Finding acute coronary syndrome with serial troponin testing for rapid assessment of cardiac ischemic symptoms (FAST-TRAC): a study protocol

Objective@#To determine the utility of a highly sensitive troponin assay when utilized in the emergency department. @*Methods@#The FAST-TRAC study prospectively enrolled >1,500 emergency department patients with suspected acute coronary syndrome within 6 hours of symptom onset and 2 hours of emergency department presentation. It has several unique features that are not found in the majority of studies evaluating troponin. These include a very early presenting population in whom prospective data collection of risk score parameters and the physician’s clinical impression of the probability of acute coronary syndrome before any troponin data were available. Furthermore, two gold standard diagnostic definitions were determined by a pair of cardiologists reviewing two separate data sets; one that included all local troponin testing results and a second that excluded troponin testing so that diagnosis was based solely on clinical grounds. By this method, a statistically valid head-to-head comparison of contemporary and high sensitivity troponin testing is obtainable. Finally, because of a significant delay in sample processing, a unique ability to define the molecular stability of various troponin assays is possible.Trial registration ClinicalTrials.gov Identifier NCT00880802

Diagnostic accuracy and temporal impact of ultrasound in patients with dyspnea admitted to the emergency department

OBJECTIVE: Few studies have prospectively evaluated the diagnostic accuracy and temporal impact of ultrasound in the emergency department (ED) in a randomized manner. In this study, we aimed to perform a randomized, standard therapy controlled evaluation of the diagnostic accuracy and temporal impact of a standardized ultrasound strategy, versus standard care, in patients presenting to the ED with acute dyspnea.METHODS: The patients underwent a standardized ultrasound examination that was blinded to the team caring for the patient. Ultrasound results remained blinded in patients randomized to the treating team but were unblinded in the interventional cohort. Scans were performed by trained emergency physicians. The gold standard diagnosis (GSDx) was determined by two physicians blinded to the ultrasound results. The same two physicians reviewed all data >30 days after the index visit.RESULTS: Fifty-nine randomized patients were enrolled. The mean±standard deviation age was 54.4±11 years, and 37 (62%) were male. The most common GSDx was acute heart failure with reduced ejection fraction in 13 (28.3%) patients and airway diseases such as acute exacerbation of asthma or chronic obstructive pulmonary disease in 10 (21.7%). ED diagnostic accuracy, as compared to the GSDx, was 76% in the ultrasound cohort and 79% in the standard care cohort (P=0.796). Compared with the standard care cohort, the final diagnosis was obtained much faster in the ultrasound cohort (mean±standard deviation: 12±3.2 minutes vs. 270 minutes, P<0.001).CONCLUSION: A standardized ultrasound approach is equally accurate, but enables faster ED diagnosis of acute dyspnea than standard care.

Incidence and characteristics of major bleeding among rivaroxaban users with renal disease and nonvalvular atrial fibrillation

OBJECTIVE: Patients with nonvalvular atrial fibrillation (AF) and renal disease (RD) who receive anticoagulation therapy appear to be at greater risk of major bleeding (MB) than AF patients without RD. As observed in past studies, anticoagulants are frequently withheld from AF patients with RD due to concerns regarding bleeding. The objective of this study was to evaluate the incidence and pattern of MB in those with RD, as compared to those without RD, in a population of rivaroxaban users with nonvalvular AF. METHODS: Electronic medical records of over 10 million patients from the Department of Defense Military Health System were queried to identify rivaroxaban users with nonvalvular AF. A validated algorithm was used to identify MB-related hospitalizations. RD was defined through diagnostic codes present within 6 months prior to the bleeding date for MB cases and end of study participation for non-MB patients. Data were collected on patient characteristics, comorbidities, MB management, and outcomes. RESULTS: Overall, 44,793 rivaroxaban users with nonvalvular AF were identified. RD was present among 6,921 patients (15.5%). Patients with RD had a higher rate of MB than those without RD, 4.52 per 100 person-years versus 2.54 per 100 person-years, respectively. The fatal bleeding outcome rate (0.09 per 100 person-years) was identical between those with and without RD. CONCLUSION: In this post-marketing study of 44,793 rivaroxaban users with nonvalvular AF, RD patients experienced a higher MB rate than those without RD. The higher rate of MB among those with RD may be due to the confounding effects of comorbidities.

Study design of Real World Evidence for Treatment of Hyperkalemia in the Emergency Department (REVEAL-ED): a multicenter, prospective, observational study

OBJECTIVE: Hyperkalemia affects up to 10% of hospitalized patients and, if left untreated, can lead to serious cardiac arrhythmias or death. Although hyperkalemia is frequently encountered in the emergency department (ED), and is potentially life-threatening, standard of care for the treatment is poorly defined, with little supporting evidence. The main objectives of this observational study are to define the overall burden of hyperkalemia in the ED setting, describe its causes, the variability in treatment patterns and characterize the effectiveness and safety of ED standard of care therapies used in the United States. METHODS: This is an observational study evaluating the management of hyperkalemia in the ED. Two hundred and three patients who presented to the ED with a potassium value ≥5.5 mmol/L were enrolled in the study at 14 sites across the United States. Patients were treated per standard of care practices at the discretion of the patient’s physician. In patients who received a treatment for hyperkalemia, blood samples were drawn at pre-specified time points and serum potassium values were recorded. The change in potassium over 4 hours and the adverse events after standard of care treatment were analyzed. RESULTS AND CONCLUSION: This article describes the background, rationale, study design, and methodology of the REVEAL-ED (Real World Evidence for Treatment of Hyperkalemia in the Emergency Department) trial, a multicenter, prospective, observational study evaluating contemporary management of patients admitted to the ED with hyperkalemia.

A retrospective study of emergency department potassium disturbances: severity, treatment, and outcomes

OBJECTIVE: Disturbances in potassium (K) levels are relatively common and may be associated with significant morbidity and mortality; however, treatments vary. Our purpose was to determine the incidence, treatments, and outcomes associated with hyperkalemia and hypokalemia in emergency department (ED) patients. METHODS: We performed a structured, retrospective review of electronic medical records of consecutive adult ED patients with K measured while in the ED. Demographic, clinical, and laboratory data as well as treatments, disposition, and in-hospital complications were collected. Univariate and multivariate analyses, presented as adjusted odds ratios, were used to compare outcomes by K levels. RESULTS: Of 100,260 visits in 2014, an ED K level was ordered in 48,827 (49%). A total of 1,738 patients (3.6%) were excluded because of sample hemolysis. The K was low (5.0 mEq/L) in 3.6% of patients. Patients with hyperkalemia were older (64 vs. 49 years, P6 mEq/L. CONCLUSION: Hyperkalemia or hypokalemia occur in 1 of 11 ED patients and are associated with inpatient admission and mortality. Treatment of hyperkalemia varies greatly suggesting the need for evidence-based treatment guidelines.

Safety and efficiency of emergency department interrogation of cardiac devices

OBJECTIVE: Patients with implanted cardiac devices may wait extended periods for interrogation in emergency departments (EDs). Our purpose was to determine if device interrogation could be done safely and faster by ED staff. METHODS: Prospective randomized, standard therapy controlled, trial of ED staff device interrogation vs. standard process (SP), with 30-day follow-up. Eligibility criteria: ED presentation with a self-report of a potential device related complaint, with signed informed consent. SP interrogation was by company representative or hospital employee. RESULTS: Of 60 patients, 42 (70%) were male, all were white, with a median (interquartile range) age of 71 (64 to 82) years. No patient was lost to follow up. Of all patients, 32 (53%) were enrolled during business hours. The overall median (interquartile range) ED vs. SP time to interrogation was 98.5 (40 to 260) vs. 166.5 (64 to 412) minutes (P=0.013). While ED and SP interrogation times were similar during business hours, 102 (59 to 138) vs. 105 (64 to 172) minutes (P=0.62), ED interrogation times were shorter vs. SP during non-business hours; 97 (60 to 126) vs. 225 (144 to 412) minutes, P=0.002, respectively. There was no difference in ED length of stay between the ED and SP interrogation, 249 (153 to 390) vs. 246 (143 to 333) minutes (P=0.71), regardless of time of presentation. No patient in any cohort suffered an unplanned medical contact or post-discharge adverse device related event. CONCLUSION: ED staff cardiac device interrogations are faster, and with similar 30-day outcomes, as compared to SP.

Can a Point-of-Care Troponin I Assay be as Good as a Central Laboratory Assay? A MIDAS Investigation

BACKGROUND: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA). METHODS: Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI). The MIDAS dataset, described elsewhere, is a prospective multicenter dataset of emergency department (ED) patients with suspected acute coronary syndrome (ACS) and a planned objective myocardial perfusion evaluation. Myocardial infarction (MI) was diagnosed by central adjudication. RESULTS: The C-statistic with 95% confidence intervals (CI) for diagnosing MI by using a common population (n=241) was 0.95 (0.91-0.99), 0.95 (0.91-0.99), and 0.93 (0.89-0.97) for the Triage, Singulex, and PathFast assays, respectively. Of samples with detectable troponin, the absolute values had high Pearson (R(P)) and Spearman (R(S)) correlations and were R(P)=0.94 and R(S)=0.94 for Triage vs Singulex, R(P)=0.93 and R(S)=0.85 for Triage vs PathFast, and R(P)=0.89 and R(S)=0.73 for PathFast vs Singulex. CONCLUSIONS: In a single comparative population of ED patients with suspected ACS, the Triage Cardio3 TnI, PathFast, and Singulex TnI assays provided similar diagnostic performance for MI.

Admission rates for emergency department patients with venous thromboembolism and estimation of the proportion of low risk pulmonary embolism patients: a US perspective

OBJECTIVE: Introduction of target specific anticoagulants and recent guidelines encourage outpatient management of low risk patients with venous thromboembolism. We describe hospital admission rates over time for patients presenting to US emergency departments (EDs) with deep vein thrombosis (DVT) and pulmonary embolism (PE) and estimate the proportion of low-risk PE patients who could potentially be managed as outpatients. METHODS: We performed a structured analysis of the National Hospital Ambulatory Medical Care Survey (a nationally representative weighted sampling of US ED visits) database for the years 2006–2010 including all adult patients with a primary diagnosis of DVT or PE. Simplified pulmonary embolus scoring index (sPESI) scores were determined in patients with PE to identify low risk patients. RESULTS: There were an estimated 652,000 and 394,000 ED visits for DVT and PE over the 5-year period (0.17%). Mean (SE) age was 59 (1.3), 50% were female, and 40% were > 65 years. Admission rates for DVT and PE were 52% and 90% respectively with no significant changes over time. In patients with DVT, predictors for admission were age (odds ratio, 1.03 per year of age [95% confidence interval, 1.01 to 1.05]) and race (odds ratio, 4.1 [95% confidence interval, 0.9 to 19.8] for Hispanics and 2.9 [1.2 to 7.4] for Blacks). Of all ED patients with PE, 51% were low risk based on sPESI scores. CONCLUSION: Admission rates for DVT and PE have remained high and unchanged, especially with PE, minorities, and in older patients. Based on sPESI scores, up to half of PE patients might be eligible for early discharge or outpatient therapy.