endovascular treatment of acute ischemic stroke
DESCRIPTION
McGill Neurology Academic half-day Wednesday, May 8 th , 2013 Alexandre Y. Poppe MD CM, FRCPC Stroke neurologist Notre-Dame Hospital, CHUM [email protected]. Endovascular treatment of acute ischemic stroke. Disclosures. CHUM PI for IMS-3 Honoraria - PowerPoint PPT PresentationTRANSCRIPT
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Centre hospitalier de l’Université de Montréal
Endovascular treatment of acute ischemic stroke
McGill Neurology Academic half-dayWednesday, May 8th, 2013
Alexandre Y. Poppe MD CM, FRCPCStroke neurologist
Notre-Dame Hospital, [email protected]
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Disclosures
CHUM PI for IMS-3 Honoraria
• Conferences: Boehringer-Ingelheim, Sanofi-BMS
• Advisory boards: Octapharma, Pfizer-BMS
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Plan
Evidence for endovascular stroke therapy• Before 2013• In 2013
CHUM experience The future
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Time is Brain!During an acute ischemic stroke
1.9 million neurons, 14 billion synapses,
12 km of myelinated fibres
Are lost PER MINUTEStroke. 2006 Jan;37(1):263-6
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La pénombre ischémiqueOcclusion artérielle Baisse de
CBF
“Coeur” de l’infarcissement: CBF trop bas pour maintenir
l’intégrité membranaire des cellules (échec des pompes ioniques)
<10ml/100g/minMort cellulaire en qq minutes
Pénombre ischémique:CBF trop bas pour soutenir
activite électrique, mais intégrité membranaire intacte
10-20ml/100g/minTissu pouvant être “sauvé”
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Basic principle of acute ischemic stroke therapy:
rapid and complete recanalisation of the arterial
occlusive lesion!
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Courtesy A. Demchuk
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Neurology. 2009 September 29; 73(13): 1066–1072
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Traitement standard: Thrombolyse IV
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AVC aigu: Thrombolyse 0-6 hrs
Lancet 2012 Jun 23;379(9834):2352-63
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IST-3
RCT ouvert 156 hôpitaux dans 12 pays européens
3035 patients traités avec placebo vs tPA-IV
1515 tPA, 1520 placebo
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IST-3
OTTT médian: 4.2 heures Issue favorable: 37% vs 35%
(p=0.181) HIC à 7 jours: 3% vs 1%
(p<0.0001) Mortalite à 6 mois: 27% vs 27%
(p=0.672)
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Negative study, but supports IV tPA use• In patients >80 years-old• Within < 3 heures
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tPA IV: Méta-analyse 2010 NINDS, ATLANTIS, ECASS (1, 2, et 3) et
EPITHET (n=3670) “Outcome” favorable (mRS 0-1)
Delai de Tx (min) OR (95% CI) NNT
0-90 2.6 (1.4-4.5) 4.5
91-180 1.6 (1.1-2.4) 9
181-270 1.3 (1.1-1.7) 14.1
271-360 1.2 (0.9-1.6) 21.4
Lees KR et al. Lancet. 2010;375(9727):1695.
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Meretoja et al. Neurology 2012; 79: 306-313
YD
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Neurol.; 79: 306-313
YD
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Courtesy A. Demchuk
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tPA IVAvantages
Disponibilité Acces rapide Facilité
d’administration Bénéfice clinique
documenté dans plusieurs études et registres
Inconvénients Faible taux de
recanalisation (TIMI 2-3)1
• CI 10%• ACM M1 25%• M2-M3 40%
Hémorragie intracérébrale
Hémorragie systémique
1 Wolpert AJNR 1993, Yamaguchi Cerebrovasc Dis 1993, Mori, Neurology 1992
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Endovascular therapy
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Endovascular therapy(tPA +/- mechanical thrombectomy)
Avantages Meilleurs taux de
recanalisation:• 40-85%
Plus longue fenêtre de Tx ?
Visualisation en temps réel de la recanalisation
Inconvénients Delai entre AVC et
angio Centres spécialisés
seulement Complications
(dissection, perforation etc.)
Embolies distales Anesthésie/
intubation?
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Intra-arterial thrombolysisPROACT II RCT de patients avec occlusion ACM traités en
<6 heures NIHSS médian = 17 Pro-urokinase IA + héparine IV (n=121) vs
héparine IV (n=59) Recanalisation (par angio): 66 vs 18%
(p<0.001) mRS 0-2 a 90 jours: 40% vs 25% (p=0.04) HIC symptomatique: 10% vs 2% (p=0.06)
Furlan A et al. JAMA. 1999;282(21):2003.
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Mechanical thrombectomy 3 appareils
approuvés par le FDA• MERCI• Penumbra• Solitaire
Registres, séries mono-centriques, contrôles historiques
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Mechanical thrombectomy
MERCI
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MERCI Study N=151 Contre-indication au tPA-IV <3hrs ou Tx 3-8 hrs Occlusion CI, ACM, AB, AV NIHSS médian = 19 Comparaison avec groupe témoin de PROACT-II
• Recanalisation 46% vs 18%• sICH 8% vs 2%• Mortalité 44% vs 27% • mRS 0-2 à 90jrs 27.7% vs 25%
Recanalisation associée avec meilleur outcome• mRS 0-2: 46% vs 10%
Smith WS et al. Stroke. 2005;36(7):1432.
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Multi MERCI trial N=164 NIHSS médian = 19 Tx IA ad 8 hrs avec CI au tPA-IV ou
après «echec» de tPA-IV• Recanalisation 57.3%• mRS 0-2 à 90jrs 36%• sICH 9.8%• Mortalité 34%
Smith WS et al. Stroke. 2008 Apr;39(4):1205-12.
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Multi MERCI trial
Smith WS et al. Stroke. 2008 Apr;39(4):1205-12.
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Mechanical thrombectomyPENUMBRA
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Penumbra pivotal stroke trial
N=125 Tx IA ad 8 hrs avec CI au tPA-IV ou
après «echec» de tPA-IV• Recanalisation 81.6%• mRS 0-2 à 90jrs 25%• sICH 11.2%• Mortalité 32.8%
Stroke. 2009 Aug;40(8):2761-8.
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Mechanical thrombectomy“Stentrievers”SOLITAIRE
TREVO
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Lancet. 2012 Oct 6;380(9849):1241-9.
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Lancet 2012 Oct 6;380(9849):1231-40
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Combined therapy or “bridging”
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IV-IA “bridging”: l’evidence
Emergency Management of Stroke (EMS)
tPA IV/IA (n=17) versus placebo IV/tPA IA (n=18)
Meilleure recanalisation (TIMI 2-3) pour IV/IA (81% versus 50%)
Pour occlusions M1-M2: 100% recanalisation
Lewandowksi CA et al. Stroke. 1999 Dec;30(12):2598-605.
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IV-IA “bridging”: l’évidenceIMS I Jan-Oct 2001 IV-IA < 3 heures avec NIHSSS ≥ 10 (median 18) “Open-label” sans groupe contrôle n=80 Pour NIHSS ≥ 20
• mRS 0-2 a 3 mois: IMS I 42% NINDS tPA 21%
Comparaison avec cohort NINDS
Stroke. 2004;35(4):904.
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IV-IA “bridging”: l’évidence
IMS II Prolongation de IMS I avec ajout du
système EKOS MicroLysus n=73 NIHSSS médian = 19 IMS II versus NINDS tPA
• mRS 0-2 a 3 mois: 48% versus 36%
Stroke. 2007;38(7):2127.
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Combined IV-IA therapy: the evidence
RECANALISE
Registre prospectif “before and after”
tPA IV versus tPA IV + endovasculaire
IV (n=107)
IV-IA (n=53)
P value
Recanalisation
52% 87% <0.0001
Early neurological improvement
39% 60% 0.07
mRS 0-2 at 90 days
44% 57% 0.13
Death at 90 days
17% 17% 0.98
sICH 11% 9% 0.73
Mazighi M et al. Lancet Neurol. 2009 Sep;8(9):802-9.
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IV-IA “bridging”: l’évidence
Étude retrospective comparant 2 groupes: tPA IV-IA (n=42) vs tPA IV sans amélioration
à 1 heure (n=84)• Equilibrés pour occlusion, NIHSS et temps de Tx
avec tPA-IV NIHSS médian = 20 Occlusion documentée par TCD
Rubiera M et al. Stroke. 2011;42:993-997.
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Should we call our INRs?
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Thrombolyse au CHUMAnnée Nombre de
cas IV-IANombre de
cas IVNombre de cas IA seul
2003 0 31 32004 1 24 72005 0 31 92006 2 32 92007 3 34 72008 5 36 112009 13 48 102010 17 43 122011 26 60 92012 22 62 29
Données colligées par R. Cournoyer
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YD
Données colligées par Y. Deschaintre et R. Cournoyer
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7 8 9 10 11 12
CombinéIA seulIV seul
105
Années 2001 à 2012
Thrombolyse au CHUM
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CHUM experience N=39 (nov 2009 – janv 2011) NIHSS moyen = 18.7
• MERCI: 4 (+ Penumbra ou ballon) (10%)
• Penumbra: 33 (85%) • Solitaire: 1 (2%)
Recanalisation 66% mRS 0-2 à 90jrs 33% Mortalité 10%
Courtesy Dr. F. Bing, unpublished data
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NEJM February 7th 2013
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Phase 3 RCT, open-label with blinded outcome
N=656 (IV only=222, IV-IA=434) Tx within 3 hours IA Tx within 5 hours and not
beyond 7 hours• MERCI, Ekos, Penumbra, Solitaire
N Engl J Med 2013;368:893-903
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mRS 0-2: 40.8% vs 38.7% (95% CI -6.1-9.1%)
N Engl J Med 2013;368:893-903
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IMS-3
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IMS-3
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IMS-3: Recanalisation* rates at 24hrs
IV only IV-IA
ICA 35% 81%
M1 68% 86%
M2 77% 88%
*Partial or complete on follow-up CTA
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IMS-3: post-mortem
IV tPA better than we assumed? Patients treated too late? Ischemic changes too extensive?
(>40% ASPECTS <8) Less effective first-generation
devices?
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SYNTHESIS ExpansionN Engl J Med 2013;368:904-913
Pragmatic open-treatment RCT with blinded endpoint
N= 362 (IV=181, IA=181) Median time to treatment
(p<0.001)• IV: 2.75 hrs• IA: 3.75 hrs
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mRS 0-1: 30.4% vs 34.8% (95%CI 0.44-1.14)
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SYNTHESIS Expansion
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MR Rescue N Engl J Med 2013;368:914-923
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IV tPA remains the only proven recanalisation therapy for stroke within 4.5hrs
Patients receiving IV tPA within 2 hours and endovascular Tx within 90 minutes of IV tPA may benefit
Extension of the treatment time window using penumbral imaging remains unproven
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Can guidelines help?
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Endovasclar therapyCanadian Best Practise Recommendations 2010
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Endovasclar therapy AHA Guidelines 2013
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Endovasclar therapy ACCP Guidelines 2012
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When to consider endovascular therapy...Clinical Age? Stroke severity (NIHSS
>20?) Ultra-rapid door-to-clot
time possible
Imaging Small core volume Occlusion site “Clot burden/length”
(>2cm) Significant mismatch? Good collaterals
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Courtesy A. Demchuk
Stroke 2011 Jan;42(1):93-7
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Algorithm for acute recanalisation therapy <4.5hrs
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Case 1ID: Homme 71 ans,
droitier
HMA: Hémiplégie gauche et
dysarthrie à 8h00
ATCD: Insuffisance cardiaque
(FEVG 25%) FAP Néo vessie
E/P: SVS Hemiparesie G Hemianesthesie G
avec heminegligence G
Dysarthrie
NIHSS 15
Labos: OK
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CT C- à 9h47
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Bolus tPA-IV à 10h15
CTA-Source Images
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Recanalisation TICI 3 à 11h25
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CT C- à 48 heuresCongé jour 5 avec NIHSS 1
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CaseID: Femme 68 ans,
droitiere
HMA: Plegie hemicorps D
avec mutisme a 13h50
ATCD: Anemie severe
(rectorragie) Tabagisme
E/P: SVS Hemiplegie B-F D Aphasie globale
severe
NIHSS 18
Labos: Hb 60
ECG: FA
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CT C- 14h00
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Echec de Tx endovasculaire – angioplastie, MERCI, tPA-IA
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Jour 1NIHSS 20
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Case 23 year-old woman, no PMH Sudden onset nausea, vomiting Altered level of consciousness Brought to peripheral hospital Rapidly progressive bilateral facial
weakness, tetraparesis, dysarthria and dysconjugate gaze
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Baseline NCCT (<2hrs after onset)
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CTA 4 hrs post-onset
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Angio 5 hrs post-onset
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Recanalization 5h45min post-onset
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NCCT Day 4NIHSS 0, mRS 0 at 3 years
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Conclusions Degree of recanalisation and time to
recanalisation are associated with better outcomes
Recanalisation rates are modest with IV tPA
Recanalisation rates are higher with endovascular therapy
Newer generation stentrievers are superior to MERCI for opening arteries (and possible improving outcomes)
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Conclusions The discordance between better
angiographic results and clinical outcomes despite comparable safety, suggests that patient selection may be the problem
Endovascular therapy has a similar safety profile as IV tPA
After IMS-3, endovascular therapy remains unproven...
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ENROLL PATIENT IN A STUDY
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Ongoing or planned studies
EASI ESCAPE SWIFT prime REVASCAT BASICS-2 THRACE …
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Merci
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Algorithme pour l’approche IV vs IV-IA vs IA
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Algorithme pour l’approche IV vs IV-IA vs IA
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Case 2 – Mr. RD 75 year-old RHD male
• Lives with wife, baseline mRS 0
PMH:• HTN• Never-smoker
Meds:• Acebutalol 400 mg qd
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Case 2 – Mr. RD
HPI: 19h17: witnessed sudden onset R
hemiplegia, speech arrest and fall. 911 called.
19h27: ambulance arrival on site 20h04: arrival at HND 20h13: NCCT 20h30: stroke team assessment
• Dysarthria, expressive aphasia, R hemiplegia
• NIHSS 13
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NCCT 1 hour
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Case 2 – Mr. RD
NCCT L eye deviation, L HMCA ASPECTS 10
CTA not done… Obvious HMCA Disabling NIHSS Avoid delays to Angio (NCCT already
done)
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Case 2 – Mr. RD
20h55: IV t-PA bolus, 2/3 dose 21h05: Angio suite. No sedation.
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Angio 2 hours
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22h40: M1 recanalization
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NCCT day 1
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Case 2 – Mr. RD
Favourable in-hospital course Discharged on ASA + Clopidogrel
+ atorvastatin NIHSS 1 at discharge At 6 months and 1 year:
• NIHSS 0• mRS 2 (no longer drives car)
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M. N.
Homme de 62 ans, droitier• DLP• Db2 de novo
AVC ACM gauche• Déficit fluctuant; NIHSS 16 10• Famille indécise re. tPA
CT…
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ASPECTS 10
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M. N.
tPA-IV• OTTT: 3h15
Hyperglycémie malgré insuline IV Aucune amélioration clinique
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CT: 18 hres
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CTA: 18 hres
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CTA: 18 hres
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M. N.
Jour 3• Plus somnolent, mutique• Parésie jambe gauche
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Angio-IRM: jour 3
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IRM: jour 3
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M. N.
Jour 5• Comateux• Mydriase fixe OS• Consult NeuroChx aucune
intervention
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CT: jour 5
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M. N.
Jour 6:• Comateux, tetraplégique• Mydriase bilatérale• Soins de confort• Décès le même jour
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CT: jour 6
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M. A.: un autre exemple...
Homme de 50 ans, droitier• Aucuns antecedents
AVC ACM gauche• NIHSS 9 (aphasie)
CT: pas de changements precoces tPA-IV
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CT: 18 hres
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CTA: 18 hres
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M. A.
24 hres post-tPA• Deterioration subite• NIHSS 23
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CTA: 24 hres
IA = echec
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M. A. NIHSS ~ 20 au conge