P2676Prospective validation of the 2015 ESC 0-hour/1-hour algorithm using high-sensitivity cardiac troponin T in Asian countries

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Shiozaki ◽  
K Inoue ◽  
S Suwa ◽  
C C Lee ◽  
S J Chiang ◽  
...  

Abstract Background/Introduction Implementation of the 2015 ESC 0-hour/1-hour algorithm using high-sensitivity troponin (hs-cTn) T in Asian countries presents a challenge for clinical practice. Purpose We aimed to prospectively validate the 0-hour/1-hour algorithm in Asian countries. Methods We conducted a prospective, multi-center, international cohort already utilizing 0-hour/1-hour algorithm using hs-cTnT for evaluation of patients with suspected of non-ST elevation acute coronary syndrome (NSTE-ACS). All patients underwent a clinical assessment the included medical history, physical examination, 12-lead ECG, continuous ECG monitoring, pulse oximetry, standard blood test, chest radiography, cardiac and abdominal ultrasonography. Patients presenting with congestive heart failure, terminal kidney disease on hemodialysis state, arrhythmia, or infection disease (which cause to increase troponin level) were excluded. Patients were divided into three groups according to the algorithm: hs-cTnT below 12 ng/L and delta 1 hour below 3 ng/L were the “rule out” group; hs-cTnT at least 52 ng/L or delta 1 hour at least 5 ng/L were in the “rule in” group; the remaining patients were classified as the “observational” group. The final diagnosis was then adjudicated by 2 independent cardiologists using all available information, including coronary angiography, coronary computed tomography, stress electrocardiography and follow-up data. The presence of acute myocardial infarction (AMI) was defined according to the Fourth Universal Definition of Myocardial Infarction. Results Of the 1,332 patients enrolled in 2014 to 2018, 933 patients were analyzed after exclusion. AMI was the final diagnosis for 122 (13.1%) patients. The algorithm ruled out AMI in 401 patients with a negative predictive value and sensitivity of 100% (95% confidential interval [CI], 98.6%-100%) and 100% (95% CI, 94.0%-100%), respectively, in the rule-out group. None of the patients were diagnosed with AMI. Among the 211 patients classified into the rule-in group, 90 were diagnosed as having AMI. The positive predictive value and specificity were 43.1% (95% CI, 36.2%-50.2%) and 78.3% (95% CI, 74.5%-81.7%), respectively. The median length of hospital stay was 159 min (142–180) in rule out group. Conclusion(s) Our findings suggest that the 0-hour/1-hour algorithm using hs-cTnT provides very high safety and efficacy for the triage toward rapid rule-out to rule-in of AMI. Acknowledgement/Funding JSPS KAKENHI Grant Number JP18K09554

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Shiozaki ◽  
K Inoue ◽  
S Suwa ◽  
C C Lee ◽  
S J Chiang ◽  
...  

Abstract Background The European Society Cardiology guidelines recommend that a 0-hour/1-hour (0–1hr) algorithm using high sensitivity cardiac troponin T (hs-cTnT) improves the early triage of patients with suspected non-ST elevation acute coronary syndrome (NSTE-ACS). However, diagnostic uncertainty remains in the 25–30% of patients assigned to “observe” group. Purpose To establish a step wise risk score system using HEART score and 0-hour/1-hour algorithm to identify the low risk group from observation group. Methods This study was a prospective, multi-center, observational study of patients with suspected NSTE-ACS admitted to five hospitals in Japan and Taiwan from 2014 to 2018, respectively. We applied the algorithm and calculated HEART score simultaneously. Patients were divided into three groups according to the algorithm: hs-cTnT below 12 ng/L and delta 1 hour below 3 ng/L were the “rule out” group; hs-cTnT at least 52 ng/L or delta 1 hour at least 5 ng/L were in the “rule in” group; the remaining patients were classified as the “observe” group. All patients underwent a clinical assessment the included medical history, physical examination, 12-lead ECG, continuous ECG monitoring, pulse oximetry, standard blood test, chest radiography, cardiac and abdominal ultrasonography. Patients presenting with congestive heart failure, terminal kidney disease on hemodialysis state, arrhythmia, or infection disease (which causes to increase troponin level) were excluded. Thirty-day MACE was defined as acute myocardial infarction, unstable angina (UA), or death. Results Of the 1,332 patients enrolled, 933 patients were analyzed after exclusion. NSTE-ACS was the final diagnosis for 122 (13.1%) patients and none of death. The HEART score less than 4 points in observation groups identified as very low risk with a negative predictive value (NPV) of 98.1% (95% confidential interval (CI); 90.1%-100%) and sensitivity of 98.0% (95% CI; 89.6%-100%). There were only one patient (0.5%) with AMI. In case of the HEART score less than 5 points, it could also identify as very low risk with a NPV of 96.7% (95% CI; 90.8%-99.3%%) and sensitivity of 94.1% (95% CI; 83.8%-98.8%). There were only three patients (1.2%) with AMI. Conclusion A combination of HEART score and the 0-hour/1-hour algorithm strategy rapidly identified the patient in observation group of 30-day MACE including UA where nor further cardiac testing would be needed. Acknowledgement/Funding JSPS KAKENHI Grant Number JP18K09554


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T R Johannessen ◽  
D Atar ◽  
S Halvorsen ◽  
A C Larstorp ◽  
I Mdala ◽  
...  

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


2019 ◽  
Vol 65 (11) ◽  
pp. 1437-1447 ◽  
Author(s):  
Thomas Nestelberger ◽  
Jasper Boeddinghaus ◽  
Jaimi Greenslade ◽  
William A Parsonage ◽  
Martin Than ◽  
...  

Abstract BACKGROUND We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay. METHODS We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion. RESULTS AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration <4 ng/L in patients with an onset of chest pain >3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration <5 ng/L and an absolute change within 2 h <5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3–100) and sensitivity of 99.4% (95% CI, 96.5–99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1–79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3–100) and sensitivity of 97.7% (95% CI, 92.0–99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8–86) in the validation cohort. CONCLUSIONS Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high. TRIAL REGISTRATION APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.


2010 ◽  
Vol 56 (4) ◽  
pp. 642-650 ◽  
Author(s):  
Evangelos Giannitsis ◽  
Meike Becker ◽  
Kerstin Kurz ◽  
Georg Hess ◽  
Dietmar Zdunek ◽  
...  

Abstract Background: We sought to determine the diagnostic performance of the new high-sensitivity cardiac troponin T (hs-cTnT) assay for early detection of non–ST-segment myocardial infarction (NSTEMI) in patients with acute coronary syndrome. Methods: We enrolled patients with retrospectively confirmed unstable angina or NSTEMI and an initially negative cTnT concentration and compared the performance of baseline concentrations and serial changes in concentration within 3 and 6 h. Percentage change criteria included ≥20% δ change and ROC-optimized value. Results: Based on the standard fourth-generation cTnT result of ≥0.03 μg/L, an evolving NSTEMI was diagnosed in 26 patients, and 31 patients were classified as having unstable angina. With the use of the hs-cTnT assay at the 99th-percentile cutoff, the percentage of NSTEMI cases detected increased gradually from 61.5% on presentation to 100% within 6 h, and the overall number of MI diagnoses increased by 34.6% (35 vs 26 cases). A δ change ≥20% or ≥ROC-optimized value of >117% within 3 h or ≥243% within 6 h yielded a specificity of 100% at sensitivities between 69% and 76%. The standard cTnT at the 99th percentile was less sensitive than hs-cTnT for early diagnosis of MI on presentation, and follow-up samples obtained within the initial 3 h demonstrated very low specificity of cTnT compared with hs-cTnT. Conclusions: The high-sensitivity cTnT assay increases the number of NSTEMI diagnoses and enables earlier detection of evolving NSTEMI. A doubling of the hs-cTnT concentration within 3 h in the presence of a second concentration ≥99th percentile is associated with a positive predictive value of 100% and a negative predictive value of 88%.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Shiozaki ◽  
K Inoue ◽  
S Suwa ◽  
C.C Lee ◽  
S.J Chiang ◽  
...  

Abstract   Background/Introduction; A rapid rule-out or rule-in protocol based on the 0-h/1-hour algorithm using high-sensitivity cardiac troponin T (hs-cTnT) is recommended by the European Society of Cardiology (ESC). Around 40–50% were stratified into “rule-out” group, and their 30-days prognosis was excellent. However, the one-year prognosis is uncertain. We aimed to better characterize these patients. Methods This study was a prospective, multi-center, observational study of patients with suspected non-ST elevation acute coronary syndrome (NSTE-ACS) admitted to 5 hospitals in Japan and Taiwan from 2014 November to 2018 December, respectively. All patients underwent a clinical assessment the included medical history, physical examination, 12-lead ECG, standard blood test, chest radiography. Exclusion criteria were ST elevated myocardial infarction, chronic kidney disease (serum creatinine more than 3 mg/dL) and congestive heart failure, arrhythmia, or infection disease. The patients were divided into three groups according to the algorithm; “rule-out”, “observe” and “rule-in”. The final diagnosis was then adjudicated by 2 independent cardiologists using all available information, including coronary angiography, coronary computed tomography, stress electrocardiography and follow-up data. The presence of acute myocardial infarction (AMI) was defined according to the Fourth Universal Definition of Myocardial Infarction. After hospital discharge patients were follow after one-year b telephone or in written form. Major adverse cardiovascular events (including death myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (PCI)) were recorded by establishing contact with the patient and the family physicians. The primary prognosis end point was all-cause mortality. Results Of the 1,187 patients were analyzed after exclusion. The prevalence rate of AMI was 16.1%. According to the algorithm, 42% (n=493) of patients were assigned to “rule-out” group and had no AMI nor death. The most common final adjudicated diagnoses were atypical chest pain (80%), gallstone attack (3%) and vasospastic angina pectoris (2%). All patients with unstable angina (4.7%) underwent PCI. Conclusion(s) Our findings suggest that the “rule-out” group patients according to ESC 0-h/1-hour algorithm provides very high safety and efficacy for the triage toward AMI. Funding Acknowledgement Type of funding source: None


CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S13-S13
Author(s):  
C. O'Rielly ◽  
J. Andruchow ◽  
A. McRae

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.


Author(s):  
Philipp Bahrmann ◽  
Anke Bahrmann ◽  
Ole-A. Breithardt ◽  
Werner G. Daniel ◽  
Michael Christ ◽  
...  

AbstractIdentifying older patients with non-ST- elevation myocardial infarction (NSTEMI) within the very large proportion with elevated high-sensitive cardiac troponin T (hs-cTnT) is a diagnostic challenge because they often present without clear symptoms or electrocardiographic features of acute coronary syndrome to the emergency department (ED). We prospectively investigated the diagnostic and prognostic performance of copeptin ultra-sensitive (copeptin-us) and hs-cTnT compared to hs-cTnT alone for NSTEMI at prespecified cut-offs in unselected older patients.We consecutively enrolled 306 non-surgical patients ≥70 years presenting to the ED. In addition to clinical examination, copeptin-us and hs-cTnT were measured at admission. Two cardiologists independently adjudicated the final diagnosis of NSTEMI after reviewing all available data. All patients were followed up for cardiovascular-related death within the following 12 months.NSTEMI was diagnosed in 38 (12%) patients (age 81±6 years). The combination of copeptin-us ≥14 pmol/L and hs-cTnT ≥0.014 µg/L compared to hs-cTnT ≥0.014 µg/L alone had a positive predictive value of 21% vs. 19% to rule in NSTEMI. The combination of copeptin-us <14 pmol/L and hs-cTnT <0.014 µg/L compared to hs-cTnT <0.014 µg/L alone had a negative predictive value of 100% vs. 99% to rule out NSTEMI. Hs-cTnT ≥0.014 µg/L alone was significantly associated with outcome. When copeptin-us ≥14 pmol/L was added, the net reclassification improvement for outcome was not significant (p=0.809).In unselected older patients presenting to the ED, the additional use of copeptin-us at predefined cut-offs may help to reliably rule out NSTEMI but may not help to increase predicted risk for outcome compared to hs-cTnT alone.


2015 ◽  
Vol 61 (12) ◽  
pp. 1466-1474 ◽  
Author(s):  
Petra Hillinger ◽  
Raphael Twerenbold ◽  
Cedric Jaeger ◽  
Karin Wildi ◽  
Tobias Reichlin ◽  
...  

Abstract BACKGROUND Combined testing of high-sensitivity cardiac troponin T (hs-cTnT) and copeptin at presentation provides a very high—although still imperfect—negative predictive value (NPV) for the early rule-out of acute myocardial infarction (AMI). We hypothesized that a second copeptin measurement at 1 h might further increase the NPV. METHODS In a prospective diagnostic multicenter study, we measured hs-cTnT and copeptin concentrations at presentation and at 1 h in 1439 unselected patients presenting to the emergency department with suspected AMI. The final diagnosis was adjudicated by 2 independent cardiologists blinded to copeptin concentrations. We investigated the incremental value of 1-h copeptin in the rule-out setting (0-h hs-cTnT negative and 0-h copeptin negative) and the intermediate-risk setting (0-h hs-cTnT negative and 0-h copeptin positive). RESULTS The adjudicated diagnosis was AMI in 267 patients (18.6%). For measurements obtained at presentation, the NPV in the rule-out setting was 98.6% (95% CI, 97.4%–99.3%). Whereas 1-h copeptin did not increase the NPV significantly, 1-h hs-cTnT did, to 99.6% (95% CI, 98.7%–99.9%, P = 0.008). Similarly, in the intermediate-risk setting (NPV 92.8%, 95% CI, 88.7%–95.8%), 1-h copeptin did not significantly increase the NPV (P = 0.751), but 1-h hs-cTnT did, to 98.6 (95% CI, 96%–99.7%, P &lt; 0.001). CONCLUSIONS One-hour copeptin increased neither the safety of the rule-out process nor the NPV in the intermediate-risk setting. In contrast, the incremental value of 1-h hs-cTnT was substantial in both settings. ClinicalTrials.gov/NCT00470587


2012 ◽  
Vol 58 (1) ◽  
pp. 209-218 ◽  
Author(s):  
Matthias Mueller ◽  
Moritz Biener ◽  
Mehrshad Vafaie ◽  
Susanne Doerr ◽  
Till Keller ◽  
...  

Abstract BACKGROUND We evaluated kinetic changes of high-sensitivity cardiac troponin T (hs-cTnT) in patients with acute coronary syndrome (ACS) and patients with hs-cTnT increases not due to ACS to rule in or rule out non–ST-segment elevation myocardial infarction (STEMI). METHODS hs-cTnT was measured serially in consecutive patients presenting to the emergency department. Patients with ACS who had at least 2 hs-cTnT measurements within 6 h and non-ACS patients with hs-cTnT concentrations above the 99th percentile value (14 ng/L) were enrolled to compare absolute and relative kinetic changes of hs-cTnT. RESULTS For discrimination of non-STEMI (n = 165) in the entire study population (n = 784), the absolute δ change with the ROC-optimized value of 9.2 ng/L yielded an area under the curve of 0.898 and was superior to all relative δ changes (P &lt; 0.0001). The positive predictive value for the absolute δ change was 48.7%, whereas the negative predictive value was 96.5%. In a specific ACS population with exclusion of STEMI (n = 342), the absolute δ change with the ROC-optimized value of 6.9 ng/L yielded a positive predictive value of 82.8% and a negative predictive value of 93.0%. In comparison to the ≥20% relative δ change, the ROC-optimized absolute δ change demonstrated a significantly added value for the entire study population and for the ACS cohort (net reclassification index 0.331 and 0.499, P &lt; 0.0001). CONCLUSIONS Absolute δ changes appear superior to relative δ changes in discriminating non-STEMI. A rise or fall of at least 9.2 ng/L in the entire study population and 6.9 ng/L in selected ACS patients seems adequate to rule-out non-STEMI. However, δ-values are useful to rule-in non-STEMI only in a specific ACS population.


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