implications for clinical practice
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UCLA Stroke Center
Implications for Clinical Practice
Jeffrey L. Saver, MDProfessor of Neurology
Director, UCLA Stroke Center
--All slides in presentation are freely available under a Creative Commons “Share Freely with Attribution” License – Saver
Talk Outline
• Implications for clinical practice guidelines» Statistical significance
• Implications for clinicians at bedside» Clinical significance» Systems of care
• Implications for future
UCLA Stroke Center
Guidelines
UCLA Stroke Center
European EUSI Recommendations 2006
UCLA Stroke Center
US AHA/ASA Guidelines 2010
UCLA Stroke Center
INTERACT 2: A Near Win Trial
Trial Intervention OR P primary
P ordinal
INTERACT 2 BP↓ for ICH 0.87 (0.75-1.01) 0.06 0.04
UCLA Stroke Center
Stroke and Near Win Trials
Trial Intervention OR P primary
P ordinal
INTERACT 2 BP↓ for ICH 0.87 (0.75-1.01) 0.06 0.04
IST 3 TPA to 6 hours 1.13 (0.95-1.35) 0.18 0.001
SPS3 BP Arm BP↓ prevent recurrent stroke
0.81 (0.64-1.03) 0.08
UCLA Stroke Center
Meta-Analysis of INTERACT 1, 2 and ATACH Trials
UCLA Stroke Center
UCLA Stroke Center
Clinical Significance
“A difference, to be a difference, must make a difference”
UCLA Stroke Center
INTERACT 2
UCLA Stroke Center
INTERACT 2
UCLA Stroke Center
INTERACT 2
UCLA Stroke Center
Benefit on Dichotomized Outcome
• 52.0% vs 55.6%• ARR 3.6%• Benefit per Thousand: 36• NNT: 27.8
UCLA Stroke Center
INTERACT 2
UCLA Stroke Center
INTERACT 2
UCLA Stroke Center
Automated Algorithmic Joint Outcome Table Analysis
UCLA Stroke Center
--Saver et al, Stroke 2009;40:2433-7
Benefit Over All Health State Transitions
• Benefit per Thousand: 81• NNT: 12.3
UCLA Stroke Center
Benefit in INTERACT 2 vs Other Acute Stroke Interventions
Intervention Net Benefit per ThousandTPA under 3h 290IA Pro-UK 208Coiling in SAH 169TPA 3-4.5h 136BP lowering for ICH 81Clinician worthwhile 50Socioeconomic model worthwhile 20
UCLA Stroke Center
--Samsa et al, Am Heart J 1998;136:703-13--Saver, Stroke 2007;38:3055-3062--Saver et al, Stroke 2009;40:2433-7
Door to BP Control in Community Practice in ICH
• 100 patients, 32 Emergency Departments
• At ED arrival» NIHSS 18» Time from LKW 63 mins» Mean BP 176/94
• 54% received BP therapy in ED• Among the 48 patients with SBP ≥
180» Control (<180) never achieved in 19%» Median door to control 118 mins» Door to control ≤ 90m in 31%
UCLA Stroke Center
--Sanossian et al, Ann Emerg Med 2012;60: S56
Other Treatment Recommendations for ICH
• ICU monitoring• Antipyretics in febrile patients• Early mobilization• ICP management
» Head of bed, analgesia, sedation» Osmotic diuretics, CSF drainage,
hyperventilation• Maintain serum glucose < 185• Seizures
» Prophylactic antiepileptics for lobar ICH» Antiepileptics for clinical seizures» Antiepileoptics for electrographic
seizures
• DVT prophylaxis» Intermittent compression on arrival» SQ LMWH or UH after 3-4d
• For DVT, consider vena cava filter• Reversal of coagulopathies
» Protamine for heparin» Vitamin K, PCC, rF7 for warfarin
• Surgery» Definite for select cerebellar» Consider for lobar» Consider minimally invasive for deep
UCLA Stroke Center
--Morgenstern et al, Stroke 2010
ICH Critical PathwayIdentify Signs of Possible Stroke
Critical EMS Assessments & Actions
Immediate General Assessment/Stabilization
Immediate Neurologic Assessment (stroke team or designee)
Does CT scan show hemorrhage?
No Hemorrhage Hemorrhage
Possible ischemic stroke
• Consult neurologist or neurosurgeon• If not available, consider transfer
BP Management
ICP Management
Seizure Prevention and Management
Fluid ManagementBody Temperature
Management
Surgical Treatment of ICH Cerebellar hemorrhage >3 cm with
neurologic deterioration or brain stem compression and/or hydrocephalus
Consider in lobar clots <1 cm of surface
AHA Adult Stroke Guidelines. Circulation. 2005;112(suppl 24):IV-111-IV-120; Broderick J, et al. Stroke. 2007;38:2001-2023; Qureshi AI, et al. N Engl J Med. 2001;344:1450-1460.
NINDS Time Goals
Monitor Blood Glucose and Treat (if needed)
Begin ICH Pathway Admit to stroke unit (if available) or ICU Monitor BP and treat (if indicated) Monitor neurologic status
(emergent CT if deterioration) Monitor blood glucose & treat (if needed) Supportive therapy Treat comorbidities
ICH Critical Pathway Sample ChecklistEMS ED (60 min) ICU/NCCU Surgical
Intervention•Medical history (risk factors, similar recent events)
•Determine any medications currently taken
•Cincinnati Prehospital Stroke Scale
•Los Angeles Prehospital Stroke Screen
•ABCs•Time of onset•Medic Alert tag
•ABCs•Vital signs•Medical history •Time of onset•Blood pressure•Neurologic status (GCSS)•Blood glucose
•ABCs•Vital signs•Blood pressure•Intracranial pressure•Neurologic status•Blood glucose•Body temperature
•Routine evacuation of supratentorial ICH with standard craniotomy within 96 hours not recommended
•Surgical candidates (cerebellar hemorrhage >3 cm with neurologic deterioration; consider with lobar clots <1 cm from surface)
•Vital signs•Support ABCs (oxygen if needed)
•Transport (consider triage to stroke center)
•Vital signs•Obtain IV access & blood samples
•Support ABCs•Intubation(?)•Supportive therapy•Treat comorbidities
•Vital signs •Support ABCs•Intubation(?)•Supportive therapy•Treat comorbidities•Fluid management (euvolemia)
•Positional factors (head at midline, raise head of bed 30º)
•Blood glucose (if possible)•12-lead ECG (if possible)
• CT/MRI•Neurologic examination (NIH Stroke Scale, Canadian Neurologic Scale)
•Blood pressure•Electrolytes•Blood glucose•12-lead ECG on admission•CBC, PT, aPTT, INR, electrolytes•Toxicology•Platelet function •CXR
•Blood pressure – MAP, SAP, CPP
•ICP (ventriculostomy, fiberoptic ICP monitor, etc)
•Blood glucose•12-lead ECG•CT/MRI
Ass
essm
ent
Nur
sing
Test
ing
ICH Critical Pathway Sample Checklist
ICH Critical Pathway Sample Checklist (cont.)EMS ED (60 min) ICU/NCCU Surgical Intervention
•Oxygen •Oxygen (if hypoxemic)•Treat blood glucose abnormalities •Blood pressure (labetalol, esmolol, nitroprusside, hydralazine, enalapril)
•Blood pressure (labetalol, esmolol, hydralazine, enalapril, nicardipine)
•ICP (head elevation, osmotic diuretics, CSF drainage; neuromuscular blockade, hyperventilation)
•Seizures (lorazepam, diazepam, phenytoin, fos-phenytoin)
•Warfarin coagulopathy (PCC, FFP, Vitamin K, Factor VIIa)
•Treat blood glucose abnormalities
•Alert hospital •Activate stroke team•Consult neurologist or neurosurgeon
•Consider transfer to stroke center
•Consult neurologist or neurosurgeon
•Begin stroke pathway•Admit to stroke unit (if available) or ICU
•Follow stroke pathway
Adapted from AHA Adult Stroke Guidelines. Circulation. 2005;112(suppl 24):IV-111-IV-120; Broderick JP, et al. Stroke. 1999;30:905-915; Broderick J, et al. Stroke. 2007;38:2001-2023; Marik PE, et al. Chest. 2002;122:699-711; Passero S, et al. Epilepsia. 2002;43:1175-1180; Qureshi AI, et al. Stroke. 2001;33:1916-1919.
ABCs = airway-breathing-circulation aPTT = activated partial thromboplastin timeCBC = complete blood count CPP = cerebral perfusion pressureCXR = chest x-rayED = emergency departmentFFP = fresh frozen plasma
GCSS = Glascow Coma Scale scoreICP = intracranial pressureINR = international normalized ratio MAP = mean arterial pressure NCCU = neuro-critical care unitPCC = prothrombin complex concentrate PT = prothrombin timeSAP = systolic arterial pressure
Med
icat
ions
Con
sults
Path
way
sICH Critical Pathway Sample Checklist (cont.)
Next Steps
UCLA Stroke Center
Time is Brain for Hemorrhagic Stroke
UCLA Stroke Center
--Arima et al, Stroke 2012;43:2236-8
Dynamics of Hyperacute Hematoma Growth 0-120 Minutes: Not Well Delineated
--Kazui et al, Stroke 1996;27:1783-1787
Intracerebral Hemorrhage and the Golden Hour
• Narrow therapeutic time window
• Early intervention critical• Prehospital personnel
» 35-70% of stroke patients arrive by ambulance
» Unique position: first medical professional to come in contact with stroke patient
UCLA Stroke Center
-15 -5 0 20 30 40 60 100 160 200 3600
5
10
15
20
25
30
35
40
45
Time in minutes from onset of symptoms
Volu
me
of H
emat
oma
in m
L
Rupture of blood vessel
Onset of Symptoms
Activation of EMS
EMS Arrival
EMS Transport
EMS Arrival in ED
Initial ED Evaluation CT scan
obtained
CT scan evaluated
Hospital Treatment initiated
Final Hematoma Volume Established
Sanossian, FAST-BP Trial
-15 -5 0 20 30 40 60 100 160 200 3600
5
10
15
20
25
30
35
40
45
Time in minutes from onset of symptoms
Volu
me
of H
emat
oma
in m
L
Rupture of blood vessel
Onset of Symptoms
Activation of EMS
EMS Arrival
EMS Transport
EMS Arrival in ED
Initial ED Evaluation CT scan
obtained
CT scan evaluated
Hospital Treatment initiated
Final Hematoma Volume Established
Field Treatment Initiated
Goal: Control Hematoma expansion Earlier in
Course
Sanossian, FAST-BP Trial
-15 -5 0 20 30 40 60 100 160 200 3600
5
10
15
20
25
30
35
40
45
--All hypertensive pts--All severely hypertensive pts--Likely ICH pts
Time in minutes from onset of symptoms
Volu
me
of H
emat
oma
in m
L
Rupture of blood vessel
Onset of Symptoms
Activation of EMS
EMS Arrival
EMS Transport
EMS Arrival in ED
Initial ED Evaluation CT scan
obtained
CT scan evaluated
Hospital Treatment initiated
Final Hematoma Volume Established
Field Treatment Initiated
Goal: Control Hematoma expansion Earlier in
Course
Sanossian, FAST-BP Trial
Onset to Treatment Times in Recent Trials Enrolling ICH Patients
Trial Setting Intervention Onset to Treatment
INTERACT 1 Hospital Target SBP ≤ 140 4h 00mATACH 1 Hospital Nicardipine 4h 17mINTERACT 2 Hospital Target SBP ≤ 140 4h 00mRIGHT Prehospital Glyceryl trinitrate 55mPIL-FAST Prehospital Lisinopril 1h 17mFAST-MAG Prehospital Magnesium 47m
UCLA Stroke Center
Preserve / Treat / Cure
Condition EMS ED OR/Cath LabAcute ischemic stroke
Neuroprotection TPA Endovascular recanalization
Acute intracerebral hemorrhage
BP lowering Hemostatic agent Minimally invasive hem evacuation
UCLA Stroke Center
Preserve / Treat / Cure
Condition EMS ED OR/Cath LabAcute ischemic stroke
Neuroprotection TPA Endovascular recanalization
Acute intracerebral hemorrhage
BP lowering Hemostatic agent Minimally invasive hem evacuation
UCLA Stroke Center
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