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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2005.03.069 Byline: Saif S. Rathore (a), Kevin P. Weinfurt (c), JoAnne M. Foody (a), Harlan M. Krumholz (a)(b)(d)(e)(f) Abstract: The TIMI ST-elevation myocardial infarction (STEMI) score was developed and validated in a randomized controlled trial population. We sought to assess its accuracy in a community-based cohort of elderly patients hospitalized with STEMI. Author Affiliation: (a) Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Conn (b) Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Conn (c) Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (d) Qualidigm, Middletown, Conn (e) Yale-New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Conn (f) The Robert Wood Johnson Clinical Scholars Program, Yale University School of Medicine, New Haven, Conn Article History: Received 18 November 2003; Accepted 29 March 2005 Article Note: (footnote) Saif Rathore was supported by NIH/National Institute of General Medical Sciences Medical Scientist Training Grant GM07205.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2004.08.018 Byline: Saif S. Rathore (a)(b), Paul D. Frederick (e), Nathan R. Every (e), Hal V. Barron (f), Harlan M. Krumholz (a)(c)(d) Abstract: Racial differences in reperfusion therapy use among patients hospitalized with myocardial infarction (MI) have been previously reported as national phenomenon. However, it is unclear whether racial differences in treatment vary by region. Author Affiliation: (a) Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Conn (b) MD/PhD Program, Yale University School of Medicine, New Haven, Conn (c) Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Conn (d) Yale-New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Conn (e) Ovation Research Group, Chicago, Ill (f) Genentech, Incorporated, South San Francisco, Calif Article History: Received 13 January 2004; Accepted 17 August 2004 Article Note: (miscellaneous) The National Registry of Myocardial Infarction-2 and -3 is supported by Genentech, Inc, South San Francisco, Calif. Mr Rathore is supported by National Institutes of Health National Institute of General Medical Sciences Medical Scientist Training Grant GM07205.

Background: Randomized clinical trials (RCTs) suggest benefits for the transradial approach to percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). However, transradial PCI may delay reperfusion, leading to its avoidance. We sought to quantify the delay in reperfusion from transradial PCI (“transradial delay”) that would need to be introduced to offset the potential mortality benefit of transradial PCI, compared with transfemoral, observed in RCTs. Methods: We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI. Thirty-day mortality rates were estimated by pooling STEMI patients from 2 RCTs comparing transfemoral and transradial PCI. We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays. Sensitivity analyses were performed to understand the impact of uncertainty in assumptions. Results: In the base case, a transradial delay of 83.0 minutes was needed to offset the mortality benefit of transradial PCI. When the mortality benefit of transradial PCI was one-quarter that observed in RCTs, the delay associated with equivalent mortality was 20.9 minutes. In probabilistic sensitivity analyses, transradial PCI was preferred over transfemoral PCI in 97.5% of simulations when transradial delay was 30 minutes and in 79.0% of simulations when delay was 60 minutes. Conclusions: A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs. Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI because of concern for delaying reperfusion. [Copyright &y& Elsevier]

Considerable attention has been devoted to the effect of social support on patient outcomes after acute myocardial infarction (AMI). However, little is known about the relation between patient living arrangements and outcomes. Thus, we used data from PREMIER, a registry of patients hospitalized with AMI at 19 United States centers from 2003 through 2004, to assess the association of living alone with outcomes after AMI. Outcome measurements included 4-year mortality, 1-year readmission, and 1-year health status using the Seattle Angina Questionnaire (SAQ) and the Short Form-12 Physical Health Component scales. Patients who lived alone had higher crude 4-year mortality (21.8% vs 14.5%, p <0.001) but comparable rates of 1-year readmission (41.6% vs 38.3%, p = 0.79). Living alone was associated with lower unadjusted quality of life (mean SAQ −2.40, 95% confidence interval [CI] −4.44 to −0.35, p = 0.02) but had no impact on Short Form-12 Physical Health Component (−0.45, 95% CI −1.65 to 0.76, p = 0.47) compared to patients who did not live alone. After multivariable adjustment, patients who lived alone had a comparable risk of mortality (hazard ratio 1.35, 95% CI 0.94 to 1.93) and readmission (hazard ratio 0.99, 95% CI 0.76 to 1.28) as patients who lived with others. Mean quality-of-life scores remained lower in patients who lived alone (SAQ −2.91, 95% CI −5.56 to −0.26, p = 0.03). In conclusion, living alone may be associated with poorer angina-related quality of life 1 year after MI but is not associated with mortality, readmission, or other health status measurements after adjusting for other patient and treatment characteristics. [Copyright &y& Elsevier]

Current guidelines recommend patients with ST-elevation myocardial infarction receive primary percutaneous coronary intervention (PCI) within 90 minutes of admission, although there are conflicting data regarding the relation between time to treatment and mortality in these patients. We used logistic regression analyses employing a fractional polynomial model to evaluate the association between door-to-balloon time and 1-year mortality in patients with ST-elevation myocardial infarction ≥65 years old undergoing primary PCI from 1994 to 1996 (n = 1,932). Median door-to-balloon time was 128 minutes (interquartile range 92 to 178, 24.2% treated within 90 minutes). Overall 1-year mortality was 21.1%. Longer door-to-balloon times were associated with higher 1-year mortality in a continuous, nonlinear fashion (30 minutes 10.9%, 60 minutes 13.6%, 90 minutes 16.5%, 120 minutes 19.5%, 150 minutes 22.5%, 180 minutes 25.3%, 210 minutes 27.9%). The nature of the association between door-to-balloon time and 1-year mortality was best modeled by a second-degree fractional polynomial (p <0.001). Findings were similar after multivariable adjustment as any increase in door-to-balloon time was associated with successive increases in patients'' 1-year mortality (30 minutes 8.8%, 60 minutes 12.9%, 90 minutes 16.6%, 120 minutes 19.9%, 150 minutes 22.9%, 180 minutes 25.5%, 210 minutes 27.7%). In conclusion, any delay in primary PCI is associated with increased 1-year mortality, suggesting efforts should focus on decreasing time to treatment as much as possible, even among those centers currently providing primary PCI within 90 minutes. [Copyright &y& Elsevier]

A uniform policy for regionalization of ST-segment elevation myocardial infarction (STEMI) care raises several concerns. Transferring all STEMI patients to obtain primary percutaneous coronary intervention (PCI) may be less effective than transferring only high-risk STEMI patients. Delays in time to treatment >60 min associated with transferring patients for primary PCI may result in increased mortality for the average patient as compared with providing immediate fibrinolytic therapy at their initial hospital; yet more than 95% of patients transferred for primary PCI in the U.S. exceed this 60-min benchmark. Superior outcomes associated with treatment at higher-volume regional STEMI centers are inconsistent among centers, and there is no direct evidence that patients will benefit by a transfer to a high-volume hospital from a low-volume hospital. Published data suggest as many as 800 PCI patients would need to be transferred to a high-volume PCI hospital to avoid a single death at a low-volume PCI hospital. Although European randomized trial data suggest transferring patients with STEMI for primary PCI may be superior to immediate fibrinolytic therapy, these findings are unlikely to generalize to the U.S. health care system given size, geography, and organization. ST segment elevation myocardial infarction care regionalization would require a massive redistribution of health care resources, depriving several hospitals of advanced cardiac care facilities, expertise, and associated revenue. Clearer evidence of the benefits and discussion of potential harms are needed before adopting a national STEMI regionalization policy. [Copyright &y& Elsevier]

Abstract: Background: Although B-type natriuretic peptide (BNP) levels have been proposed as a means of assessing disease severity in patients with heart failure, it is not known if BNP levels are correlated with health status (symptom burden, functional limitation, and quality of life). Methods and Results: We studied 342 outpatients with systolic heart failure from 14 centers at baseline and 6 ± 2 weeks with BNP levels and the Kansas City Cardiomyopathy Questionnaire (KCCQ), a heart-failure-specific health status instrument. We assessed the correlation between KCCQ scores and BNP at baseline and changes in KCCQ according to changes in BNP levels between baseline and follow-up. Mean baseline BNP levels were 379 ± 387 pg/mL and mean KCCQ summary scores were 62 ± 23 points. Although baseline BNP and KCCQ were both associated with New York Heart Association classification (P < .001 for both), BNP and KCCQ were not correlated (r2 =0.008, P =.15). There was no significant relationship between changes in BNP and KCCQ regardless of the threshold used to define a clinically meaningful BNP change. For example, using >50% BNP change threshold, KCCQ improved by 3.7 ± 14.2 in patients with decreasing BNP, improved by 1.7 ± 13.6 in patients with no BNP change, and improved by 1.0 ± 13.4 in patients with increasing BNP (P =.6). Conclusion: BNP and health status are not correlated in outpatients with heart failure in the short term. This suggests that these measures may assess different aspects of heart failure severity, and that physiologic measures do not reflect patients'' perceptions of the impact of heart failure on their health status. [Copyright &y& Elsevier]

Objectives: The aim of this study was to evaluate current American College of Cardiology/American Heart Association (ACC/AHA) hospital percutaneous coronary intervention (PCI) volume minimum recommendations.Background: In order to reduce procedure-associated mortality, ACC/AHA guidelines recommend that hospitals offering PCIs perform at least 400 PCIs annually. It is unclear whether this volume standard applies to current practice.Methods: We conducted a retrospective analysis of the Agency for Healthcare Research and Quality''s Nationwide In-patient Sample hospital discharge database to evaluate in-hospital mortality among patients (n = 362,748) who underwent PCI between 1998 and 2000 at low (5 to 199 cases/year), medium (200 to 399 cases/year), high (400 to 999 cases/year), and very high (1,000 cases or more/year) PCI volume hospitals.Results: Crude in-hospital mortality rates were 2.56% in low-volume hospitals, 1.83% in medium-volume hospitals, 1.64% in high-volume hospitals, and 1.36% in very high-volume hospitals (p < 0.001 for trend). Compared with patients treated in high-volume hospitals (odds ratio [OR] 1.00, referent), patients treated in low-volume hospitals remained at increased risk for mortality after adjustment for patient characteristics (OR 1.21, 95% confidence interval [CI] 1.06 to 1.28). However, patients treated in medium-volume hospitals (OR 1.02, 95% CI 0.92 to 1.14) and patients treated in very high-volume hospitals (OR 0.94, 95% CI 0.85 to 1.03) had a comparable risk of mortality. Findings were similar when high- and very high-volume hospitals were pooled together.Conclusions: We found no evidence of higher in-hospital mortality in patients undergoing PCI at medium-volume hospitals compared with patients treated at hospitals with annual PCI volumes of 400 cases of more, suggesting current ACC/AHA PCI hospital volume minimums may merit reevaluation. [Copyright &y& Elsevier]

Background: The Centers for Medicare and Medicaid Services provides public reporting on the quality of hospital care for patients with acute myocardial infarction (AMI). The Centers for Medicare and Medicaid Services Core Measures allow discretion in excluding patients because of relative contraindications to aspirin, β-blockers, and angiotensin-converting enzyme inhibitors. We describe trends in the proportion of patients with AMI with contraindications that could lead to discretionary exclusion from public reporting. Methods: We completed cross-sectional analyses of 3 nationally representative data cohorts of AMI admissions among Medicare patients in 1994-1995 (n = 170,928), 1998-1999 (n = 27,432), and 2000-2001 (n = 27,300) from the national Medicare quality improvement projects. Patients were categorized as ineligible (eg, transfer patients), automatically excluded (specified absolute medical contraindications), discretionarily excluded (potentially excluded based on relative contraindications), or “ideal” for treatment for each measure. Results: For 4 of 5 measures, the percentage of discretionarily excluded patients increased over the 3 periods (admission aspirin 15.8% to 16.9%, admission β-blocker 14.3% to 18.3%, discharge aspirin 10.3% to 12.3%, and angiotensin-converting enzyme inhibitors 2.8% to 3.9%; P < .001). Of patients potentially included in measures (those who were not ineligible or automatically excluded), the discretionarily excluded represented 25.5% to 69.2% in 2000-2001. Treatment rates among patients with discretionary exclusions also increased for 4 of 5 measures (all except angiotensin-converting enzyme inhibitors). Conclusions: A sizeable and growing proportion of patients with AMI have relative contraindications to treatments that may result in discretionary exclusion from publicly reported quality measures. These patients represent a large population for which there is insufficient evidence as to whether measure exclusion or inclusion and treatment represents best care. [Copyright &y& Elsevier]

Prior Aspirin Use and Outcomes in Elderly Patients Hospitalized With Acute Myocardial Infarction Edward L. Portnay, JoAnne M. Foody, Saif S. Rathore, Yongfei Wang, Frederick A. Masoudi, Jeptha P. Curtis, Harlan M. Krumholz We examined the association between prior aspirin use and mortality at one month and six months in 118,992 elderly patients and prior aspirin use and readmissions in 78,975 elderly patients with myocardial infarction (MI) in a national sample. After multivariable adjustment, prior aspirin use was associated with lower risk of one-month mortality (relative risk 0.93, 95% confidence interval [CI] 0.90 to 0.96) and six-month mortality (hazard ratio 0.94, 95% CI 0.91 to 0.96). Prior aspirin use tended to reduce all-cause or coronary artery disease readmission at one month or six months. Prior aspirin use is not a marker of increased mortality in elderly patients hospitalized with MI. Objectives: We sought to assess the association between prior aspirin use and mortality, all-cause readmission, and condition-specific readmission at one month and six months in a national sample of Medicare beneficiaries hospitalized with a confirmed myocardial infarction (MI). Background: Prior aspirin use is considered a marker of higher risk in patients with MI, yet the prognostic significance of this factor has been debated. Methods: Medicare beneficiaries ≥65 years old hospitalized with MI were evaluated to determine whether there was an association between prior aspirin use and mortality (n = 118,992), all-cause readmission, and condition-specific readmission (n = 78,975) at one month and six months. Results: One-third of the patients (n = 39,531, 33.2%) were using aspirin before admission. Those with prior aspirin use had significantly lower mortality at one month (16.1% vs. 19.0%, p &#60; 0.0001) and six months (24.7% vs. 27.5%, p &#60; 0.0001). After multivariable adjustment, prior aspirin use was found to be associated with a lower risk of one-month (relative risk ratio 0.93, 95% confidence interval [CI] 0.90 to 0.96) and six-month mortality (hazard ratio 0.94, 95% CI 0.91 to 0.96). Prior aspirin use tended to reduce all-cause or coronary artery disease readmissions at one month or six months. Conclusions: Prior aspirin use is not a marker of increased mortality in patients ≥65 years old hospitalized with MI. [Copyright &y& Elsevier]

Objectives: We evaluated whether appropriateness and baseline risk of cardiac catheterization varied according to regional intensity of invasive therapy after acute myocardial infarction (AMI), and whether AMI mortality varied according to invasive intensity regions. Background: Marked regional variations exist in cardiac invasive procedure use after AMI within the U.S. Methods: We performed an analysis of 44,639 Medicare fee-for-service beneficiaries hospitalized with AMI between 1998 and 2001. Invasive procedure intensity was determined based on overall cardiac catheterization rates for Medicare enrollees. Cardiac catheterization appropriateness was determined by the American College of Cardiology/American Heart Association classification and baseline risk was estimated using the GRACE (Global Registry of Acute Coronary Events) risk score. The primary outcomes of the study were cardiac catheterization use within 60 days and 3-year mortality after hospital admission. Results: Higher invasive intensity regions were more likely to perform cardiac catheterizations on class I patients (appropriate) (RR 1.38, 95% confidence interval [CI] 1.27 to 1.48), class II patients (equivocal) (RR 1.42, 95% CI 1.31 to 1.53), and class III patients (inappropriate) (RR 1.29, 95% 0.97 to 1.67) compared with low-intensity regions after adjusting for patient and physician characteristics. The overall cardiac catheterization use was 5.2% lower for each increase in GRACE risk decile, and this relationship was observed similarly in all regions. Risk-standardized mortality rates of AMI patients at 3 years were not substantially different between regions. Conclusions: Although higher-risk patients and those with more appropriate indications may have the most to benefit from an invasive strategy after AMI, we found that higher-invasive regions do not differentiate procedure selection based on the patients’ appropriateness or their baseline risks. [Copyright &y& Elsevier]

Fibrinolytic therapy is the most common reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), particularly in smaller centers. Previous studies evaluated the relation between time to treatment and outcomes when few patients were treated within 30 minutes of hospital arrival and many did not receive modern adjunctive medications. To quantify the impact of a delay in door-to-needle time on mortality in a recent and representative cohort of patients with STEMI, a cohort of 62,470 patients with STEMI treated using fibrinolytic therapy at 973 hospitals that participated in the National Registry of Myocardial Infarction from 1999 to 2002 was analyzed. Hierarchical models were used to evaluate the independent effect of door-to-needle time on in-hospital mortality. In-hospital mortality was lower with shorter door-to-needle times (2.9% for ≤30 minutes, 4.1% for 31 to 45 minutes, and 6.2% for >45 minutes; p <0.001 for trend). Compared with those experiencing door-to-needle times ≤30 minutes, adjusted odd ratios (ORs) of dying were 1.17 (95% confidence interval [CI] 1.04 to 1.31) and 1.37 (95% CI 1.23 to 1.52; p for trend <0.001) for patients with door-to-needle times of 31 to 45 and >45 minutes, respectively. This relation was particularly pronounced in those presenting within 1 hour of symptom onset to presentation time (OR 1.25, 95% CI 1.01 to 1.54; OR 1.54, 95% CI 1.27 to 1.87, respectively; p for trend <0.001). In conclusion, timely administration of fibrinolytic therapy continues to significantly impact on mortality in the modern era, particularly in patients presenting early after symptom onset. [Copyright &y& Elsevier]

Objectives: We tested the hypothesis that one health status measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), provides prognostic information independent of other clinical data in outpatients with heart failure (HF). Background: Health status measures are used to describe a patient’s clinical condition and have been shown to predict mortality in some populations. Their prognostic value may be particularly useful among patients with HF for identifying candidates for disease management in whom increased care may reduce hospitalizations and prevent death. Methods: We evaluated 505 HF patients from 13 outpatient clinics who had an ejection fraction <40% using the KCCQ summary score. Proportional hazards regression was used to evaluate the association between the KCCQ summary score (range, 0 to 100; higher scores indicate better health status) and the primary outcome of death or HF admission, adjusting for baseline patient characteristics, 6-min walk distance, and B-type natriuretic peptide (BNP). Results: The mean age was 61 years, 76% of patients were male, 51% had an ischemic HF etiology, and 5% were New York Heart Association functional class IV. At 12 months, among the 9% of patients with a KCCQ score <25, 37% had been admitted for HF and 20% had died, compared with 7% (HF admissions) and 5% (death) of those with a KCCQ score ≥75 (33% of patients, p < 0.0001 for both comparisons). In sequential multivariable models adjusting for clinical variables, 6-min walk, and BNP levels, the KCCQ score remained significantly associated with survival free of HF hospitalization. Conclusions: A low KCCQ score is an independent predictor of poor prognosis in outpatients with HF. [Copyright &y& Elsevier]

Aspirin Use in Older Patients with Heart Failure and Coronary Artery Disease Frederick A. Masoudi, Pam Wolfe, Edward P. Havranek, Saif S. Rathore, JoAnne M. Foody, Harlan M. Krumholz Aspirin use in patients with coronary artery disease (CAD) and concomitant heart failure (HF) is controversial. We studied 24,012 hospitalized Medicare beneficiaries ≥65 years old with the primary diagnosis of HF and documented CAD. Only 52% were treated with aspirin. In multivariable analyses, aspirin was associated with lower risks of death at one year (risk ratio 0.94; 95% confidence interval 0.90 to 0.99) and lower risks of death and all-cause readmission or death and HF readmission. These results suggest that withholding aspirin in patients with CAD and HF may deprive patients of important clinical benefits. Objectives: We sought to determine patterns of aspirin use and the relationship between aspirin prescription and outcomes in patients with coronary artery disease (CAD) and heart failure (HF). Background: Because of the potential for exacerbating hypertension or renal insufficiency and possible interactions with angiotensin-converting enzyme (ACE) inhibitors, the use of aspirin for secondary prevention of coronary events is controversial in patients with HF. Methods: We studied a national sample of Medicare beneficiaries ≥65 years old after hospitalization for HF with CAD and without aspirin contraindications between April 1998 and June 2001. We assessed factors associated with aspirin prescription and the relationship between aspirin and outcomes in regression models accounting for differences in patient, physician, and hospital characteristics and for clustering of patients by hospital. Results: Of the 24,012 patients, 54% received aspirin. Treated patients had lower unadjusted rates of death (31% vs. 39% for those not receiving aspirin, p &#60; 0.001). In multivariable analyses, aspirin remained associated with a lower risk of death (risk ratio [RR] 0.94; 95% confidence interval [CI] 0.90 to 0.99). This association was similar regardless of hypertension, renal insufficiency, or treatment with ACE inhibitors (p for all interactions > 0.2). Aspirin also was associated with lower risks of death or all-cause readmission (RR 0.98; 95% CI 0.97 to 0.99) and of death or readmission for HF (RR 0.98; 95% CI 0.96 to 0.99). Conclusions: Almost one-half of patients with CAD hospitalized for HF in the U.S. are not treated with aspirin. This study found no evidence of harm from aspirin in this population and suggests a treatment benefit. Withholding aspirin based upon theoretical concerns about adverse effects appears to be unjustified. [Copyright &y& Elsevier]

: ObjectivesThe aim of this study was to assess the prognostic importance of left ventricular ejection fraction (LVEF) in stable outpatients with heart failure (HF).: BackgroundAlthough LVEF is an accepted prognostic indicator of prognosis in HF patients, the relationship of LVEF and mortality across the full spectrum of LVEF is incompletely understood.: MethodsWe examined the association of LVEF and outcomes among 7,788 stable HF patients enrolled in the Digitalis Investigation Group trial.: ResultsDuring mean follow-up of 37 months, mortality was substantial in all LVEF groups (range, LVEF ≤ 15%, 51.7%, LVEF > 55%, 23.5%). Among patients with LVEF ≤ 45%, mortality decreased in a near linear fashion across successively higher LVEF groups (LVEF < 15%, 51.7%; LVEF 36% to 45%, 25.6%; p < 0.0001). This association was present after multivariable adjustment, although the magnitude of this associated risk was reduced (LVEF ≤ 15%: hazard ratio [HR] 1.77, 95% confidence interval [CI] 1.48 to 2.11; LVEF 16% to 25%: HR 1.44, 95% CI 1.28 to 1.61; LVEF 26% to 35%: HR 1.10, 95% CI 0.98 to 1.28; LVEF 36% to 45%: referent). In contrast, mortality rates were comparable among patients with LVEF > 45% both before (LVEF 46% to 55%: 23.3%; LVEF > 55%: 23.5%; p = 0.25), and after multivariable adjustment (LVEF 46% to 55%: HR 0.92, 95% CI 0.77 to 1.10; LVEF > 55%: HR 0.88, 95% CI 0.71 to 1.09; LVEF 36% to 45%: referent). Patients with lower LVEF were at increased absolute risk of death due to arrhythmia and worsening HF, but these were leading causes of death in all LVEF groups.: ConclusionsAmong HF patients in sinus rhythm, higher LVEFs were associated with a linear decrease in mortality up to an LVEF of 45%. However, increases above 45% were not associated with further reductions in mortality. [Copyright &y& Elsevier]