Abstract Introduction The HEART Pathway is a diagnostic protocol designed to identify low-risk patients presenting to the Emergency Department (ED) with chest pain that are safe for early discharge. ...This protocol has been shown to significantly decrease healthcare resource utilization compared to 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 ED without further testing. We compared index visit cost, cost at 30 days, and cardiac-related healthcare cost at 30 days between the two 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 healthcare cost at 30 days included the index encounter and costs adjudicated to be cardiac-related within that period. 270 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 (TIMI 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 Utilizing the HEART Pathway as a decision aid for patients with undifferentiated chest pain resulted in significant cost savings.
Study objective Three large, multicenter, randomized, clinical trials have shown that coronary computed tomography (CT) angiography allows efficient evaluation and safe discharge of patients with ...low- to intermediate-risk chest pain who present to the emergency department (ED). We report 1-year event rates and resource use from the American College of Radiology Imaging Network-Pennsylvania 4005 multicenter trial. Methods Patients with low- to intermediate-risk chest pain and presenting to the ED were randomized in a 2:1 ratio to a coronary CT angiography care pathway or traditional care. Subjects were contacted by telephone at least 1 year after ED presentation. Medical record review was performed for all cardiac hospitalizations, procedures and diagnostic tests, and adverse cardiac events. Our main outcome was the composite of cardiac death and myocardial infarction within 1 year. The secondary outcome was resource use. Results One thousand three hundred sixty-eight patients enrolled and 1,285 (94%) had direct participant or proxy contact at 1 year. All others had record review or death index search. From index presentation through 1 year, there was no difference between patients in the coronary CT angiography arm versus traditional care with respect to major adverse cardiac event (1.4% versus 1.1%; difference 0.3%; 95% CI –5.5% to 6.0%). From hospital discharge through 1 year, there was also no difference in ED revisits (36% versus 38%; difference –2.1%; 95% CI –7.9% to 3.7%), hospital admissions (16% versus 17%; difference –0.9%; 95% CI –6.7% to 4.9%), or subsequent cardiac testing (13% versus 13%; difference –0.4%; 95% CI –6.2% to 5.5%). One of 640 subjects with a negative coronary CT angiography result had a major adverse cardiac event within 1 year of presentation (0.16%; 95% CI 0.004% to 0.87%). Conclusion A coronary CT angiography–based strategy for evaluation of patients with low- to intermediate-risk chest pain who present to the ED does not result in increased resource use during 1 year. A negative coronary CT angiography result is associated with a less than 1% major adverse cardiac event rate during the first year after testing.
Study objective We determine whether imaging with cardiac magnetic resonance imaging (MRI) in an observation unit would reduce medical costs among patients with emergent non-low-risk chest pain who ...otherwise would be managed with an inpatient care strategy. Methods Emergency department patients (n=110) at intermediate or high probability for acute coronary syndrome without electrocardiographic or biomarker evidence of a myocardial infarction provided consent and were randomized to stress cardiac MRI in an observation unit versus standard inpatient care. The primary outcome was direct hospital cost calculated as the sum of hospital and provider costs. Estimated median cost differences (Hodges-Lehmann) and distribution-free 95% confidence intervals (Moses) were used to compare groups. Results There were 110 participants with 53 randomized to cardiac MRI and 57 to inpatient care; 8 of 110 (7%) experienced acute coronary syndrome. In the MRI pathway, 49 of 53 underwent stress cardiac MRI, 11 of 53 were admitted, 1 left against medical advice, 41 were discharged, and 2 had acute coronary syndrome. In the inpatient care pathway, 39 of 57 patients initially received stress testing, 54 of 57 were admitted, 3 left against medical advice, and 6 had acute coronary syndrome. At 30 days, no subjects in either group experienced acute coronary syndrome after discharge. The cardiac MRI group had a reduced median hospitalization cost (Hodges-Lehmann estimate $588; 95% confidence interval $336 to $811); 79% were managed without hospital admission. Conclusion Compared with inpatient care, an observation unit strategy involving stress cardiac MRI reduced incident cost without any cases of missed acute coronary syndrome in patients with emergent 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 )
Objectives The impact of regulatory requirements, which require central adjudication for the diagnosis of acute myocardial infarction (AMI) in cardiac biomarker studies, is unclear. We determined the ...impact of local (at the site of subject enrollment) versus central adjudication of AMI on final diagnosis. Methods This is a retrospective analysis of data from the Myeloperoxidase in the Diagnosis of Acute Coronary Syndromes Study, an 18-center prospective study of patients with suspected acute coronary syndromes, with enrollment from December 19, 2006, to September 20, 2007. Local adjudication of AMI was performed by a single site investigator at each center following the protocol-specified definition and according to the year 2000 definition of AMI, which based cardiac troponin (cTn) elevation on local cut points for each of the 13 different assays. After completion of the Myeloperoxidase in the Diagnosis of Acute Coronary Syndromes Study primary analysis and to evaluate a new troponin assay, a Food and Drug Administration–mandated central adjudication was performed by 3 investigators at different institutions. This adjudication used the 2007 Universal Definition of AMI, which differs by use of the manufacturer's 99th percentile cTn cut point. We describe the outcome of this process and compare it with the local adjudication. Central adjudicators were not blinded to local adjudications. For central adjudication, discrepant diagnoses were resolved by consensus. Local versus central cTn cut points differed for 6 assays. Both definitions required a rise and/or fall of cTn. Discrepant cases were reviewed by the lead author. Difficult cases were defined as having a difference between local and central adjudication, an elevated cTn with a temporal rise and fall, and a negative or absent risk stratification test. Statistics were by χ2 , κ, and logistic regression. Results Of 1,107 patients enrolled, 11 had indeterminate central adjudication, leaving 1,096 for analysis. In spite of high agreement across central versus local adjudicators, κ = 0.79 (95% CI 0.73, 0.85), AMI was diagnosed more often by central adjudication, 134 (12.2%) versus 104 (9.5%), with 44 local diagnoses (4%) changed from non-AMI to AMI (n = 37) or AMI to non-AMI (n = 7) ( P < .001). These 44 represented 34% (95% CI 26%-42%) of 141 cases in which either central or local adjudication was AMI. Of diagnoses changed to AMI, 3 reasons contributed approximately one-third each: the local use of a non-99th percentile cTn cutoff (32%), the possibility of human error (34%), and difficult cases (34%). Conclusion Despite an acceptable κ, over a third of patients with a diagnosis of AMI were not assigned that diagnosis by both sets of adjudicators. This supports the importance of 1 standard method for diagnosis of AMI.
Abstract Objective The aim of this study was to determine if patients presenting with symptoms of acute coronary syndrome and found to have 25% to 50% diameter reduction with coronary computed ...tomographic angiography (CCTA) are likely to benefit from further diagnostic testing. Methods A registry study of 213 subjects (median age, 51 years; 53% women) with symptoms concerning for possible acute coronary syndrome with low-risk features found to have 25% to 50% maximal diameter stenosis on CCTA was performed at 2 academic medical centers. The analysis was approved by an institutional review board and was conducted with waiver of consent. The potential contribution of additional testing was determined by measuring the major adverse cardiac events (MACEs) from presentation through 30 days. The MACEs included myocardial infarction, coronary revascularization, unstable angina, and cardiovascular death. Sample size calculations were predicated on a 0% MACE rate leading to upper bounds of a 2-sided exact 95% confidence interval less than 2%. Results Thrombolysis in myocardial infarction risk score of less than 2 was present in 92% subjects, 70% (150 of 213) had 2 or more serial cardiac markers performed, and 40% (87 of 213) had stress testing or cardiac catheterization. The MACEs occurred in 1 (0.5%) of 213 subjects (95% confidence interval, 0%-2.6%) and was identified by an elevation of serial cardiac markers during the index hospitalization. No patients experienced cardiovascular death or required revascularization. Conclusions In patients with emergent low-risk chest pain and 25% to 50% diameter coronary stenosis by CCTA, the rate of near-term MACE is very low. Serial cardiac markers may be beneficial in this subgroup. Routine provocative testing is unlikely to be beneficial during the index visit.
Objectives In a large U.S. sample, this study measured the presentation features, testing, treatment strategies, and outcomes of patients diagnosed with pulmonary embolism (PE) in the emergency ...department (ED). Background No data have quantified the demographics, clinical features, management, and outcomes of outpatients diagnosed with PE in the ED in a large, multicenter U.S. study. Methods Patients of any hemodynamic status were enrolled from the ED after confirmed acute PE or with a high clinical suspicion prompting anticoagulation before imaging for PE. Exclusions were inability to provide informed consent (where required) or unavailability for follow-up. Results A total of 1,880 patients with confirmed acute PE were enrolled from 22 U.S. EDs. Diagnosis of PE was based upon positive results of computerized tomographic pulmonary angiogram in most cases (n = 1,654 88%). Patients represented both sexes equally, and racial and ethnic composition paralleled the overall U.S. ED population. Most (79%) patients with PE were employed, and one-third were older than age 65 years. The mortality rate directly attributed to PE was 20 in 1,880 (1%; 95% confidence interval CI: 0% to 1.6%). Mortality from hemorrhage was 0.2%, and the all-cause 30-day mortality rate was 5.4% (95% CI: 4.4% to 6.6%). Only 3 of 20 patients with major PE that ultimately proved fatal had systemic anticoagulation initiated before diagnostic confirmation, and another 3 of these 20 received a fibrinolytic agent. Conclusions Patients diagnosed with acute PE in U.S. EDs have high functional status, and their mortality rate is low. These registry data suggest that appropriate initial medical management of ED patients with severe PE with anticoagulation is poorly standardized and indicate a need for research to determine the appropriate threshold for empiric treatment when PE is suspected before diagnostic confirmation.
Objectives This study sought to compare the direct cost of medical care and clinical events during the first year after patients with intermediate risk acute chest pain were randomized to stress ...cardiac magnetic resonance (CMR) observation unit (OU) testing versus inpatient care. Background In a recent study, randomization to OU-CMR reduced median index hospitalization cost compared with the cost of inpatient care in patients presenting to the emergency department with intermediate risk acute chest pain. Methods Emergency department patients with intermediate risk chest pain were randomized to OU-CMR (OU care, cardiac markers, stress CMR) or inpatient care (admission, care per admitting provider). This analysis reports the direct cost of cardiac-related care and clinical outcomes (myocardial infarction, revascularization, cardiovascular death) during the first year of follow-up subsequent to discharge. Consistent with health economics literature, provider cost was calculated from work-related relative value units using the Medicare conversion factor; facility charges were converted to cost using departmental-specific cost-to-charge ratios. Linear models were used to compare cost accumulation among study groups. Results We included 109 randomized subjects in this analysis (52 OU-CMR, 57 inpatient care). The median age was 56 years; baseline characteristics were similar in both groups. At 1 year, 6% of OU-CMR and 9% of inpatient care participants experienced a major cardiac event (p = 0.72) with 1 patient in each group experiencing a cardiac event after discharge. First-year cardiac-related costs were significantly lower for participants randomized to OU-CMR than for participants receiving inpatient care (geometric mean = $3,101 vs. $4,742 including the index visit p = 0.004 and $29 vs. $152 following discharge p = 0.012). During the year following randomization, 6% of OU-CMR and 9% of inpatient care participants experienced a major cardiac event (p = 0.72). Conclusions An OU-CMR strategy reduces cardiac-related costs of medical care during the index visit and over the first year subsequent to discharge, without an observed increase in major cardiac events. (Cost Comparison of Cardiac Magnetic Resonance Imaging MRI Use in Emergency Department ED Patients With Chest Pain; NCT00678639 )
Abstract Purpose Early use of beta-blockers is a quality indicator for the treatment of patients with non–ST-segment elevation myocardial infarction (NSTEMI), despite limited data from randomized ...clinical trials in this population. We sought to determine the impact of acute beta-blocker therapy on outcomes in patients with NSTEMI. Subjects and Methods We examined acute (<24 hours) beta-blocker use in 72,054 patients with NSTEMI from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) initiative at 509 US hospitals from 2001-2004. We analyzed patient and provider factors associated with beta-blocker use and the impact of beta-blocker therapy on unadjusted, risk-adjusted, and propensity matched outcomes in the overall sample and among selected high-risk subgroups. Results A total of 82.5% of patients without documented contraindications received acute beta-blocker therapy. Factors strongly associated with acute beta-blocker use included prior beta-blocker use, higher presenting systolic blood pressure, lower heart rate, lack of signs of heart failure, and cardiology care. Acute beta-blocker use was associated with lower in-hospital mortality (unadjusted 3.9% vs 6.9%, P <.001, adjusted odds ratio 0.66, 95% confidence interval 0.60-0.72), lower adjusted mortality among most of 6 subgroups determined by propensity to receive acute beta-blockers, and lower adjusted mortality in patients with and without signs of heart failure and in those <80 years and those ≥80 years old. Conclusions The majority of NSTEMI patients receive acute beta-blocker therapy. Certain patient subgroups remain undertreated. Because treatment with acute beta-blockers was associated with improved clinical outcomes in nearly all patient subgroups assessed, broader use in patients with NSTEMI appears warranted.
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