ornato - plenary on the future of resuscitation · name type design n status 1 cardiac arrest...
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5/26/2014
1
Creating a High-PerformanceResuscitation System
Paris Hotel and Casino Las Vegas, Nevada
Joseph P. Ornato, MD, FACP, FACC, FACEP
Professor & Chairman, Dept. of Emergency MedicineProfessor, Internal Medicine (Cardiology)
Virginia Commonwealth University Health System
Operational Medical DirectorRichmond Ambulance Authority
Richmond Fire & EMSHenrico County Division of Fire
Richmond, VA
Disclosure Information
Joseph P. Ornato, MD, FACP, FACC, FACEP Creating a High-Performance Resuscitation System
FINANCIAL DISCLOSURE: Cardiac Co-Chair & Consultant: NIH Resuscitation Outcomes
Consortium (ROC) American Editor, Resuscitation Advisory Board, Key Technologies, Inc.
(Transnasal Cooling Device)
UNLABELED/UNAPPROVED USES DISCLOSURE: Wriskwatch™, Emergency Medical Technologies
How are we going to reduce the mortality from OOH-CA meaningfully?
Accurate data Prevention Implementing effective
community systems of care Changing research funding priorities Breakthrough approaches Detecting unwitnessed OOH cardiac arrest Effective therapy for pulseless electrical activity (PEA) Adapting principles & practices from high
performance industries
Accurate Data
Cardiac arrest data
No national U.S.registryData sourcesNIH Resuscitation Outcomes
Consortium (ROC)8 U.S., 3 Canadian sitesResearch sitesEpistry
CDC Cardiac Arrest Registry to Enhance Survival (CARES)46 communities in 31 states & DCVoluntary sites
ROC
CARES
Public Health Burden of Cardiac ArrestHeart Disease and Stroke StatisticsGo et al. Circulation. 2013;127:e6-e245
10 x more deaths/year from OOH-CA than MI
Out-of-hospital Cardiac ArrestAcute Myocardial Infarction
720,000 cases per year in the USA 21% of these are “silent” 73% of MI deaths occur out-of-
hospital (i.e., cardiac arrests) In-hospital mortality rate= 4.6%
In-hospital deaths/year Out-of-hospital deaths/year
359,400 out-of-hospital cardiac arrest cases per year in the USA
23% have an initial documented CA rhythm of VF
Out-of-hospital mortality rate= 90.5%
MI Cardiac Arrest
32,959
0
100,000
200,000
300,000
400,000325,257
0
100,000
200,000
300,000
400,000
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5/26/2014
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Prevention
Prevention: Prediction of SCD riskPiccini et al. JACC 2010; 56: 206-14
Demographic, historical, & clinical variables
Identification of occult heart disease (e.g., ECG, signal averaging, ejection fraction)
Detection of channelopathies(e.g., Brugada, long & short QT) by ECG, genetic screening
Challenges in SCD PreventionMyerburg et al. JACC 2009; 54:747-63
0% 10% 20% 30%
Individual Patient’s SCD Risk0 100,000 200,000 300,000
General population
High risk for CAD; noclinical events
Prior coronary event
EF<30%, HF
Cardiac arrest survivor
Arrhythmia riskmarkers, post-MI
Total # of SCD cases/year in USA
MADIT I, MUSTT
AVID, CIDS, CASH
MADIT II, SCD-HeFT Implementing Community Systems of Care
Community Systems of CareKong et al. Am Heart J 2010; 160:605-18
+ EducationPAD
Regional variation in OOH-CA survival Resuscitation Outcomes Consortium (ROC)Nichol et al. JAMA 2008; 300:1423-31
1.1%
2.4%
6.1%
3.3% 3.3%
6.5%
8.1%
3.2%
6.7%
0%
3%
5%
8%
10%
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Survival over Time: All Sites (Unadjusted)
ROC PRIMED study
AHA Mission Lifeline History
2010 2011
Regional Systems of Care for Out-of-Hospital Cardiac Arrest: A Policy Statement from the American Heart Association
Task Force convened to explore addition of Cardiac Resuscitation quality improvement efforts to current M:L Program
Overlapping clinical conditions
Common providers and procedures
Well-documented effectiveness of regionalized STEMI systems
Development of Ideal systems for Cardiac Arrest
Launch of STEMI and Cardiac Resuscitation Systems of Care Mission: Lifeline program
April 2012
AHA Mission Lifeline Ideal System
Patient centered care High quality care that is safe, effective, and timely Stakeholder consensus on systems infrastructure Increased operational efficiencies Measurable patient outcomes Evaluation mechanism to ensure that quality of care
measures reflect changes in evidence-based research A role for local community hospitals so as to avoid a
negative impact that could eliminate critical access to local healthcare
Reduction in disparities of healthcare delivery
Guiding Principles for Regionalization of Post-Arrest Care
Richmond EMS system
2-3 min fire AED first response
6 min all-ALS system
12-lead ECGs, capnography,pulse oximetry, AutoPulse™, wireless internet, GPS automated vehicle locators on all units
Resuscitation strategy approach
Optimize blood flow/oxygen delivery• Vasopressin 40u IV alternating with
epinephrine 1 mg IV every 5 min• Autopulse™ CPR (2 min) before DF with
continuous chest compression– No interruptions of CPR for defibrillation
Shorten the time to airway & drug therapy• King LTS™• EZ-IO™
Protect the brain & heart• Pre-hospital therapeutic hypothermia
during & post-arrest
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dvanced esuscitation ooling herapeutics ntensive are
ARCTIC Alert from field VCU never on diversion for ARCTIC
pts ARCTIC Team ED physician and nurse ARCTIC attending (only 5) CCU / interventional fellow CCU NP RN Coordinator Inclusion criteria for ARCTIC Comatose or unable to follow verbal
commands Initial rhythm VF, or Initial rhythm witnessed PEA or ASYS Exclusion criteria DNAR, terminal illness Shock unresponsive to vasopressors Uncontrolled bleeding
dvanced esuscitation ooling herapeutics ntensive are
“Induction Center Concept”
0102030405060708090
100
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
VCU ARCTIC Patients/Year
EM focuses on stabilizing patientInitiates early goal directed therapy
CICU/cath team places cooling catheter and continues standardized post-arrest careEndovascular cooling strategy with 5
dedicated machinesContinuous EEGs with aggressive seizure Rx
Patients admitted to only one ICU (CICU) with specially trained, dedicated ARCTIC nurse staffingElectronic order sets & personal checklists72-hour pathway for goal directed therapyFull time RN ARCTIC coordinatorCICU NP
Clinical consistency Multidisciplinary ongoing education process EMS and satellite hospital feedback on all
cases Continuous quality review of data and ongoing
evidence based system changes
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Immediate memory
List learning Store memory
Visuospatial / constructional orientation Complex figure copy / trail making Line orientation
Language Picture naming Semantic fluency
Attention Digit spanning Coding
Delayed memory Recall of above
Beck Depression Scale Brain injury rehabilitation 3 and 6 month neuro-cognitive testing
Detailed neuro-cognitive testing & brain injury rehabilitation program
CPC is not accurate in assessing true neurocognitive function
Short term memory deficitProfoundTransientVariable resolution
“Reverse PTSD” “Flock back behavior”
Question ability to return to workFamily stress and re-integration
Neuro-cognitive issues
Changing Research Funding Priorities
Reasons for the paucity of SCD funding and research
Misperception that SCD is largely an untreatable problem
Most of the existing therapies are generic, patent unprotected drugs or devices
Few novel, patented-protected pharmaceuticals are in the pipeline
Funding circle paradox
Investigator perception of little NIH interest in
topic
Few grant applications
NIH perception of little investigator interest in topic
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Need for Cardiac Arrest ResearchOrnato JP, Becker LB, Weisfeldt ML, Wright BA. Circulation 2010:1876-9
NIH Resuscitation Outcomes Consortium (ROC) 2005-15 First large-scale,
governmentally-sponsored, North American effort to conduct definitive pre-hospital, randomized clinical trials in out-of-hospital cardiac arrest (OHCA) and severe traumatic injury
Focus is on very early delivery of interventions by EMS providers, when there is optimal potential for benefit
ROC
ROC focus areas
Primary Pre-hospital, randomized clinical trials that test very early (i.e., field
or ED) administration of promising drugs, devices, and strategies with a goal of improving outcomes in victims of cardiac arrest or severe traumatic injury
Secondary Smaller pilot, feasibility or surrogate endpoint studies Epidemiological Registry = EPISTRY # cases in Epistry 179,310 cardiac arrests; 21,656 traumas
Unique CPR digital process data capture requested by PRC and DSMB ET Tube
Placement
30 sec CPR Interruption
ETCO2
Signal
Name Type Design N Status1 Cardiac Arrest Epistry Cardiac Observational 179,310 Ongoing2 Trauma Epistry/PROPHET Trauma Observational 21,656 Completed3 PRIMED ITD Cardiac RCT 11,892 Completed4 PRIMED AEvAL Cardiac RCT 13,126 Completed5 CPR feedback Cardiac Ancillary RCT 1,586 Completed6 Hypertonic Shock Trauma RCT 895 Completed7 Hypertonic TBI Trauma RCT 1,331 Completed8 Dallas RESCUE TBI Trauma RCT pilot 50 Completed9 Dallas RESCUE Shock Trauma RCT pilot 50 Completed10 BLAST ground cohort Trauma Case series 389 Completed11 Hypo Resus – shock Trauma RCT pilot 192 Completed12 ALPS for VF Cardiac RCT 3,000 Ongoing13 CCC vs 30:2 in OHCA Cardiac RCT 23,600 Ongoing14 BLAST air cohort - shock Trauma Case series 218 Completed15 PROPPR massive transfusions Trauma RCT 680 Completed
Total 257,957
ROC clinical trials (2003-14)
Publications 54 abstracts at national meetings AHA, ReSS, NAEMSP, SAEM
58 peer-reviewed publications
ROC accomplishments (2003-14)Change in medical practice AHA/ILCOR Resuscitation Guidelines
(GL) 15 GL worksheets 31 chapters in CPR GLs 7 additional publications 41 consensus panel statements ROC is the key data source for
OHCANew hypotheses & funding 490 additional resuscitation &
trauma publications by ROC PI’s and its leadership (2003-12)
Additional grants - 10 NIH, 9 DOD, 1 CDC, 31 other
Journal Impact factor
N Engl J Med (2) 53.3
JAMA 30.0
Circulation 14.7
J Amer Coll Cardiol 14.2
Brit Med J 14.1
Ann Surg 7.3
Crit Care Med 6.3
J Amer College Surg 4.5
Ann Emerg Med 4.1
Am J Public Health 3.9
Resuscitation 3.6
J Trauma 2.5
ROC training a new generation of resuscitation/trauma researchers
5 funded core training sites provides salary for core leader (Toronto, Ottawa, Oregon, Alabama, Pittsburgh)
Leveraging site support - trainee funding comes from the site’s institution
Trainees attend ROC meetings & learn from multiple site mentors
Trainees conduct research on local or ROC-wide databases
Data sharing - ROC provides an 18 month Epistry data set that can be used for local analysis
Examples
University of Toronto 18 graduate students (4 masters
graduated to date; 4 EM fellows; 1 paramedic associate scientist; 2 post-docs; 10 young investigators (EM, Critical Care, Trauma, Surgery)
20 have conducted research with local or ROC-wide data
16 publications, 8 new grants Oregon Health & Sciences University
13 fellows trained (3 current) 33 abstracts, 32 manuscripts, 8 new
grants Pittsburgh
15 fellows, 7 have completed Master’s, 2 now research directors elsewhere
81 publications
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5/26/2014
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Breakthrough Approaches:Unwitnessed Cardiac Arrest
The challenge of unwitnessed OOH-CAAmbient Intelligence
Detection of the unwitnessed OOH-CA
Wriskwatch™Emergency Medical
Technologies, N Miami Beach, Floridahttp://www.emergency
medtech.com
Difference between conventional 911 response and Wriskwatch™ detected unwitnessed cardiac arrest
Breakthrough Approaches:Pulseless Electrical Activity (PEA)
Pulseless electrical activityParadis NA et al. Resuscitation 2012; 83:1287-91
8 domestic Yorkshire swine
PEA induced by ventilation with a hypoxic mixture
Autopulse™ synchronized compressions applied
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Breakthrough Approaches:Adapting Principles & Practices from High Performance Industries
Aviation vs. resuscitationOrnato JP, Peberdy MA. Resuscitation 2014; 85:173-6
Aviation ResuscitationPreflight checks Code cart/equipment checksPreflight crew brief Delegation of tasksTake-off/climb Initiate CPR/DF/airway/IVCruise Continue CPR/DF/drugsDescent/landing ROSC or cease resuscitationPost-flight checks Stabilization, post-resusc careCrew debriefing Team debriefing
Phases of Flight Phases of Resuscitation
Aviation & resuscitation are team effortsOrnato JP, Peberdy MA. Resuscitation 2014; 85:173-6
Aviation ResuscitationPerson in charge Pilot in Command Team LeaderLives at stake Up to hundreds 1Multiple phases Yes YesDidactic training Flight School BCLS, ACLS, PALSScenario-based training Flight Simulator Code SimulationStandard setting organization FAA AHAStandardized approach Checklists AlgorithmsConsistent standardization Absolutely No
What’s different about aviation?Ornato JP, Peberdy MA. Resuscitation 2014; 85:173-6
Pilots understand that flying is a privilege
Aviation functions in a rigorous culture of safety
Skills & procedures are standardized
Teamwork is the daily routine
Pilots anticipate, train, plan & brief for emergencies
Pilots lives are on the line every flight
Aviation toolboxOrnato JP, Peberdy MA. Resuscitation 2014; 85:173-6
Communication Sterile cockpit rule
Procedures Crosschecks
Mandatory readbacks
Mandatory checklist use
Instrument guided flight
Aviation toolboxOrnato JP, Peberdy MA. Resuscitation 2014; 85:173-6
Communication Sterile cockpit rule
Procedures Crosschecks
Mandatory readbacks
Mandatory checklist use
Instrument guided flight
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Summary Accurate data Prevention Implementing effective
community systems of care Changing research funding priorities Breakthrough approaches Detecting unwitnessed OOH cardiac arrest Effective therapy for pulseless electrical activity (PEA) Adapting principles & practices from high
performance industries
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