scholarly journals Implementation of an early rule-out pathway for myocardial infarction using a high-sensitivity cardiac troponin T assay

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001769
Author(s):  
Dennis Sandeman ◽  
Maaz B J Syed ◽  
Dorien M Kimenai ◽  
Kuan Ken Lee ◽  
Atul Anand ◽  
...  

ObjectivesPatients with suspected acute coronary syndrome and high-sensitivity cardiac troponin (hs-cTn) concentrations below the limit of detection at presentation are low risk. We aim to determine whether implementing this approach facilitates the safe early discharge of patients.MethodsIn a prospective single-centre cohort study, consecutive patients with suspected acute coronary syndrome were included before (standard care) and after (intervention) implementation of an early rule-out pathway. During standard care, myocardial infarction was ruled out if hs-cTnT concentrations were <99th centile (14 ng/L) at presentation and at 6–12 hours after symptom onset. In the intervention, patients were ruled out if hs-cTnT concentrations were <5 ng/L at presentation and symptoms present for ≥3 hours or were ≥5 ng/L and unchanged within the reference range at 3 hours. We compared duration of stay (efficacy) and all-cause death at 1 year (safety) before and after implementation.ResultsWe included 10 315 consecutive patients (64±16 years, 46% women) with 6642 (64%) and 3673 (36%) in the standard care and intervention groups, respectively. Duration of stay was reduced from 534 (IQR, 220–2279) to 390 (IQR, 218–1910) min (p<0.001) after implementation. At 1 year, all-cause death occurred in 10.9% (721 of 6642) and 10.4% (381 of 3673) of patients in the standard care group (referent) and intervention group, respectively (adjusted OR 1.02, 95% CI 0.88 to 1.18).ConclusionIn patients with suspected acute coronary syndrome, implementing an early rule-out pathway using hs-cTnT concentrations <5 ng/L at presentation reduced the duration of stay in hospital without compromising safety.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Wereski ◽  
K.K Lee ◽  
S Smith ◽  
A.R Chapman ◽  
D Lowe ◽  
...  

Abstract Background The widespread adoption of high-sensitivity cardiac troponin testing has encouraged the use of pathways to accelerate the rule-out and rule-in myocardial infarction in the Emergency Department. These pathways are not recommended for patients with ST-segment elevation, but there is a risk they may be applied incorrectly given that interpretation of the electrocardiogram is subjective, dependent on experience, and signs may be masked in those with posterior myocardial infarction. Methods Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge cluster randomized controlled trial across ten hospitals in Scotland. The index diagnosis was adjudicated two clinicians independently in all patients with high-sensitivity cardiac troponin I concentrations above the sex-specific 99th centile on serial testing and abnormalities on the electrocardiogram recorded. The proportion of patients with ST-segment elevation myocardial infarction and concentrations below the rule-out threshold (&lt;5 ng/L), 99th centile (&lt;16 ng/L and &lt;34 ng/L for women and men) and rule-in threshold (&lt;52 ng/L) at presentation were determined. Results In total 48,282 patients were recruited between June 2013, and March 2016 of which 22% (10,360/48,282) had peak cardiac troponin concentrations above the 99th centile. The adjudicated diagnosis was type 1 myocardial infarction in 55% (4,981/9,115) of patients and 10% (925/9,115) had ST-segment elevation myocardial infarction (age 65 [14] years, 68% men). The majority presented within 6 hours of symptom onset (67%, 619/925), and 84% (772/925) had cardiac troponin concentrations above the 99th centile at presentation. However, troponin concentrations were below the rule-out threshold in 2% (20/925) and the rule-in threshold in 26% (240/925) of patients with ST-segment elevation myocardial infarction. Discussion In patients with suspected acute coronary syndrome who have a final diagnosis of ST-segment elevation myocardial infarction, high-sensitivity cardiac troponin concentrations are below the rule-out and rule-in threshold at presentation in 1 in 50 and 1 in 4 patients, respectively. Clinicians should not rely on cardiac troponin concentrations to guide initial treatment decisions in patients with possible ST-segment elevation myocardial infarction. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): British Heart Foundation


Heart ◽  
2018 ◽  
pp. heartjnl-2018-314093 ◽  
Author(s):  
Andrew R Chapman ◽  
Takeshi Fujisawa ◽  
Kuan Ken Lee ◽  
Jack Patrick Andrews ◽  
Atul Anand ◽  
...  

BackgroundHigh-sensitivity cardiac troponin assays enable the early risk stratification of patients with suspected acute coronary syndrome to identify those at low risk of myocardial infarction or cardiac death. We evaluated the performance of a novel high-sensitivity cardiac troponin I assay in early rule out pathways.MethodsIn 1920 patients with suspected acute coronary syndrome, cardiac troponin was measured using the Siemens Atellica high-sensitivity cardiac troponin I assay (99th centile: 34 ng/L women, 53 ng/L men). We evaluated three pathways which use either low risk-stratification thresholds of cardiac troponin (High-SensitivityTroponin in the Evaluation of patients with Acute Coronary Syndrome (High-STEACS) and the European Society of Cardiology (ESC) 1 hour pathway) or the 99th centile diagnostic threshold (ESC 3 hour pathway) to rule out myocardial infarction.ResultsThe primary outcome of myocardial infarction or cardiac death at 30 days occurred in 14.4% (277/1920). The High-STEACS pathway ruled out 63% of patients (1218/1920), with five missed events for a negative predictive value (NPV) of 99.5% (95% CI (CI) 99.1% to 99.8%). Similar performance was observed for the ESC 1 hour pathway with an NPV of 99.0% (97.6% to 99.8%). In contrast, the ESC 3 hour pathway ruled out 65% of patients (1248/1920), but missed 25 events for an NPV of 98.0% (97.1% to 98.7%).ConclusionsA novel high-sensitivity cardiac troponin I assay can safely identify patients at low risk of myocardial infarction or cardiac death. Diagnostic pathways that use low cardiac troponin concentrations for risk stratification miss fewer events than those that rely on the 99th centile to rule out myocardial infarction.Trial registrationNCT1852123.


2018 ◽  
Vol 64 (5) ◽  
pp. 820-829 ◽  
Author(s):  
Jaimi Greenslade ◽  
Elizabeth Cho ◽  
Christopher Van Hise ◽  
Tracey Hawkins ◽  
William Parsonage ◽  
...  

Abstract BACKGROUND Low concentrations of cardiac troponin (cTn) have been recommended for rapid rule-out of acute myocardial infarction (AMI). We examined the Beckman Coulter Access high-sensitivity cardiac troponin I (hs-cTnI) assay to identify a single test threshold that can safely rule out AMI. METHODS This analysis used stored samples collected in 2 prospective observational studies. In all, 1871 patients presenting to a tertiary emergency department with symptoms of acute coronary syndrome had blood taken for measurement of cTnI on presentation. The endpoint was type 1 myocardial infarction (T1MI). Sensitivity and negative predictive value (NPV) were calculated for hs-cTnI values below the 99th percentile. RESULTS Ninety-eight patients had T1MI (5.2%), and 638 (34.1%) patients had an hs-cTnI &lt;2 ng/L (limit of detection), with sensitivity of 99.0% (95% CI, 94.4%–100%) and NPV of 99.8% (95% CI, 99.1%–100%). No hs-cTnI value above a concentration of 2 ng/L achieved sensitivity of 99%. However, an NPV of 99.5% was achieved at values &lt;6 ng/L. A cutoff &lt;6 ng/L enabled 1475 (78.8%) patients to be ruled out on presentation with sensitivity of 93.9% (95% CI, 87.1%–97.7%). CONCLUSIONS A single baseline cTn &lt;2 ng/L measured with the Access hs-cTnI assay performed well for rule-out of AMI. This cutoff concentration identified 99% of patients with AMI and could reduce the number of patients requiring lengthy assessment. A cutoff of &lt;6 ng/L yielded a high NPV but missed more cases of AMI than would be acceptable to clinicians.


2020 ◽  
pp. 204887262093539 ◽  
Author(s):  
Lucrecia M Burgos ◽  
Marcelo Trivi ◽  
Juan P Costabel

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.


Author(s):  
Paul Simpson ◽  
Rosy Tirimacco ◽  
Penelope Cowley ◽  
May Siew ◽  
Narelle Berry ◽  
...  

Background The management of patients presenting with symptoms suggestive of acute coronary syndrome is a significant challenge for clinicians. Guidelines for the diagnosis of acute myocardial infarction require a rise and/or fall of cardiac troponin, along with other criteria. Knowing what constitutes a significant delta change from baseline is still unclear and the literature is varied. Methods We compared three methods for determining cardiac troponin delta changes (relative, absolute and z-scores) for detecting acute myocardial infarction in 806 patients presenting to an emergency department with symptoms suggestive of acute coronary syndrome. Blood specimens were collected at admission and 2, 3, 4 and 6 h postadmission and tested on the Roche Elecsys high-sensitivity troponin T assay. Results A positive diagnosis for acute myocardial infarction was found in 39 (4.8%) patients. ROC AUC showed better performance for the absolute and z-score delta change (0.959–0.988 and 0.956–0.988, respectively) compared with relative delta change (0.921–0.960) at all time points in the diagnosis of acute myocardial infarction. Optimal timing for the second sample was at 4–6 h postadmission. Conclusions Although not statistically significant, the results show a trend of absolute and z-score delta change performing better than relative delta change for the diagnosis of acute myocardial infarction. The z-score approach allows for a single cut-off value across multiple high-sensitivity assays which could be useful in the clinical setting. Our study also highlighted the importance of interpreting cardiac troponin changes in the clinical context with a combination of the patient’s clinical history and electrocardiogram.


Author(s):  
Atul Anand ◽  
Kuan Ken Lee ◽  
Andrew R. Chapman ◽  
Amy V. Ferry ◽  
Philip D. Adamson ◽  
...  

Background: High-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early-rule out pathway is safe and effective for patients with suspected acute coronary syndrome. Methods: We performed a stepped-wedge cluster randomized controlled trial in the Emergency Departments of seven acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a prior validation phase, myocardial infarction was ruled out where troponin concentrations were <99th centile at 6-12 hours after symptom onset. The co-primary outcome was length of stay (efficacy), and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes. Results: We enrolled 31,492 patients (59±17 years, 45% women) with troponin concentrations <99th centile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio 0.78, 95% confidence interval [CI] 0.73 to 0.83, P<0.001) following implementation, and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio [aOR] 1.59, 95% CI 1.45 to 1.75). Non-inferiority was not demonstrated for the 30-day safety outcome (upper limit of one-sided 95% CI for adjusted risk difference 0.70%, non-inferiority margin 0.50%, P=0.068), but the observed differences favoured the early rule-out pathway (0.4% [57/14,700] versus 0.3% [56/16,792]). At 1 year, the safety outcome occurred in 2.7% (396/14,700) and 1.8% (307/16,792) of patients before and after implementation (aOR 1.02, 95% CI 0.74 to 1.40, P=0.894), and there were no differences in hospital reattendance or all-cause mortality. Conclusions: Implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Whilst non-inferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and healthcare providers. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT03005158


2020 ◽  
Author(s):  
Atul Anand ◽  
Kuan Ken Lee ◽  
Andrew R Chapman ◽  
Amy V Ferry ◽  
Philip D Adamson ◽  
...  

Objectives: High-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the efficacy and safety of this approach is uncertain. We investigated whether an early-rule out pathway is safe and effective for the management of patients with suspected acute coronary syndrome. Design: A stepped-wedge cluster randomised controlled trial. Setting: Seven acute care hospitals in Scotland. Participants: 31,492 consecutive patients with suspected acute coronary syndrome between December 2014 to December 2016. Intervention: Sites were randomised to implement an early rule-out pathway where myocardial infarction was ruled out if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a prior validation phase, myocardial infarction was ruled out where troponin concentrations were <99th centile at 6-12 hours after symptom onset. Main outcome measures: The co-primary outcome was length of stay (efficacy), and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate the safety outcome and other secondary outcomes. Results: We enrolled 31,492 patients (59±17 years, 45% women) with troponin concentrations <99th centile at presentation. The length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio 0.78, 95% confidence interval [CI] 0.73 to 0.83, P<0.001) following implementation, and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio [aOR] 1.59, 95% CI 1.45 to 1.75). Non-inferiority was not demonstrated for the 30-day safety outcome (upper limit of one-sided 95% CI for adjusted risk difference 0.70%, non-inferiority margin 0.50%, P=0.068), but the observed differences favoured the early rule-out pathway (0.4% [57/14,700] versus 0.3% [56/16,792]). At 1 year, the safety outcome occurred in 2.7% (396/14,700) and 1.8% (307/16,792) of patients before and after implementation (aOR 1.02, 95% CI 0.74 to 1.40, P=0.894), and there were no differences in hospital reattendance or all-cause mortality. Conclusions: Implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Whilst non-inferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway will have major benefits for patients and healthcare providers. Trial registration: ClinicalTrials.gov number, NCT03005158


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Bularga ◽  
A Anand ◽  
F E Strachan ◽  
K K Lee ◽  
S Stewart ◽  
...  

Abstract Background Guidelines acknowledge the emerging role of high-sensitivity cardiac troponin (hs-cTn) assays for the risk stratification and rapid rule-out of myocardial infarction, but multiple approaches have been described. We previously demonstrated the utility of a single hs-cTnI concentration <5 ng/L at presentation to risk stratify patients with suspected acute coronary syndrome (ACS). Purpose To assess the safety and efficacy of a hs-cTnI concentration <5 ng/L at presentation in consecutive patients included in the High-STEACS (High-SensitivityTroponin in the Evaluation of patients with Acute Coronary Syndrome) randomised controlled trial. Methods The High-STEACS trial was a stepped wedge cluster randomised controlled trial in ten hospitals across Scotland that included 48,282 patients in whom high-sensitivity cardiac troponin was requested by the attending clinician for evaluation of suspected ACS. Patients with ST-segment elevation myocardial infarction (STEMI) were excluded. We evaluated the negative predictive value (NPV) and sensitivity of a presentation hs-cTnI <5 ng/L for a composite outcome of type 1 myocardial infarction, or subsequent type 1 myocardial infarction or cardiac death at 30 days. To assess safety, we report the one-year risk of type 1 myocardial infarction or cardiac death. To assess efficacy, we report the proportion of patients with cardiac troponin <5 ng/L at presentation. Results We included 47,101 consecutive patients in the analysis (mean 61±17 years old, 47% female). Of these patients, 27,500 (58%) had a cardiac troponin <5 ng/L at presentation. Overall, 4,313/47,101 (9%) patients had a composite outcome at 30 days, but the event rate was only 0.4% in those with troponin <5 ng/L (98/27,500). The NPV for the composite outcome in those <5 ng/L was 99.7% (95% confidence intervals [CI] 99.6–99.7) and the sensitivity was 98.0% (95% CI 97.6–98.4). In those without evidence of myocardial injury at presentation (hs-cTnI <99thcentile), type 1 myocardial infarction or cardiac death at one year occurred in 197 (0.7%) patients with cardiac troponin <5 ng/L, compared to 647 (5.5%) of those ≥5 ng/L. The NPV was unchanged across all age groups, although efficacy fell as fewer older patients had hs-cTnI concentrations below the risk stratification threshold (see Figure). Conclusion A hs-cTnI concentration <5 ng/L at presentation identifies the majority of patients with suspected ACS as low-risk of early or late cardiac events. Although the proportion identified as low risk is reduced in older populations, the safety of this risk stratification approach is maintained across patients of all ages. Acknowledgement/Funding British Heart Foundation


2017 ◽  
Vol 63 (1) ◽  
pp. 403-414 ◽  
Author(s):  
Colleen Shortt ◽  
Jinhui Ma ◽  
Natasha Clayton ◽  
Jonathan Sherbino ◽  
Richard Whitlock ◽  
...  

Abstract BACKGROUND Early rule-in/rule-out of myocardial infarction (MI) in patients presenting to the emergency department (ED) is important for patient care and resource allocation. Given that dysglycemia is a strong risk factor for MI, we sought to explore and compare different combinations of cardiac troponin (cTn) cutoffs with glycemic markers for the early rule-in/rule-out of MI. METHODS We included ED patients (n = 1137) with symptoms suggestive of acute coronary syndrome (ACS) who had cTnI, high-sensitivity cTnI (hs-cTnI), hs-cTnT, glucose, and hemoglobin A1c (Hb A1c) measurements. We derived rule-in/rule-out algorithms using different combinations of ROC-derived and literature cutoffs for rule-in and rule-out of MI within 7 days after presentation. These algorithms were then tested for MI/cardiovascular death and ACS/cardiovascular death at 7 days. ROC curves, sensitivity, specificity, likelihood ratios, positive and negative predictive values (PPV and NPV), and CIs were determined for various biomarker combinations. RESULTS MI was diagnosed in 133 patients (11.7%; 95% CI, 9.8–13.8). The algorithms that included cTn and glucose produced the greatest number of patients ruled out/ruled in for MI and yielded sensitivity ≥99%, NPV ≥99.5%, specificity ≥99%, and PPV ≥80%. This diagnostic performance was maintained for MI/cardiovascular death but not for ACS/cardiovascular death. The addition of hemoglobin A1c (Hb A1c) (≥6.5%) to these algorithms did not change these estimates; however, 50 patients with previously unknown diabetes may have been identified if Hb A1c was measured. CONCLUSIONS Algorithms incorporating glucose with cTn may lead to an earlier MI diagnosis and rule-out for MI/cardiovascular death. Addition of Hb A1c into these algorithms allows for identification of diabetes. Future studies extending these findings are needed for ACS/cardiovascular death. ClinicalTrials.gov identifier: NCT01994577


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