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Stroke: Lysis and Beyond September 15, 2008 Andy Jagoda, MD, FACEP Professor and Vice Chair of Emergency Medicine Mount Sinai School of Medicine New York,

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Presentation on theme: "Stroke: Lysis and Beyond September 15, 2008 Andy Jagoda, MD, FACEP Professor and Vice Chair of Emergency Medicine Mount Sinai School of Medicine New York,"— Presentation transcript:

1 Stroke: Lysis and Beyond September 15, 2008 Andy Jagoda, MD, FACEP Professor and Vice Chair of Emergency Medicine Mount Sinai School of Medicine New York, New York

2 Disclosures Advisory Board: The Medicines CompanyAdvisory Board: The Medicines Company Speakers Bureau: GenentechSpeakers Bureau: Genentech Past Chair, ACEP Clinical Policies CommitteePast Chair, ACEP Clinical Policies Committee Executive Board, Brain Attack Coalition, NINDSExecutive Board, Brain Attack Coalition, NINDS Executive Board, Foundation for Education and Research in Neurologic Emergencies Board, Foundation for Education and Research in Neurologic Emergencies

3 Key Points A (documented) systematic neurologic evaluation is critical to minimizing risk... And providing good patient careA (documented) systematic neurologic evaluation is critical to minimizing risk... And providing good patient care EMS plays a pivotal role in acute stroke care and thus is assuming increasing liability associated with their decision makingEMS plays a pivotal role in acute stroke care and thus is assuming increasing liability associated with their decision making Alteplase is a FDA approved treatment for acute ischemic stroke and therefore a decision to not use it for qualified patients must be supported in the medical recordAlteplase is a FDA approved treatment for acute ischemic stroke and therefore a decision to not use it for qualified patients must be supported in the medical record

4 Introduction Stroke is the 3ird most common cause of death in the United StatesStroke is the 3ird most common cause of death in the United States  Second most common cause for patients to be in a nursing home 500, ,000 strokes / year500, ,000 strokes / year  % Ischemic  % Hemorrhagic or SAH  % Mortality within 3 months Leading cause of disabilityLeading cause of disability

5 The Facts: Ischemic Stroke TIAsTIAs  20% – 50% of strokes preceded by a TIA  75% resolve in <15 minutes; 97% <3 hours  New definition: event lasting less than 1 hour and not associated with changes on neuroimaging Acute Ischemic strokeAcute Ischemic stroke  Hemorrhagic conversion within 36 hours: 1% symptomatic, 4% asymptomatic  30% have little or no disability at 3 months  30% have mild to moderate disability at 3 months  30% have severe disability  10% dead at 3 months

6 ICH High Mortality / Limited Recovery ICH High Mortality / Limited Recovery Manno EM, et al. Mayo Clin Proc. 2005;80: ; Mayer SA, Rincon F. Lancet Neurol. 2005;4: ; Qureshi AI, et al. N Engl J Med. 2001;344: ; Taylor TN, et al. Stroke. 1996;27: ; Reed SD, et al. Neurology. 2001;57: MortalityMortality  6-month, 30%-50%  1-year, 50% Only 20% of ICH patients are independent at 6 months vs 60% of ischemic stroke patients Medical costs US$125,000 lifetime cost per person (1990) Direct and indirect costs (lost productivity + caregiver burden)

7 NINDS t-PA Acute Ischemic Stroke. NEJM 1995 A two part, double blind study: 624 patientsA two part, double blind study: 624 patients  Randomized to t-PA or placebo “Favorable outcome” defined as normal or near normal at 90 days“Favorable outcome” defined as normal or near normal at 90 days  4 outcome measures: Barthel Index, Modified Rankin Scale, Glasgow Outcome Scale, NIHSS Adjusted t-PA to placebo global OR for favorable outcome was 1.7 (95%CI, )Adjusted t-PA to placebo global OR for favorable outcome was 1.7 (95%CI, )  No increase in mortality and a decrease in hospital stay

8 NIH-Recommended Emergency Department Response Times The “golden hour” for evaluating and treating acute stroke Door-to-needle time ≤60 minutes 0 Suspected stroke patient arrives at ED CT scan initiated CT & labs interpreted tPA given if patient is eligible Minutes: Initial MD evaluation Stroke team notified NINDS Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke, December 12-13, Accessed November 8, 2007.

9 NINDS Proceedings: 1997 / 2002 Public educationPublic education Prehospital emergency responsePrehospital emergency response Designated stroke centersDesignated stroke centers Emergency departmentsEmergency departments Hospital stroke unitsHospital stroke units RehabilitationRehabilitation

10 The Public Message WEAKNESS OR NUMBNESS ON ONE SIDE OF THE BODYWEAKNESS OR NUMBNESS ON ONE SIDE OF THE BODY DIFFICULTY WITH VISIONDIFFICULTY WITH VISION DIFFICULTY WITH SPEECH OR UNDERSTANDINGDIFFICULTY WITH SPEECH OR UNDERSTANDING UNUSUALLY SEVERE HEADACHEUNUSUALLY SEVERE HEADACHE DIZZINESS OR UNSTEADINESSDIZZINESS OR UNSTEADINESS

11 External validityExternal validity Imbalance of baseline NIHSS between the t-PA and placebo groupsImbalance of baseline NIHSS between the t-PA and placebo groups Treatment effect favored those patients treated within 90 minutesTreatment effect favored those patients treated within 90 minutes Unclear which patients were at risk for intracerebral hemorrhageUnclear which patients were at risk for intracerebral hemorrhage NINDS Trial Criticism

12 NINDS Date Re-analysis Committee Kjell Asplund MDKjell Asplund MD  Umeå University, Umeå, Sweden Lewis R. Goldfrank MDLewis R. Goldfrank MD  New York University, New York, USA Timothy Ingall MDTimothy Ingall MD  Mayo Clinic Scottsdale, Arizona, USA Vicki Hertzberg PhD  Emory University, Georgia, USA Thomas Louis PhD  Johns Hopkins Bloomberg School of Public Health, Maryland, USA Michael O’Fallon PhD  Mayo Clinic Rochester, Minnesota, USA

13 Committee Methods Concerns assessed included:Concerns assessed included:  Baseline NIHSS imbalance  Time from symptom onset to treatment  Risk factors for intracerebral hemorrhage  Predictors of favorable outcome The analysis was adjusted for treating hospital, time to treatment, age, baseline NIHSS, diabetes,The analysis was adjusted for treating hospital, time to treatment, age, baseline NIHSS, diabetes,

14 ICH Analysis # of Risk Factors # of patients treated with t- PA (n=310) # of Symptomatic ICH’s (# of placebo patients with ICH) Percentage (%) (1) (1) 4.9 > Risk Factors for ICH:  Baseline NIHSS > 20  Age > 70 years  Ischemic changes present on initial CT  Glucose > 300 mg/dl (16.7 mmol/L)

15 NINDS Re-analysis Initial NIHSS <20, no diabetes, age <70, normal CT predict best outcome from t-PA and low risk for ICHInitial NIHSS <20, no diabetes, age <70, normal CT predict best outcome from t-PA and low risk for ICH The committee concluded, despite an increased incidence of symptomatic intracerebral hemorrhage in t ‑ PA treated patients and subgroup imbalances in baseline stroke severity, there was a statistically significant benefit of t- PA treatment measured by an adjusted t-PA to placebo global odds ratio of 2.1 (95% CI: ) for a favorable clinical outcome at 3 monthsThe committee concluded, despite an increased incidence of symptomatic intracerebral hemorrhage in t ‑ PA treated patients and subgroup imbalances in baseline stroke severity, there was a statistically significant benefit of t- PA treatment measured by an adjusted t-PA to placebo global odds ratio of 2.1 (95% CI: ) for a favorable clinical outcome at 3 months

16 Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST). Lancet 2007; 369: Prospective, open, multicentre, multinational, observational monitoring study established as a condition by the European Union for licensingProspective, open, multicentre, multinational, observational monitoring study established as a condition by the European Union for licensing 6483 patients6483 patients 4.6% symptomatic hemorrhage at 24 hours4.6% symptomatic hemorrhage at 24 hours 39% with no or mild disability at 3 months (vs 29% in pooled placebo)39% with no or mild disability at 3 months (vs 29% in pooled placebo)

17 The Case: Roseville, Illinois, year old male called EMS at 21:00 with a chief complaint of feeling dizzy and weak. Vomited once. No headache, no vision change.  Symptoms began after dinner; 2 cocktails and 2 glasses of wine  Dizziness described as room spinning

18 Case PMHx:PMHx:  Hypertension MedicationsMedications  Enalapril, 10 mg  Aspirin, 81 mg Social HxSocial Hx  Smoking - 1 pack per day

19 EMS called Upon arrival at 21:30 - symptoms resolvedUpon arrival at 21:30 - symptoms resolved BP 190 / 110, P 80, RR 14BP 190 / 110, P 80, RR 14 Alert, O x 3Alert, O x 3  No facial droop  No UE drift  Speech fluent

20 Question 1 Can vertigo be the sole presenting complaint of posterior circulation ischemia? a)Yes b)No

21 Posterior Circulation Stroke: Anatomy

22 Emergency Department Presentation Clinical Findings: Depends on the syndromeClinical Findings: Depends on the syndrome  Range: asymptomatic to comatose The 5 Ds: Dizziness, Diplopia, Dysarthria, Dysphagia, DystaxiaThe 5 Ds: Dizziness, Diplopia, Dysarthria, Dysphagia, Dystaxia Hallmarks: Crossed findingsHallmarks: Crossed findings  Cranial nerve deficits - Ipsilateral  Motor / Sens deficits - Contralateral

23 Lee et al. Cerebellar infarction presenting isolated vertigo. Neurology 2006; 67: consecutive patients with confirmed cerebellar infarction by MRI240 consecutive patients with confirmed cerebellar infarction by MRI 25 patients presented with isolated spontaneous prolonged vertigo with imbalance25 patients presented with isolated spontaneous prolonged vertigo with imbalance “Cerebellar infarction simulating vestibular neuritis is more common than previously thought”“Cerebellar infarction simulating vestibular neuritis is more common than previously thought”

24 Pitfalls in the diagnosis of cerebellar infarction. Acad Emerg Med 2007:14:63-68 Retrospective chart review: 15 cases of misdiagnosisRetrospective chart review: 15 cases of misdiagnosis 12 patients presented with “dizziness”12 patients presented with “dizziness” 7 patients were younger than 50 and presented with headache and dizziness7 patients were younger than 50 and presented with headache and dizziness Majority did not have gait / coordination testedMajority did not have gait / coordination tested

25 Pitfalls in the diagnosis of cerebellar infarction. Acad Emerg Med 2007:14:63-68 All of the patients had initial CT read as normalAll of the patients had initial CT read as normal ED diagnosisED diagnosis  migraine, gastroenteritis, presyncope Final diagnoses:Final diagnoses:  4 vertebral artery dissections  3 vertebral artery occlusions  1 atrial thrombus  1 patent foramen ovale

26 Can vertigo be the sole presenting complaint of posterior circulation ischemia? Kerber et al. Stroke among patients with dizziness, vertigo, imbalance in the ED: a population based study. Stroke 2006:37:2484Kerber et al. Stroke among patients with dizziness, vertigo, imbalance in the ED: a population based study. Stroke 2006:37:2484  1666 patients presenting with dizziness, vertigo or imbalance  9 (0.7%) had a stroke or TIA If the neurologic exam is normal, including careful assessment of gait and cerebellar function, it is unlikely that isolated dizziness or vertigo is the result of CNS ischemiaIf the neurologic exam is normal, including careful assessment of gait and cerebellar function, it is unlikely that isolated dizziness or vertigo is the result of CNS ischemia

27 Question 2 Which of the following would you recommend to EMS: a)Do not transport b)Transport to the closest hospital c)Transport to a designated stroke center

28 Stroke Centers: The Thesis Thrombolytic and other interventions are effective treatments in improving outcomes from acute strokeThrombolytic and other interventions are effective treatments in improving outcomes from acute stroke Protocols facilitate efficient resource utilization and lead to improved outcomesProtocols facilitate efficient resource utilization and lead to improved outcomes Failure to adhere to protocols increase morbidity and mortalityFailure to adhere to protocols increase morbidity and mortality

29 11 elements of a Primary Stroke Center JAMA 2000; 283: EMS integrated into the acute stroke responseEMS integrated into the acute stroke response Acute stroke team available 24 / 7Acute stroke team available 24 / 7 Written care protocolsWritten 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 institutionCommitment from the institution Neuroimaging done / interpreted within 45 min of arrivalNeuroimaging done / interpreted within 45 min of arrival Laboratory services with rapid turn around of testsLaboratory services with rapid turn around of tests Quality improvement program including a database or registryQuality improvement program including a database or registry Continuing education programContinuing education program

30 JCAHO Disease Specific Care Certification Joint initiative between ASA and JCAHOJoint initiative between ASA and JCAHO Voluntary participationVoluntary participation  Approximately 1000 centers certified(25%) Premise is that accreditation process will drive quality measures and improve outcomesPremise is that accreditation process will drive quality measures and improve outcomes No emergency medicine society has endorsed this initiativeNo emergency medicine society has endorsed this initiative  t-PA controversy  Overcrowding  Medical legal implications

31

32 Is there a standard of care? Canadian Association of Emergency Physicians Canadian Association of Emergency Physicians American Academy of Emergency Medicine American Academy of Emergency Medicine Society for Academic Emergency Medicine Society for Academic Emergency Medicine American College of Emergency Physicians American College of Emergency Physicians

33 American College of Emergency Physicians IV t-PA may be an efficacious therapy for the management of acute ischemic stroke if properly used incorporating the guidelines established by the NINDSIV t-PA may be an efficacious therapy for the management of acute ischemic stroke if properly used incorporating the guidelines established by the NINDS The decision for an ED to use IV t-PA for acute stroke should begin at the institutional level with commitments from hospital administration, the ED, neurology, neurosurgery, radiology, and laboratory services to ensure that the systems necessary for the safe use of fibrinolytic agents are in place.The decision for an ED to use IV t-PA for acute stroke should begin at the institutional level with commitments from hospital administration, the ED, neurology, neurosurgery, radiology, and laboratory services to ensure that the systems necessary for the safe use of fibrinolytic agents are in place.

34 Case Patient is transported to the closest hospitalPatient is transported to the closest hospital  BP- 190 / 110, P-80, RR-14, 98%, BS 110  Alert, Ox3; NAD  Heart and lungs: “normal”  CN: “intact”  Sensation: “intact”  ECG: normal sinus rhythm

35 Question 3 Which of the following would you recommend? a)Discharge with PMD follow up b)Discharge on increased aspirin c)Discharge on clopidogrel d)Discharge on ASA / dipyridamole e)Admit to the hospital

36 TIA and Stroke Johnston, et al. JAMA 2000; 284:2901Johnston, et al. JAMA 2000; 284:2901  Follow-up of 1707 ED patients diagnosed with TIA  Stroke rate at 90 days was 10.5% Half of these occurred in the first 48 hours after ED presentationHalf of these occurred in the first 48 hours after ED presentation Gladstone, et al. CMAJ 2004; 170: Gladstone, et al. CMAJ 2004; 170:  371 consecutive patients with TIA  8% ischemic stroke in 30 days; ½ within 48 hours 12% in motor deficit group12% in motor deficit group

37 Patients at highest risk for stroke after TIA Age > 60Age > 60 Blood pressure elevationBlood pressure elevation Clinical feature:Clinical feature:  Focal weakness  Speech Impairment DiabetesDiabetes Duration > 60 minutesDuration > 60 minutes

38 ED Disposition Consider ED discharge if:Consider ED discharge if:  Further testing will not change treatment  Prior work-up  Not a candidate for CEA or anticoagulation ECGECG Cardiac echoCardiac echo Carotid ultrasoundCarotid ultrasound

39 Case Discharge diagnosis: “Dizziness – resolved”Discharge diagnosis: “Dizziness – resolved”  Limit alcohol use  Return to ED if symptoms reoccur  Call your doctor in the am

40 Case Continued 5 days later while visiting son, patient acutely developed vertigo, left sided facial droop, right sided weakness, slurred speech5 days later while visiting son, patient acutely developed vertigo, left sided facial droop, right sided weakness, slurred speech Lethargic with decreased gagLethargic with decreased gag BP 210 / 120, P 110, RR 14, POx 92% RABP 210 / 120, P 110, RR 14, POx 92% RA BS 110BS 110 Transported to the same ED and arrived within 45 minutes of symptom onsetTransported to the same ED and arrived within 45 minutes of symptom onset

41 Case CT obtained and showed no blood, no edemaCT obtained and showed no blood, no edema “Clot buster” treatment discussed with the family who give consent for treatment“Clot buster” treatment discussed with the family who give consent for treatment t-PA box is opened and only contains Retaplaset-PA box is opened and only contains Retaplase  There is no alteplase in the hospital Regional stroke center contacted and arrangements made for aero-medical transportRegional stroke center contacted and arrangements made for aero-medical transport Patient is intubatedPatient is intubated

42 Question 4 How would you manage the blood pressure? a)No BP intervention b)Labetolol IV c)Nicardipine IV d)Nitroprusside IV e)Nitroglycerin paste

43 Case The patient arrived at the stroke center 2 hours and 15 minutes from the onset of symptoms)The patient arrived at the stroke center 2 hours and 15 minutes from the onset of symptoms) BP 160 / 90BP 160 / 90 CT was not sent with the patientCT was not sent with the patient  decision made to repeat the study

44 Question 5 CT showed no infarct, edema, or hemorrhage 3 hours and 30 minutes post symptom onset. Which of the following would you recommend? a)Nothing b)Intravenous t-PA c)Intra-arterial t-PA / clot retrival

45 Indication and Usage tPA is indicated for the management of acute ischemic stroke in adults to improve neurological recovery and reduce the incidence of disability Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a CT scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS in the full Prescribing Information) Appropriate Treatment With tPA: Bleeding Risk Bleeding Risk The most common complication encountered during tPA treatment is bleeding The rate of symptomatic intracranial hemorrhage* was 6.4% in the NINDS trials The type of bleeding associated with thrombolytic therapy can be divided into 2 broad categories:  Internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tract  Superficial or surface bleeding, observed mainly at invaded or disturbed sites (eg, venous cutdowns, arterial punctures, sites of recent surgical intervention) Should serious bleeding (not controlled by local pressure) occur, the infusion of tPA should be terminated immediately

46 Appropriate Treatment With tPA: Contraindications & Selected Eligibility Considerations Contraindications Evidence of intracranial hemorrhage on pretreatment evaluation Suspicion of subarachnoid hemorrhage on pretreatment evaluation Intracranial or intraspinal surgery, serious head trauma, or stroke in the previous 3 months History of intracranial hemorrhage Active internal bleeding Intracranial neoplasm, arteriovenous malformation, or aneurysm Known bleeding diathesis Seizure at the onset of stroke Uncontrolled hypertension at time of treatment (ie, >185 mm Hg systolic or >110 mm Hg diastolic) Selected eligibility considerations Included in the AHA/ASA 2007 Guidelines Diagnosis of ischemic stroke causing measurable neurological deficit No gastrointestinal or urinary tract hemorrhage in previous 21 days No major surgery in the previous 14 days No arterial puncture at a noncompressible site in the previous 7 days Not taking an oral anticoagulant or, if anticoagulant being taken, INR ≤ 1.7 If receiving heparin in previous 48 hours, aPTT must be in normal range. Platelet count ≥ 100,000/mm 3 Blood glucose concentration ≥ 50 mg/dL No seizure with postictal residual neurological impairments CT does not show a multilobar infarction (hypodensity >1/3 cerebral hemisphere).

47 tPA Should Be Used With Caution in Certain Patients Patients with severe neurologic deficit (eg, NIHSS >22) at presentationPatients with severe neurologic deficit (eg, NIHSS >22) at presentation Patients with major and early infarct signs on a cranial CT scan (eg, substantial edema, mass effect, or midline shift)Patients with major and early infarct signs on a cranial CT scan (eg, substantial edema, mass effect, or midline shift) Patients of advanced age (eg, >75 years)Patients of advanced age (eg, >75 years) Due to the increased risk of misdiagnosis of acute ischemic stroke, special diligence is required in making this diagnosis in patients whose blood glucose values are 400 mg/dLDue to the increased risk of misdiagnosis of acute ischemic stroke, special diligence is required in making this diagnosis in patients whose blood glucose values are 400 mg/dL Patients with minor strokes or rapidly resolving symptomsPatients with minor strokes or rapidly resolving symptoms Alteplase full Prescribing Information 2005.

48 Case Study: Outcome Patient did not receive t-PAPatient did not receive t-PA 6 month modified Rankin scale score: 36 month modified Rankin scale score: 3  Ambulate with walker Patient does well enough to sue:Patient does well enough to sue:  EMS for not taking him to a stroke center  The first emergency physician for failure to diagnose  The second EP for not treating with t-PA EP sues hospital for not having alteplase EP sues hospital for not having alteplase  Stroke Center physicians for delay in care (repeated CT) and failure to treat

49 Do you want to take the case for: a)The plaintiff b)The defense

50 Conclusions A (documented) systematic neurologic evaluation is critical to minimizing risk... And providing good patient careA (documented) systematic neurologic evaluation is critical to minimizing risk... And providing good patient care EMS plays a pivotal role in acute stroke care and is assuming increasing liability associated with their decision makingEMS plays a pivotal role in acute stroke care and is assuming increasing liability associated with their decision making Alteplase is a FDA approved treatment for acute ischemic stroke and therefore a decision to not use it for qualified patients must be supported in the medical recordAlteplase is a FDA approved treatment for acute ischemic stroke and therefore a decision to not use it for qualified patients must be supported in the medical record


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