Developing and applying stroke systems of care Andrew M. Demchuk MD FRCPC Director, Calgary Stroke Program Deputy Department Head, Dept Clinical Neurosciences HSF Chair in Stroke Research Professor, Depts of Clinical Neurosciences and Radiology Cumming School of Medicine University of Calgary
Disclosure Slide • I have not received an honorarium from Hoffman LaRoche (licensure of tPA) but have received honorarium from Medtronic (supplier of SOLITAIRE FR stentriever) for CME events • No stocks or direct investments with pharmaceutical or device companies involved in stroke • Co-founder/shareholder Quikflo Health start-up (acute stroke software) • Several clinical trial responsibilities: • IMS-3- Exec committee, CT core lab PI • ESCAPE- Neuro-PI • REVASCAT- CT core lab co-PI • CLOTBUST-ER – CTA substudy PI • ARTSS-2 – CTA substudy core lab PI • ENCHANTED – International Advisory Committee • PRACTICE- DMC chair • DEFUSE 3- Safety monitor • ANNEXA-4 – Adjudication committee
Stroke Care Continuum Primary Prevention Stroke Stroke EMS ED Acute Team Imaging Onset Transport Time Treatment Assessment Clinical Worsening/ Reintegration Rehabilitation Admission Complication Prevention Secondary Prevention 3
Treatments for Complication Prevention ASA Early enteral No Early BP feeding good lowering Stroke units 1970 1980 2000 2002 2004 2015 2013 2010 1990 1995 CT scan Above knee Hemicraniectomy pneumatic compression stockings
Per million population
Reperfusion Treatment Advances tPA<3h Endovascular tx 1970 1980 2000 2002 2004 2008 2011 2013 CT scan 1990 1995 tPA 3-4.5h tPA for 2015 elderly Thrombectomy
Two Decades Behind But Finally an Impactful Treatment 2016 Goyal et al Mechanical Thrombectomy*** 1976 2016
Intravenous rtPA Balance between benefit and risk
Large clot Proximal artery Severe deficits 10
Thrombectomy: Stent retrieval devices Thrombus in the stent and aspirate Solitaire TM FR TREVO
Stent Retrieval Devices: High Reperfusion Rates Series 3 90 80 70 60 50 40 Series 3 TICI 2b- 30 3 20 10 0 Stroke 2004 1 ; Stroke 2007 2 ; NEJM 2013 3,4 ; Lancet 2012 5 ; Lancet 2012 6 ; ISC 2012 7 ; Stroke 2012 8 ; ISC 2013 9
Independence Dependence 14
15
ESCAPE Inclusion criteria Stroke Care in the 21st Century • Acute ischemic stroke (NIHSS > 5) • 12 hour window • No upper age limit Shifting the Paradigm in Alberta • Good functional status 16
The 3-5 minute CT/CTA protocol EIC- ASPECTS Small core >6 Occlusion site M1+/-ICA “Collaterals” good/mod 17
Overall Results 29.3% 53.0% RR: 1.8 (1.4-2.4) NNT = 4.2 [1/0.237] 2016-03-21 www.escapetrial.org 18
Overall Results cOR: 2.6 (1.7-3.8) NNT ~3 19
Safety Outcomes Adjusted § Intervention Control RR (CI 95 ) [n=150] [ n=165] RR (CI 95 ) Death [N=311] 10.4% 19.0% 0.5 (0.3-0.95) 0.5 (0.3-0.8) Large/malignant 4.9% 10.7% 0.5 (0.2-1.0) 0.3 (0.1-0.7) MCA stroke sICH (clinically determined 3.6% 2.7% 1.4 (0.4-4.7) 1.2 (0.3-4.6) at site) --- --- Access site 1.8% 0% 6% hematoma --- --- MCA perforation 0.6% 0% 20
Endovascular thrombectomy after large-vessel ischemic stroke: a meta-analysis of individual patient data from five randomised trials HERMES Collaborators Highly Effective Reperfusion evaluated in Multiple Endovascular Stroke trials (HERMES) 2016-03-21 HERMES Collaboration 21
Overall Treatment Effect 2016-03-21 HERMES Collaboration 22
Overall Treatment Effect NNT = 2.6 25.5% 46% 2016-03-21 HERMES Collaboration 23
Benefit even if not tPA eligible 2016-03-21 HERMES Collaboration 24
Patients much improved the next day 2016-03-21 HERMES Collaboration 25
No increased bleeding Reduction in Mortality trend 2016-03-21 HERMES Collaboration 26
Treatment effect by age mRS 0-2 at 90 days 2016-03-21 HERMES Collaboration 27
Effect size by NIHSS 2016-03-21 HERMES Collaboration 28
Treatment effect is strongest if carotid occlusion (p int =0.17) 2016-03-21 HERMES Collaboration
Treatment effect is strong if cervical ICA too (p int =0.17) 2016-03-21 HERMES Collaboration
Onset to Substantial Reperfusion and Disability Outcomes (mRS) at 3 Months 2016-03-21 HERMES Collaboration 31
Onset to Randomization and Disability Outcomes (mRS) at 3 Months 3-5% absolute decrease in good outcome per hour 1-2% absolute increase in mortality per hour 2016-03-21 HERMES Collaboration 32
What is the potential for EVT? ~1 in 4 or 5 strokes = EVT accessible occlusion 100-150 endo eligible/1 million/yr
During this Morning Somewhere in Western Canada…. At least one individual has suffered a major ischemic stroke that is very suitable for endovascular rescue if….
Endovascular Treatment How Do We Build The System of Care To Do This?
~ 40 PCI Facilities in Canada for Acute Myocardial Infarction
Is Your Region Equipped with Stroke Thrombectomy Facilities Nearby? Are there neurointerventionalists available 24h/365d at these facilities?
The How To? • EMS transport to right hospital
How are ambulances routing hyperacute major deficit patients? PSC CSC PSC PSC EMS transport to any hospital should be unacceptable!
Centralize care: Redirect ambulance to stroke centre PSC CSC PSC PSC
US Model of Hubs and Spoke Model
Stroke Centre Designation Criteria Primary Stroke Centre (PSC) Criteria: CT scan availability Door to CT time less than 20 minutes with pre-alert Stroke expertise on-site or available by Telestroke link rtPA treatment availability Serves all surrounding communities in which it is the nearest PSC “Time Comprehensive Stroke Centre (CSC) Criteria: is CT scan availability Brain” Door to CT time less than 20 minutes with pre-alert Stroke team on-site Neurosurgical expertise on-site Neuro-interventionist expertise on-site Central hub of stroke neurologist expertise in a telestroke network 42
Alberta Acute Stroke Treatment 2016 Comprehensive Stroke Centre Primary Stroke Centre 43
Transport decisions evolving
Transport decisions evolving angio EVT
The How To? • EMS transport to right hospital • Primary Stroke Centres • CT/CTA 24/7 • Telestroke capability to hub CSC
Mechanical thrombectomy Ideal If Carotid Occlusion M1 MCA Occlusion
NCCT/CTA now standard of care and should be performed sequentially while on CT table 49
“Neurons over nephrons” in major stroke
“CIN” called into question
Primary Stroke Centre Model with Telestroke
The How To? • EMS transport to right hospital • Primary Stroke Centres • CT/CTA 24/7 • Telestroke capability to hub CSC • DTN<30 min • DIDO <45 min
Target: Stroke Best Practice Strategies 1. *EMS Pre-Notification 7. *POC Laboratory Testing 2. Stroke Toolkit 8. *Premix TPA 3. Rapid Triage and Stroke Team 9. *Rapid TPA Access - Notification store TPA in ED/radiology, start in 4. *Single Call Activation imaging suite System 10.Team approach 5. *Transfer Directly to CT 11.*Prompt data feedback 6. Rapid Brain Imaging
STAT! STROKE Prehospital Notification Patient care attendant ED bedside nurse Angio team Neuro-IR Stroke neurologist Triage nurse ED physician CT tech
DTN <30 min/ DIDO <45 min Door to CT scanner <10 min Keep on the CT table for immediate CTA! NCCT prep/scanning time <5 min NCCT CTA prep/scanning time <5 min CTA reformatting time <5 min CTA CTA Phase� 2� All images to decision <10 min Keep on EMS stretcher! Phase� 1� Phase� 2� Phase� 3� Decision to door out <10 min Door in door out <45 minutes NCCT to tPA decision via telestroke <10 min mix/prep for bolus <5 min Door to needle <30 minutes 57
FUTURE Repeat Groin LSN Time CT/CTA Puncture EMS Second Revasculariz Activation door in -ation First door First Door Second door out in Out Home time IV tPA CT/CTA % in first 90 start time days 58
The How To? • EMS transport to right hospital • Primary Stroke Centres • CT/CTA 24/7 • Telestroke capability to hub CSC • DTN<30 min • DIDO <45 min • Comprehensive Stroke Centre • Bypass of PSCs if severe+by distance
Onset to Substantial Reperfusion and Disability Outcomes (mRS) at 3 Months 2016-03-21 HERMES Collaboration 60
61
Transport decisions evolving angio EVT
Transport decisions evolving angio EVT
Transport decisions evolving angio EVT
What to do when more than one stroke centre in metro area? PSC CSC PSC PSC
Golden 2 Hours of Stroke P=0.001 66.9% 8.3% 2016-03-21 HERMES Collaboration 66
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