Update on CSCs and Acute Stroke Care Mark J. Alberts, MD

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1 The Role of Different Types of Stroke Centers in a Stroke System of Care Professor of Neurology Northwestern University Medical School Northwestern Memorial Hospital Chicago, Illinois, USA 2 Presenter Disclosure Information FINANCIAL DISCLOSURE: Speakers Bureau/Consultant: Genentech, Inc. Unpaid Consultant: The Joint Commission UNLABELED/UNAPPROVED USES DISCLOSURE: None 3 What is a Stroke System of Care? A comprehensive, diverse, longitudinal system that address all aspects of stroke care in an organized and coordinated manner Spans the spectrum of stroke care from primary prevention, calling 9-1-1, acute care, secondary prevention, rehabilitation, return to the community As with any system, it is only as strong as its weakest link This talk will focus on the acute care aspects But all elements are important Will be addressed in an upcoming AHA/ASA publication 1

Pictorial Stroke System of Care 4 Primary Prevention Return to the community Public Education Rehabilitation Calling 911 Secondary Prevention EMS elements Acute Care Transportation to hospital Stroke Centers EMS Plays a Key Role in a Stroke System 5 Is typically the first medical professionals with direct patient contact Their initial assessments, actions, treatments, and decisions will have significant consequences in the patient s subsequent care Their role in patient triage, diversion, and routing cannot be under-estimated Characteristics of Different Stroke Centers 6 Comprehensive Stroke Center Academic Medical Center Tertiary Care facility Primary Stroke Center Wide range of hospitals; standard stroke care; stroke unit; use TPA Acute Stroke Ready Hospital Rural hospitals; basic care; drip and ship; use tele-technologies 2

Numbers of Various Types of Stroke Centers 7 Comprehensive Stroke Center 75 to 250 total Primary Stroke Center Final count 1000-1300 Acute Stroke Ready Hospital Perhaps 1200-1800 > 5000 total acute care hospitals in the U.S. 8 Stroke and National Care Paradigms CMS is set to introduce 2 new national care measures related to stroke in 2013 These apply to all stroke patients in any hospital 1. 30 day all cause mortality for ischemic stroke 2. 30 day re-admission rates after stroke discharge These results will be publicly available and will almost certainly affect reimbursement rates CMS will likely not pay for re-admissions ASRH: Concept and Targets 9 Many stroke patients are in small urban, suburban, and rural areas Many have no access to a PSC or CSC Defining a sub-psc tier would be helpful for several reasons: Better define which hospitals in a specific area have some capabilities to care for acute stroke patients Help guide EMS about where to take patients Provide information to patients about where to go if a stroke occurs ASRHs are referred to in some state laws but without specific elements and definitions The intent is for an ASRH to be some distance away from a PSC or CSC, not across the street 3

Key Elements of the ASRH 10 Acute Stroke Team Stroke Protocols EMS ED Laboratory Testing Rapid Imaging Neurosurgical Services Stroke Unit (not needed since typically no admissions) Transfer agreements to a PSC or CSC Telemedicine links to a PSC or CSC Medical Leadership and Administrative Support!!! Elements of an ASRH and PSC 11 Neurosurgical Services at ASRH 12 Available within 3 hours of when needed Most likely via transfer Local availability also an option Unlikely this would be achievable with tele-technologies Cannot operate via remote control? Whether remote triage would be reasonable 4

13 Tele-technologies at an ASRH Video conference (VC) or teleconference (TC) for screening for TPA and other acute therapies VC generally more supported and reliable TC for screening and other consultative cases Tele-radiology for interpretation of CT/MRI Obviously have to see the images ACR has published technical aspects System must be FDA approved (several already available) Must have signed agreements with a PSC or CSC for these services on a 24/7 basis Primary Stroke Centers 14 About 950 PSCs currently certified by TJC Perhaps another 100 or so certified by another organization Mostly urban, suburban Provide organized care in most states and regions Some academic, some not Typically have 300-400 stroke admissions per year Some up to 800-1000/yr Updated PSC Recommendations 15 MRI with diffusion available for stroke patients Vascular imaging for stroke patients MRA of head/neck CTA head/neck Doppler alone not acceptable Cardiac imaging TTE, TEE, or cardiac MRI Stroke Unit monitoring protocols Multichannel telemetry Clinical monitoring plans Who to call/when to call plans Begin rehabilitation efforts ASAP Certification by an independent organization Alberts et al, Stroke, 2011 5

16 NY State PSC Study 30,947 patients with acute ischemic stroke 2005-2006 One year follow-up 15,297 admitted to a designated stroke center (PSC) Used 39,000 and 40,000 patients with GI hemorrhage and MI as internal controls Xian et al, JAMA, 2011 NY State Study Mortality Outcomes 17 Xian et al, JAMA, 2011 Impact of Reduced Death Rates for Stroke 18 Stroke is the 4 th leading of death in the US and the 2 nd leading cause of death globally 2% to 3% reduction in deaths in US means 16,000 to 24,000 fewer deaths in the US Globally this means 320,000 to 480,000 fewer stroke deaths each year There are very few medical interventions that reduce deaths Trauma centers DO Coronary stenting vs angioplasty DOES NOT CEA vs medical therapy DOES NOT 6

19 Hypotheses Hospitals certified as Primary Stroke Centers (PSCs) would increase the use of IV TPA in eligible patients The longer a hospital was a certified PSC, the rate of IV TPA administration would increase Methods 20 We analyzed data from PSCs certified by The Joint Commission (TJC) from 2008-2011 Rates of IV TPA use in eligible patients (ischemic strokes, presentation within 2 hr. of Sx onset/last known normal, no contraindications to TPA therapy) Analyzed number of certification cycles, hospital setting, and teaching status Results 21 34,909 eligible patients at 842 PSCs were identified 455 teaching hospitals; 367 non-teaching 783 urban; 39 rural 1 cycle = 278 2 cycles = 235 3 cycles = 246 4 cycles = 83 Alberts et al, presented at ISC, February 2011, New Orleans 7

TPA Use by Year Overall TPA was given to 81% of eligible patients 22 The overall rate of TPA use increased from 79.4% in 2008 to 83.5% in 2011 (p < 0.001) P < 0.001 TPA Use by Number of Certification Cycles 23 Overall 10% absolute increase in rate of TPA use between 1 and 4 certification cycles (p < 0.004) TPA Use Comparing 1 vs 4 Cycles and Year 24 Overall the differences have narrowed over time P < 0.001 8

IV TPA Use by Hospital Characteristics 25 TPA use was higher at teaching hospitals vs non-teaching hospitals, though the actual numbers are quite close: 82.2% Teaching 79.0% Non-teaching ( p < 0.001) Urban hospitals had higher rates of TPA use compared to non-urban hospitals 81.3% Urban 72.5 Non-urban (p < 0.001) TPA Use at Teaching vs Non-Teaching PSCs 26 PSCs Achieve High Rates of Compliance with other Care Paradigms 27 * * * * = statistically significant Alberts et al, ISC 2011 9

PERFECT Study-Finland 28 Compared outcomes among patients admitted to different types of hospitals Used BAC criteria for PSC and CSC Adjusted for baseline differences CSC = 20,045 PSC = 10,749 GH = 30,891 CSC PSC GH Meretoja et al, Stroke, 2010 Patient Types at a Comprehensive Stroke Center 29 Large complex ischemic strokes Endovascular therapy Hemicraniectomy Systemic disease with multi-organ involvement High ICP Cryptogenic etiology Intracerebral hemorrhage ICU level care Neurosurgical interventions Subarachnoid hemorrhage ICU level care Endovascular and neurosurgical therapies Vasospasm treatments Key Elements of a Comprehensive Stroke Center 30 All components of a Primary Stroke Center, plus Availability of advanced imaging techniques MRI/MRA, CTA, DSA, TCD Availability of personnel trained in vascular neurology, neurosurgery, endovascular techniques 24/7 availability of personnel, imaging, OR, and endovascular facilities (i.e. a hospital cannot be a CSC from just 8AM to 5PM) ICU/Neuroscience ICU Stroke registry Experience and expertise treating patients with large strokes, ICH, SAH DSA = digital subtraction angiography; TCD = transcranial Doppler. Alberts MJ, et al. Stroke. 2005;36:1597-1618. 30 10

31 Key Personnel at a CSC CSC Director most likely an MD with advanced training in vascular neurology Neurosurgeon(s) with training in vascular neurosurgery Endovascular expertise for lytic/mechanical therapy, coiling, stenting, etc. Intensivist/Neuro-intensivist for ICU staffing Nursing personnel for stroke unit, ICU/NICU, endovascular, OR, etc. Advanced practice nurses for stroke registry, education, referrals Therapists and pharmacists--patient care and research studies 32 CSC Requirements MRI available for stroke patients; 24/7 MRI with diffusion 24/7 Vascular imaging for stroke patients MRA of head/neck 24/7 CTA head/neck 24/7 TCD Carotid Doppler Catheter angiography 24/7 33 CSC must have NICU beds MDs and nurses with experience and expertise caring for complex stroke patients Includes ischemic strokes, ICH, SAH 24/7 staffing and capability Does this need to be a separate NICU? probably not Does this require a certified neuro-intensivist? Unlikely Can this requirement be met by a few NICU beds in a larger MICU/SICU with a general intensivist/pulmonologist/anesthesiologist? Perhaps 11

CSC-Volume Requirements The CSC will care for at least 20 subarachnoid hemorrhage patients per year. The CSC will perform at least 10 craniotomy surgeries for aneurysm per year. The CSC will perform at least 15 endovascular coiling surgeries (either acute or elective) for aneurysm per year. Some of these may be revised based on concerns from NSGY The CSC will administer IV tpa to at least 25 eligible patients per year. Telemedicine cases are counted 34 Research at a CSC 35 This is a new, unique requirement Based on two factors: 1. This should be part of the mission of a CSC 2. Participation in research generally improves outcomes Must be an IRB-approved project This is meant to avoid data-base and registry type projects Research must be patient-oriented This is meant to exclude animal focused projects which may not impact patient care Telemedicine at a CSC 36 Most CSCs will have some type of telemedicine arrangement Telephone consults Full video conferencing with radiology feeds Remote robotic interactions Link CSC to PSCs and ASRHs in their network Pre-arranged consultations and transfers Specify vendors, logistical issues, platforms, reimbursement, legal issues Decide who to transfer and how to transfer 12

Outcomes at a CSC: Finland Study 37 Meretoja et al, Stroke, 2010 Steps in Transforming From a PSC to a CSC 38 Key PSC elements Stroke Unit; no NICU MRI, MRA, CTA NSGY within 2 hours No endovascular No vascular neurology No specific volume requirements No research requirement Key CSC elements Stroke Unit + NICU MRI, CTA, MRA, angiography available 24/7 NSGY 24/7 Endovascular 24/7 Vascular neurology 24/7 Specific volume requirements Research requirement Growth from a PSC to CSC: Key Questions 39 Does my hospital have the case volume to support the programs and investments and meet TJC requirements? A large focus of CSCS is on ICH, SAH; these make up about 15% to 20% of all strokes Can my hospital make the financial commitment to become a CSC? Hiring new personnel Dedicated endovascular suites NSGY programs NICU programs 24/7 coverage needed in many areas 13

Stroke Systems: Population and Patient Perspective 40 CSC PSC ASRH By-passing Hospitals in a Stroke System of Care 41 With multiple hospitals of various capabilities in a geographic area (or Stroke System), how can we properly triage and divert patients to the most appropriate facility? Guiding Principles # 1 If all are close, go to the highest level Stroke Center initially WHY? We do not know the type of stroke Patients can deteriorate Unclear what tests and treatments will be needed. 42 By-passing Hospitals Guiding Principle # 2 Time is more important than distance, because time is brain Factors to consider include: Weather Traffic Local geography Mode of transportation 14

By-passing Hospitals 43 Guiding Principle # 3 To make the best decision, personnel must know the actual capabilities of their local hospitals as well as the EMS system Not every hospital that claims to be a PSC or CSC will have those capabilities EMS triage and routing skills may vary by city and region All politics are local!!! EMS Field Triage and By-Pass 44 Final Principle 1. Avoid by-passing another hospital (PSC, CSC) if that will add more than 15-20 minutes of transportation time 2. This time is used for many other field transportation systems 3. Exception would be some compelling reason to by-pass lower level facility 1. High likelihood they will need a CSC level facility 45 C C P P P P P P P ASR ASR ASR ASR ASR ASR ASR ASR 15

Conclusions The Stroke Center care paradigm ensures that patients will receive the proper level of care in each case Becoming a CSC will involve a significant investment for some hospitals, but will provide benefits for patients and the hospitals A Stroke System of Care will promote a flexible system that can adapt and fit a variety of regional and geographic scenarios Improved outcomes will reduce the financial burdens on government and health care systems 46 16