Managing Quality of ACS Care in VHA The IDH Guideline Key Points and Metrics

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1 Managing Quality of ACS Care in VHA The IDH Guideline Key Points and Metrics Robert L. Jesse, MD, PhD National Program Director for Cardiology Veterans Health Administration Washington, DC Chief, Cardiology Section Veterans Affairs Medical Center Richmond, VA Director, Acute Cardiac Care Virginia Commonwealth University Health System

2 Managing Quality of ACS Care in VHA The IDH Guideline Key Points and Metrics Dr. Bob Jesse Ischemic Heart Disease Champion

3 Inflammatory Atherothrombotic Coronary Artery Disease Disease State Primary Prevention Acute Events ACS ACS 2 o Prevention = Stroke AMI CHF Modified from Libby, Circ 104:365,2001 Sudden Cardiac Death

4 Inflammatory Atherothrombotic Coronary Artery Disease Disease State Primary Prevention Acute Events ACS ACS 2 o Prevention = Stroke AMI CHF Modified from Libby, Circ 104:365,2001 Sudden Cardiac Death

5 Death Pump Failure Stress O 2 demand Thrombosis Reperfusion Arrhythmias O 2 supply Vasoconstriction Myocardial Injury Reperfusion Inflammation Infection, Trauma Myocyte Death Plaque Rupture CAD Vascular Remodeling Ischemia Ventricular Remodeling Heart Failure Systolic Dysfunction Inflammation Vascular Injury Neuro-hormonal Activation Volume Overload Infection Risk Factors Diet Smoking Inactivity Genetics Dyslipidemia Hypertension Diabetes Hormones Oxidation O 2 supply O 2 demand Arrhythmias Aging, Infiltrative diseases Diastolic Dysfunction Pressure Overload

6 Death Pump Failure Stress O 2 demand Thrombosis Reperfusion Arrhythmias O 2 supply Vasoconstriction Myocardial Injury Reperfusion Inflammation Infection, Trauma Myocyte Death Plaque Rupture CAD Vascular Remodeling Ischemia Ventricular Remodeling Heart Failure Systolic Dysfunction Inflammation Vascular Injury Neuro-hormonal Activation Volume Overload Infection Risk Factors Diet Smoking Inactivity Genetics Dyslipidemia Hypertension Diabetes Hormones Oxidation O 2 supply O 2 demand Arrhythmias Aging, Infiltrative diseases Diastolic Dysfunction Pressure Overload

7 Death Pump Failure Stress O 2 demand Thrombosis Reperfusion Arrhythmias O 2 supply Vasoconstriction Myocardial Injury Reperfusion Inflammation Infection, Trauma Myocyte Death Plaque Rupture CAD Vascular Remodeling Ischemia Ventricular Remodeling Heart Failure Systolic Dysfunction Inflammation Vascular Injury SNS/RAA Neuro-hormonal Activation Volume Overload Infection Risk Factors Diet Smoking Inactivity Genetics Dyslipidemia Hypertension Diabetes Hormones Oxidation O 2 supply O 2 demand Arrhythmias Aging, Infiltrative diseases Diastolic Dysfunction Pressure Overload

8 Death Pump Failure Stress O 2 demand Thrombosis Reperfusion Arrhythmias O 2 supply Vasoconstriction Myocardial Injury Reperfusion Inflammation Infection, Trauma Myocyte Death Plaque Rupture CAD Vascular Remodeling Ischemia Ventricular Remodeling Heart Failure Systolic Dysfunction Inflammation Vascular Injury BNP Volume Overload Infection Risk Factors Diet Smoking Inactivity Genetics Dyslipidemia Hypertension Diabetes Hormones Oxidation O 2 supply O 2 demand Arrhythmias Aging, Infiltrative diseases Diastolic Dysfunction Pressure Overload

9 Acute Coronary Syndromes Risk Stratification

10 Primary Risk Stratification Secondary Risk Stratification Clinical Diagnosis History Physical Exam ECG No CAD Unstable Angina Myocardial Infarction Diagnostic Tests + History Physical Exam ECG + Prognostic Tests Risk Sensitivity < 95% Sensitivity > 99%

11 Chronology of an Acute Coronary Syndrome First Chest Pain Initial ED Presentation AMI r/o D/C August September

12 Chronology of an Acute Coronary Syndrome First Chest Pain Initial ED Presentation AMI r/o D/C ETT MPI Clinic f/u Cath PCI August September

13 Chronology of an Acute Coronary Syndrome Antecedent Care Onset of Chest Pain First Contact Defintive Diagnosis Definitive Therapy Follow up

14 Evaluation of Chest Pain Primary Risk Stratification Number of Patients * 35% * 66% low Risk high

15 Evaluation of Chest Pain Primary Risk Stratification Number of Patients low Risk high

16 Patient Presents with Chest Pain 5 Non Cardiac D/C Home History ECG Physical Exam Primary Risk Stratification AMI UA Non-Diagnostic (Higher - Risk) Non-Diagnostic (Lower - Risk) Lytics PCI Anti-thrombin Anti-platelet Anti-ischemia

17 Secondary Risk Stratification AMI UA Non-Diagnostic (Higher - Risk) Non-Diagnostic (Lower - Risk) Further Assessment

18 Chest Pain Evaluation A Heirarchy of Risk Rapidly rule-in STEMI and initiate therapy ECG Rapidly rule-in ACS and initiate therapy Cardiac Markers Rule-out acute coronary syndromes Identify stable coronary disease ETT Identify high risk individuals Lipids, HTN, DM, etc. Risk factor modification

19 Secondary Risk Stratification AMI UA Non-Diagnostic (Low Risk) 30 Minutes 1 ECG 10 Minutes Lytics PCI

20 Secondary Risk Stratification AMI UA Non-Diagnostic (Low Risk) 1 2 ECG Lytics PCI Anti-thrombin Anti-platelet Anti-ischemia

21 Secondary Risk Stratification AMI UA Non-Diagnostic (Low Risk) 1 2 Cardiac Markers 3 60 Minutes Lytics PCI +Tn Anti-thrombin Anti-platelet Anti-ischemia +Tn / IMA / MPI

22 4 Non Cardiac D/C Home Secondary Risk Stratification Cardiac markers Serial ECG Perfusion imaging Echocardiography Stress testing Angiography AMI UA Non-Diagnostic (Low Risk) D/C Home Lytics PCI +TnI Anti-thrombin Anti-platelet Anti-ischemia Further Outpatient Assessment

23 Acute Coronary Syndromes Management

24 Current Management of ACS Presumed prognosis: low risk of in-hospital death, unless MI develops Treatment goal: stabilize with aspirin heparin & monitor for MI development + Cardiac enzymes Cardiac Enzymes Presumed prognosis: very high risk of in-hospital death Treatment goal: prevent death by restoring coronary blood flow Scheduled PCI Medical stabilization Highrisk features Low - risk features Manage medically Fibrinolytic therapy Direct PCI

25 Current Management of ACS Presumed prognosis: low risk of in-hospital death, unless MI develops Treatment goal: stabilize with aspirin heparin & monitor for MI development + Cardiac Markers Cardiac Markers Presumed prognosis: very high risk of in-hospital death Treatment goal: prevent death by restoring coronary blood flow Scheduled PCI Medical stabilization Highrisk features Low - risk features Manage medically Fibrinolytic therapy Direct PCI

26 Acute Coronary Syndrome No ST Elevation ST Elevation Rapid Markers Unstable Angina NSTEMI NQMI Q-wave MI Fibrinolytics GP IIb/IIIa Blockers Aspirin Clopidogrel UFH / LMWH (Enoxaprin) P C I

27 Acute Coronary Syndrome No ST Elevation ST Elevation Rapid Markers NSTEMI Unstable Angina * Aspirin UFH / LMWH (Enoxaprin) NQMI Q-wave MI * * Fibrinolytics P GP IIb/IIIa Blockers Clopidogrel * * * C I

28 In-hospital Mortality in NSTE ACS Adjusted Risk of by Peak Troponin Level Peak Tn* Ratio Relative Risk of In-hospital Mortality (n = 21,694) 1-2 x ULN* P = x ULN P = 0.02 > 5 x ULN P < Roe M. J Am Coll Cardiol. 2003;41:390A Increasing Risk of Mortality

29 Early Invasive vs Conservative Strategy TACTICS-TIMI 18 Outcomes By Troponin Status % Death, MI, Rehospitalization at 6 Months Conservative Early invasive 24.2% 16.9% 14.5% 14.3% n = 414 n = 396 n = 463 n = 495 Treatment Interaction P < Tn Tn + Boden W. J Am Coll Cardiol. 2003;41(suppl 4):113S-122S; Morrow D. J Am Med Assoc. 2001;286:

30 Incidence of MI Prior to PCI Patients with Non-ST Elevation ACS % 8 % MI % PCI 24 <hours PCI 2-3 days Post-randomization analysis Roe MT, et al. J Am Coll Cardiol. 2000; 35: 40A.

31 Mortality in Patients With MI Prior to PCI Cumulative Mortality % MI prior to early PCI (n=46) No MI prior to early PCI (n=1,204) 15.2% 3.5% 11.7% (P=0.001) Months following randomization Post-randomization analysis Fintel DJ et al. J Am Coll Cardiol. 2000; 35A: A375.

32 Early Catheterization in NSTE ACS Benefit Observed in CRUSADE % % In-hospital Mortality by Risk Group Low Risk Moderate Risk High Risk Early Catheterization (< 48 hrs) No Early Catheterization (> 48 hr/ none) Bhatt D, et al. [abstract]. Circulation. 2002;106:II-494.

33 Benefits of GP IIb-IIIa Inhibition Outcome by Troponin Status in NSTE ACS PARAGON B Tn Positive Tn Negative PRISM CAPTURE COMBINED IIb-IIIa Better IIb-IIIa Worse IIb-IIIa Better IIb-IIIa Worse Newby K. Circulation. 2003;103(24):

34 In-hospital Mortality in NSTE ACS Early GP IIb-IIIa Inhibitor Use Within 24 Hours 8% 41% P < No Early GP IIb-IIIa Inhibitor * (n = 41,896) Early GP IIb-IIIa Inhibitor (n = 24,168) 6% 4% 2% 4.6% 2.7% * Risk adjusted OR = 0.96 (0.86, 1.07) 0% % In-hospital Mortality * Includes patients who received late GP IIb-IIIa inhibitor (> 24 hrs) therapy.

35 Turn-Around Time (minutes) Troponin Turnaround Times in the ED U.S. CRUSADE Hospitals 100 Overall 103 Central Lab Testing 63 Bedside Testing 109 n = 1333 n = 1198 n = 68 n = 972 n = 361 Revasc Hospitals 82 No Revasc Hospitals Vein-to-brain = time from blood draw until troponin results reach the physician

36 VHA Performance Measures Troponin Turn-Around Time Troponin identifies patients who are at higher risk for poor outcomes and who will benefit most from many treatments ACC/AHA and NACB/AACC recommend 60 minute turnaround for troponin VHA began 60 minute troponin turnaround as a network-wide performance standard in November 2003

37 VHA Performance Measures Troponin Turn-Around < 60 Minutes Q

38 The explicit goal in ACS must be to identify high risk patients early and to prevent any necrosis!

39 Managing Quality in ACS

40 Assessing Quality in Healthcare Quality is in the eye of the beholder Outcome is the ultimate gauge of quality We can t measure outcomes with any statistical validity We can measure processes RCTs link processes to outcomes Quality is defined by process adherence

41 Data That Drives Quality Assessment Demographics Medical history Initial evaluation Disease specific Hospital course Laboratory data Medications Procedures Clinical events Disposition

42 Quality in ACS Care Performance Measures versus Guidelines

43 Performance Measures Founded on the highest level of evidencebased practice Imposes accountability for outcomes

44 Performance Measures Rationale Decrease variation in processes known to impact outcomes Improve the consistency of desired outcomes across the healthcare network Demonstrate quality within a clinical system National benchmarking

45 Performance Measures Information that compels action

46 Performance Measures Implementation Strategies Achieve global goals through local implementation Clear delineation of expectations Feedback Frequent Accurate Transparency JACHO core measures posted on the web

47 Performance Measures Accountability Commitment to success by leadership Set high standards Accept current performance as a basis to move forward with improvement plans Network-level accountability Accountability at the provider level Sometimes is difficult Always is useful

48 The Focus of Guidelines Targeted patients Any person eligible for care under a condition of interest Targeted interventions Diagnosis Pharmacologic treatments Non-pharmacologic management

49 Observation Randomized Clinical Trial Class I: Evidence that a procedure or treatment is useful Class II: Conflicting evidence IIa Weight of evidence in favor of efficacy IIb Weight of evidence less well established 1. Quality of Evidence 2. Strength of recommendation Guideline Class III: Evidence that a procedure or treatment may be harmful

50 Observation For Health Services Research Randomized Clinical Trial hypothesis generating Guideline Registries CQI data sets confirmation of RCT results in an unselected population Observation

51 6 5 Non-STE-ACS Trials vs CRUSADE Early Mortality In-hospital mortality rate 4.7% % day mortality rate 1.8% 1.9% 1.8% 1 0 PURSUIT 1 (n=9,461) PRISM-PLUS 2 (n=1,915) GUSTO IV- ACS 3 (n=7,800) CRUSADE Q (n=27,786)

52 Observation For the Individual: Randomized Clinical Trial Appropriate Adherence Feedback Guideline CRUSADE/EPRP Performance Measurement

53 Acute Medication Use in NSTE ACS The First 24 Hours (n = 44,306)* 100% 80% 60% 93% 82% 81% 40% 38% 20% 0% Aspirin Beta Blockers Heparin (LMWH + UFH) GP IIb-IIIa Inhibitors *Data collected January 2003 to December Excludes contraindications. Data on file, Duke Clinical Research Institute.

54 Discharge Actions in NSTE-ACS (n = 44,306) 100% 80% 60% 40% 60% 74% 45% 71% 20% 0% Lipid Panel Drawn Dietary Counseling Cardiac Rehab Referral Smoking Cessation Counseling *Data collected January 2003 to December Data on file, Duke Clinical Research Institute.

55 VHA Performance Measures Set Targets Methodology Top performers upper 20 % For new measures use existing non-vha benchmarks Accreditation Compare Within VHA Externally HEDIS, CMS NCDR, CRUSADE, GWTG

56 Key Elements of Early ACS Care Leading and Lagging Hospital Quartiles* NSTE ACS (n = 64,775) 100% 80% 96% 85% 85% 90% 70% 66% 60% 40% 20% 50% 17% 0% Aspirin Beta Blocker Heparin GP IIb-IIIa Inhibitor Leading Centers Lagging Centers (Top quartile) (Bottom quartile) * Excludes contraindications and transfers out. Data collected November 2001 to December Data on file, Duke Clinical Research Institute.

57 Key Elements in Discharge Care Leading and Lagging Hospital Quartiles* 100% 80% 60% 40% 94% 91% 80% (n = 64,775) 71% 70% 48% 83% 62% 62% 38% 20% 0% Aspirin Beta Blocker ACE Inhibitor Statin Clopidogrel Leading Centers Lagging Centers *Data collected from November 2001 to December Excludes contraindications. LVEF < 40% Known hyperlipidemia

58 In-hospital Mortality (%) Performance Matters! Relationship between Process and Outcome <65% 65-75% 75-80% >80% Hospital Composite Adherence Quartiles * Data Collected from November 2001 to December 2003.

59 Overall Composite Adherence Trends Quarter 1, 2002 Quarter 3, % 70% % 60% Q Q Q Q Q Q Q Data on file, Duke Clinical Research Institute.

60 Knowledge is Information Put to Productive Use or There Can be No Evidencebased Medicine Without Implementation

61 What s New on the Horizon?

62 What s New on the Horizon? Timer starts with first diagnostic ECG Pre-hospital, antecedent ECG (NH, clinic, EMS) Primary PCI lowered to 90 min Increased use of facilitated PCI Emphasis on non-stemi ACS Anti-platelet agent performance markers Time constraints placed on ACS care Map care to appropriate risk status (Tn)

63 What s New on the Horizon? Right care at the right place Protective environment Rapid risk assessment Appropriate initial care Timely transfer Continuity of care System accountability

64 What s New on the Horizon? Lipid targets redefined Start in-hospital Start in ED? New targets (70 mg/dl?) vs max statin dose Antecedent care accountability

65 What s New on the Horizon? Stronger CHF Performance Measures Resynchronization therapy AICD utilization Diastolic dysfunction guidelines / PMs A role for BNP?

66 Quality in Cardiac Care Lessons Learned The effectiveness of processes of care in practice are defined by RCTs and structured by guidelines. Large gaps persist between ideal care and that received by many in community. Processes are the accepted surrogate for outcomes and will be reviewed and reported as scorecards of quality When metrics are not up to expectation first validate the data, then examine the process

67 Encourage Quality NSTE ACS Care Clinicians need to rapidly assess patient risk Clinical factors and biochemical markers Patients at highest risk tend to benefit most from aggressive interventions paradoxical care highest risk patients treated less Reduce variance in NSTE ACS care: wide variability between leading and lagging centers Define the linkage between care and outcome healthcare professionals need to work together to develop successful ACS quality improvement efforts

68 How to Make a Difference Look critically at your data Identify areas that need improvement Examine your systems Understand your processes Learn from your neighbors Identify high performance models Make practical, actionable plans Follow-up Continue to improve

69 Quality in ACS Care Ensuring outcomes for an n of 1

70 END

71 I IIa IIb III Initial Evaluation Risk Stratification (1) Early risk stratification by symptoms, physical findings, ECG, cardiac markers 12-lead ECG within 10 min for ongoing pain, or ASAP if pain has resolved at presentation Cardiac markers, Troponins and CK-MB, for initial assessment Monitoring, repeat ECG and cardiac markers in 6-12 hours, if initial results normal

72 Initial Evaluation Risk Stratification (2) I IIa IIb III If <6 hours after symptom onset, add early myoglobin or CK-MB to troponin C-reactive protein, other markers of inflammation Total CK, SGOT, HBDH, LDH

73 Immediate Management I IIa IIb III Classify as non-cardiac, chronic stable angina, possible ACS, or definite ACS Evaluate for immediate reperfusion therapy if definite ACS and ST-segment present Pharmacological or exercise stress test, if possible ACS and serial biomarkers and ECGs are normal Admit pts with definite ACS, ongoing pain, biomarkers, new ST or deep T-wave inversion, abnormal hemodynamics, or (+) stress test

74 Immediate Management I IIa IIb III Antiplatelet tx initiated promptly ASA or clopidogrel if ASA-allergic Clopidogrel + ASA for a non-early interventional approach 30 days (A) 9 months (B) Add a IIb/IIIa + ASA + Heparin when PCI is planned Clopidogrel for patients for planned PCI (and not at high risk for bleeding)

75 Immediate Management I IIa IIb III Eptifibitide or tirofiban + ASA + heparin in high risk patients for planned PCI Add a IIb/IIIa antagonist in addition to clopidogrel when PCI is planned Eptifibitide or tirofiban + ASA + heparin in nonhigh risk patients not for planned PCI Reopro when PCI not planned Lytics in non ST-elevation patients

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