Presentation on theme: "Stroke Systems of Care V.T. Doss, D.O."— Presentation transcript:
1Stroke Systems of Care V.T. Doss, D.O. Stroke Medical Director, BMH-MemphisAssistant Professor, Neurology & Neurosurgery, UTHSC
2Intro Neurological emergency Ischemic vs. Hemorrhagic TOAST classificationthrombosis /embolism due to atherosclerosis of a large arterycardioembolic originocclusion of a small blood vesselother determined cause (CSVT, vasculitis, trauma)undetermined cause (two possible causes, no cause identified, or incomplete investigation)thrombosis or embolism due to atherosclerosis of a large artery, (2) embolism of cardiac origin, (3) occlusion of a small blood vessel, (4) other determined cause (5) undetermined cause (two possible causes, no cause identified, or incomplete investigation).
5US Stats 95% of strokes at age >45, and 2/3 of strokes occur in those >65leading cause death/disability10% deaths worldwide795,000 strokes/yr, 610,000 of these are first strokes. About 185,000 people who survive a stroke go on to have anotherIn 2010, stroke cost the US $53.9 billionSomeone in the United States has a stroke every 40 seconds. Every four minutes someone dies of strokeThis total includes the cost of health care services, medications, and missed days of work.Compared to whites, African Americans are at nearly twice the risk of having a first stroke. Hispanic Americans' risk falls between the two. Moreover, African Americans and Hispanics are more likely to die following a stroke than are whites.SE has highest mortality rates
6According to the WHO, 15 million people suffer stroke worldwide each year. Of these, 5 million die and another 5 million are permanently disabled.Stroke is the second single most common cause of death in Europe: accounting for almost 1.1 million deaths each year.Over one in seven women (15%) and one in ten men (10%) die from the disease.
7Why is Time Important?The area peripheral to a core infarct where metabolism is active but blood flow is diminished is called the ischemic penumbraThis is salvageable tissue that is at risk for infarction.The penumbra lies in a 'no-man's land' between a zone of low blood flow that is < 25 ml/100 mg brain tissue/min and a zone where brain tissue is undergoing necrosis/death, flow of < 8-10 ml/100 mg/min1Without restoration of blood flow/oxygen, the ischemic penumbra will convert to ischemic core or tissue deathCore InfarctIschemic PenumbraBrain1-
9IV TPA APPROVED by FDA in 1996 NOW THE ACCEPTED STANDARD OF CARE THROUGHOUT US, EUROPE AND ASIARPCT – TPA v. Placebo < 3 hours (Dose .9mg/kg IV)Inclusion Criteria: Stroke with clear time of onset, CT without ICH, & measurable deficit on NIHSSExclusion Criteria:Recent GI or GU Bleed w/in 21 days, Ischemic stroke within 3 months,hx of ICH, recent arterial puncture at a noncompressible site w/in 7 days, SBP > 185 or DBP > 110 that can’t be controlled, INR > 1.5, platelets < 100K, glucose > 400 or < 50 Seizure at onsetPhase I (N=291): TPA clinical 24 hours NIHSS improvement of >/= 447% TPA vs. 39% placebo, p= 0.21Phase II (N=333): Primary Outcomes (MRS < 2) at 90 days, ARR 12%, NNT = 8SICH 6.4 % vs % (P < 0.001)
10Number Needed to Treat = 14 Expanded time window for milder strokes, NIHHS < 25 with less than 1/3 of MCA territory on CTN=821Primary endpoint: MRS < 90 days. 52.4% vs. 45.2, P = 0.04Number Needed to Treat = 14
11Modified Rankin Scale 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
12NINDSNINDS randomized 624 subjects within 3 hours of stroke onset to receive 0.9 mg/kg of intravenous tPA or placebofound that patients treated with tPA within 3 hours of onset had a substantially better chance of functional independence with minimal or no disability 3 months after treatmentThe proportion of patients with minimal or no disability increased from 38% with placebo to 50% with tPA, a 12% absolute improvementThe NNT for 1 more patient to have a normal or near normal outcome was 8NNT for 1 more patient to have an improved outcome was 3.1Brain hemorrhages related to tPA caused severe worsened final outcome in 1% of patientsOverall, for every 100 patients treated within the first 3 hours, 32 had a better outcome as a result and 3 had a worse outcome.
13ECASS III821 pts, hrno difference in mortality between the two groups (approximately 8%) sICH higher in tpa group (2.4%)odds for a favorable outcome (MRS 0-1) after stroke were 28% higher with alteplase than with placeboTime is tissue
14 NINDS and ACLS Recommended Benchmarks for Potential Thrombolysis Candidate IntervalTargetDoor to doctor10 minAccess to neuro expertise15 minDoor to CT completion25 minDoor to CT interpretation45 minDoor to IV-rTPA60 minAdmission to stroke unit or ICU3 hours
15Casting a wider net Expanding time window Stroke centers- primary, comprehensiveTele-strokeMulti-modal imagingNew agents/devicesLess is more?Neuroprotection
16Direction/Innovations EMS AdvancesTelemedicineSpoke and Hub Models
18Tele-Stroke 24hr access to neuro specialist Avoids stroke mimickers Allows smaller hospitals to keep these patients
19CSC Physicians Vascular Neurology Vascular Neurosurgery InfrastructureStroke UnitIntensive Care UnitOperating room staffed 24/7Interventional staff available 24/7Stroke registryDiagnostic techniquesMRI with diffusionMRA and MRVComputed Tomography Angiogram (CTA)Digital cerebral angiographyTranscranial dopplersCarotid duplex ultrasoundTTE and TEERehabilitation (PT/OT/ST)Advanced Practice Nursing /Staff stroke nursesRespiratory TherapistsEducational/research programsClinical researchCommunity education/preventionProfessional educationPhysiciansVascular NeurologyVascular NeurosurgeryVascular SurgeryDiagnostic radiology and neuroradiologyInterventional/endovascular physiciansCritical care medicinePhysiatristsSurgical and interventional therapiesCEAIntracranial aneurysm clippingSurgical removal or draining of blood from the brainPlacement of EVD and intracranial pressure monitorsEndovascular treatment of aneurysms and arteriovenous malformationsIntra-arterial reperfusion therapyEndovascular treatment of vasospasmPSCs certified within the past 2 years, 72.7% of eligible patients received tPA. The longer a PSC was in the certification program, the higher its tPA participation rate. Hospitals in their second certification cycle achieved a 78.6% IV tPA participation rate, and those certified for a third 2-year cycle achieved 94.4% participation. Among teaching hospitals in their first certification cycle, the rate of IV tPA use for eligible patients was 81% compared with 70% of nonteaching hospitals. Most studies have found Tx at PSC you’re more likely to have a better outcome and lower mortality.
20Mobile Stroke Unit Point-of-Care-based laboratory compact CT scan results, reviewed remotely by hospital physiciansresults in early pre-hospital IV-thrombolysis and subsequent bridging therapy later with IA recanalization in the hospitalA hospital system in Hamburg Germany developed a mobile stroke (treatment) ambulance to address the issue of suburban and rural stroke patient management and shorten time to treatment - bring the stroke care to the patientThey have been able to dramatically reduce Call-to-Lab time, Call to CT time and, most importantly, Call-to-Therapy Decision-Advanced Treatment time, reduced from 120 minutes (two hours), to just minutes.
21Options for Patients Experiencing an Ischemic Stroke IV tPAGold-standard in ischemic stroke care. Drug is designed to break apart the clot.Endovascular Clot RemovalMechanical disruption or removal of the clot using standard endovascular approachesBridging TherapyMedical ManagementMonitor vitals and provide secondary stroke prevention. Patient is send to rehab or a nursing facility when stable.
22Endovascular Therapy Anterior 12 hours Posterior <24h NIHSS >7 Evidence of Large vessel occlusion, hemodynamically unstableLarge penumbra or clinical mismatch
2325% vs 42.9%## MCA Occlusion Basilar Occlusion Recanalization rate IV TPA:M1: 22%, M2:44%‡Mortality:25% vs 42.9%##Recanalization rate with IV TPA: <10%Mortality: 90%(persistent occlusion)**Internal Carotid OcclusionRecanalization rate with IV TPA: <10%Mortality: 73%(persistent occlusion)^^‡Alexandrov et al. Stroke## Proact II: Jama 1999**Meta analysis Furlan et al^^ Flint et al. MERCI Registry Stroke 2008
24The Importance of Recanalization Recanalization is strongly associated with improved function outcomes and reduced mortality.
25Meta-analysis shows a strong correlation between opening the blood vessel and patient good outcomes Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke Mar;38(3):
29IMS III: Interventional Management of Stroke 3 Patients who had received intravenous rt-PA within 3 hours after symptom onset were randomized 2:1 to:IV tPA + IA therapyIV t-PA alonePrimary outcome measure: 90-day mRS ≤ 2Broderick JP. NEJM 2013;368:
30Primary outcome: IMS III mRS < 2 95% CI: -6.1% to +9.1%40.8% with endovascular + IV rt-PA38.7% with IV rt-PA aloneBroderick JP. NEJM 368: , 2013
32MR RESCUE: Methods ≤ 8 hours of onset Anterior circulation LVO Randomized to either EVT or Medical Mgmt“penumbral” pattern by CT or MRIPenumbra : “Small core” (<90 cc), large penumbraNon-Penumbral: Large core and small/absent penumbraIV tPA treated patients without recan were eligible if MRA or CTA showed persistent occlusionKidwell CS. NEJM 2013 Mar 7;368(10):914-2332
33MR RESCUE: 90-day mRS NO DIFFERENCE IN OUTCOMES Endovascular vs. medical therapyPenumbra vs. no penumbrap=0.23p=0.32Kidwell CS. NEJM 368: , 2013
35Synthesis Expansion: Outcomes Primary Outcome (mRS < 1)30.4% EVT34.8% IV tPADeath RatesEVT: 14 (8%)IV tPA: 11 (6%)Italian Medicines Agency (AIFA)“EVT is not superior to standard treatment with IV tPA”Ciccone A. NEJM 368: , 2013
36IMS III Protocol Versus Contemporary Practice The majority of patients included in the studyWere not imaged using modern approachesWere not triaged using modern approachesWere not treated using modern approaches
37Imaging Assessment Basic Head CT only in most patients More than 40% of IMS III patients had baseline CT with ASPECTS < 7
40Patient Selection Matters: Penumbra Pivotal Trial Independent Blinded Retrospective Analysis Baseline NCCT Data Using ASPECTSmRS ≤ 2Large Infarct8/53 ptsSmall Infarct15/30 ptsGoyal M. Stroke 2010
41IMS III - Imaging Assessment Patients with “large clear regions of hypodensity” (darker than white matter and brighter than CSF) on CT, greater than 1/3rd of MCA territory were excludedSulcal effacement and loss of grey-white matter differentiation were not contraindicationsMany patients would have likely been excluded with more conservative CT reading (ASPECTS), CTA-SI (source image) ASPECTS, MR Diffusion ASPECTS, CT Perfusion or MR Perfusion
43IMS III – EVT Arm Would ALL have been screened out with CTA 89 patients with ”no treatable or treated thrombus”33 no thrombus seen34 thrombus not treatable by EVT12 with treatable thrombus but not treatedNo reason (1)Couldn’t safely cross occlusion (3)Recanalization during angio (2)Occlusion not responsible for clinical presentation (2)No reason (2)Would ALL have been screened out with CTA
44Clot characteristics (length) No Clot > 8mm recanalized with IV tPA43% of large vessel occlusions have greater than 8 mm clot lengths144
45IMS III: Baseline CTA Occlusion Present – 90 day mRS van Elteren test p-value
46IMS III: Baseline CTA Occlusion Present - NIHSS > 20 van Elteren test p-value
47TICI Score Grade 0 No perfusion Grade 1 Perfusion past the initial obstruction, but limited distal branch filling with little or slow distal perfusionGrade 2a Perfusion of less than ½ of the vascular distribution of the occluded artery (e.g., filling and perfusion through 1 M2 division)Grade 2b Perfusion of ½ or greater of the vascular distribution of the occluded artery (e.g., filling and perfusion through 2 or more M2 divisions)Grade 3 Full perfusion with filling of all distal branches
48Percentage of Patients Who Achieved a Functional Outcome in IMS III Based on Reperfusion Result (p=0.001)In IMS III, independent functional outcome (mRS 0-2) was strongly associated with TICI 2b-3 revascularization.
49IMS III ‘modern’ devices = 13% of endovascular cohort Total endovascular treatments = 334/434IA tPAEKOS + tPA 22Merci 38Merci + tPA 57Penumbra 16Penumbra + tPA 38Solitaire 2Solitaire + tPA 3‘modern’ devices= 13% of endovascular cohort
50IMS III IMS-III endovascular reperfusion rates: ≥ TICI 2a ≥ TICI 2b ICA % %M % %M % %Overall % %TREVO2* 92% 68%SWIFT* 94% 76%*Both are high quality independent core lab adjudicated, published in Lancet
51Systems and Process Issues in the Era of Comprehensive Stroke Center Designation Relative to IMS I and II, the IMS III trial suffered from a dramatic delay between the initiation of iv tPA and endovascular therapyAt over two hours, this lag impedes the ability of reperfusion to realize clinical benefit.
52IMS III patients further suffered a significant lag between groin access and initiation of IAT at the lesion Fourty-four minutes is far beyond reported standards with modern guide and distal access catheter technology
53Time to Treatment IMS III Onset to arrival: 57 min Arrival to IV tPA: 66 minIV to groin puncture: 86 minsGroin puncture to IA: 44 minsMR RESCUEMean time from imaging to groin puncture:2h 4 minSYNTHESISTime from onset to start of treatmentEVT hrsIV 2.75 hrs130 mins between IV tPA and start of IA therapyBy comparison STAR registry:Groin Puncture to guide cath placement: 12 minsGuide cath to TICI 2B/3 flow: 20 minsCritical as IA group did NOT receive IV tpa
54Lessons Learned Endovascular Therapy is safe – as safe as IV rt-PA
55Lessons Learned from Recent Ischemic Stroke Trials It is not IV vs EVTIV tPA is proven Class 1 – it should not be denied from patientsFuture trials should compare best medical management versus best medical management + EVTOnly enroll patients with LVO (large vessel occlusion)Excellent recanalization is neededTICI 2B or 3Time is BrainBetter determination of salvageable brain tissueASPECTSCT PerfusionMRI Diffusion/PerfusionSet the stage for final portion of talk – can quickly review point 1 on this slide. We have already made the argument for point 2. Will then get into greater discussion of points 3-555
60Distal aspiration with retrievable stent assisted thrombectomy for the treatment of acute ischemic strokeWilliam Humphries1, Daniel Hoit1, Vinodh T Doss1, Lucas Elijovich1, Adam S Arthur1AbstractObjective Flexible large lumen aspiration catheters and stent retrievers have recently become available in the USA for the revascularization of large vessel occlusions presenting within the context of acute ischemic stroke (AIS). We describe a multicenter experience using a combined aspiration and stent retrieval technique for thrombectomy.Design A retrospective analysis to identify patients receiving combined manual aspiration and stent retrieval for treatment of AIS between August 2012 and April 2013 at six high volume stroke centers was conducted. Outcome variables, including recanalization rate, post-treatment National Institutes of Health Stroke Scale (NIHSS) score, symptomatic intracranial hemorrhage, discharge 90 day modified Rankin Scale (mRS) score, and mortality were evaluated.Results 105 patients were found that met the inclusion criteria for this retrospective study. Successful recanalization (Thrombolysis in Cerebral Infarction score 2B) was achieved in 92 (88%) of these patients. 44% of patients had favorable (mRS score 0–2) outcomes at 90 days. There were five (4.8%) symptomatic intracerebral hemorrhages and three procedure related deaths (2.9%).Conclusions Mechanical thrombectomy utilizing combined manual aspiration with a stent retriever is an effective and safe strategy for endovascular recanalization of large vessel occlusions presenting within the context of AIS.J NeuroIntervent Surg doi: /neurintsurg
61Case 1 53yo male presented with L MCA syndrome NIHSS 21 Onset 1 hour Received iv-tpa within 60 min from door
80Conclusions Stroke systems and patient selection critical to outcomes EMS critical to triage, stabilizing and transporting to stroke centerImperative to recognize signs and symptoms of stroke especially large vessel occlusionIV-TPA standard of careEndovascular treatment can be performed quickly and safelyTime is Brain!