STEMI Care in WV Mission: Lifeline -AHA initiative. Christopher B. Granger, MD, FACC Mayme Lou Roettig, RN, MSN

Transcription

1 STEMI Care in WV Mission: Lifeline -AHA initiative Christopher B. Granger, MD, FACC Mayme Lou Roettig, RN, MSN

2 Christopher B. Granger, MD, F.A.C.C Director of Cardiac Care Unit Duke University Medical Center Duke Clinical Research Institute Durham, NC

3 AMI- Just the Facts Myocardial infarction is a major cause of mortality worldwide More than 3 million people each year are estimated to have acute STEMI More than 4 million having a non-stemi #1 Killer of Americans Shifting from being an illness observed predominantly in developed countries to becoming increasingly more common in developing countries. Progressive urbanization yields Diobesity (Diabetes/Obesity) & a newly emerging epidemic of CAD Problem- health-care services are not as well developed White HD, Lancet September 2008? How well are systems working in developed countries? In the US? In North Carolina? In WV?

4 ACUTE CORONARY SYNDROME No ST Elevation ST Elevation NSTEMI Unstable Angina 1.2 million ~400,000 a year

5 Pathophysiology of AMI Generally caused by a partially occlusive, platelet-rich thrombus in a coronary artery Generally caused by a completely occlusive thrombus in a coronary artery

6 FTT Overview Mortality Fibrinolytic BBB or Therapy < 12 hours Overview ST Elevation Control 13.0% (2018/15576) Fibrinolytic 10.1% (1600/15837) Weeks Lancet, 1994

7 ACC/AHA 2007 STEMI Focused Update Slide Set Reperfusion I IIa IIb III I IIa IIb III III STEMI patients presenting to a hospital with PCI capability should be treated with primary PCI within 90 minutes of first medical contact. Modified recommendation STEMI patients presenting to a hospital without PCI capability and who cannot be transferred to a III PCI center for intervention within 90 minutes of first medical contact should be treated with fibrinolytic therapy within 30 minutes of hospital presentation, unless contraindicated. Modified recommendation

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9 CASE Study

10 Patient journey through systems of AMI care STEMI Patient Primary PCI Center EMS EMS STEMI Patient EMS Non-PCI Hospital Primary PCI Center EMS EMS EMS STEMI Patient Patient features Time from sx onset Size of MI/CHF/shock Fibrinolytic eligibility Age

11 Reperfusion Strategies When should patients receive lytics versus transfer for primary PCI? When getting lytics, what should be strategy of transfer and cath? Is there a role for facilitated PCI?

12 Earliest diagnosis and activation of reperfusion plan Selected use of destination protocols of EMS bypass of non-pci centers Single reperfusion plan for each hospital emergency department

13 Time (min) CRUSADE to ACTION Door-to-Balloon Times Median Times for Transfer In and Non-Transfer In Patients Q Q Transfer in DTB Times 236 Transfer in DTB Times Are Static Q Q Non-Transfer in DTB Times

14 Opportunities to Improve Plan White HD, Lancet September 2008

15 Reperfusion Strategies When should patients receive lytics versus transfer for primary PCI? When getting lytics, what should be strategy of transfer and cath? Is there a role for facilitated PCI?

16 Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction The TRANSFER-AMI trial Warren J. Cantor, David Fitchett, Bjug Borgundvaag, Michael Heffernan, Eric A. Cohen, Laurie J. Morrison, John Ducas, Anatoly Langer, Shamir Mehta, Charles Lazzam, Brian Schwartz, Vladimir Dzavik, Amparo Casanova, Paramjit Singh, Shaun G. Goodman on behalf of the TRANSFER-AMI Investigators 9803mo01, 16

17 Objective To compare: Pharmacoinvasive strategy (transfer to PCI centre for routine early PCI within 6 hrs) with Standard treatment (early transfer only for failed reperfusion, otherwise cath > 24 hrs) for high-risk STEMI patients receiving thromboysis at non-pci centres. 9803mo01, 17

18 High Risk ST Elevation MI within 12 hours of symptom onset Community Hospital Emergency Department TNK + ASA + Heparin / Enoxaparin + Clopidogrel Pharmacoinvasive Strategy Urgent Transfer to PCI Centre Standard Treatment Assess chest pain, ST resolution at minutes after randomization Failed Reperfusion* Successful Reperfusion PCI Centre Cath Lab Cath / PCI within 6 hrs regardless of reperfusion status Cath and Rescue PCI ± GP IIb/IIIa Inhibitor Elective Cath ± PCI > 24 hrs later Repatriation of stable patients within 24 hrs of PCI * ST segment resolution < 50% & persistent chest pain, or hemodynamic instability Randomization stratified by age ( 75( 75 vs. > 75) and by enrolling site 9803mo01, 18

19 Inclusion Criteria Within 12 hrs of symptom onset 2 mm ST-segment elevation in 2 anterior leads OR 1 mm ST-segment elevation in 2 inferior leads and at least one of the following: SBP < 100 HR > 100 Killip Class II-III 2mm ST-segment depression in anterior leads 1 mm ST-segment elevation in V 4 R 9803mo01, 19

20 PCI for Pharmacoinvasive Group PCI of culprit lesion at time of cath if 70% stenosis or 50-70% stenosis with high-risk features (thrombus, ulceration, spont dissection) regardless of coronary flow Stents used whenever technically possible, use of Abbott vascular stents (ML Vision, Mini Vision) encouraged GP IIb/IIIa inhibitors left to operator s discretion 9803mo01, 20

21 Cardiac Cath performed (%) Time- TNK to Cath (hrs) PCI performed (%) Stent used (% of PCI cases) Time- TNK to PCI (hrs) PCI within 6 hrs of TNK (%) PCI within 12 hrs of TNK (%) GP IIb/IIIa inhibitor use (%) Time- TNK to GP IIb/IIIa inhib IABP use (%) CABG performed (%) Procedures Standard Pharmacoinvasive Treatment Strategy (n=508) (n=522) (4, 69) (4, 73) inhib.. (hrs) 11 (4, 63) (2, 4) (3, 5) (3, 5) mo01, 21

22 Selected Medications Used ASA 1 st 6 hrs Clopidogrel 1 st 6 hrs * Heparin Enoxaparin Beta Blocker 1 st 6 hrs ASA at discharge Clopidogrel at discharge Beta Blocker at discharge ACE Inhibitor at discharge Lipid Lowering at discharge Standard Treatment (n=508) Pharmacoinvasive Strategy (n=522) * p< mo01, 22

23 Primary Endpoint: 30-Day Death, re-mi, CHF, Severe Recurrent Ischemia, Shock % of Patients n=496 n= OR=0.537 (0.368, 0.783); p= Days from Randomization Standard (n=496) Pharmacoinvasive (n=508) mo01, 23

24 Components of Primary Endpoint Death Reinfarction Recurrent Ischemia Death/MI/Ischemia New / worsening CHF Cardiogenic Shock Standard Pharmacoinvasive Treatment Strategy P-Value (n=498) (n=512) mo01, 24

25 Safety Endpoints - Bleeding Intracranial hemorrhage TIMI scale Major Major (non-cabg) GUSTO scale Moderate Severe Severe (non-cabg) Transfusions Standard Pharmacoinvasive Treatment Strategy P-Value (n=498) (n=512) mo01, 25

26 Conclusions For high-risk STEMI patients receiving thrombolysis at non-pci centres, urgent transfer and PCI within 6 hours is associated with significantly less ischemic complications and no excess in bleeding Transfers to PCI centres should be initiated immediately after thrombolysis without waiting to see whether reperfusion is successful Regional systems should be developed to ensure timely transfers of STEMI patients to PCI centres 9803mo01, 26

27 30 Day Mortality Heparin + GPIIb/IIIa inhibitor (n=1802) Bivalirudin monotherapy (n=1800) Death (%) HR [95%CI] = 0.66 [0.44, 1.00] P= % 2.1% Number at risk Bivalirudin Heparin + GPIIb/IIIa Time in Days

28 Efficacy endpoints at 30 days Clopidogrel Proportion of population (%) p= 0.04 p= 0.01 p= 0.13 p= Prasugrel All Death MI UTVR Stent CV Death/ Thrombosis* MI p= p= 0.02 CV Death/ MI/UTVR p= CV Death/ MI/Stroke * ARC def/probable Montalescot et al. ESC 2008

29 Reperfusion of Acute Myocardial Infarction in Carolina Emergency Departments (RACE) Project

30 RACE Objectives Establish a state-wide system for reperfusion, as exits for trauma care, to overcome systematic barriers to: 1) Increase speed of reperfusion 2) Increase reperfusion rate Organize regions Baseline data Intervention Post data 2005 Q Q1 2007

31 RACE Centers and Regions 65 hospitals (10 PCI, 55 non PCI) Winston-Salem Durham-Chapel Hill- Greensboro Asheville 10 PCI centers 16 Transfer for PCI 28 Lytics 11 Mixed Charlotte East Carolina Each non-pci center was assessed for reperfusion designation based on resources, transfer ability, and transfer time to PCI center

32 RACE Interventions OPERATIONS MANUAL Optimal system specifications by point of care EMS Non-PCI and PCI ED Transfer Catheterization lab Other system issues payers, regulations Choice of PCI or lytic reperfusion regimens New version available at

33 RACE Interventions Focus on SYSTEMATIC BARRIERS to care STEMI team hospital administration, ED, EMS, nursing, cardiology, QI Prespecified reperfusion plan for hospital and region Prehospital ECGs, interpretation, and earliest activation Emergency physician (or paramedic) able to activate the cath lab Intense education with focus on EMS and EDs

34 RACE Interventions PCI Hospitals Single number cath lab activation Accept all STEMI patients regardless of bed availability Ongoing QI and data feedback NRMI database Transitioning to the NCDR ACTION Registry-GWTG tool RACE Regional Coordinator Responsible for improving process in every hospital - EMS system in the region

35 Available online at

36 RACE results Arrival and transfer features PCI hospital Non-PCI hospital Pre Post Pre Post n Arrival mode Self-transport 11% 12% 57% 56% Ambulance 71% 63% 42% 44% Helicopter 16% 21% Pre-hosp ECG 41% 61% 38% 43% Transferred from another hosp 61% 53% Transferred to a PCI hosp % 95% Transfer mode EMS ground 40% 43% Critical care transport 34% 24% Helicopter 25% 43% AMI Hotline used 32% 85%

37 RACE results Non-reperfusion rates 100 % without reperfusion Pre Post 23 P< Non-PCI hospitals PCI Hospitals

38 RACE results PCI hospitals: Door to device times median times in minutes Pre P<0.001* All patients Post P< P< P= Direct All transfers Transfer for presenters PCI hospitals * Remained significant in analysis accounting for clustering

39 RACE results Non-PCI hospitals: Reperfusion times median times in minutes P<0.001* Door-in door-out, all hospitals P< Door-in door-out, transfer hosps P= Pre Post 29 Fibrinolysis, doorto-needle * Remained significant in analysis accounting for clustering

40 RACE results vs secular trends: PCI hospitals Pre Post Change Transfer National* RACE Non transfer National* RACE Median time in minutes *NRMI participating hospitals

41 Summary and Conclusions RACE represents the largest regional STEMI reperfusion system in the United States. We focused on moving care forward: enabling EMS to diagnose and ED personnel to initiate treatment, with improved communication, integration, and data feedback. All times door-to-balloon at PCI centers, door-in to door out in non-pci centers, 1 st door-to-balloon in transfer patients, and door-to-needle for fibrinolysis were significantly improved. Improved application of reperfusion care on a broad scale is possible and should be a high national priority.

42 RACE-Emergency Response RACE-ER 21 primary PCI labs 540 EMS systems 5,240 paramedics 18,000 EMTs 122 emergency departments

43 RACE Centers and Regions 122 hospitals (21 PCI, 101 non PCI) Western NC Triad Triangle PCI centers Transfer for PCI Lytics Mixed Metro Charlotte Coastal Plains

44 Integrated, Integrated, Systematic Systematic AMI AMI Care Care

45 North Carolina-WV Stats Caution Big MTNS Population 9.06 million (10 th most populous) 1.18 million WV (37th) Size (sq. miles) 53,819 (28th in total area) KS (41st) Hospitals 122 Acute care hospitals *21 PCI hospitals with Surgical Backup Acute care hospitals? Primary PCI hospitals WV Counties 100 (101 Cherokee Nation) 55 WV counties NC has multiple metro highly populated cities Charlotte, Raleigh and Greensboro in the top 100- WV has none

46 Strategies for STEMI in WV

47 Emergency Cardiovascular Care 2009: Building STEMI Systems of Care May Rosemont, IL Co-sponsored by: American College of Cardiology & American College of Emergency Physicians In Cooperation with: The Society for Academic Emergency Medicine Program Co-directors: Christopher B. Granger, M.D., F.A.C.C., James G. Jollis, M.D., F.A.C.C. Mayme Lou Roettig, R.N., M.S.N.

48 Mayme Lou Roettig, RN, MSN Executive Director, RACE Duke University/Duke Clinical Research Institute Durham, North Carolina, USA National Director, Mission: Lifeline American Heart Association, Consultant

49 Mission :Lifeline Defined Mission: Lifeline is a national community- based multidisciplinary initiative Overarching Goal Improve the mortality and morbidity and quality of care for the AMI population, specifically through the development of STEMI systems of care Guiding principle: Patient centric, addressing the continuum of care for STEMI patients from symptom onset into the point of entry into the healthcare system, touching each aspect of the system, and return the patient back to the local community and physician

50 Mission :Lifeline Defined (Cont) To meet the overarching goal, Mission: Lifeline will bring together the necessary partnerships between: Patients EMS Non-PCI capable (STEMI Referral) hospitals PCI capable (STEMI-Receiving) hospitals Healthcare providers- (Physicians, nurses, EMT-P, EMT-I and B, and other providers) Departments of Health EMS regulatory authority/ Office of EMS State hsopital associations Rural Health Association Quality Improvement Organizations State and local policymakers Third-party payers

51 May 2007 Eleven manuscripts were published in Circulation Mission: Lifeline was formally launched 51

52 History May 2004 Advisory Working Group (AWG) recruited to explore the issue of increasing the number of STEMI patients with timely access to primary PCI June 2005 Presented market research conducted by Price Waterhouse Coopers to AWG March 2006 AWG Consensus Statement Published in Circulation Market research results Stakeholder Call To Action

53 Circulation 2006;113:

54 Administrative Structure David Burt, MD Graham Nichol, MD (VC) Lee Garvey, MD Louis Gonzalas, EMT-P David Larson, MD Peter Moyer, MD Ivan Rokos, MD Michael Sayer, MD Robert Solomon, MD Gary Windgrove, EMT-P ECC Task Force Chair: Robert O'Conner,MD Advisory Working Group Chair: Alice Jacobs,MD Model Evaluation Task Force Chair: Elliott Antman, MD EMS System Assessment and Improvement Evaluate Existing Models Establish Local Initiatives Elliott Antman, MD Bob O Connor, MD Gray Ellrodt, MD Chris Granger, MD (VC) Mary Hand, RN Tim Henry, MD Neil Meltzer Bob Harrington, MD George Mensah, MD Jean McSweeny, phd, RN Eric Peterson, MD David Williams, MD Peter Berger, MD Chris Granger, MD Tim Henry, MD James Jollis, MD (VC) Peter Moyer, MD Frank Pratt, MD Ivan Rokos, MD John Rumsfeld, MD 54 Explore Possibility of National STEMI Certification

55 AMI Guidelines Consider time and risk Preferred if you can make the Time line goal No Longer a debate over which is best- Follow the Guidelines & Apply RAPID Reperfusion!!! PCI preferred Fibrinolysis preferred Late presentation < 3 hours from symptom onset PCI available > 90 min 1st door to balloon Cardiogenic shock / Killip class 3+ Delay to PCI vs Lysis > 60 min Lysis contraindication PCI not an option Dx. of STEMI in doubt JACC 2004;44:686

56 How do we increase the number of patients with timely access to reperfusion therapy? For the preferred Primary PCI?

57 State of the System Approximately 30% of STEMI patients do not receive any reperfusion therapy (with PCI or fibrinolysis) Up to 20% of STEMI patients are not eligible for fibrinolytic therapy, yet 70% of these patients do not receive primary PCI

58 State of the System Of the 70% of STEMI patients who are treated with reperfusion therapy, less than half are treated within the guideline recommended time frames.

59 STEMI D2B and D2N Times: Cumulative 12 Month Data ACTION Registry Data 80% 67% 60% 40% 39% 20% 0% DTB <= 90 min - Non-Transfer In 7% DTB <= 90 min - Transfer In DTN <= 30 min - All

60 Mission: Lifeline EMS System Assessment and Improvement Evaluate Existing Models Establishing Local Initiatives Explore possibility of National STEMI Certification Program

61 Jacobs. Circulation 2007;116: STEMI System of Care Activate EMS Avoid delay Focus on EMS ED POE EMS ED 12-lead ECG interhospital transport Activate team SYSTEM OF CARE Non-PCI capable CENTER OF CARE STEMI Referral PCI capable CENTER OF CARE STEMI Receiving

62 State of the System Many EMS vehicles with out12 lead ECG equipment Little information on integration of ECGs into the system of care Is EMS prepared for championing STEMI systems?

63 EMS System Assessment and Improvement The American Heart Association is currently participating in a needs assessment/survey in collaboration with EMS organizations and will analyze the effectiveness of EMS for STEMI patients as part of a STEMI system of care.

64 Evaluate Existing Models The American Heart Association convened a group of thought leaders to review existing local or regional STEMI Systems of Care models. Grandfathers in EMS Bypass Boston EMS Point of Entry -LA County EMS Model Grandfather in USA Transfer for PCI Level 1 MNPLS Heart/Abbott NW State Model for Both RACE- North Carolina

65 Boston Population: Population: 580,000 by night 1.2 million by day Boston POE

66 Southern California STEMI Consortium Regional STEMI Networks URBAN SETTING Ventura Co. Los Angeles Co. Orange Co. San Diego Co

67 Red Zone II ( mins) Blue Zone I (< 90 mins)

68 Establishing Local Initiatives The American Heart Association will convene the task force initiative at the state and local levels to identify ways to implement national recommendations for STEMI systems in local communities

69 STEMI System Evaluation & Registration 69

70 Explore Possibility of National STEMI Certification Program The American Heart Association will develop recommendations for a STEMI certification program. Possible models include: - two-tiered hospital certification (STEMI referral and treatment centers) - EMS System Certification - Regional System Certification

71 AHA Staff State Health Alliances State Advocacy Communications Quality Improvement Mission: Lifeline Development Cultural Health Initiatives ECC 71

72 Mission: Lifeline Implementation Phase 1 Greater Midwest Affiliate IL, IN, MI, MN, ND, SD & WI NE Heartland Affiliate Glenn Horn, EVP KS

73 Mission: Lifeline Implementation Phase 2 (Vision) Greater Midwest Affiliate IL, IN, MI, MN, ND, SD & WI NH NE DE Heartland Affiliate Glenn Horn, EVP KS HI

74 Mission: Lifeline Implementation Phase 3 (Vision) Greater Midwest Affiliate IL, IN, MI, MN, ND, SD & WI NE Heartland Affiliate Glenn Horn, EVP KS

75 STEMI System of Care Activate EMS Avoid delay Consider integrated payment No penalty to patients Payer Patient EMS ED 12-lead ECG interhospital transport Activate team No diversion SYSTEM OF CARE Policy Makers Protocols and toolkits STEMI Center Certification Quality improvement measures Non-PCI capable PCI capable CENTER OF CARE CENTER OF CARE STEMI Referral Treatment protocols and clinical pathways STEMI Receiving Jacobs. Circulation 2007;116: