1. AMI Strategy How to Achieve Door-to-Balloon Times of 90 Minutes and What to Do Next? Aaron Kugelmass, MD Director, Cardiac Cath Lab Associate Division Chief Henry Ford Hospital Detroit, Michigan, USA

2. Overview Introduction –The Argument for Primary PCI Overview of the Henry Ford Program Program Specifics –Process Dictates Outcomes Alternative Opportunities

3. Acute MI: Introduction 1.1 million people yearly in the US* About 500,000 have STEMI 220,000 die from their AMI 50% of deaths in the first hour Outlook of hospitalized patients better *AHA: 2001 Heart and stroke statistics

4. Acute MI: Early Management Reperfusion Pharmacological (Thrombolysis) –Fibrinolytics –Antithrombins –Platelet Inhibitors Mechanical (Direct/Primary PCI) Angioplasty Stent Thrombectomy Combined –? Facilitated PCI

5. Acute MI: Direct PCI Advantages Rapid assessment of anatomy and hemodynamics TIMI-3 flow rates 75-95% in infarct artery Low incidence of hemorrhagic stroke Can be done in patients with contraindications for thrombolysis Results superior to thrombolytics in randomized trials

6. Direct PTCA vs. Thrombolysis PAMI-1 N Engl J Med 1993; 328:673-679

7. Primary Angioplasty vs. Thrombolysis: Meta-analysis Death p=0.02 Death+MI p<0.01 Weaver DW, JAMA 1997;278:2093-2098

8. Primary Angioplasty vs. Thrombolysis: Meta-analysis Weaver DW, JAMA 1997;278:2093-2098

9. PCI vs Lysis Meta Analysis Keeley E, Lancet 2003; 361: 13–20

10. Lytics vs Transfer for PCI: DANAMI

11. Acute MI: Direct PCI Limitations Only 20% of US hospitals have cath labs and fewer have PTCA facilities To achieve results similar to randomized trials the following has to be met: –PTCA within 90 minutes of presentation –Skilled operator (>75 cases/year) –Skilled lab (>200 cases/year) –Surgical back up necessary

12. Is Time as Critical in Primary PCI? 30-day mortality Time from onset of CP to randomization Zijlstra, Eur Heart J 2002;23:550

13. ACC/AHA Recommendations for Direct PCI in AMI 2004 Class I General: –Patients presenting within 12 hours; if performed in a timely fashion by individuals skilled in the procedure and supported by experienced personnel in high volume centers Specific: –Door To Balloon Time <90 min – 1 hour –Symptom >3 hours, PCI preferred <90min –Within 36 hours of MI when patient develops cardiogenic shock, is <75 years and revascularization can be done within 18 hours of shock onset. –<12 hours of symptoms and severe CHF or pulmonary edema (2004) Http://www.acc.org/clinical/guidelines

14. Primary PCI in the United States Minority of US Hospitals Achieve a median Door to Balloon Time of 90 minutes or less Majority of MI occur during “Off Hours” (nights and weekends) Off Hour Primary PCI is associated with increased door to balloon times and mortality Henry Ford 2002 –Door to Balloon218 minutes –Cath Lab to Balloon60 minutes

15. Primary PCI Pathway An Opportunity for Process Improvement Patient Presentation to Diagnosis20 min Page Fellow, Fellow Responds10 min Fellow Proceeds to ER15 min Fellow Evaluates Patient 15 min Fellow Pages CCU Staff, Staff Responds 10 min + PCI, Fellow Pages Int Staff, Staff Responds 10 min Fellow goes to Cath Lab, Pages Team10 min Patient Stays in ER or Goes to CICU Cath Team Arrives60 min Find Patient and Transport 15 min Perform PCI45 min Total 210 minutes

16. Process Change Centralize Communications Focus Clinical Decision Making Transfer SEMI Patients Directly to Site of Therapy Establish Transport Pathways Unite CICU/Cath Lab Nursing Functions Improve Door to Balloon Times!

17. Door-To Balloon Time Henry Ford Hospital Detroit

18. Door-To Balloon Time Henry Ford System Wide 2005

19. Henry Ford Acute Myocardial Infarction Program 6 Emergency Rooms –Henry Ford Hospital90,000 visits –HF Wyandotte Hospital72,000 –HF Bicounty Hospital28,000 –Fairlane ER47,000 –West Bloomfield ER22,000 –Sterling Heights ER21,000 Primary PCI @ Henry Ford Hospital –Large Urban Teaching Hospital in Detroit

21. Henry Ford ER Locations Henry Ford Owned (5) Partially Owned (3) HF Medical Center (24) 20 m, 33 min 14 m, 25 min 9 m, 24 min 8 m, 17 min 12 m, 26 min

22. Door-To Balloon Time Henry Ford System Wide 2005

23. Improving Door to Balloon Time How Do You Change The Process?

24. Create A Multi Disciplinary Team Identify Advocates Cath Lab –Doctors, Nurses, Managers CCU –Doctors, Nurses, Managers Emergency Room –Doctors, Nurses Cardiologists –Staff and Trainees Hospital Administration Ambulance Transport

25. Changing the Process Improve the Process to Meet the Science Dissect Complex Activities into Quantifiable Steps –Team members help to redesign the processes in their areas Establish Parallel (not serial) Processes Avoid Duplication –Example: IV Compatibility

26. Changing the Process Activation –Simple 1 Phone Call- 24 hours a day –Staffed by Decision Maker (MD who accepts patient and activates team) –Team Activation is Invisible to the Outside »Coordinator then activates staff members, arranges admission, etc…

27. Changing the Process Transport –Activate transport (ambulance) as early as possible, usually before activating central team. –Establish well known dispatch pathway –Minimize emergency room time –Communicate during transport

28. Changing the Process Minimize Steps –Patients Transported Directly to Cath Lab Business Hours- Easy Off Hours – In House Nurses and MD’s »Staff Cath Lab while Cath Lab Staff Travel to Hospital »Prep Room and Patient

29. Changing the Process Cath Lab –Focused Pathway to Reperfusion 7 F Sheath Diagnostic Angiography of non-IRV Guide Catheter for suspected IRV “Standard” initial PTCA Equipment –Floppy Wire –2.0/2.5 mm Balloon Establish Reperfusion First, Optimize Result Later Remember the Team! –Call the ER and let them know the results

30. Cath Lab Times Arrival to Balloon Inflation

31. HFH AMI Flow Chart

32. AMI Gann Chart

33. Changing the Process Metrics –Measure Your Lean Processes Door to EKG EKG to Activation –Transport –Cath Lab Activation to Ambulance Arrival “Pick Up Time”Ambulance arrival to departure Transport Time ER departure to cath lab arrival Cath Prep TimeCath arrival to arterial access Procedure TimeArterial access to balloon or reperfusion

34. Changing the Process Feedback –Share Outcomes and Pertinent Metrics with Participants –Constructive Criticism is the Only Way to Improve the Process –Success Begets Success Foster Participant Pride and Enthusiasm

35. Alternative Strategies and Next Steps Remote 12 lead EKG –EKG in Ambulance Transmit EKG from field Activate Cath Lab field Disseminate Primary PTCA Centers –Offsite Surgical Back Up Centralize MI Centers –Practice Makes Perfect –Staff Lab 24/7

36. HFHS Initiatives Improve Door to EKG Time Improve Transport Times –New ambulance Structure Activation to Arrival “PickUp” Times Improve Cath Lab Response Times Remote EKG –In Field 12 lead EKG with telephonic transmission

37. Conclusions Careful Process Engineering Can Dramatically Reduce Door To Balloon Times –This Requires: A Multi-Disciplinary Team and Institutional Commitment Careful Metrics to Guide Improvement Ongoing Feedback to Team Members Continuous Evaluation to Drive Process Improvement