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

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


1
Stroke Care 2006 Clinical Consensus and
OpportunitiesA Case Study to Challenge the
Experts
2
Clinical Decision Making in Emergency
MedicineAn Evidence-Based ConferencePonte
Vedra Beach, FLJune 15-17, 2006
3
Thank you to AstraZeneca for their support of
this stroke educational meeting
4
Panelists
  • Andy Jagoda, MD, FACEP (Moderator)
    Mount Sinai School of Medicine
  • Thomas G. Brott, MD Mayo Clinic Jacksonville
  • E. Bradshaw Bunney, MD, FACEP University of
    Illinois at Chicago
  • J. Stephen Huff, MD, FACEP
    University of Virginia
  • Edward P. Sloan, MD, MPH, FACEP
    University of Illinois at Chicago

5
Disclosures
  • Andy Jagoda, MD
  • AstraZeneca
  • Thomas G. Brott, MD
  • None
  • E. Bradshaw Bunney, MD
  • AstraZeneca, Genentech consultant
  • J. Stephen Huff, MD
  • None
  • Edward P. Sloan, MD, MPH
  • None

6
Global Objectives
  • Improve acute stroke patient care
  • Minimize morbidity and mortality
  • Expedite disposition
  • Optimize resource utilization
  • Enhance our job satisfaction

7
Session Activities
  • Present a relevant clinical case
  • Poll the audience about care
  • Discuss the questions
  • Understand areas of consensus
  • Explore areas of uncertainty
  • Go forth and prosper

8
Case Presentation
  • 62 year-old professor has an apparent stroke
    while teaching at the local community college.
  • Contact to the local EMS base station occurs
    within 15 minutes of the onset of symptoms.
  • He arrives at the closest ED within 30 minutes of
    symptom onset.

9
Case Presentation
  • VS 178/80 RR 18 P 96 Temp 98.6
  • Cardiopulmonary exam OK
  • Mental Status OK
  • Neurological Exam
  • Awake and alert
  • R facial weakness
  • Slurred speech
  • Right visual field neglect
  • Unable to purposefully move RUE / RLE

10
Question TIA 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?

11
Question TIA ED Visit
  1. I admit all TIA patients regardless of the
    severity of the symptoms.

12
Question TIA ED Visit
  • B. I only admit those patients who have clear
    motor weakness or visual symptoms (amaurosis
    fugax) because of a greater stroke risk.

13
Question TIA 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).

14
Question TIA 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.

15
Question TIA ED Visit
  • E. I dont really have an opinion on what to do
    with this TIA patient, and so would depend on my
    neurologist for a disposition decision.

16
Question TIA ED Visit
  1. I admit all TIA patients.
  2. I only admit those patients who have clear motor
    weakness or visual symptoms.
  3. Send home after a cranial CT and a carotid
    evaluation.
  4. Send home, outpatient TIA workup.
  5. No opinion, ask the neurologist.

17
Question EMS Triage
  • Regarding EMS triage, should this patient be

18
Question EMS Triage
  • Transported to the closest hospital?

19
Question EMS Triage
  • B. Diverted to the closest primary stroke center?

20
Question EMS Triage
  • C. Diverted to the closest tertiary center with
    24/7 interventional radiology?

21
Question EMS Triage
  • D. Diverted to the closest
    comprehensive stroke center?

22
Question EMS Triage
  • E. Asked to finish his class first?

23
Question EMS Triage
  1. Closest hospital
  2. Closest primary stroke center
  3. Closest 24/7 IR tertiary center
  4. Closest comprehensive stroke center
  5. Asked to finish the class first

24
Question Inter-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?

25
Question Inter-hospital Transfer
  • A. There are no indications for inter-hospital
    transfer to take place.

26
Question Inter-hospital Transfer
  • B. The patient should be transferred after IV tPA
    is administered.

27
Question Inter-hospital Transfer
  • C. Transfer should take place only if IV tPA is
    not indicated and CNS intra-arterial thrombolytic
    therapy or thrombus removal is likely.

28
Question Inter-hospital Transfer
  • D. Transfer should take place for all patients if
    the time from symptom onset is between three and
    ten hours in order to allow advanced diagnostics
    to be provided acutely.

29
Question Inter-hospital Transfer
  • E. Transfer to a primary stroke center should
    take place for all stroke patients, regardless of
    the time of symptom onset, whether IV tPA has
    been provided, and whether an acute clot
    intervention is contemplated

30
Question Inter-hospital Transfer
  • F. I have no idea when inter-hospital transfer
    should take place for patients such as this one.

31
Question Inter-hospital Transfer
  1. No indications
  2. After IV tPA is administered.
  3. IV tPA is not indicated and CNS intra-arterial
    thrombolytic therapy or thrombus removal is
    likely
  4. Symptoms 3-10 hours, diagnostics
  5. Transfer all stroke patients
  6. I have no idea

32
Cincinnati Prehospital Stroke Scale
One positive possible stroke
33
11 elements of a Primary Stroke CenterJAMA 2000
2833102-3109
  • EMS integrated into the acute stroke response
  • Stroke team available 24 / 7
  • Written care protocols
  • ED integrated into the acute stroke team
  • Stroke unit
  • Neurosurgical services available within 2 hours
  • Commitment from the institution
  • Neuroimaging interpreted within 45 min of arrival
  • Laboratory services with rapid turn around of
    tests
  • CQI program including a database or registry
  • Continuing education program

34
NINDS Symposium 2002Improving the Chain of
Recovery for Acute Stroke in Your Community
  • ED basic
  • Recognizes that not all EDs can provide
    thrombolytic care
  • Stabilization ABC / BP / glucose / temp
  • Transfer protocols
  • Primary Stroke Center
  • Comprehensive Stroke Center
  • Tertiary care center
  • Advanced stroke expertise in neuroimaging,
    neurosurgery, interventional neuro-radiology

35
Stroke Centers
  • Improves outcomes?
  • Newell et al. clinical efficiency tools improve
    stroke management in a rural southern health
    system. Stroke 1998 291092-1098
  • Wentworth et al. Implementation of an acute
    stroke program decreases hospitalization cost and
    length of stay. Stroke 1996 271040-1043.
  • Douglas et al. Do the brain attach coalitions
    criteria for stroke centers improve care for
    ischemic stroke? Neurology 2005 64 422-427
  • Implementation increased incidence of t-PA use

36
AHRQ 127 Acute Stroke
  • Are designated centers effective in reducing
    stroke related disability and mortality?
  • No studies were identified
  • Studies have shown that stroke teams decrease the
    time to evaluation
  • Lattimore et al showed that creation of stroke
    team increased tPA use from 1.5 to 10.5 of
    acute stroke patients seen

37
IV tPA Utilization Cleveland Clinic Health
System
  • July 1997 - June 1998
  • 70 pts treated with IV tPA
  • 1.8 ischemic strokes
  • 11.1 of ischemic strokes arriving lt 3 hrs
  • 31 selected protocol deviations
  • 16 symptomatic
  • intracranial hemorrhage
  • July 1999 - June 2000
  • 53 pts treated with IV tPA
  • 2.4 ischemic strokes
  • 23.4 of ischemic strokes arriving lt 3 hrs
    (53/226)
  • 17 selected protocol deviations
  • 6.5 symptomatic
  • intracranial hemorrhage

Katzan et al, Stroke 200334799-800
38
JCAHO Disease Specific Care Certification
  • Joint initiative between ASA and JCAHO
  • Voluntary participation
  • 94 accredited hospitals
  • 36 site visits in progress
  • 718 applications pending
  • Premise is that accreditation process will drive
    quality measures and improve outcomes
  • No emergency medicine society has endorsed this
    initiative
  • t-PA controversy
  • Overcrowding
  • Medical legal implications

39
Question Use 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?

40
Question Use of the NIHSS
  • 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.

41
Question Use of the NIHSS
  • B. It is obvious how severe this patients stroke
    is, and the need for all potential stroke
    therapies can be determined clinically without
    actually calculating the NIHSS.

42
Question Use of the NIHSS
  • C. The NIHSS can be reliably estimated by
    determining symptom severity in four categories
    motor, speech, mental status, and visual/neglect.

43
Question Use of the NIHSS
  • D. The NIHSS is a research tool that can be
    calculated retrospectively as needed as long as
    the neurological exam in the ED is documented
    appropriately.

44
Question Use of the NIHSS
  • E. When I am considering IV tPA, I just quickly
    calculate the NIHSS using Internet tools.

45
Question Use of the NIHSS
  • F. What does NIHSS stand for, anyways?

46
Question Use of the NIHSS
  1. NIHSS is the standard of care
  2. Determine Rx clinically, no NIHSS
  3. Estimate NIHSS in 4 clinical areas
  4. Calculate retrospectively from exam
  5. Quickly calculate NIHSS with Internet
  6. What does NIHSS stand for?

47
Question Patient NIHSS
  • What is the approximate NIHSS of this patient?
  • Awake and alert
  • R facial weakness
  • Slurred speech
  • Right visual field neglect
  • Unable to purposefully move his RUE / RLE

48
Question Patient NIHSS
  1. 0-5
  2. 5-10
  3. 10-15
  4. 15-20
  5. Greater than 20

49
Question Use of Scales
  • Regarding the use of stroke outcome scales such
    as the Modified Rankin Scale (MRS) or the Barthel
    Index (BI), which of the following is your
    clinical approach?

50
Question Use of Scales
  • A. I use these scales in assessing stroke patient
    severity in the ED.

51
Question Use of Scales
  • B. I understand the MRS and the BI, and I use
    them to help in assessing the effectiveness of
    new stroke therapies from published clinical
    trials.

52
Question Use of Scales
  • C. I do not have any idea how these outcome
    scales are utilized, either in the ED or after
    hospital disposition.

53
Question Use of Scales
  • D. These scales correlate with the NIHSS, making
    their use superfluous.

54
Question Use of Scales
  • E. I have not ever heard of these scales, let
    alone use them!

55
Question Use of Scales
  1. I use these scales in the ED
  2. Scales assess the effectiveness of new stroke
    therapies
  3. No idea how these outcome scales are utilized
  4. Scales correlate with the NIHSS, making their use
    superfluous
  5. I have never heard of these stroke scales

56
The utility of clinical scales
  • Allow gross quantification of injury/pathology
  • Aid in communication to consultants
  • Can be used to track improvement or deterioration
    in the acute treatment phase
  • Can be used to track outcome
  • Can be useful research tools

Adapted from slide set of Kama Guluma, MD
57
The NIH Stroke Scale
Adapted from slide set of Kama Guluma, MD
58
The NIHSS
  1. Level of consciousness
  2. Gaze
  3. Visual fields
  4. Facial strength
  5. Arm strength
  6. Leg strength
  7. Limb ataxia (FNF, heel-down-shin)
  8. Sensation (pinch/pinprick)
  9. Language (re aphasia)
  10. Dysarthria
  11. Extinction/inattention (bilat sensory)

Maximum Score 42
Maximum score from ischemic stroke 31
59
The NIH Stroke Scale
LEVEL OF CONSCIOUSNESS
60
The NIH Stroke Scale
GAZE VISUAL FIELDS
61
The NIH Stroke Scale
FACIAL MOTOR
62
The NIH Stroke Scale
MOTOR OF THE ARM MOTOR OF THE LEG ATAXIA
63
The NIH Stroke Scale
SENSORY
64
The NIH Stroke Scale
LANGUAGE
65
The NIH Stroke Scale
DYSARTHRIA
66
The NIH Stroke Scale
EXTINCTION/NEGLECT
67
What the NIHSS score means to the EP
  • NIHSS 1 - 4 mild stroke
  • NIHSS 5 -15 moderate stroke
  • NIHSS 15 20 moderate to severe stroke
  • NIHSS gt 20 severe stroke
  • Prognosis likelihood of favorable outcome
  • NIHSS lt 10 60 70
  • NIHSS gt 20 4 -16

68
What the NIHSS score means to the EP
  • Chance of ICH with tPA
  • NIHSS lt 10 3
  • NIHSS gt 20 17

Stroke. 2003341056 1083.
69
Consideration the low NIHSS score stroke with
a devastating effect on livelihood
70
(No Transcript)
71
Functional Outcome Scales
  • Modified Rankin scale (mRS)
  • Barthel Index (BI)
  • Glasgow Outcome Scale (GOS)
  • Utilize scored assessments of patients
    functional status
  • Can be used to gauge
  • pre-morbid baseline
  • outcome

72
Modified Rankin Scale
Score Description
6 Dead
5 Severe disability bedridden, incontinent, and requiring constant nursing care and attention
4 Moderately severe disability unable to walk without assistance and unable to attend to own bodily needs without assistance
3 Moderate disability requiring some help, but able to walk without assistance
2 Slight disability unable to carry out all previous activities, but able to look after own affairs without assistance
1 No significant disability despite symptoms, able to carry out all usual duties and activities
0 No symptoms at all
Good outcome score of 0 - 1
73
Barthel Index
Feeding 0 unable 5 needs help cutting, spreading butter, etc, or requires modified diet 10 independent
Bathing 0 dependent 5 independent (or in shower)
Grooming 0 needs help with personal care 5 independent face/hair/teeth/shaving (implements provided)
Dressing 0 dependent 5 needs help but can do about half unaided 10 independent (including buttons, zips, laces, etc)
Bowels 0 incontinent (or needs enemas) 5 occasional accident 10 continent
74
Barthel Index
Bladder 0 incontinent, or catheterized and unable to manage alone 5 occasional accident 10 continent
Toilet use 0 dependent 5 needs some help but can do something alone 10 independent (on and off, dressing, wiping)
Transfers (bed to chair and back) 0 unable, no sitting balance 5 major help (1 or 2 people, physical), can sit 10 minor help (verbal or physical) 15 independent
Mobility (on level surfaces) 0 immobile or lt50 yards 5 wheelchair-independent, including corners, gt50 yards 10 walks with help of 1 person (verbal or physical) gt50 yards 15 independent (but may use any aideg, stick) gt50 yards
Stairs 0 unable 5 needs help (verbal, physical, carrying aid) 10 independent
100 point scale good outcome 95 - 100
75
Glasgow Outcome Scale
Score Description
1 DEAD
2 VEGETATIVE STATE Unable to interact with environment unresponsive
3 SEVERE DISABILITY Able to follow commands/ unable to live independently
4 MODERATE DISABILITY Able to live independently unable to return to work or school
5 GOOD RECOVERY Able to return to work or school
76
Functional Scales and tPA Outcome
  • NINDS tPA trial
  • 13 absolute increase in mRS 0 1 in treatment
    group
  • 12 increase in BI 95-100 in treatment group
  • Means 9 patients need to be treated for one
    improvement in outcome (NNT 9)

77
1-Year Outcome in NINDS trial
Kwiatkowski TG, et al. N Engl J Med.
19993401781-1787.
78
Looking at NINDS data more closelyThe sliding
scale dichotomy endpoint
NNT 3
Saver J, 31st International Stroke Conference,
Kissimmee, FL, Feb 2006
79
Summary
  • The NIHSS helps quantify and stratify acute
    stroke
  • Key aspects of the stroke-focused (NIH scale)
    neuro exam
  • LOC, vision, motor, coordination, sensation,
    language
  • Understanding the mRS, BI, and GOS can aid
    interpretation of outcome in stroke clinical
    trials.

80
Question Use of IV tPA
  • This patients stroke is deemed to be moderate to
    severe in its severity and is a suitable
    candidate for thrombolytic therapy with IV tPA .
    Which of the following is your viewpoint
    regarding the use of IV tPA given the published
    efficacy data?

81
Question Use of IV tPA
  • A. If IV tPA is indicated, I use it because the
    clinical data supports its use and I am
    adequately supported in its use.

82
Question Use of IV tPA
  • B. Although I am not opposed to the use of tPA, I
    do not use it often because patients rarely meet
    the criteria for use in the ED.

83
Question Use of IV tPA
  • C. I try not to use tPA because the published
    efficacy data does not adequately support its use
    and because I am not well supported to use it.

84
Question Use of IV tPA
  • D. I simply am so concerned about the risk of a
    symptomatic ICH that I cannot bear to use this
    drug when treating stroke patients such as this
    one.

85
Question Use of IV tPA
  • E. I leave the tPA use decision to the stroke
    team or neurology consultant.

86
Question Use of IV tPA
  • F. Havent we discussed tPA enough already?

87
Question Use of IV tPA
  1. Clinical data supports its use
  2. Patients rarely meet the criteria
  3. Published efficacy data does not adequately
    support its use
  4. Concerned about the risk of a symptomatic ICH
  5. Decided by the stroke team
  6. Havent we discussed tPA enough already?

88
Question tPA Data
  • Regarding the reanalysis of the NINDS tPA
    clinical trial data and the phase IV tPA use
    data, which of the following describe your
    understanding of the info?

89
Question tPA Data
  • A. I understand that the reanalysis of the NINDS
    data suggests that there is a real treatment
    effect and that the phase IV data confirms that
    the outcomes of the NINDS study can be replicated
    in clinical practice.

90
Question tPA Data
  • B. I know that the NINDS clinical trial data was
    confirmed, but the numbers are too small to allow
    for widespread clinical use, even with
    confirmatory phase IV clinical data.

91
Question tPA Data
  • C. I have trouble believing phase IV reports,
    since they are inherently biased, making the use
    of tPA still somewhat experimental in my practice.

92
Question tPA Data
  • D. I do not have enough familiarity with the
    reanalysis or the phase IV publications, such
    that I have not changed my tPA clinical practice.

93
Question tPA Data
  • E. Why was the data reanalyzed, and what is a
    phase IV study?

94
Question tPA Data
  1. I understand the reanalysis of the NINDS data
    phase IV data
  2. Numbers are too small to allow for widespread
    clinical use.
  3. I have trouble believing phase IV reports and
    have not changed
  4. I do not have enough familiarity
  5. What is a phase IV study?

95
NINDS Trial Results Patients with Favorable
Outcome
t-PA Placebo t-PA Placebo t-PA Placebo
No. of patients 312 157 145
Modified Rankin Scale 40 28
Glasgow Outcome Scale 43 32
NIHSS 34 20
Symptomatic ICH (within 36 hr) 6.4 0.6
Death (by 90 days) 17 21
96
IV Thrombolysis
  • 14 absolute increase for the best clinical
    outcomes (mRS of 0-1).
  • Benefit Need to treat eight patients with tPA
    in order to have one additional patient with this
    best outcome.
  • 6 absolute increase in the number of symptomatic
    ICH.
  • Harm Will have one symptomatic ICH for every 16
    patients treated with tPA.
  • 2 patients will have a minimal or no deficit for
    every patient with a symptomatic ICH

97
Meta-analyses
98
Meta-analyses
  • Wardlaw et al.
  • Net benefit despite hazards
  • For 1000 treated up to 6hrs
  • 55 improve, 20 die
  • Heterogeneity, wide CI make results unreliable
  • Additional trial data required

99
Meta-analyses
  • Graham et al., 15 published reports
  • ICH rate 5.2, total death rate 13.4
  • All better than NINDS
  • Lysis can be used safely across wide variety of
    practice settings

100
Meta-analyses
  • Hacke et al.
  • 6 randomized trials
  • Sooner thrombolytics given the greater the
    benefit
  • Particularly when given within 90 minutes of onset

101
CONTROVERSY Meta-analysis
  • Hoffman and Cooper
  • Pooled data can not replace new or confirmatory
    data
  • Meta-analyses did not include streptokinase
    trials which were negative
  • No reason to exclude streptokinase

102
Phase IV tPA trials
Author Eligible patients Patients receiving tPA() Mean time to Rx Median NIHSS score Favorable outcome ICH Symptomatic ICH Protocol deviation
NINDS 312 14 31-54 10.9 6.4
Chiu 1035 30(2.9) 237 14 63 10 6.6
Tanne 189 gt2 11-15 9 5.8 30
Wang 900 57(6.3) 228 15 44-54 9 5 9
Buchan 1540 68(4.4) 15 95 31 9 16
Albers 389 244 13 35-43 11.5 3.3 33
Katzan 3948 70(1.8) 12 22 15.7 50
Chapman 2556 46(1.8) 245 14 30-48 9 2.2 17
Grotta 1689 269(16) 217 14 33 4.5 13
Bravata 63 15 17 6 67
Total 12,282 928(5.8) 225 10-15 33-95 9.6 5.2 13-67
103
Re-analysis
104
NINDS Re-analysis
  • Does the protocol work?
  • Do subgroup imbalances invalidate the entire
    trial?
  • What about BP?

105
Baseline NIHSS Imbalance
NIHSS Score NIHSS Score 0-5 6-10 11-15 16-20 gt 20
No. of patients Placebo (n312) 16 83 66 70 77
No. of patients t-Pa (n310) 42 67 65 73 63
Chi-square (4 DF) 14.8 p 0.005
106
OTT Analysis Report
  • Review Committee had concerns about analyzing OTT
    as a continuous variable
  • Uncertainty about the exact time of stroke onset.
  • OTT distribution was nonlinear with 25 of all
    the patients having OTT values of either 89 or 90
    minutes.

107
Symptom onset vs Cumulative
108
NINDS ICH Analysis
  • Risk Factors for ICH
  • Baseline NIHSS gt 20
  • Age gt 70 years
  • Ischemic changes present on initial CT
  • Glucose gt 300 mg/dl (16.7 mmol/L)

of Risk Factors of patients treated with t-PA (n310) Symptomatic ICHs ( of placebo patients with ICH) Percentage ()
0 114 2 (1) 1.8
1 144 7 (1) 4.9
gt 1 52 11 21.2
109
IV Thrombolysis
  • The independent reanalysis of the NINDS tPA
    clinical trial confirms the results from the
    initial NEJM publication
  • Support the use of tPA in stroke patients within
    three hours of symptom onset
  • Number needed to treat calculation based on this
    reanalysis confirms that approximately 8-10
    patients need to be treated with tPA in order to
    cause one extra patient to have the best clinical
    outcome.
  • 2 patients will improve for every one that
    develops a symp ICH

110
EM Physicians and Lysis
  • Brown et al.
  • 1,105 of 2600 ACEP members responded
  • 40 not likely to use thrombolytics
  • 65 risk of ICH
  • 23 perceived lack of benefit
  • 12 both
  • Upper limit ICH rate 3.4
  • Lowest acceptable relative improvement 40

111
Informed Consent Documentation
  • With tPA, there is a 30 greater chance of a good
    outcome at 3 months
  • With tPA use, there is 10x greater risk of a
    symptomatic ICH (severe bleeding stroke)
  • Mortality rates at 3 months are the same
    regardless of whether tPA is used
  • 2 patients will have a minimal or no deficit for
    everyone patient with a symptomatic ICH

112
Documentation
  • Just as important
  • The patient is NOT a candidate for tPA because

113
Question Utilizing Tests
  • Many diagnostic tests are available when
    attempting to intervene positively in acute
    stroke patients. If the initial CT is negative
    for hemorrhage, how do you utilize tests such as
    MRI, MRA, CTA, or cerebral angiography when
    treating stroke patients?

114
Question Utilizing Tests
  • A. I do not know when these tests are indicated
    in acute ischemic stroke patients, and so do not
    order them in the ED.

115
Question Utilizing Tests
  • B. I am aware that these tests may enhance the
    ability to diagnose the vascular lesion
    responsible for the stroke, but I rely on my
    neurology consultants to determine the need for
    these tests.

116
Question Utilizing Tests
  • C. I know that these tests are most useful when
    considering advanced stroke therapies such as IA
    thrombolysis or clot retrieval, and only order
    them when the patient is due to have an
    interventional radiology procedure.

117
Question Utilizing Tests
  • D. I order these tests often in order to expedite
    the diagnostic workup of my ED stroke patients,
    whether these patients are to receive IV tPA or
    who might receive an acute interventional
    radiology procedure.

118
Question Utilizing Tests
  • E. Have any of these diagnostic tests been proven
    to be effective at improving outcome in stroke
    patients?

119
Question Utilizing Tests
  1. I do not order them in the ED.
  2. I rely on my neurology consultants.
  3. I order them when the patient is due to have an
    interventional radiology procedure.
  4. I order these tests often.
  5. Have these tests been proven to be effective?

120
Question Advanced Therapies
  • There are many options that exist after the
    three-hour IV tPA window, including IA
    thrombolysis, the Merci clot retrieval device,
    and devices that enhance cerebral blood flow.
    What is your clinical practice regarding these
    advanced stroke therapies?

121
Question Advanced Therapies
  • A. I do not have a clear understanding of these
    advanced therapies, and do not access them for my
    stroke patients.

122
Question Advanced Therapies
  • B. I know of these therapies, but my
    understanding is that they are experimental in
    nature and are not a part of the standard of care.

123
Question Advanced Therapies
  • C. I have noted these therapies to be used by my
    neurology consultants on occasion, but I am not
    sure of the indications for their use.

124
Question Advanced Therapies
  • D. I understand the utility of these
    interventions, and I aggressively pursue them for
    my stroke patients who do not meet the IV tPA
    criteria.

125
Question Advanced Therapies
  • E. Have any of these therapies been proven to be
    effective in any published clinical trials?

126
Question Advanced Therapies
  1. Do not access them.
  2. Experimental in nature.
  3. used by my neurology consultants on occasion.
  4. I aggressively pursue them.
  5. Have any of these therapies been proven to be
    effective in any published clinical trials?

127
Foundation for Education and Researchin
Neurological EmergenciesStroke Care 2006
Clinical Consensus and Opportunities June 16,
2006Treatment of Stroke Beyond Three Hours
Thomas G. Brott, MD, Professor of Neurology Mayo
Clinic Jacksonville College of Medicine
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Results I
  • 2776 patients
  • Over 300 hospitals
  • 18 countries
  • Median age 68 years
  • Median baseline NIHSSS 12

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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

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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)

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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 difference15...NNT of 7
  • FDA did not approve

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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
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Beyond Thrombolysis Combination Therapy,
Devices, and Other Approaches

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Concentric Retriever Device With Nitinol Coil
(White Arrow) and Inflated Balloon (Black Arrow)
Leary MC, et al. Ann Emerg Med. 2003
Jun41(6)838-46
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MERCI Recanalization and Outcomes
ICA (n47) MCA (n80)
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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Question Clinical Guidelines
  • Regarding ischemic stroke patients, what is your
    understanding and use of clinical guidelines?

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

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

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

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

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

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Question Clinical Guidelines
  1. Not aware of any clinical guidelines.
  2. My neurology consultants utilize these
    guidelines.
  3. I refer to them on occasion.
  4. Our hospital has integrated them.
  5. I wish that there were guidelines.

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

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Question Optimal Therapies
  • A. I am not aware of any specific neuroprotection
    therapies for ischemic stroke patients.

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Question Optimal Therapies
  • B. I believe that the only useful therapies
    involve ASA use and blood pressure and glucose
    management in the majority of ischemic stroke
    patients.

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

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Question Optimal Therapies
  • D. I am aware of the trials of specific
    neuroprotectants, and I utilize them in my
    clinical practice.

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

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Question Optimal Therapies
  1. Not aware of any therapies.
  2. Only useful therapies involve ASA use and blood
    pressure and glucose management.
  3. Optimal cerebral blood flow is another critical
    neuroprotectant.
  4. I utilize them.
  5. I do not believe that neuroprotection is possible.

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

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Question Stroke and ICH
  1. I would admit this patient to neurosurgery for
    further orders.

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Question Stroke and ICH
  • B. I would transfer this patient to another
    hospital because I dont have neurosurgery
    coverage and/or it is our institutions protocol.

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

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Question Stroke and ICH
  • D. Not only would I manage the patient as in (C.)
    above, I would also discuss the use of Factor
    VIIa with neurosurgery in this ICH patients
    care.

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

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Question Stroke and ICH
  • A. Admit to neurosurgery.
  • B. Transfer for neurosurgery care.
  • C. I can manage pt prior to transfer.
  • D. FVIIa is an issue I would address.
  • E. I know how to manage elevated INRs in pts who
    are on warfarin.

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Conclusions
  • Important EM patient clinical area
  • Many questions
  • Some areas of consensus
  • Many areas of opportunity
  • Further work is needed
  • The interest is there

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Questions?Thank you!
ferne_at_ferne.org edsloan_at_uic.edu www.ferne.org
ferne_pv_2006_strokecare_final 3/15/2014
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