Search

Background Current guidelines recommend sacubitril/valsartan for patients with heart failure with reduced ejection fraction, but the rate of adoption in the United States has been slow. Methods and Results Using data from CHAMP-HF (Change the Management of Patients With Heart Failure), we described current sacubitril/valsartan use and identified patient, provider, and practice characteristics associated with its use. We considered patients to be on sacubitril/valsartan if they were prescribed it before enrollment or initiated on it at the baseline visit. We excluded patients with a contraindication to sacubitril/valsartan and practices with <10 patients enrolled. Of 4216 patients from 121 sites, 616 (15%) were prescribed sacubitril/valsartan, 2506 (59%) an angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB), and 1094 (26%) neither. Patients prescribed sacubitril/valsartan were younger (63 years versus 66 years ACE inhibitor/ARB versus 69 years neither, P<0.001), less likely to have chronic kidney disease (15% versus 17% ACE inhibitor/ARB versus 30% neither, P<0.001), more likely to have cardiac resynchronization therapy (12% versus 7% ACE inhibitor/ARB versus 7% neither, P<0.001), and had lower ejection fraction (27% versus 30% ACE inhibitor/ARB versus 30% neither, P<0.001). Larger practices, based on number of cardiologists and advanced practice providers, were associated with the highest sacubitril/valsartan use. After multivariable adjustment, the number of advanced practice providers was associated with sacubitril/valsartan use (adjusted odds ratio,1.08; 95% CI, 1.03-1.14). Conclusions Despite current guideline recommendations, adoption of sacubitril/valsartan remains low. Provider and practice characteristics associated with sacubitril/valsartan use were related to general practice size and were not associated with practice characteristics specific for heart failure. Further research is needed to identify strategies for effective quality improvement interventions in chronic heart failure with reduced ejection fraction.

Background: Many clinical trials use composite end points to reduce sample size, but the relative importance of each individual end point within the composite may differ between patients and researchers., Methods and Results: We asked 785 cardiovascular patients and 164 clinical trial authors to assign 25 "spending weights" across 5 common adverse events comprising composite end points in cardiovascular trials: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. We then calculated end point ratios for each participant's ratings of each nonfatal end point relative to death. Whereas patients assigned an average weight of 5 to death, equal or greater weight was assigned to myocardial infarction (mean ratio, 1.12) and stroke (ratio, 1.08). In contrast, clinical trialists were much more concerned about death (average weight, 8) than myocardial infarction (ratio, 0.63) or stroke (ratio, 0.53). Both patients and trialists considered revascularization (ratio, 0.48 and 0.20, respectively) and hospitalization (ratio, 0.28 and 0.13, respectively) as substantially less severe than death. Differences between patient and trialist end point weights persisted after adjustment for demographic and clinical characteristics (P<0.001 for all comparisons)., Conclusions: Patients and clinical trialists did not weigh individual components of a composite end point equally. Whereas trialists are most concerned about avoiding death, patients place equal or greater importance on reducing myocardial infarction or stroke. Both groups considered revascularization and hospitalization as substantially less severe. These findings suggest that equal weights in a composite clinical end point do not accurately reflect the preferences of either patients or trialists., (© 2014 American Heart Association, Inc.)

An editorial is presented on Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction. Topics include providing the complete understanding of the health status benefits of empagliflozin on patients' health status; and diminishing the mean population-level benefits of empagliflozin by improving the health status of patients being minimally symptomatic.

Background: Prior studies have reported higher in-hospital survival with prompt defibrillation and epinephrine treatment in patients with in-hospital cardiac arrest (IHCA). Whether this survival benefit persists after discharge is unknown.Methods: We linked data from a national IHCA registry with Medicare files and identified 36 961 patients ≥65 years of age with an IHCA at 517 hospitals between 2000 and 2011. Patients with IHCA caused by pulseless ventricular tachycardia or ventricular fibrillation were stratified by prompt (≤2 minutes) versus delayed (>2 minutes) defibrillation, whereas patients with IHCA caused by asystole or pulseless electric activity were stratified by prompt (≤5 minutes) versus delayed (>5 minutes) epinephrine treatment. The association between prompt treatment and long-term survival for each rhythm type was assessed with multivariable hierarchical modified Poisson regression models.Results: Of 8119 patients with an IHCA caused by ventricular tachycardia or ventricular fibrillation, the rate of 1-year survival was higher in those treated with prompt defibrillation than with delayed defibrillation (25.7% [1466 of 5714] versus 15.5% [373 of 2405]; adjusted relative risk [RR], 1.49; 95% confidence interval [CI] 1.32-1.69; P<0.0001). This survival advantage persisted at 3 years (19.1% versus 11.0%; adjusted RR, 1.45; 95% CI, 1.23-1.69; P<0.0001) and at 5 years (14.7% versus 7.9%; adjusted RR, 1.50; 95% CI, 1.22-1.83; P<0.0001). Of 28 842 patients with an IHCA caused by asystole/pulseless electric activity, the rate of 1-year survival with prompt epinephrine treatment was higher than with delayed treatment (5.4% [1341 of 24 885] versus 4.3% [168 of 3957]; adjusted RR, 1.20; 95% CI, 1.02-1.41; P=0.02), but this survival benefit was no longer present at 3 years (3.5% versus 2.9%; adjusted RR, 1.17; 95% CI, 0.95-1.45; P=0.15) and at 5 years (2.3% versus 1.9%; adjusted RR, 1.18; 95% CI, 0.88-1.58; P=0.27).Conclusions: Prompt defibrillation for IHCA caused by ventricular tachycardia or ventricular fibrillation was associated with higher rates of long-term survival throughout 5 years of follow-up, whereas prompt epinephrine treatment for asystole/pulseless electric activity was associated with greater survival at 1 year but not at 3 or 5 years. By quantifying the greater survival associated with timely defibrillation and epinephrine administration, these findings provide important insights into the durability of survival benefits for 2 process-of-care measures in current resuscitation guidelines. [ABSTRACT FROM AUTHOR]

Background: National guidelines endorse recombinant tissue-type plasminogen activator (r-tPA) in eligible patients with acute ischemic stroke to improve patients' functional recovery. However, 23% to 40% of ideal candidates with acute ischemic stroke for reperfusion are not treated, perhaps because of the difficulty in explaining the benefits and risks of r-tPA within the frenetic pace of emergency department care. To support better knowledge transfer and creation of a shared decision-making tool, we conducted qualitative interviews to define the information needs and preferred presentation format for stroke survivors, caregivers, and clinicians considering r-tPA treatment.Methods and Results: A multidisciplinary team used qualitative research methods to identify informational needs and strategies for describing the benefits and risks of r-tPA in a clinical setting. Through focus groups (n=10) of stroke survivors (n=39) and caregivers (n=24) and individual interviews with emergency physicians (n=23) and advanced practice nurses (n=20), several themes emerged. Survivors and caregivers preferred a broader definition of a good outcome (independence, rather than no significant disability), simpler graphs as compared with detailed pictographs, and presentation of both population and individualized benefits (framed positively) and risk of receiving r-tPA. Some physicians expressed skepticism with the data and the ability to present risk/benefit information emergently, whereas other physicians and most advanced practice nurses thought such information would improve care. Physicians stressed the importance of presenting the risk of thrombolytic-related intracranial hemorrhage.Conclusions: This study suggests that a positively framed risk-benefit tool with graphical presentations of general and patient-specific risk estimates could support patients and providers in considering r-tPA for acute ischemic stroke.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01864928. [ABSTRACT FROM AUTHOR]

Objectives: To describe trends in the availability of biomarker testing in Chinese hospitals and how practice complies with established standards for the diagnosis of acute myocardial infarction (AMI). Background: Cardiac biomarker testing is standard in high-income countries, but little is known about the availability and use of cardiac biomarker testing in low- and middle-income countries (LMICs) such as China. Methods: Based on a nationally representative sample of Chinese hospitals in 2001, 2006 and 2011, we describe the temporal trends and regional differences in the hospital capability and rates of use of cardiac biomarker testing, as well as the variation in use across hospitals with testing capability, for patients labeled with the diagnosis of AMI. Results: We sampled 175 hospitals (162 participated in the study) and 18,631 AMI admissions. 14,370 patients were included in analysis of biomarker use. The proportion of hospitals with biomarker testing capability was 57.4% in 2001 (25.0% troponin and 32.4% creatine kinase MB fraction (CK-MB) only) and 96.3% (81.4% troponin and 14.9% CK-MB only) in 2011. The proportion of hospitals with troponin testing capability in 2011 was significantly higher in urban compared with rural hospitals (96.8% vs. 71.4%, p< 0.001). In 2011, only 55.9% of hospitals with troponin testing capability (71 out of 127 hospitals) used the assay for more than 80% of their patients with AMI. Among hospitals with either biomarker testing capability, there was marked variation in use in both rural (from 7.1% to 100.0% of patients) and urban hospitals (from 57.9% to 100.0% of patients). In 2011, 36.1% of the patients with AMI did not have troponin tested and 4.9% did not have either biomarker measured. Conclusions: The recommended biomarker tests for AMI diagnosis are not universally available and the testing is not consistently applied when it is available in China. Trial Registration: ClinicalTrials.gov [ABSTRACT FROM AUTHOR]

Background: Angina and depression are common in ischemic heart disease (IHD), but their association remains understudied. Purpose: This study was conducted in order to evaluate the association of 1 year change in depression with change in patient-reported outcomes of stable angina. Methods: Five hundred sixty-nine stable angina patients completed the Seattle Angina Questionnaire and Patient Health Questionnaire (PHQ) at baseline and 1 year. Participants were divided into four groups: not depressed, new onset of depression at 1 year, remitted at 1 year, and persistently depressed. Associations between depression and angina symptoms were evaluated using regression models. Results: Compared to those not depressed, newly depressed participants reported more angina ( β = −11.7, p < 0.001) and physical limitations ( β = −11.8, p < 0.001) and lower treatment satisfaction ( β = −15.03, p < 0.001) and quality of life ( β = −15.4, p < 0.001). Persistently depressed participants reported physical limitations ( β = −7.4, p < 0.05), lower treatment satisfaction ( β = −10.1, p < 0.001), and poorer quality of life ( β = −10.03, p < 0.001). Conclusions: Changes in depression scores and angina outcomes were significantly associated. [ABSTRACT FROM AUTHOR]

Many patients undergo elective coronary angiography without preprocedural stress testing that may be suitable if performed in patients with more angina pectoris or more frequently identified obstructive coronary artery disease (CAD). Patients in the National Cardiovascular Data Registry CathPCI Registry undergoing elective coronary angiography from July 2009 to April 2013 were assessed for differences in angina (Canadian Cardiovascular Society [CCS] class) and severity of obstructive CAD in those with and without preprocedural stress testing, stratified by CAD history. Given the large sample size, differences were considered clinically meaningful if the standardized difference (SD) was >10%. Of 790,601 patients without CAD history, 36.9% did not undergo preprocedural stress testing. Compared with patients with preprocedural stress testing, patients without preprocedural stress testing were more frequently angina free (CCS class 0; 28.2% with stress test vs 38.5% without, SD = 14.8%) and had similar rates of obstructive CAD (40.1% with stress test vs 35.7% without, SD = 9.0). Of 449,579 patients with CAD history, 44.2% did not undergo preprocedural stress testing. Patients without preprocedural stress testing reported more angina (CCS class III/IV angina: 17.8% vs 13.4%; SD = 11.3%) but were not more likely to have obstructive CAD (78.7% vs 81.1%; SD = 5.8%) than patients with preprocedural stress testing. In conclusion, approximately 40% of patients undergoing elective coronary angiography did not have preprocedural risk stratification with stress testing. For these patients, the clinical decision to proceed directly to invasive evaluation was not driven primarily by severe angina and did not result in higher detection rates for obstructive CAD. [ABSTRACT FROM AUTHOR]

The article discusses the depression treatment and health status outcomes in young patients with acute myocardial infarction (AMI) and presents study on same. Topics include continued antidepressant medications and depression counseling received by patients; measuring treatment effects with random effects for marital status, diabetes mellitus, and heart failure; and higher depression rates in women among AMI survivors.

IMPORTANCE The FREEDOM trial demonstrated that among patients with diabetes mellitus and multivessel coronary artery disease, coronary artery bypass graft (CABG) surgery resulted in lower rates of death and myocardial infarction but a higher risk of stroke when compared with percutaneous coronary intervention (PCI) using drug-eluting stents. Whether there are treatment differences in health status, as assessed from the patient's perspective, is unknown. OBJECTIVES To compare the relative effects of CABG vs PCI using drug-eluting stents on health status among patients with diabetes mellitus and multivessel coronary artery disease. DESIGN, SETTING, AND PARTICIPANTS Between 2005 and 2010, 1900 patients from 18 countries with diabetes mellitus and multivessel coronary artery disease were randomized to undergo either CABG surgery (n = 947) or PCI (n = 953) as an initial treatment strategy. Of these, a total of 1880 patients had baseline health status assessed (935 CABG, 945 PCI) and comprised the primary analytic sample. INTERVENTIONS Initial revascularization with CABG surgery or PCI. MAIN OUTCOMES AND MEASURES Health statuswas assessed using the angina frequency, physical limitations, and quality-of-life domains of the Seattle Angina Questionnaire at baseline, at 1, 6, and 12 months, and annually thereafter. For each scale, scores range from 0 to 100 with higher scores representing better health. The effect of CABG surgery vs PCI was evaluated using longitudinal mixed-effect models. RESULTS At baseline, mean (SD) scores for the angina frequency, physical limitations, and quality-of-life subscales of the Seattle Angina Questionnaire were 70.9 (25.1), 67.3 (24.4), and 47.8 (25.0) for the CABG group and 71.4 (24.7), 69.9 (23.2), and 49.2 (25.7) for the PCI group, respectively. At 2-year follow-up, mean (SD) scores were 96.0 (11.9), 87.8 (18.7), and 82.2 (18.9) after CABG and 94.7 (14.3), 86.0 (19.3), and 80.4 (19.6) after PCI, with significantly greater benefit of CABG on each domain (mean treatment benefit, 1.3 [95%CI, 0.3-2.2], 4.4 [95%CI, 2.7-6.1], and 2.2 [95%CI, 0.7-3.8] points, respectively; P < .01 for each comparison). Beyond 2 years, the 2 revascularization strategies provided generally similar patient-reported outcomes. CONCLUSIONS AND RELEVANCE For patients with diabetes and multivessel CAD, CABG surgery provided slightly better intermediate-term health status and quality of life than PCI using drug-eluting stents. Themagnitude of benefit was small, without consistent differences beyond 2 years, in part due to the higher rate of repeat revascularization with PCI. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00086450 [ABSTRACT FROM AUTHOR]

Background: In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, some patients with stable ischemic heart disease randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown.Methods and Results: We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire. To quantify the potential consequences of initiating OMT without percutaneous coronary intervention, we compared the outcomes of crossover patients with a matched cohort randomized to immediate percutaneous coronary intervention. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline Seattle Angina Questionnaire scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to percutaneous coronary intervention, rates of mortality (hazard ratio=0.51 [0.13-2.1]) and nonfatal myocardial infarction (hazard ratio=1.9 [0.75-4.6]) were similar, as were 1-year Seattle Angina Questionnaire scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio=2.8 [1.1-7.5]).Conclusion: Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657. [ABSTRACT FROM AUTHOR]

Objectives: This study examined the association between insurance status and physicians'' adherence with providing evidence-based treatments for coronary artery disease (CAD). Methods: Within the PINNACLE (Practice Innovation and Clinical Excellence) registry of the NCDR (National Cardiovascular Data Registry), the authors identified 60,814 outpatients with CAD from 30 U.S. practices. Hierarchical modified Poisson regression models with practice site as a random effect were used to study the association between health insurance (no insurance, public, or private health insurance) and 5 CAD quality measures. Results: Of 60,814 patients, 5716 patients (9.4%) were uninsured and 11,962 patients (19.7%) had public insurance, whereas 43,136 (70.9%) were privately insured. After accounting for exclusions, uninsured patients with CAD were 9%, 12%, and 6% less likely to receive treatment with a beta-blocker, an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACE-I/ARB), and lipid-lowering therapy, respectively, than privately insured patients, and patients with public insurance were 9% less likely to be prescribed ACE-I/ARB therapy. Most differences by insurance status were attenuated after adjusting for the site providing care. For example, whereas uninsured patients with left ventricular dysfunction and CAD were less likely to receive ACE-I/ARB therapy (unadjusted RR: 0.88; 95% CI: 0.84 to 0.93), this difference was eliminated after adjustment for site (adjusted RR: 0.95; 95% CI: 0.88 to 1.03; p = 0.18). Conclusions: Within this national outpatient cardiac registry, uninsured patients were less likely to receive evidence-based medications for CAD. These disparities were explained by the site providing care. Efforts to reduce treatment differences by insurance status among cardiac outpatients may additionally need to focus on improving the rates of evidence-based treatment at sites with high proportions of uninsured patients. [Copyright &y& Elsevier]

Background: Little is known about the association between financial stress and health care outcomes. Our objective was to examine the association between self-reported financial stress during initial hospitalization and long-term outcomes after acute myocardial infarction (AMI). Materials and Methods: We used Prospective Registry Evaluating Myocardial Infarction: Event and Recovery (PREMIER) data, an observational, multicenter US study of AMI patients discharged between January 2003 and June 2004. Primary outcomes were disease-specific and generic health status outcomes at 1 year (symptoms, function, and quality of life (QoL)), assessed by the Seattle Angina Questionnaire [SAQ] and Short Form [SF]-12. Secondary outcomes included 1-year rehospitalization and 4-year mortality. Hierarchical regression models accounted for patient socio-demographic, clinical, and quality of care characteristics, and access and barriers to care. Results: Among 2344 AMI patients, 1241 (52.9%) reported no financial stress, 735 (31.4%) reported low financial stress, and 368 (15.7%) reported high financial stress. When comparing individuals reporting low financial stress to no financial stress, there were no significant differences in post-AMI outcomes. In contrast, individuals reporting high financial stress were more likely to have worse physical health (SF-12 PCS mean difference -3.24, 95% Confidence Interval [CI]: -4.82, -1.66), mental health (SF-12 MCS mean difference: -2.44, 95% CI: -3.83, -1.05), disease-specific QoL (SAQ QoL mean difference: -6.99, 95% CI: -9.59, -4.40), and be experiencing angina (SAQ Angina Relative Risk = 1.66, 95%CI: 1.19, 2.32) at 1 year post-AMI. While 1-year readmission rates were increased (Hazard Ratio = 1.50; 95%CI: 1.20, 1.86), 4-year mortality was no different. Conclusions: High financial stress is common and an important risk factor for worse long-term outcomes post-AMI, independent of access and barriers to care. [ABSTRACT FROM AUTHOR]

Background--Cardiac rehabilitation (CR) after acute myocardial infarction (AMI) is a Class I recommendation. Although referral to CR after an AMI has recently become a performance measure, many patients may not participate. To illuminate potential barriers to participation, we examined the prevalence of, and patient-related factors associated with, CR participation within 1 and 6 months after an AMI. Methods and Results--We studied 2096 AMI patients enrolled from 19 US sites in the Prospective Registry Evaluating outcomes after Myocardial Infarction: Events and Recovery (PREMIER) registry. Analyses were limited to those patients referred for CR at the time of AMI hospitalization. A multivariable, conditional logistic regression model, stratified by hospital, was used to identify sociodemographic, comorbidity, and clinical factors independently associated with CR participation within 1 and 6 months of AMI hospital discharge. Only 29% (419/1450) and 48.25% (650/1347) of AMI patients who received referral for CR participated within 1 and 6 months after discharge, respectively. Women (odds ratio [OR], 0.61; 95% confidence interval [CI], 0.44-0.86), uninsured (OR, 0.39; 95% CI, 0.21-0.71), and patients with hypertension (OR, 0.58; 95% CI, 0.43-0.78) and peripheral arterial disease (OR, 0.43; 95% CI, 0.22-0.85) were less likely to participate at 1 month. At 6 months after AMI, older patients (OR, 0.85 for each 10-year increment; 95% CI, 0.74-0.97), smokers (OR, 0.59; 95% CI, 0.44-0.80), and patients with economic burden (OR, 0.56; 95% CI, 0.38-0.81) were less likely to participate. Caucasians (OR, 1.73; 95% CI, 1.16-2.58) and educated patients (OR, 1.81; 95% CI, 1.42-2.30) were more likely to participate at 6 months. Patients with previous percutaneous interventions were less likely to participate at both 1 and 6 months post-AMI. Conclusions--Among patients referred for CR post-AMI, participation remains low both at 1 and 6 months after AMI. Because CR is associated with beneficial changes in cardiovascular risk factors and better outcomes after AMI, more aggressive efforts are needed to increase CR participation after referral. [ABSTRACT FROM AUTHOR]

The article discusses a study which examined whether increased awareness has resulted into a decline in acute kidney injury (AKI) incidents from 2000 to 2008 in patients with acute myocardial infarction (AMI). Temporal trends in AKI incidents analyzed for the period revealed a decline in AKI cases from 26.6 per cent to 19.7 per cent in patients 66.5 to 68.6 years of age. The study concluded that despite the aging population, AKI incidence in patients with AMI decreased significantly.

Objectives: The aim of this study was to describe differences in treatment and in-hospital mortality of early, late, and very late stent thrombosis (ST). Background: Early, late, and very late ST may differ in clinical presentation, management, and in-hospital outcomes. Methods: We analyzed definite (angiographically documented) ST cases identified from February 2009 to June 2010 in the CathPCI Registry. We stratified events by timing of presentation: early (≤1 month), late (1 to 12 months), or very late (≥12 months) following stent implantation. Multivariable logistic regression modeling was performed to compare in-hospital mortality for each type of ST after adjusting for baseline comorbidities. Results: During the study period, 7,315 ST events were identified in 7,079 of 401,662 patients (1.8%) presenting with acute coronary syndromes. This ST cohort consisted of 1,391 patients with early ST (19.6%), 1,370 with late ST (19.4%), and 4,318 with very late ST (61.0%). Subjects with early ST had a higher prevalence of black race and diabetes, whereas subjects with very late ST had a higher prevalence of white race and a lower prevalence of prior myocardial infarction or diabetes. In-hospital mortality was significantly higher in early ST (7.9%) compared with late (3.8%) and very late ST (3.6%, p < 0.001). This lower mortality for late and very late ST persisted after multivariable adjustment (odds ratio: 0.53 [95% confidence interval (CI): 0.36 to 0.79] and 0.58 [95% CI: 0.43 to 0.79], respectively). Conclusions: Significant differences exist in the presentation and outcomes of early, late, and very late ST. Among patients with acute coronary syndromes who are undergoing percutaneous coronary intervention for angiographically documented ST, early ST is associated with the highest in-hospital mortality. [ABSTRACT FROM AUTHOR]

Background: Somatic depressive symptoms and certain biomarkers are each associated with worse acute myocardial infarction (AMI) prognosis, but the relationship between depressive symptom domains and inflammatory, neurohormonal, and coagulation markers is unknown. Methods: We examined the relationship between depressive symptoms and 1-month biomarker levels (high-sensitivity C-reactive protein [hs-CRP], N-terminal pro-brain natriuretic peptide [NT-proBNP], white blood cell [WBC], platelet counts) in 1265 AMI patients. Depressive symptoms (9-item Patient Health Questionnaire) were assessed during index hospitalization and categorized as somatic or cognitive. Using median regression models, the upper quartile of somatic and cognitive depression scores and each biomarker were compared with the lower three quartiles, adjusting for site, demographics, and clinical characteristics. Results: Although hs-CRP values were higher in patients with somatic symptoms, this association was attenuated after adjustment (Bper SD increase = .02, 95% confidence interval: .00; .05, p = .07). WBC count was independently associated with somatic depressive symptoms (Bper SD increase = .28, 95% confidence interval: .12; .44, p < .001). Cognitive depressive symptoms were not associated with hs-CRP or WBC count. Neither dimension was associated with NT-proBNP or platelet levels. For each biomarker, the depression dimensions explained <1% of their variation. Conclusions: Neither somatic nor cognitive depressive symptoms were meaningfully associated with hs-CRP, NT-proBNP, WBC, or platelet counts 1 month after AMI, suggesting that the association between depression and long-term outcomes may be unrelated to these biomarkers. Future research should explore other biomarkers to better illuminate pathways by which depression adversely impacts AMI prognosis. [Copyright &y& Elsevier]

Depressive symptoms are known to compromise health status in cardiac disease, but this relationship has not been described in peripheral artery disease (PAD). Depressive symptoms (PHQ-9) and disease-specific health status (Peripheral Artery Questionnaire, PAQ) were assessed in 242 PAD patients undergoing percutaneous transluminal angioplasty (PTA) at baseline and 1 year. Patients were classified by baseline and follow-up depression status (moderate–severe depressive symptoms = PHQ ≥ 10). Changes were categorized as no depression/improvement of depression versus persistent/worsened depression. At baseline, 20% of patients were depressed; at 1 year, 17% of patients experienced persistent/worsened depression. Although this group improved on most PAQ subscales, they improved to a significantly lesser degree than those without depressive symptoms or those who improved by 1 year (p-values < 0.05). Baseline depressive symptoms (Bper 5-point increment = −11.9, 95% CI −15.3, −8.5, p < 0.0001) and changes in depression were independently associated with a decrease in 1-year health status (Bper 5-point increment = −11.7, 95% CI −14.3, −9.2, p < 0.0001). In conclusion, depressive symptoms are associated with less improvement in health status 1 year after undergoing a peripheral endovascular revascularization (PER) as compared with those having no depression or whose depressive symptoms improve. Efforts to improve depression detection and treatment among patients with PAD may improve the health status outcomes of these patients. [ABSTRACT FROM AUTHOR]

The article explores the study Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH), which aims to find out the impact of racial differences in patients with myocardial infarction (MI). TRIUMPH was participated by 6,152 people with eligible MI and 4,340 patients from 24 U.S. centers. According to the author, TRIUMPH is a helpful tool for practitioners in terms of examining factors that could affect their patients.

Background: Achieving 'personalized medicine' requires enrolling representative cohorts into genetic studies, but patient self-selection may introduce bias. We sought to identify characteristics associated with genetic consent in a myocardial infarction (MI) registry. Methods: We assessed correlates of participation in the genetic sub-study of TRIUMPH, a prospective MI registry (n = 4,340) from 24 US hospitals between April 2005 and December 2008. Factors examined included extensive sociodemographics factors, clinical variables, and study site. Predictors of consent were identified using hierarchical modified Poisson regression, adjusting for study site. Variation in consent rates across hospitals were quantified by the median rate ratio (MRR). Results: Most subjects consented to donation of their genetic material (n = 3,484; 80%). Participation rates varied greatly between sites, from 40% to 100%. After adjustment for confounding factors, the MRR for hospital was 1.22 (95% confidence interval (CI) 1.11 to 1.29). The only patient-level factors associated with consent were race (RR 0.93 for African Americans versus whites, 95% CI 0.88 to 0.99) and body mass index (RR 1.03 for BMI ≥ 25, 95% CI 1.01 to 1.06). Conclusion: Among patients with an MI there were notable differences in genetic consent by study site, but little association with patient-level factors. This suggests that variation in the way information is presented during recruitment, or other site factors, strongly influence patients' decision to participate in genetic studies. B [ABSTRACT FROM AUTHOR]

Abstract: Background: Premature stopping of anti-platelet therapy has potentially fatal consequences for myocardial infarction (MI) patients who have received a drug-eluting stent (DES). Exploring multiple perspectives to identify contributing factors to the problem is essential. Aim: We gained patient and clinician perspectives as to why MI patients prematurely stop anti-platelet therapy (clopidogrel) after DES implantation. Methods: This qualitative, descriptive study of DES-treated MI patients (n =22) and of clinicians (physicians and nurse practitioners; n =17) from multiple U.S. cities used content analysis of interview data. Findings across patients and clinicians were then compared to examine congruent and contrasting reasons for premature clopidogrel discontinuance. Findings: Patients frequently identified communication and education (e.g. unaware they should be taking clopidogrel, unaware of intended duration of therapy) as the primary reasons for having stopped. Patients rarely cited cost, while clinicians most commonly cited cost as a reason for premature stopping. Conclusions: The discrepancy in perceptions of patients and clinicians as to the primary reason for early discontinuance suggests an important opportunity for improving persistence. Rather than focusing on the high costs of medications, something outside of their control, physicians should consider communicating more effectively the importance and intended duration of clopidogrel to their patients. [Copyright &y& Elsevier]

The article presents the results of a study on the use of Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) in the treatment of patients with atrial fibrillation (AF). According to the authors, they established four conceptual domains using factor analyses which include symptoms, daily activities, treatment concern, and treatment satisfaction. They add that patients with lower AFEQT scores showed an increased AF severity, classified as asymptomatic, mild, moderate, and severe.

The article investigates the delay from the onset of symptoms to hospital presentation for patients with non-ST-segment elevation myocardial infarction (non-STEMI) in 104,622 cases at 568 hospitals in the U.S. from January 1, 2001 to December 31, 2006. The American College of Cardiology/American Heart Association guidelines suggest calling 911 for those experiencing acute coronary syndrome if symptoms do not improve after five minutes. The results show a median delay time of 2.6 hours and cite older age and female sex among reasons for longer delay time.

Background: Anemia is common among patients hospitalized with acute myocardial infarction and is associated with poor outcomes. Less is known about the incidence, correlates, and prognostic implications of acute, hospital-acquired anemia (HAA).Methods and Results: We identified 2909 patients with acute myocardial infarction who had normal hemoglobin (Hgb) on admission in the multicenter TRIUMPH registry and defined HAA by criteria proposed by Beutler and Waalen. We used hierarchical Poisson regression to identify independent correlates of HAA and multivariable proportional hazards regression to identify the association of HAA with mortality and health status. At discharge, 1321 (45.4%) patients had HAA, of whom 348 (26.3%) developed moderate-severe HAA (Hgb <11 g/dL). The incidence of HAA varied significantly across hospitals (range, 33% to 69%; median rate ratio for HAA, 1.13; 95% confidence interval, 1.07 to 1.23, adjusting for patient characteristics). Although documented bleeding was more frequent with more severe HAA, fewer than half of the patients with moderate-severe HAA had any documented bleeding. Independent correlates of HAA included age, female sex, white race, chronic kidney disease, ST-segment elevation myocardial infarction, acute renal failure, use of glycoprotein IIb/IIIa inhibitors, in-hospital complications (cardiogenic shock, bleeding and bleeding severity), and length of stay. After adjustment for GRACE score and bleeding, patients with moderate-severe HAA had higher mortality rates (hazard ratio, 1.82; 95% confidence interval, 1.11 to 2.98 versus no HAA) and poorer health status at 1 year.Conclusions: HAA develops in nearly half of acute myocardial infarction hospitalizations among patients treated medically or with percutaneous coronary intervention, commonly in the absence of documented bleeding, and is associated with worse mortality and health status. Better understanding of how HAA can be prevented and whether its prevention can improve patient outcomes is needed. [ABSTRACT FROM AUTHOR]

Background: The EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure and Survival Study) showed that the use of aldosterone blockade with eplerenone decreased mortality in patients with heart failure after acute myocardial infarction, and a subsequent analysis showed eplerenone to be highly cost effective in this population. Objective: To assess the cost effectiveness of eplerenone in an EPHESUS subgroup population who were taking both ACE inhibitors and β-blockers (β-adrenoceptor antagonists) at baseline. Intervention: In the EPHESUS, a total of 6632 patients were randomized to receive eplerenone 25-50 mg/day (n = 3319) or placebo (n = 3313) concurrently with standard therapy and were followed for up to 2.5 years. Of these, 4265 (64.3%) patients (eplerenone: n = 2113; placebo: n = 2152) were taking both ACE inhibitors and β-blockers at baseline. Methods and Main Outcome Measures: Resource use after the initial hospitalization included additional hospitalizations, outpatient services, emergency room visits, and medications. Eplerenone was priced at an average wholesale price of $US3.60 per day (year 2004 value). Bootstrap methods were used to estimate the fraction of the joint distribution of the cost and effectiveness. A net-benefit regression model was used to derive the propensity score-adjusted cost-effectiveness curve. The incremental cost effectiveness of eplerenone in cost per life-year gained (LYG) and cost per quality-adjusted life-year (QALY) gained beyond the trial period was estimated using data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. Both costs and effectiveness were discounted at 3%. Allthough not all resource use could be accounted for, the overall perspective was societal. Results: As in the overall EPHESUS population, the total direct treatment costs were higher in the eplerenone arm than the placebo arm for patients who were taking both ACE inhibitors and β-blockers ($US14 563 vs $US12 850, difference = $US1713; 95% CI 721, 2684). The number of LYGs with eplerenone compared with placebo was 0.1665 based on the Framingham data, 0.0979 using the Saskatchewan data, and 0.2172 using the Worcester data. The incremental cost-effectiveness ratio (ICER) was $US10 288/LYG with the Framingham data, $US17 506/LYG with the Saskatchewan data, and $US7888/LYG with the Worcester data (99% <$US50 000/LYG for all three sources). The ICERs were systematically higher when calculated as the cost per QALY gained ($US14 926, $US25 447, and $US11 393, respectively) as the utilities were below 1 with no difference between the treatment arms. Conclusions: As for the overall EPHESUS population, aldosterone blockade with eplerenone is effective in reducing mortality and is cost effective in increasing years of life for the EPHESUS subgroup of patients who were taking both ACE inhibitors and β-blockers. [ABSTRACT FROM AUTHOR]

The article focuses on an observational study which estimated hospital-level 30-day risk-standardized mortality rates (RSMRs) for patients discharged with acute myocardial infarction (AMI). Administrative data and a validated risk model were used to evaluate 3,195,672 discharges in 2,755,370 patients discharged from nonfederal acute care hospitals in the U.S. between January 1, 1995 to December 31, 2006. A significant decrease was observed in the risk-standardized hospital mortality rate for Medicare patients discharged with AMI, as well as between-hospital variation.

The article reports on the results of research which was conducted in an effort to determine whether the mortality risk associated with hypoglycemic events is similar in patients who develop hypoglycemia spontaneously and those who develop it as a result of insulin therapy. Researchers used a retrospective cohort study which used data from Health Facts, a database of patients hospitalized across the U.S. They found that while hypoglycemia was associated with increased mortality in patients with acute myocardial infarction, this risk was confined to patients who developed hypoglycemia spontaneously. They also found that iatrogenic hypoglycemia after insulin therapy was not associated with higher mortality risk.

The article reports on the results of research which was conducted in an effort to test the effects of exercise training on health status among patients with heart failure. researchers conducted a multicenter, randomized controlled trial among 2,331 medical stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Researchers found that exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training.

Background: Little information is available about factors associated with racial differences across a broad spectrum of post-myocardial infarction outcomes, including patients' symptoms and quality of life. Objective: To determine racial differences in mortality, rehospitalization, angina, and quality of life after myocardial infarction and identify the factors associated with these differences. Design: Prospective cohort study. Setting: 10 hospitals in the United States. Patients: 1849 patients who had myocardial infarction, 28% of whom were black. Measurements: Demographic, economic, clinical, psychosocial, and treatment characteristics and outcomes were prospectively collected. Outcomes included time to 2-year all-cause mortality, 1-year rehospitalization, and Seattle Angina Questionnaire-assessed angina and quality of life. Results: Black patients had higher unadjusted mortality (19.9% vs. 9.3%; P < 0.001) and rehospitalization rates (45.4% vs. 40.4%; P = 0.130), more angina (28.0% vs. 17.8%; P = 0.001), and worse mean quality of life (80.6 [SD, 22.5] vs. 85.9 [SD, 17.2]; P < 0.001). After adjustment for patient characteristics, black patients trended toward greater mortality (hazard ratio, 1.29 [95% CI, 0.92 to 1.81]; P = 0.142), fewer rehospitalizations (hazard ratio, 0.82 [CI, 0.66 to 1.02]; P = 0.071), and higher likelihood of angina at 1 year (odds ratio, 1.41 [CI, 1.03 to 1.94]; P = 0.032) but similar quality of life (mean difference, -0.6 [CI, -3.4 to 2.2]). Adjustment for site of care further attenuated mortality differences (hazard ratio, 1.04 [CI, 0.71 to 1.52]; P = 0.84). Adjustment for treatments had minimal effect on any association. Limitation: Residual confounding and missing data may have introduced bias. Conclusion: Although black patients with myocardial infarction have worse outcomes than white patients, these differences did not persist after adjustment for patient factors and site of care. Further adjustment for treatments received minimally influenced observed differences. Strategies that focus on improving baseline cardiac risk and hospital factors may do more than treatment-focused strategies to attenuate racial differences in myocardial infarction outcomes. Funding: The National Heart, Lung, and Blood Institute Specialized Center of Clinically Oriented Research in Cardiac Dysfunction and Disease, CV Therapeutics, and Cardiovascular Outcomes. [ABSTRACT FROM AUTHOR]

Background: It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease. Methods: We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]). Results: At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P<0.001). Baseline mean (±SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66±25 for physical limitations, 54±32 for angina stability, 69±26 for angina frequency, 87±16 for treatment satisfaction, and 51±25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76±24 versus 72±23 for physical limitation (P=0.004), 77±28 versus 73±27 for angina stability (P=0.002), 85±22 versus 80±23 for angina frequency (P<0.001), 92±12 versus 90±14 for treatment satisfaction (P<0.001), and 73±22 versus 68±23 for quality of life (P<0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups. Conclusions: Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657.) N Engl J Med 2008;359:677-87. [ABSTRACT FROM AUTHOR]

The article presents a study on the elimination of angina one year after myocardial infarction. It aims to describe the instances of angina one year after myocardial infarction. The study examines 2498 patients from nineteen hospitals in the U. S. The patients were given the Seattle Angina Questionnaire one year after their treatment for angina. The patients were also studied for clinical history and demographics. The study found that 19.9 percent or three hundred eighty-nine out of 1,957 patients experienced angina one year after myocardial infarction. It concludes that factors including depression and smoking are associated with angina.

Background: Weight loss is recommended among overweight survivors of myocardial infarction (MI). This study describes patterns of weight change among overweight patients with MI and identifies factors associated with weight change. Methods: A prospective cohort of 1253 overweight or heavier (body mass index [BMI] ≥25 kg/m2) post-MI patients were enrolled in the 19-center PREMIER study and followed up for 1 year to determine changes in weight. Patients were categorized at 1 month as overweight (BMI = 25-29.9 kg/m2), obese (BMI = 30-39.9 kg/m2), or morbidly obese (BMI ≥40 kg/m2). Unadjusted percent weight change was assessed at 1 year, and multivariable linear regression was used to identify independent correlates of change. Results: Mean weight change was −0.2% and varied by the severity of baseline obesity (+0.4% for overweight patients, −0.5% for obese patients, and −3.7% for morbidly obese patients [P < .001]). Multivariable analyses revealed the following to be significantly associated with weight change: depression 1 month post-MI (+2.7%, P = .001), lack of health insurance (+2%, P = .01), smoking cessation 1 month post-MI (+2.7% vs current smokers, P < .001), morbid obesity (+4.7% vs overweight patients, P < .0001), and increasing age (−0.8% per decade, P = .001). An interaction between smoking cessation and weight class was detected in that overweight patients who quit had a mean increase of 5.3% (95% CI 3.1%-7.4%), whereas no significant change was observed among obese and morbidly obese patients who quit. Conclusions: Although post-MI patients had negligible weight loss over 1 year, several sociodemographic, clinical, and lifestyle characteristics were associated with weight change. New, targeted interventions will likely be needed to improve weight management after an MI. [Copyright &y& Elsevier]

The article presents a medical research study that examined self-reported financial barriers to medical care services or medication in patients with acute myocardial infarction. Data was achieved through the Prospective Registry Evaluating Myocardial Infarction: Event and Recovery study. The health status symptoms, overall health status function, and rehospitalization rates of the patients were measured. The authors found that financial barriers to health care services and medications are associated with worse recovery after acute myocardial function, as evidenced by more angina, a poorer quality of life, and a greater risk of rehospitalization.

Background: Diabetes mellitus (DM) is a common comorbidity among patients with acute coronary syndrome (ACS). The frequency with which physicians assess diabetic patients'' glycemic control during an ACS hospitalization is not known and may represent an opportunity for quality improvement. Methods: This study describes the proportion of diabetic patients who had an assessment of their glycemic control (HbA1c) at the time of an ACS hospitalization. Secondary analyses examined characteristics associated with HbA1c assessment and physicians'' responses to poor glycemic control. Results: Among 968 enrolled patients with ACS, 235 (24%) had DM. HbA1c values were known or obtained in 162 (69%) patients; 60% were poorly controlled (HbA1c >7). Older patients were less likely to have an HbA1c assessment (relative risk [RR] = 0.81 [95% CI 0.64-1.01] for patients 60-69 years and RR = 0.71 [95% CI 0.58-0.88] for those ≥70 years compared to patients <60 years, P = .004). Among patients without an HbA1c, only consultation by an endocrinologist was independently associated with obtaining a subsequent assessment (RR 1.60, 95% CI 1.33-1.92, P < .001). Among those with an elevated HbA1c, 42% with an HbA1c of 7 to 9 and 69% of those with HbA1c >9 had their diabetic regimen increased. Conclusions: Almost one third of diabetic patients with ACS do not have HbA1c assessment at discharge; particularly older patients and those not evaluated by an endocrinologist. Although >60% of those assessed had poor control, many did not have adjustments of their diabetic therapy. Assessment of diabetes represents an opportunity to improve the quality of care for diabetic patients with ACS. [Copyright &y& Elsevier]

The article focuses on a study which examined the influence of β2-adrenergic receptor genotype on the survival rate of patients prescribed with the drug following an acute coronary syndrome. The methodology of the study is described. The clinical implications of the study findings are also discussed.

Background: Diabetes is an important predictor of mortality patients with ACS. However, little is known about the association between diabetes and health status after ACS. The objective of this study was to examine the association between diabetes and patients' health status outcomes one year after an acute coronary syndrome (ACS). Methods: This was a prospective cohort study of patients hospitalized with ACS. Patients were evaluated at baseline and one year with the Seattle Angina Questionnaire (SAQ). Sociodemographic and clinical characteristics were ascertained during index ACS hospitalization. One year SAQ Angina Frequency, Physical Limitation, and Health-Related Quality of Life (HRQoL) scales were the primary outcomes of the study. Results: Of 1199 patients, 326 (37%) had diabetes. Patients with diabetes were more likely to present with unstable angina (52% vs. 40%; p < 0.001), less likely to present with STEMI (20% vs. 31%; p < 0.001), and less likely to undergo coronary angiography (68% vs. 82%; p < 0.001). In multivariable analyses, the presence of diabetes was associated with significantly more angina (OR 1.36; 95% CI 1.01-1.38), cardiac-related physical limitation (OR 1.94; 95% CI 1.57-3.24) and HRQoL deficits (OR 1.43; 95% CI 1.01-2.04) at one year. Conclusion: Diabetes is associated with more angina, worse physical limitation, and worse HRQoL one year after an ACS. Future studies should assess whether health status outcomes of patients with diabetes could be improved through more aggressive ACS treatment or postdischarge surveillance and angina management. [ABSTRACT FROM AUTHOR]

Background: Responsiveness, or sensitivity to clinical change, is an important consideration in selection of a health-related quality of life (HRQL) measure for trials or clinical applications. Many approaches can be used to assess responsiveness, which may affect the interpretation of study results. We compared the relative responsiveness of generic and heart failure specific HRQL instruments, as measured both by common psychometric indices and by external clinical criteria. Methods: We analyzed data collected at baseline and 6-weeks in 298 subjects with heart failure on the following HRQL measures: EQ-5D (US, UK, and VAS Scoring), Kansas City Cardiomyopathy Questionnaire (KCCQ) (Clinical and Overall Summary Score), and RAND12 (Physical and Mental Component Summaries). Three external indicators of clinical change were used to classify subjects as improved, deteriorated, or unchanged: 6-minute walk test, New York Heart Association (NYHA) class, and physician global rating of change. Four responsiveness statistics (T-test, effect size, Guyatt's responsiveness statistic, and standardized response mean) were used to evaluate the responsiveness of the select measures. The median rank of each HRQL measure across responsiveness indices and clinical criteria was then determined. Results: Average age of subjects was 60 years, 75 percent were male, and had moderate to severe heart failure symptoms. Overall, the KCCQ Summary Scores had the highest relative ranking, irrespective of the responsiveness index or external criterion used. Importantly, we observed that the relative ranking of responsiveness of the generic measures (i.e. EQ-5D, RAND12) was influenced by both the responsive indices and external criterion used. Conclusion: The disease specific KCCQ was the most responsive HRQL measure assessing change over a 6-week period, although generic measures provide information for which the KCCQ is not suitable. The responsiveness of generic HRQL measures may be affected by the index used, as well as the external criterion to classify patients who have clinically change or remained stable. [ABSTRACT FROM AUTHOR]

: BackgroundPreoperative severity of illness in patients undergoing coronary artery bypass grafting (CABG) surgery is a major determinant of clinical postoperative outcomes and surgical length of stay (SLOS). Preoperative patient reported health status and social risk have not been quantified as predictors of SLOS post-CABG. Our hypothesis was that poorer self-reported health and greater social risk, as measured by standardized instruments, are significantly associated with extended SLOS defined as greater than or equal to 7 days.: MethodsIn the pilot phase of the Washington State Clinical Outcomes Assessment Program (COAP) patients in a case series between 1995 and 1996 at all hospitals with a cardiac surgery program were administered preoperative SF-36 and Seattle Angina Questionnaires (SAQ) in addition to the collection of prospective clinical data with Society of Thoracic Surgeons'' compatible definitions (n = 1073). Factors found significant from bivariate analysis were incorporated into a logistic regression model to assess relative association with extended SLOS (≥ 7 days).: ResultsThe final model included the following elements in descending order of significance: site, SF-36 health perceptions (HP) scale, social risk factors, age, intraaortic balloon pump, congestive heart failure, comorbidity score more than 2, preoperative days more than 2, emergency operation, prior CABG, and gender.: ConclusionsThe HP subscore of the SF-36 and the composite social risk factors score were significantly associated with extended SLOS after controlling for other standard clinical variables. “Hospital site” remained the factor with the greatest variance independent of patient severity of illness. [Copyright &y& Elsevier]

Background: The objective of this study was to demonstrate the use of the Heckman two-step method to assess and correct for bias due to missing health related quality of life (HRQL) surveys in a clinical study of acute coronary syndrome (ACS) patients. Methods: We analyzed data from 2,733 veterans with a confirmed diagnosis of acute coronary syndromes (ACS), including either acute myocardial infarction or unstable angina. HRQL outcomes were assessed by the Short-Form 36 (SF-36) health status survey which was mailed to all patients who were alive 7 months following ACS discharge. We created multivariable models of 7-month post-ACS physical and mental health status using data only from the 1,660 survey respondents. Then, using the Heckman method, we modeled survey non-response and incorporated this into our initial models to assess and correct for potential bias. We used logistic and ordinary least squares regression to estimate the multivariable selection models. Results: We found that our model of 7-month mental health status was biased due to survey nonresponse, while the model for physical health status was not. A history of alcohol or substance abuse was no longer significantly associated with mental health status after controlling for bias due to non-response. Furthermore, the magnitude of the parameter estimates for several of the other predictor variables in the MCS model changed after accounting for bias due to survey nonresponse. Conclusion: Recognition and correction of bias due to survey non-response changed the factors that we concluded were associated with HRQL seven months following hospital admission for ACS as well as the magnitude of some associations. We conclude that the Heckman two-step method may be a valuable tool in the assessment and correction of selection bias in clinical studies of HRQL. [ABSTRACT FROM AUTHOR]

Background: Previous investigations suggest an important role of social support in the outcomes of patients treated for ischemic heart disease. The ENRICHD Social Support Instrument (ESSI) is a 7-item self-report survey that assesses social support. Validity and reliability of the ESSI, however, has not been formally tested in patients undergoing percutaneous coronary intervention (PCI). Methods: The ESSI, along with the Short Form-36 (SF-36), was sequentially administered to a cohort of 271 patients undergoing PCI. The test-retest reliability was examined with an intra-class correlation coefficient by comparing scores among 174 patients who completed both instruments 5 and 6 months after their procedure. Internal reliability was assessed using Cronbach's alpha at the time of patients' baseline procedure. The concurrent validity of the ESSI was assessed by comparing scores between depressed (MHI-5 score < 44) vs. non-depressed patients. The correlation between the ESSI and the SF-36 Social Functioning sub-scale, an accepted measure of social functioning, was also examined. Results: Test-retest reliability showed no significant differences in mean scores among ESSI questionnaires administered 1 month apart (27.8+/-1.4 vs 27.8+/-1.5, p = 0.98). The intra-class correlation coefficient was 0.94 and Cronbach's alpha was 0.88. Mean ESSI scores were significantly lower among depressed vs. non-depressed patients (24.6+/-1.7 vs 27+/-1.4, p < 0.018) and a positive albeit modest correlation with social functioning was seen (r = 0.19, p = 0.002). Conclusion: The ESSI appears to be a valid and reliable measure of social support in patients undergoing treatment for coronary artery disease. It may prove to be a valuable method of controlling for patient variability in outcomes studies where the outcomes are related to patients' social support. [ABSTRACT FROM AUTHOR]

Background: Understanding minimum clinically important differences (MCID) in patient-reported outcomes is essential in interpreting the magnitude of changes in these measures. No MCID from patients' perspectives has ever been published for peripheral artery disease-specific health status assessment tools. The Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral artery disease-specific health status instrument for which we sought to prospectively establish its MCID from patients' perspectives.Methods and Results: Patients presenting to vascular clinics with new or worsened claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry who completed baseline and follow-up PAQ assessments along with the Global Assessment of Functioning scale were included. Mean change in PAQ summary scores from 3- to 6-month follow-up was calculated according to Global Assessment of Functioning category. MCID was defined as the mean difference in scores between those with small improvement or deterioration and those with no change. Multivariable linear regression was used to provide an MCID estimate after adjusting for patients' 3-month PAQ score. Of the 483 patients who completed the Global Assessment of Functioning score at 6 months and who had available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were female, and 71% were White. The MCIDs for PAQ summary scale improvement and worsening were 8.7 (2.9-14.5) and -11.0 (-18.6 to -3.3), respectively. After multivariable adjustment, these were 8.9 (3.0-14.8) and -11.2 (-18.2 to -4.2), respectively. There was no significant interaction between treatment (invasive versus noninvasive) and Global Assessment of Functioning response (P=0.75).Conclusions: In patients with new or worsened claudication, a 10-point change in PAQ summary score represents an MCID. This estimate needs external validation and may inform the interpretation of PAQ scores when used as outcomes in clinical trials or in routine clinical care. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080. [ABSTRACT FROM AUTHOR]

Examines the relationship between variables that predict mortality and the use of angiography and revascularization after acute myocardial infarction among cardiac patients. Clinical factors which predict higher mortality; Preference for bypass surgery for patients at high risk of mortality; Influence of prognosis on the use of angioplasty and bypass surgery.

Supplemental Digital Content is available in the text. [ABSTRACT FROM AUTHOR]

Background: While smoking is a major modifiable risk factor for secondary prevention of myocardial infarction (MI), active smoking is common among patients hospitalized with acute MI. Recent studies suggest that nicotinic receptor variants, and specifically the high-risk CHRNA5 rs16969968 A allele, are associated with cessation failure among noncardiac patients. This study investigates the association between CHRNA5 rs16969968 and smoking cessation in patients hospitalized with acute MI. Methods: Using data from the TRIUMPH study, we ascertained smoking status at the time of index hospitalization for acute MI and 1 year after hospitalization. After adjusting for age and sex, we used logistic regression to model the association between smoking cessation and CHRNA5 rs16969968. Results: At index admission, 752 (Caucasian) subjects were active smokers and 699 were former smokers. Among these ever smokers, the A allele was associated with significantly decreased abstinence (45.0% abstinence for A allele carriers vs. 51.7% for GG homozygotes; OR = 0.70, 95% CI = 0.56–0.88, p = .0027). The A allele was also significantly associated with decreased abstinence at 1 year (69.1% abstinence for A allele carriers vs. 76.0% for GG homozygotes; OR = 0.70, 95% CI = 0.53–0.94, p = .0185). Conclusions: Among patients who have smoked and who are hospitalized with acute MI, the high-risk CHRNA5 allele was associated with lower likelihood of quitting before hospitalization and significantly less abstinence 1 year after hospitalization with MI. CHRNA5 rs16969968 genotype may therefore identify patients who would benefit from aggressive, personalized smoking cessation intervention. [ABSTRACT FROM PUBLISHER]

Background: Implementation of medical emergency teams has been identified as a potential strategy to reduce hospital deaths, because these teams respond to patients with acute physiological decline in an effort to prevent in-hospital cardiac arrest. However, prior studies of the association between medical emergency teams and hospital mortality have been limited and typically have not accounted for preimplementation mortality trends.Methods: Within the Pediatric Health Information System for freestanding pediatric hospitals, annual risk-adjusted mortality rates were calculated for sites between 2000 and 2015. A random slopes interrupted time series analysis then examined whether implementation of a medical emergency team was associated with lower-than-expected mortality rates based on preimplementation trends.Results: Across 38 pediatric hospitals, mean annual hospital admission volume was 15 854 (range, 6684-33 024), and there were a total of 1 659 059 hospitalizations preimplementation and 4 392 392 hospitalizations postimplementation. Before medical emergency team implementation, hospital mortality decreased by 6.0% annually (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.92-0.96) across all hospitals. After medical emergency team implementation, hospital mortality continued to decrease by 6% annually (OR, 0.94; 95% CI, 0.93-0.95), with no deepening of the mortality slope (ie, not lower OR) in comparison with the preimplementation trend, for the overall cohort (P=0.98) or when analyzed separately within each of the 38 study hospitals. Five years after medical emergency team implementation across study sites, there was no difference between predicted (hospital mean of 6.18 deaths per 1000 admissions based on preimplementation trends) and actual mortality rates (hospital mean of 6.48 deaths per 1000 admissions; P=0.57).Conclusions: Implementation of medical emergency teams in a large sample of pediatric hospitals in the United States was not associated with a reduction in hospital mortality beyond existing preimplementation trends. [ABSTRACT FROM AUTHOR]

Background: Hyperkalemia is common and potentially dangerous in hospitalized patients; its contemporary prevalence and prognostic importance after acute myocardial infarction are not well described.Methods: In 38,689 consecutive patients with acute myocardial infarction from the Cerner Health Facts database, we evaluated the association between maximum in-hospital potassium levels and in-hospital mortality. Patients were stratified by dialysis status and grouped by maximum potassium as follows: <5 mEq/L, 5 to <5.5 mEq/L, 5.5 to <6.0 mEq/L, 6.0 to <6.5 mEq/L, and ≥6.5 mEq/L. Multivariable logistic regression was used to adjust for multiple patient and site characteristics. The relationship between the number of hyperkalemic values and the in-hospital mortality was evaluated.Results: Of 38,689 patients with acute myocardial infarction, 886 were on dialysis. The rate of hyperkalemia (maximum potassium ≥5.0 mEq/L) was 22.6% in patients on dialysis and 66.8% in patients not on dialysis. Moderate to severe hyperkalemia (maximum potassium ≥5.5 mEq/L) occurred in 9.8% of patients. There was a steep increase in mortality with higher maximum potassium levels. In-hospital mortality exceeded 15% once maximum potassium was ≥5.5 mEq/L regardless of dialysis status. The relationship between higher maximum potassium and increased mortality risk persisted after multivariable adjustment. In addition, patients with a greater number of hyperkalemic values (vs a single value) experienced higher in-hospital mortality.Conclusions: Hyperkalemia is common in patients who are hospitalized with acute myocardial infarction. Higher maximum potassium levels and number of hyperkalemic events are associated with a steep mortality increase, with higher risks for adverse outcomes observed even at mild levels of hyperkalemia. Whether more intensive management of hyperkalemia may improve outcomes in patients with acute myocardial infarction merits further study. [ABSTRACT FROM AUTHOR]