1. HEART PATHWAY Brian O’Neal, MD
Assistant Professor, UNC School of Medicine
Wake Emergency Medicine Physicians, LLC

2. What’s The Problem?
Each year, 8 to 10 million patients in the United States present to the emergency department with the chief complaint of chest pain.
When caring for these patients, emergency physicians use liberal testing strategies to prevent missing an acute coronary syndrome (ACS).
Why?
Because ACS can kill you, we care about our patients, and we don’t want to get sued.

3. What’s The Problem?
This pervasive over triage results in >50% of ED patients with acute chest pain receiving a comprehensive cardiac evaluation (serial cardiac biomarkers and stress testing or angiography) at a cost of $10 to 13 billion annually.
Yet <10% of these patients are ultimately diagnosed with ACS.

4. So What To Do?.....

5. HEART PATHWAY Origination
Developed by the European Society of Cardiology, the HEART score is a cardiovascular disease risk assessment and management tool aimed at supporting clinicians in optimizing individual cardiovascular risk reduction.

6. Origination
Original framing of the score collected data from 12 European cohort studies (N=205,178) covering a wide geographic spread of countries at different levels of cardiovascular risk. The SCORE data contains some 3-million person-years of observation and 7,934 fatal cardiovascular events.

7. HEART Score
Intended to help the provider predict the 6 week risk of a major adverse cardiac event (MACE).
Comprised primarily of 5 factors
History
EKG
Age
Risk Factors
Troponin Results

8. HEART Score
Risk factors encompass: hypercholesterolemia, hypertension, diabetes mellitus, cigarette smoking, family history, obesity

9. HEART Score
HEART score of 0-3 points, indicated a 6 week risk of MACE of 1.6%. Possibly early discharge.
HEART score of 4-6 points, indicated a 6 week risk of MACE of 13%.
HEART score ≥ 7 points, indicated a 6 week risk of MACE of 50%.

10. HEART Score/Pathway

11. What’s Some Of The Evidence??? Three Trials
1) A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013
2) Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013
3) The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015

12. A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department Int J Cardiology, 2013

13. A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013
Prospective randomized trial of patients presenting to 10 different Netherlands emergency departments with the chief complaint of chest pain.
2,388 patients were enrolled. All STEMIS were excluded.
The HEART Score was compared to the TIMI and GRACE scores in their ability to diagnose AMI.
Primary endpoint was the occurrence of major adverse cardiac events (MACE) in 6 weeks.
Secondary endpoints
The occurrence of AMI and death
ACS
The performance of a coronary angiogram

14. A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013

15. What did they find? TIMI scores of 0-1, 6 week MACE was 2.8%
A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013
What did they find?
TIMI scores of 0-1, 6 week MACE was 2.8%
GRACE scores 0-60, 6 week MACE was 2.9%
HEART score (NOT pathway) 0-3, 6 week MACE was 1.7%

16. A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013
What did they find?

17. A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013
Author’s Conclusion?
The HEART score performed significantly better (p <0.001) as compared with TIMI and GRACE in the primary endpoint of MACE in 6 weeks.
Not only did the HEART score perform statistically better, but it is the only of the three scores particularly designed to risk stratify patients in the emergency department as opposed to the inpatient cardiac care unit.

18. A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013
And…..
The HEART Score performed statistically better than TIMI and GRACE (p <0.001) in all three secondary endpoints as well.
The HEART Score retained its discriminative ability in three relevant subgroups in which ACS diagnosis can be tricky!
Diabetics
Females
Elderly over 65 years of age

19. A Prospective Validation of the HEART Score for Chest Pain Patients At The Emergency Department, Int J Cardiology, 2013
And…… And…..
This study used the HEART score, instead of the also prospectively validated HEART Pathway (HEART score with a 3 hour repeat troponin).
Studies of the HEART Pathway among patients presenting with chest pain have demonstrated % sensitivity and % NPV for MACE at 30 days. (Mahler, "Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events?" Critical Pathway Cardiology, 2011; 10: ; PUBMED: )

21. Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain Int J Cardiology, 2013

22. Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013
Retrospective study by Mahler (one of the main pioneers of the HEART score) of 1005 patients presenting to 18 different US EDs over a 2 year time period.
Subjects had to be greater than 18 with symptoms suggestive of ACS starting within 6 hours, in whom the physician planned objective cardiac testing (i.e. the very low risk chest pain patients weren't even included in the sample study).
Coronary angiography, CT coronary angiography, stress testing, cardiac MRI, or echo.
Primary outcome was rate of ACS within 30 days of presentation defined as cardiac death, AMI, and unstable angina.

23. Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013
Definition of AMI was a typical rise and gradual fall of troponin with at least one of the following: ischemic symptoms, development of pathological ECG Q waves, ECG changes indicative of ischemia, or coronary revascularization.
UA was defined by ischemia confirmed by ECG ST-segment changes with recurrent symptoms or a troponin elevation that did not meet AMI criteria with either >70% coronary stenosis on coronary angiography, or inducible ischemia with stress testing if catheterization was not performed.

24. Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013
The study evaluated the difference in clinical utility of three different pathways to identify acute chest pain patients able to be discharged early without stress testing or cardiac imaging with an acceptable miss rate of less than 1%:
“Unstructured assessment”
North American Chest Pain Rule (NACPR)
Heart PATHWAY (HEART score with a 3 hour repeat troponin).

25. Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013
The study population had an ACS event at index visit or within 30 days of 22%.
Unstructured assessment identified 13.5% of participants for early discharge with a 98% sensitivity for ACS.
NACPR identified 4.4% for early discharge with 100% sensitivity for ACS.
HEART pathway identified 20% for early discharge with a 99% sensitivity for ACS.

26. Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013

27. Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013
Interesting and scary
Serial troponins alone at 0 and 3 hours had a sensitivity of 56% and would have missed 98 patients with ACS at 30 days in this study.
Addition of a decision rule resulted in an absolute increase in sensitivity of 42-44% for 30 day ACS!
But again, remember that in this study eligibility required patients identified by their providers as needing objective cardiac testing….. hence the high event rate of 22%.

28. Author’s Conclusions:
Identifying Patients For Early Discharge: Performance of Decision Rules Among Patients With Acute Chest Pain, Int J Cardiology, 2013
Author’s Conclusions:
Researchers concluded that the HEART pathway was better than the NACPR and simple physician judgment in deciding which patients could be safely discharged home without advanced cardiac testing without sacrificing any missed MACE cases at 30 days.
Researcher went on to say that "the HEART pathway has demonstrated a miss rate of 0% and 0.2% in two separate analyses with over 2000 patients".

30. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge Circulation, 2015

31. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
Trial by Mahler again (Wake Forest Baptist Medical Center), randomizing 282 patients to either the HEART Pathway (HEART score with a 3 hour repeat troponin) or “usual care” (following ACC/AHA guidelines) in the treatment chest pain patients presenting to the ED.
All STEMI’s were excluded

32. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
HEART PATHWAY ARM – For patients with a score of 0-3 and negative serial troponins, the physicians were encouraged to discharge their patients and have them follow up with their primary care providers.
Score of 4 or more, or elevated troponin, they were encouraged to admit for observation or objective cardiac testing.
Usual Care – providers were encouraged to follow the ACC/AHA guidelines.

33. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015

34. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
Care delivered in both randomization arms was ultimately determined by provider discretion and not mandated by the trial protocol.
The HEART Pathway was used by providers, in a manner consistent with its intent, as a decision aid rather than a substitute for clinical judgment.
Patients randomized to the HEART Pathway received a second HEART score assessment by an attending physician study investigator blinded to the initial assessment by the patient’s attending physician.
Based on their Institutional Review Board recommendations, if a disagreement occurred in which the attending provider determined the patient to be low-risk, but the study investigator found the patient to be high-risk, the attending provider was made aware of this discrepancy.

35. Secondary outcomes included
The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
Primary outcome was the rate of objective cardiac testing within 30 days of presentation, defined as the proportion of patients receiving any stress testing modality, coronary computed tomographic angiography, or invasive coronary angiography at the index visit or within 30 days as well as the presence of a 30 day MACE event.
Secondary outcomes included
Early discharge rate
Index LOS
Cardiac-related recurrent ED visits and non-index hospitalization at 30 days.
Early discharge was defined as discharge from the ED without objective cardiac testing. Hospitalization was defined as bedding a patient to an OU or inpatient ward in observation or inpatient status.

36. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
RESULTS:
Patients randomized to the HEART Pathway had a 30-day objective cardiac testing rate of 56.7% (80/141) compared with a rate of 68.8% (97/141) in the usual care group: an absolute reduction of 12.1% (P=0.048).
Early discharge occurred in 39.7% (56/141) of patients in the HEART Pathway arm compared with 18.4% (26/141): an absolute increase of 21.3% (P<0.001).
Patients in the HEART Pathway group had a median LOS of 9.9 hours compared with 21.9 hours in the usual care group: a median reduction in LOS of 12 hours (P=0.013).

37. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
RESULTS:
Within the HEART Pathway arm, 2.8% (4/141) had cardiac-related repeat ED visits compared with 4.3% (6/141) in the usual care arm (P=0.75). Cardiac-related non-index hospitalizations occurred in 3.6% (5/141) of patients in the HEART Pathway arm compared with 2.8% (4/141) in the usual care arm (P>0.999).
No patients identified for early discharge had missed MACE in either group during the 30-day follow-up period. No patients identified as low-risk by the HEART Pathway had an index or non-index MACE. Index MACE occurred in 5.7% (8/141) patients in the HEART Pathway arm compared with 6.4% (9/141) in the usual care arm (P=1).

38. The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
RESULTS:
Non-adherence to the HEART Pathway occurred in 29% (19/66) of low-risk patients and 13% of (9/75) high-risk patients.
But NONE of the 19 low-risk patients had MACE at index or 30 days.
Perfect adherence among high- and low-risk patients would have increased the early discharge rate to 46.8% (66/141).

39. In summary, following the HEART pathway in this study:
The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
In summary, following the HEART pathway in this study:
Objective cardiac testing at 30 days decreased by 12.1 percent
Length of stay dropped by 12 hours
Early discharges increased by 21.3%
6% of patients had a major adverse cardiac event (MACE) within 30 days but this occurred in NO patients that were discharged.

40. Furthermore, this group was not a “low” risk group!
The HEART Pathway Randomized Trial - Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge, Circulation, 2015
Furthermore, this group was not a “low” risk group!
Almost 20 percent of the study group enrolled had a previous history of MI, PCI, or CABG.

41. So What Are We Doing At Wakemed?