1 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 Emergency PCI in the GTA: From Myth to Reality Introduction: Dr. Vlad Dzavik The York-Simcoe

1University of Toronto City-wide Cardiology Rounds November 29, 2007

Emergency PCI in the GTA:From Myth to Reality

Introduction: Dr. Vlad Dzavik

The York-Simcoe Regional Primary PCI Program Dr. Warren Cantor

The UofT Hospitals initiative Dr. Vlad Dzavik

Current Emergency PCI Status and initiatives

at St. Michael’s Dr. Neil Fam

at Sunnybrook Dr. Dennis Ko

at UHN Dr. Chris Overgaard

EMS Initiatives Alan Craig

Prehospital fibrinolysis or direct transport for primary PCI in acute STEMI (PREDESTINY): A proposal for a randomized controlled trial

Background Dr. Shaun Goodman

Protocol Dr. Laurie Morrison

Discussion




Keeley et al. Lancet 2003; 361:13–20


Metanalysis of 23 Trials

Keeley et al. Lancet 2003; 361:13–20


D2B TIME AND MORTALITYNRMI REGISTRY

McNamarra et al. JACC Vol. 47, No. 11, 2006


NRMI 2-4: PCI-related delay where PCI and Thrombolysis mortality rates are equal


bradley et al. www.nejm.org november 30, 200

http://www.nejm.org/













Number of Strategies and Door-to-Balloon Time



9803mo01,

Regional Primary PCI Southlake Regional Health Centre

Warren J. Cantor, MD, FRCPC

Physician Director, Regional Primary PCI ProgramAssistant Professor of Medicine, Univ. of Toronto

Regional Primary PCI Southlake Regional Health Centre

Warren J. Cantor, MD, FRCPC

Physician Director, Regional Primary PCI ProgramAssistant Professor of Medicine, Univ. of Toronto

9803mo01,

Regional Cardiac Care Program at SRHCRegional Cardiac Care Program at SRHC

1998 – MOH designated former York County Hospital to be an Advanced Regional Cardiac Centre for York Region, Simcoe County & Muskoka to provide PCI, cardiac surgery & PPM

Redevelopment in 2002, $170 million capital expansion

1st PCI Nov 2003

Serve 11 hospitals, over 1 Million residents served

York Region & Simcoe County are the fastest growing areas in Canada

1998 – MOH designated former York County Hospital to be an Advanced Regional Cardiac Centre for York Region, Simcoe County & Muskoka to provide PCI, cardiac surgery & PPM

Redevelopment in 2002, $170 million capital expansion

1st PCI Nov 2003

Serve 11 hospitals, over 1 Million residents served

York Region & Simcoe County are the fastest growing areas in Canada

9803mo01,

PCI Volumes at SRHCPCI Volumes at SRHC

9803mo01,

Regional Cardiac Care Program at Southlake Regional Health Centre

Regional Cardiac Care Program at Southlake Regional Health Centre

One of the major goals is to provide best management for all STEMI patients within our

region

One of the major goals is to provide best management for all STEMI patients within our

region

9803mo01,

Primary PCI vs. ThrombolysisPrimary PCI vs. Thrombolysis

—Keeley EC, Lancet 2003—Keeley EC, Lancet 2003

Death MI Stroke MajorBleed

RecurrentIschemia

Hemorr.Stroke

Death / MI/ Stroke

Long-term outcomes

Short-term outcomes

Fre

qu

enc

y (%

)

Death, excluding SHOCK

PTCA

Thrombolytic Therapy

23 trials

n=7,739

23 trials

n=7,739

9803mo01,

88

66

44

22

00

Per

cen

tag

e o

f p

atie

nts

wit

h e

ven

tsP

erce

nta

ge

of

pat

ien

ts w

ith

eve

nts

1010

4.24.2 4.64.65.15.1

6.76.7

8.58.57.97.9

0-600-60 61-9061-90 91-12091-120 121-150121-150 151-180151-180 >180>180Door-to-Balloon Time (minutes)Door-to-Balloon Time (minutes)

n=2230n=2230 n=5734n=5734 n=6616n=6616 n=4461n=4461 n=2627n=2627 n=5412n=5412

p=0.51p=0.51p=0.08p=0.08

P<0.001P<0.001

P<0.001P<0.001P<0.001P<0.001

In-Hospital MortalityIn-Hospital Mortality

Door-to-Balloon TimeDoor-to-Balloon Time

Cannon CP, et al. JAMA 2000Cannon CP, et al. JAMA 2000

NRMI-2

27,080 pts

NRMI-2

27,080 pts

Goal: Door-to-Balloon Time ≤ 90 minutes

Fibrinolysis generally preferred

Early presentation (≤ 3h from sx onset and delay to

invasive strategy)

Invasive strategy not an option (cath lab not

available, no vasc access, lack of skilled PCI lab)

Delay to Invasive Strategy med contact to balloon

>90

Fibrinolysis generally preferred

Early presentation (≤ 3h from sx onset and delay to

invasive strategy)

Invasive strategy not an option (cath lab not

available, no vasc access, lack of skilled PCI lab)

Delay to Invasive Strategy med contact to balloon

>90

Primary PCI generally preferred

Skilled PCI lab available (med contact to balloon <

90 min)

High risk STEMI (cardiogenic shock, Killip

class ≥3)

Contraindication to lysis

Late presentation (>3 hrs)

Diagnosis in doubt

Primary PCI generally preferred

Skilled PCI lab available (med contact to balloon <

90 min)

High risk STEMI (cardiogenic shock, Killip

class ≥3)

Contraindication to lysis

Late presentation (>3 hrs)

Diagnosis in doubt

2004 ACC/AHA Guideline Considerations

ACC/AHA STEMI Guidelines 2004, Figure 3ACC/AHA STEMI Guidelines 2004, Figure 3ACC/AHA STEMI Guidelines 2004, Figure 3ACC/AHA STEMI Guidelines 2004, Figure 3

9803mo01,

6 Proven Strategies to Reduce Door-to-Balloon Times6 Proven Strategies to Reduce Door-to-Balloon Times

1) Having emerg physicians activate the cath lab

2) Having a single call to a central page operator activate cath lab

3) Having the emergency dept activate the cath lab while the patient is en route to the hospital

4) Expecting staff to arrive in the cath lab within 20 minutes after being paged (vs. >30 minutes)

5) Having an attending cardiologist always on site

6) Having staff in the emerg dept and the cath lab use real-time data feedback

1) Having emerg physicians activate the cath lab

2) Having a single call to a central page operator activate cath lab

3) Having the emergency dept activate the cath lab while the patient is en route to the hospital

4) Expecting staff to arrive in the cath lab within 20 minutes after being paged (vs. >30 minutes)

5) Having an attending cardiologist always on site

6) Having staff in the emerg dept and the cath lab use real-time data feedback

Bradley EH, N Engl J Med 2006

9803mo01,

6 Proven Strategies to Reduce Door-to-Balloon Times6 Proven Strategies to Reduce Door-to-Balloon Times

Having emerg physicians activate the cath lab

Having a single call to a central page operator activate cath lab

Having the emergency dept activate the cath lab while the patient is en route to the hospital

Expecting staff to arrive in the cath lab within 20 minutes after being paged (vs. >30 minutes)

Having an attending cardiologist always on site

Having staff in the emerg dept and the cath lab use real-time data feedback

Having emerg physicians activate the cath lab

Having a single call to a central page operator activate cath lab

Having the emergency dept activate the cath lab while the patient is en route to the hospital

Expecting staff to arrive in the cath lab within 20 minutes after being paged (vs. >30 minutes)

Having an attending cardiologist always on site

Having staff in the emerg dept and the cath lab use real-time data feedback

Bradley EH, N Engl J Med 2006

9803mo01,

How our PPCI program was implementedHow our PPCI program was implemented

Identified by Division & senior hospital administration as priority for hospital & region

EMS & base hospital directors invited to join committee which met regularly to plan implementation

“Mock” run-in done to assess paramedic ECG interpretation, patient volume, impact on beds

Start with late-presenters to minimize impact of any potential treatment delays related to transfers

Identified by Division & senior hospital administration as priority for hospital & region

EMS & base hospital directors invited to join committee which met regularly to plan implementation

“Mock” run-in done to assess paramedic ECG interpretation, patient volume, impact on beds

Start with late-presenters to minimize impact of any potential treatment delays related to transfers

9803mo01,

Primary PCI - SRHC Emerg DeptPrimary PCI - SRHC Emerg Dept

Started 24/7 Primary PCI March 1/06

Approx 60 pts / yr (5 pts / month)

Median Door-to-Balloon Time: 85 min

Emerg MD calls ‘Code STEMI’, directly activates cath lab

STEMI nurse gets patient up to cath lab quickly

Immediate feedback to ED after each case

Feb /08- EMS will bypass SRHC emerg dept

Started 24/7 Primary PCI March 1/06

Approx 60 pts / yr (5 pts / month)

Median Door-to-Balloon Time: 85 min

Emerg MD calls ‘Code STEMI’, directly activates cath lab

STEMI nurse gets patient up to cath lab quickly

Immediate feedback to ED after each case

Feb /08- EMS will bypass SRHC emerg dept

9803mo01,

Primary PCI – Simcoe EMSPrimary PCI – Simcoe EMS

Jan/07- STEMI pts in Simcoe County ambulances brought directly to SRHC for primary PCI (Late presenters or contraindications to lysis) if within 45 min to SRHC

Paramedics directly activate cath lab, STEMI nurse meets EMS at front door & accompanies to cath lab

16 patients, Median Time from EMS arrival at scene to 1st Inflation: 95 minutes

Median 53 min from ECG to arrival in cath lab

Only 1 incorrect ECG interpretation (paced rhythm)

Jan/07- STEMI pts in Simcoe County ambulances brought directly to SRHC for primary PCI (Late presenters or contraindications to lysis) if within 45 min to SRHC

Paramedics directly activate cath lab, STEMI nurse meets EMS at front door & accompanies to cath lab

16 patients, Median Time from EMS arrival at scene to 1st Inflation: 95 minutes

Median 53 min from ECG to arrival in cath lab

Only 1 incorrect ECG interpretation (paced rhythm)

9803mo01,

9803mo01,

Distances to SRHCDistances to SRHCRVH: 58 kmRVH: 58 km

Stevenson: 51 kmStevenson: 51 km

9803mo01,

Primary PCI – RVH Emerg deptPrimary PCI – RVH Emerg dept

Feb/07- STEMI pts in RVH Emerg Dept (“walk-ins”) transferred to SRCH for primary PCI (Late presenters or contraindications to lysis)

Transfer time from RVH to cath lab: 46 min

Time from ECG to ED departure remains too long

Developing strategies to minimize delays (eg. abciximab pretreatment eliminated- FINESSE)

Feb/07- STEMI pts in RVH Emerg Dept (“walk-ins”) transferred to SRCH for primary PCI (Late presenters or contraindications to lysis)

Transfer time from RVH to cath lab: 46 min

Time from ECG to ED departure remains too long

Developing strategies to minimize delays (eg. abciximab pretreatment eliminated- FINESSE)

9803mo01,

Call Southlake DispatchCall Southlake Dispatch905-895-4521 ext 7777905-895-4521 ext 7777““Code STEMI - RVH”Code STEMI - RVH”

ASA 160 mg poASA 160 mg poClopidogrel 600 mg poClopidogrel 600 mg po

Heparin 70 U/kg (Heparin 70 U/kg (≤≤ 7000 U) 7000 U) bolusbolus

Send for 1Send for 1oo PCI PCI

Does patient have cardiogenic shock Does patient have cardiogenic shock OROR AbsoluteAbsolute contraindications to thrombolysis? * contraindications to thrombolysis? *

History & ECG consistent with ST-elevation MI *History & ECG consistent with ST-elevation MI *

Consider ThrombolysisConsider Thrombolysis + TRANSFER-AMI if eligible+ TRANSFER-AMI if eligible

YESYES

Did symptoms start > 3 hours (and < 12 hours) ago?Did symptoms start > 3 hours (and < 12 hours) ago?

NONO

Transfer for Rescue PCI if Transfer for Rescue PCI if requiredrequired

NONO

Call EMS- “Code STEMI, Code 4”Call EMS- “Code STEMI, Code 4”Anticipate arrival at SRHC within 60 minutes of diagnostic ECG?Anticipate arrival at SRHC within 60 minutes of diagnostic ECG?

YESYES

NONO

* If diagnostic uncertainty or * If diagnostic uncertainty or relative relative contraindications to thrombolysis, page contraindications to thrombolysis, page

interventional cardiologist on-callinterventional cardiologist on-call905-895-4521 ext 2216905-895-4521 ext 2216

YESYES

RVH STEMI RVH STEMI AlgorithmAlgorithm

9803mo01,

Prehospital vs. Emerg DeptPrehospital vs. Emerg Dept

Treatment times much quicker when STEMI diagnosed pre-hospital

“Walk-In” patients often have more atypical, milder symptoms

ED pts face additional delay of waiting for ambulance

Physicians tend to slow down the process Less protocol-driven Initially reluctant to activate cath lab without

discussing case with another MD first Many different Emerg MD’s, each seeing only

few STEMI’s per year

Treatment times much quicker when STEMI diagnosed pre-hospital

“Walk-In” patients often have more atypical, milder symptoms

ED pts face additional delay of waiting for ambulance

Physicians tend to slow down the process Less protocol-driven Initially reluctant to activate cath lab without

discussing case with another MD first Many different Emerg MD’s, each seeing only

few STEMI’s per year

9803mo01,

Regional Primary PCI Program- PrinciplesRegional Primary PCI Program- Principles

Direct EMS / Emerg MD activation of cath lab

Bed must always be available

STEMI nurse in CCU available

Repatriation within 24 hrs





9803mo01,










9803mo01,

Code STEMI “Hotline”Code STEMI “Hotline”

Ext 7777 answered immediately by hospital operator 24/7

Only 3 questions asked: EMS vs. ED, location, ETA

Cath lab staff, interventionalist, STEMI nurse paged simultanously

Ext 7777 answered immediately by hospital operator 24/7

Only 3 questions asked: EMS vs. ED, location, ETA

Cath lab staff, interventionalist, STEMI nurse paged simultanously

9803mo01,










CCU

Southlake – 5th Floor PCI Lab

PCI Unit Elevators

STEMI beds

Car

diol

ogy

War

d

Working Model

• STEMI Beds• Pre-PCI preparation• Post-PCI high-risk• Virtual bed• PCI Unit• Repatriation Unit• STEMI Nurse

Bed status is Bed status is nevernever checked prior to activating cath lab for primary PCI checked prior to activating cath lab for primary PCI

Duration Duration of stay of stay < 24 hrs< 24 hrs

9803mo01,

RepatriationRepatriation

Stable patients routinely repatriated within 24 hrs of PCI

Formal repatriation agreement developed with RVH, MSH, OSMH, YCH

Includes patients who were brought by EMS, never seen in community hospital

Stable patients routinely repatriated within 24 hrs of PCI

Formal repatriation agreement developed with RVH, MSH, OSMH, YCH

Includes patients who were brought by EMS, never seen in community hospital

9803mo01,

Lessons learnedLessons learned

The fewer physicians involved in decision-making the better

Gradual implementation in steps works best

Need complete ‘buy-in’ from hospital administration, EMS, community hospitals

Start with late presenters until ‘well-greased’ system in place for consistent rapid transfers

Keep protocol as simple as possible

The fewer physicians involved in decision-making the better

Gradual implementation in steps works best

Need complete ‘buy-in’ from hospital administration, EMS, community hospitals

Start with late presenters until ‘well-greased’ system in place for consistent rapid transfers

Keep protocol as simple as possible

9803mo01,

Future DirectionsFuture Directions

ECG Transmission

Prehospital Thrombolysis (Predestiny)

Pharmacoinvasive Strategy (Transfer-AMI)

ECG Transmission

Prehospital Thrombolysis (Predestiny)

Pharmacoinvasive Strategy (Transfer-AMI)

9803mo01,

PCI CentrePCI CentreCath LabCath Lab

CommunityCommunityHospitalHospitalEmergencyEmergencyDepartmentDepartment

Cath / PCI within 6 hrsCath / PCI within 6 hrs““PharmacoinvasivePharmacoinvasive

Strategy”Strategy”

Cath and Rescue Cath and Rescue PCI PCI GP IIb/IIIa GP IIb/IIIa

InhibitorInhibitor

TNK + Heparin / Enoxaparin + ClopidogrelTNK + Heparin / Enoxaparin + Clopidogrel

UrgentUrgent Transfer to Transfer to PCI CentrePCI Centre

Assess chest pain, STAssess chest pain, ST↑↑ resolution resolution at 60-90 minutesat 60-90 minutes

Primary Endpoint: 30-day death / re-MI / CHF / severe recurrent ischemia/ shockSecondary Endpoints: Major bleeding, 90-minute ST↑ resolution, ECG- and Echo-derived infarct size / extent

‘‘High Risk’ ST Elevation MI within 12 hours of symptom onsetHigh Risk’ ST Elevation MI within 12 hours of symptom onset N=1200N=1200

Failed ReperfusionFailed Reperfusion Successful ReperfusionSuccessful Reperfusion

Elective Cath Elective Cath PCIPCI

> 24 hrs later> 24 hrs later

Standard Treatment Standard Treatment

Cantor WJ. Am Heart J, In PressCantor WJ. Am Heart J, In Press

9803mo01,

1044 pts1044 pts

9803mo01,

Primary PCI

Other strategies


ACUTE MI PCI

University of Toronto Hospital Initiatives


IMPROVING ACUTE MI CAREPHASE ONE

• The three University of Toronto Interventional Cardiology Programs, St. Michael’s Hospital, Sunnybrook Health Sciences Centre and the University Health Network, have agreed in principle to improve and optimize existing emergent interventional services by joining forces and thus providing a ‘guaranteed accept’ 24/7 service for patients in the region requiring interventional care for failed thrombolysis, very high risk patients in cardiogenic shock or advanced Killip class, and those with contraindications to thrombolytic therapy. This service, agreed to and signed off on by the Administration of each of the three hospitals, St. Michael’s Hospital, Sunnybrook Hospital and the University Health Network, will apply the following principles:

43


PHASE ONEA single contact number to reach emergent interventional care administered by CritiCall

A call schedule involving the three programs will be made available to Criticall

The interventional cardiologist on call will be the contact at the receiving interventional cardiology centre

There will be a NO REJECT policy, as is currently the case with trauma and in some centres organ transplants.

In the case that the primary interventional on-call team is already in the midst of an emergent procedure, the second on-call centre will be contacted by CritiCall to accept a new patient.

Patients transferred from community hospitals who are deemed stable following the interventional procedure will be transferred back to that hospital within 24 hours of the procedure and could be transferred as soon as the procedure is done and acute vascular access site care has been completed.

44

45

University of Toronto City-wide Cardiology Rounds November 29, 2007

RECOMMENDED TARGETS

• Door-to-ECG <10 minutes

• ECG-to-ER Decision <10 minutes

• Decision-to- Cath Lab <20 minutes

• Cath Lab-to-Balloon<30 minutes


PHASE 2In the second phase, the University interventional cardiology programs will implement the elements necessary to establish a timely and efficient 24/7 program for primary PCI for patients arriving by ambulance or walking into their own institutions. The ideal call-to-arrival time of CCL staff of <30 minutes must be implemented in this phase by the means most achievable in each individual centre. The possible options that can be implemented include the following:

An evening shift that would extend to 11 pm or midnight

Ensuring that at least one of the on-call nurses for a particular night lives within a 30 minute radius of the hospital

Ensuring that all interventional cardiologists and fellows can be in the hospital within 30 minutes.

Cross-training of CICU nurses to help begin an emergent procedure until the arrival of the CCL on call nurses and possibly to assist during the entire procedure

46


PHASE 3In the third phase the University of Toronto interventional cardiology collaboration will implement a strategy of performing primary PCI for eligible patients presenting to GTA hospitals or identified by EMS in the pre-hospital phase.

Implementation timelines

Phase 1 is to be implemented by July 1, 2007

Phase 2 is to be implemented by April 1, 2008

Phase 3 is to be implemented by July 1, 2008

48

Enhancing the effectiveness of health carefor Ontarians through research

STEMI InitiativesSTEMI Initiatives

Dennis T. Ko MD MSc FRCPC

Interventional Cardiologist, Sunnybrook Health Sciences CentreScientist, Institute for Clinical Evaluative Sciences

University of Toronto

TCT October 23, 2007

Dennis T. Ko MD MSc FRCPC

Interventional Cardiologist, Sunnybrook Health Sciences CentreScientist, Institute for Clinical Evaluative Sciences


TCT October 23, 2007

ObjectivesObjectives

• Discuss local STEMI initiative at Sunnybrook Health Sciences Centre

• Discuss ongoing national initiatives and opportunities

• Discuss local STEMI initiative at Sunnybrook Health Sciences Centre

• Discuss ongoing national initiatives and opportunities

PCI versus Fibrinolysis with Fibrin-Specific PCI versus Fibrinolysis with Fibrin-Specific Agents: Is Timing (Almost) Everything?Agents: Is Timing (Almost) Everything?

Favors PCI

Favors fibrinolysis

13 RCTsN = 5494 P = 0.04

Ab

so

lute

Ris

k D

iffe

ren

ce

in D

eath

(%

)

30 40 50 60 70 80

PCI-Related Time Delay (minutes)

10 −

5 −

0 −

-5 − ┬ ┬ ┬ ┬ ┬ ┬

Nallamothu and Bates. Am J Cardiol 2003;92:824.

Recommendation for reperfusion therapyRecommendation for reperfusion therapy

• Minimize delay to reperfusion Door to needle: <30 minutes Door to balloon: <90 minutes

• Not “Median”, but all patients should be treated within the recommended timeframe

• Minimize delay to reperfusion Door to needle: <30 minutes Door to balloon: <90 minutes

• Not “Median”, but all patients should be treated within the recommended timeframe

Reperfusion Therapy

EFFECT STUDY (99-01)

0

20

40

60

80

100

Pe

rce

nt

All STEMI patients

Ideal* STEMI patients

75%59%

*Ideal as per GRACE Registry criteria

Door-to-Needle time for thrombolytic therapy

Average = 40 min 6/41 hospital corps met benchmark

EFFECT STUDY (99-01)

10

20

30

40

50

60

Teaching Comm Small

Median Time in Minutes

Benchmark < 30Minutes

40 4046

Sunnybrook STEMI InitiativeSunnybrook STEMI Initiative

Improve the Quality of Care and Outcomes of STEMI at Sunnybrook

Health Sciences Centre

Improve the Quality of Care and Outcomes of STEMI at Sunnybrook

Health Sciences Centre

Characteristics of Good STEMI hospitalsCharacteristics of Good STEMI hospitals

1. Commitment to goal “This is a part of the culture of the organization in that time to

reperfusion needs to be excellent” (VP, Cardiology)

2. Visible Senior Management “Holding people accountable. I think that’s the role of administration…”

(Medical Director, ER)

3. Innovative, Standardized Protocols“All of us got together and came up with the steps to get a patient from the ED

to the cath lab. We broke it into 8-9 steps. At each step, we allowed a certain # of minutes, and we lived up to it.” (Cardiologist)

1. Commitment to goal “This is a part of the culture of the organization in that time to

reperfusion needs to be excellent” (VP, Cardiology)

2. Visible Senior Management “Holding people accountable. I think that’s the role of administration…”

(Medical Director, ER)

3. Innovative, Standardized Protocols“All of us got together and came up with the steps to get a patient from the ED

to the cath lab. We broke it into 8-9 steps. At each step, we allowed a certain # of minutes, and we lived up to it.” (Cardiologist)

Bradley EH, et al. Circ 2006; 113:1079-85

Characteristics of Good STEMI hospitalsCharacteristics of Good STEMI hospitals

4. Resilience to challenges with flexibility in refining protocols

“It’s a continual thing…even though we refine the process…things change…and we have to refine how we’re doing things…” (Cath Lab Nurse)

5. Collaborative, interdisciplinary teams“I feel like when I talk to somebody, they respect my opinion, so if I call the

cardiologist and say this person is having an anterior MI, they believe me. They don’t try to talk me out of it…” (ER physician)

6. Data/QI feedback“It helped the ED staff that the cardiologist would come back from the cath lab

with a picture of the open artery, so the staff felt like --- this is what we’ve done!” And the cardiologist would say the patient is doing great, you guys did a great job!” (VP, ER)

4. Resilience to challenges with flexibility in refining protocols

“It’s a continual thing…even though we refine the process…things change…and we have to refine how we’re doing things…” (Cath Lab Nurse)

5. Collaborative, interdisciplinary teams“I feel like when I talk to somebody, they respect my opinion, so if I call the

cardiologist and say this person is having an anterior MI, they believe me. They don’t try to talk me out of it…” (ER physician)

6. Data/QI feedback“It helped the ED staff that the cardiologist would come back from the cath lab

with a picture of the open artery, so the staff felt like --- this is what we’ve done!” And the cardiologist would say the patient is doing great, you guys did a great job!” (VP, ER)

Bradley EH, et al. Circ 2006; 113:1079-85

Before Initiative Before Initiative

• Median door to balloon – 90 min

• % of D2B within 90 min – 54%

• Median time to needle – 56 min

• % within 30 min – 16%

• Median door to balloon – 90 min

• % of D2B within 90 min – 54%

• Median time to needle – 56 min

• % within 30 min – 16%

After initiativeAfter initiative

• 38 STEMI March 1, 2007 to November 2007 (14 received fibronolysis, 22 primary PCI)

• Median door to balloon – 63 min (IQR 49-77)

• % within 90 min – 82 % (daytime 90%)

• Median door to needle – 40 min (IQR 15– 53)

• % within 30 min – 36%

• 38 STEMI March 1, 2007 to November 2007 (14 received fibronolysis, 22 primary PCI)

• Median door to balloon – 63 min (IQR 49-77)

• % within 90 min – 82 % (daytime 90%)

• Median door to needle – 40 min (IQR 15– 53)

• % within 30 min – 36%

D2B time pre and post initiativeD2B time pre and post initiative

Ongoing initiativesOngoing initiatives

• Canadian Cardiovascular Research Team (CCORT) Survey National survey on primary PCI services across Canada

• Enhanced Feedback for Effective Treatment (EFFECT II) 2004-2005

• D2B Alliance/Canadian D2B

• Canadian Cardiovascular Research Team (CCORT) Survey National survey on primary PCI services across Canada

• Enhanced Feedback for Effective Treatment (EFFECT II) 2004-2005

• D2B Alliance/Canadian D2B

“This is where we show that we are not just about research -- in QI we are not just about measurement -- but that we can lead meaningful change by supporting hospitals and clinicians. This is the idea.”

-- Harlan Krumholz, MD

“This is where we show that we are not just about research -- in QI we are not just about measurement -- but that we can lead meaningful change by supporting hospitals and clinicians. This is the idea.”

-- Harlan Krumholz, MD

Sunnybrook TeamSunnybrook Team

• Cardiology (Harindra Wijeysundera, Claudia Bucci, Chris Morgan, Eric Cohen)

• ER (Jeff Tyberg, Paul Hawkings, Michael Schull, nurses)

• Cath lab team (nurses, interventional cardiologists)

• Cardiology (Harindra Wijeysundera, Claudia Bucci, Chris Morgan, Eric Cohen)

• ER (Jeff Tyberg, Paul Hawkings, Michael Schull, nurses)

• Cath lab team (nurses, interventional cardiologists)

Diagnosis uncertain?

Hemodynamically unstable?

1. ER MD ACTIVATES CATH LAB DIRECTLY: “CODE STEMI”

-0800h-1700h: page PCI coordinator 685-9388 -Evenings / weekends: call CCU 58092. ER MD NOTIFIES CCU RESIDENT3. GIVE MEDICATIONS -ASA 160 mg -Clopidogrel 300mg (75mg if >75 years old) -Heparin 60IU/kg bolus (no drip), max 4000IU

STEMI or new LBBB < 12 hours duration

No anticipated delay to PCI:-Add Reopro 0.25mg/kg bolus (no drip)

Anticipated delay to PCI > 90 minutes:-Do NOT give Reopro-Assess for possible thrombolysis

CCU resident to decide activation of

cath lab

Y

Y

N

N

STEMI TREATMENT ALGORITHM

Heart Attack Response Team

• ER MD activates cath lab: Code STEMI• CCU resident sees pt in ER• CCU RN turns on cath lab equipment, then

proceeds to ER• CCU resident, CCU RN, ER RN (HART)

immediately transfer pt to cath lab• Interventional fellow scrubs, preps pt, table• Case starts when cath lab RN, tech arrive

24-7 Primary PCI

• Prompt feedback to all caregivers: CQI• Data collection: Time intervals, Outcomes• STEMI committee

University Health Network:

Emergency PCI Status and Initiatives

Dr. Christopher OvergaardInterventional Cardiology

69

0

20

40

60

80

100

120

140

TGH MSH TWH

Tim

e (m

inu

tes)

5

46

28

7

29

28

10

10

13 11

72 91

1st ECG

Rx + Transfer

Scrub toBalloon

Pt setup

124

86

140

n=9 n=20 n=13

}} }

53%

58%65%

UHN Median ER Door to Balloon Times April 06 - October 07

0

10

20

30

40

50

60

29

18

4

5

Fastest Door to Balloon Time - 53 minutes

Tim

e (m

inu

tes)

0

20

40

60

80

100

120

Door to Balloon Times With or Without Prior CCU Consultation

101

77

Tim

e (m

inut

es)

CCU +ve CCU -ve

50

35

UHN Primary PCI Initiatives• Single TGH/MSH + TWH triage number to call• Standardized ER STEMI protocols with time codes;

improved ER communication• Concurrent activation of CCU with cath lab to

avoid time delays• MD (cath lab fellow + CCU team member) to assist

with patient transfer• MD and nursing committee working on cath lab

efficiency protocols (eg. increasing involvement of staff and fellow with patient setup)

Short term outcomesShort term outcomes Long term outcomesLong term outcomes

Primary Angioplasty vs. Thrombolysis for Acute MIPrimary Angioplasty vs. Thrombolysis for Acute MIQuantitative Review of 23 Randomized Trials (N=7739)Quantitative Review of 23 Randomized Trials (N=7739)

Keeley et al Keeley et al LancetLancet 2003;361:13-20 2003;361:13-20

00

55

1010

1515

2020

DeathDeath reMIreMI RecurrentRecurrentIschemiaIschemia

ICHICH Major Major BleedBleed

2525

DeathDeath reMIreMI RecurrentRecurrentIschemiaIschemia

p=0.0003p=0.0003 p<0.0001p<0.0001

p<0.0001p<0.0001

p<0.0001p<0.0001

p=0.032p=0.032

p=0.0053p=0.0053p<0.0001p<0.0001

p<0.0001p<0.0001

% of Patients% of Patients

00

1010

2020

3030

4040

5050PTCA

Thrombolysis

7799

2.52.5

6.86.866

2121

0.050.05 1.11.1

6.86.85.35.3

6.26.2 8.78.74.84.8

1010

2222

3939

Transport of Patients for Primary PCITransport of Patients for Primary PCI

* Median ** Mean * Median ** Mean † † Without AIR-PAMIWithout AIR-PAMI

StudyStudy

DANAMI-2DANAMI-2

PRAGUE-1PRAGUE-1

PRAGUE-2PRAGUE-2

Vermeer et alVermeer et al

AIR-PAMIAIR-PAMI

CAPTIMCAPTIM

TotalTotal

ASSENT-3+ASSENT-3+

EMIPEMIP

N TransportedN Transported

599599

101101

429429

7575

7171

421421

16561656

16391639

54695469

Distance Distance Range (km)Range (km)

3-1503-150

5-745-74

5-1205-120

25-5025-50

10-6910-69

1-1001-100

1-1501-150

Death During Death During TransportTransport

00

00

22

00

00

00

2 (0.1%)2 (0.1%)

13 (0.8%)13 (0.8%)

60 (1.1%)60 (1.1%)

Time Between Time Between Randomization and Randomization and

BalloonBalloon

90 min*90 min*

80 min**80 min**

97 min**97 min**

85 min**85 min**

155 min**155 min**

82 min**82 min**

>50% of pts <90 >50% of pts <90 minmin††

00

55

1010

1515

2020

DeathDeath ReinfarctionReinfarction Total strokeTotal stroke ICHICH Death, reMIDeath, reMIor strokeor stroke

p=0.057p=0.057

p<0.0001p<0.0001

p=0.049p=0.049 p=0.25p=0.25

p<0.0001p<0.0001PTCA (n=1466)

Thrombolysis (n=1443)


Keeley et al Keeley et al LancetLancet 2003;361:13-20 2003;361:13-20

Primary Angioplasty vs. Thrombolysis for Acute MIPrimary Angioplasty vs. Thrombolysis for Acute MI5 Randomized Trials With On-Site Lysis or After Emergent Transfer for Primary PTCA5 Randomized Trials With On-Site Lysis or After Emergent Transfer for Primary PTCA

Mean 39 minute delayMean 39 minute delay

StudyStudy

MITIMITI

EMIPEMIP

GREATGREAT

Roth et alRoth et al

Schofer et alSchofer et al

Castaigne et alCastaigne et al

OverallOverall

NN

360360

5,4695,469

311311

116116

7878

100100

6,4346,434

Randomized Trials of Prehospital ThrombolysisRandomized Trials of Prehospital ThrombolysisOdds Ratio & 95% ClOdds Ratio & 95% Cl

Favours Prehospital LysisFavours Prehospital Lysis Hospital LysisHospital Lysis

Morrison et al Morrison et al JAMAJAMA 2000; 283:2686-92 2000; 283:2686-92

Pre (%)Pre (%)

5.75.7

9.19.1

6.86.8

5.65.6

2.52.5

5.35.3

8.68.6

Hosp (%)Hosp (%)

8.68.6

10.410.4

11.511.5

6.86.8

5.35.3

7.07.0

10.210.2

10105522110.50.50.20.20.10.10.050.050.020.02

0.83 (0.70-0.98)0.83 (0.70-0.98)

Time to lysis:Time to lysis:104 vs. 162 min (p=0.007)104 vs. 162 min (p=0.007)

00

22

44

66

88

1010

1212

DeathDeath re-MIre-MI StrokeStroke CompositeComposite

30-Day Outomes30-Day Outomes


4.84.8

1.71.700

6.26.2

3.83.8 3.73.7

11

8.28.2

Bonnefoy et al for the Bonnefoy et al for the CComparison of omparison of AAngioplasty and ngioplasty and PPrehospital rehospital TThrombolysis hrombolysis iin Acute n Acute MMyocardial Infarction (CAPTIM) Investigators yocardial Infarction (CAPTIM) Investigators Lancet Lancet 2002;360:825-292002;360:825-29

Primary PCI (n=421)

Pre-hospital Lysis (n=419)

p=0.61p=0.61

Pre-Hospital Fibrinolysis vs. Primary PCIPre-Hospital Fibrinolysis vs. Primary PCI

p=0.13p=0.13

p=0.12p=0.12

p=0.29p=0.29

Pre-Hospital Fibrinolysis vs. Primary Pre-Hospital Fibrinolysis vs. Primary PCIPCI

ThrombolysisThrombolysisn=419n=419

PCIPCIn=421n=421

pp

Primary EndpointsPrimary Endpoints

DeathDeath 3.83.8 4.84.8 0.610.61

re-MIre-MI 3.73.7 1.71.7 0.130.13

Disabling StrokeDisabling Stroke 1.01.0 0.00.0 0.120.12

CompositeComposite 8.28.2 6.26.2 0.290.29

Secondary EndpointsSecondary Endpoints

Hemorrhagic StrokeHemorrhagic Stroke 0.50.5 0.00.0 0.500.50

Severe HemorrhageSevere Hemorrhage

Cardiogenic ShockCardiogenic Shock

Bonnefoy et al for the Bonnefoy et al for the CComparison of omparison of AAngioplasty and ngioplasty and PPrehospital rehospital TThrombolysis hrombolysis iin Acute n Acute MMyocardial Infarction (CAPTIM) Investigators yocardial Infarction (CAPTIM) Investigators Lancet Lancet 2002;360:825-292002;360:825-29

* From randomization to * From randomization to admissionadmission

2.22.2

00

5.75.7

3.63.6

00

22

44

66

88% of Patients% of Patients

p=0.058p=0.058

p=0.007p=0.007

DeathDeath Cardiogenic Cardiogenic Shock*Shock*

<2 Hours<2 HoursN=460N=460

5.95.9

00

3.73.7

0.50.500

22

44

66

88% of Patients% of Patients

p=0.47p=0.47

p=1.0p=1.0

DeathDeath Cardiogenic Cardiogenic Shock*Shock*

≥≥2 Hours2 HoursN=374N=374

Steg et al for the CAPTIM Investigators Steg et al for the CAPTIM Investigators Circulation Circulation 2003;108:2851-562003;108:2851-56

Impact of Time to Treatment on Mortality After Impact of Time to Treatment on Mortality After Prehospital Fibrinolysis vs. Primary PCIPrehospital Fibrinolysis vs. Primary PCI

Primary PCI

Prehospital Lysis

First Author First Author (Year)(Year)Study DesignStudy Design

Provider of Provider of ECG andECG and

ECG locationECG location

TreatmentTreatment ControlControl MortalityMortality 30 day Composite 30 day Composite Outcome§Outcome§

Door-to-balloon or drug Door-to-balloon or drug interval (minutes)interval (minutes)Median (25Median (25thth-75-75thth

percentiles)percentiles)

TreatmentTreatment ControlControl TreatmentTreatment ControlControl TreatmentTreatment ControlControl

Le May (2006)Le May (2006)Before and after Before and after studystudy

ParamedicParamedicOn-sceneOn-scene

Prehospital Prehospital ECG and ECG and Primary PCIPrimary PCI

Historical controlsHistorical controlsIn-hospitalIn-hospitalfibrinolysis and fibrinolysis and primary PCIprimary PCI

1.9%1.9%n = 108n = 108

8.9%8.9%n = 225n = 225

N/AN/A N/AN/A 6363(36-83)(36-83)

4141(30-58)(30-58)

Armstrong (2006)Armstrong (2006)RCTRCT

ParamedicParamedicOn-sceneOn-scene

Primary PCIPrimary PCI TNK and TNK and enoxaparin; mix of enoxaparin; mix of inhospital and inhospital and prehospital prehospital

1%1%n = 100n = 100

4%4%n = 100n = 100

23%23%11

n = 100n = 10025%25%11

n = 100n = 100176 176

(140-280)(140-280)113 113

(74-179)(74-179)

van ‘t Hof (2005, van ‘t Hof (2005, 2006)2006)Retrospective Retrospective CohortCohort

NurseNurseOn-sceneOn-scene

Prehospital Prehospital ECG and ECG and primary PCIprimary PCI

Transfer to PCI from Transfer to PCI from Community hospitalCommunity hospital

1%1%n=209n=209

3.2%3.2%n=258n=258

2% 2% 22

n=209n=2094% 4% 22

n=258n=258*177 *177

(144-237)(144-237)*208*208

(175-264)(175-264)

Terkelson (2005)Terkelson (2005)Prospective Prospective CohortCohort

PhysicianPhysicianOn-sceneOn-scene

Prehospital Prehospital ECG and ECG and Primary PCIPrimary PCI

Transfer to PCI from Transfer to PCI from Community hospitalCommunity hospital

11%11%††

n = 55n = 550%0%

n = 21n = 21N/AN/A N/AN/A 21 21

(17-31)(17-31)30 30

(26-38)(26-38)

Clemmensen Clemmensen (2005)(2005)Prospective Prospective CohortCohort

Ambulance Ambulance Personnel Personnel On-sceneOn-scene

Prehospital Prehospital ECG and ECG and Bypass for Bypass for PCIPCI

Historical controls Historical controls (DANAMI-2)(DANAMI-2)In-hospitalIn-hospitalFibrinolysisFibrinolysis

N/AN/A N/AN/A N/AN/A N/AN/A 4040 9494

Bonnefoy (2002)Bonnefoy (2002)RCTRCT

PhysicianPhysicianOn-sceneOn-scene

Prehospital Prehospital ECG and ECG and Bypass for Bypass for Primary PCIPrimary PCI

Prehospital Prehospital fibrinolysis- fibrinolysis- accelerated tPAaccelerated tPA

4.8%4.8%n = 421n = 421

3.8% 3.8% n = 419n = 419

6.2% 6.2% 33

n = 421n = 4218.2% 8.2% 33

n = 419n = 419190 190

(149-255)(149-255)130 130

(95-180)(95-180)

Studies of Direct Transportation from Scene to PCI CentersStudies of Direct Transportation from Scene to PCI Centers

*Symptom onset-to-balloon §Composite Outcomes: *Symptom onset-to-balloon §Composite Outcomes: 11 death, reMI, refractory ischemia, CHF, cardiogenic shock or major ventricular arrhythmia; death, reMI, refractory ischemia, CHF, cardiogenic shock or major ventricular arrhythmia; 2 2 death, reMI or stroke; death, reMI or stroke; 33 death, reMI, disabling stroke death, reMI, disabling stroke

Rationale for a Trial ComparingRationale for a Trial ComparingPre-hospital Fibrinolysis vs.Pre-hospital Fibrinolysis vs.

Direct Transport for Primary PCIDirect Transport for Primary PCI

Among patients with STEMI diagnosed by Among patients with STEMI diagnosed by paramedics in the pre-hospital settingparamedics in the pre-hospital setting Insufficient high quality evidence to Insufficient high quality evidence to

recommend pre-hospital bypass and direct recommend pre-hospital bypass and direct transport to a PCI center for primary PCItransport to a PCI center for primary PCI

Lack of clinical trial data comparing pre-Lack of clinical trial data comparing pre-hospital fibrinolysis vs. direct transport for hospital fibrinolysis vs. direct transport for primary PCIprimary PCI

Among patients with STEMI diagnosed by Among patients with STEMI diagnosed by paramedics in the pre-hospital settingparamedics in the pre-hospital setting Insufficient high quality evidence to Insufficient high quality evidence to

recommend pre-hospital bypass and direct recommend pre-hospital bypass and direct transport to a PCI center for primary PCItransport to a PCI center for primary PCI

Lack of clinical trial data comparing pre-Lack of clinical trial data comparing pre-hospital fibrinolysis vs. direct transport for hospital fibrinolysis vs. direct transport for primary PCIprimary PCI

Prehospital Perspective Contributing to

STEMI care and Science

Laurie J. Morrison

Declaration of Conflict of Interest

Aventis

HAS Solutions

Hewlett Packard

Hoffman La Roche

• Interdev• Panasonic• Zoll Medical Inc.

Prehospital Fibrinolysis or Direct Transport for Primary Percutaneous Coronary Intervention in Acute ST-Elevation Myocardial Infarction - PREDESTINY: A

Randomized Controlled Trial

PREDESTINY Investigators

Prehospital and Transport Medicine Research Program


Investigators

Rick Verbeek Brian Schwartz Michelle Welsford Alan Craig Mina Madan Madhu NatarajanShaun Goodman Neal Fam

Warren Cantor Michael Schull Alex Kiss Ron GoereeJean-Eric Tarride Jim BowenSteven Brooks Valeria Rac

Potential Prehospital Interventions

• What we do now?– 3 lead ECG and drive fast• Prehospital diagnosis of STEMI – 12 lead ECG and advance ED

notification• Prehospital intervention– +/- Bypass to PCI site – Prehospital fibrinolysis

Steering group submitted a pilot

CIHR – RCT preliminary step

Approved

Concerns

Feasible from a prehospital perspective

Feasible from a Toronto perspective

Final submission will require data

Objective

To determine:

Safety and effectiveness Prehospital bypass to PCI center vs. ALS intervention – 12 lead, advance ED

notification prehospital fibrinolysis ORBLS intervention – advance ED notification

Primary Outcome Measure

• 30-day composite of all cause mortality and reinfarction, and stroke defined as any new neurological deficit lasting >24 hours.

• Survival and reinfarction rates – 6 and 12 months

Study Population

• 11 geographical regions in Ontario – 121,959 km2 – population of 7.5M • 10 EMS systems – 52 receiving hospitals – within 60 minutes of ≥ 1 of 12 PCI

centres.

Where are we?

Pulling together our steering cteEMS, medical directors each region

Provincial approval – Dec 10-11PCI centers representativesAcquiring baseline data estimates from

the population and from CCN

RCT application to CIHR Feb 2008

We need data to judge what we are getting ourselves into!

Prehospital incidence Chest pain – guessingSTEMI – even more guessingWithin 60 minutes – speculation

Reperfusion dataCCN data on those that receive PCISketchy on those that received TPA or

nothing at all

Prehospital Evaluation and Economic Analysis of Different Coronary Syndrome

Treatment Strategies – PREDICT

PREDICT Investigators

Funded by the MOHLTC

What is it?

• PREDICT – observational study – comprehensive WEB based database– provide incidence numbers to all

partners

Study Design

Identify the four groups

3 lead and transport to ED

3 lead and transport to ED within 60 mins of a PCI center

12 lead and transport to ED

12 lead and transport to ED within 60 mins of a PCI center

TPATPA

12 lead12 lead

BypassBypass

BypassBypass

Show me the data!


NEXT STEPS

• CITY-WIDE COLLABORATION

97

Documents

1 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 Emergency PCI in the GTA: From Myth to Reality Introduction: Dr. Vlad Dzavik The York-Simcoe