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Identifying low-risk patients within the observation zone of a 0/2-h high-sensitivity troponin diagnostic protocol
Daniel D DiLena1, Jie Huang1, Adina S Rauchwerger1
1Kaiser Permanente Northern California Division of Research, Pleasanton, CA, United States of America.
Insights
Clinical risk scores like HEART and EDACS-ADP are less effective than objective testing for stratifying intermediate-risk acute coronary syndrome patients. Objective testing offers higher efficacy in identifying low-risk individuals, but requires careful consideration of the miss rate.
Area of Science:
- Cardiology
- Emergency Medicine
- Diagnostic Protocols
Background:
- Accelerated diagnostic protocols using high-sensitivity cardiac troponin (hs-cTn) for suspected acute coronary syndrome (ACS) often classify patients as intermediate-risk.
- This intermediate-risk group, or "observation zone," necessitates further risk stratification according to expert consensus.
Purpose of the Study:
- To evaluate the test characteristics and efficacy of the HEART pathway and EDACS-ADP in risk stratifying intermediate-risk ACS patients.
- To compare the performance of clinical risk strategies versus objective testing in excluding 30-day myocardial infarction (MI) or death.
Main Methods:
- Retrospective cohort study of 11,178 adult chest pain encounters in community emergency departments (EDs).
- Assessed HEART pathway and EDACS-ADP efficacy in patients classified as intermediate-risk by a 0/2-h hs-cTnI protocol.
- Compared clinical risk strategies with objective testing (hs-cTnI, ECG) and ED discharge disposition.
Main Results:
- Both HEART and EDACS-ADP showed high negative predictive value (NPV) but low efficacy (8-14%) in identifying low-risk patients.
- Objective testing (hs-cTnI <99th percentile and non-ischemic ECG) demonstrated higher efficacy (31%) with a slightly lower NPV (98.2%).
- ED discharge disposition had the highest efficacy (57%) with a comparable NPV (98.1%).
Conclusions:
- While HEART and EDACS-ADP identify patients with a low risk of 30-day MI/death (≤1%), their efficacy in classifying patients as low-risk is limited.
- Objective testing and ED discharge disposition offer significantly higher efficacy but necessitate an acceptable miss rate of ≤2%.
- The findings suggest a need to reconsider risk stratification strategies for intermediate-risk ACS patients in the ED.
Background:
High-sensitivity cardiac troponin (hs-cTn) based accelerated diagnostic protocols for suspected acute coronary syndrome (ACS) in the emergency department (ED) can classify up to 40 % of patients as intermediate-risk (the "observation zone"). Expert consensus pathways recommend further risk stratification with additional hs-cTn testing and clinical risk scores.
Methods:
We conducted a retrospective cohort study of adult encounters for chest pain across 21 community EDs from January 1, 2023, to June 30, 2024. We assessed the test characteristics and efficacy (proportion identified as low risk) of two clinical risk strategies [History, ECG, Age, Risk Factors, and Troponin (HEART) pathway or the ED Assessment of Chest Pain Score Accelerated Diagnostic Pathway (EDACS-ADP)] in excluding 30-day myocardial infarction (MI) or death among patients classified as intermediate-risk by a 0/2-h hs-cTnI diagnostic protocol (Beckman Access hsTnI).
Results:
We identified 11,178 intermediate-risk encounters, of which 789 (7.1 %) had 30-day MI or death. Both clinical risk strategies had high negative predictive value (NPV; EDACS-ADP 99.1 %, 95 % CI 98.5-99.4 %; HEART pathway 99.0 %, 95 % CI 98.1-99.5 %) but also low efficacy (14 % and 8 %, respectively). In contrast, objective testing alone (hs-cTnI <99th percentile and non-ischemic ECG) and ED discharge disposition had higher efficacy (31 % and 57 %) with slightly lower NPV (98.2 % and 98.1 %, respectively).
Conclusion:
Both EDACS-ADP and the HEART pathway identified intermediate-risk patients with ≤1 % risk of 30-day MI or death, but with low efficacy. Objective testing or ED discharge disposition had notably higher efficacy, but require an acceptable "miss-rate" of ≤2 %.
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