1

UCSF Advances in Heart DiseaseUCSF Advances in Heart Disease

Elliott M. Antman, MDElliott M. Antman, MD

Cardiovascular DivisionCardiovascular Division

Brigham and WomenBrigham and Women’’s Hospitals Hospital

Harvard Medical SchoolHarvard Medical School

Contemporary Management of STEMI:Contemporary Management of STEMI:

Emphasis on Systems of CareEmphasis on Systems of Care

December 2008

2

Disclosure

Accumetrics, Inc. Accumetrics, Inc.

Amgen, Inc. Amgen, Inc.

AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP

BaxterBaxter

Bayer Healthcare LLCBayer Healthcare LLC

Beckman Coulter, Inc. Beckman Coulter, Inc.

Biosite IncorporatedBiosite Incorporated

BristolBristol--Myers SquibbMyers Squibb

CardioKinetixCardioKinetix

CV Therapeutics, Inc.CV Therapeutics, Inc.

DaiichiDaiichi--Sankyo Sankyo

Eli Lilly and CompanyEli Lilly and Company

FoldRxFoldRx

GlaxoSmithKlineGlaxoSmithKline

INO Therapeutics LLCINO Therapeutics LLC

Inotek Inotek Pharmaceuticals CorporationPharmaceuticals Corporation

The National Institutes of HealthThe National Institutes of Health

Integrated Therapeutics CorporationIntegrated Therapeutics Corporation

KAI PharmaceuticalsKAI Pharmaceuticals

Merck & Co., Inc.Merck & Co., Inc.

Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals, Inc.

Novartis PharmaceuticalsNovartis Pharmaceuticals

Nuvelo, Inc. Nuvelo, Inc.

OrthoOrtho--Clinical Diagnostics, Inc. Clinical Diagnostics, Inc.

Pfizer, Inc. Pfizer, Inc.

Roche Diagnostics CorporationRoche Diagnostics Corporation

Roche Diagnostics GmbHRoche Diagnostics GmbH

SanofiSanofi--AventisAventis

SanofiSanofi--SynthelaboSynthelabo RechercheRecherche

ScheringSchering--Plough Research InstitutePlough Research Institute

St Jude MedicalSt Jude Medical

The TIMI Study Group has received research / grant support in thThe TIMI Study Group has received research / grant support in the past 2 yrs e past 2 yrs

through the Brigham & Womenthrough the Brigham & Women’’s Hospital with funding froms Hospital with funding from

(in alphabetical order):(in alphabetical order):

3

Case PresentationCase Presentation

• 55 year female--PCI of LAD (angina) at Hospital A

• 2 days later:4:30 PM SSCP--takes TNG4:35 PM calls 9114:43 PM EMS arrives--Hosp A on diversion

Shock develops during transport5:04 PM Arrive at Hosp B (no PCI capability)

6:00 PM Full cardiac arrest; CPR initiated7:03 PM Patient expires

Yr = 2000 Hospital A = Mount Auburn Hosp, Cambridge , MA

Hospital B = Cambridge Hospital, Cambridge , MA

133

min

Informed Patient Who “Did Everything Right”The System Failed Her

Sick: The Untold Story of America’s Health Care Crisis-And the People Who Pay the Price

Jonathan Cohn (Harper Collins; 2007)

4

PCI vs. Fibrinolysis:PCI vs. Fibrinolysis:ShortShort--term Clinical Outcomes (23 RCTs)term Clinical Outcomes (23 RCTs)

7

4.52.2

6

10

7 89

7 7

21

21

5

13

0

5

10

15

20

25

30

35

PCI

Fre

qu

en

cy (

%)

Keeley E, et al. Lancet. 2003;361:13.

P = 0.0002

P = 0.0003 P < 0.0001

P < 0.0001

P < 0.0001P = 0.0004

P = 0.032

P < 0.0001

Death Death, no

SHOCK

data

Re-MI Rec.

isch

Total

stroke

Hem.

stroke

Major

bleed

Death

MI

CVA

Fibrinolysis

N = 7,739N = 7,739

5

Time and Myocardial SalvageTime and Myocardial Salvage

0

20

40

60

80

100

1 3 6 12 24

HoursHours

Mo

rta

lity

Re

du

cti

on

(%

)M

ort

ali

ty R

ed

uc

tio

n (

%)

Extent of salvage (% of area at risk)

Time to treatment is criticalTime to treatment is criticalOpening the artery is the Opening the artery is the

primary goal (PCI > lysis)primary goal (PCI > lysis)

DD

EE

E – D — harm

A – B — no benefit

Potential outcomes

BA

CA – C — benefit

B – C — benefit

Gersh Gersh BJ, et al. BJ, et al. JAMAJAMA. 2005;293:979.. 2005;293:979.

6

EMS TransportEMS Transport

Onset of

symptoms of

STEMI

9-1-1

EMS

dispatch

EMS on scene• Encourage 12-lead ECGs

• Consider prehospital fibrinolytic

if capable and EMS–to–needle

within 30 min

GOALS

PCI

capable

Not PCI

capable

Hospital fibrinolysis: Hospital fibrinolysis:

DoorDoor––toto––needle needle

≤≤ 30 min30 min

EMS EMS

triage triage

planplan

InterInter--

hospitalhospital

transfertransfer

“Golden Hour” = 1st 60 min Total ischemic time: within 120 min

PatientPatient EMSEMS Prehospital fibrinolysisPrehospital fibrinolysis

EMSEMS––toto––needleneedle

≤≤ 30 min30 min

EMS transportEMS transport

EMSEMS--toto--balloon balloon ≤≤ 90 min90 min

Patient selfPatient self--transport transport

Hospital doorHospital door--toto--balloon balloon

≤≤ 90 min90 min

DispatchDispatch

1 min1 min

5

min

8

min

Options for Transport of Patients with STEMI Options for Transport of Patients with STEMI and Initial Reperfusion Treatmentand Initial Reperfusion Treatment

J Am J Am Coll CardiolColl Cardiol. 2004;44:671; . 2004;44:671; CirculationCirculation. 2004;110: 588.. 2004;110: 588.

7

Improving Access to Primary PCIImproving Access to Primary PCI

PCIPCI

capablecapable

Not PCINot PCI

capablecapablePCI w/oPCI w/o

Surg Surg BUBUCommunity Community

CenterCenter

PCIPCI

CenterCenter

8

Core StrategiesCore Strategies

1. ED physician activates the 1. ED physician activates the cath cath lab;lab;

2. One call activates the 2. One call activates the cath cath lab;lab;

3. 3. Cath Cath lab team ready in 20 lab team ready in 20 –– 30 minutes;30 minutes;

4. Prompt data feedback; 4. Prompt data feedback;

5. Senior management commitment;5. Senior management commitment;

6. Team6. Team--based approach. based approach.

A preA pre--hospital ECG to activate the hospital ECG to activate the cath cath lab is optional.lab is optional.

While other strategies exist, including having a cardiologist inWhile other strategies exist, including having a cardiologist in the the

hospital 24/7, they are not required for participation in the D2hospital 24/7, they are not required for participation in the D2B campaign.B campaign.

http://www.d2balliance.org/http://www.d2balliance.org/

9

Medical Simulation Training and Research to

Improve D2B Time Among Healthcare Teams

• Pt is 55 yr old male(wheelchair)

• Brought to ED by grandson• SSCP• Intermittent unresponsiveness• DM, Prior MI• Triage RN

Pages Resusc. TeamSends Grandson to Regist.

• BP 70/30• Pages Card x2• Call for CXR• Transport by main

elevator to cath lab

• BP 49/29• 9 persons in lab• ED RN unsure of

communication role• Room loud• Repeated briefings

on pt as morepersons arrive

Advances in Simulation-Based Team Training

HammanWR et al

10

Will issue reports on D2B time

11

AHA 08 AHA 08 Abst Abst 3173 3173 Nallomothu Nallomothu et alet al

0

20

40

60

80

100

06Q3 06Q4 07Q1 07Q2 07Q3 07Q4 08Q1

D2B

Non D2B% Rx

% RxWithin 90 min

Within 90 min

Prim PCI (non transfer) in GWTG hospitalsPrim PCI (non transfer) in GWTG hospitals

in D2B in D2B vs vs Not in D2BNot in D2B

5555

7575

7272

5353

12

Zone1 Protocol

Aspirin 325 mgAspirin 325 mg

Clopidogrel 600mgClopidogrel 600mg

UFHUFH

BetaBeta--blockerblocker

PCIPCI

Zone 2 Protocol

Aspirin 325 mgAspirin 325 mg

Clopidogrel 600mgClopidogrel 600mg

UFHUFH

TNK TNK ½½ dosedose

BetaBeta--blockerblocker

PCIPCI

Regional STEMI

System for PCI

Minneapolis

< 60 miles

< 60-210

miles

Henry et al Circ 2007

13

• ASA tablets in package

• Clopidogrel tables in package

• Metoprolol bolus x3

• Heparin bolus

• Heparin drip and tubing

• Alcohol swabs

• Calculator

• Standing orders with fibrinolytic calculations

• Blood vials

• PCS forms (Physician Certification Statement for Transfer)

• Transfer datasheet

• Standing orders

Level 1 MI Emergency Department Kit

14

Hot Load Transport of

STEMI Patients

15

Level 1 Page

Patient

PlacementPt Placement

SupervisorTelecommunications

Director

Chaplaincy

Security/Dispatch

ER Charge RN

CV Holding Room

CV/OR Manager

Answering Service

MCA Coordinator

CV Operations

CCU Charge RN

STEMI Program

ManagerHouse Supervisor

ED Com Physician

Admitting Director

Minneapolis Heart Institute

16

Minneapolis Heart Institute

17

Regional STEMI System for PCIMinneapolis Mar 2003 - Nov 2006; N= 1345

65

95

120

171

203214

4.4 4.6 5.7

0

50

100

150

200

PPCI Ctr Zone1 Zone2

Door 1-Balloon (min)

Sx-Balloon (min)

30 Day Mortality (%)

Henry et al Circ 2007

N=297 N=620 N=396

18

Regional STEMI

System for PCI

Mayo Clinic

PPCI Ctr

(St Mary’s)

28 Regional Hosp

Sx < 3h: lytic

Sx > 3 h: transfer

for PCI

Ting et al Circ 2007

19

Regional STEMI System for PCIMayo Clinic May 2004 - Dec 2006; N= 597

71

116

25

188

278

103

7.2 7.1 3.70

50

100

150

200

250

PPCI Ctr Transfer PCI Regional Lytic

Door 1-Rx (min)

Sx-Rx (min)

30 Day Mortality (%)

Ting et al Circ 2007

N=258 N=105 N=131

20

RACE Centers (N=65) and Regions

10 PCI centers

16 Transfer for PCI

28 Lytics

11 Mixed

Asheville

Winston-Salem Durham-Chapel Hill-

Greensboro

Charlotte

East Carolina

Each non-PCI center was assessed for

reperfusion designation based on resources,

transfer ability, and transfer time to PCI center

Jollis. JAMA 2007;298:2371-2380.

21

STEMI Treatment Time in RACE Hospitals

85

165

120

35

90

74

128

71

29

108

0

20

40

60

80

100

120

140

160

180

200

All Direct Transfer Door in to

Door out

D2N

Preintervention

Postintervention

Me

dia

n, M

inu

tes

P<0.001

P<0.001

P<0.001

Jollis. JAMA 2007;298:2371-2380.

P<0.001

P<0.002

First Door-to-Device at PCI Hosp Mx at non PCI Hosp

22

Improving the System of Care for STEMI Patients

STEMI Chain of Survival

23

Road Map for Transformation of Road Map for Transformation of

Reperfusion Therapy for STEMIReperfusion Therapy for STEMI

ACC D2B Alliance

AHA Mission:Lifeline

How Should Care Be Delivered ?

Measurement + accountability

System redesign

Spread of interventions

Research in above domains

3

ACTION Registry®-GWTG™

Who benefits ?

Outcomes Research

Effectiveness Research

Health Services Research

2

RCTs of Lysis vs PCI

What care works ?

Clinical Efficacy Research1

Reperfusion for STEMIKey AspectsStep

Dougherty D, Conway PH. JAMA 2008;299:2319-21 Antman EM JACC 2008

24

• National initiative

• Improve quality of care + outcomes in STEMI

• Improve health care system readiness and

response to STEMI.

Jacobs et al Circ. 116: 217, 2007

25

Improving Access to Improving Access to TimelyTimely Care for STEMICare for STEMI

Jacobs et al Circ. 116: 217, 2007

THE IDEAL SYSTEMTHE IDEAL SYSTEM

26

PCI

capable

Not PCI

capable

Patient

EMS

ED

STEMI

Referral

Payers

Policy

Makers STEMI

Receiving

NHAAP

CDC NAEMT

NAEMSP

NASEMSO

NEMSIS

ACEP

American Ambulance Assn

AACCN

ENA

ACTION/GWTG

NRHA

SCAI

Society of

Chest Pain

Centers

ACP

STS

AACCN

ENA

CMSAetna

UnitedHealth Networks

CMS

Center of

Care

Adapted from Jacobs et al. Circulation. 2007;116:217-230.

Evaluation

& Outcomes

AHRQ

FDA

JCAHO

Mission: Lifeline:Mission: Lifeline: Collaborating OrganizationsCollaborating Organizations

27

ECC

Task Force

Model Evaluation

Task Force

Advisory

Working Group

EMSEMS Point ofPoint of

EntryEntry

• Survey of Existing Systems

Administration

Locale (Urban, Rural)

Processes of Care

Financial Considerations

• Construct Templates for

System Development to Be

Used by Other Providers

Circ 116: e64, 2007Circ 116: e64, 2007

28

Circ 116: e64, 2007Circ 116: e64, 2007

Evaluation of Systems for STEMI Care

Structural Measures

EMS: staff, equipment, protocols

ED: staff, protocols, one-contact hotline

PPCI Ctr: 24/7, volume/experience, ?SOS

QA: feedback system, oversight comm.

29

Improving the System of Care for STEMI Patients

System Assessment & Improvement---on line surveys

29

30

Patient Flow Through STEMI System and Data CollectionPatient Flow Through STEMI System and Data Collection

STEMI

PT

Hosp A

Non PCI

Hosp B

PCI

1

2 3

4

5 6

911-EMSHybrid

NEMSIS

M:L EMS

M:L Bridging Form ACTION-GWTG

NCDR-PCI

Long Term Follow up--? sources

Pt self-

transport to

non PCI hosp

Pt self-

transport to PCI

hosp

Interhospital

transfer

Hosp C

Non PCI

CMS Data Only

7

Hosp D

PCI

Not participating in

ACTION/GWTG

CMS or NCDR Cath

PCI only

8

31

Dept of HHS Response to IOM Reports on Emergency Care:Dept of HHS Response to IOM Reports on Emergency Care:

1.1. Creation of lead agency within HHS to coordinate Creation of lead agency within HHS to coordinate

Emergency CareEmergency Care

2.2. Coordinate with AHRQ,Coordinate with AHRQ, FDA, CDC, NIH to promote FDA, CDC, NIH to promote

systems based Emergency Care researchsystems based Emergency Care research

3.3. Promote regionalization of Emergency CarePromote regionalization of Emergency Care

www.www.hhshhs..govgov

32

33

Potential Geometry ofPotential Geometry of

STEMI NetworksSTEMI Networks

Single Hub (PCI) w

Multiple Spokes

Multiple Hubs (PCI) w

Multiple Spokes

Intregrated Hubs (PCI)

and Spokes

Adapted from:

Exploring The Geometry

of Treatment Networks

Salanti Ann Int Med 148: 544, 2008

34

GRACE--Trends in STEMI Rx

N=44,372 ACS Pts

113 Hosp 14 Countries

49.5

16.1

3.2

34.127.8

52.7

2.7

28.6

0

20

40

60

80

100

Lytic PPCI CABG NoReperfusion

July-Dec 1999

July-Dec 2005

%%<0.001<0.001

<0.001<0.001

NSNS

NSNS

Fox et al JAMAFox et al JAMA 297 : 1892, 2007297 : 1892, 2007

35

Reperfusion Strategies for STEMI Reperfusion Strategies for STEMI

Widely availableWidely available

Quickly administeredQuickly administered

Less effectiveLess effective

Bleeding riskBleeding risk

Limited availabilityLimited availability

Treatment delay Treatment delay

More effectiveMore effective

Bleeding risk lowerBleeding risk lower

PharmacologicPharmacologic PCIPCI