External validation of a suggested extension of the ESC 0/1h-algorithm for early rule out of myocardial infarction

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Lopez Ayala ◽  
T Nestelberger ◽  
I Strebel ◽  
P.D Ratmann ◽  
J Boeddinghaus ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Troponin T ◽  
Clinical Care ◽  
External Validation ◽  
High Sensitivity ◽  
University Hospital ◽  
Funding Source ◽  
Absolute Change ◽  
The University ◽  
Rule Out

Abstract Background The European Society of Cardiology (ESC) high sensitivity cardiac troponin T 0/1h-algorithm has substantially improved the management of patients with suspected acute myocardial infarction (AMI) by triaging about 75% of patients to rapid rule-out and/or rapid rule-in. However, about 25% of patients remain in the “observe-zone”, and the optimal management of these patients is unknown. Recently, a pilot single center study with a low prevalence of AMI suggested that an absolute change of less than 7ng/L between the 0h and 3h hs-cTnT concentration would allow to help in the evaluation of patients in the observe-zone and allow triage towards rule-out with very high negative predictive value [NPV]. Purpose To externally validate this suggested modification of the ESC 0/1h-algorithm for early rule out of AMI. Methods In an ongoing multicentre international study, we prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of MI. Final diagnoses were centrally adjudicated by two independent cardiologists using all available medical records obtained during clinical care including 90 day follow-up information and cardiac imaging. High sensitivity-cTnT (Elecsys) concentrations were measured at presentation and after 1 and 3 hours. The primary outcome was safety, quantified by the sensitivity and NPV for early rule out of NSTEMI. Results Among 1633 enrolled patients with available 0, 1 and 3h hs-cTnT concentrations, NSTEMI was the adjudicated final diagnosis in 337 (20.6%) patients. The ESC 0/1h-algorithm ruled out 918 (56.2%) patients, with a sensitivity of 98.8% (95% confidence interval [CI], 97.0–99.5) and a NPV of 99.6% (95% CI, 98.9–99.8). A total of 428 patients (26.2%) remained in the observe zone. After applying the suggested 0–3 hour absolute change cut-off criteria of 7ng/L, 393 (92.0%) additional patients from the observe zone were triaged towards ruled out. However, the safety of this triage step was poor with 62 patients with NSTEMI missed, resulting in a sensitivity of 33.3% and a NPV of 84.2% for rule-out. Conclusions The suggested 0/3h absolute change cut-off of 7ng/L for patients remaining in the observe zone of the ESC 0/1h-algorithm does NOT allow safe rule-out of AMI and should therefore NOT be implemented into routine clinical care. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Swiss National Science Foundation, the Swiss Heart Foundation, the Stiftung für kardiovaskuläre Forschung Basel, the University of Basel and the University Hospital Basel

scholarly journals Derivation and validation of a novel 3-hour pathway for the observe-zone of the ESC 0/1h-algorithm

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Lopez Ayala ◽  
T Nestelberger ◽  
J Boeddinghaus ◽  
L Koechlin ◽  
I Strebel ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin T ◽  
External Validation ◽  
High Sensitivity ◽  
Diagnostic Study ◽  
The Novel ◽  
Absolute Change ◽  
Number Of Patients ◽  
Rule Out

Abstract Background The latest non-ST elevation myocardial infarction (NSTEMI) guidelines from the European Society of Cardiology (ESC) recommend a 3h cardiac troponin determination in patients triaged to the observe-zone of the ESC 0/1h-algorithm; however, no specific cut-off for further triage is endorsed. Purpose To derive and internally, as well as externally, validate a novel 3-hour pathway for the observe-zone of the ESC 0/1h-algorithm. Methods In an ongoing multicentre international diagnostic study, we prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of myocardial infarction (MI). Final diagnoses were centrally adjudicated by two independent cardiologists applying the 4th universal definition of MI, based on complete cardiac work-up including cardiac imaging, serial high sensitivity cardiac troponin T (hs-cTnT) sampling and 90-day follow-up information. High sensitivity-cTnT concentrations were measured at presentation and after 1 and 3 hours. The primary outcome was safety, quantified by the sensitivity and NPV for early rule out of NSTEMI. External validation was performed in an independent multicentre international study. Results Among 2076 eligible patients, application of the ESC 0/1h-algorithm triaged 1512 patients (72.8%) to either rule-out or rule-in of NSTEMI, remaining 564 patients (27.2%) in the observe-zone (adjudicated NSTEMI prevalence 120/564 patients, 21.3%). The novel derived 3h-pathway for the observe-zone patients ruled-out NSTEMI with a 3h hs-cTnT concentration <15 ng/L and a 0/3h-hs-cTnT absolute change <4 ng/L, triaging 138 patients (25%) towards rule-out, resulting in a sensitivity of 99.2% (95% CI 96.0–99.9) and a NPV of 99.3% (95% CI 95.4–99.9). A 0/3h-hs-cTnT absolute change ≥6 ng/L ruled-in 63 patients (11.2%), resulting in a specificity of 98% (95% CI 96.2–98.9) and a PPV of 85.7% (95% CI75.0–92.3). The novel 3h-pathway reduced the number of patients in the observe zone by 36%, and the number of T1MI by 50% (Figure 1). Findings were confirmed in both internal and external validation. Conclusions A novel derived pathway combining a 3h hs-cTnT concentration <15 ng/L and a 0/3h absolute change <4 ng/L allowed to very safely rule-out NSTEMI in patients remaining in the observe-zone of the ESC 0/1h-algorithm. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Swiss Heart FoundationThe Swiss National Science Foundation Figure 1

scholarly journals Early diagnosis of acute myocardial infarction in patients with a history of percutaneous coronary intervention

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Lopez Ayala ◽  
L Koechlin ◽  
J Boeddinghaus ◽  
I Strebel ◽  
T Nestelberger ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Diagnostic Performance ◽  
Acute Chest Pain ◽  
High Sensitivity ◽  
Coronary Intervention ◽  
Funding Source ◽  
Percutaneous Coronary ◽  
History Of ◽  
The University ◽  
Rule Out

Abstract Background Recurrence of acute chest pain after percutaneous coronary intervention (PCI) is common. The early detection of acute myocardial infarction (AMI) as a possible cause of acute chest pain can be challenging in patients with a history of PCI due to e.g. pre-existing electrocardiographic abnormalities. It is unknown, whether high-sensitivity cardiac troponin T (hs-cTnT) concentrations and hs-cTnT-based rapid algorithms perform equally well in patients with a history of PCI. Purpose To investigate the impact of prior PCI on the diagnostic performance of hs-cTnT concentrations for early rule-out and rule-in of AMI. Methods In an ongoing multicentre international study, we prospectively enrolled unselected patients presenting to the emergency department (ED) with symptoms suggestive of AMI. Final diagnoses were centrally adjudicated by two independent cardiologists using all available medical records obtained during clinical care including 90 day follow-up information and cardiac imaging. High-sensitivity cTnT concentrations at presentation and after 1h were compared against the adjudicated final diagnosis. Patients were stratified according to the presence or absence of previous PCI. Results Among 5536 patients (1313 with and 4223 without previous PCI), incidence of AMI was significantly higher in patients with previous PCI (26.3% versus 21.4%; p<0.001). Patients with prior PCI and a final diagnoses other than AMI had significantly higher concentrations of hs-cTnT at presentation to the ED (median 9ng/l [IQR 6 to 15.8] vs 5.5ng/l [IQR 3 to 10]; p<0.001). However, in patients with final adjudicated diagnosis of AMI, hs-TnT concentrations at presentation were lower in patients with previous PCI (median 46ng/l [IQR 23 to 94] vs 55ng/l [IQR 25 to 175]; p=0.003). The diagnostic accuracy of hs-cTnT was high in patients with history of PCI, but significantly lower compared to patients without PCI (AUC 0.91 [95% CI 0.89–0.92] versus AUC 0.94 [95% CI 0.94–0.95]; p<0.001, respectively). When applying the ESC 0/1-algorithm among patients with previous history of PCI, the rule out pathway showed also very high safety in patients with a history of PCI (sensitivity 99.2 [95% CI 97.2–99.8] and negative predictive value 99.6 [95% CI 98.5–99.9]). However, the efficacy of the ESC 0/1h-algorithm for early rule out of NSTEMI was lower in the PCI group compared to no PCI (45.2% vs 65.1%; P<0.001, respectively), triaging more patients to the observe zone (36.8% versus 18.8%; p<0.001). Time to discharge from the ED was significantly longer in patients with prior PCI (334 min vs 290 min; p<0.001). When stratified for index AMI, patients with history of PCI waited longer for a final diagnoses of AMI (285 vs 217 min; p<0.001). Conclusions History of PCI impacts on the diagnostic performance of hs-cTnT. Although the ESC 0/1h-algorithm still performs very safe when applied to patients with a history of PCI, its efficacy is significantly reduced. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the Stiftung für kardiovaskuläre Forschung Basel the University of Basel and the University Hospital Basel

scholarly journals Novel Criteria for the Observe-Zone of the ESC 0/1h-hs-cTnT Algorithm

Circulation ◽  
2021 ◽  
Author(s):  
Pedro Lopez-Ayala ◽  
Thomas Nestelberger ◽  
Jasper Boeddinghaus ◽  
Luca Koechlin ◽  
Paul David Ratmann ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin T ◽  
External Validation ◽  
High Sensitivity ◽  
Diagnostic Study ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Absolute Change ◽  
Number Of Patients ◽  
Rule Out

Background: The non-ST elevation myocardial infarction (NSTEMI) guidelines of the European Society of Cardiology (ESC) recommend a 3h cardiac troponin determination in patients triaged to the observe-zone of the ESC 0/1h-algorithm; however, no specific cut-off for further triage is endorsed. Recently, a specific cut-off for 0/3h high-sensitivity cardiac troponin T (hs-cTnT) change (7ng/L) was proposed warranting external validation. Methods: Patients presenting with acute chest discomfort to the emergency department were prospectively enrolled into an international multicenter diagnostic study. Final diagnoses were centrally adjudicated by two independent cardiologists applying the 4th universal definition of MI, based on complete cardiac work-up, cardiac imaging and serial hs-cTnT. Hs-cTnT concentrations were measured at presentation, after 1h and 3h. The objective was to externally validate the proposed cut-off, and if necessary, derive and internally as well as externally validate novel 0/3h-criteria for the observe-zone of the ESC 0/1h-hs-cTnT-algorithm in an independent multicenter cohort. Results: Among 2076 eligible patients, application of the ESC 0/1h-hs-cTnT-algorithm triaged 1512 patients (72.8%) to either rule-out or rule-in of NSTEMI, remaining 564 patients (27.2%) in the observe-zone (adjudicated NSTEMI prevalence 120/564 patients, 21.3%). The suggested 0/3h-hs-cTnT-change of <7ng/L triaged 517 patients (91.7%) towards rule-out, resulting in a sensitivity of 33.3% (95%CI 25.5-42.2), missing 80 patients with NSTEMI, and ≥7ng/L triaged 47 patients towards rule-in (8.3%), resulting in a specificity of 98.4% (95%CI 96.8-99.2). Novel derived 0/3h-criteria for the observe-zone patients ruled-out NSTEMI with a 3h hs-cTnT concentration <15 ng/L and a 0/3h-hs-cTnT absolute change <4 ng/L, triaging 138 patients (25%) towards rule-out, resulting in a sensitivity of 99.2% (95%CI 96.0-99.9), missing 1 patient with NSTEMI. A 0/3h-hs-cTnT absolute change ≥6 ng/L triaged 63 patients (11.2%) towards rule-in, resulting in a specificity of 98% (95%CI 96.2-98.9) Thereby, the novel 0/3h-criteria reduced the number of patients in the observe zone by 36%, and the number of T1MI by 50%. Findings were confirmed in both internal and external validation. Conclusions: A combination of a 3h hs-cTnT concentration (<15 ng/L) and a 0/3h absolute change (<4 ng/L) is necessary to safely rule-out NSTEMI in patients remaining in the observe-zone of the ESC 0/1h-hs-cTnT-algorithm. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT00470587

248Real-world Outcome of the ESC 0/1-hour Algorithm when Routinely Applied in Early Presenters

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Twerenbold ◽  
J P Costabel ◽  
R Campos ◽  
R Arbucci ◽  
T Nestelberger ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Real World ◽  
Cardiac Troponin ◽  
Troponin T ◽  
Clinical Care ◽  
High Sensitivity ◽  
Outpatient Management ◽  
Late Presenters ◽  
Very High ◽  
Rule Out

Abstract Background The European Society of Cardiology (ESC) recommends the use of a 0/1h-algorithm for rapid triage of patients with suspected non-ST-elevation myocardial infarction (NSTEMI) using high-sensitivity cardiac troponin (hs-cTn). Concerns were articulated about its efficacy and particularly safety when applied in patients presenting early (≤3 hours) after chest pain onset, as hs-cTn concentrations might still be very low or even undetectable in these high-risk patients. Purpose We aimed to assess the real-world effectiveness, efficacy, and ultimately safety of the ESC 0/1h-algorithm when routinely applied in early presenters. Methods In a prospective international multicenter study enrolling unselected patients presenting with suspected NSTEMI to the ED, patients were assessed according to the ESC 0/1h-algorithm using high-sensitivity cardiac troponin T embedded in routine clinical care. Patients with ST-segment elevation myocardial infarctions were excluded. Safety was quantified by the 30-day incidence of major adverse cardiac events (MACE, defined as the composite of cardiovascular death and myocardial infarction including the index event) in the rule-out group and in outpatients. Results Among 2296 patients, 819 (36%) were early presenters. NSTEMI prevalence in early presenters was 11%. Effectiveness was very high as 97% of patients triaged towards rule-out by the ESC 0/1h-algorithm did not require additional cardiac investigations including hs-cTnT measurements at later time points (e.g. 3–12h) or coronary CT-angiography in the ED. Median time to discharge or transfer from the ED was 150 minutes [q1130, q3215]. Efficacy of the ESC 0/1h-algorithm was very high: 67% of patients were triaged towards rule-out and 14% towards rule-in of NSTEMI. Overall, 75% of early presenters underwent outpatient management. Safety of rule-out and outpatient management were excellent in early presenters with a 30-day MACE incidence of both 0% and comparable with 0.3% and 0.1% in late presenters, respectively (p=ns). Conclusions These real-world data document for the first time the excellent effectiveness, efficacy and particularly safety of the ESC 0/1h-algorithm when routinely applied in early presenters. No differences in safety could be observed when compared with late presenters.

A single high-sensitivity cardiac troponin T compared to the HEART score for a rapid rule-out of acute myocardial infarction at a prehospital emergency clinic

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T.R Johannessen ◽  
D Atar ◽  
O.M Vallersnes ◽  
A.C.K Larstorp ◽  
I Mdala ◽  
...  
Keyword(s):  
Primary Care ◽  
Cardiac Troponin ◽  
Troponin T ◽  
High Sensitivity ◽  
Low Risk ◽  
Symptom Duration ◽  
Funding Source ◽  
Emergency Setting ◽  
Heart Score ◽  
Rule Out

Abstract Background Patients presenting with acute chest pain outside of hospitals represent a diagnostic challenge. Purpose We aimed to validate whether a single high-sensitivity cardiac troponin T (hs-cTnT) safely can rule out acute myocardial infarction (AMI) in a primary care emergency setting. In addition, we aimed to investigate if the hs-HEART (History, Electrocardiogram (ECG), Age, Risk factors, and hs-Troponin) score would add valuable diagnostic information. Methods This is a secondary analysis from a prospective diagnostic study, including 1711 patients with acute non-specific chest pain presenting to a primary care emergency clinic from November 2016 to October 2018. The European Society of Cardiology (ESC) 0/1-hour algorithm triages patients towards direct rule-out if the 0-hour hs-cTnT is below 5 ng/L, combined with a normal ECG and a 3-hour symptom duration. The hs-HEART score (0–10 points) was calculated retrospectively, and a score ≤3 points was considered low-risk. In addition, a modified hs-HEART score, with more comparable hs-cTnT cut-off values, was applied. The primary endpoint was AMI during the index episode; the secondary the 90-day incidence of AMI (including index) and all-cause death. Results Among 1711 patients, 61 (3.6%) had an AMI, and 525 (30.7%) were assigned towards direct rule-out. With no AMIs in this group, the rule-out safety was high (negative predictive value (NPV) and sensitivity 100%). The hs-HEART score triaged more patients (n=966) as low-risk, but missed six AMIs (NPV 99.4% and sensitivity 90.2%). The modified hs-HEART score (n=707, AMI=3) increased the low-risk sensitivity to 95.1%. The 90-day incidence of AMI and all-cause death in the direct rule-out, low-risk hs-HEART, and modified hs-HEART group, were 0.0%, 0.7%, and 0.4%, respectively. Conclusions The ESC direct rule-out approach, with a single hs-cTnT below 5 ng/L, combined with a normal ECG, and a 3-hour symptom duration, is superior to the two hs-HEART scores in ruling out AMI in a primary care emergency setting. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): The Norwegian Research Fund for General Practice

scholarly journals Use of copeptin for rapid rule-out of acute myocardial infarction

2017 ◽  
Vol 7 (6) ◽  
pp. 570-576 ◽  
Author(s):  
Christian Mueller ◽  
Martin Möckel ◽  
Evangelos Giannitsis ◽  
Kurt Huber ◽  
Johannes Mair ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Clinical Care ◽  
High Sensitivity ◽  
Cardiac Care ◽  
Routine Clinical Care ◽  
Incremental Value ◽  
Rule Out

Copeptin is currently understood as a quantitative marker of endogenous stress. It rises rapidly in multiple acute disorders including acute myocardial infarction. As a single variable, it has only modest diagnostic accuracy for acute myocardial infarction. However, the use of copeptin within a dual-marker strategy together with conventional cardiac troponin increases the diagnostic accuracy and particularly the negative predictive value of cardiac troponin alone for acute myocardial infarction. The rapid rule-out of acute myocardial infarction is the only application in acute cardiac care mature enough to merit consideration for routine clinical care. However, the dual-marker approach seems to provide only very small incremental value when used in combination with sensitive or high-sensitivity cardiac troponin assays. This review aims to update and educate regarding the potential and the procedural details, as well as the caveats and challenges of using copeptin in clinical practice.

scholarly journals Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay

2015 ◽  
Vol 187 (8) ◽  
pp. E243-E252 ◽  
Author(s):  
Tobias Reichlin ◽  
Raphael Twerenbold ◽  
Karin Wildi ◽  
Maria Rubini Gimenez ◽  
Nathalie Bergsma ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin T ◽  
High Sensitivity ◽  
Cardiac Troponin T ◽  
Rule Out

scholarly journals Novel low-delta value troponin algorithms have good precision for rule-out of NSTE-ACS

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Tjora ◽  
O.T Steiro ◽  
J Langorgen ◽  
T Omland ◽  
P Collinson ◽  
...  
Keyword(s):  
False Negative ◽  
False Negative Rate ◽  
High Sensitivity ◽  
Public Institution ◽  
University Hospital ◽  
P Value ◽  
Funding Source ◽  
Good Precision ◽  
Serum Samples ◽  
Rule Out

Abstract Background Rapid rule-out algorithms for non-ST-elevation infarction (NSTEMI) may be beneficial for logistics in the emergency room. Current algorithms are designed to rule-out NSTEMI, but do not differentiate between unstable angina (UAP) in need of revascularization and non-cardiac chest pain patients (NCCP) who could be discharged. Recent improvements in analytical precision of high sensitivity troponin (cTn) assays allow for trialing algorithms with very small delta values. Purpose Could the use of lower delta values produce rule-out algorithms for NSTE-ACS with a false negative rate of ≤5%, and a sufficient high rule-out rate of patients with NCCP. Method 927 patients with suspected NSTE-ACS were consecutively included. Serum samples were collected at 0, 3 and 8–12 hours. The final diagnosis was adjudicated by two independent cardiologists based on all clinical data including routine cTnT. The 0- and 3-hour samples were additionally measured for cTnIand cTnI from Singulex Clarity System (cTnI(sgx)). The diagnostic performance to rule-out NSTE-ACS was compared between one low-delta value algorithm from each assay (cTnT, cTnI and cTnT). Results The prevalence of NSTEMI was 13.4%, UAP 11.4% and NCCP 60%. Median age was 63 years, 60% males. Fig. 1 shows baseline and 3-hour delta cTn values for the UAP and NCCP patients for the three different assays. The baseline cTn value differed significantly between UAP and NCCP for all assays, p value &lt;0.001. The novel low-delta cTnT algorithm (Table 1) ruled out 8 NSTE-ACS patients (3.5%), the cTnI algorithm and cTnI (sgx) algorithm ruled out 11 (4.8%) and 12 (5.2%) patients with NSTE-ACS, respectively. Moreover, the cTnT algorithm allocated 35.3% of the NCCP patients to discharge. Respective numbers for the cTnI(sgx) and cTnI algorithm were 30.6% and 33.5%. Comparing the ROC curves, the cTnT algorithm had significantly higher AUC compared to the cTnI(sgx) algorithm (p value =0.005, DeLong test). Conclusion The low-delta value algorithms correctly ruled in ≥95% of the NSTE-ACS patients whilst &gt;30% of NCCP patients were ruled out. The cTnT algorithm had the best performance with a significant higher AUC compared to the cTnI(sgx) algorithm. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Western Norway Regional Health Authority, Haukeland and Stavanger University hospital

Sign in / Sign up

Export Citation Format

Share Document