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Acute Stroke Slide Kit

Acute Stroke Slide Kit. March 2013. Disclaimer. Please be aware pharmaceuticals presented here may have slightly different labels in different countries.

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Acute Stroke Slide Kit

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  1. Acute StrokeSlide Kit March 2013

  2. Disclaimer Please be aware pharmaceuticals presented here may have slightly different labels in different countries. For more detailed information on the regulatory status, please contact the BoehringerIngelheim affiliate in your country in order to obtain the relevant information for your region.

  3. Contents • Background • Stroke is an emergency: Act FAST • How to improve: optimisation of stroke patient management • Pre-hospital • In-hospital • Stroke centre care • Networks • Telemedicine • Studies and registries • Guidelines • Actilyse® product details • Prescribing information • Appendix • Impressum

  4. Background

  5. StrokeEpidemiology Stroke is the third most common cause of death in developed countries, exceeded only by coronary heart disease and cancer Stroke in the US • 795,000 new or recurrent strokes per year, accounting for approximately 1 in 19 deaths1 • Prevalence of stroke is estimated at 2.8% (2007-2010)1 • Estimated cost (direct and indirect) is 312.6 billion US-$1 Stroke in Europe • Incidence of 101.1 to 239.3 per 100,000 in men and 63.0 to 158.7 per 100,000 in women2 • Causes 1.1 million deaths (8%) per year and is the second most common cause of death2 • Estimated cost (direct and indirect) € 64.1 billion per year3 (€ 38 billion per year in the EU)2 Stroke in China • Incidence for all stroke types is 601.9 per 100,000 (age-adjusted)4 • Prevalence ranges between 1.6% (rural areas) and 9.3% (urban areas)5 • Causes 28.8% (urban) to 29.1% (rural) of all deaths - one of the highest rates worldwide6 • 1. AHA and Stroke Statistics Writing Group. Circulation 2013;127:e6-e245 • 2. Nichols et al, Eur Heart Network & EurSocCardiol. Cardiovasc Dis Stats 2012. • 3. Gustavsson et al. EurNeurpsychopharmacol 2011;21:718-779. 4. Sun et al. Int J Stroke 2013;ePub. • 5. Ferri et al. J NeurolNeurosurg Psychiatry 2011;82:1074-1082. 6. Ferri et al. PLoS Med 2012;9:ePub.

  6. Stroke Types and Incidence Haemorrhagic 12% Other5% Atherosclerotic cerebrovascular disease 20% Cryptogenic30% Small vessel disease “lacunes” 25% Cardiacembolism20% Ischaemic stroke 88% Albers et al. Chest 2004;126 (3 Suppl):438S-512S. Thom et al. American Heart Association. Circulation 2006;113:e85-e151.

  7. Transient Ischaemic Attack (TIA): Definition • TIA was traditionally defined as a neurological deficit, which resolves completely within 24 hours • However, up to 1/3, and in selected patient samples (aphasia and/or hemiparesis lasting for more than 6 h) up to 80% of such defined TIAs show lesions on diffusion weighted imaging (DWI) • The recently recommended definition of TIA has 2 principles: • Acute onset neurological dysfunction, due to focal brain or retinal ischaemia, which completely resolves within 60 min • No evidence of cerebral ischaemia • TIA is a strong prognostic factor for a subsequent stroke • Gorelick. J Med2009;2:1-8. • Albers et al. N Engl J Med2002;347:1713-1716. • Ovbiageleet al. Stroke 2003;34:919-924. • Coull et al. BMJ 2004;328;326.

  8. Strokeis an Emergency Act FAST

  9. Time is Brain Tissue Ischaemic core (brain tissue destined to die) Penumbra (salvageable brain area) An untreated patient loses approximately 1.9 million neurons every minute in the ischaemic area Reperfusion offers the potential to reduce the extent of ischaemic injury Saver. Stroke 2006;37:263-266. González. Am J Neuroradiol2006;27:728-735. Donnan. Lancet Neurol2002;1:417-425.

  10. Stroke is an Emergency • Acute stroke is as much an emergency as acute myocardial infarction • Emergency services should be called immediately • Consultation of primary care physicians* almost doubles the time from onset to hospital arrival • Assessment algorithms in the call centre can help detect a suspected stroke and alert the emergency team and nearest stroke centre • Paramedics or emergency doctors at the scene can reliably recognise stroke symptoms after training • EMS transportation should use priority signals • Kothari et al. Stroke 1995;26:937-941. • Kothari et al. Stroke 1995;26:2238-2241. • Kaste et al. Cerebrovasc Dis 2000;10(Suppl 3):S1-S11. *Primary care physicians means general practitioners, and not the physician who has the first contact to the patient EMS, emergency medical services

  11. Time is Brain: Act FAST! • 1.9 million neurons are lost every minute in the acute phase of an ischaemic stroke if left untreated • 2004 and 2010 pooled analyses of rt-PA trials for ischaemic stroke showed that the earlier treatment is initiated, the better the outcome • NINDS recommends a door-to-needle time (DTN) ≤1 hour • Streamlining of local guidelines and standard operating procedures may shorten the DTN in experienced stroke centres to <30 min on average • Saver. Stroke 2006;37:263-266. • The ATLANTIS, ECASS, and NINDS rt-PA Study Group Investigators. Lancet 2004;363:768-774. • NINDS NIH website. Strokeproceedings. Latest update 2008.

  12. Thrombolysis is Underused • Only 2-12% of AIS patients receive IV thrombolysis with rt-PA • In two thirds of cases that receive rt-PA, the door-to-needle time is >60 min • Problems included: • Delayed arrival (outside the time window) • rt-PA was not available at the hospital • In-hospital delays beyond the time of eligibility for rt-PA • Prolonged time to imaging (CT or MRI) after arrival • Improvement of pre- and in-hospital procedures can increase the number of patients who receive rt-PA • Etgen et al. Acta NeurolScand2011;123:390-395; • Roos et al. Cerebrovasc Dis 2011;31:33. AIS, acuteischaemicstroke

  13. Thrombolysis: Number of Patients Needed to Treat (NNT) to Achieve Excellent Recovery (mRS0-1) ≤ 90 mins NNT=4 to 5 90 min - 3 h NNT=9 3 - 4.5 h NNT=14 mRS, modified Rankin Scale Lees et al. Lancet 2010;375:1695-1703.

  14. rt-PA Effects are Time Dependent Numbers needed to treat (NNT) to reach a modified Rankin score of 0-1 5 Odds ratio estimated by model 95% CI for estimated odds ratio 4 NNT 4 - 5 NNT 9 NNT 14 3 2 0 60 90 120 150 180 210 240 270 300 330 360 OTT (min) OTT, time from stroke onset to start of treatment (and not from hospital arrival time) Wahlgren et al. Lancet 2008;372:1303-1309. Lees et al. Lancet 2010;375:1695-1703.

  15. rt-PA Effects are Time Dependent Only 11% of all thrombolysed AIS patients receive rt-PA within 90 min of symptom onset 11% % patientstreated 180 90 AIS, acuteischaemicstroke Wahlgren et al. Lancet 2008;372:1303-1309. Lees et al. Lancet 2010;375:1695-1703.

  16. Conclusions Remember: ACT Fast  Time is brain! • Most effective are: • Early recognition of stroke symptoms, including public education • Establishment of stroke networks • Prioritisation and direct transfer to specialised stroke centres or stroke units • Management by multidisciplinary teams • Act fast to initiate treatment with thrombolysis as early as possible The earlier treatment of acute ischaemic stroke with thrombolysis is initiated, the better the outcome

  17. How to Improve Optimisation of Stroke Patient Management – Pre-hospital

  18. Raising Public Awareness Campaigns • Target the general public as stroke witnesses • Symptom awareness • Awareness to take action Keep the message easy The ultimate aim is to keep the time to treatment as short as possible Public awareness campaigns can increase ambulance dispatches for stroke Exampleof a German strokeawarenesscampaign

  19. Stroke Chain ofSurvival • Rapid patient recognition and reaction to stroke warning signs • Rapid emergency medical services (EMS) dispatch • Rapid EMS system transport and hospital pre-notification • Delivery direct to imaging • Rapid in-hospital diagnosis and treatment Effective EMS systems can minimise delays in pre-hospital dispatch, assessment, and transport, and ultimately increase the number of stroke patients reaching the hospital and being prepared for thrombolytic therapy within the approved time window • AHA. Circulation 2005;112:111-120. • Wojner-Alexandrov. Stroke 2005;36:1512-1518. • Deng et al. Neurology 2006;66:306-312.

  20. Cincinnati Stroke Scale: A Checklist for Emergency Medical Dispatchers Total score: 3 Clear evidence of stroke 2 Strong evidence of stroke 1 Partial evidence of stroke 0 No evidence of stroke Govindarajan et al. BMC Neurology 2011;11:14.

  21. Hospital Arrival Times andThrombolysis Rates in AIS PatientsAccordingto Mode of Transport % patients arriving within 2 h of stroke onset according to transport mode % thrombolysed patients according to transport mode 80 35 389/524 (n=2,501 thrombolysedpatients) 2,668/3,794 Directtransport to a strokeunit 70 44/153 30 Indirect: transferredfrom a peripheral hospital 60 180/745 25 3,499/6,767 50 20 1,050/5,842 280/708 40 % ofpatients % ofpatients 38/111 165/1,102 15 30 351/1,425 10 978/11,289 20 5 84/2,442 10 39.5 51.7 70.3 74.2 34.2 24.6 0 0 AMBP AMB AMBP AMB HEMS HEMS HEMS, helicopter emergency service AMBP, ambulance with accompanying physician AMB, ambulance without accompanying physician Reiner-Deitemyer et al. Stroke 2011;42(5):1295-1300. Reiner-Deitemyer et al. Stroke 2011;42(5):1295-1300.

  22. Pre-admission Notification by EMS: The Best Way to Shorten Door-to-Needle Time Ischaemic strokes admitted at the Lille University Hospital After emergency call = 50% No emergency call = 50% Thrombolysis rate: 22.5% Median DNT: 41 min Thrombolysis rate: 5.1% Median DNT: 57 min Not adjusted on case-mix. A part of the difference may be explained by differences in profiles Didier Leys, personal communication.

  23. Interaction Between Pre- and Intra-hospital Services EMS, emergency medical services ED, emergency doctor Regional committee with EMS, ED, neurologists, radiologists, rehab physicians, patients organisations, administration and health authorities to organise stroke care at the regional level (3 per year) Joint teaching activities (national training program for stroke) Annual meeting with all physicians in the area, involved in stroke care for continuous training Population campaigns Registries to evaluate the network

  24. How to Improve Optimisation of Stroke Patient Management – In-hospital

  25. WaystoImprovert-PA Application in Hospital • Pre-notification that patient is on the way and direct access to imaging • Rapid triage by emergency physician or paramedic before arrival • Vital parameters stabilised (O2, temperature) • 2 medium-large bore venous lines with crystalloid infusions on one or both • POC test for blood glucose (100-180 mg/dl) and INR • BP optimum (150-160 mmHg systolic) • NIHSS assessment • Priority CT/imaging access • Use scales such as ASPECTS • Rapid read, always neurologist and radiologist to analyse images • Set-up that allows weighing the patient e.g. lying in CT/imaging • Decision to treat and bolus application in the CT/imaging suite • Decision whether to perform additional imaging or rescue treatment in CT/imaging suite • Fonarow et al. Stroke 2011;42:2983-2989; • Adams et al. Stroke 2007;38:1655-1711.

  26. SITS: Door-to-Needle vs Time Window Doctors who have more time, take more time, but the sooner thrombolysis is initiated, the greater the benefit 2:30 2:00 Time from arrival to treatment (Door-to-needle time) 1:30 1:00 0:30 0:00 0:30 1:00 1:30 2:00 2:30 Time fromsymptomonsettoarrival (Prehospital time) 0:00 SITS-Database https://sitsinternational.org

  27. Target: Stroke • A multidimensional initiative from the AHA/ASA • Aim: to ensure that as many patients as possible with AIS achieve a DTN ≤60 min • 10 key best practice strategies, associated with faster DTN: • Fonarow et al. Stroke 2011;42:2983-2989. • Follow-up will be after 1 year, in line with GWTG-Stroke data and rate of improvement in DTN AIS, acute ischaemic stroke; DTN, door-to-needle time; POC, point of care

  28. NIH-recommended Emergency Department Response Times DTN ≤60 min: the “golden hour” for evaluating and treating acute stroke T=0 Suspected stroke patient arrives at stroke unit ≤10 min Initial MD evaluation (including patient history, lab work initiation, & NIHSS) ≤ 15 min Stroke team notified (including neurologic expertise) ≤ 25 min CT scan initiated ≤ 45 min CT & labs interpreted ≤ 60 min rt-PA given if patient is eligible IDEALLY performed pre-hospital NINDS NIH website. Strokeproceedings. Latest update 2008.

  29. Preparing the Patient for rt-PA in 30 min (Optimally 15 min) Personal communication, Peter Schellinger, Jan 2011.

  30. Howtoimprove Optimisationofstroke Patient Management – StrokeCentre Care

  31. Benefits of Stroke Units in the Acute Phase Stroke centre designation improves: Quality of care Patient access Timely evaluation Stroke units improve early survival across age groups Stroke units are more cost effective than care on other hospital wards/teams Higher stroke care volume is related to less urinary tract infections, pneumonia, and a lower mortality rate Norrving & Adams. Stroke 2006;37:326-328; Duncan et al. Stroke 2002;33:167-178; Gropen et al. Neurology 2006;67:88-93; Stradling et al. Neurology 2007;68:469-470; Saposnik et al. Neurology 2007;69:1142-1151.

  32. Stroke Unit: Effect Survival curves for patients admitted to a stroke unit or a conventional ward 100 Stroke unit 75 Conventional ward 50 Survival (%) 25 0 Time (months) 0 12 24 Candelise et al. Lancet 2007;369:299-305.

  33. Swedish Stroke Register (2003-2008): Importance of Stroke Units A B C Proportion treatedwiththrombolysis (%) • Use of thrombolysis in Sweden increased from 0.9% in 2003 to 6.6% in 2008 • In 2008, patients admitted to a stroke unit were 5 times more likely to receive thrombolysis than those admitted to general wards Eriksson et al. Stroke 2010;41:1115-1122.

  34. Stroke Unit Care Benefits All Age Groups Stroke unit care reduces death at 30 days across all age groups The intensity of organised care received affects outcomes across all age groups OCI, organised care index, refers to patients receiving 0, 1, 2, or 3 of the following: physiotherapy, occupational therapy, admission to a stroke unit, stroke team assessment SU, stroke unit Saposnik et al. Stroke 2009;40:3321-3327.

  35. How to Improve Optimisation of Stroke Patient Management - Networks

  36. Stroke Network Stroke networks and protocols are essential to ensure as many patients as possible are treated as quickly as possible Emergency Services Paramedics / Physicians Central Admission Neuro Emergency Room Outpatient Care / GP Neuroradiology Ultrasound Rehabilitation Geriatric Rehabilitation Stroke Unit Neurocritical Care Unit Hacke. Personal communication, unpublished.

  37. Benefits of Integrated Stroke Networks • Centralised emergency number ensures one stop access to stroke care • Call centre triages patients prior to dispatch of emergency team • Transport patient to a stroke centre as quickly as possible after symptom onset • Direct transport to stroke centre • Rapid transfer from non-stroke centre • Telemedicine • 24/7 acute specialty cover within a region • Ensure the right care for the right patient at the right time • Ongoing coordination of multiple clinical services throughout stroke care • Carr et al. AcadEmergMed2010;17:1354-1358. • Rymer. OMAG Mar-Apr 2010, available online.

  38. Benefits of Integrated Stroke Networks Ongoing coordination of multiple clinical services throughout stroke care Ensure the right care for the right patient at the right time Centralised emergency number ensures one stop access to stroke care Stroke Networks 24/7 acute specialty cover within a region Call centre triages patients prior to dispatch of emergency team Transport patient to a stroke centre as quickly as possible after symptom onset Direct transport to stroke centre Telemedicine Rapid transfer from non-stroke centre Carr et al. AcadEmergMed2010;17:1354-1358. Rymer. OMAG Mar-Apr 2010, available online.

  39. How to Improve Optimisation of Stroke Patient Management - Telemedicine

  40. Rationale forTelemedicine in Stroke Geography, lack of knowledge and poor funding are the 3 main reasons for unequal access to stroke care, and the rationale behind telemedicine Stroke facilities not available Remote rural area Geography Public awareness Inexperienced* physicians Knowledge Costs and funding <24/7 access to facilities Funding *Refers to physicians not working in a stroke unit

  41. Telestroke Concept Tools to improve stroke care in underserved hospitals: • Remote evaluation of stroke patient by videoconferencing or telephone • Transfer of CT/MRI data for interpretation • 24/7 teleconsultation and educational programme to identify patients suitable for thrombolysis • Müller-Barna et al. CurrOpinNeurol2012;25:5-10.

  42. Purposes of Telestroke *Data from survey of 38 telestrokeprogrammes in the USA Silva et al. Stroke 2012;43:2078-2085.

  43. Retrospective Case Series: TelephoneConsultation for IV Thrombolysis of AIS Patient at ED 0800–1800 h weekdays Assessment by stroke specialist in person Patient at ED at any othertime Assessment by stroke specialist by telephone Brain imaging viewed remotely IV, intravenous AIS, acute ischaemic stroke ED, emergency department Rudd et al. Emerg Med J 2012;29(9):704-708.

  44. Retrospective Case Series: TelephoneConsultationfor IV ThrombolysisofAIS mRS outcomes at 3 months for patients treated by IV thrombolysis were similar whether stroke specialist was present in person (55% alive & mRS <3) or by telephone (48%) IV, intravenous AIS, acute ischaemic stroke mRS, modified Rankin Scale Rudd et al. Emerg Med J 2012; 29(9):704-708.

  45. TEMPiS: Telethrombolysis as Effective as Stroke Centres and RCTs 2 university stroke centres 24-h telemedicine image transmission 12 community hospitals 132 rt-PA patients (69.6 years, NIHSS 11) 170 rt-PA patients (69.4 years, NIHSS 12) Continuous stroke teaching 11.5% death 30.9% goodoutcome (mRS ≤1) 11.2% death 39.5% good outcome (mRS ≤1) RCT, randomisedcontrolledtrial mRS, modified Rankin Scale Schwab et al. Neurology 2007;69:898-903.

  46. TEMPiS: Telemedicine Networks Can Improve Other Aspects of Stroke Care Use of telemedicine not only gives patients rapid access to specialised care, but can also increase accessibility to other stroke services Audebert et al. Lancet Neurol2006;5:742-748.

  47. Telemedicine in Acute Stroke:Findings from TEMPiS Telemedicine-guided thrombolysis Is feasible Is safe and efficient TEMPiS improves many other aspects of acute stroke care Marked reduction of “death and dependency” (mRS >3) at one year Audebert et al. Stroke 2009;40:902-908. Schwab et al. Neurology 2007;69:898-903.

  48. How to Improve Summary

  49. Summary: The Neurologist’s Perspective arrival quick check transport preparation trans- port hand-over regi- stration nursing admission medical history body-check neuro exam blood tests CT-applic. trans-port CT- exam Lab results • Audebert. Presentation at the ESC in Hamburg, 2011. • IV-thrombolysis is the second most powerful AIS intervention available (after stroke unit) • Stroke experts are needed • Optimisation of infrastructure will • Increase thrombolysis rates • Improve safety • Shorten time to treatment • TeleStroke can help to achieve treatment goals (best within TeleStroke units) • Take every effort to shorten time to treatment

  50. Summary: The Emergency Physician’s Perspective arrival quick check transport preparation trans- port hand-over regi- stration nursing admission medical history body-check neuro exam blood tests CT-applic. trans-port CT- exam Lab results • Lambert. Presentation at the ESC in Hamburg, 2011. • Education campaigns • Calling the right number • Early stroke recognition • Pre-notification of patient arrival • Preparation of patient for thrombolysis, including iv access, blood samples, etc • Take every effort to shorten time to treatment • Use of protocols • Organisation and evaluation of networks

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