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.

3297Real-world outcome of applying the ESC 0/1-hour algorithm in clinical routine

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Twerenbold ◽  
J P Costabel ◽  
T Nestelberger ◽  
R Campos ◽  
R Arbucci ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Median Time ◽  
Real World ◽  
Troponin T ◽  
Clinical Care ◽  
Outpatient Management ◽  
Cardiac Events ◽  
Real World Data ◽  
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). To date, its impact on patient management and ultimately also safety when routinely applied in emergency departments (ED) is unknown. We therefore aimed to determine these important real-world outcome data. Methods In a prospective international multicenter study enrolling unselected patients presenting with suspected NSTEMI to the ED, we assessed the real-world feasibility, adherence, efficacy, effectiveness, and safety of 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, NSTEMI prevalence was 9.8% (224/2296). Feasibility was very high with a median time to the “1h-draw” of 65 minutes [q1 61, q3 72]. Adherence was very high with 94% (95% confidence interval [CI], 93–95) of patients managed without protocol violations. Effectiveness was very high: 98% (95% CI, 97–98) 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 from the ED was 150 [q1134, q3235] minutes in the overall population. The ESC 0/1h-algorithm triaged 62% (95% CI, 60–64) of patients towards rule-out and 13% (95% CI, 12–14) towards rule-in of NSTEMI. Overall, 71% (95% CI, 69–72) of patients underwent outpatient management (Figure 1). Safety of rule-out and outpatient management were very high with a 30-day MACE incidence of 0.2% (95% CI, 0–0.5) and 0.1% (95% CI, 0–0.2), respectively. These findings were consistent in several predefined subgroups. Figure 1 Conclusions These real-world data document the excellent feasibility, adherence, effectiveness, efficacy and safety of the ESC 0/1h-algorithm for the rapid management of patients presenting with suspected NSTEMI to the ED when applied in routine clinical practice.

scholarly journals Optimizing Early Rule-Out Strategies for Acute Myocardial Infarction: Utility of 1-Hour Copeptin

2015 ◽  
Vol 61 (12) ◽  
pp. 1466-1474 ◽  
Author(s):  
Petra Hillinger ◽  
Raphael Twerenbold ◽  
Cedric Jaeger ◽  
Karin Wildi ◽  
Tobias Reichlin ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin T ◽  
High Sensitivity ◽  
Final Diagnosis ◽  
Intermediate Risk ◽  
Incremental Value ◽  
Very High ◽  
Rule Out

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 < 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

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

PD41 Use Of High-Sensitivity Cardiac Troponin Assays In Real-Practice Within Emergency Departments

2018 ◽  
Vol 34 (S1) ◽  
pp. 143-143
Author(s):  
Marco Marchetti ◽  
Laura Camoni ◽  
Luz Irene Urbina ◽  
Alessia Biondi ◽  
Tiziana Grassi ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Real World ◽  
Emergency Departments ◽  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Real World Data ◽  
Multicenter Observational Study ◽  
Number Of Patients ◽  
Rule Out

Introduction:Acute myocardial infarction (AMI) is one of the leading causes of death and disability worldwide. The European Society of Cardiology Guidelines have established a new definition of myocardial infarction and have strengthened the central role of cardiac troponins in cardiology diagnostics for rule-in and rule-out of non ST-elevation myocardial infarction (NSTEMI). High-sensitivity cardiac troponin I assays (hsTnI) should increase diagnostic sensitivity, and a shorter interval for ruling-in and ruling-out AMI. This analysis aims to provide an overview of the clinical, economic, organizational and ethical impact of the use of hsTnI in clinical practice of Emergency Departments (ED) in Italy.Methods:HsTnl for rule-in and rule-out of AMI in the ED is being evaluated using the EUnetHTA Core Model® framework for health technology assessment. The hsTnI HTA assessment will be completed with real-world evidence derived from a multicenter observational study which has been designed to be conducted in 12 Italian EDs, enrolling 6000 patients with chest pain of suspected cardiac origin, aiming to provide data from the Italian context on clinical, organizational and economic aspects of the use of the test in the ED. Endpoints of the study include: time lapses related to diagnosis, admission, treatment and discharge of patients; number of tests performed; and number of patients diagnosed with AMI.Results:Initial results from a literature review confirm the usefulness of the hsTnI assay in diagnosing AMI. Generated real-world data will be collected, analyzed and integrated to existing evidence to assess the utility of the test in real contexts, providing details relevant for organizational aspects of the use of the test in the ED.Conclusions:The use of hsTnl could improve diagnosis of AMI by allowing a faster ruling-in or ruling-out, and reducing inappropriate hospitalizations. Furthermore, this technology could represent an opportunity to reduce overall costs for the healthcare system.

P1579Impact of Renal Dysfunction on Real-world Outcome of the ESC 0/1-hour Algorithm

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Twerenbold ◽  
J P Costabel ◽  
R Campos ◽  
M Cortes ◽  
T Nestelberger ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Renal Function ◽  
Renal Dysfunction ◽  
Real World ◽  
Normal Renal Function ◽  
Clinical Care ◽  
Outpatient Management ◽  
Cardiac Events ◽  
Real World Data ◽  
Rule Out

Abstract Background The 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) concentrations irrespective of renal function. Patients with renal dysfunction (RD, defined as a GFR <60ml/min) are at higher risk of NSTEMI and are presenting more often with elevated levels of hs-cTn even in absence of NSTEMI, which may contribute to an impaired efficacy and safety of the ESC 0/1h-algorithm. Purpose We aimed to assess and directly compare the real-world adherence, effectiveness, efficacy, and ultimately safety of the ESC 0/1h-algorithm when applied in patients with RD and normal renal function. 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 embedded in routine clinical care. 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 enrolled patients, RD was present in 129 (6%) patients. NSTEMI prevalence was substantially higher in RD as compared with normal renal function (19% versus 9%, p<0.001). Adherence to the ESC 0/1h-algorithm protocol was excellent with no violations observed in patients with RD as compared with 132 (6%) violations in patients with normal renal function (p=0.004). Effectiveness was very high in RD and comparable to normal renal function: 94% 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 as compared with 98% in normal renal function. Median time to discharge or transfer from the ED was significantly longer in RD (285 minutes [q1174, q3392]) as compared with normal renal function (150 minutes [q1132, q3222]). Efficacy of the ESC 0/1h-algorithm was lower in RD as it triaged 13% of patients towards rule-out and 34% towards rule-in of NSTEMI as compared with 65% and 12% in normal renal function, respectively (p<0.001). Overall, 30% of patients with RD underwent outpatient management as compared with 73% in normal renal function (p<0.001). Safety of rule-out and outpatient management were excellent in RD with a 30-day MACE incidence of both 0% and comparable with 0.2% and 0.1% in normal renal function, respectively (p=0.010). Conclusions These real-world data document for the first time the excellent adherence, effectiveness, and safety of the ESC 0/1h-algorithm when routinely applied in patients with RD. Compared with patients with normal renal function, fewer patients with RD could be triaged towards rule-out or were treated as outpatients, most likely due to the higher prevalence of NSTEMI and comorbidities in RD.

scholarly journals Serial high-sensitivity cardiac troponin T measurements to rule out acute myocardial infarction and a single high baseline measurement for swift rule-in: A systematic review and meta-analysis

2019 ◽  
Vol 9 (1) ◽  
pp. 14-22 ◽  
Author(s):  
M Arslan ◽  
A Dedic ◽  
E Boersma ◽  
EA Dubois
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Acute Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin T ◽  
Meta Analysis ◽  
High Sensitivity ◽  
Cardiac Troponin T ◽  
Single Baseline ◽  
Rule Out

Aims: The purpose of this study was to determine (a) the ability of serial high-sensitivity cardiac troponin T measurements to rule out acute myocardial infarction and (b) the ability of a single high baseline high-sensitivity cardiac troponin T measurement to rule in acute myocardial infarction in patients presenting to the emergency department with acute chest pain. Methods and results: Embase, Medline, Cochrane, Web of Science and Google scholar were searched for prospective cohort studies that evaluated parameters of diagnostic accuracy of serial high-sensitivity cardiac troponin T to rule out acute myocardial infarction and a single baseline high-sensitivity cardiac troponin T value>50 ng/l to rule in acute myocardial infarction. The search yielded 21 studies for the systematic review, of which 14 were included in the meta-analysis, with a total of 11,929 patients and an overall prevalence of acute myocardial infarction of 13.0%. For rule-out, six studies presented the sensitivity of serial measurements <14 ng/l. This cut-off classified 60.1% of patients as rule-out and the summary sensitivity was 96.7% (95% confidence interval: 92.3–99.3). Three studies presented the sensitivity of a one-hour algorithm with a baseline high-sensitivity cardiac troponin T value<12 ng/l and delta 1 hour <3 ng/l. This algorithm classified 60.2% of patients as rule-out and the summary sensitivity was 98.9% (96.4–100). For rule-in, six studies reported the specificity of baseline high-sensitivity cardiac troponin T value>50 ng/l. The summary specificity was 94.6% (91.5–97.1). Conclusion: Serial high-sensitivity cardiac troponin T measurement strategies to rule out acute myocardial infarction perform well, and a single baseline high-sensitivity cardiac troponin T value>50 ng/l to rule in acute myocardial infarction has a high specificity.

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

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