The HEART Pathway Randomized Controlled Trial One-year Outcomes.

OBJECTIVE: The objective was to determine the impact of the HEART Pathway on health care utilization and safety outcomes at 1 year in patients with acute chest pain. METHODS: Adult emergency department (ED) patients with chest pain (N = 282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, ED providers used the HEART score and troponin measures (0 and 3 hours) to risk stratify patients. Usual care was based on American College of Cardiology/American Heart Association guidelines. Major adverse cardiac events (MACE-cardiac death, myocardial infarction [MI], or coronary revascularization), objective testing (stress testing or coronary angiography), and cardiac hospitalizations and ED visits were assessed at 1 year. Randomization arm outcomes were compared using Fisher's exact tests. RESULTS: A total of 282 patients were enrolled, with 141 randomized to each arm. MACE at 1 year occurred in 10.6% (30/282): 9.9% in the HEART Pathway arm (14/141; 10 MIs, four revascularizations without MI) versus 11.3% in usual care (16/141; one cardiac death, 13 MIs, two revascularizations without MI; p = 0.85). Among low-risk HEART Pathway patients, 0% (0/66) had MACE, with a negative predictive value (NPV) of 100% (95% confidence interval = 93%-100%). Objective testing through 1 year occurred in 63.1% (89/141) of HEART Pathway patients compared to 71.6% (101/141) in usual care (p = 0.16). Nonindex cardiac-related hospitalizations and ED visits occurred in 14.9% (21/141) and 21.3% (30/141) of patients in the HEART Pathway versus 10.6% (15/141) and 16.3% (23/141) in usual care (p = 0.37, p = 0.36). CONCLUSIONS: The HEART Pathway had a 100% NPV for 1-year safety outcomes (MACE) without increasing downstream hospitalizations or ED visits. Reduction in 1-year objective testing was not significant.

Validation of the No Objective Testing Rule and Comparison to the HEART Pathway.

BACKGROUND: The no objective testing rule (NOTR) is a decision aid designed to safely identify emergency department (ED) patients with chest pain who do not require objective testing for coronary artery disease. OBJECTIVES: The objective was to validate the NOTR in a cohort of U.S. ED patients with acute chest pain and compare its performance to the HEART Pathway. METHODS: A secondary analysis of 282 participants enrolled in the HEART Pathway randomized controlled trial was conducted. Each patient was classified as low risk or at risk by the NOTR. Sensitivity for major adverse cardiac events (MACE) at 30 days was calculated in the entire study population. NOTR and HEART Pathways were compared among patients randomized to the HEART Pathway in the parent trial using McNemar's test and the net reclassification improvement (NRI). RESULTS: Major adverse cardiac events occurred in 22/282 (7.8%) participants, including no deaths, 16/282 (5.6%) with myocardial infarction (MI), and 6/282 (2.1%) with coronary revascularization without MI. NOTR was 100% (95% confidence interval [CI] = 84.6%-100%) sensitive for MACE and identified 78/282 patients (27.7%, 95% = CI 22.5-33.3%) as low risk. In the HEART Pathway arm (n = 141), both NOTR and HEART Pathway identified all patients with MACE as at risk. Compared to NOTR, the HEART Pathway was able to correctly reclassify 27 patients without MACE as low risk, yielding a NRI of 20.8% (95% CI = 11.3%-30.2%). CONCLUSIONS: Within a U.S. cohort of ED patients with chest pain, the NOTR and HEART Pathway were 100% sensitive for MACE at 30 days. However, the HEART Pathway identified more patients suitable for early discharge than the NOTR.

Use of the HEART Pathway with high sensitivity cardiac troponins: A secondary analysis.

OBJECTIVES: The HEART Pathway combines a decision aid and serial contemporary cardiac troponin I (cTnI) measures to achieve >99% sensitivity for major adverse cardiac events (MACE) at 30days and early discharge rates >20%. However, the impact of integrating high-sensitivity troponin (hs-cTn) measures into the HEART Pathway has yet to be determined. In this analysis we compare test characteristics of the HEART Pathway using hs-cTnI, hs-cTnT, or cTnI. DESIGN & METHODS: A secondary analysis of participants enrolled in the HEART Pathway RCT was conducted. Each patient was risk stratified by the cTn-HEART Pathway (Siemens TnI-Ultra at 0- and 3-h) and a hs-cTn-HEART Pathway using hs-cTnI (Abbott) or hs-cTnT (Roche) at 3-h. The early discharge rate, sensitivity, specificity, and negative predictive value (NPV) for MACE (death, myocardial infarction, or coronary revascularization) at 30days were calculated. RESULTS: hs-cTnI measures were available on 133 patients. MACE occurred in 11/133 (8%) of these patients. Test characteristics for the HEART Pathway using serial cTnI vs 3hour hs-cTnI were the same: sensitivity (100%, 95%CI: 72-100%), specificity (49%, 95%CI: 40-58%), NPV (100%, 95%CI: 94-100%), and early discharge rate (45%, 95%CI: 37-54%). The HEART Pathway using hs-cTnT missed one MACE event (myocardial infarction): sensitivity (91%, 95%CI: 59-100%), specificity (48%, 95%CI: 39-57%), NPV (98%, 95%CI: 91-100%), and early discharge rate (45%, 95%CI: 37-54%). CONCLUSIONS: There was no difference in the test characteristics of the HEART Pathway whether using cTnI or hs-cTnI, with both achieving 100% sensitivity and NPV. Use of hs-cTnT with the HEART Pathway was associated with one missed MACE.

Cost analysis of the History, ECG, Age, Risk factors, and initial Troponin (HEART) Pathway randomized control trial.

INTRODUCTION: The HEART Pathway is a diagnostic protocol designed to identify low-risk patients presenting to the emergency department with chest pain that are safe for early discharge. This protocol has been shown to significantly decrease health care resource utilization compared with usual care. However, the impact of the HEART Pathway on the cost of care has yet to be reported. METHODS AND RESULTS: We performed a cost analysis of patients enrolled in the HEART Pathway trial, which randomized participants to either usual care or the HEART Pathway protocol. For low-risk patients, the HEART Pathway recommended early discharge from the emergency department without further testing. We compared index visit cost, cost at 30 days, and cardiac-related health care cost at 30 days between the 2 treatment arms. Costs for each patient included facility and professional costs. Cost at 30 days included total inpatient and outpatient costs, including the index encounter, regardless of etiology. Cardiac-related health care cost at 30 days included the index encounter and costs adjudicated to be cardiac-related within that period. Two hundred seventy of the 282 patients enrolled in the trial had cost data available for analysis. There was a significant reduction in cost for the HEART Pathway group at 30 days (median cost savings of $216 per individual), which was most evident in low-risk (Thrombolysis In Myocardial Infarction score of 0-1) patients (median savings of $253 per patient) and driven primarily by lower cardiac diagnostic costs in the HEART Pathway group. CONCLUSIONS: Using the HEART Pathway as a decision aid for patients with undifferentiated chest pain resulted in significant cost savings.

Chest Pain Risk Stratification: A Comparison of the 2-Hour Accelerated Diagnostic Protocol (ADAPT) and the HEART Pathway.

BACKGROUND: The 2-hour accelerated diagnostic protocol (ADAPT) and the history electrocardiogram age risk factors troponin (HEART) Pathway are decision aids designed to identify Emergency Department (ED) patients with chest pain who are safe for early discharge. Both have demonstrated high sensitivity (>99%) for major adverse cardiac events (MACE) at 30 days and early discharge rates ≥20%. The objective of this study is to compare the sensitivity and early discharge rates of the ADAPT and HEART Pathway decision aids in a cohort of ED patients with acute chest pain. METHODS: A secondary analysis of participants enrolled and randomized to the HEART Pathway arm of the HEART pathway randomized controlled trial was conducted. Each patient was prospectively classified as low risk (suitable for early discharge) or high risk by ADAPT and the HEART Pathway. Sensitivity for MACE at 30 days and the number of patients identified as low-risk were calculated for each decision aid. Decision aid performance was compared using McNemar's test. RESULTS: MACE occurred in 8 of 141 (5.7%); there were no deaths, 7 patients had myocardial infarction, and 1 patient had coronary revascularization without myocardial infarction. ADAPT and the HEART pathway identified all patients with MACE as high risk; sensitivity for MACE of 100% [95% confidence interval (CI): 63-100%]. ADAPT identified 34 of 141 patients (24%; 95% CI: 17-32%) as low-risk, whereas the Heart pathway identified 66 of 141 patients (47%, 95% CI: 38-55%) as low risk (P < 0.001). CONCLUSIONS: Within a cohort of ED patients with acute chest pain, ADAPT and the HEART pathway had high sensitivity for MACE. The HEART pathway outperformed ADAPT by correctly identifying more patients as low risk and safe for early discharge.

Association of Early Stress Testing with Outcomes for Emergency Department Evaluation of Suspected Acute Coronary Syndrome.

BACKGROUND: Professional society guidelines suggest early stress testing (within 72 hours) after an emergency department (ED) evaluation for suspected acute coronary syndrome (ACS). However, there is increasing concern that current practice results in over-testing without evidence of benefit. We test the hypothesis that early stress testing improves outcomes. METHODS: We analyzed prospectively collected data from 9 EDs on patients with suspected ACS, 1999-2001. We excluded patients with an ED diagnosis of ACS. The primary outcome was 30-day major adverse cardiac events (MACEs), including all-cause death, acute myocardial infarction, and revascularization. We used the HEART score to determine pretest ACS risk (low, intermediate, and high). To mitigate potential confounding, patients with and without early stress testing were matched within pretest risk strata in a 1:2 ratio using propensity scores. RESULTS: Of 7127 potentially eligible patients, 895 (13%) received early stress testing. The analytic cohort included 895 patients with early stress testing matched to 1790 without early stress testing. The overall 30-day MACE rate in both the source and analytic population was 3%. There were no baseline imbalances after propensity score matching (P > 0.1 for more than 30 variables). There was no association between early stress testing and 30-day MACE [odds ratio, 1.0; 95% confidence interval (CI), 0.6-1.7]. There was no effect modification by pretest risk (low: odds ratio, 1.0; 95% CI, 0.2-3.7; intermediate: 1.2; 95% CI, 0.6-2.6; high: 0.4; 95% CI, 0.1-1.6). CONCLUSIONS: Early stress testing is not associated with reduced MACE in patients evaluated for suspected ACS. Early stress testing may have limited value in populations with low MACE rate.

Comparison of the HEART and TIMI Risk Scores for Suspected Acute Coronary Syndrome in the Emergency Department.

OBJECTIVES: The emergency department evaluation for suspected acute coronary syndrome (ACS) is common, costly, and challenging. Risk scores may help standardize clinical care and screening for research studies. The Thrombolysis in Myocardial Infarction (TIMI) and HEART are two commonly cited risk scores. We tested the null hypothesis that the TIMI and HEART risk scores have equivalent test characteristics. METHODS: We analyzed data from the Internet Tracking Registry of Acute Coronary Syndromes (i*trACS) from 9 EDs on patients with suspected ACS, 1999-2001. We excluded patients with an emergency department diagnosis consistent with ACS, or without sufficient data to calculate TIMI and HEART scores. The primary outcome was 30-day major adverse cardiovascular events, including all-cause death, acute myocardial infarction, and urgent revascularization. We describe test characteristics of the TIMI and HEART risk scores. RESULTS: The study cohort included 8255 patients with 508 (6.2%) 30-day major adverse cardiovascular events. Receiver operating curve and reclassification analyses favored HEART [c statistic: 0.753, 95% confidence interval (CI): 0.733-0.773; continuous net reclassification improvement: 0.608, 95% CI: 0.527-0.689] over TIMI (c statistic: 0.678, 95% CI: 0.655-0.702). A HEART score 0-3 [negative predictive value (NPV) 0.982, 95% CI: 0.978-0.986; positive predictive value (PPV) 0.103, 95% CI: 0.094-0.113; likelihood ratio (LR) positive 1.76; LR negative 0.28] demonstrates similar or superior NPV/PPV/LR compared with TIMI = 0 (NPV 0.978, 95% CI: 0.971-0.983; PPV 0.077, 95% CI: 0.071-0.084; LR positive 1.28; LR negative 0.35) and TIMI = 0-1 (NPV 0.963, 95% CI: 0.958-0.968; PPV 0.102, 95% CI: 0.092-0.113; LR positive 1.73; LR negative 0.58). CONCLUSIONS: The HEART score has better discrimination than TIMI and outperforms TIMI within previously published "low-risk" categories.

Adherence to an Accelerated Diagnostic Protocol for Chest Pain: Secondary Analysis of the HEART Pathway Randomized Trial.

OBJECTIVES: Accelerated diagnostic protocols (ADPs), such as the HEART Pathway, are gaining popularity in emergency departments (EDs) as tools used to risk stratify patients with acute chest pain. However, provider nonadherence may threaten the safety and effectiveness of ADPs. The objective of this study was to determine the frequency and impact of ADP nonadherence. METHODS: A secondary analysis of participants enrolled in the HEART Pathway RCT was conducted. This trial enrolled 282 adult ED patients with symptoms concerning for acute coronary syndrome without ST-elevation on electrocardiogram. Patients randomized to the HEART Pathway (N = 141) were included in this analysis. Outcomes included index visit disposition, nonadherence, and major adverse cardiac events (MACEs) at 30 days. MACE was defined as death, myocardial infarction, or revascularization. Nonadherence was defined as: 1) undertesting-discharging a high-risk patient from the ED without objective testing (stress testing or coronary angiography) or 2) overtesting-admitting or obtaining objective testing on a low-risk patient. RESULTS: Nonadherence to the HEART Pathway occurred in 28 of 141 patients (20%, 95% confidence interval [CI] = 14% to 27%). Overtesting occurred in 19 of 141 patients (13.5%, 95% CI = 8% to 19%) and undertesting in nine of 141 patients (6%, 95% CI = 3% to 12%). None of these 28 patients suffered MACE. The net effect of nonadherence was 10 additional admissions among patients identified as low-risk and appropriate for early discharge (absolute decrease in discharge rate of 7%, 95% CI = 3% to 13%). CONCLUSIONS: Real-time use of the HEART Pathway resulted in a nonadherence rate of 20%, mostly due to overtesting. None of these patients had MACE within 30 days. Nonadherence decreased the discharge rate, attenuating the HEART Pathway's impact on health care use.

Impact of anticoagulation regimen prior to revascularization in patients with non-ST-segment elevation acute coronary syndromes: The ACUITY trial.

AIM: To evaluate the impact of antithrombotic regimens during the medical phase of treatment among 13,819 patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) treated with an early invasive strategy in the acute catheterization and urgent intervention triage strategy (ACUITY) trial. METHODS AND RESULTS: Endpoints included composite major adverse cardiac events (MACE), major bleeding, and net adverse clinical events (NACE; MACE or major bleeding). The median (interquartile range) duration of antithrombin use in the medical only treatment phase was 6.5 (1.8-22.5) hours. MACE, major bleeding, and NACE during the medical only phase occurred in 63 (0.5%), 117 (0.9%), and 178 (1.3%) patients, respectively. MACE rates in the medical-treatment-only phase were not significantly different between the four randomized medical regimens used (heparin alone, bivalirudin alone, heparin plus a glycoprotein IIb/IIIa inhibitor [GPI], and bivalirudin plus GPI) (Ptrend = 0.65). The lowest rates of major bleeding and NACE during the medical treatment phase occurred in patients treated with bivalirudin alone (Ptrend = 0.0006 and Ptrend = 0.0004, respectively). CONCLUSIONS: In patients with NSTE-ACS undergoing an early invasive strategy, treatment with bivalirudin alone significantly reduced major bleeding and improved net clinical outcomes during the upstream medical management phase with comparable rates of MACE. © 2015 Wiley Periodicals, Inc.

Performance of the EDACS-accelerated Diagnostic Pathway in a Cohort of US Patients with Acute Chest Pain.

BACKGROUND: The Emergency Department Assessment of Chest pain Score-Accelerated Diagnostic Protocol (EDACS-ADP) is a decision aid designed to safely identify emergency department (ED) patients with chest pain for early discharge. Derivation and validation studies in Australasia have demonstrated high sensitivity (99%-100%) for major adverse cardiac events (MACE). OBJECTIVES: To validate the EDACS-ADP in a cohort of US ED patients with symptoms suspicious for acute coronary syndrome (ACS). METHODS: A secondary analysis of participants enrolled in the HEART Pathway Randomized Controlled Trial was conducted. This single-site trial enrolled 282 ED patients≥21 years old with symptoms concerning for ACS, inclusive of all cardiac risk levels. Each patient was classified as low risk or at risk by the EDACS-ADP based on EDACS, electrocardiogram, and serial troponins. Potential early discharge rate and sensitivity for MACE at 30 days, defined as cardiac death, myocardial infarction (MI), or coronary revascularization were calculated. RESULTS: MACE occurred in 17/282 (6.0%) participants, including no deaths, 16/282 (5.6%) with MI, and 1/282 (0.4%) with coronary revascularization without MI. The EDACS-ADP identified 188/282 patients [66.7%, 95% confidence interval (CI): 60.8%-72.1%] as low risk. Of these, 2/188 (1.1%, 95% CI: 0.1%-3.9%) had MACE at 30 days. EDACS-ADP was 88.2% (95% CI: 63.6%-98.5%) sensitive for MACE, identifying 15/17 patients. Of the 2 patients identified as low risk with MACE, 1 had MI and 1 had coronary revascularization without MI. CONCLUSIONS: Within a US cohort of ED patients with symptoms concerning for ACS, sensitivity for MACE was 88.2%. We are unable to validate the EDACS-ADP as sufficiently sensitive for clinical use.

The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge.

BACKGROUND: The HEART Pathway is a decision aid designed to identify emergency department patients with acute chest pain for early discharge. No randomized trials have compared the HEART Pathway with usual care. METHODS AND RESULTS: Adult emergency department patients with symptoms related to acute coronary syndrome without ST-elevation on ECG (n=282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, emergency department providers used the HEART score, a validated decision aid, and troponin measures at 0 and 3 hours to identify patients for early discharge. Usual care was based on American College of Cardiology/American Heart Association guidelines. The primary outcome, objective cardiac testing (stress testing or angiography), and secondary outcomes, index length of stay, early discharge, and major adverse cardiac events (death, myocardial infarction, or coronary revascularization), were assessed at 30 days by phone interview and record review. Participants had a mean age of 53 years, 16% had previous myocardial infarction, and 6% (95% confidence interval, 3.6%-9.5%) had major adverse cardiac events within 30 days of randomization. Compared with usual care, use of the HEART Pathway decreased objective cardiac testing at 30 days by 12.1% (68.8% versus 56.7%; P=0.048) and length of stay by 12 hours (9.9 versus 21.9 hours; P=0.013) and increased early discharges by 21.3% (39.7% versus 18.4%; P<0.001). No patients identified for early discharge had major adverse cardiac events within 30 days. CONCLUSIONS: The HEART Pathway reduces objective cardiac testing during 30 days, shortens length of stay, and increases early discharges. These important efficiency gains occurred without any patients identified for early discharge suffering MACE at 30 days. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01665521.

Lessons in flying: crew resource management as a quality improvement method for acute coronary syndromes care.

Providing timely, high-quality, guideline-based care to patients with acute coronary syndromes (ACS) who present to the emergency department is critically dependent on cooperation, coordination, and communication between emergency medicine physicians and cardiologists. However, to achieve sustained improvement at the individual institution level, consistent implementation of quality improvement (QI) activities is needed. We describe a QI initiative for ACS care in the emergency setting that combined clinical education with a curriculum based on crew resource management (CRM) principles-a set of tools and techniques for communication, teamwork, and error avoidance used in the aviation industry and with proven applicability in the healthcare setting. Educational training sessions were open to multidisciplinary healthcare teams at 3 hospital sites, and participants were provided practical tools and resources to enhance communication, teamwork, and patient-centered care. Through patient chart reviews, participant surveys, and clinician interviews, baseline assessments of clinical performance measures and team communication-, logistics-, and skills-based efficiencies were performed and reported before the educational training was delivered at each QI site. Reviews of pre- and postinitiative participant surveys demonstrated improvement in knowledge and confidence in the delivery of appropriate and effective ACS care; however, reviews of pre- and postinitiative patient charts revealed limited process improvements. Altogether, this multicenter study of a continuing medical education program based on CRM principles was associated with improvements in provider knowledge and confidence regarding the delivery of appropriate ACS care, but had limited impact on clinical performance measures.

Anticoagulation with otamixaban and ischemic events in non-ST-segment elevation acute coronary syndromes: the TAO randomized clinical trial.

IMPORTANCE: The optimal anticoagulant for patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) managed with an invasive strategy remains controversial. OBJECTIVE: To compare the clinical efficacy and safety of otamixaban, a novel intravenous direct factor Xa inhibitor, with that of unfractionated heparin plus downstream eptifibatide in patients with NSTE-ACS undergoing a planned early invasive strategy. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, active-controlled superiority trial that enrolled 13,229 patients with NSTE-ACS and a planned early invasive strategy, at 568 active sites in 55 countries and conducted between April 2010 and February 2013. A planned interim analysis was conducted for otamixaban dose selection. INTERVENTIONS: Eligible participants were randomized to otamixaban (bolus and infusion, at 1 of 2 doses) or unfractionated heparin plus, at the time of percutaneous coronary intervention, eptifibatide. The otamixaban dose selected at interim analysis was an intravenous bolus of 0.080 mg/kg followed by an infusion of 0.140 mg/kg per hour. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was the composite of all-cause death or new myocardial infarction through day 7. RESULTS: Rates of the primary efficacy outcome were 5.5% (279 of 5105 patients) randomized to receive otamixaban and 5.7% (310 of 5466 patients) randomized to receive unfractionated heparin plus eptifibatide (adjusted relative risk, 0.99 [95% CI, 0.85-1.16]; P = .93). There were no differences for the secondary end points, including procedural thrombotic complications. The primary safety outcome of Thrombosis in Myocardial Infarction major or minor bleeding through day 7 was increased by otamixaban (3.1% vs 1.5%; relative risk, 2.13 [95% CI, 1.63-2.78]; P < .001). Results were consistent across prespecified subgroups. CONCLUSIONS AND RELEVANCE: Otamixaban did not reduce the rate of ischemic events relative to unfractionated heparin plus eptifibatide but did increase bleeding. These findings do not support the use of otamixaban for patients with NSTE-ACS undergoing planned early percutaneous coronary intervention. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01076764.

Stress CMR reduces revascularization, hospital readmission, and recurrent cardiac testing in intermediate-risk patients with acute chest pain.

OBJECTIVES: The aim of this study was to determine the effect of stress cardiac magnetic resonance (CMR) imaging in an observation unit (OU) on revascularization, hospital readmission, and recurrent cardiac testing in intermediate-risk patients with possible acute coronary syndromes (ACS). BACKGROUND: Intermediate-risk patients commonly undergo hospital admission with high rates of coronary revascularization. It is unknown whether OU-based care with CMR is a more efficient alternative. METHODS: A total of 105 intermediate-risk participants with symptoms of ACS but without definite ACS on the basis of the first electrocardiogram and troponin were randomized to usual care provided by cardiologists and internists (n = 53) or to OU care with stress CMR (n = 52). The primary composite endpoint of coronary artery revascularization, hospital readmission, and recurrent cardiac testing at 90 days was determined. The secondary endpoint was length of stay from randomization to index visit discharge; safety was measured as ACS after discharge. RESULTS: The median age of participants was 56 years (range 35 to 91 years), 54% were men, and 20% had pre-existing coronary disease. Index hospital admission was avoided in 85% of the OU CMR participants. The primary outcome occurred in 20 usual care participants (38%) versus 7 OU CMR participants (13%) (hazard ratio: 3.4; 95% confidence interval: 1.4 to 8.0, p = 0.006). The OU CMR group experienced significant reductions in all components: revascularizations (15% vs. 2%, p = 0.03), hospital readmissions (23% vs. 8%, p = 0.03), and recurrent cardiac testing (17% vs. 4%, p = 0.03). Median length of stay was 26 h (interquartile range: 23 to 45 h) in the usual care group and 21 h (interquartile range: 15 to 25 h) in the OU CMR group (p < 0.001). ACS after discharge occurred in 3 usual care participants (6%) and no OU CMR participants. CONCLUSIONS: In this single-center trial, management of intermediate-risk patients with possible ACS in an OU with stress CMR reduced coronary artery revascularization, hospital readmissions, and recurrent cardiac testing, without an increase in post-discharge ACS at 90 days. (Randomized Investigation of Chest Pain Diagnostic Strategies; NCT01035047).

Avoidable utilization of the chest pain observation unit: evaluation of very-low-risk patients.

BACKGROUND: Very-low-risk patients treated in a chest pain observation unit (CPOU) may threaten efficient care delivery. To optimize the efficiency of CPOU evaluations, it is necessary to quantify the avoidable CPOU utilization rate, examine physician variability, and determine patient and physician characteristics associated with avoidable CPOU utilization. METHODS: Consecutive chest pain patients were evaluated in an Emergency Department-based CPOU. Patients were risk stratified based on the American College of Cardiology/American Heart Association framework, age, and electrocardiogram findings. Very-low-risk was defined as age <35, physician assessment of low-risk, and normal or nondiagnostic electrocardiogram. Patients identified as very-low-risk were considered avoidable CPOU evaluations. Individual physicians' avoidable CPOU utilization rates were calculated. Patients were followed for 30-day major adverse cardiac events, defined as the composite of death, acute myocardial infarction, and coronary revascularization. RESULTS: Over 33 months, the registry included 1731 chest pain patients. The study definition of avoidable CPOU evaluations was met by 174 patients (10.1%, 95% confidence interval: 8.7-11.6%). The median rate of physician's avoidable CPOU utilization was 10% (interquartile range: 5.9-13.6%) and varied from 1.9% to 18.4%. None of the patients with an avoidable CPOU evaluation had a major adverse cardiac events within 30 days. Physician predictors of avoidable CPOU utilization included recent residency graduation (<5 years), part-time status, and moderate or high rates of CPOU use. CONCLUSIONS: Approximately 10% of CPOU evaluations were avoidable. Wide variability exists among physicians regarding their individual rates of avoidable CPOU utilization. This variability could represent an opportunity to improve the efficiency of CPOU care delivery.

Comparison of an automated algorithm to expert physician interpretation of 80-lead body surface mapping in the evaluation of acute myocardial ischemia and infarction in patients presenting to the emergency department with chest pain: results from the Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction trial.

INTRODUCTION/BACKGROUND: Eighty-lead (80 L) body surface map (BSM) technology provides electrocardiogram data for the clinician to interpret. A BSM device also offers an automated interpretation. Little information is available about the performance of automated algorithm interpretation in comparison to human interpretation of the 80 L BSM. METHODS: Interpretations of BSMs by automated algorithm and a core laboratory of physician readers from The Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction trial were compared. The κ statistic and its 95% confidence interval for concordance were calculated. The effect of BSM quality on concordance was also analyzed. RESULTS: 3405 maps for 1601 subjects were reviewed by the core laboratory and automated algorithm. There was a combined concordance rate of 87.3% (κ = 0.46; 95% confidence interval, 0.40-0.52). A decrease in signal quality was associated with a decrease in concordance between human and automated algorithm interpretation (κ = 0.52 for good quality vs κ = 0.30 for poor quality). CONCLUSION: A moderate degree of concordance was noted between physician and automated algorithm interpretation of 80 L BSMs. Signal quality of 80 L electrocardiographic BSM directly affected concordance.

Self-reported cocaine use, emergency physician testing and outcomes in suspected acute coronary syndromes: a nested matched case-control study.

OBJECTIVES: The primary purpose was to compare the odds of acute coronary syndrome-pertinent diagnostic testing between self-reported cocaine users and non-users at the turn of the century. The secondary purpose was to compare the odds of acute coronary syndrome outcomes between cocaine users and non-users. DESIGN: Nested matched case-control study using data from the Internet Tracking Registry of Acute Coronary Syndromes. SETTING: Extracted data of patients from eight US institutions composed of six academic and two community hospitals, with census varying between 10 000 and 160 000 visits per year. PARTICIPANTS: 249 cases of self-reported cocaine users and 249 matched controls. Matching was based on age, race, sex and any history of known coronary artery disease. Exclusion criteria were new ST elevations on initial ECG and initial physician impression of acute myocardial infarction. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was the conditional odds of undergoing non-invasive and invasive testing for coronary artery disease. Secondary outcome was the occurrences of adverse cardiac outcomes within 30 days. RESULTS: Cocaine users underwent diagnostic testing at similar rates compared with non-users (9.6% vs 8.0%, OR 1.24, CI 0.65 to 2.34). Adverse cardiovascular outcomes occurred in four (1.6%) cocaine users and in seven (2.8%) controls. CONCLUSIONS: There was no increase in tendency for testing associated with self-reported history of cocaine use between 1999 and 2001. This suggests that even 10 years ago, cocaine use already had only a limited role in the Emergency Department (ED) physician's decision-making process. Similar data analyses of detailed registries can offer important contextual information that can better direct resources for future comparative effectiveness research.

Provider-directed imaging stress testing reduces health care expenditures in lower-risk chest pain patients presenting to the emergency department.

BACKGROUND: Among intermediate- to high-risk patients with chest pain, we have shown that a cardiac magnetic resonance (CMR) stress test strategy implemented in an observation unit (OU) reduces 1-year health care costs compared with inpatient care. In this study, we compare 2 OU strategies to determine among lower-risk patients if a mandatory CMR stress test strategy was more effective than a physicians' ability to select a stress test modality. METHODS AND RESULTS: On emergency department arrival and referral to the OU for management of low- to intermediate-risk chest pain, 120 individuals were randomly assigned to receive (1) a CMR stress imaging test (n=60) or (2) a provider-selected stress test (n=60: stress echo [62%], CMR [32%], cardiac catheterization [3%], nuclear [2%], and coronary CT [2%]). No differences were detected in length of stay (median CMR=24.2 hours versus 23.8 hours, P=0.75), catheterization without revascularization (CMR=0% versus 3%), appropriateness of admission decisions (CMR 87% versus 93%, P=0.36), or 30-day acute coronary syndrome (both 3%). Median cost was higher among those randomly assigned to the CMR-mandated group ($2005 versus $1686, P<0.001). CONCLUSIONS: In patients with lower-risk chest pain receiving emergency department-directed OU care, the ability of a physician to select a cardiac stress imaging modality (including echocardiography, CMR, or radionuclide testing) was more cost-effective than a pathway that mandates a CMR stress test. Contrary to prior observations in individuals with intermediate- to high-risk chest pain, in those with lower-risk chest pain, these results highlight the importance of physician-related choices during acute coronary syndrome diagnostic protocols. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00869245.

Take heart: a one-on-one peer-based strategy to improve acute coronary syndrome patient care.

Acute coronary syndromes (ACS) result in more than 1 million hospitalizations each year in the United States and are a leading cause of morbidity and mortality. Despite evidence-based treatment guidelines and advances in therapeutic strategies, the need for well-educated practitioners to provide quality patient care is still evident. As such, continuing medical education (CME) and consultation with recognized experts are valuable tools that can enhance clinical knowledge and lead to improvements in best practices. In a CME platform, collaborative dialogue with nationally recognized opinion leaders within the field of ACS enabled 111 clinician participants to develop strategies for personal practice improvement. Faculty experts addressed specific challenging clinical questions posed by participants regarding 1 of 4 preselected topics related to the care of patients with ACS. After a 3-month period, 94% of participants reported that their strategies for practice improvement had affected patient care. Participants also rated the utility of national guidelines in their practices higher following participation in the activity and demonstrated improved clinical knowledge. As a result of this activity, participants were able to solve self-identified issues in clinical practice as well as improve their understanding of current clinical practice guidelines. Adherence to guideline-recommended care was associated with improvements in patient outcomes, and participant feedback suggests that this was an effective type of CME platform that resulted in positive changes in patient care. Furthermore, considerable interest exists for the application of this model in other therapeutic areas.

Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events?

BACKGROUND: Patients with low-risk chest pain have high utilization of stress testing and cardiac imaging, but low rates of acute coronary syndrome (ACS). The objective of this study was to determine whether the HEART score could safely reduce objective cardiac testing in patients with low-risk chest pain. METHODS: A cohort of chest pain patients was identified from an emergency department-based observation unit registry. HEART scores were determined using registry data elements and blinded chart review. HEART scores were dichotomized into low (0-3) or high risk (>3). The outcome was major adverse cardiac events (MACE); a composite end point of all-cause mortality, myocardial infarction, or coronary revascularization during the index visit or within 30 days. Sensitivity, specificity, and potential reduction of cardiac testing were calculated. RESULTS: In a span of 28 months, the registry included 1070 low-risk chest pain patients. MACE occurred in 0.6% (5/904) of patients with low-risk HEART scores compared with 4.2% (7/166) with a high-risk HEART scores (odds ratio = 7.92; 95% confidence interval [95% CI]: 2.48-25.25). A HEART score of >3 was 58% sensitive (95% CI: 32-81%) and 85% specific (95% CI: 83-87%) for MACE. The HEART score missed 5 cases of ACS among 1070 patients (0.5%) and could have reduced cardiac testing by 84.5% (904/1070). Combination of serial troponin >0.065 ng/mL or HEART score >3 resulted in sensitivity of 100% (95% CI: 72-100%), specificity of 83% (95% CI: 81-85%), and potential reduction in cardiac testing of 82% (879/1070). CONCLUSIONS: If used to guide stress testing and cardiac imaging, the HEART score could substantially reduce cardiac testing in a population with low pretest probability of ACS.