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 Regional Primary PCI Program Dr. Warren Cantor The UofT Hospitals initiative Dr. Vlad Dzavik Current Emergency PCI Status and initiatives at St. Michael’sDr. Neil Fam at SunnybrookDr. Dennis Ko at UHNDr. Chris Overgaard EMS InitiativesAlan Craig Prehospital fibrinolysis or direct transport for primary PCI in acute STEMI (PREDESTINY): A proposal for a randomized controlled trial BackgroundDr. Shaun Goodman ProtocolDr. Laurie Morrison Discussion

2 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007

3

4 Keeley et al. Lancet 2003; 361:13–20

5 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 Metanalysis of 23 Trials Keeley et al. Lancet 2003; 361:13–20

6 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 D2B TIME AND MORTALITY NRMI REGISTRY McNamarra et al. JACC Vol. 47, No. 11, 2006

7 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 NRMI 2-4: PCI-related delay where PCI and Thrombolysis mortality rates are equal

8 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 ER activities and door-balloon times Written criteria for immediate ECG in ER 99.8 min -5.3 Dedicated ECG tech in ER 99.7 min -2.9 Dedicated space in triage for immediate ECG 100 min -3.2 ER physician activates cath lab on weekdays 90.5 min ER physician activates cath lab at night & w/e 90.2 min ER makes single call to central operator who pages PCI operator and cath lab 89.2 min Locating calls, no confirmation needed 90.4 min bradley et al. november 30, 200www.nejm.org

9 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 ER activities and door-balloon times Interv. cardiologist first MD called after Dx of MI made 97.3 min -3.7 Labs and CXR needed to activate cath lab min EMS calls in ECG result to ER 96.0 min -6.2 ER activates cath lab with patient en route 85.4 min vs. calling cardiologist -10.3; vs. no EMS ECG done Page to cath lab staff arriving ≤ 20 min vs. >30 min Page to interv. cardiologist ≤ 20 min 94.6 min vs. >30 min Transport from ER to cath lab set interval after call 84.9 min vs. cath lab calling for patient -15.7; vs. other bradley et al. november 30, 2006www.nejm.org

10 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 Other variables and door-to- balloon time An attending cardiologist is always at the hospital 92.6 min -8.2 ER routinely gives data feedback to EMS 90.7 min bradley et al. november 30, 200www.nejm.org

11 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 bradley et al. november 30, 200www.nejm.org

12 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 bradley et al. november 30, 2006www.nejm.org

13 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 Number of Strategies and Door-to- Balloon Time bradley et al. november 30, 2006www.nejm.org

9803mo01, Regional Primary PCI Southlake Regional Health Centre Warren J. Cantor, MD, FRCPC Physician Director, Regional Primary PCI Program Assistant Professor of Medicine, Univ. of Toronto

9803mo01, Regional 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 1 st 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 1 st 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 SRHC

9803mo01, 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

9803mo01, Primary PCI vs. Thrombolysis —Keeley EC, Lancet 2003 Death MI Stroke Major Bleed Recurrent Ischemia Hemorr. Stroke Death / MI / Stroke Long-term outcomes Short-term outcomes Frequency (%) Death, excluding SHOCK PTCA Thrombolytic Therapy 23 trials n=7, trials n=7,739

9803mo01, Percentage of patients with events >180 Door-to-Balloon Time (minutes) n=2230n=5734n=6616n=4461n=2627n=5412 p=0.51 p=0.08 P<0.001 P<0.001 P<0.001 In-Hospital Mortality Door-to-Balloon Time Cannon 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 n Early presentation (≤ 3h from sx onset and delay to invasive strategy) n Invasive strategy not an option (cath lab not available, no vasc access, lack of skilled PCI lab) n Delay to Invasive Strategy med contact to balloon >90 Fibrinolysis generally preferred n Early presentation (≤ 3h from sx onset and delay to invasive strategy) n Invasive strategy not an option (cath lab not available, no vasc access, lack of skilled PCI lab) n Delay to Invasive Strategy med contact to balloon >90 Primary PCI generally preferred n Skilled PCI lab available (med contact to balloon < 90 min) n High risk STEMI (cardiogenic shock, Killip class ≥3) n Contraindication to lysis n Late presentation (>3 hrs) n Diagnosis in doubt Primary PCI generally preferred n Skilled PCI lab available (med contact to balloon < 90 min) n High risk STEMI (cardiogenic shock, Killip class ≥3) n Contraindication to lysis n Late presentation (>3 hrs) n Diagnosis in doubt 2004 ACC/AHA Guideline Considerations ACC/AHA STEMI Guidelines 2004, Figure 3

9803mo01, 6 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 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 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 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 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 1 st 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 1 st Inflation: 95 minutes Median 53 min from ECG to arrival in cath lab Only 1 incorrect ECG interpretation (paced rhythm)

9803mo01,

Distances to SRHC RVH: 58 km Stevenson: 51 km

9803mo01, Primary 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 Dispatch ext 7777 “Code STEMI - RVH” ASA 160 mg po Clopidogrel 600 mg po Heparin 70 U/kg (  7000 U) bolus Send for 1 o PCI Does patient have cardiogenic shock OR Absolute contraindications to thrombolysis? * History & ECG consistent with ST-elevation MI * Consider Thrombolysis + TRANSFER-AMI if eligible + TRANSFER-AMI if eligible YES Did symptoms start > 3 hours (and 3 hours (and < 12 hours) ago? NO Transfer for Rescue PCI if required NO Call EMS- “Code STEMI, Code 4” Anticipate arrival at SRHC within 60 minutes of diagnostic ECG? YES NO * If diagnostic uncertainty or relative * If diagnostic uncertainty or relative contraindications to thrombolysis, page interventional cardiologist on-call ext 2216 YES RVH STEMI Algorithm

9803mo01, Prehospital 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 l Less protocol-driven l Initially reluctant to activate cath lab without discussing case with another MD first l 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 l Less protocol-driven l Initially reluctant to activate cath lab without discussing case with another MD first l Many different Emerg MD’s, each seeing only few STEMI’s per year

9803mo01, Regional 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- 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” 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- 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 – 5 th Floor PCI Lab PCI UnitElevators STEMI beds Cardiology Ward Working Model STEMI Beds Pre-PCI preparation Post-PCI high-risk Virtual bed PCI Unit Repatriation Unit STEMI Nurse Bed status is never checked prior to activating cath lab for primary PCI Duration of stay < 24 hrs

9803mo01, Repatriation 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 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 Directions ECG Transmission Prehospital Thrombolysis (Predestiny) Pharmacoinvasive Strategy (Transfer-AMI) ECG Transmission Prehospital Thrombolysis (Predestiny) Pharmacoinvasive Strategy (Transfer-AMI)

9803mo01, PCI Centre Cath Lab CommunityHospitalEmergencyDepartment Cath / PCI within 6 hrs “PharmacoinvasiveStrategy” Cath and Rescue PCI  GP IIb/IIIa Inhibitor TNK + Heparin / Enoxaparin + Clopidogrel Urgent Transfer to PCI Centre Assess chest pain, ST ↑ resolution at minutes at minutes Primary Endpoint: 30-day death / re-MI / CHF / severe recurrent ischemia/ shock Secondary Endpoints: Major bleeding, 90-minute ST ↑ resolution, ECG- and Echo-derived infarct size / extent ‘High Risk’ ST Elevation MI within 12 hours of symptom onset N=1200 N=1200 Failed Reperfusion Successful Reperfusion Elective Cath  PCI > 24 hrs later Standard Treatment Cantor WJ. Am Heart J, In Press

9803mo01, 1044 pts

9803mo01, Primary PCI Other strategies

42 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 ACUTE MI PCI University of Toronto Hospital Initiatives

43 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 IMPROVING ACUTE MI CARE PHASE 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

44 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 PHASE ONE A 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 TorontoCity-wide Cardiology RoundsNovember 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

46 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 PHASE 2 In 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

47 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 PHASE 3 In 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 care for Ontarians through research STEMI Initiatives Dennis T. Ko MD MSc FRCPC Interventional Cardiologist, Sunnybrook Health Sciences Centre Scientist, Institute for Clinical Evaluative Sciences University of Toronto TCT October 23, 2007 Dennis T. Ko MD MSc FRCPC Interventional Cardiologist, Sunnybrook Health Sciences Centre Scientist, Institute for Clinical Evaluative Sciences University of Toronto TCT October 23, 2007

Objectives 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 Agents: Is Timing (Almost) Everything? Favors PCI Favors fibrinolysis 13 RCTs N = 5494 P = 0.04 Absolute Risk Difference in Death (%) PCI-Related Time Delay (minutes) 10 − 5 − 0 − -5 − ┬ ┬ ┬┬ ┬ ┬ Nallamothu and Bates. Am J Cardiol 2003;92:824.

Recommendation 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) Percent 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) TeachingCommSmall Median Time in Minutes Benchmark < 30 Minutes 40 46

Sunnybrook STEMI Initiative Improve the Quality of Care and Outcomes of STEMI at Sunnybrook Health Sciences Centre

Characteristics 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:

Characteristics 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:

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 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 initiative

Ongoing initiatives Canadian Cardiovascular Research Team (CCORT) Survey  National survey on primary PCI services across Canada Enhanced Feedback for Effective Treatment (EFFECT II) 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) 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 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 Evenings / weekends: call CCU ER MD NOTIFIES CCU RESIDENT 3. 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 Overgaard Interventional Cardiology

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

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 outcomes Long term outcomes Primary Angioplasty vs. Thrombolysis for Acute MI Quantitative Review of 23 Randomized Trials (N=7739) Keeley et al Lancet 2003;361: DeathreMI Recurrent Ischemia ICH Major Bleed 25 DeathreMI Recurrent Ischemia p= p< p< p< p=0.032 p= p< p< % of Patients PTCA Thrombolysis

Transport of Patients for Primary PCI * Median ** Mean † Without AIR-PAMI StudyDANAMI-2PRAGUE-1PRAGUE-2 Vermeer et al AIR-PAMICAPTIMTotalASSENT-3+EMIP N Transported Distance Range (km) Death During Transport (0.1%) 13 (0.8%) 60 (1.1%) Time Between Randomization and Balloon 90 min* 80 min** 97 min** 85 min** 155 min** 82 min** >50% of pts 50% of pts <90 min †

DeathReinfarction Total stroke ICH Death, reMI or stroke p=0.057 p< p=0.049 p=0.25 p< PTCA (n=1466) Thrombolysis (n=1443) % of Patients Keeley et al Lancet 2003;361:13-20 Primary Angioplasty vs. Thrombolysis for Acute MI 5 Randomized Trials With On-Site Lysis or After Emergent Transfer for Primary PTCA Mean 39 minute delay

StudyMITIEMIPGREAT Roth et al Schofer et al Castaigne et al OverallN3605, ,434 Randomized Trials of Prehospital Thrombolysis Odds Ratio & 95% Cl Favours Prehospital Lysis Hospital Lysis Morrison et al JAMA 2000; 283: Pre (%) Hosp (%) ( ) Time to lysis: 104 vs. 162 min (p=0.007)

Deathre-MIStrokeComposite 30-Day Outomes % of Patients Bonnefoy et al for the Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) Investigators Lancet 2002;360: Primary PCI (n=421) Pre-hospital Lysis (n=419) p=0.61 Pre-Hospital Fibrinolysis vs. Primary PCI p=0.13 p=0.12 p=0.29

Bonnefoy et al for the Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) Investigators Lancet 2002;360: Thrombolysisn=419PCIn=421p Primary Endpoints Death Death re-MI re-MI Disabling Stroke Disabling Stroke Composite Composite Secondary Endpoints Hemorrhagic Stroke Hemorrhagic Stroke Severe Hemorrhage Severe Hemorrhage Recurrent Ischemia Recurrent Ischemia Cardiogenic Shock Cardiogenic Shock Pre-Hospital Shock Pre-Hospital Shock

* From randomization to admission % of Patients p=0.058 p=0.007 Death Cardiogenic Shock* <2 Hours N= % of Patients p=0.47 p=1.0 Death Cardiogenic Shock*  2 Hours N=374 Steg et al for the CAPTIM Investigators Circulation 2003;108: Impact of Time to Treatment on Mortality After Prehospital Fibrinolysis vs. Primary PCI Primary PCI Prehospital Lysis

First Author (Year) Study Design Provider of ECG and ECG location TreatmentControlMortality 30 day Composite Outcome§ Door-to-balloon or drug interval (minutes) Median (25 th -75 th percentiles) TreatmentControlTreatmentControlTreatmentControl Le May (2006) Before and after study ParamedicOn-scene Prehospital ECG and Primary PCI Historical controls In-hospital fibrinolysis and primary PCI 1.9% n = % n = 225 N/AN/A63(36-83)41(30-58) Armstrong (2006) RCTParamedicOn-scene Primary PCI TNK and enoxaparin; mix of inhospital and prehospital 1% n = 100 4% 23% 1 n = % 1 n = ( )113(74-179) van ‘t Hof (2005, 2006) Retrospective Cohort NurseOn-scene Prehospital ECG and primary PCI Transfer to PCI from Community hospital 1%n=2093.2%n=258 2% 2 n=209 4% 2 n=258*177( )*208( ) Terkelson (2005) Prospective Cohort PhysicianOn-scene Prehospital ECG and Primary PCI Transfer to PCI from Community hospital 11% † n = 55 0% n = 21 N/AN/A21(17-31)30(26-38) Clemmensen (2005) Prospective Cohort Ambulance Personnel On-scene Prehospital ECG and Bypass for PCI Historical controls (DANAMI-2) In-hospitalFibrinolysisN/AN/AN/AN/A4094 Bonnefoy (2002) RCTPhysicianOn-scene Prehospital ECG and Bypass for Primary PCI Prehospital fibrinolysis- accelerated tPA 4.8% n = % n = % 3 n = % 3 n = ( )130(95-180) Studies of Direct Transportation from Scene to PCI Centers *Symptom onset-to-balloon §Composite Outcomes: 1 death, reMI, refractory ischemia, CHF, cardiogenic shock or major ventricular arrhythmia; 2 death, reMI or stroke; 3 death, reMI, disabling stroke

Rationale for a Trial Comparing Pre-hospital Fibrinolysis vs. Direct Transport for Primary PCI n Among patients with STEMI diagnosed by paramedics in the pre-hospital setting n Insufficient high quality evidence to recommend pre-hospital bypass and direct transport to a PCI center for primary PCI n Lack of clinical trial data comparing pre- hospital fibrinolysis vs. direct transport for primary PCI n Among patients with STEMI diagnosed by paramedics in the pre-hospital setting n Insufficient high quality evidence to recommend pre-hospital bypass and direct transport to a PCI center for primary PCI n Lack of clinical trial data comparing pre- hospital fibrinolysis vs. direct transport for primary 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 Natarajan Shaun Goodman Neal Fam Warren Cantor Michael Schull Alex Kiss Ron Goeree Jean-Eric Tarride Jim Bowen Steven 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 OR BLS 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 km 2 –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 cte EMS, medical directors each region Provincial approval – Dec PCI centers representatives Acquiring 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 – guessing STEMI – even more guessing Within 60 minutes – speculation Reperfusion data CCN data on those that receive PCI Sketchy 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 TPA 12 lead Bypass

Show me the data!

97 University of TorontoCity-wide Cardiology RoundsNovember 29, 2007 NEXT STEPS CITY-WIDE COLLABORATION 97