pinch/pinprick)9.9. Language (re: aphasia)Language (re: aphasia)10.10. DysarthriaDysarthria11.11. Extinction/inattention (bilat sensory)Extinction/inattention (bilat sensory)

Maximum Score = 42

Maximum score from ischemic stroke = 31

Page 59: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke ScaleLEVEL OF CONSCIOUSNESS

Page 60: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke Scale

GAZEVISUAL FIELDS

Page 61: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke Scale

FACIAL MOTOR

Page 62: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke ScaleMOTOR OF THE ARM MOTOR OF THE LEG

ATAXIA

Page 63: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke Scale

SENSORY

Page 64: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke ScaleLANGUAGE

Page 65: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke ScaleDYSARTHRIA

Page 66: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

The NIH Stroke ScaleThe NIH Stroke ScaleEXTINCTION/NEGLECT

Page 67: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

What the NIHSS score means to the What the NIHSS score means to the EPEP

• NIHSS 1 - 4: mild strokeNIHSS 1 - 4: mild stroke• NIHSS 5 -15: moderate stroke NIHSS 5 -15: moderate stroke • NIHSS 15 – 20: moderate to severe strokeNIHSS 15 – 20: moderate to severe stroke• NIHSS > 20: severe strokeNIHSS > 20: severe stroke• Prognosis: likelihood of favorable outcomePrognosis: likelihood of favorable outcome

• NIHSS < 10: 60 – 70%NIHSS < 10: 60 – 70%• NIHSS > 20: 4 -16% NIHSS > 20: 4 -16%

Page 68: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

What the NIHSS score means to the What the NIHSS score means to the EPEP

• Chance of ICH with tPAChance of ICH with tPA• NIHSS < 10: 3%NIHSS < 10: 3%• NIHSS > 20: 17% NIHSS > 20: 17%

Stroke. 2003;34:1056 –1083.

Ann Emerg Med. 2001;37:202-216

Page 69: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Consideration: the “low NIHSS

score” stroke with a devastating effect

on livelihood

Page 70: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Page 71: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Functional Outcome ScalesFunctional Outcome Scales• Modified Rankin scale (mRS)Modified Rankin scale (mRS)• Barthel Index (BI)Barthel Index (BI)• Glasgow Outcome Scale (GOS)Glasgow Outcome Scale (GOS)• Utilize scored assessments of patient’s Utilize scored assessments of patient’s

functional statusfunctional status• Can be used to gauge:Can be used to gauge:

• pre-morbid baseline pre-morbid baseline • outcomeoutcome

Page 72: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

ScoreScore DescriptionDescription

66 DeadDead

55 Severe disabilitySevere disability: bedridden, incontinent, and requiring constant nursing : bedridden, incontinent, and requiring constant nursing care and attentioncare and attention

44 Moderately severe disabilityModerately severe disability: unable to walk without assistance and : unable to walk without assistance and unable to attend to own bodily needs without assistanceunable to attend to own bodily needs without assistance

33 Moderate disabilityModerate disability: requiring some help, but able to walk without : requiring some help, but able to walk without assistanceassistance

22 Slight disabilitySlight disability: unable to carry out all previous activities, but able to look : unable to carry out all previous activities, but able to look after own affairs without assistanceafter own affairs without assistance

11 No significant disabilityNo significant disability: despite symptoms, able to carry out all usual : despite symptoms, able to carry out all usual duties and activitiesduties and activities

00 No symptoms at allNo symptoms at all

Modified Rankin ScaleModified Rankin Scale

Good outcome = score of 0 - 1

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Barthel IndexBarthel IndexFeedingFeeding 0 = unable0 = unable

5 = needs help cutting, spreading butter, etc, or requires modified diet5 = needs help cutting, spreading butter, etc, or requires modified diet

10 = independent10 = independent

BathingBathing 0 = dependent0 = dependent

5 = independent (or in shower)5 = independent (or in shower)

GroomingGrooming 0 = needs help with personal care0 = needs help with personal care

5 = independent face/hair/teeth/shaving (implements provided)5 = independent face/hair/teeth/shaving (implements provided)

DressingDressing 0 = dependent0 = dependent

5 = needs help but can do about half unaided5 = needs help but can do about half unaided

10 = independent (including buttons, zips, laces, etc)10 = independent (including buttons, zips, laces, etc)

BowelsBowels 0 = incontinent (or needs enemas)0 = incontinent (or needs enemas)

5 = occasional accident5 = occasional accident

10 = continent10 = continent

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Barthel IndexBarthel IndexBladderBladder 0 = incontinent, or catheterized and unable to manage alone0 = incontinent, or catheterized and unable to manage alone

5 = occasional accident5 = occasional accident

10 = continent10 = continent

Toilet useToilet use 0 = dependent0 = dependent

5 = needs some help but can do something alone5 = needs some help but can do something alone

10 = independent (on and off, dressing, wiping)10 = independent (on and off, dressing, wiping)

TransfersTransfers

(bed to chair and (bed to chair and back)back)

0 = unable, no sitting balance0 = unable, no sitting balance

5 = major help (1 or 2 people, physical), can sit5 = major help (1 or 2 people, physical), can sit

10 = minor help (verbal or physical)10 = minor help (verbal or physical)

15 = independent15 = independent

MobilityMobility

(on level surfaces)(on level surfaces)

0 = immobile or <50 yards0 = immobile or <50 yards

5 = wheelchair-independent, including corners, >50 yards5 = wheelchair-independent, including corners, >50 yards

10 = walks with help of 1 person (verbal or physical) >50 yards10 = walks with help of 1 person (verbal or physical) >50 yards

15 = independent (but may use any aid—eg, stick) >50 yards15 = independent (but may use any aid—eg, stick) >50 yards

StairsStairs 0 = unable0 = unable

5 = needs help (verbal, physical, carrying aid)5 = needs help (verbal, physical, carrying aid)

10 = independent10 = independent

100 point scale; good outcome = 95 - 100

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ScoreScore DescriptionDescription

11 DEADDEAD

22 VEGETATIVE STATE VEGETATIVE STATE

Unable to interact with environment; unresponsive Unable to interact with environment; unresponsive

33 SEVERE DISABILITYSEVERE DISABILITY

Able to follow commands/ unable to live independently Able to follow commands/ unable to live independently

44 MODERATE DISABILITYMODERATE DISABILITY

Able to live independently; unable to return to work or school Able to live independently; unable to return to work or school

55 GOOD RECOVERYGOOD RECOVERY

Able to return to work or school Able to return to work or school

Glasgow Outcome ScaleGlasgow Outcome Scale

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Functional Scales and tPA Functional Scales and tPA OutcomeOutcome

• NINDS tPA trial: NINDS tPA trial: • 13% absolute increase in mRS 0 – 1 in treatment 13% absolute increase in mRS 0 – 1 in treatment

groupgroup• 12% increase in BI 95-100 in treatment group12% increase in BI 95-100 in treatment group• Means: 9 patients need to be treated for one Means: 9 patients need to be treated for one

improvement in outcome (NNT = 9)improvement in outcome (NNT = 9)

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1-Year Outcome in NINDS 1-Year Outcome in NINDS trialtrial

38

50

16

13

17

13

28

24

Placebo

t-PA

28

41

24

20

21

15

28

24

Placebo

t-PA

32

43

18

16

22

16

28

24

Placebo

t-PA

Percentage of Patients

Minimal or No Disability Moderate Disability Severe Disability Death

Barthel Index

Modified Rankin Scale

Glasgow Outcome Scale

Kwiatkowski TG, et al. N Engl J Med. 1999;340:1781-1787.

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Looking at NINDS data more closelyLooking at NINDS data more closelyThe sliding scale dichotomy endpointThe sliding scale dichotomy endpoint

Saver J, 31st International Stroke Conference, Kissimmee, FL, Feb 2006

mRS: 0 1 2 3 4 5 6 Baseline-adjusted severity endpoint reanalysis, 3-month outcome

NIHSS 0-7

“GOOD”

NIHSS 8-14

“GOOD” “GOOD”

NIHSS >14

mRS: 0 1 2 3 4 5 6

All NIHSS

“GOOD”

NNT = 9

NNT = 3

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Stroke 2006 Debate

SummarySummary• The NIHSS helps quantify and stratify The NIHSS helps quantify and stratify

acute strokeacute stroke• Key aspects of the stroke-focused (NIH Key aspects of the stroke-focused (NIH

scale) neuro exam:scale) neuro exam: LOC, vision, motor, coordination, LOC, vision, motor, coordination,

sensation, languagesensation, language• Understanding the mRS, BI, and GOS can Understanding the mRS, BI, and GOS can

aid interpretation of outcome in stroke aid interpretation of outcome in stroke clinical trials.clinical trials.

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Question: Question: Use of IV tPAUse of IV tPA

• This patient’s stroke is deemed This patient’s stroke is deemed to be moderate to severe in its to be moderate to severe in its severity and is a suitable severity and is a suitable candidate for thrombolytic candidate for thrombolytic therapy with IV tPA . Which of therapy with IV tPA . Which of the following is your viewpoint the following is your viewpoint regarding the use of IV tPA given regarding the use of IV tPA given the published efficacy data?the published efficacy data?

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Stroke 2006 Debate

Question: Question: Use of IV tPAUse of IV tPA

A.A. If IV tPA is indicated, I use it If IV tPA is indicated, I use it because the clinical data because the clinical data supports its use and I am supports its use and I am adequately supported in its adequately supported in its use.use.

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Stroke 2006 Debate

Question: Question: Use of IV tPAUse of IV tPA

B.B. Although I am not opposed Although I am not opposed to the use of tPA, I do not use to the use of tPA, I do not use it often because patients it often because patients rarely meet the criteria for rarely meet the criteria for use in the EDuse in the ED..

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Stroke 2006 Debate

Question: Question: Use of IV tPAUse of IV tPA

C.C. I try not to use tPA because I try not to use tPA because the published efficacy data the published efficacy data does not adequately support does not adequately support its use and because I am not its use and because I am not well supported to use it.well supported to use it.

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Question: Question: Use of IV tPAUse of IV tPA

D.D. I simply am so concerned I simply am so concerned about the risk of a about the risk of a symptomatic ICH that I symptomatic ICH that I cannot bear to use this drug cannot bear to use this drug when treating stroke patients when treating stroke patients such as this one.such as this one.

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Stroke 2006 Debate

Question: Question: Use of IV tPAUse of IV tPA

E.E. I leave the tPA use decision I leave the tPA use decision to the stroke team or to the stroke team or neurology consultant.neurology consultant.

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Stroke 2006 Debate

Question: Question: Use of IV tPAUse of IV tPA

F.F. Haven’t we discussed tPA Haven’t we discussed tPA enough already?enough already?

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Stroke 2006 Debate

Question: Question: Use of IV tPAUse of IV tPA

A. Clinical data supports its useB.B. Patients rarely meet the criteriaPatients rarely meet the criteria C.C. Published efficacy data does not Published efficacy data does not

adequately support its useadequately support its useD.D. Concerned about the risk of a Concerned about the risk of a

symptomatic ICHsymptomatic ICHE.E. Decided by the stroke teamDecided by the stroke teamF.F. Haven’t we discussed tPA Haven’t we discussed tPA

enough already?enough already?

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Question: Question: tPA DatatPA Data

• Regarding the reanalysis of Regarding the reanalysis of the NINDS tPA clinical trial the NINDS tPA clinical trial data and the phase IV tPA data and the phase IV tPA use data, which of the use data, which of the following describe your following describe your understanding of the info?understanding of the info?

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Question: Question: tPA DatatPA Data

A.A. I understand that the reanalysis I understand that the reanalysis of the NINDS data suggests that of the NINDS data suggests that there is a real treatment effect there is a real treatment effect and that the phase IV data and that the phase IV data confirms that the outcomes of confirms that the outcomes of the NINDS study can be the NINDS study can be replicated in clinical practice.replicated in clinical practice.

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Question: Question: tPA DatatPA Data

B.B. I know that the NINDS clinical I know that the NINDS clinical trial data was confirmed, but trial data was confirmed, but the numbers are too small to the numbers are too small to allow for widespread clinical allow for widespread clinical use, even with confirmatory use, even with confirmatory phase IV clinical data.phase IV clinical data.

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Question: Question: tPA DatatPA Data

C.C. I have trouble believing I have trouble believing phase IV reports, since they phase IV reports, since they are inherently biased, making are inherently biased, making the use of tPA still somewhat the use of tPA still somewhat experimental in my practiceexperimental in my practice..

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Question: Question: tPA DatatPA Data

D.D. I do not have enough I do not have enough familiarity with the reanalysis familiarity with the reanalysis or the phase IV publications, or the phase IV publications, such that I have not changed such that I have not changed my tPA clinical practicemy tPA clinical practice..

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Question: Question: tPA DatatPA Data

E.E. Why was the data reanalyzed, Why was the data reanalyzed, and what is a phase IV and what is a phase IV study?study?

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Stroke 2006 Debate

Question: Question: tPA DatatPA Data

A. I understand the reanalysis of the NINDS data & phase IV data

B.B. Numbers are too small to allow Numbers are too small to allow for widespread clinical use.for widespread clinical use.

C.C. I have trouble believing phase IV I have trouble believing phase IV reports and have not changed reports and have not changed

D.D. I do not have enough familiarityI do not have enough familiarityE.E. What is a phase IV study?What is a phase IV study?

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NINDS Trial ResultsNINDS Trial Results % Patients with Favorable Outcome% Patients with Favorable Outcome

t-PA Placebot-PA Placebo

No. of patients: 312No. of patients: 312 157157 145145

Modified Rankin ScaleModified Rankin Scale 40%40% 28%28%

Glasgow Outcome ScaleGlasgow Outcome Scale 43%43% 32%32%

NIHSSNIHSS 34%34% 20%20%

Symptomatic ICH (within 36 hr)Symptomatic ICH (within 36 hr) 6.4%6.4% 0.6%0.6%

Death (by 90 days)Death (by 90 days) 17%17% 21%21%

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IV ThrombolysisIV Thrombolysis 14% absolute increase for the best clinical 14% absolute increase for the best clinical

outcomes (mRS of 0-1).outcomes (mRS of 0-1). BenefitBenefit = Need to treat eight patients with tPA = Need to treat eight patients with tPA

in order to have one additional patient with in order to have one additional patient with this best outcome.this best outcome.

6% absolute increase in the number of 6% absolute increase in the number of symptomatic ICH.symptomatic ICH.

HarmHarm = Will have one symptomatic ICH for = Will have one symptomatic ICH for every 16 patients treated with tPA.every 16 patients treated with tPA.

2 patients will have a minimal or no deficit for 2 patients will have a minimal or no deficit for every patient with a symptomatic ICHevery patient with a symptomatic ICH

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Meta-analysesMeta-analyses

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Meta-analysesMeta-analyses• Wardlaw et al.Wardlaw et al.• Net benefit despite hazardsNet benefit despite hazards• For 1000 treated up to 6hrs:For 1000 treated up to 6hrs:

55 improve, 20 die55 improve, 20 die• Heterogeneity, wide CI make results Heterogeneity, wide CI make results

unreliableunreliable• Additional trial data requiredAdditional trial data required

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Meta-analysesMeta-analyses

• Graham et al., 15 published reportsGraham et al., 15 published reports• ICH rate 5.2%, total death rate 13.4%ICH rate 5.2%, total death rate 13.4%• All better than NINDSAll better than NINDS• Lysis can be used safely across Lysis can be used safely across

wide variety of practice settingswide variety of practice settings

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Meta-analysesMeta-analyses• Hacke et al.Hacke et al.• 6 randomized trials6 randomized trials• Sooner thrombolytics given the Sooner thrombolytics given the

greater the benefitgreater the benefit• Particularly when given within 90 Particularly when given within 90

minutes of onsetminutes of onset

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Stroke 2006 Debate

CONTROVERSY: CONTROVERSY: Meta-analysisMeta-analysis

• Hoffman and CooperHoffman and Cooper• Pooled data can not replace new or Pooled data can not replace new or

confirmatory dataconfirmatory data• Meta-analyses did not include Meta-analyses did not include

streptokinase trials which were streptokinase trials which were negativenegative

• No reason to exclude streptokinaseNo reason to exclude streptokinase

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Stroke 2006 Debate

Phase IV tPA trialsPhase IV tPA trialsAuthorAuthor Eligible Eligible

patientspatientsPatients Patients receiving receiving tPA(%)tPA(%)

Mean time Mean time to Rxto Rx

Median Median NIHSS NIHSS scorescore

Favorable Favorable outcomeoutcome

% ICH% ICH % % SymptomSymptomatic ICHatic ICH

% % Protocol Protocol deviationdeviation

NINDSNINDS 312312 1414 31-54%31-54% 10.9%10.9% 6.4%6.4%

ChiuChiu 10351035 30(2.9%)30(2.9%) 2’37”2’37” 1414 63%63% 10%10% 6.6%6.6%

TanneTanne 189189 >2’>2’ 11-1511-15 9%9% 5.8%5.8% 30%30%

WangWang 900900 57(6.3%)57(6.3%) 2’28”2’28” 1515 44-54%44-54% 9%9% 5%5% 9%9%

BuchanBuchan 15401540 68(4.4%)68(4.4%) 1515 95%95% 31%31% 9%9% 16%16%

AlbersAlbers 389389 2’44”2’44” 1313 35-43%35-43% 11.5%11.5% 3.3%3.3% 33%33%

KatzanKatzan 39483948 70(1.8%)70(1.8%) 1212 22%22% 15.7%15.7% 50%50%

ChapmanChapman 25562556 46(1.8%)46(1.8%) 2’45”2’45” 1414 30-48%30-48% 9%9% 2.2%2.2% 17%17%

GrottaGrotta 16891689 269(16%)269(16%) 2’17”2’17” 1414 33%33% 4.5%4.5% 13%13%

BravataBravata 6363 1515 17%17% 6%6% 67%67%

TotalTotal 12,28212,282 928(5.8%)928(5.8%) 2’25”2’25” 10-1510-15 33-95%33-95% 9.6%9.6% 5.2%5.2% 13-67%13-67%

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Stroke 2006 Debate

Re-analysisRe-analysis

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Stroke 2006 Debate

NINDS Re-analysisNINDS Re-analysis• Does the protocol work?Does the protocol work?• Do subgroup imbalances invalidate Do subgroup imbalances invalidate

the entire trial?the entire trial?• What about BP?What about BP?

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Baseline NIHSS ImbalanceBaseline NIHSS Imbalance

NIHSS ScoreNIHSS Score 0-50-5 6-106-10 11-1511-15 16-2016-20 > 20> 20

No. of No. of patientspatients

PlaceboPlacebo

(n=312)(n=312)

1616 8383 6666 7070 7777

t-Pat-Pa

(n=310)(n=310)

4242 6767 6565 7373 6363

Chi-square (4 DF) = 14.8; p = 0.005Chi-square (4 DF) = 14.8; p = 0.005

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OTT Analysis ReportOTT Analysis Report• Review Committee had concerns Review Committee had concerns

about analyzing OTT as a about analyzing OTT as a continuous variablecontinuous variable

• Uncertainty about the exact time of Uncertainty about the exact time of stroke onset.stroke onset.

• OTT distribution was nonlinear with OTT distribution was nonlinear with 25% of all the patients having OTT 25% of all the patients having OTT values of either 89 or 90 minutes.values of either 89 or 90 minutes.

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Symptom onset vs Cumulative Symptom onset vs Cumulative %%

Time from symptom onset to treatment (minutes)Time from symptom onset to treatment (minutes)

Cum

ulat

ive

perc

enta

geC

umul

ativ

e pe

rcen

tage

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NINDS ICH AnalysisNINDS ICH Analysis

# of Risk # of Risk FactorsFactors

# of patients treated # of patients treated with t-PAwith t-PA

(n=310)(n=310)

# Symptomatic ICHs# Symptomatic ICHs

(# of placebo patients with (# of placebo patients with ICH)ICH)

Percentage Percentage (%)(%)

00 114114 2 (1)2 (1) 1.81.8

11 144144 7 (1)7 (1) 4.94.9

> 1> 1 5252 1111 21.221.2

Risk Factors for ICH:Risk Factors for ICH:• Baseline NIHSS > 20Baseline NIHSS > 20• Age > 70 yearsAge > 70 years• Ischemic changes present on initial CTIschemic changes present on initial CT• Glucose > 300 mg/dl (16.7 mmol/L)Glucose > 300 mg/dl (16.7 mmol/L)

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IV ThrombolysisIV Thrombolysis The independent reanalysis of the NINDS tPA The independent reanalysis of the NINDS tPA

clinical trial confirms the results from the clinical trial confirms the results from the initial initial NEJM NEJM publicationpublication

Support the use of tPA in stroke patients Support the use of tPA in stroke patients within three hours of symptom onsetwithin three hours of symptom onset

Number needed to treat calculation based on Number needed to treat calculation based on this reanalysis confirms that approximately this reanalysis confirms that approximately 8-10 patients need to be treated with tPA in 8-10 patients need to be treated with tPA in order to cause one extra patient to have the order to cause one extra patient to have the best clinical outcome.best clinical outcome.

2 patients will improve for every one that 2 patients will improve for every one that develops a symp ICHdevelops a symp ICH

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EM Physicians and LysisEM Physicians and Lysis• Brown et al. Brown et al. • 1,105 of 2600 ACEP members responded1,105 of 2600 ACEP members responded• 40% not likely to use thrombolytics40% not likely to use thrombolytics

• 65% risk of ICH65% risk of ICH• 23% perceived lack of benefit23% perceived lack of benefit• 12% both12% both

• Upper limit ICH rate 3.4%Upper limit ICH rate 3.4%• Lowest acceptable relative improvement 40%Lowest acceptable relative improvement 40%

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Informed Consent: Informed Consent: DocumentationDocumentation

• With tPA, there is a 30% greater chance of a With tPA, there is a 30% greater chance of a good outcome at 3 monthsgood outcome at 3 months

• With tPA use, there is 10x greater risk of a With tPA use, there is 10x greater risk of a symptomatic ICH (severe bleeding stroke)symptomatic ICH (severe bleeding stroke)

• Mortality rates at 3 months are the same Mortality rates at 3 months are the same regardless of whether tPA is usedregardless of whether tPA is used

• 2 patients will have a minimal or no deficit for 2 patients will have a minimal or no deficit for everyone patient with a symptomatic ICHeveryone patient with a symptomatic ICH

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DocumentationDocumentation• Just as importantJust as important

• ““The patient is NOT a candidate for The patient is NOT a candidate for tPA because…”tPA because…”

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Stroke 2006 Debate

Question: Question: Utilizing TestsUtilizing Tests

• Many diagnostic tests are Many diagnostic tests are available when attempting to available when attempting to intervene positively in acute intervene positively in acute stroke patients. If the initial CT stroke patients. If the initial CT is negative for hemorrhage, how is negative for hemorrhage, how do you utilize tests such as MRI, do you utilize tests such as MRI, MRA, CTA, or cerebral MRA, CTA, or cerebral angiography when treating angiography when treating stroke patients?stroke patients?

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Stroke 2006 Debate

Question: Question: Utilizing TestsUtilizing Tests

A.A. I do not know when these I do not know when these tests are indicated in acute tests are indicated in acute ischemic stroke patients, and ischemic stroke patients, and so do not order them in the so do not order them in the EDED..

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Stroke 2006 Debate

Question: Question: Utilizing TestsUtilizing Tests

B.B. I am aware that these tests I am aware that these tests may enhance the ability to may enhance the ability to diagnose the vascular lesion diagnose the vascular lesion responsible for the stroke, responsible for the stroke, but I rely on my neurology but I rely on my neurology consultants to determine the consultants to determine the need for these testsneed for these tests..

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Stroke 2006 Debate

Question: Question: Utilizing TestsUtilizing Tests

C.C. I know that these tests are most I know that these tests are most useful when considering useful when considering advanced stroke therapies such advanced stroke therapies such as IA thrombolysis or clot as IA thrombolysis or clot retrieval, and only order them retrieval, and only order them when the patient is due to have when the patient is due to have an interventional radiology an interventional radiology procedure.procedure.

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Stroke 2006 Debate

Question: Question: Utilizing TestsUtilizing Tests

D.D. I order these tests often in order I order these tests often in order to expedite the diagnostic to expedite the diagnostic workup of my ED stroke workup of my ED stroke patients, whether these patients patients, whether these patients are to receive IV tPA or who are to receive IV tPA or who might receive an acute might receive an acute interventional radiology interventional radiology procedure.procedure.

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Stroke 2006 Debate

Question: Question: Utilizing TestsUtilizing Tests

E.E. Have any of these diagnostic Have any of these diagnostic tests been proven to be tests been proven to be effective at improving effective at improving outcome in stroke patients?outcome in stroke patients?

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Stroke 2006 Debate

Question: Question: Utilizing TestsUtilizing Tests

A. I do not order them in the ED..B.B. I rely on my neurology I rely on my neurology

consultants.consultants.C.C. I order them when the patient is I order them when the patient is

due to have an interventional due to have an interventional radiology procedure.radiology procedure.

D.D. I order these tests often.I order these tests often.E.E. Have these tests been proven to Have these tests been proven to

be effective?be effective?

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Stroke 2006 Debate

Question: Question: Advanced TherapiesAdvanced Therapies

• There are many options that There are many options that exist after the three-hour IV tPA exist after the three-hour IV tPA window, including IA window, including IA thrombolysis, the Merci clot thrombolysis, the Merci clot retrieval device, and devices that retrieval device, and devices that enhance cerebral blood flow. enhance cerebral blood flow. What is your clinical practice What is your clinical practice regarding these advanced stroke regarding these advanced stroke therapies?therapies?

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Stroke 2006 Debate

Question: Question: Advanced TherapiesAdvanced Therapies

A.A. I do not have a clear I do not have a clear understanding of these understanding of these advanced therapies, and do advanced therapies, and do not access them for my not access them for my stroke patients.stroke patients.

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Stroke 2006 Debate

Question: Question: Advanced TherapiesAdvanced Therapies

B.B. I know of these therapies, but I know of these therapies, but my understanding is that my understanding is that they are experimental in they are experimental in nature and are not a part of nature and are not a part of the standard of carethe standard of care..

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Stroke 2006 Debate

Question: Question: Advanced TherapiesAdvanced Therapies

C.C. I have noted these therapies I have noted these therapies to be used by my neurology to be used by my neurology consultants on occasion, but consultants on occasion, but I am not sure of the I am not sure of the indications for their use.indications for their use.

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Stroke 2006 Debate

Question: Question: Advanced TherapiesAdvanced Therapies

D.D. I understand the utility of I understand the utility of these interventions, and I these interventions, and I aggressively pursue them for aggressively pursue them for my stroke patients who do my stroke patients who do not meet the IV tPA criterianot meet the IV tPA criteria..

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Stroke 2006 Debate

Question: Question: Advanced TherapiesAdvanced Therapies

E.E. Have any of these therapies Have any of these therapies been proven to be effective in been proven to be effective in any published clinical trials?any published clinical trials?

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Stroke 2006 Debate

Question: Question: Advanced TherapiesAdvanced Therapies

A. Do not access them.B.B. Experimental in natureExperimental in nature..C.C. used by my neurology used by my neurology

consultants on occasion.consultants on occasion.D.D. I aggressively pursue them.I aggressively pursue them.E.E. Have any of these therapies been Have any of these therapies been

proven to be effective in any proven to be effective in any published clinical trials?published clinical trials?

Page 127: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Foundation for Education and Researchin Neurological Emergencies

Stroke Care 2006: Clinical Consensus and Opportunities June 16, 2006

Treatment of Stroke Beyond Three Hours

Thomas G. Brott, MD, Professor of NeurologyMayo Clinic Jacksonville

College of Medicine

Page 128: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Results I

• 2776 patients

• Over 300 hospitals

• 18 countries

• Median age 68 years

• Median baseline NIHSSS 12

Page 129: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Results II

• Median onset-to-treatment time 4 hours

• Of the 929 (33%) treated within 3 hours, one-third were from studies other than NINDS

Page 130: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Results IV

Odds Ratios for Favorable Outcome

Time Odds Ratio 95% Conf. Interval

0-90 2.8 1.8, 4.5

91-180 1.5 1.1, 2.1

181-270 1.4 1.1, 1.9

271-360 1.2 0.9, 1.5

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What about IA thrombolysis?

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PROACT II

• Stroke within 6 hours

• 2/3 treated with pro-UK (121)

• 1/3 treated with placebo (59)

Page 135: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Results of ProACT II

• 40% of the UK patients had a good recovery

• 25% of the control patients had a good recovery

• P=.04

• Absolute % difference=15%...=NNT of ~ 7

• FDA did not approve

Page 136: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

                                       

A score of 2 (yellow) on the modified Rankin scale (mRS) indicates a favorable outcome of slight or no disability. A score of 6 represents death. R-proUK = recombinant prourokinase

Page 137: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Beyond Thrombolysis: Combination Therapy, Devices,

and Other Approaches

Page 138: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts
Page 139: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Concentric Retriever Device With Nitinol Coil (White Arrow) and Inflated

Balloon (Black Arrow)

Leary MC, et al. Ann Emerg Med. 2003 Jun;41(6):838-46

Page 140: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

MERCI Recanalization and Outcomes

ICA

(n=47)

MCA

(n=80)

BL NIHSS 19 20

TIMI II/III* 53% 45%

NIHSS 10 pts.** 33% 29%

Sx ICH 15% 4%

Death** 51% 39%

* About half were TIMI III

** At 90 days

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ICH in 11 (8%) of patients

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Stroke 2006 Debate

Question: Question: Clinical GuidelinesClinical Guidelines

• Regarding ischemic stroke Regarding ischemic stroke patients, what is your patients, what is your understanding and use of understanding and use of clinical guidelines?clinical guidelines?

Page 143: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Clinical GuidelinesClinical Guidelines

A.A. I am not aware of any clinical I am not aware of any clinical guidelines that direct my care guidelines that direct my care of ischemic stroke patients.of ischemic stroke patients.

Page 144: Stroke 2006 Debate Stroke Care 2006: Clinical Consensus and Opportunities A Case Study to Challenge the Experts

Stroke 2006 Debate

Question: Question: Clinical GuidelinesClinical Guidelines

B.B. I am sure that there are I am sure that there are guidelines that exist from guidelines that exist from organizations such as the organizations such as the American Stroke Association, American Stroke Association, but I do not use them because but I do not use them because primarily my neurology primarily my neurology consultants utilize these consultants utilize these guidelines.guidelines.

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Stroke 2006 Debate

Question: Question: Clinical GuidelinesClinical Guidelines

C.C. I am familiar with guidelines I am familiar with guidelines that direct stroke patient that direct stroke patient care, and I refer to them on care, and I refer to them on occasion in order to optimize occasion in order to optimize my acute caremy acute care..

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Stroke 2006 Debate

Question: Question: Clinical GuidelinesClinical Guidelines

D.D. I follow clinical guidelines I follow clinical guidelines and protocols in my ED and protocols in my ED because our hospital has because our hospital has integrated them into clinical integrated them into clinical policies for the institution.policies for the institution.

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Stroke 2006 Debate

Question: Question: Clinical GuidelinesClinical Guidelines

E.E. I wish that there were I wish that there were guidelines that would direct guidelines that would direct my treatment of stroke my treatment of stroke complications such as complications such as elevated blood pressureelevated blood pressure..

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Stroke 2006 Debate

Question: Question: Clinical GuidelinesClinical Guidelines

A. Not aware of any clinical guidelines.

B.B. My neurology consultants utilize My neurology consultants utilize these guidelines.these guidelines.

C.C. I refer to them on occasion.I refer to them on occasion.D.D. Our hospital has integrated them.Our hospital has integrated them.E.E. I wish that there were guidelines.I wish that there were guidelines.

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Stroke 2006 Debate

Question: Question: Optimal TherapiesOptimal Therapies

• Regarding neuroprotection in Regarding neuroprotection in acute ischemic stroke acute ischemic stroke patients, what is your patients, what is your understanding of current understanding of current optimal therapies?optimal therapies?

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Stroke 2006 Debate

Question: Question: Optimal TherapiesOptimal Therapies

A.A. I am not aware of any I am not aware of any specific neuroprotection specific neuroprotection therapies for ischemic stroke therapies for ischemic stroke patientspatients..

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Stroke 2006 Debate

Question: Question: Optimal TherapiesOptimal Therapies

B.B. I believe that the only useful I believe that the only useful therapies involve ASA use therapies involve ASA use and blood pressure and and blood pressure and glucose management in the glucose management in the majority of ischemic stroke majority of ischemic stroke patientspatients..

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Stroke 2006 Debate

Question: Question: Optimal TherapiesOptimal Therapies

C.C. Besides BP and glucose control, Besides BP and glucose control, I consider optimal cerebral blood I consider optimal cerebral blood flow to be another critical flow to be another critical neuroprotectant, and I pursue neuroprotectant, and I pursue aggressive thrombolysis and aggressive thrombolysis and clot retrieval of the target vessel clot retrieval of the target vessel in order to achieve itin order to achieve it..

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Stroke 2006 Debate

Question: Question: Optimal TherapiesOptimal Therapies

D.D. I am aware of the trials of I am aware of the trials of specific neuroprotectants, specific neuroprotectants, and I utilize them in my and I utilize them in my clinical practiceclinical practice..

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Stroke 2006 Debate

Question: Question: Optimal TherapiesOptimal Therapies

E.E. I do not believe that I do not believe that neuroprotection is possible. neuroprotection is possible. Once the initial damage is Once the initial damage is done, there is no way to done, there is no way to protect the infarct zone or protect the infarct zone or ischemic penumbraischemic penumbra..

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Stroke 2006 Debate

Question: Question: Optimal TherapiesOptimal Therapies

A. Not aware of any therapies.B.B. Only useful therapies involve Only useful therapies involve

ASA use and blood pressure and ASA use and blood pressure and glucose management.glucose management.

C.C. Optimal cerebral blood flow is Optimal cerebral blood flow is another critical neuroprotectant.another critical neuroprotectant.

D.D. I utilize them.I utilize them.E.E. I do not believe that I do not believe that

neuroprotection is possible.neuroprotection is possible.

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Stroke 2006 Debate

Question: Question: Stroke and ICHStroke and ICH

• Consider if this patient had been Consider if this patient had been on warfarin and had an on warfarin and had an intracerebral hemorrhage of the intracerebral hemorrhage of the left temporal lobe of 3 cm left temporal lobe of 3 cm diameter associated with diameter associated with moderate edema and mass moderate edema and mass effect. What might be your effect. What might be your management of this ICH patient?management of this ICH patient?

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Stroke 2006 Debate

Question: Question: Stroke and ICHStroke and ICH

A. I would admit this patient to neurosurgery for further orders.

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Stroke 2006 Debate

Question: Question: Stroke and ICHStroke and ICH

B.B. I would transfer this patient to I would transfer this patient to another hospital because I don’t another hospital because I don’t have neurosurgery coverage have neurosurgery coverage and/or it is our institution’s and/or it is our institution’s protocol.protocol.

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Stroke 2006 Debate

Question: Question: Stroke and ICHStroke and ICH

C. C. I would be able to manage BP, I would be able to manage BP, ICP, the airway, and ICH ICP, the airway, and ICH complications in the ED prior to complications in the ED prior to disposition to another service for disposition to another service for admission.admission.

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Stroke 2006 Debate

Question: Question: Stroke and ICHStroke and ICH

D. D. Not only would I manage the Not only would I manage the patient as in (C.) above, I would patient as in (C.) above, I would also discuss the use of Factor also discuss the use of Factor VIIa with neurosurgery in this ICH VIIa with neurosurgery in this ICH patient’s care.patient’s care.

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Stroke 2006 Debate

Question: Question: Stroke and ICHStroke and ICH

D. D. I am aware of ICH management I am aware of ICH management guidelines, including those that guidelines, including those that govern the care of patients with govern the care of patients with an elevated INR, and would follow an elevated INR, and would follow these guidelines in managing this these guidelines in managing this patient.patient.

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Stroke 2006 Debate

Question: Question: Stroke and ICHStroke and ICH

A. A. Admit to neurosurgery. Admit to neurosurgery. B. B. Transfer for neurosurgery care.Transfer for neurosurgery care.C. C. I can manage pt prior to transfer.I can manage pt prior to transfer.D. D. FVIIa is an issue I would address.FVIIa is an issue I would address.E. E. I know how to manage elevated I know how to manage elevated

INRs in pts who are on warfarin.INRs in pts who are on warfarin.

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Stroke 2006 Debate

ConclusionsConclusions

• Important EM patient clinical areaImportant EM patient clinical area• Many questionsMany questions• Some areas of consensusSome areas of consensus• Many areas of opportunityMany areas of opportunity• Further work is neededFurther work is needed• The interest is thereThe interest is there

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Stroke 2006 Debate

Questions?Questions?Thank you!Thank you!

[email protected]@uic.eduwww.ferne.org

ferne_pv_2006_strokecare_final 04/21/23 01:26