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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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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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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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