Reperfusion Therapy: Challenges of Measuring Performance

1. Reperfusion Therapy:Challenges of Measuring Performance Frederick A Masoudi, MD, MSPH, FACC Associate Professor of Medicine Denver Health Medical Center & University of Colorado Denver

2. Presenter Disclosure Information Frederick A Masoudi, MD, MSPH, FACC The following relationships exist related to this presentation: Advisory boards: Takeda NA, United Healthcare, Amgen Research support: Amgen, NHLBI, AHRQ Contracts: Oklahoma Foundation for Medical Quality

3. A word of caution� �An expert is somebody who is more than 50 miles from home, has no responsibility for implementing the advice he gives, and shows slides.� Edwin Meese III

4. Objectives Why care about door-to-balloon (D2B) times? Understand attributes of performance measures D2B as a performance measure CMS/Joint Commission NCDR Understand the challenges to measuring D2B Measures alignment Future measures of reperfusion performance

5. A case for prompt reperfusion 52 year old woman with diabetes and hypertension with exertional chest discomfort for two weeks. 18:20�develops persistent severe substernal chest discomfort at rest with diaphoresis 18:50�calls 911 as pain worsens 19:05�paramedics arrive; ECG not performed in field 19:20�arrives in ED 19:30�placed in triage room; ECG ordered 19:45�ECG assessed by physician

6. A case for prompt reperfusion

7. A case for prompt reperfusion 52 year old woman with acute IMI 19:20�arrives in ED 19:47�ED physician pages consulting cardiologist 20:00�on-call cardiologist asks for fax of ECG 20:10�on-call cardiologist pages interventionalist 20:20�interventionalist answers call to discuss case 20:28�interventionalist calls ED to page cath lab staff 20:40�all lab staff alerted 20:55�Patient develops bradycardia and hypotension

8. A case for prompt reperfusion

9. A case for prompt reperfusion 19:20�arrives in ED 21:25�cath lab staff arrive 21:40�patient transferred to lab on pressors 22:05�access obtained; temporary wire placed 22:20�proximal RCA occlusion with thrombus identified 22:23�balloon angioplasty of RCA performed Door-to-balloon time: 183 minutes Prolonged hospital stay due to heart failure with LVSD

10. What went wrong? Patterns of care�wasting time at every turn No in-field ECG Delay in obtaining and interpreting ECG ED staff contacted intermediary Cath lab staff activated with several calls Lab staff took 45 minutes to arrive Lack of coordination between EMS and hospital and within the hospital

11. It must be someone else�s problem �Nothing so needs reforming as other people�s habits.� --Mark Twain

12. Not an Isolated Case�

13. �with important implications

15. Guidelines & performance measures Guidelines ~ suggestions Performance measures ~ requirements Identify aspects of care where the failure to provide a particular process of care is considered poor clinical performance

16. Attributes of a Performance Measure Evidence-based (class I or III recommendations) Interpretable Actionable Well-defined numerators and denominators Valid (face, construct, and content) Reliable/reproducible Feasible

17. What is the focus?

18. Reasons to measure time to primary PCI To improve patient care To ensure that programs providing primary PCI are performing well (accountability) To provide information to �consumers� (transparency)

19. Timely reperfusion & performance measures 1994: HCFA Cooperative Cardiovascular Project 1998-2001: CMS National Heart Care Project 2002: CMS/Joint Commission measures alignment Median time from arrival to PCI in patients with ST-segment elevation or LBBB on the ECG performed closest to hospital arrival time Proportion of patients receiving PCI within 90 minutes in patients with ST-segment elevation or LBBB on the ECG performed closest to hospital arrival time

20. Timely reperfusion & performance measures

22. Challenges to measuring performance Retrospective: abstraction by non-clinicians Marked variability in medical records formats Consideration of gaming Burden of non-aligned measures

23. Measuring D2B: practical considerations Who is included in the measure? What are the exclusions? Identifying non-primary PCI Clinically important reasons for delay What �counts� as successful treatment? What�s the �B� in D2B?

24. CMS/JC: who is in the measure? Principal discharge diagnosis of AMI (ICD-9) Receiving PCI STE or LBBB on ECG closest to arrival PCI performed within 24 hours of arrival

25. Qualifying ECG The 12-lead ECG closest to hospital arrival, including ECGs within 1 hour prior to arrival ST-segment elevation/LBBB derived from the documented ECG interpretation (ECG itself not interpreted)

26. Implications of Inclusions Time of treatment only (not �appropriateness�) Patients developing ST-elevation after presentation not included Patients with NSTEMI undergoing early invasive strategy not included

27. CMS/JC: Who is excluded? Age <18 Comfort measures only Receiving fibrinolysis prior to PCI Transferred from another acute care hospital (including ED) Non-primary PCI Reason for delay documented

28. CMS/JC: Primary PCI Only In some circumstances, patients with ST elevation on their qualifying ECG receive PCI that is not primary e.g. resolution of ST elevation and symptoms Non-primary PCI are excluded If not documented, assumed primary

29. CMS/JC: Reasons for Delay Documented patient-related reason for PCI delay Diagnostic testing to exclude contraindication Refusal of consent Cardiac arrest Must be linked to timing of PCI (except cardiac arrest in first 90 minutes) System-related issues not permitted Lab team late Equipment malfunction Applies only times >90 minutes

30. CMS/JC: Implications of Exclusions Patients transferred for PCI are not included in either hospitals� data �Salvage� PCI not included Patient-centered reasons for delay exclude cases with times >90 minutes

31. When does the clock stop?

32. When does the clock stop? The earliest of the following times: Time of first balloon/stent deployment Time of first treatment of lesion with other devices (e.g. rotablator, thrombectomy device) Not time of achieving access or flow Assesses process of care (device time) Does not assess outcome (restoring flow)

33. Challenge - Why use device time? Reperfusion can occur Contrast injection Time of wire crossing Guiding catheter �Dottering� Adequate blood flow allows for longer deliberation for important decisions. Why not use an earlier time?

34. Why device time? The reperfusion measures focus on a process of care rather than an outcome Process goal: deliver a device intended to result in reperfusion Outcome goal: restoration of blood flow Extremely burdensome to abstract accurately Penalizes cases where flow not restored despite timely and appropriate treatment Other times (e.g. door-to-lab or door-to-angiogram) don�t account for the total time from presentation to device therapy as recommended in guidelines.

35. Implications of using device time Among those with spontaneous reperfusion or flow with wire, time does not stop until deployment of first device, BUT Failure to achieve flow after deployment of first device not �punished�

36. Key points The patient is the focus Limitations of reperfusion measures apply evenly to all sites and operators

38. Measures alignment �The nice thing about standards is that there are so many of them to choose from.� --Anon.

39. Measures alignment: NCDR reports Patients receiving PCI in patients with ST-segment elevation or left bundle branch block Proportion of patients receiving PCI w/in 90� Median time Includes transfer patients Note � CMS/JC and NCDR algorithms are not aligned

40. Joint Commission and NCDR D2b Inclusions

41. CMS/JC and NCDR Alignment Goal NCDR (ACTION and CathPCI) and CMS/JC definition and data element alignment with new NCDR versions where possible. NCDR reports on a broader group of patients Subsequent ECG and in-hospital MI Transfers (separate measures) Issues Case identification: CMS/JC uses ICD9 codes, while NCDR uses clinical data Some algorithm differences will still be present

42. Reperfusion performance: transfers Benefits: assesses performance in systems where transfer for PCI predominant strategy What is measured� door-in-door out, or first-door-to-balloon? Challenges: determining times of presentation and treatment in two centers Attribution�who is responsible?

43. Reperfusion performance: Reperfusion rates Measuring rates of reperfusion therapy in eligible candidates Benefits: important additional perspective on therapy; addresses a persistent gap in care Challenges: refining the ECG element; increased burden of abstraction (contraindications)

44. Reperfusion workgroup Multidisciplinary/multiconsitutent Cardiology (interventional and noninterventional) Emergency medicine Performance measurement experts Addressed challenges of measurement Proposed additional measures to characterize the quality of reperfusion care Summary document under peer review

45. Conclusions Reperfusion has a substantial impact on optimizing patient outcomes after STEMI We all have room for improvement All measures have limitations Recommendations of �Time to Reperfusion Workgroup� intended to optimize measure Optimizing alignment between CMS/JC and NCDR will reduce burden of measurement

46. Q & A �If you're right 90% of the time, why quibble about the remaining 3%?� --Anon.

47. Q & A

48. Background What is Primary PCI? Primary PCI is the use of a percutaneous reperfusion procedure in the acute phase of ST-segment elevation MI (usually within 12 hours or less from the onset of ischemic symptoms). D2B measures the treatment of STEMI patients who have a strategy of primary reperfusion

49. Background What is the goal of D2B? The intent is to treat patients as rapidly as possible with the goal of restoring blood flow to the affected myocardium, thereby improving outcomes including reduced mortality rates.

50. Why 90 minutes?

51. �with important implications

52. Background Door to balloon time is everywhere. Why is it so important? Trial results ACC/AHA Guidelines ACC/AHA Performance Measure

53. CMS/Joint Commission Time to PCI Measures Median time from arrival to PCI in patients with ST-segment elevation or left bundle branch block on the ECG performed closest to hospital arrival time. Proportion of patients receiving PCI within 90 minutes in patients with ST-segment elevation or left bundle branch block on the ECG performed closest to hospital arrival time.

54. Challenge - Why use device time? D2b is a process measure, not a patient outcome measure Process goal: to deliver a device that is intended to result in reperfusion Patient outcome goal: restoration of blood flow or successful procedure is more burdensome on the abstractor Does not account for patient outcomes when flow is not restored despite timely and appropriate treatment. Door to cath lab and door to angio times have been considered. However, they don�t account for the focus on total time from presentation to device therapy and the overall focus of reperfusion.

56. Challenge - Why use device time?

57. What is new in the Reperfusion Measure ? Patient-centered reason for delay cardiac arrest Documentation of need to do CAT scan to r/o bleed Patient waiting for family and clergy to arrive Note � system reasons for delay (equipment, staff, consultations, clinical trails) are not acceptable reasons for delay. Note � this only applies to patients for whom reperfusion was provided outside of the guideline-recommended threshold.

58. What is new in the Reperfusion Measure ? Non-Primary PCI A PCI that is not emergent Rescue PCI Salvage PCI Elective PCI

59. Challenges of Measuring Reperfusion Appropriateness When does reperfusion occur Device time? Angiography time? Guidewire time? Joint Commission Exclusions Transfers ST-segment elevation on 2nd ECG ST-segment elevation during hospital admission Temptation of �gaming� to skew results to your benefit

60. Challenges of Measuring Reperfusion Measuring �time� When does the clock start? When does the clock stop? Synchronization of time-keeping devices Impression and expectation that every patient needs to have a d2b of <90 minutes

61. Challenges of Measuring Reperfusion Inclusions and exclusions in the numerator and denominators Public availability of data Pay for performance programs State mandates Lack of alignment (Joint Commission and NCDR)