1. Disclosures There are no financial conflicts of interest relevant to this presentation.

2. Webinar Objective Help you to use the 2012 Appropriate Use Criteria (AUC) for Coronary Revascularization to improve the care of your patients

3. AUC: What Did You Mean? “AUC” could mean Area Under the Curve (Receiver Operating Characteristic Curve; pharmacokinetic curve) The 2009 JACC/Circulation Paper on Appropriateness Criteria for Coronary Revascularization The 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update Bedside assessment of the appropriateness of PCI or CABG for a given patient A score (or statistics about scores) from the NCDR CathPCI Registry or other vendors

4. Appropriateness Criteria, 2009 Developed as a supplement to ACC/AHA Guideline documents. Appropriateness criteria are designed to examine the use of diagnostic and therapeutic procedures to support efficient use of medical resources during the pursuit of quality medical care Patel, et al. JACC 2009; 53:530-553

5. The Writing Committee Extensive literature review and synthesis of the evidence What are the known indications for coronary revascularization? - Major randomized trials - Guidelines - Other sources Current understanding of technical capabilities and potential patient benefits of the procedures examined Appropriateness review of ~180* common clinical scenarios encountered in everyday practice in which coronary revascularization is frequently considered *Did not include every conceivable situation (>4,000 possible scenarios) Appropriateness Criteria, 2009

6. Appropriateness Criteria: Intended to assist patients and clinicians Not intended to diminish the difficulty or uncertainty of clinical decision making Cannot act as substitutes for sound clinical judgment and practice experience Allow assessment of utilization patterns for a test or procedure, including across providers Appropriateness Criteria, 2009 Patel, et al. JACC 2009; 53:530-553

7. “The ACCF and its collaborators believe that an ongoing review of one’s practice using these criteria will help guide a more effective, efficient, and equitable allocation of health care resources, and ultimately, better patient outcomes.” Appropriateness Criteria, 2009 Patel, et al. JACC 2009; 53:530-553

8. Scenarios scored by a technical panel (17 members in a modified Delphi exercise) on a scale of 1-9. Scores 7-9: Appropriate, revascularization likely to improve health outcomes or survival Scores 4-6: Uncertain, likelihood that revascularization would improve health outcomes or survival was considered uncertain Scores 1-3: Inappropriate, revascularization unlikely to improve health outcomes or survival Health outcomes: symptoms, functional status, and/or quality of life Patel, et al. JACC 2009; 53:530-553 Appropriateness Criteria: 2009 Methodology

9. In other words Scores 7-9: Appropriate, revascularization is generally acceptable and is a reasonable approach for the indication Scores 4-6: Uncertain, revascularization may be acceptable and may be a reasonable approach for the indication, but more research and/or patient information is needed to classify the indication definitively Scores 1-3: Inappropriate, revascularization is not generally acceptable and is not a reasonable approach for the indication Patel, et al. JACC 2009; 53:530-553 Appropriateness Criteria: 2009 Methodology

10. Patel, et al. JACC 2009; 53:530-553 Clinical Presentation Stable anginaSTEMI Severity of Angina ASx, CCS Class I CCS Class IV Ischemia Tests/Prognostic Factors* None, Low risk High risk NoneMax Medical Therapy No sig. CAD LM + 3v CAD Anatomic Disease * CHF, DM, Low LVEF A U I Appropriateness Criteria: Key Variables

11. Appropriate Use Criteria for Coronary Revascularization Focused Update 2012 Endorsed by:

12. AUC 2012 Reassessment of clinical scenarios felt to be affected by significant changes in the medical literature or gaps from prior criteria A practical standard upon which to assess and better understand variability in the use of cardiovascular procedures Patel, et al. JACC 2012; 59:

13. AUC 2012: The Fine Print Significant coronary stenosis: LMCA stenosis ≥50% luminal diameter narrowing in the worst view by visual assessment Epicardial non-LMCA stenosis ≥70% luminal diameter narrowing in the worst view by visual assessment “Borderline” coronary stenosis: Epicardial non-LMCA stenosis 50-60% luminal diameter narrowing Patel, et al. JACC 2012; 59:

14. Assumptions No other CAD present except as specified in the clinical scenario. All patients are receiving standard care, including guideline-based risk factor modification for primary or secondary prevention Operators performing PCI or CABG have appropriate clinical training and experience and have satisfactory outcomes as assessed by quality assurance monitoring AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

15. Assumptions PCI or CABG is performed in a manner consistent with established standards of care. No unusual extenuating circumstances exist, e.g., inability to comply with antiplatelet agents do not resuscitate status patient unwilling to consider revascularization technically not feasible to perform revascularization comorbidities likely to markedly increase procedural risk substantially AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

16. Maximal Anti-Ischemic Medical Therapy: the use of at least 2 classes of therapies to reduce anginal symptoms Risk of Findings on Noninvasive Testing Low-Risk (<1% annual cardiac mortality) Intermediate-Risk (1-3% annual cardiac mortality) High-Risk (>3% annual cardiac mortality) AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

17. High Risk Findings on Noninvasive Testing Severe resting left ventricular dysfunction (LVEF <35%) High-risk treadmill score (score ≤ –11) Severe exercise left ventricular dysfunction (exercise LVEF <35%) Stress-induced large perfusion defect (particularly if anterior) Stress-induced multiple perfusion defects of moderate size Large, fixed perfusion defect with LV dilation or increased lung uptake (thallium-201) Stress-induced moderate perfusion defect with LV dilation or increased lung uptake (thallium-201) Echocardiographic wall motion abnormality (involving greater than two segments) developing at low dose of dobutamine (≤10 mg/kg/min) or at a low heart rate (<120 beats/min) Stress echocardiographic evidence of extensive ischemia AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

18. Intermediate Risk Findings on Noninvasive Testing Mild/moderate resting left ventricular dysfunction (LVEF = 35% to 49%) Intermediate-risk treadmill score (–11 < score <5) Stress-induced moderate perfusion defect without LV dilation or increased lung intake (thallium-201) Limited stress echocardiographic ischemia with a wall motion abnormality only at higher doses of dobutamine involving less than or equal to two segments AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

19. Low Risk Findings on Noninvasive Testing Low-risk treadmill score (score ≥5) Normal or small myocardial perfusion defect at rest or with stress* Normal stress echocardiographic wall motion or no change of limited resting wall motion abnormalities during stress* * Although the published data are limited, patients with these findings will probably not be at low risk in the presence of either a high-risk treadmill score or severe resting left ventricular dysfunction (LVEF <35%) AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

20. Classification of Chest Pain Typical Angina (Definite): Substernal chest pain or discomfort Provoked by exertion or emotional stress Relieved by rest and/or nitroglycerin Atypical Angina (Probable): Lacks one of the characteristics of definite or typical angina Nonanginal Chest Pain: Meets one or none of the typical angina characteristics AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

21. Canadian Cardiovascular Society (CCS) Classification of Angina Pectoris CCS I: Ordinary physical activity does not cause angina, such as walking, climbing stairs. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation. CCS II: Slight limitation of ordinary activity. Angina occurs on walking more than 2 blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal condition. AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

22. Canadian Cardiovascular Society (CCS) Classification of Angina Pectoris CCS III: Marked limitations of ordinary physical activity. Angina occurs on walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at a normal pace. CCS IV: Inability to carry on any physical activity without discomfort—anginal symptoms may be present at rest. Patel, et al. JACC 2012; 59: AUC 2012: The Fine Print

23. TIMI Risk Score for Patients With Suspected Acute Coronary Syndrome 1 point per item Age ≥65 years ≥ 3 Risk Factors for CAD Diabetes mellitus; Cigarette smoking; Hypertension (BP 140/90 mm Hg or on antihypertensive medication); Low HDL cholesterol (<40 mg/dL); Family history of premature CAD (CAD in male first-degree relative, or father less than 55, or female first-degree relative or mother less than 65) AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

24. TIMI Risk Score for Patients With Suspected Acute Coronary Syndrome, continued 1 point per item Known CAD (stenosis ≥50%) Aspirin Use in Past 7 days Severe angina (≥2 episodes within 24 hrs) ST segment deviation ≥0.5 mm Elevated Cardiac Myonecrosis Biomarkers AUC 2012: The Fine Print Patel, et al. JACC 2012; 59:

25. TIMI Risk Score for Patients With Suspected Acute Coronary Syndrome Low Risk (0-2): 4.7-8.3% risk of death or ischemic events through 14 days Intermediate Risk (3-4): 13.2-19.9% risk of death or ischemic events through 14 days High Risk (5-7): 26.2-40.9% risk of death or ischemic events through 14 days Patel, et al. JACC 2012; 59: AUC 2012: The Fine Print

26. AUC 2012: What’s New 15 Updated Indications Patel, et al. JACC 2012; 59:

27. AUC 2012: What’s New 15 Updated Indications Patel, et al. JACC 2012; 59:

28. 13 scenarios for acute coronary syndromes 36 scenarios for non-ACS without prior bypass surgery 12 scenarios for non-ACS with prior bypass surgery 8 scenarios for advanced CAD, CCS III or IV, and/or intermediate- to high-risk findings on non-invasive testing AUC 2012: The Whole Thing 69 Categories of Indications Patel, et al. JACC 2012; 59:

29. AUC 2012: At the Bedside Patel, et al. JACC 2012; 59:

30. AUC 2012: At the Bedside Patel, et al. JACC 2012; 59:

31. AUC 2012: At the Bedside Patel, et al. JACC 2012; 59:

32. AUC 2012: At the Bedside Patel, et al. JACC 2012; 59:

33. AUC 2012: At the Bedside Patel, et al. JACC 2012; 59:

34. SCAI AUC 2012 Tool

37. AUC and the CathPCI Registry

38. 36 - Patients WITHOUT Acute Coronary Syndrome (Test Metric): Proportion of evaluated PCI procedures that were inappropriate AUC and the CathPCI Registry

40. Limitations of the AUC “Maximal antianginal medical therapy is defined as the use of at least 2 classes of therapies to reduce anginal symptoms.”–intolerance, allergies, resting heart rate and blood pressure are not taken into account. Inter-rater variability in coding the results of non-invasive testing for low, intermediate and high risk. Patel, et al. JACC 2012; 59:

41. Challenges in Documentation of the AUC Inputs Insufficient primary documentation to assess CCS class (e.g., “worsening exertional angina”) Lack of documentation of formal evaluation of CCS class by a cardiologist (which leads to inter-rater variability in imputing CCS class from the clinical documentation and thus difficulties with audits of CCS class against source documentation).

42. Improving Your AUC Results CathPCI Registry AUC algorithm is proprietary. Nonetheless, you can improve your AUC scores by Improving clinical documentation of symptom precipitants and non- invasive test results Formally documenting assessment of CCS class and severity/risk of non-invasive test results (which makes life easier for your CathPCI data abstractors) Assess AUC at the bedside prior to undertaking a coronary revascularization Documenting thoroughly for cases rated to be of uncertain or inappropriate appropriateness

43. AUC 2012: In a Nutshell The primary objective of the appropriate use criteria is to improve physician decision making and patient education regarding expected benefits from revascularization and to guide future research. The AUC are intended to evaluate overall patterns of care regarding revascularization rather adjudicating specific cases. It is not anticipated that all physicians or facilities will have 100% of their revascularization procedures deemed appropriate. Patel, et al. JACC 2012; 59:

44. The use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/or ischemia was felt to be appropriate (or appropriate or uncertain). Revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy were viewed less favorably. AUC 2012: In a Nutshell Patel, et al. JACC 2012; 59:

45. There may be clinical situations in which a use of coronary revascularization for an indication considered to be appropriate does not always represent reasonable practice, such that the benefit of the procedure does not outweigh the risks. AUC 2012: In a Nutshell Patel, et al. JACC 2012; 59:

46. The rating of a revascularization indication as inappropriate or uncertain should not preclude a provider from performing revascularization procedures when there are patient- and condition-specific data to support that decision. Indeed, this may reflect optimal clinical care, if supported by mitigating patient characteristics. AUC 2012: In a Nutshell Patel, et al. JACC 2012; 59:

47. Uncertain indications require individual physician judgment and understanding of the patient to better determine the usefulness of revascularization for a particular scenario. The ranking of uncertain (4 to 6) should not be viewed as excluding the use of revascularization for such patients. AUC 2012: In a Nutshell Patel, et al. JACC 2012; 59:

48. When a procedure is classified as “Uncertain” it generally means one of two things 1.There was insufficient clinical information in the scenario. For example: What would you do if: This were an 85 y/o patient with typical age-related limitations? This were a 35 y/o firefighter? Uncertainty about “Uncertain”

49. When a procedure is classified as “Uncertain” it generally means one of two things 1.There was insufficient clinical information in the scenario. 2.There is not a substantial literature base upon which to make a firm recommendation No randomized trials on: This were an 85 y/o patient with typical age-related limitations? This were a 35 y/o firefighter? Uncertainty about “Uncertain”

50. When a procedure is classified as “Uncertain” it generally means one of two things 1.There was not enough clinical information in the scenario. 2.There is not a substantial literature base upon which to make a firm recommendation Is there literature that identifies the correct treatment for this? Uncertainty about “Uncertain”

51. JAMA June 6, 2011 Appropriateness: How do we rate?

52. NCDR Data July 1, 2009 thru Sept 30, 2010 Appropriateness mapping done by MAHI 500,154 PCI procedures at 1091 facilities 355,417 (71%) Acute: STEMI, NSTEMI, High-risk UA 144,737 (29%) Non-acute: Appropriateness: How do we rate?

53. From: WSJ July 6, 2011 Uncertainty about “Uncertain”

54. Did the Media Get it Right?

58. “Shares of Boston Scientific, St. Jude and Medtronic stock were all down by the end of the day today. Boston Scientific closed at $7.14, down 1.24 percent on the day; St. Jude was down 1.73 percent to $47.74 and Medtronic dropped 2.97 percent to $37.96.” Did the Media Get it Right?

59. Clarifying the Meaning of Uncertain

60. Variation in Hospital Rates of Inappropriate PCIs for Non-Acute Indications JAMA June 6, 2011

61. What Can You Do? Make certain you understand “uncertain” More importantly, make sure those entering your NCDR data are entering variables correctly Develop an action plan to evaluate patients graded as inappropriate and uncertain NCDR facilities can get a detailed listing of patients with these classifications.