Objective
The objective was to determine the effect of frailty on risk of 30‐day mortality in nonseverely disabled older patients with acute heart failure (AHF) attended in emergency departments ...(EDs).
Methodology
The Frailty‐AHF Study is a retrospective analysis of a multicenter, observational, prospective, cohort study (Older‐AHF Register). This study included consecutive patients ≥ 65 years of age without severe functional dependence or dementia attended for AHF in three Spanish EDs for 4 months. Frailty was defined by frailty phenotype as the presence of three or more domains. Baseline and episode characteristics and 30‐day mortality were collected in all the patients.
Results
A total of 465 patients with a mean (±SD) age of 82 (±7) years were included, 283 (61.0%) being female and 225 (51.3%) with severe comorbidity (Charlson index ≥ 3). Frailty was present in 169 (36.3%). The rate of 30‐day mortality was 7.3%. Frailty adjusted for potential confounding factors was an independent factor associated with 30‐day mortality (adjusted hazard ratio = 2.5; 95% confidence interval = 1.0 to 6.0; p = 0.047).
Conclusion
The presence of frailty is an independent risk factor of 30‐day mortality in nonsevere dependent older patients attended with AHF in EDs.
It is currently unknown whether the uniform (universal clinical practice for more than 2 decades) or 2 sex-specific cutoff levels are preferable when using high-sensitivity cardiac troponin T ...(hs-cTnT) levels in the diagnosis of acute myocardial infarction (AMI).
To improve the management of suspected AMI in women by exploring sex-specific vs uniform cutoff levels for hs-cTnT.
In an ongoing prospective, diagnostic, multicenter study conducted at 9 emergency departments, the present study evaluated patients enrolled from April 21, 2006, through June 5, 2013. The participants included 2734 adults presenting with suspected AMI. Duration of follow-up was 2 years, and data analysis occurred from June 5 to December 21, 2015.
The final diagnosis was centrally adjudicated by 2 independent cardiologists using all available information, including measurements of serial hs-cTnT blood concentrations twice: once using the uniform 99th percentile cutoff value level of 14 ng/L and once using sex-specific 99th percentile levels of hs-cTnT (women, 9 ng/L; men, 15.5 ng/L).
Diagnostic reclassification in women and men using sex-specific vs the uniform cutoff level in the diagnosis of AMI.
Of the 2734 participants, 876 women (32%) and 1858 men (68%) were included. Median (interquartile range) age was 68 (55-77) and 59 (48-71) years, respectively. With the use of the uniform cutoff value, 127 women (14.5%) and 345 men (18.6%) received a final diagnosis of AMI. Among these, at emergency department presentation, levels of hs-cTnT were already above the uniform cutoff value in 427 patients (sensitivity, 91.3% 95% CI, 85%-95.6% in women vs 90.7% 95% CI, 87.1%-93.5% in men; specificity, 79.2% 95% CI, 76.1%-82.1% in women vs 78.5% 95% CI, 76.4%-80.6% in men). After readjudication using sex-specific 99th percentile levels, diagnostic reclassification regarding AMI occurred in only 3 patients: 0.11% (95% CI, 0.02-0.32) of all patients and 0.6% (95% CI, 0.13-1.85) of patients with AMI. The diagnosis in 2 women was upgraded from unstable angina to AMI, and the diagnosis in 1 man was downgraded from AMI to unstable angina. These diagnostic results were confirmed when using 2 alternative pairs of uniform and sex-specific cutoff values.
The uniform 99th percentile should remain the standard of care when using hs-cTnT levels for the diagnosis of AMI.
Objectives
We investigated the natural history of patients after a first episode of acute heart failure (FEAHF) requiring emergency department (ED) consultation, focusing on: the frequency of ED ...visits and hospitalisations, departments admitting patients during the first and subsequent hospitalisations, and factors associated with difficult disease control.
Methods and results
We included consecutive patients diagnosed with FEAHF (either with or without previous heart failure diagnosis) in four EDs during 5 months in three different time periods (2009, 2011, 2014). Diagnosis was adjudicated by local principal investigators. The clinical characteristics of the index event were prospectively recorded, and all post‐discharge ED visits and hospitalisations related/unrelated to acute heart failure (AHF), as well as departments involved in subsequent hospitalisations were retrospectively ascertained. ‘Uncontrolled disease’ during the first year after FEAHF was considered if patients were attended at ED (≥ 3 times) or hospitalised (≥ 2 times) for AHF or died. Overall, 505 patients with FEAHF were included and followed for a mean of 2.4 years. In‐hospital mortality was 7.5%. Among 467 patients discharged alive, 288 died median survival 3.9 years, 95% confidence interval (CI) 3.5–4.4, 421 (90%) revisited the ED (2342 ED visits; 42.4% requiring hospitalisation, 34.0% AHF‐related) and 357
(77%) were hospitalised (1054 hospitalisations; 94.1% through ED, 51.4% AHF‐related). AHF‐related hospitalisations were mainly in internal medicine (28.0%), short‐stay unit (26.3%), cardiology (20.8%), and geriatrics (14.1%). Only 47.4% of AHF‐related hospitalisations were in the same department as the FEAHF, and internal medicine involvement significantly increased with subsequent hospitalisations (P = 0.01). Uncontrolled disease was observed in 31% of patients, which was independently related to age > 80 years odds ratio (OR) 1.80, 95% CI 1.17–2.77, systolic blood pressure < 110 mmHg at ED arrival (OR 2.61, 95% CI 1.26–5.38) and anaemia (OR 2.39, 95% CI 1.51–3.78).
Conclusion
In the present aged cohort of AHF patients from Barcelona, Spain, the natural history after FEAHF showed different patterns of hospital department involvement. Advanced age, low systolic blood pressure and anaemia were factors related to uncontrolled disease during the year after debut.
The non-ST-segment-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 cutoff for further triage is endorsed. Recently, a specific cutoff for 0/3h high-sensitivity cardiac troponin T (hs-cTnT) change (7 ng/L) was proposed, warranting external validation.
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 2 independent cardiologists applying the fourth universal definition of myocardial infarction, on the basis of complete cardiac workup, cardiac imaging, and serial hs-cTnT. Hs-cTnT concentrations were measured at presentation, after 1 hour, and after 3 hours. The objective was to externally validate the proposed cutoff, 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.
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 NSTEMI, leaving 564 patients (27.2%) in the observe-zone (adjudicated NSTEMI prevalence, 120/564 patients, 21.3%). The suggested 0/3h-hs-cTnT-change of <7 ng/L triaged 517 patients (91.7%) toward rule-out, resulting in a sensitivity of 33.3% (95% CI, 25.5-42.2), missing 80 patients with NSTEMI, and ≥7 ng/L triaged 47 patients toward 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%) toward 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%) toward 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%s and the number of type 1 myocardial infarction by 50%. Findings were confirmed in both internal and external validation.
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. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT00470587.
Four strategies for very early rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I (hs-cTnI) have been identified. It remains unclear which strategy is most attractive ...for clinical application.
We prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction. The final diagnosis was adjudicated by 2 independent cardiologists. Hs-cTnI levels were measured at presentation and after 1 hour in a blinded fashion. We directly compared all 4 hs-cTnI-based rule-out strategies: limit of detection (LOD, hs-cTnI<2 ng/L), single cutoff (hs-cTnI<5 ng/L), 1-hour algorithm (hs-cTnI<5 ng/L and 1-hour change<2 ng/L), and the 0/1-hour algorithm recommended in the European Society of Cardiology guideline combining LOD and 1-hour algorithm.
Among 2828 enrolled patients, acute myocardial infarction was the final diagnosis in 451 (16%) patients. The LOD approach ruled out 453 patients (16%) with a sensitivity of 100% (95% confidence interval CI, 99.2%-100%), the single cutoff 1516 patients (54%) with a sensitivity of 97.1% (95% CI, 95.1%-98.3%), the 1-hour algorithm 1459 patients (52%) with a sensitivity of 98.4% (95% CI, 96.8%-99.2%), and the 0/1-hour algorithm 1463 patients (52%) with a sensitivity of 98.4% (95% CI, 96.8%-99.2%). Predefined subgroup analysis in early presenters (≤2 hours) revealed significantly lower sensitivity (94.2%, interaction
=0.03) of the single cutoff, but not the other strategies. Two-year survival was 100% with LOD and 98.1% with the other strategies (
<0.01 for LOD versus each of the other strategies).
All 4 rule-out strategies balance effectiveness and safety equally well. The single cutoff should not be applied in early presenters, whereas the 3 other strategies seem to perform well in this challenging subgroup.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587.
The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) assay.
We enrolled patients presenting to the emergency department ...with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists with 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 1 h. The primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI Access vs the hs-cTnT Elecsys and hs-cTnI Architect assays. Secondary objectives included the derivation and validation of an hs-cTnI Access-specific 0/1-h algorithm.
AMI was the adjudicated final diagnosis in 243 of 1579 (15.4%) patients. The AUC at presentation for hs-cTnI Access was 0.95 (95% CI, 0.94-0.96), higher than hs-cTnI Architect 0.92 (95% CI, 0.91-0.94;
< 0.001) and comparable to hs-cTnT Elecsys 0.94 (95% CI, 0.93-0.95;
= 0.12). Applying the derived hs-cTnI Access 0/1-h algorithm (derivation cohort n = 686) to the 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 0/1-h algorithm had a survival rate of 100% at 30 days. Findings were confirmed in the secondary analyses by the adjudication including serial measurements of Architect hs-cTnI.
Diagnostic accuracy and clinical utility of the Beckman hs-cTnI Access assay are very high and at least comparable to Roche hs-cTnT and Abbott hs-cTnI assays.
NCT00470587.
We aimed to assess the diagnostic utility of the Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay.
This multicenter study included patients with chest discomfort presenting to the ...emergency department. Diagnoses were centrally and independently adjudicated by two cardiologists using all available clinical information. Adjudication was performed twice including serial measurements of high-sensitivity cardiac troponin (hs-cTn) I-Architect (primary analysis) and serial measurements of hs-cTnT-Elecsys (secondary analysis) in addition to the clinically used (hs)-cTn. The primary objective was to assess and compare the discriminatory performance of hs-cTnI-EXL, hs-cTnI-Architect and hs-cTnT-Elecsys for acute myocardial infarction (MI). Furthermore, we derived and validated a hs-cTnI-EXL-specific 0/1h-algorithm.
Adjudicated MI was the diagnosis in 204/1454 (14%) patients. The area under the receiver operating characteristics curve for hs-cTnI-EXL was 0.94 (95%CI, 0.93-0.96), and comparable to hs-cTnI-Architect (0.95; 95%CI, 0.93-0.96) and hs-cTnT-Elecsys (0.93; 95%CI, 0.91-0.95). In the derivation cohort (n = 813), optimal criteria for rule-out of MI were <9ng/L at presentation (if chest pain onset >3h) or <9ng/L and 0h-1h-change <5ng/L, and for rule-in ≥160ng/L at presentation or 0h-1h-change ≥100ng/L. In the validation cohort (n = 345), these cut-offs ruled-out 56% of patients (negative predictive value 99.5% (95%CI, 97.1-99.9), sensitivity 97.8% (95%CI, 88.7-99.6)), and ruled-in 9% (positive predictive value 83.3% (95%CI, 66.4-92.7), specificity 98.3% (95%CI, 96.1-99.3)). Secondary analyses using adjudication based on hs-cTnT measurements confirmed the findings.
The overall performance of the hs-cTnI-EXL was comparable to best-validated hs-cTnT/I assays and an assay-specific 0/1h-algorithm safely rules out and accurately rules in acute MI.
ClinicalTrials.gov number, NCT00470587
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Abstract Background We aimed to derive and validate a 0/2 h-algorithm using the new high-sensitivity cardiac troponin I (hs-cTnI)-VITROS assay (VITROS® Immunodiagnostic Products hs-Troponin I Reagent ...Pack, Ortho Clinical Diagnostics) for rapid rule-out/in of non-ST-segment elevation myocardial infarction (NSTEMI). Methods The final diagnosis was centrally adjudicated by 2 independent cardiologists according to the fourth universal definition of myocardial infarction (MI) among 1888 patients presenting to the emergency department with acute chest pain. hs-cTnI-VITROS concentrations were measured at presentation and at 2 h in a blinded fashion. The optimal assay-specific thresholds for the hs-cTnI-VITROS 0/2 h-algorithm were derived in a randomly selected 70% of the cohort and validated in the remaining 30%. Results NSTEMI was the final diagnosis in 216/1322 (16.3%) patients of the derivation cohort. Rule-out was defined as baseline hs-cTnI concentrations of <1 ng/L in patients presenting with chest pain onset >3 h or a baseline hs-cTnI concentration of <2 ng/L and an absolute change of <3 ng/L within 2 h. Thresholds for rule-in were either ≥40 ng/L at presentation or an absolute change within 2 h of ≥ 5ng/L. In the derivation cohort, these thresholds ruled-out 50.8% of patients with a negative predictive value (NPV) and sensitivity of 99.7% (95% Confidence Interval (CI), 98.8–99.9%) and 99.1% (95% CI, 96.7–99.9%), and ruled-in 17.9% with a positive predictive value (PPV) of 79.2% (95% CI, 74.3–83.5%). In the validation cohort, NSTEMI was the final diagnosis in 91/566 (16.1%) patients. The derived 0/2 h-algorithm ruled-out 46.3% of patients with a NPV and sensitivity of 100% (95% CI, 95.6–100%) and 100% (95% CI, 96.0–100%), and ruled-in 18.9% with a PPV of 73.8% (95% CI, 66.1–80.3%) in the validation cohort. Conclusion hs-cTnI-VITROS concentrations at presentation combined with absolute changes within the first 2 h allowed safe rule-out and accurate rule-in of NSTEMI in two-thirds of unselected patients presenting with acute chest pain to the emergency department. Trial registration www.clinicaltrials.gov: NCT0047058
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