ST- Segment Elevation Myocardial Infarction Challenges in Diagnosis & Current Measures of Quality

Transcription

1 ST- Segment Elevation Myocardial Infarction Challenges in Diagnosis & Current Measures of Quality James M. McCabe, MD, FACC, FAHA Cath Lab Director, University of Washington

2 Disclosures I, James McCabe, have no relevant financial disclosures

3 03-AUG-1925 (84 yr) Female Unknown Room:904 Loc:206 Option:1 Vent. rate 62 PR interval 202 QRS duration 76 QT/QTc 468/475 P-R-T axes 25 0 BPM ms ms ms -28 Normal sinus rhythm with sinus arrhythmia Minimal voltage criteria for LVH, may be normal variant Cannot rule out Anterior myocardial infarction, age undetermined Abnormal ECG No previous ECGs available Technician: Test ind: Referred by: PETER LIBBY, M.D. Confirmed By: DALE ADLER M.D. I avr V1 V4 II avl V2 V5 III avf V3 V6 V1 II V5

4 Analysis of intermediate risk ECGs alone for STEMI diagnosis 36 ECGs for which a cath lab activation had occured 124 physicians at various levels surveyed All cases described as moderate risk of acute coronary syndrome without further clinical details provided Q: Is there a blocked coronary artery present causing a STEMI? (please provide your best guess) ECG 51 McCabe et al. JAHA

5 Reader Performance by Experience Sens Spec PPV NPV Kappa C Computer Algorithm n/a 0.65 All Participants By Training Level All Residents All Fellows All Attendings McCabe et al. JAHA. 2013

6 Accuracy of ECG Read for STEMI OR 95% CI p Value Residents Experience Matters! Fellows Attendings % increased odds of accuracy <0.01 for every 5 years since medical school Experience (per year) ED & IM Physicians* Non- invasive Cardiologists* Interventional Cardiologists* * Attendings only Statistical methods: generalized estimating equations to account for repeated measures

7 Sensitivity & Specificity by ECG Characteristics 4% é odds of accuracy per ECG lead with diagnostic STE (p = 0.03, 95%CI ) Maximal height of STE (per mm) doesn t improve accuracy (p 0.59, 95%CI ) Lateral and posterior STE more often inaccurate (vs anterior) small samples

8 03-AUG-1925 (84 yr) Female Unknown Room:904 Loc:206 Option:1 Vent. rate 62 PR interval 202 QRS duration 76 QT/QTc 468/475 P-R-T axes 25 0 BPM ms ms ms -28 Normal sinus rhythm with sinus arrhythmia Minimal voltage criteria for LVH, may be normal variant Cannot rule out Anterior myocardial infarction, age undetermined Abnormal ECG No previous ECGs available Technician: Test ind: Referred by: PETER LIBBY, M.D. Confirmed By: DALE ADLER M.D. I avr V1 V4 II avl V2 V5 III avf V3 V6 V1 II V5

9 PRE- POST-

10 03-AUG-1925 (84 yr) Female Unknown Vent. rate 62 PR interval 202 QRS duration 76 QT/QTc 468/475 P-R-T axes 25 0 NOT COUNTED BY CMS Room:904 Loc:206 Option:1 BPM ms ms ms -28 Normal sinus rhythm with sinus arrhythmia Minimal voltage criteria for LVH, may be normal variant Cannot rule out Anterior myocardial infarction, age undetermined Abnormal ECG No previous ECGs available Technician: Test ind: Referred by: PETER LIBBY, M.D. Confirmed By: DALE ADLER M.D. I avr V1 V4 II avl V2 V5 III avf V3 V6 V1 II V5

11 Measuring Quality of Care in STEMI In- hospital Mortality primary outcome measure of quality Public Reporting (eg COAP) and national registries (NCDR) CMS began tracking 30 day post- MI mortality as part of Value Based Purchasing in 2014 Typically risk- adjusted Crude in- hospital mortality ~5-6% Massachusetts Crude In- Hospital Mortality following PCI for STEMI or Shock

12 Measuring Quality of Care in STEMI Cont d Time to Reperfusion primary process measure of quality Door- to- Balloon time Should maintain relationship with outcome measure Easily measured Allows for systemic changes targeting controllable processes D2B time should be within our control, mortality may not be. Why mortality is risk- adjusted and D2B time is not.

13 Mr. C. 59 yo man with no significant PMHx (former tobacco and +FHx early CAD) presented to the ED with chest discomfort. Felt well in AM. Went skydiving for first time. Queasy and nervous in plane (approx 1 PM). Jumped and developed chest pain as parachute deployed. Returned home by 2 PM. Continued chest discomfort. Took nap for approx until approximately 5:30 PM. On waking continued discomfort. Girlfriend drove him to UW ED. Arrived at 6 PM with continued chest discomfort.

14 18:05

15 Mr. C Code STEMI activated within 6 mins of ECG. STAT chest CTA to evaluate for aortic dissection was ordered in ED. Left ED and arrived in cath lab at 18:50.

16 Mr. C. PMHx: Erectile dysfunction NKA Meds: Tadalafil PRN SHx: divorced. Long- term girlfriend. 35 pack year tobacco history (quit 20 years ago) FHx: Father with MI at age 48. Mother alive with HTN, depression. No children. Exam: 114/56, HR 65, RR 18, 96% RA Uncomfortable and diaphoretic. JVP 6 cm. Normal PMI. RRR. normal s1, s2. No gallops or murmurs. No rub. Normal radial, femoral, DP/PT pulses bilaterally. Lungs CTA b/l. Abdomen soft/non- tender. Alert, non- focal

17 Mortality and D2B Time Relationship 2 nd National Registry of Myocardial Infarctions (NRMI- 2) 1474 Hospitals (only 661 could perform PTCA) 6/1994-3/1998 All acute MI s (by ECG and CK- MB) Observational Angioplasty only

18 Symptom Duration to Balloon Time NRMI 2 Door- to- Balloon Time Cannon CP. JAMA. 2000;283: Minutes

19 NRMI 3&4: Confirmed Findings of NRMI ,222 STEMIs at 395 hospitals P <0.001 for trend McNamara RL. J Am Coll Cardiol. 2006;47:2180

20 DBT and 1 year mortality patients Angioplasty only Regression Model of TOTAL ISCHEMIC TIME vs mortality Introduced the notion of per minute increases in mortality DeLuca G et al. Circulation. 2004;109:1223

21 D2B Alliance Hospitals Bradley EH. J Am Coll Cardiol. 2009;54:2423

22 CMS Codified D2B Time Centers for Medicaid and Medicare Services (CMS) arguably most important in altering care delivery for STEMI patients Began tracking D2B in 2005 Original target 120 min mean D2B per hosp 2006 changed to 90 min median D2B per hosp Reimbursement was tied to performance

23 Improvements in D2B in U.S Review of 973 U.S. hospitals providing Primary PCI for STEMI demonstrated dramatic improvement in proportion of patient treated within 90 minutes of emergency department arrival. 48% absolute Δ Krumholz, et al. Circulation. 2011;124:

24 What drives DTB time? r = 0.97 Door- to- activation 20 min 89% achieved D2B <90 min Door- to- activation > 20 min 28% achieved D2B < 90 min McCabe JM. Circ Cardiovasc Qual Outcomes. 2012;5:672

25 ED Crowding Important Predictor of D2B p = Adjusted for time of day and physician staffing McCabe, unpublished

26 What drive DTB time: Can We Skip the ED? Action- GWTG registry, ,461 STEMI patients Bagai A. Circulation. 2013;128:352

27 ED Bypass In hospitals with >25 STEMI/year Median times Unadjusted mortality lower in patient who had ED bypass. Adjusted mortality was similar. Bagai A. Circulation. 2013;128:352

28 The Price of Doing Business When Focus is Solely on Expedience Barnes GD. Am J Man Care. 2013;19:671

29 The confusing semantics of STEMI (mis)diagnoses Generally a surrogate for diagnostic accuracy but variously defined in relationship to available angiography, clinical history, and biomarker assays. 1,2,3 1. Larson. JAMA, Kontos. Am J Em Med, McCabe. Arch Int Med, Garvey. Circ, Rokos. Am Heart J, Mixon. Circ Qual, 2012 False Positive Activation Inappropriate Activation Over- activation Weighs cases against criteria available at the time of activation; not directly related to outcomes. 5,6 [activation] for patients who do not ultimately require emergent catheterization or performing angiography on patients who are ultimately found not to require coronary intervention. 4

30 14% No culprit on angio 11% Negative biomarkers

31 Generally a surrogate for diagnostic accuracy but variously defined in relationship to available angiography, clinical history, and biomarker assays. 1,2,3 The confusing semantics of STEMI (mis)diagnoses False Positive Activation McCabe et al. JAMA Int Med. 2012;172, % 39% N/A Inappropriate Activation Over- activation Weighs cases against criteria available at the time of activation; not directly related to outcomes. 5,6 [activation] for patients who do not ultimately require emergent catheterization or performing angiography on patients who are ultimately found not to require coronary intervention Larson. JAMA, Kontos. Am J Em Med, McCabe. JAMA Int Med, Garvey. Circ, Rokos. Am Heart J, Mixon. Circ Qual, 2012

32 Factors Independently Associated with False Positives Multivariate Analysis AOR 95%CI p value BMI (per unit kg/m 2 ) Anginal chief complaint <0.001 Known coronary disease Illicit Drug Abuse Left Ventricular Hypertrophy by ECG Criteria Heavier weight and a classic angina chief complaint associated with diminished false positive rates Known CAD, prior drug abuse, and presence of LVH are strongly associated with false positive diagnoses McCabe et al. Arch Int Med, ,

33 Adjudicated Admission Diagnoses for False Positives % false Positives N= 146 Structural/valvular heart disease +/- CHF exacerbation 19 Non- specific chest pain, including soft tissue ailments 17 Demand ischemia and severe concomitant illness 14 Primary rhythm disturbance 10 Metabolic derangements (including toxins/drugs) 10 Out of hospital cardiac arrest 6 Myocarditis/Pericarditis 6 Known CAD & stable symptoms 4 Abdominal pathologic condition 3 Hypertensive urgency/emergency 3 Takotsubo 1 Other diagnoses 6 McCabe. Arch Int Med, (11),

34 Can we do better than ACC/AHA guidelines in setting of LVH? Goal: create a simple ECG rule to improve specificity while preserving sensitivity for STEMI dx 79 of first 411 cases in registry had criteria for LVH (by any standard criteria) and underwent angiography; study cohort Assessed test characteristics of multiple schemes against angiographic outcome (reference standard) REF Armstrong & McCabe et al. AJC, (7),

35 Recursive Partitioning Algorithm Sensitivity = 77% Specificity = 91% NRI 37% Armstrong & McCabe et al. AJC, (7),

36 29 3 LVH 3/29 = 10% Not a STEMI

37 Primary Limitation to LVH Algorithm It has not been validated against an external cohort

38 Does the attention on Door-to- Balloon time and diagnostic specificity matter?

39 CathPCI data from ,738 STEMI admissions at 515 hospitals

40 No significant association between annual decreases in DTB time and in- hospital mortality (odds ratio for 10 min reduction in DTB time: 1.04, 95% CI: ). Menees DS. N Engl J Med. 2013;369:901

41 Improvements in D2B in U.S Review of 973 U.S. hospitals providing Primary PCI for STEMI demonstrated dramatic improvement in proportion of patient treated within 90 minutes of emergency department arrival. 48% absolute Δ Krumholz, et al. Circulation. 2011;124: CMS Specifications Manual: 9 exclusion criteria for case reporting. Updated #9: Patients who did not receive PCI within 90 minutes and had a reason for delay documented by a physician/apn/pa (e.g., social, religious, initial concern or refusal, cardiopulmonary arrest, balloon pump insertion, respiratory failure requiring intubation)

42 Is D2B Time Just a Game? Patients excluded from national registries are large, un- measured piece of puzzle McCabe JM. Circulation :

43 Gaming the system? McCabe JM. Circulation :

44 Different Registry, Same Result: non- system delays Patients in NCDR CathPCI Registry ,678 STEMIs (12,146 non- system delay patients) Swaminathan RV. J Am Coll Cardiol. 2013;61:1688

45 D2B Time as Quality 10+ years as the primary process measure of quality in ppci Functioned as a surrogate for mortality risk Have we eroded the D2B- mortality relationship by studying only idealized patients? More fundamentally, is risk- adjusted mortality even capable of determining quality?

46 Fundamental Challenges of Risk Adjusted Mortality (RAM) and Quality Sensitivity for poor performers <20% 60-70% of identified outliers Not poor performers Thomas TJ & Hoffer TP. Med Care (1): 83-92

47 The Multiple Axes of Quality in PCI

48 Other Process Measures: The radial vs. femoral example. Wimmer NJ. Am Heart J in press.

49 Conclusions: How do we move forward? Focus on a single axes of quality (like ED bypass or DTB time) is useful but not sufficient to enhance the overall system of care for STEMI patients. Greater coordination among the many pre- hospital systems in the care of STEMI patients is crucial and would be facilitated if STEMI was a reportable public health condition. Focus on total ischemic time in the care of patients with STEMI important. Patient education is paramount in this endeavor. Other advances (hemodynamic support, pharmacologic targeting, cooling [arrest patients], technical innovations) in PCI are likely to provide the next major steps forward in STEMI care. Antman EM. Circulation. 2013;128:322 Grines CL and Schreiber T. J Am Coll Cardiol. 2013;61:1696

50 Thank you!