The HEART Pathway Randomized Controlled Trial One-year Outcomes.

OBJECTIVE: The objective was to determine the impact of the HEART Pathway on health care utilization and safety outcomes at 1 year in patients with acute chest pain. METHODS: Adult emergency department (ED) patients with chest pain (N = 282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, ED providers used the HEART score and troponin measures (0 and 3 hours) to risk stratify patients. Usual care was based on American College of Cardiology/American Heart Association guidelines. Major adverse cardiac events (MACE-cardiac death, myocardial infarction [MI], or coronary revascularization), objective testing (stress testing or coronary angiography), and cardiac hospitalizations and ED visits were assessed at 1 year. Randomization arm outcomes were compared using Fisher's exact tests. RESULTS: A total of 282 patients were enrolled, with 141 randomized to each arm. MACE at 1 year occurred in 10.6% (30/282): 9.9% in the HEART Pathway arm (14/141; 10 MIs, four revascularizations without MI) versus 11.3% in usual care (16/141; one cardiac death, 13 MIs, two revascularizations without MI; p = 0.85). Among low-risk HEART Pathway patients, 0% (0/66) had MACE, with a negative predictive value (NPV) of 100% (95% confidence interval = 93%-100%). Objective testing through 1 year occurred in 63.1% (89/141) of HEART Pathway patients compared to 71.6% (101/141) in usual care (p = 0.16). Nonindex cardiac-related hospitalizations and ED visits occurred in 14.9% (21/141) and 21.3% (30/141) of patients in the HEART Pathway versus 10.6% (15/141) and 16.3% (23/141) in usual care (p = 0.37, p = 0.36). CONCLUSIONS: The HEART Pathway had a 100% NPV for 1-year safety outcomes (MACE) without increasing downstream hospitalizations or ED visits. Reduction in 1-year objective testing was not significant.

Adherence to an Accelerated Diagnostic Protocol for Chest Pain: Secondary Analysis of the HEART Pathway Randomized Trial.

OBJECTIVES: Accelerated diagnostic protocols (ADPs), such as the HEART Pathway, are gaining popularity in emergency departments (EDs) as tools used to risk stratify patients with acute chest pain. However, provider nonadherence may threaten the safety and effectiveness of ADPs. The objective of this study was to determine the frequency and impact of ADP nonadherence. METHODS: A secondary analysis of participants enrolled in the HEART Pathway RCT was conducted. This trial enrolled 282 adult ED patients with symptoms concerning for acute coronary syndrome without ST-elevation on electrocardiogram. Patients randomized to the HEART Pathway (N = 141) were included in this analysis. Outcomes included index visit disposition, nonadherence, and major adverse cardiac events (MACEs) at 30 days. MACE was defined as death, myocardial infarction, or revascularization. Nonadherence was defined as: 1) undertesting-discharging a high-risk patient from the ED without objective testing (stress testing or coronary angiography) or 2) overtesting-admitting or obtaining objective testing on a low-risk patient. RESULTS: Nonadherence to the HEART Pathway occurred in 28 of 141 patients (20%, 95% confidence interval [CI] = 14% to 27%). Overtesting occurred in 19 of 141 patients (13.5%, 95% CI = 8% to 19%) and undertesting in nine of 141 patients (6%, 95% CI = 3% to 12%). None of these 28 patients suffered MACE. The net effect of nonadherence was 10 additional admissions among patients identified as low-risk and appropriate for early discharge (absolute decrease in discharge rate of 7%, 95% CI = 3% to 13%). CONCLUSIONS: Real-time use of the HEART Pathway resulted in a nonadherence rate of 20%, mostly due to overtesting. None of these patients had MACE within 30 days. Nonadherence decreased the discharge rate, attenuating the HEART Pathway's impact on health care use.

The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge.

BACKGROUND: The HEART Pathway is a decision aid designed to identify emergency department patients with acute chest pain for early discharge. No randomized trials have compared the HEART Pathway with usual care. METHODS AND RESULTS: Adult emergency department patients with symptoms related to acute coronary syndrome without ST-elevation on ECG (n=282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, emergency department providers used the HEART score, a validated decision aid, and troponin measures at 0 and 3 hours to identify patients for early discharge. Usual care was based on American College of Cardiology/American Heart Association guidelines. The primary outcome, objective cardiac testing (stress testing or angiography), and secondary outcomes, index length of stay, early discharge, and major adverse cardiac events (death, myocardial infarction, or coronary revascularization), were assessed at 30 days by phone interview and record review. Participants had a mean age of 53 years, 16% had previous myocardial infarction, and 6% (95% confidence interval, 3.6%-9.5%) had major adverse cardiac events within 30 days of randomization. Compared with usual care, use of the HEART Pathway decreased objective cardiac testing at 30 days by 12.1% (68.8% versus 56.7%; P=0.048) and length of stay by 12 hours (9.9 versus 21.9 hours; P=0.013) and increased early discharges by 21.3% (39.7% versus 18.4%; P<0.001). No patients identified for early discharge had major adverse cardiac events within 30 days. CONCLUSIONS: The HEART Pathway reduces objective cardiac testing during 30 days, shortens length of stay, and increases early discharges. These important efficiency gains occurred without any patients identified for early discharge suffering MACE at 30 days. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01665521.