Clinical Features and Outcomes of Emergency Department Patients With High-Sensitivity Cardiac Troponin I Concentrations Within Sex-Specific Reference Intervals

Abstract Background Lately, the novel high-sensitivity cardiac troponin I (hs-cTnI) Access assay was developed. Its clinical performance in patients presenting with chest pain to the emergency department (ED) is unknown. Purpose To clinically validate the novel hs-cTnI-Access assay and to derive and validate an assay specific 0/1h-algorithm accordingly to the European Society of Cardiology (ESC) recommendations. Methods In a prospective international multicentre study we enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by two independent cardiologists including all clinical information including cardiac imaging twice: first, using serial hs-cTnT (Elecsys, primary analysis) and second, using hs-cTnI (Architect, secondary analysis) measurements in addition to the clinically used (hs)-cTn. Hs-cTnI-Access was measured at presentation and at 1h. Primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the receiver-operating-characteristic curve (AUC) of hs-cTnI-Access versus the two established hs-cTn assays (hs-cTnT-Elecsys, hs-cTnI-Architect). Secondary objectives included the derivation and internal validation of an hs-cTnI-Access specific 0/1h-algorithm. Results AMI was the adjudicated final diagnosis in 243/1579 (15.4%) patients. The AUC at presentation for hs-cTnI-Access was 0.95 (95% CI, 0.94–0.96), significantly higher as hs-cTnI-Architect (0.92 [95% CI, 0.91–0.94; p<0.001]), and comparable to hs-cTnT-Elecsys (0.94 [95% CI, 0.93–0.95; p=0.12]) Applying the derived hs-cTnI-Access 0/1h-algorithm (derivation cohort n=686) to the internal validation cohort (n=680), 60% of patients were ruled-out (sensitivity 98.9% [95% CI, 94.3–99.8]), and 15% of patients were ruled-in (specificity 95.9% [95% CI, 94.0–97.2]). Patients ruled-out by the 0/1h-algorithm had a survival rate of of 100% after 30-days and 98.4% after two years of follow up. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI (Architect). Performance of the 0/1h-algorithm Conclusions Diagnostic accuracy of the novel hs-cTnI-Access assay is excellent and at least comparable to the two established hs-cTn assays. The assay-specific 0/1h-algorithm allows a safe rule-out and accurate rule-in of MI in about 75% of patients within 1-hour after presentation to the ED. Survival of patients ruled-out by the 0/1h-algorithm was very high. Acknowledgement/Funding Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the Stiftung für kardiovaskuläre Forschung Basel

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Prospective validation of 0-hour/1-hour algorithm using high-sensitivity cardiac troponin I in Japanese patients presenting to emergency department

European Heart Journal ◽

10.1093/ehjci/ehaa946.1707 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

H Ohtake ◽

J Ishii ◽

H Nishimura ◽

H Kawai ◽

T Muramatsu ◽

...

Keyword(s):

Myocardial Infarction ◽

Emergency Department ◽

Predictive Value ◽

Cardiac Troponin ◽

Troponin I ◽

High Sensitivity ◽

Japanese Patients ◽

Cardiac Troponin I ◽

St Segment Elevation ◽

Rule Out

Abstract Background The diagnostic performance of 0-hour/1-hour algorithm using high-sensitivity cardiac troponin I (hsTnI) for non-ST-segment elevation myocardial infarction (NSTEMI) has not been evaluated in an Asian population. Purpose We aimed to prospectively validate the 0-hour/1-hour algorithm using hsTnI in a Japanese population. Method We enrolled 754 Japanese patients (mean age of 70 years, 395 men) presenting to our emergency department with symptoms suggestive of NSTEMI. The hsTnI concentration was measured using the Siemens ADVIA Centaur hsTnI assay at presentation and after 1 hour. Patients were divided into three groups according to the algorithm: hsTnI below 3 ng/L (only applicable if chest pain onset >3 hours) or below 6 ng/L and delta 1 hour below 3 ng/L were the “rule-out” group; hsTnI at least 120 ng/L or delta 1 hour at least 12 ng/L were in the “rule-in” group; the remaining patients were classified as the “observe” group. Based on the Fourth Universal Definition of Myocardial Infarction, the final diagnosis was adjudicated by 2 independent cardiologists using all available information, including coronary angiography, coronary computed tomography, and follow-up data. Safety of rule-out was quantified by the negative predictive value (NPV) for NSTEMI, accuracy of rule-in by the positive predictive value (PPV), and overall efficacy by the proportion of patients triaged towards rule-out or rule-in within 1 hour. Results Prevalence of NSTEMI was 6.5%. The safety of rule-out (NPV 100%), accuracy of rule-in (PPV 26%), and overall efficacy (54%) were shown in Figure. Conclusion The 0-hour/1-hour algorithm using hsTnI is very safe and effective in triaging Japanese patients with suspected NSTEMI. Funding Acknowledgement Type of funding source: None

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Incidence of Undetectable, Measurable, and Increased Cardiac Troponin I Concentrations Above the 99th Percentile Using a High-Sensitivity vs a Contemporary Assay in Patients Presenting to the Emergency Department

Clinical Chemistry ◽

10.1373/clinchem.2016.256305 ◽

2016 ◽

Vol 62 (8) ◽

pp. 1115-1119 ◽

Cited By ~ 22

Author(s):

Sara A Love ◽

Yader Sandoval ◽

Stephen W Smith ◽

Jennifer Nicholson ◽

Jing Cao ◽

...

Keyword(s):

Emergency Department ◽

Cardiac Troponin ◽

Troponin I ◽

Limit Of Detection ◽

High Sensitivity ◽

Cardiac Troponin I ◽

Clinical Indication ◽

Edta Plasma ◽

Abbott Architect ◽

F 31

Abstract INTRODUCTION We compared the incidence of undetectable [below the limit of detection (LoD)], measurable (LoD to 99th percentile), and increased cardiac troponin I (cTnI) concentrations above the 99th percentile between Abbott high-sensitivity cTnI (hs-cTnI) and contemporary cTnI assays in a US emergency department population. METHODS Patients (n = 2100) presenting to the emergency department who had serial cTnI (0, 3, 6, 9 h) measurements ordered on clinical indication were enrolled. Contemporary cTnI [Abbott Architect used clinically; 99th percentile: 0.030 μg/L (30 ng/L)] and hs-cTnI [Abbott investigational; sex-specific 99th percentiles: female (F) 16 ng/L, male (M) 34 ng/L] assays simultaneously measured fresh EDTA plasma. RESULTS The hs-cTnI assay measured fewer undetectable cTnI concentrations compared to the contemporary cTnI assay across baseline (F: 31% vs 47%, M: 22% vs 40%) and serial (F: 21% vs 46%; M: 19% vs 54%) measurements. Conversely, the proportion of measurable cTnI concentrations was higher using hs-cTnI compared to contemporary cTnI assay across both baseline (F: 46% vs 31%; M: 60% vs 33%) and serial (F: 48% vs 28%; M: 83% vs 40%) measurements. The overall proportion of patients with increased cTnI concentrations above the 99th percentile was not significantly different between the contemporary (31%) and hs-cTnI (26%) assays (P = 0.09). CONCLUSIONS In patients presenting to the emergency department, the use of the Abbott hs-cTnI assay provides clinicians with more numeric cTnI concentrations. This occurs via a shift from results below the LoD to those between the LoD and the 99th percentile and does not increase in the number of cTnI concentrations above the 99th percentile.

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