1 university of torontocity-wide cardiology roundsnovember 29, 2007 emergency pci in the gta: from...
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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
2University of Toronto City-wide Cardiology Rounds November 29, 2007
3University of Toronto City-wide Cardiology Rounds November 29, 2007
4University of Toronto City-wide Cardiology Rounds November 29, 2007
Keeley et al. Lancet 2003; 361:13–20
5University of Toronto City-wide Cardiology Rounds November 29, 2007
Metanalysis of 23 Trials
Keeley et al. Lancet 2003; 361:13–20
6University of Toronto City-wide Cardiology Rounds November 29, 2007
D2B TIME AND MORTALITYNRMI REGISTRY
McNamarra et al. JACC Vol. 47, No. 11, 2006
7University of Toronto City-wide Cardiology Rounds November 29, 2007
NRMI 2-4: PCI-related delay where PCI and Thrombolysis mortality rates are equal
11University of Toronto City-wide Cardiology Rounds November 29, 2007
bradley et al. www.nejm.org november 30, 200
12University of Toronto City-wide Cardiology Rounds November 29, 2007
bradley et al. www.nejm.org november 30, 2006
13University of Toronto City-wide Cardiology Rounds November 29, 2007
Number of Strategies and Door-to-Balloon Time
bradley et al. www.nejm.org november 30, 2006
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
Direct EMS / Emerg MD activation of cath lab
Bed must always be available
STEMI nurse in CCU available
Repatriation within 24 hrs
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
Direct EMS / Emerg MD activation of cath lab
Bed must always be available
STEMI nurse in CCU available
Repatriation within 24 hrs
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,
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
Direct EMS / Emerg MD activation of cath lab
Bed must always be available
STEMI nurse in CCU available
Repatriation within 24 hrs
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
42University of Toronto City-wide Cardiology Rounds November 29, 2007
ACUTE MI PCI
University of Toronto Hospital Initiatives
43University of Toronto City-wide Cardiology Rounds November 29, 2007
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
44University of Toronto City-wide Cardiology Rounds November 29, 2007
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
46University of Toronto City-wide Cardiology Rounds November 29, 2007
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
47University of Toronto City-wide Cardiology Rounds November 29, 2007
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
University of Toronto
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)
% of Patients% of Patients
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
% of Patients% of Patients
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
University of Toronto
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!
97University of Toronto City-wide Cardiology Rounds November 29, 2007
NEXT STEPS
• CITY-WIDE COLLABORATION
97