Gerard X. Brogan

Evaluation of a New Rapid Quantitative Immunoassay for Serum Myoglobin Versus CK-MB for Ruling Out Acute Myocardial Infarction in the Emergency Department

STUDY OBJECTIVE To compare the predictive values of serum myoglobin and creatine kinase (CK)-MB for ruling out acute myocardial infarction in the emergency department. DESIGN Prospective, observational study. SETTING University teaching hospital. PARTICIPANTS One hundred eighty nine consecutive patients aged 30 years and older who presented within 12 hours from onset of chest discomfort, dyspnea, syncope, congestive heart failure, symptomatic dysrhythmia, pulmonary edema, or epigastric pain were entered into the study. Patients with trauma or renal failure were excluded. INTERVENTIONS Standardized history and physical examination and blood sampling for serum myoglobin (S-Mgb) and CK-MB were done at the time of presentation (T0) and 1 hour later (T1). RESULTS Using World Health Organization criteria, 22 acute myocardial infarction patients were identified. Mean time from symptom onset to presentation was 3.2 hours. S-Mgb was more sensitive than CK-MB at T0 and T1, 55% versus 23% (P < .05) and 73% versus 41% (P < .05), respectively. Respective specificities of S-Mgb versus CK-MB were 98% versus 99% (P = NS) at T0 and 97% versus 99% (P = NS) at T1. Negative predictive values of S-Mgb versus CK-MB were 94% versus 91% (P = NS) at T0 and 96% versus 93% (P = NS) at T1. The S-Mgb assay yielded quantitative results allowing the difference between the T0 and T1 values to be analyzed. A difference of 40 or more ng/mL between T0 and T1 was considered positive. When using a positive result in either the T0 or T1 value or a difference between the two values of 40 or more ng/mL, the sensitivity of S-Mgb was 91% (P < .05 versus CK-MB), the specificity was 96% (P = NS versus CK-MB), and the negative predictive value was 99% (95% confidence interval for S-Mgb, 97.0 to 100 versus CK-MB, 95% confidence interval, 88.9 to 96.6). CONCLUSION In the first hour of presentation to the ED, the rapid quantitative assay for S-Mgb was statistically more sensitive than CK-MB and had an excellent negative predictive value for ruling out acute myocardial infarction in patients with typical or atypical symptoms. Due to the relatively small sample size, we could not exclude the possibility that differences in specificity might become statistically significant (beta error) with a larger sample size of acute myocardial infarction patients.

Chest Pain Associated With Cocaine: An Assessment of Prevalence in Suburban and Urban Emergency Departments

STUDY OBJECTIVE Chest pain and myocardial infarction following the use of cocaine have been well documented. We assessed the prevalence of cocaine use in patients who presented to the emergency department with chest pain of possibly ischemic origin. DESIGN During times of research assistant availability, consecutive adults with the chief complaint of chest pain unexplained by trauma or radiographic abnormality were questioned about cocaine use in the preceding week. Urine was tested for the presence of cocaine or cocaine metabolites with a highly accurate bedside urine test kit (specificity, 100%; sensitivity 98%). Anonymous unlinked data-collection methods were used. Therefore we could not determine whether the patients who used cocaine had sustained myocardial infarctions. SETTING One suburban and three urban EDs. RESULTS We enrolled 359 patients with a mean age of 51 years, 8% of whom sustained myocardial infarctions. Sixty patients (17%) had cocaine or cocaine metabolites in urine. The likelihood of testing positive for cocaine varied by age group: 18 to 30 years, 29%; 31 to 40 years, 48%; 41 to 50 years, 18%; 51 to 60 years, 3%; 61 years or older, 0% (P < .0001). Of the 60 patients who tested positive for cocaine, only 43 (72%) admitted recent use. CONCLUSION Many ED patients with chest pain have recently used cocaine. Because the recent use of cocaine is not uncommon in patients with chest pain up to 60 years old, such patients should be questioned about cocaine use. When treatment or disposition may be altered, consideration should be given to objective assessment of cocaine use because patient self-report does not appear reliable.

Comparison of Plain, Warmed, and Buffered Lidocaine for Anesthesia of Traumatic Wounds

STUDY OBJECTIVE To compare pain on infiltration, need for additional anesthesia, and pain on suturing in patients given plain, warm, and buffered lidocaine preparations before the suturing of traumatic wounds in the emergency department. DESIGN Randomized, prospective, single-blinded convenience sample. SETTING University hospital ED. PARTICIPANTS Patients with traumatic lacerations. Patients allergic to lidocaine and patients with abnormal mental status or altered pain sensorium were excluded. INTERVENTIONS All wounds were anesthetized by use of a standard injection technique. Wound margins were anesthetized with plain, buffered, or warm lidocaine in a randomized fashion. Pain of infiltration was recorded for each margin by means of a previously validated visual-analogue pain scale. RESULTS The main outcome parameter was pain of infiltration. Need for additional anesthesia and pain on suturing were secondary outcome parameters. We evaluated 45 patients. Pain on injection varied by the type of lidocaine (mean pain scores: plain, 8.2; buffered, 4.7 [P < .05 versus plain]; warm, 4.9 [P < .05 versus plain]). There was no significant difference between the mean pain scores of the groups given warm and buffered lidocaine (P = NS). Need for additional anesthesia and pain on suturing did not vary by the type of anesthesia. The order of injection was not found to influence results. Mean pain scores were not different for margins 1 and 2 in any of the groups (P = NS). CONCLUSION Both buffered and warmed lidocaine were as efficacious as plain lidocaine, and they had significantly less pain associated with infiltration than did plain lidocaine. In EDs with fluid warmers, warmed lidocaine may be the most convenient, well-tolerated, efficacious lidocaine preparation for anesthesia of traumatic wounds.

Insurance Coverage and Care of Patients with Non–ST-Segment Elevation Acute Coronary Syndromes

Context Medicaid and Medicare reimbursement is typically lower than that of private insurance. This might affect access to care for Medicaid and Medicare patients. Contribution The authors studied the care received for nonST-segment elevation acute coronary syndromes by 37345 patients younger than age 65 years and 59550 patients age 65 years or older. Compared with privately insured patients, Medicaid patients received fewer guideline-recommended services at admission or discharge and experienced greater delays in receiving invasive procedures. Differences for Medicare patients were fewer and smaller, although delays were common. The in-hospital mortality rate was higher in Medicaid patients but not Medicare patients. Cautions The authors could not assess the appropriateness of invasive procedures, socioeconomic status, severity of comorbid conditions, or patient preferences. The Editors For patients with nonST-segment elevation acute coronary syndromes (NSTE ACS), novel therapeutic approaches, such as low-molecular-weight heparin, glycoprotein (GP) IIb/IIIa inhibitors, and early invasive management strategies, have been shown to have beneficial effects and have been incorporated into practice guidelines of the American College of Cardiology and American Heart Association (ACC/AHA) (15). However, the extent to which these and other guideline-recommended therapies are reaching all segments of the U.S. population is unclear. Specifically, although U.S. Medicaid and Medicare programs often provide coverage for patients with limited incomes, reimbursements to health care providers by these programs may differ from those of private insurance plans (6). Because novel therapies and invasive cardiac procedures for NSTE ACS are costly, differential patterns of reimbursement in Medicaid and Medicare programs may affect treatment patterns and guideline adherence. Thus, we first evaluated patients younger than age 65 years with NSTE ACS from the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines) quality improvement initiative to determine the impact of primary Medicaid coverage on the use of guideline-recommended medications, invasive cardiac procedures, and in-hospital clinical outcomes compared with that of patients with primary health maintenance organization (HMO) or private insurance coverage. We then performed a similar comparison between patients 65 years of age or older with primary Medicare coverage and patients of the same age with primary HMO or private insurance coverage. Furthermore, we sought to determine the degree to which any differences in care patterns and outcomes resulted from differences in clinical characteristics or to preferential care of Medicare or Medicaid patients at lower-quality hospitals. Methods Patient Inclusion Criteria Patients with NSTE ACS were included if they had ischemic symptoms at rest within 24 hours of presentation and high-risk features, including ST-segment depression levels of 0.5 mm or more, transient ST-segment elevation levels of 0.5 to 1.0 mm (lasting for less than 10 minutes), positive cardiac markers (elevated troponin I or T levels, creatine kinase [CK]-MB levels, or both greater than the upper limit of normal for the local laboratory assay) or both. Data Collection CRUSADE is a voluntary quality improvement initiative that began in November 2001 (with retrospective data collection from January 2001), and data collection is ongoing. At the beginning of the project, queries were sent to a geographically diverse sample of hospitals. Participation was voluntary. Because data were collected retrospectively and do not include any patient identifying information, informed consent was waived. The local institutional review board at each hospital approved participation in CRUSADE. No specific quality initiative was implemented in all institutions, although sites were provided with sample order sets and discharge forms to use at their discretion. Data on hospital characteristics were obtained from the American Hospital Association database. Participating institutions were instructed to submit consecutive eligible patients to the CRUSADE database. Data were abstracted directly from the medical chart by trained data collectors using standardized definitions. Administrative claims data were not abstracted for this study. Abstracted variables included demographics, clinical characteristics, medical therapies and major contraindications, use and timing of cardiac procedures, laboratory results, and in-hospital outcomes. Insurance status was defined as the patients primary insurance provider. Data abstractors at the participating sites were aware of the patients primary insurance status and were given specific definitions for categorization of primary insurance status. Health maintenance organization and private insurance were defined as any health insurance provided by a commercial plan, regardless of restrictions or payment arrangements. Medicare coverage was defined as the federal health care plan that reimburses hospitals and physicians for the care of elderly patients 65 years of age or older. Medicaid coverage was defined as state-administered plans jointly funded by state and federal funding mechanisms providing primary coverage to patients younger than 65 years of age who cannot finance their own medical expenses or who have qualifying comorbid conditions. Medicare or Medicaid coverage was recorded on the data collection form as a single, dichotomous variable until November 2003; thus, we could not clearly specify primary Medicaid versus Medicare coverage for patients included in CRUSADE before this time. Self or no insurance coverage was defined as when individuals were the sole payers, regardless of ability to pay. Self or no coverage was recorded on the data collection form as a single, dichotomous variable, and we excluded patients in this category from the analysis because of the inconsistent reporting of this variable. Military or Veterans Affairs Medical Center coverage was used to describe patients with a military or Veterans Administration health plan. This group also was excluded from the primary analysis because of the small number of patients covered by these programs. Data Accuracy Routine procedures have been established to maintain and monitor the quality of the CRUSADE database. At data entry and during quarterly quality control procedures, values that exceed expected ranges are flagged and excluded from analysis. In addition, sites receive a quarterly report summarizing any data quality problems observed in their submitted data. In September 2002, CRUSADE formally assessed the reliability of data abstraction. Sites and records were randomly selected. Study coordinators from one fourth of CRUSADE hospitals were contacted and asked to send the CRUSADE Coordinating Center copies of medical records without patient identifiers for audit by CRUSADE project officials. In addition to selected clinical characteristics, audited variables included all medical therapies, procedures, and in-hospital clinical events. The overall accuracy of audited case report forms compared with medical records was 94.8%. The overall degree of missing data averaged approximately 5% across all collected data elements. Of note, such variables as age and sex were missing in fewer than 0.5% of all audited cases. In addition, we reviewed the degree of missing variables among 119257 patients included in the overall database through 30 September 2004 and determined that key clinical characteristics, such as age (0.18%), sex (0.29%), race (1.45%), insurance status (1.0%), and such clinical outcomes as death (1.33%) and reinfarction (1.29%) were infrequently missing on data collection forms. Analysis Cohorts A total of 138719 patients was entered into the CRUSADE database from January 2001 through March 2005 at 521 U.S. hospitals. For the Medicaid analysis, we excluded 80423 patients 65 years of age or older or who had missing age values, 11438 patients from hospitals without percutaneous and surgical revascularization capabilities, 2587 patients with Medicare listed as the primary payer, 413 patients with insurance status listed as military or Veterans Affairs Medical Center, 6025 patients with insurance status listed as self or none, and 488 patients with missing data on insurance status. The total population for the Medicaid analysis was thus 37345 patients from 358 hospitals. For the Medicare analysis, we excluded 58537 patients younger than 65 years of age or who had missing age values, 18922 patients from hospitals without percutaneous and surgical revascularization capabilities, 214 patients with Medicaid as the primary payer, 275 patients with insurance status listed as military or Veterans Affairs Medical Center, 756 patients with insurance status listed as self or none, and 465 patients with missing data on insurance status. The total population for the Medicare analysis was thus 59550 patients from 359 hospitals. Statistical Analysis We evaluated patient baseline demographics, clinical characteristics, in-hospital care patterns, and in-hospital outcomes for patients younger than 65 years of age with Medicaid as the primary payer compared with those younger than 65 years of age with HMO or private insurance as the primary payer. Likewise, we compared patients 65 years of age or older with Medicare as the primary payer with those 65 years of age or older with HMO and private insurance as the primary payer. Health maintenance organization refers to private HMO coverage in our analysis. We were unable to distinguish whether Medicare or Medicaid coverage was received through a managed care program. Also, we could not ascertain whether supplemental insurance coverage was available for Medicare patients older than 65 years of age. We performed these comparisons within separate age categories beca

Effect of Duration From Symptom Onset on the Negative Predictive Value of a Normal ECG for Exclusion of Acute Myocardial Infarction

STUDY OBJECTIVE We hypothesized that the negative predictive value of the ECG would improve with time and assessed the effect of time elapsed from symptom onset to ED presentation on the negative predictive value, sensitivity, specificity, and positive predictive value of the initial ECG in patients presenting with symptoms suggestive of acute myocardial infarction (AMI). METHODS We conducted a cross-sectional study in a university teaching hospital. Our structured data instrument, completed at the time of presentation included demographics, time of onset of symptoms, history, laboratory, and ECG findings. AMI was diagnosed with the use of international diagnostic criteria. Patients were stratified according to duration of time from symptom onset at 3-hour intervals. RESULTS We enrolled 526 patients in the study group. The mean age was 59 years; 40% were female. The mean time elapsed from symptom onset to presentation was 185 minutes. A diagnosis of AMI was made in 104 patients (20%). The negative predictive values of a normal ECG for exclusion of AMI, stratified by duration of time from symptom onset, were: 0 to 3 hours, 93.2% (95% confidence interval [CI], 87.4% to 96.1%); 3 to 6 hours, 93.0% (95% CI, 83.0% to 98.1%); 6 to 9 hours, 92.6% (95% CI, 75.8% to 99.1%); and 9 to 12 hours, 94.1% (95% CI, 71.3% to 99.9%) (P = 1.0). The sensitivity, specificity, and positive predictive value of the ECG were similar in all groups. CONCLUSION The negative predictive value of a normal ECG for exclusion of AMI does not improve as the duration of time from symptom onset to presentation increases. Normal ECG findings cannot be used to rule out an AMI, even those obtained up to 12 hours after symptom onset.

Age, treatment, and outcomes in high-risk non-ST-segment elevation acute coronary syndrome patients: Insights from the EARLY ACS trial

BACKGROUND Elderly patients with acute coronary syndromes (ACS) are at high risk for death and recurrent thrombotic events. We evaluated the efficacy and safety of intensive treatment with glycoprotein IIb/IIIa inhibitors in an elderly population, and the relationships between age, timing of administration, and clinical outcomes. METHODS We used data from high-risk non-ST-segment elevation ACS patients randomized to early eptifibatide vs. delayed provisional use at percutaneous coronary intervention. In multivariable models, we included age×treatment interaction terms to assess whether treatment effect varied by age after adjusting for confounders. RESULTS Of 9406 patients, 13.9% were aged <55 years; 27.6%, 55-64 years; 33.2%, 65-74 years; and 25.3%, ≥ 75 years. For each 10-year age increase, the adjusted odds ratio (OR) (95% confidence interval [CI]) for 96-hour death, myocardial infarction (MI), recurrent ischemia requiring urgent revascularization, or thrombotic bailout was 1.13 (1.04-1.23) and for 30-day death or MI was 1.13 (1.04-1.22). Increasing age was also associated with greater 1-year mortality (adjusted hazard ratio per 10 years: 1.44, 95% CI 1.30-1.60). There was no interaction between age and treatment (p interaction=0.99, 0.54, and 0.87, respectively). Increasing age was associated with more non-coronary artery bypass grafting-related TIMI major bleeding (adjusted OR and 95% CI per 10 years: 1.54 [1.24-1.92]), GUSTO moderate/severe bleeding (1.52 [1.33-1.75]), and transfusion (1.25 [1.07-1.45]). The amount by which TIMI major bleeding was increased with early vs. delayed provisional eptifibatide use was significantly greater with increasing age (p interaction=0.02), but the age×treatment interactions were not significant for GUSTO moderate/severe bleeding or transfusion (p interaction=0.33 and 0.54, respectively). CONCLUSION Increasing age was associated with greater risk for ischemic events and more bleeding. Despite higher baseline ischemic risk in older patients, there was no preferential benefit of early vs. delayed provisional eptifibatide use for ischemic outcomes as age increased, but the incremental bleeding risk was amplified.

Safety and Efficacy of Bivalirudin in High-risk Patients Admitted Through the Emergency Department

OBJECTIVES The objective was to assess the safety and efficacy of bivalirudin monotherapy in patients with high-risk acute coronary syndrome (ACS) presenting to the emergency department (ED). METHODS Data from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial were used to conduct a post hoc subgroup analysis of high-risk ACS patients (cardiac biomarker elevation or ST-segment deviation) who initially presented to the ED. The ACUITY trial randomized patients to receive heparin (unfractionated [UFH] or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Endpoints included composite ischemia, major bleeding (not coronary artery bypass graft (CABG) related), and net clinical outcome (major bleeding plus composite ischemia). RESULTS Of 13,819 participants in the ACUITY trial, 6,441 presented initially to the ED, met high-risk criteria, and were included in the primary analysis. Bivalirudin alone when compared to heparin plus GPI, after adjusting for covariates, was associated with an improvement in net clinical outcome (12.3% vs. 14.3%, adjusted odds ratio [OR] = 0.81, 95% confidence interval [CI] = 0.66 to 0.99), similar composite ischemia (9.3% vs. 9.1%, adjusted OR = 0.98, 95% CI = 0.77 to 1.24), and less major bleeding (4.0% vs. 6.8%, adjusted OR = 0.57, 95% CI = 0.42 to 0.75). Bivalirudin plus GPI when compared to heparin plus GPI had similar net clinical outcome (13.8% vs. 14.3%, adjusted OR = 0.91, 95% CI = 0.75 to 1.11), composite ischemia (8.8% vs. 9.1%, adjusted OR = 0.87, 95% CI = 0.69 to 1.11), and major bleeding (6.8% vs. 6.8%, adjusted OR = 1.01, 95% CI = 0.79 to 1.30). CONCLUSIONS Bivalirudin monotherapy decreases major bleeding while providing similar protection from ischemic events compared to heparin plus GPI in patients with high-risk ACS admitted through the ED.

ED to catheterization laboratory: a roundtable integrating trials with practice.

BACKGROUND Clinical trials are the foundation underlying clinical decision-making. However, stringent inclusion and exclusion criteria may reduce the generalizability of their results, especially for patients seen in the emergency department (ED). Guideline recommendations, based on clinical trials and pertinent registries, apply to broad populations, but not all patients cared for at the bedside fit the predefined categories that make guidelines practical. Furthermore, these documents may not incorporate the latest evidence. As a result, other factors (eg, individual patient characteristics, clinician experience, cost, regulatory labels, expert opinions) often result in clinical decision-making that varies from strict adherence to guideline recommendations. OBJECTIVES These challenges demonstrate a need to integrate clinical data and guidelines advice with actual ED practice in a manner that will be consistent with decisions made later in the continuum of care. DISCUSSION In recognition of these issues, a roundtable was convened in New York City on June 5, 2009, to discuss the implications of recent trials involving patients with non-ST-segment elevation acute coronary syndromes. Eight physicians, representing both emergency medicine and cardiology, shared information on advances and clinical trial results in antiplatelet treatment, guidelines, and other developments in patient care. This article is based on transcripts of their presentations and the ensuing discussions that were of particular importance for emergency physicians. CONCLUSIONS Although guidelines and clinical registries can provide broad direction for practice, there is no substitute for a prospective, multidisciplinary, institution-specific, consistent, evidence-based approach to patient management.