1. Role of the ED in Cardiac Care: Matching Treatment to Risk James Hoekstra, MD Department of Emergency Medicine Wake Forest University Health Sciences

2. Role of the ED in Acute Cardiac Care n Outreach and Awareness n Seamless Transition from EMS to Hospital Care n Acute Stabilization of Emergencies n Risk Stratification of Patients with Chest Pain n Guideline Driven Care n The ED is the Front Door! n Outreach and Awareness n Seamless Transition from EMS to Hospital Care n Acute Stabilization of Emergencies n Risk Stratification of Patients with Chest Pain n Guideline Driven Care n The ED is the Front Door!

3. ED Risk Stratification for Chest Pain In 2006:  Does this patient need fibrinolytic therapy?  Should this patient get anti- thrombin and anti-platelet agents?  Can I safely send this patient home? In 2006:  Does this patient need fibrinolytic therapy?  Should this patient get anti- thrombin and anti-platelet agents?  Can I safely send this patient home? R/O MI For the past 20 years...

4. Rapid Triage of Chest Pain Patients n Chest Pain >25 years old goes straight back to a bed (bypass triage) n ECG in 10 minutes, shown to physician n IV, O2, Monitor, blood drawn Watch for Atypical Presentations: ECG in Triage Prehospital ECGs hasten appropriate care for STEMI n Chest Pain >25 years old goes straight back to a bed (bypass triage) n ECG in 10 minutes, shown to physician n IV, O2, Monitor, blood drawn Watch for Atypical Presentations: ECG in Triage Prehospital ECGs hasten appropriate care for STEMI

5. Risk Stratification Tools in the ED History and Physical History and Physical Standard ECG and Non-standard ECG leads Standard ECG and Non-standard ECG leads  Cardiac Biomarkers Troponin I or T, CK-MB, myoglobin Troponin I or T, CK-MB, myoglobin  Predictive Indices / Schemes  Better as research tools than for real-time clinical decision-making History and Physical History and Physical Standard ECG and Non-standard ECG leads Standard ECG and Non-standard ECG leads  Cardiac Biomarkers Troponin I or T, CK-MB, myoglobin Troponin I or T, CK-MB, myoglobin  Predictive Indices / Schemes  Better as research tools than for real-time clinical decision-making

6. ECG Groups Adapted from Savonitto S, et al. JAMA 281: February 24, 1999

7. Serum Markers n Myoglobin: Early peak in serum after MI, nonspecific, good negative predictive value for MI. n CKMB: Gold standard for many years. False elevation in muscle damage, renal failure. Must take relative index into account. Good risk stratifier if positive n TnI, TnT: Peaks at same time as CKMB, prolonged elevation in serum after MI, more sensitive and specific for MI than CKMB, but low levels (<1.0) can still be false positives. Best predictor of increased risk for bad outcomes n Myoglobin: Early peak in serum after MI, nonspecific, good negative predictive value for MI. n CKMB: Gold standard for many years. False elevation in muscle damage, renal failure. Must take relative index into account. Good risk stratifier if positive n TnI, TnT: Peaks at same time as CKMB, prolonged elevation in serum after MI, more sensitive and specific for MI than CKMB, but low levels (<1.0) can still be false positives. Best predictor of increased risk for bad outcomes

8. All patients; excludes enrolling MI enzymes Mortality by Peak CK-MB 56811098294302249211 CK-MB x ULN % mortality —Alexander J et al, 1998; Circulation

9. Long Term Survival and Troponin-T Status GUSTO-IIa Results TnT + TnT - 1-Year Mortality Rates: Troponin-T Positive: 14% Troponin-T Negative: 5% 1-Year Mortality Rates: Troponin-T Positive: 14% Troponin-T Negative: 5% p < 0.001

10. Troponin Levels and Mortality (NSTE-ACS) 8311741481345067

11. TIMI Risk Score (NSTE-ACS) n Age > 65 n > 3 CRF n Prior cath demonstrating CAD n ST segment deviation n > 2 anginal events within 24 hours n ASA use within 7 days n Elevated cardiac markers n Age > 65 n > 3 CRF n Prior cath demonstrating CAD n ST segment deviation n > 2 anginal events within 24 hours n ASA use within 7 days n Elevated cardiac markers

12. The TIMI Risk Score and Incidence of Adverse Ischemic Events in Patients with NSTE-ACS Adapted with permission from Antman EM, et al. JAMA. 2000; 284: 835-42 4.7 8.3 13.2 19.9 26.2 40.9 0 10 20 30 40 50 0/123456/7 Number of Risk Factors Death, MI, or Urgent Revascularization (%)

13. History, Physical EKG Chest Pain STEMI UA/NSTEMI/ High Risk Inter RiskLow Risk Definite Non-Cardiac Initial Risk Stratification Scheme

14. ACS Risk Stratification Levels n Level 1 or STEMI: Pain less than 12 hours, ST segment elevation, New LBBB n Level 2 or High Risk ACS: ST depression, Transient ST elevation, positive markers n Level 3 or Intermediate Risk CP: No ECG or marker changes but high risk of UA by history (good story, high risk demographics) n Level 4 or Low Risk CP: No ECG or marker changes and possibility of UA n Level 5: Noncardiac Pain n Level 1 or STEMI: Pain less than 12 hours, ST segment elevation, New LBBB n Level 2 or High Risk ACS: ST depression, Transient ST elevation, positive markers n Level 3 or Intermediate Risk CP: No ECG or marker changes but high risk of UA by history (good story, high risk demographics) n Level 4 or Low Risk CP: No ECG or marker changes and possibility of UA n Level 5: Noncardiac Pain

15. Case 1 ECG: STEMI

16. Class I ED Treatment of STEMI: AHA/ACC Guidelines (ST Elevation, New BBB, Pain<12 Hours) n Targeted ED Protocol and Collaboration n O2, IV, monitor n ASA immediately (162-325 mg) n Nitrates, beta blockers (IV) n Clopidogrel 300 mg po n Heparin weight based dosing (60 IVP and 12/k/h, max 4000/1000) n Fibrinolytics in less than 30 minutes (esp if CP<3 hours) n PCI less than 90 minutes if available, with IIb/IIIa on board n Treatment of Complications n Targeted ED Protocol and Collaboration n O2, IV, monitor n ASA immediately (162-325 mg) n Nitrates, beta blockers (IV) n Clopidogrel 300 mg po n Heparin weight based dosing (60 IVP and 12/k/h, max 4000/1000) n Fibrinolytics in less than 30 minutes (esp if CP<3 hours) n PCI less than 90 minutes if available, with IIb/IIIa on board n Treatment of Complications

17. Time to Therapy n The Four D’s n Door: Patient education, EMS n Data: Triage protocols, ECG in 5 minutes n Decision: ED decisions, or rapid protocols n Drug: Drug in ED, administration in ED n 30 MINUTES DOOR to DRUG n The Four D’s n Door: Patient education, EMS n Data: Triage protocols, ECG in 5 minutes n Decision: ED decisions, or rapid protocols n Drug: Drug in ED, administration in ED n 30 MINUTES DOOR to DRUG

18. Rapid time to treatment with fibrinolytics improves outcomes in ST  MI Absolute % difference in mortality at 35 days 0-12-34-67-1212-24 The Fibrinolytics Therapy Trialists’ collaborative group. Lancet. 1994; 343: 311-322 Time from onset of symptoms to treatment (hours) 3.5%  2.5%  1.8%  1.6%  0.5% 

19. Facilitated PCI n Primary angioplasty or stent placement is the gold standard treatment of STEMI in cath lab centers. n ASA, NTG, Heparin weight based dosing n IIb/IIIa inhibitor either prior to or at the same time as PCI decreases reocclusion and has some fibrinolytic effects equal to streptokinase. n Benefits of cath over thrombolytics lost if time from door to cath lab greater than 90 minutes. n Primary angioplasty or stent placement is the gold standard treatment of STEMI in cath lab centers. n ASA, NTG, Heparin weight based dosing n IIb/IIIa inhibitor either prior to or at the same time as PCI decreases reocclusion and has some fibrinolytic effects equal to streptokinase. n Benefits of cath over thrombolytics lost if time from door to cath lab greater than 90 minutes.

20. Case 2 ECG

21. Level 2 or High Risk ACS Clinical Features:  Accelerated pattern of angina  Ongoing rest pain > 20 min  Signs of CHF (esp S3, rales)  Hemodynamic instability  Arrhythmias - Atrial or ventricular  Advanced age (> 75 years)  ECG ST Changes  Elevated Serum Markers  TRS 4+  Accelerated pattern of angina  Ongoing rest pain > 20 min  Signs of CHF (esp S3, rales)  Hemodynamic instability  Arrhythmias - Atrial or ventricular  Advanced age (> 75 years)  ECG ST Changes  Elevated Serum Markers  TRS 4+

22. ED Treatment of Level 2 or High Risk ACS (ST Changes or +Markers) n O2, IV, monitor n ASA immediately n Nitrates, Beta Blockers n Heparin weight based dosing or LMWH n Clopidogrel if going to cath, or medical (ED?) n IIb/IIIa therapy, with or without PCI, initiated early in the ED n PCI in high risk, continued symptoms n O2, IV, monitor n ASA immediately n Nitrates, Beta Blockers n Heparin weight based dosing or LMWH n Clopidogrel if going to cath, or medical (ED?) n IIb/IIIa therapy, with or without PCI, initiated early in the ED n PCI in high risk, continued symptoms

23. Level 3 or Intermediate Risk Clinical Criteria n Nondiagnostic ECG and TnI n High likelihood that chest pain is secondary to ACS (good story) n Age > 70 n History of CAD, CVD, PVOD n T Wave Inversion/Confounders on ECG n Indeterninant TnI levels n TRS 3-4 n Nondiagnostic ECG and TnI n High likelihood that chest pain is secondary to ACS (good story) n Age > 70 n History of CAD, CVD, PVOD n T Wave Inversion/Confounders on ECG n Indeterninant TnI levels n TRS 3-4

24. ED Treatment of Level 3 or Intermediate Risk CP (High or Moderate Risk UA, Nonspecific ECG and -Markers) n O2, IV, monitor n ASA immediately n Nitrates n Heparin weight based dosing or LMWH (preferred) n Clopidogrel 300 mg po n Serial enzymes (short stay?) n Protocol driven care n Angio versus provocative testing n O2, IV, monitor n ASA immediately n Nitrates n Heparin weight based dosing or LMWH (preferred) n Clopidogrel 300 mg po n Serial enzymes (short stay?) n Protocol driven care n Angio versus provocative testing

25. Level 4 or Low Risk Chest Pain Clinical Criteria n Normal ECG and Normal Cardiac Markers n Possibility of UA by History n Atypical Pain, usually resolved n Minimal Risk Factors n No known CAD n TRS 0-2 n Normal ECG and Normal Cardiac Markers n Possibility of UA by History n Atypical Pain, usually resolved n Minimal Risk Factors n No known CAD n TRS 0-2

26. ED Treatment of Level 4 or Low Risk Chest Pain: Observational Chest Pain Evaluation Chest Pain Resolved, Neg ECG, Neg Enzymes n ECG, CK, CKMB, TnI on arrival n Obs Unit, Telemetry,Day Hospital Admission n Serial ECGs as indicated n CK, CKMB, TnI at 0,3,6 or 0,4, and 8 hours n Stress Test, or Negative Rest Sestamibi, ?CT Angio n Admit if positive stress, enzymes, or ECG changes n D/C if negative n ECG, CK, CKMB, TnI on arrival n Obs Unit, Telemetry,Day Hospital Admission n Serial ECGs as indicated n CK, CKMB, TnI at 0,3,6 or 0,4, and 8 hours n Stress Test, or Negative Rest Sestamibi, ?CT Angio n Admit if positive stress, enzymes, or ECG changes n D/C if negative

27. ACS Diagnostic Flow Summary Non STE patients suspicious for ACS Risk Stratification History and age History and age ECG/ECG criteria ECG/ECG criteria Serum markers Serum markers History and age History and age ECG/ECG criteria ECG/ECG criteria Serum markers Serum markers Positive (High Risk) Admit Serial markers Serial markers Serial ECGs Serial ECGs ST-trend monitoring ST-trend monitoring Serial markers Serial markers Serial ECGs Serial ECGs ST-trend monitoring ST-trend monitoring Positive Negative GXT GXT Radionuclide Radionuclide Stress Echo Stress Echo GXT GXT Radionuclide Radionuclide Stress Echo Stress Echo Negative (Low/Moderate Risk) Chest Pain Center Treat Accordingly DischargePositiveNegative

28. ACS Diagnostic Algorithm Keys: n Early Risk Stratification (?Bedside Testing) n Push the Serial Enzymes Early: 0,3,6 or 0,4,8 n Low Risk Patients may be D/Ced for outpatient stress, or may undergo rest sestamibi, CT angio after 2 sets of markers n Keep it simple, protocol driven, with cardiology consultation on the back side. n Early Risk Stratification (?Bedside Testing) n Push the Serial Enzymes Early: 0,3,6 or 0,4,8 n Low Risk Patients may be D/Ced for outpatient stress, or may undergo rest sestamibi, CT angio after 2 sets of markers n Keep it simple, protocol driven, with cardiology consultation on the back side.

29. ACC/AHA Guidelines 2002 Update Recommendations for Antithrombotic Therapy Braunwald E, et al. J Am Coll Cardiol 2000;36:970-1062; www.acc.org 3/15/2002. Invasive Cath Strategy Conservative Cath Strategy High Risk or Definite ACS With Cath and PCI Likely/Definite ACS Possible ACS Aspirin+ IV heparin/LMWH* + IV platelet GP IIb/IIIa antagonist clopidogrel Aspirin+ SQ LMWH* or IV UFH clopidogrel Aspirin

30. Chest Pain Centers n Outreach Protocol l Bringing Patients In n Patient Identification Protocol l Triage l Risk Stratification n Attack Protocol n Observation Protocol n CQI Monitoring, Accreditation, Marketing n Outreach Protocol l Bringing Patients In n Patient Identification Protocol l Triage l Risk Stratification n Attack Protocol n Observation Protocol n CQI Monitoring, Accreditation, Marketing

31. Drivers of CDU Observation Protocols n High cost of inpatient stays n Denial of payment n Medical malpractice climate n Improved serum markers n Available stress testing modalities n High cost of inpatient stays n Denial of payment n Medical malpractice climate n Improved serum markers n Available stress testing modalities

32. Early Chest Pain Protocols n Goldman Protocol: R/O MI n Goal: to identify likely AMI; improve CCU triage l AMI Only l Not clinically practicable n Gaspoz: Ruling Out AMI is not sufficient n Hamm: Enzymes alone don’t do it n Goldman Protocol: R/O MI n Goal: to identify likely AMI; improve CCU triage l AMI Only l Not clinically practicable n Gaspoz: Ruling Out AMI is not sufficient n Hamm: Enzymes alone don’t do it Goldman L, Cook EF, Brand DA, et al. N Engl J Med 1988;318:797-803.

33. University of Cincinnati “Heart ER” Strategy Symptoms suspicious for ACS ECG changes of AMI or UA Non-diagnostic ECG Treat and admit Positive Negative Consider rest nuclear imaging in patients able to be injected during pain Discharge with follow-up 6-hour CPC evaluation Serial cardiac markers 0, 3, 6 hours ST-segment trend monitoring ECG exercise stress test Discharge Negative Gibler, et al. Ann Emer Med 1995;25. Storrow, et al. Circulation 1998;98.

34. Mayo Clinic Strategy Chest pain consistent with unstable angina H&P, ECG AHCPR Guidelines Low risk Intermediate risk CKMB 0, 2, 4 hours ST-segment monitoring Six Hour Observation Positive or recurrent symptoms of UA Negative ECG exercise test or Nuclear stress test or Echocardiographic stress test High risk Admit Negative Positive Equivocal Home 72 Hour Follow-up Farkouh ME, et al. NEJM 1998 Admit

35. Chest Pain Level 1 Level 2 Level 3Level 4 Level 5 ECG and History Triage Decision ECG criteria for STEMI Reperfusion CCU High probability of acute ongoing UA or non Q-Wave AMI ST-segment depression or T-wave inversion or known CAD with typical symptoms. + Markers Heparin, ASA, Ntg, IIB/IIIA CCU High probability of UA Low probability of AMI Typical symptoms >30 minutes, non- diagnostic ECG, no CAD history Cardiac markers and nuclear imaging 23-h CCU stay Low to moderate probability of UA <30 minutes typical symptoms or prolonged atypical symptoms, nondiagnostic ECG, no history CAD Immediate nuclear imaging in ED Discharge and outpatient stress testing Non-cardiac chest pain Clear diagnosis not related to ACS Treat as needed Medical College of Virginia clinical pathways “Track” strategy

36. Level 3 and 4 ED Evaluations n Level 3: Probable UA n ED Evaluation n Serial CKMB, TnI at 0,3,6 hours n Resting and Stress Sestamibi n D/C if negative n Admit if Positive n Level 3: Probable UA n ED Evaluation n Serial CKMB, TnI at 0,3,6 hours n Resting and Stress Sestamibi n D/C if negative n Admit if Positive n Level 4: Possible UA n ED Evaluation n Serial CKMB, TnI at 0,3,6 hours n Resting Sestamibi n D/C if Negative n Outpatient Stress Test in 48 hours

37. CPC Cost Effectiveness

38. APC 0339 Chest Pain DRG 143 Chest Pain Level III/IV < 8 hours……………..$177 APC 0339 > 8 hours………………$350 Billable (UB92) Reimbursable EKG yes yes Enzymes yes yes Nuclear Studies yes yes Stress Test yes yes Total……………………… $900/$1000 Fixed Cost (FC)……………………($570) FC varies per institution Mean Variable Cost (VC)………….($252) OP diagnostic testing enhancing bottom line **PROFITABLE $32,000 Average Reimbursement $1997 ALOS __2.1 days_ Billable (UB92) Reimbursable EKG yes bundled in DRG Enzymes yes bundled in DRG Nuclear Studies yes bundled in DRG Stress Test yes bundled in DRG Fixed Cost (FC)…………………..($1498) FC varies per institution, usually 3 times OP Mean Variable Cost (VC)………...($1168) All diagnostics are bundled under corresponding DRG **LOSER ($-188,000) 289 Patient Study SSieck. Journal of Critical Pathways in Cardiology,Dec, 02

39. Observation Unit Nuts and Bolts Patient Selection, Documentation

40. Observation Services “Observation services are those services furnished by a hospital on the hospital’s premises, including use of a bed and periodic monitoring by a hospital’s nursing or other staff, which are reasonable and necessary to evaluate an outpatient’s condition or determine the need for a possible admission to the hospital as an inpatient.” Source: HCFA

41. Functional Issues n Size n Adjacency n Physician Oversight n All Patients or Just Level 3 and 4?? n Size n Adjacency n Physician Oversight n All Patients or Just Level 3 and 4??

42. Services Not Covered as Observation CMS Rules... n Services that are less than 8 hours or exceeding 48 hours (unless the patient is granted an exception based on facts of care) n Services that are not reasonable and necessary for the diagnosis or treatment, but are provided for the convenience of the patient, their family or physician n Services for postoperative monitoring during a standard recovery period n Any substitution of an outpatient observation service for a medically appropriate inpatient admission n Services ordered as inpatient services by the admitting physician, but billed as outpatient by the billing office n Standing orders for observation following outpatient surgery n Claims for inpatient care, such as complex surgery, clearly requiring an overnight stay, billed as outpatient n Services that are less than 8 hours or exceeding 48 hours (unless the patient is granted an exception based on facts of care) n Services that are not reasonable and necessary for the diagnosis or treatment, but are provided for the convenience of the patient, their family or physician n Services for postoperative monitoring during a standard recovery period n Any substitution of an outpatient observation service for a medically appropriate inpatient admission n Services ordered as inpatient services by the admitting physician, but billed as outpatient by the billing office n Standing orders for observation following outpatient surgery n Claims for inpatient care, such as complex surgery, clearly requiring an overnight stay, billed as outpatient

43. Documentation Requirements Physician: n ED or clinic visit must be provided and billed in conjunction with any observation services n Instability of patient condition (severity of illness indicators) n Timed, dated, and signed physician orders l Document order for placing patient in observation Patients are “placed” in observation Do not use term “admit to observation” l Document time patient is released from observation Either admitted to hospital or released to home This is when time clock and associated observation billing ends n Indication for any diagnostic testing or monitoring (intensity of service indicators) n The need for therapeutic interventions (intensity of service indicators) n If admitted, reason for admission (clinical indicators) n If discharged, documentation clinical stability (discharge criteria) Physician: n ED or clinic visit must be provided and billed in conjunction with any observation services n Instability of patient condition (severity of illness indicators) n Timed, dated, and signed physician orders l Document order for placing patient in observation Patients are “placed” in observation Do not use term “admit to observation” l Document time patient is released from observation Either admitted to hospital or released to home This is when time clock and associated observation billing ends n Indication for any diagnostic testing or monitoring (intensity of service indicators) n The need for therapeutic interventions (intensity of service indicators) n If admitted, reason for admission (clinical indicators) n If discharged, documentation clinical stability (discharge criteria)

44. Nursing: n Date & time nursing assessment began in observation l This is when the “time clock” for observation begins This is when billing for observation begins l Time when patient is released from observation n All procedures, testing & interventions n Patient response to treatment n Communication to physician of patient status if status changes Nursing: n Date & time nursing assessment began in observation l This is when the “time clock” for observation begins This is when billing for observation begins l Time when patient is released from observation n All procedures, testing & interventions n Patient response to treatment n Communication to physician of patient status if status changes Documentation Requirements

45. Observation Time Clock n Date & time nursing assessment begins in observation l This is the “time clock” for when observation begins This is when billing for observation begins n Physician order dated & timed for when patient is released from observation Either admitted to hospital or released to home This is when time clock and associated observation billing ends n Date & time nursing assessment begins in observation l This is the “time clock” for when observation begins This is when billing for observation begins n Physician order dated & timed for when patient is released from observation Either admitted to hospital or released to home This is when time clock and associated observation billing ends To bill for observation… Observation services must be billed in 1 hour increments (8-48 hours) Correct number of hours must be listed on bill

46. Quality Checks Front end review by clinicians for patients placed in observation Utilize medical necessity criteria InterQual Criteria are suggested guidelines, however common clinical sense should prevail Concurrent & retrospective monitoring & reporting Front end review by clinicians for patients placed in observation Utilize medical necessity criteria InterQual Criteria are suggested guidelines, however common clinical sense should prevail Concurrent & retrospective monitoring & reporting

47. InterQual Criteria n Looks at 3 types of indicators l Severity of illness l Intensity of service l Discharge criteria n Must look at indicators to determine if patient should be placed in observation, admitted, or discharged n Looks at 3 types of indicators l Severity of illness l Intensity of service l Discharge criteria n Must look at indicators to determine if patient should be placed in observation, admitted, or discharged

48. Chest Pain Interqual Criteria n Chest Pain n CKMB/TnI Negative n ECG normal/unchanged n Hemodynamic Stability (you define) n Pain Resolved in ED n Old Requirement: No Drips. Now: Drips Allowed n Chest Pain n CKMB/TnI Negative n ECG normal/unchanged n Hemodynamic Stability (you define) n Pain Resolved in ED n Old Requirement: No Drips. Now: Drips Allowed

49. Putting It All Together: The Chest Pain Evaluation Algorithm n Establish a protocol that puts risk stratification to work in a dynamic fashion n Rapidly evaluate chest pain n Serial ECGS early n Serial Serum Markers Early n Adjust treatment to risk stratification results n Establish a protocol that puts risk stratification to work in a dynamic fashion n Rapidly evaluate chest pain n Serial ECGS early n Serial Serum Markers Early n Adjust treatment to risk stratification results