Effectiveness and Safety of the European Society of Cardiology 0-/1-h Troponin Rule-Out Protocol: The Design of the ESC-TROP Multicenter Implementation Study

Chest pain is one of the most common complaints at the emergency department (ED), and it is commonly the perceived likelihood of acute coronary syndrome (ACS) that drives management. Guidelines from the European Society of Cardiology (ESC) recommend the use of a 0-/1-h high-sensitivity cardiac troponin T (hs-cTnT) protocol to rule out or in ACS, but this is mostly based on observational studies. The aim of the ESC-TROP trial is to determine the safety and effectiveness of the ESC 0-/1-h hs-cTnT protocol when implemented in routine care. Adult chest pain patients at 5 EDs in the Skåne Region, Sweden, are included in the trial. The 0-/1-h hs-cTnT ESC protocol supplemented with clinical assessment and electrocardiography (ECG) is implemented at 3 EDs, and the other 2 EDs act as concurrent controls. Outcomes will be evaluated during the 10 months after the implementation and the corresponding 10 months of the previous year. The 2 co-primary outcomes are (a) acute myocardial infarction (AMI) and all-cause death within 30 days in patients discharged from the ED, and (b) ED length of stay of the same patients. Secondary outcomes include the proportion of chest pain patients discharged from the ED and the number of ruled-out patients undergoing objective testing within 30 days. The ESC-TROP trial will determine the performance and applicability of the 0-/1-h hs-cTnT ESC protocol supplemented with clinical assessment and ECG when implemented in routine ED care. It will provide evidence whether 0-/1-h hs-cTnT testing is safe, effective, and feasible, and whether widespread implementation as recommended by ESC guidelines should be supported.

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PL001: Derivation of a 2-hour high-sensitivity troponin T algorithm for rapid rule-out of acute myocardial infarction in emergency department chest pain patients

CJEM ◽

10.1017/cem.2016.34 ◽

2016 ◽

Vol 18 (S1) ◽

pp. S29-S29

Author(s):

A. McRae ◽

Y. Ji ◽

H. Yang ◽

D. Southern ◽

D. Wang ◽

...

Keyword(s):

Chest Pain ◽

Troponin T ◽

High Sensitivity ◽

Early Discharge ◽

Coronary Syndrome ◽

Test Characteristics ◽

High Sensitivity Troponin T ◽

Testing Algorithm ◽

Pain Patients ◽

Rule Out

Introduction: Chest pain and symptoms of acute coronary syndrome are responsible for a large proportion of ED visits and acute hospitalizations. However, only about 15% of patients presenting to the ED with high-risk symptoms do, in fact, have an acute coronary syndrome. The objective of this study is to derive a 2-hour high-sensitivity Troponin T (hsTnT) testing algorithm with outcome based-cutoffs to rapidly rule out acute myocardial infarction (AMI) in a large proportion of ED chest pain patients. Methods: Patients included consecutive ED patients with a chief complaint of cardiac chest pain who had an hsTnT assay performed at ED arrival and 2 hours after ED arrival. Administrative databases were queried to identify troponin results and major adverse cardiac outcomes (MACE) including death, MI, and revascularization. Test characteristics of iterative combinations of initial troponin level and absolute change in troponin level were quantified in order to identify the testing algorithm that identified the greatest proportion of patients eligible for early discharge while maintaining a target sensitivity of 98.5% for the primary outcome of 7-day AMI. Results: 755 eligible patients had hsTnT assays performed at ED arrival and at 2 hours. 91 patients (12.1%) had a 7-day AMI while 108 (14.0%) had 7-day MACE. An initial hsTnT level of less than 14 ng/L, in combination with a 2-hour absolute change of less than 10ng/L had a sensitivity of 98.9% (95% CI 94.0,99.8) and an NPV of 99.8% (95% CI 98.7, 100.0) for 7-day AMI. This identified 58.5% of all patients as being suitable for early discharge. Sensitivity and NPV for 7-day MACE were 90.0% (95% CI 83.3, 94.2) and 97.3% (95% CI 95.3,98.4) respectively. Sex-specific differences in test characteristics were not clinically important. Rule-in hsTnT cutoffs were also evaluated, with specificities ranging from 85-95%, although cutoffs with higher specificity had less ability to rapidly rule-in AMI, leaving more patients with indeterminate results after 2 hours. Conclusion: A hsTnT algorithm can safely and accurately rule out AMI in 58.5% of ED chest pain patients within 2 hours of ED arrival. The lower sensitivity of this algorithm for MACE compared to AMI speaks to the importance of clinical assessment and ECG findings in identifying patients at risk for acute coronary syndromes.

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3298Prehospital assessment of the one-hour rule-in/rule-out algorithm using a high-sensitivity cardiac troponin t assay in a low-prevalence population for acute coronary syndrome (OUT-ACS)

European Heart Journal ◽

10.1093/eurheartj/ehz745.0062 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

T R Johannessen ◽

D Atar ◽

S Halvorsen ◽

A C Larstorp ◽

I Mdala ◽

...

Keyword(s):

Primary Care ◽

Chest Pain ◽

Predictive Value ◽

Cardiac Troponin ◽

Troponin T ◽

High Sensitivity ◽

Cardiac Troponin T ◽

Emergency Setting ◽

Coronary Syndrome ◽

Rule Out

Abstract Background The majority of patients with chest pain in Norway initially present to the primary health care system, which serves to triage them to the specialist health care services including hospitals. In some emergency primary care institutions, patients who are not hospitalised directly undergo further diagnostic testing to rule out acute myocardial infarction (AMI). Purpose Several studies have shown the advantage of using high-sensitivity assays for fast interpretation of cardiac troponins. The majority of these studies included patient populations from hospital emergency departments. In contrast, we aimed to investigate whether the 1-hour algorithm for high-sensitivity cardiac troponin T (hs-cTnT) is safe and useful for implementation in a primary care emergency setting where the patients have a much lower pre-test probability for an acute coronary syndrome. Methods In this prospective cohort study, we included 1672 patients with acute non-specific chest pain from November 2016 to October 2018 at a primary care emergency outpatient clinic in Norway. Serial hs-cTnT samples were analysed after 0, 1 and 4 hours on the Cobas 8000 e602 analyzer. We divided the results into one of three groups (rule-out, rule-in, or further observation), according to the 0/1-hour algorithm for hs-cTn from the current ESC guidelines on non-ST-elevation myocardial infarction. In the rule-out group, the 0/1-hour results were compared to the standard 4-hour hs-cTnT. Final hospital diagnoses were collected as a gold standard for the patients in the rule-in group. Results A total of 44 (2.6%) of 1672 patients were diagnosed with AMI. By applying the algorithm, 1274 (76.2%) patients were assigned to the rule-out group. One of the rule-out patients had a significant increase in hs-cTnT in the 4-hour sample. This results in a sensitivity for AMI of 97.7% (95% confidence interval [CI] 88.0–99.9) and negative predictive value of 99.9% (95% CI 99.6–100.0). There were 50 (3.0%) patients in the rule-in group, amongst whom 35 had a verified AMI. This gives a specificity for AMI of 99.1% (95% CI 98.5–99.5) and a positive predictive value at 70.0% (95% CI 55.4–82.1). Among the 348 (20.8%) patients assigned to further observation, eight patients had an AMI. The 15 rule-in patients who did not have an AMI, had other acute illnesses that required further diagnostic work-up at the hospital. Conclusions With a negative predictive value at 99.9%, the 1-hour algorithm for hs-cTnT seems safe and applicable for a faster assessment of patients with non-specific chest pain in a primary care emergency setting. Prehospital implementation of this algorithm may reduce the need for hospitalisation of these patients and hence may probably lower the costs. ClinicalTrial.gov identifier: NCT02983123 Acknowledgement/Funding Norwegian Research Fund for General Practice, The Norwegian Physicians' Association Fund for Quality Improvement and Patient Safety

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Diagnostic accuracy of the HEART Pathway and EDACS-ADP when combined with a 0-hour/1-hour hs-cTnT protocol for assessment of acute chest pain patients

Emergency Medicine Journal ◽

10.1136/emermed-2020-210833 ◽

2021 ◽

pp. emermed-2020-210833

Author(s):

Tsvetelina Nilsson ◽

Erik Johannesson ◽

Jakob Lundager Forberg ◽

Arash Mokhtari ◽

Ulf Ekelund

Keyword(s):

Chest Pain ◽

Risk Stratification ◽

Diagnostic Accuracy ◽

Troponin T ◽

Secondary Outcome ◽

Index Visit ◽

Heart Score ◽

Coronary Syndrome ◽

Pain Patients ◽

Rule Out

Background/aimIn ED chest pain patients, a 0-hour/1-hour protocol based on high sensitivity cardiac troponin T (hs-cTnT) tests combined with clinical risk stratification in diagnosing acute coronary syndrome is recommended. Two of the most promising risk stratification tools are the History, ECG, Age, Risk Factors and Troponin (HEART) and Emergency Department Assessment of Chest Pain (EDAC) scores. Few studies have assessed the diagnostic accuracy of the 0-hour/1-hour hs-cTnT protocol when combined with HEART score, and none with EDACS. In ED chest pain patients, we aimed to evaluate the diagnostic accuracy of a 0-hour/1-hour hs-cTnT protocol combined the HEART Pathway, or the EDACS accelerated diagnostic pathway (EDACS-ADP).MethodsThis was a secondary analysis of data from a prospective observational study enrolling 1167 ED chest pain patients who visited the ED at Skåne University Hospital in Lund, Sweden in the period between February 2013 and April 2014. HEART and EDAC scores were assessed together with hs-cTnT at 0 and 1 hour and compared with HEART score alone. Sensitivity, specificity, negative predictive value (NPV) and likelihood ratios were evaluated. The primary outcome was major adverse cardiac events (MACE) including unstable angina within 30 days. The secondary outcome was index visit acute myocardial infarction (AMI).ResultsA total of 939 patients were included in the final analysis. When combined with 0-hour/1-hour hs-cTnT testing, the HEART Pathway and EDACS-ADP identified 49.8% and 49.6% of the patients for rule-out, with NPVs for 30-day MACE of 99.8% and 99.1%, compared with the HEART score alone that identified 53.4% of the patients for rule-out with NPV of 99.2%. The NPV for index visit AMI were 100%, 99.8% and 99.2%, respectively.ConclusionThe combination of the HEART Pathway or the EDACS-ADP with a 0-hour/1-hour hs-cTnT protocol allows safe and early rule-out in a large proportion of ED chest pain patients.

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Use of historical high-sensitivity cardiac troponin T levels to rule out myocardial infarction

Open Heart ◽

10.1136/openhrt-2021-001682 ◽

2021 ◽

Vol 8 (1) ◽

pp. e001682

Author(s):

Andreas Roos ◽

Martin J Holzmann

Keyword(s):

Myocardial Infarction ◽

Emergency Department ◽

Chest Pain ◽

Cardiac Troponin ◽

Troponin T ◽

High Sensitivity ◽

Cardiac Troponin T ◽

All Cause Mortality ◽

European Society Of Cardiology ◽

Rule Out

ObjectiveSeveral high-sensitivity cardiac troponin (hs-cTn)-based strategies exist for rule-out of myocardial infarction (MI). It is unknown whether historical hs-cTnT concentrations can be used. This study aim to evaluate the performance of a rule-out strategy based on the European Society of Cardiology (ESC) 0/1-hour algorithm, using historical hs-cTnT concentrations.MethodsAll visits among patients with chest pain in the emergency department at nine different hospitals in Sweden from 2012 to 2016 were eligible (221 490 visits). We enrolled patients with a 0-hour hs-cTnT of <12 ng/L, a second hs-cTnT measured within 3.5 hours, and ≥1 historical hs-cTnT available. We calculated the risks of MI and all-cause mortality using two rule-out strategies: (1) a delta hs-cTnT of <3 ng/L between the 0-hour hs-cTnT and the second hs-cTnT (modified ESC algorithm) and (2) a historical hs-cTnT <12 ng/L and a delta hs-cTnT of <3 ng/L in relation to the 0-hour hs-cTnT (historical-hs-cTnT algorithm).ResultsA total of 8432 patients were included, of whom 84 (1.0%) had an MI. The modified ESC algorithm triaged 8100 (96%) patients toward ruled-out, for whom 30-day MI risk and negative predictive value (NPV) for MI (95% CI) were 0.4% (0.3% to 0.6%) and 99.6% (99.4% to 99.7%), respectively. The historical-hs-cTnT algorithm ruled out 6700 (80%) patients, with a 30-day MI risk of 0.5% (0.4% to 0.8%) and NPV of 99.5% (99.2% to 99.6%).ConclusionsThe application of algorithm resulted in similar MI risk and NPV to an established algorithm. The usefulness of historical hs-cTnT concentrations should merit further attention.

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LO01: Development and validation of an adjustment score for ruling out MI using a single high-sensitivity cardiac troponin T assay in patients with chest pain and kidney dysfunction

CJEM ◽

10.1017/cem.2019.44 ◽

2019 ◽

Vol 21 (S1) ◽

pp. S6-S7

Author(s):

A. McRae ◽

S. Vatanpour ◽

J. Ma ◽

E. Lang ◽

J. Andruchow ◽

...

Keyword(s):

Chest Pain ◽

Cardiac Troponin ◽

Validation Cohort ◽

Troponin T ◽

High Sensitivity ◽

Study Cohort ◽

Kidney Dysfunction ◽

Derivation Cohort ◽

Pain Patients ◽

Rule Out

Introduction: Very low concentrations of high-sensitivity cardiac troponin can rule-out myocardial infarction (MI) at ED arrival in patients with chest pain. However, this single troponin rule-out strategy works poorly in patients with renal impairment and elevated baseline troponin levels. The objective of this study was to develop and validate a troponin adjustment strategy to accurately rule-out MI with a single hs-cTnTmeasurement in patients with kidney dysfunction. Methods: We used data from three cohorts of ED chest pain patients to develop an adjustment score for a high-sensitivity troponin T (hs-cTnT) assay in patients with kidney dysfunction. The derivation cohort (n = 8846) used administrative and registry data. Two validation cohorts (n = 1187 and 1092) were prospectively-collected. The score assigned points for increasing hs-cTnT levels and subtracted points for lower estimated glomerular filtration rate (eGFR). In the derivation cohort, hs-cTnT concentrations achieving 98.5% sensitivity in of patients with eGFR ≥60, 45-59, 30-44, 15-29 and <15 were assigned ascending positive integer values. Negative integer values were assigned to eGFR values 45-59, 30-44, 15-29 and <15. The scpres for troponin and eGFR were summed for each patient, with scores ranging from −4 to +5. The proportion of patients with 7-day MI ruled out by a score ≤0, sensitivity, NPV, negative likelihood ratio (LR-) and area under the curve (AUC) were quantified in each study cohort. Results: The derivation and validation cohorts had 7-day MI rates of 5.7, 8.6 and 9.1%. In the derivation cohort, a score ≤0 ruled out MI in 35% of patients, with a sensitivity for 7-day MI of 99.5% (95% CI 98-100), NPV of 99.9% (95% CI 98.4-99.9), LR- of 0.02 (95% CI 0.01-0.05) and AUC of 0.88. In the first validation cohort, a score ≤0 ruled out MI in 45% of patients, with a sensitivity for 7-day MI of 97% (95% CI 90-100%), NPV of 99% (95% CI 98-100%), LR- 0.06 (0.02-0.18) and AUC of 0.89. In the second validation cohort, a score ≤0 ruled out MI in 20% of patients, with a sensitivity for 7-day MI of 96% (95% CI 93-99%), NPV of 98% (95% CI 96-100%), LR- of 0.16 (95% CI 0.07-0.39) and AUC of 0.78. Conclusion: We developed and validated a simple scoring system to adjust hs-cTnT concentrations for a patient's kidney function that enables MI to be ruled out in a large proportion of chest pain patients using a single measurement on ED presentation.

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Performance of the European Society of Cardiology 0/1-hour algorithm in the diagnosis of myocardial infarction with high-sensitivity cardiac troponin: Systematic review and meta-analysis

European Heart Journal Acute Cardiovascular Care ◽

10.1177/2048872620935399 ◽

2020 ◽

pp. 204887262093539 ◽

Cited By ~ 1

Author(s):

Lucrecia M Burgos ◽

Marcelo Trivi ◽

Juan P Costabel

Keyword(s):

Myocardial Infarction ◽

Acute Coronary Syndrome ◽

Diagnostic Accuracy ◽

Likelihood Ratio ◽

European Society ◽

Cardiac Troponin ◽

High Sensitivity ◽

Coronary Syndrome ◽

European Society Of Cardiology ◽

Rule Out

Introduction: A rapid rule-out or rule-in protocol based on the 0-hour/1-hour algorithm using high-sensitivity cardiac troponin (hs-cTn) is recommended by the European Society of Cardiology (ESC); recently multiple studies have validated it in their settings. We aimed to assess the diagnostic accuracy of the 2015 ESC guidelines for management of acute coronary syndrome in patients without ST-segment elevation 0-hour/1-hour algorithm using hs-cTn for the early rule-out and rule-in of acute myocardial infarction (AMI) on presentation. Methods: Systematic searches were conducted using PubMed, the Cochrane Library and the International Clinical Trials Registry Platform to identify prospective studies from 2015 to October 2019 involving adults presenting to the emergency department with possible acute coronary syndrome in which hs-cTn measurements were obtained according to the ESC algorithm and AMI outcomes were adjudicated during the initial hospitalization. Results: Eleven studies, involving 19,213 patients, were identified. Pooled prevalence of AMI during the index hospitalization was 11.3% (95% confidence interval (CI) 3.9–18.8%). Summary sensitivity and specificity in diagnosing AMI were 99% (95% CI 98–99%; I2 63%) and 91% (95% CI 91–92%; I2 96%) respectively. The summary positive likelihood ratio was 11.6 (95% CI 8.5–15.8; I2 97%) and the pooled likelihood ratio negative 0.02 (0.01–0.03; I2 52%). Cumulative all-cause mortality at 30 days in the rule-out group was 0.11%, and 2.8% in the rule-in group, and 30 days AMI in the rule-out group was 0.08%. Conclusion: The ESC 0-hour/1-hour algorithm using high-sensitivity cardiac troponin has high diagnostic accuracy; it allows safe rule-out as well as accurate rule-in of AMI, with low cumulative 30-day mortality and AMI in patients assigned the rule-out zone.

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LO17: Major adverse cardiac events in patients ruled-out by a validated high-sensitivity troponin algorithm for acute myocardial infarction

CJEM ◽

10.1017/cem.2020.73 ◽

2020 ◽

Vol 22 (S1) ◽

pp. S13-S13

Author(s):

C. O'Rielly ◽

J. Andruchow ◽

A. McRae

Keyword(s):

Myocardial Infarction ◽

Chest Pain ◽

Troponin T ◽

High Sensitivity ◽

Major Adverse Cardiac Events ◽

Cardiac Events ◽

Coronary Syndrome ◽

High Sensitivity Troponin ◽

Adverse Cardiac Events ◽

Rule Out

Introduction: Chest pain and symptoms of acute coronary syndrome are a leading cause of emergency department (ED) visits in Canada. Validated 2-hour high-sensitivity troponin algorithms can rapidly and accurately rule-in or rule-out myocardial infarction (MI) in most patients. The objective of this study was to quantify the incidence and timing of major adverse cardiac events (MACE: MI, death, or urgent revascularization) in the 30-days following the index ED encounter among patients who had MI ruled out using a 2-hour high-sensitivity troponin T (hs-cTnT) algorithm. We also sought to identify patient characteristics associated with very low risk of MACE. Methods: This was a secondary analysis of data prospectively collected from adult patients presenting with a primary complaint of chest pain or symptoms of ACS. This analysis focused on patients who had an MI ruled out using a validated 2-hour serial hs-cTnT diagnostic algorithm. Incidence of 30-day MACE was quantified. Sex-specific Kaplan-Meier curves were constructed to describe timing of MACE events after MI rule-out. Demographic and clinical variables of patients who did or did not have MACE were compared using simple bivariable analyses. Results: This analysis included 550 patients with serial 2h hs-cTnT testing. Of these, MI was ruled out in 344 (62.5% of patients), ruled in 67 (12.2%), and 139 (25.3%) had nondiagnostic hs-cTnT results. Among the 344 patients who had MI ruled out, 11 (3.2%) experienced a MACE in the 30 days following their index ED encounter. These included 10 (2.9%) unplanned revascularizations and 1 (0.3%) fatal MI. MACE occurred at a median of 5 days (range: 0-23 days) after the index ED encounter. Of the 11 patients experiencing MACE, 9 (81.8%) had a normal ECG at their index ED encounter. None of the 93 (27.0%) ruled-out patients under the age of 50 experienced a MACE in the follow-up period. Patients experiencing MACE were more likely to have a history of coronary disease and multiple vascular risk factors compared to those not experiencing MACE. Conclusion: The validated 2h hs-cTnT AMI algorithm ruled-out MI in a large proportion of patients. The 30-day MACE incidence after MI rule-out was 3%. Most MACE events were unplanned revascularizations. We determined that age < 50 was associated with event-free survival and may be of value in identifying patients who do not need additional cardiac testing after MI has been ruled out using high-sensitivity troponin testing.

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LO10: Low high-sensitivity troponin concentrations identify low-risk chest pain patients unlikely to benefit from further risk stratification

CJEM ◽

10.1017/cem.2020.66 ◽

2020 ◽

Vol 22 (S1) ◽

pp. S10-S10

Author(s):

J. Andruchow ◽

T. Boyne ◽

G. Innes ◽

S. Vatanpour ◽

I. Seiden-Long ◽

...

Keyword(s):

Chest Pain ◽

Risk Stratification ◽

Symptom Onset ◽

Limit Of Detection ◽

Troponin T ◽

High Sensitivity ◽

Low Risk ◽

High Sensitivity Troponin ◽

Pain Patients ◽

Rule Out

Introduction: Very low high-sensitivity troponin-T (hs-cTnT) concentrations on presentation can rule out acute myocardial infarction (AMI), but the ability to identify patients at low risk of 30-day major adverse cardiac events (MACE) is less clear. This study examines the sensitivity of low concentrations of hs-cTnT on presentation to rule out 30-day MACE. Methods: This prospective cohort study enrolled emergency department chest pain patients with non-ischemic ECGs who underwent AMI rule-out with an hs-cTnT assay. The primary outcome was 30-day MACE; secondary outcomes were individual MACE components. Because guidelines recommend using a single hs-cTnT strategy only for patients with more than 3-hours since symptom onset, a subgroup analysis was performed for this population. Outcomes were adjudicated based on review of medical records and telephone follow-up. Results: Of 1,167 patients enrolled, 125 (10.7%) experienced 30-day MACE and 97 (8.3%) suffered AMI on the index visit. More than one-third (35.6%) had presenting hs-cTnT concentrations below the limit of detection (5ng/L), which was 94.4% (95%CI 88.8-97.7%) sensitive for 30-day MACE and 99.0% (95%CI 94.5-100%) sensitive for index AMI. Of 292 (25.0%) patients with hs-cTnT < 5ng/L and at least 3-hours since symptom onset, only 3 experienced 30-day MACE (sensitivity 97.6%, 95%CI 93.2-100%) and none suffered AMI within 30-days (sensitivity 100%, 95%CI 96.3-100%). Conclusion: Among patients with non-ischemic ECGs and >3-hours since symptom onset, low hs-cTnT concentrations on presentation confer a very low risk of 30-day MACE. In the absence of a high risk clinical presentation, further risk stratification is likely to be low yield.

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