Safety and Effectiveness of the High-Sensitivity Cardiac Troponin HEART Pathway in Patients With Possible Acute Coronary Syndrome.

BACKGROUND: The HEART Pathway (History, Electrocardiogram, Age, Risk factors, Troponin) can be used with high-sensitivity cardiac troponin to risk stratify emergency department patients with possible acute coronary syndrome. However, data on whether a high-sensitivity HEART Pathway (hs-HP) are safe and effective is lacking. METHODS: An interrupted time series study was conducted at 5 North Carolina sites in 26 126 adult emergency department patients being investigated for possible acute coronary syndrome and without ST-segment-elevation myocardial infarction. Patients were accrued into 16-month preimplementation and postimplementation cohorts with a 6-month wash-in phase. Preimplementation (January 2019 to April 2020), the traditional HEART Pathway was used with 0- and 3-hour contemporary troponin measures (Siemens). In the postimplementation period (November 2020 to February 2022), a modified hs-HP was used with 0- and 2-hour high-sensitivity cardiac troponin (Beckman Coulter) measures. The primary safety and effectiveness outcomes were 30-day all-cause death or myocardial infarction and 30-day hospitalizations. These outcomes and early discharge rate (emergency department discharge without stress testing or coronary angiography) were determined from health records and death index data. Outcomes were compared preimplementation versus postimplementation using χ2 tests and multivariable logistic regression to adjust for potential confounders. RESULTS: Preimplementation and postimplementation cohorts included 12 317 and 13 809 patients, respectively, of them 52.7% (13 767/26 126) were female with a median age of 54 years (interquartile range, 42-66). Rates of 30-day death or MI were 6.8% (945/13 809) postimplementation and 7.7% (948/12 317) preimplementation (adjusted odds ratio, 1.00 [95% CI, 0.90-1.11]). hs-HP implementation was associated with 19.9% (95% CI, 18.7%-21.1%) higher early discharges (post versus pre: 63.6% versus 43.7%; adjusted odds ratio, 2.22 [95% CI, 2.10-2.35]). The hs-HP was also associated with 16.1% (95% CI, 14.9%-17.3%) lower 30-day hospitalizations (postimplementation versus preimplementation, 31.4% versus 47.5%; adjusted odds ratio, 0.51 [95% CI, 0.48-0.54]). Among early discharge patients, death or myocardial infarction occurred in 0.5% (41/8780) postimplementation versus 0.4% (22/5383) preimplementation (P=0.61). CONCLUSIONS: hs-HP implementation is associated with increased early discharges without increasing adverse events. These findings support the use of a modified hs-HP to improve chest pain care.

Performance of Prehospital Use of Chest Pain Risk Stratification Tools: The RESCUE Study.

BACKGROUND: Emergency medical services (EMS) assesses millions of patients with chest pain each year. However, tools validated to risk stratify patients for acute coronary syndrome (ACS) and pulmonary embolism (PE) have not been translated to the prehospital setting. The objective of this study is to assess the prehospital performance of risk stratification scores for 30-day major adverse cardiac events (MACE) and PE. METHODS: A prospective observational cohort study of patients ≥21 years of age with acute chest pain who were transported by EMS in two North Carolina (NC) counties was conducted from 18 April 2018-2 January 2019. In this convenience sample, paramedics completed HEAR (history, electrocardiogram, age, risk factor), ED Assessment of Chest Pain Score (EDACS), Revised Geneva Score (RGS), and pulmonary embolism rule-out criteria (PERC) assessments on each patient. MACE (all-cause death, myocardial infarction, and revascularization) and PE at 30 days were determined by hospital records and NC Death Index. The positive (+LR) and negative likelihood ratios (-LR) of the risk scores for 30-day MACE and PE were calculated. RESULTS: During the study period, 82.1% (687/837) patients had all four risk score assessments. The cohort was 51.1% (351/687) female, 49.5% (340/687) African American, and had a mean age of 55.0 years (SD 16.0). At 30 days, MACE occurred in 7.4% (51/687), PE occurred in 0.9% (6/687), and the combined outcome occurred in 8.2% (56/687). The HEAR score had a - LR of 0.46 (95% CI 0.27-0.78) and + LR of 1.48 (95% CI 1.26-1.74) for 30-day MACE. EDACS had a - LR of 0.61 (95% CI 0.46-0.81) and + LR of 2.53 (95% CI 1.86-3.46) for 30-day MACE. The PERC score had a - LR of 0 (95% CI 0.0-1.4) and a + LR of 1.38 (95% CI 1.32-1.45) for 30-day PE. The RGS score had a - LR of 0 (95% CI 0.0-0.65) and a + LR of 2.36 (95% CI 2.16-2.57) for 30-day PE. The combination of a low-risk HEAR score and negative PERC evaluation had a - LR of 0.25 (95% CI 0.08-0.76) and a + LR of 1.21 (95% CI 1.21-1.30) for 30-day MACE or PE. CONCLUSION: The combination of a paramedic-obtained HEAR score and PERC evaluation performed best to exclude 30-day MACE and PE but was not sufficient for directing prehospital decision making.

Rural and socioeconomic differences in the effectiveness of the HEART Pathway accelerated diagnostic protocol.

BACKGROUND: The HEART Pathway is a validated accelerated diagnostic protocol (ADP) for patients with possible acute coronary syndrome (ACS). This study aimed to compare the safety and effectiveness of the HEART Pathway based on patient rurality (rural vs. urban) or socioeconomic status (SES). METHODS: We performed a preplanned subgroup analysis of the HEART Pathway Implementation Study. The primary outcomes were death or myocardial infarction (MI) and hospitalization at 30 days. Proportions were compared by SES and rurality with Fisher's exact tests. Logistic regression evaluated for interactions of ADP implementation with SES or rurality and changes in outcomes within subgroups. RESULTS: Among 7245 patients with rurality and SES data, 39.9% (2887/7245) were rural and 22.2% were low SES (1607/7245). The HEART Pathway identified patients as low risk in 32.2% (818/2540) of urban versus 28.1% (425/1512) of rural patients (p = 0.007) and 34.0% (311/915) of low SES versus 29.7% (932/3137) high SES patients (p = 0.02). Among low-risk patients, 30-day death or MI occurred in 0.6% (5/818) of urban versus 0.2% (1/425) rural (p = 0.67) and 0.6% (2/311) with low SES versus 0.4% (4/932) high SES (p = 0.64). Following implementation, 30-day hospitalization was reduced by 7.7% in urban patients (adjusted odds ratio [aOR] 0.76, 95% confidence interval [CI] 0.66-0.87), 10.6% in low SES patients (aOR 0.68, 95% CI 0.54-0.86), and 4.5% in high SES patients (aOR 0.83, 95% CI 0.73-0.94). However, rural patients had a nonsignificant 3.3% reduction in hospitalizations. CONCLUSIONS: HEART Pathway implementation decreased 30-day hospitalizations regardless of SES and for urban patients but not rural patients. The 30-day death or MI rate was similar among low-risk patients.

Derivation and validation of a high sensitivity troponin-T HEART pathway.

BACKGROUND: The HEART Pathway is widely used for chest pain risk stratification but has yet to be optimized for high sensitivity troponin T (hs-cTnT) assays. METHODS: We conducted a secondary analysis of STOP-CP, a prospective cohort study enrolling adult ED patients with symptoms suggestive of acute coronary syndrome at 8 sites in the United States (US). Patients had a 0- and 1-hour hs-cTnT measured and a HEAR score completed. A derivation set consisting of 729 randomly selected participants was used to derive a hs-cTnT HEART Pathway with rule-out, observation, and rule-in groups for 30-day cardiac death or myocardial infarction (MI). Optimal baseline and 1-hour troponin cutoffs were selected using generalized cross validation to achieve a negative predictive value (NPV) >99% for rule out and positive predictive value (PPV) >60% or maximum Youden index for rule-in. Optimal 0-1-hour delta values were derived using generalized cross validation to maximize the NPV for the rule-out group and PPV for the rule-in group. The hs-cTnT HEART Pathway performance was validated in the remaining cohort (n = 723). RESULTS: Among the 1452 patients, 30-day cardiac death or MI occurred in 12.7% (184/1452). Within the derivation cohort the optimal hs-cTnT HEART Pathway classified 36.5% (266/729) into the rule-out group, yielding a NPV of 99.2% (95% CI: 98.2-100) for 30-day cardiac death or MI. The rule-in group included 15.4% (112/729) with a PPV of 55.4% (95% CI: 46.2-64.6). In the validation cohort, the hs-cTnT HEART Pathway ruled-out 37.6% (272/723), of which 2 had 30-day cardiac death or MI, yielding a NPV of 99.3% (95% CI: 98.3-100). The rule-in group included 14.5% (105/723), yielding a PPV of 57.1% (95% CI: 47.7-66.6). CONCLUSIONS: A novel hs-cTnT HEART Pathway with serial 0- and 1-hour hs-cTnT measures has high NPV and moderate PPV for 30-day cardiac death or MI.

Prehospital Comparison of the HEAR and HE-MACS Scores for 30-Day Adverse Cardiac Events.

OBJECTIVE: The History, Electrocardiogram (ECG), Age, and Risk factor (HEAR) and History and ECG-only Manchester Acute Coronary Syndromes (HE-MACS) risk scores can risk stratify chest pain patients without troponin measures. The objective of this study was to determine if either risk score could achieve the ≥99% negative predictive value (NPV) required to rule out major adverse cardiovascular events (MACE; a composite of all-cause death, myocardial infarction, or coronary revascularization) at 30 days or the ≥50% positive predictive value (PPV) indicative of a patient possibly needing interventional cardiology. METHODS: We performed a pre-planned secondary analysis of the prospective multisite PARAHEART (n = 462, 12/2016-1/2018) and RESCUE (n = 767, 4/2018-1/2019) trials, which accrued adults ≥21 years old with acute non-traumatic chest pain transported by emergency medical services (EMS). Paramedics prospectively completed risk assessment forms. Very low risk was defined by a HEAR score of 0-1 or HE-MACS probability <4%. The primary outcome was 30-day MACE, which was determined by adjudication (PARAHEART) or electronic record review (RESCUE). NPV and PPV with exact 95% confidence intervals (95%CI) for 30-day MACE were calculated for each risk score and compared using McNemar's tests. RESULTS: Among the PARAHEART and RESCUE cohorts, 30-day MACE occurred in 18.8% (87/462) and 6.9% (53/767) of patients, respectively. In PARAHEART, 7.8% (36/462) were very low risk by HEAR score vs. 7.8% (36/462) by HE-MACS (p = 1.0). The HEAR score had a NPV of 97.2% (95%CI 91.9-100.0) vs. 91.7% (95%CI 82.6-100.0) for HE-MACS (p = 0.15). The HEAR and HE-MACS PPVs were similar [46.4% (95%CI 28.0-64.9) vs. 33.3% (95%CI 13.2-53.5) (p = 0.26)]. In RESCUE, the HEAR score identified 14.2% (109/767) as low risk compared to 8.3% (64/767) by HE-MACS (p < 0.001). In this cohort, the HEAR and HE-MACS scores had similar NPVs [98.2% (95%CI 95.7-100.0) vs. 98.4% (95%CI 95.4-100.0) (p = 0.89)] and PPVs [16.2% (95%CI 6.2-32.0) vs. 22.6% (95%CI 12.3-36.2) (p = 0.41)]. CONCLUSIONS: In two prehospital chest pain cohorts, neither the HEAR score nor HE-MACS achieved sufficient NPV or PPV to rule out or rule in 30-day MACE.

Age differences in the safety and effectiveness of the HEART Pathway accelerated diagnostic protocol for acute chest pain.

BACKGROUND: The HEART Pathway is a validated protocol for risk stratifying emergency department (ED) patients with possible acute coronary syndrome (ACS). Its performance in different age groups is unknown. The objective of this study is to evaluate its safety and effectiveness among older adults. METHODS: A pre-planned subgroup analysis of the HEART Pathway implementation study was conducted. This prospective interrupted time series accrued adult ED patients with possible ACS who were without ST-elevation across three US sites from 11/2013-01/2016. After implementation, providers prospectively used the HEART Pathway to stratify patients as low-risk or non-low-risk. Patients were classified as older adults (≥65 years), middle-aged (46-64 years), and young (21-45 years). Primary safety and effectiveness outcomes were 30-day death or MI and hospitalization at 30 days, determined from health records, insurance claims, and death index data. Fisher's exact test compared low-risk proportions between groups. Sensitivity for 30-day death or MI and adjusted odds ratios (aORs) for hospitalization and objective cardiac testing were calculated. RESULTS: The HEART Pathway implementation study accrued 8474 patients, of which 26.9% (2281/8474) were older adults, 45.5% (3862/8474) middle-aged, and 27.5% (2331/8474) were young. The HEART Pathway identified 7.4% (97/1303) of older adults, 32.0% (683/2131) of middle-aged, and 51.4% (681/1326) of young patients as low-risk (p < 0.001). The HEART Pathway was 98.8% (95% CI 97.1-100) sensitive for 30-day death or MI among older adults. Following implementation, the rate of 30-day hospitalization was similar among older adults (aOR 1.25, 95% CI 1.00-1.55) and cardiac testing increased (aOR 1.25, 95% CI 1.04-1.51). CONCLUSION: The HEART Pathway identified fewer older adults as low-risk and did not decrease hospitalizations in this age group.

Major adverse cardiac event rates in moderate-risk patients: Does prior coronary disease matter?

BACKGROUND: Despite negative troponins and nonischemic electrocardiograms (ECGs), patients at moderate risk for acute coronary syndrome (ACS) are frequently admitted. The objective of this study was to describe the major adverse cardiac event (MACE) rate in moderate-risk patients and how it differs based on history of coronary artery disease (CAD). METHODS: A secondary analysis of the HEART Pathway implementation study was conducted. This prospective interrupted time-series study accrued adults with possible ACS from three sites (November 2013-January 2016). This analysis excluded low-risk patients determined by emergency providers' HEART Pathway assessments. Non-low-risk patients were further classified as high risk, based on elevated troponin measures or ischemic ECG findings or as moderate risk, based on HEAR score ≥ 4, negative troponin measures, and a nonischemic ECG. Moderate-risk patients were then stratified by the presence or absence of prior CAD (MI, revascularization, or ≥70% coronary stenosis). MACE (death, myocardial infarction, or revascularization) at 30 days was determined from health records, insurance claims, and death index data. MACE rates were compared among groups using a chi-square test and likelihood ratios (LRs) were calculated. RESULTS: Among 4,550 patients with HEART Pathway assessments, 24.8% (1,130/4,550) were high risk and 37.7% (1715/4550) were moderate risk. MACE at 30 days occurred in 3.1% (53/1,715; 95% confidence interval [CI] = 2.3% to 4.0%) of moderate-risk patients. Among moderate-risk patients, MACE occurred in 7.1% (36/508, 95% CI = 5.1% to 9.8%) of patients with known CAD versus 1.4% (17/1,207, 95% CI = 0.9% to 2.3%) in patients without known prior CAD (p < 0.0001). The negative LR for 30-day MACE among moderate-risk patients without prior CAD was 0.08 (95% CI = 0.05 to 0.12). CONCLUSION: MACE rates at 30 days were low among moderate-risk patients but were significantly higher among those with prior CAD.