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Objective: Medicare Advantage (MA), Medicare's managed care program, is quickly expanding, yet little is known about diabetes care quality delivered under MA compared with traditional fee-for-service (FFS) Medicare.Research Design and Methods: This was a retrospective cohort study of Medicare beneficiaries ≥65 years old enrolled in the Diabetes Collaborative Registry from 2014 to 2019 with type 2 diabetes treated with one or more antihyperglycemic therapies. Quality measures, cardiometabolic risk factor control, and antihyperglycemic prescription patterns were compared between Medicare plan groups, adjusted for sociodemographic and clinical factors.Results: Among 345,911 Medicare beneficiaries, 229,598 (66%) were enrolled in FFS and 116,313 (34%) in MA plans (for ≥1 month). MA beneficiaries were more likely to receive ACE inhibitors/angiotensin receptor blockers for coronary artery disease, tobacco cessation counseling, and screening for retinopathy, foot care, and kidney disease (adjusted P ≤ 0.001 for all). MA beneficiaries had modestly but significantly higher systolic blood pressure (+0.2 mmHg), LDL cholesterol (+2.6 mg/dL), and HbA1c (+0.1%) (adjusted P < 0.01 for all). MA beneficiaries were independently less likely to receive glucagon-like peptide 1 receptor agonists (6.9% vs. 9.0%; adjusted odds ratio 0.80, 95% CI 0.77-0.84) and sodium-glucose cotransporter 2 inhibitors (5.4% vs. 6.7%; adjusted odds ratio 0.91, 95% CI 0.87-0.95). When integrating Centers for Medicare and Medicaid Services-linked data from 2014 to 2017 and more recent unlinked data from the Diabetes Collaborative Registry through 2019 (total N = 411,465), these therapeutic differences persisted, including among subgroups with established cardiovascular and kidney disease.Conclusions: While MA plans enable greater access to preventive care, this may not translate to improved intermediate health outcomes. MA beneficiaries are also less likely to receive newer antihyperglycemic therapies with proven outcome benefits in high-risk individuals. Long-term health outcomes under various Medicare plans requires surveillance. [ABSTRACT FROM AUTHOR]

Background: Health status outcomes are increasingly being promoted as measures of health care quality, given their importance to patients. In heart failure (HF), an American College of Cardiology/American Heart Association Task Force proposed using the proportion of patients with preserved health status as a quality measure but not as a performance measure because risk adjustment methods were not available.Methods: We built risk adjustment models for alive with preserved health status and for preserved health status alone in a prospective registry of outpatients with HF with reduced ejection fraction across 146 US centers between December 2015 and October 2017. Preserved health status was defined as not having a ≥5-point decrease in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 1 year. Using only patient-level characteristics, hierarchical multivariable logistic regression models were developed for 1-year outcomes and validated using data from 1 to 2 years. We examined model calibration, discrimination, and variability in sites' unadjusted and adjusted rates.Results: Among 3932 participants (median age [interquartile range] 68 years [59-75], 29.7% female, 75.4% White), 2703 (68.7%) were alive with preserved health status, 902 (22.9%) were alive without preserved health status, and 327 (8.3%) had died by 1 year. The final risk adjustment model for alive with preserved health status included baseline Kansas City Cardiomyopathy Questionnaire Overall Summary, age, race, employment status, annual income, body mass index, depression, atrial fibrillation, renal function, number of hospitalizations in the past 1 year, and duration of HF (optimism-corrected C statistic=0.62 with excellent calibration). Similar results were observed when deaths were ignored. The risk standardized proportion of patients alive with preserved health status across the 146 sites ranged from 62% at the 10th percentile to 75% at the 90th percentile. Variability across sites was modest and changed minimally with risk adjustment.Conclusions: Through leveraging data from a large, outpatient, observational registry, we identified key factors to risk adjust sites' proportions of patients with preserved health status. These data lay the foundation for building quality measures that quantify treatment outcomes from patients' perspectives. [ABSTRACT FROM AUTHOR]

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: Missing health-related quality of life (HRQOL) data in longitudinal studies can reduce precision and power and bias results. Using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), we sought to identify factors associated with missing HRQOL data, examine the impact of these factors on estimated HRQOL assuming missing at random missingness, and perform sensitivity analyses to examine missing not at random (MNAR) missingness because of illness severity.Methods and Results: INTERMACS patients (n=3248) with a preimplantation profile of 1 (critical cardiogenic shock) or 2 (progressive decline) were assessed with the EQ-5D-3L visual analog scale and Kansas City Cardiomyopathy Questionnaire-12 summary scores pre-implantation and 3 months postoperatively. Mean and median observed and missing at random-imputed HRQOL scores were calculated, followed by sensitivity analyses. Independent factors associated with HRQOL scores and missing HRQOL assessments were determined using multivariable regression. Independent factors associated with preimplantation and 3-month HRQOL scores, and with the likelihood of missing HRQOL assessments, revealed few correlates of HRQOL and missing assessments (R2 range, 4.7%-11.9%). For patients with INTERMACS profiles 1 and 2 and INTERMACS profile 1 alone, missing at random-imputed mean and median HRQOL scores were similar to observed scores, before and 3 months after implantation, whereas MNAR-imputed mean scores were lower (≥5 points) at baseline but not at 3 months.Conclusions: We recommend use of sensitivity analyses using an MNAR imputation strategy for longitudinal studies when missingness is attributable to illness severity. Conduct of MNAR sensitivity analyses may be less critical after mechanical circulatory support implant, when there are likely fewer MNAR data. [ABSTRACT FROM AUTHOR]

Background: Previous studies suggest that among patients with stable coronary artery disease, patients with diabetes mellitus (DM) have less angina and more silent ischemia when compared with those without DM. However, the burden of angina in diabetic versus nondiabetic patients after elective percutaneous coronary intervention (PCI) has not been recently examined.Methods and Results: In a 10-site US PCI registry, we assessed angina before and at 1, 6, and 12 months after elective PCI with the Seattle Angina Questionnaire angina frequency score (range, 0-100, higher=better). We also examined the rates of antianginal medication prescriptions at discharge. A multivariable, repeated-measures Poisson model was used to examine the independent association of DM with angina over the year after treatment. Among 1080 elective PCI patients (mean age, 65 years; 74.7% men), 34.0% had DM. At baseline and at each follow-up, patients with DM had similar angina prevalence and severity as those without DM. Patients with DM were more commonly prescribed calcium channel blockers and long-acting nitrates at discharge (DM versus not: 27.9% versus 20.9% [P=0.01] and 32.8% versus 25.5% [P=0.01], respectively), whereas β-blockers and ranolazine were prescribed at similar rates. In the multivariable, repeated-measures model, the risk of angina was similar over the year after PCI in patients with versus without DM (relative risk, 1.04; range, 0.80-1.36).Conclusions: Patients with stable coronary artery disease and DM exhibit a burden of angina that is at least as high as those without DM despite more antianginal prescriptions at discharge. These findings contradict the conventional teachings that patients with DM experience less angina because of silent ischemia. [ABSTRACT FROM AUTHOR]

Background: Rehospitalizations after acute myocardial infarction for unplanned coronary revascularization and unstable angina (UA) are common. However, despite the inclusion of these events in composite end points of many clinical trials, their association with health status has not been studied.Methods and Results: We included 3283 patients with acute myocardial infarction enrolled in a prospective, 24-center US study who had rehospitalizations independently classified by experienced cardiologists. Health status was assessed using Seattle Angina Questionnaire and EuroQol-5D Visual Analog Scale. In the propensity-matched cohorts, 1-year health status was compared between those who did and did not experience rehospitalization for UA or revascularization using a hierarchical linear model. Overall, mean age was 59 years, 33% were women, and 70% were white. Rehospitalization rates for UA and unplanned revascularization at 1 year were 4.3% and 4.7%. One-year Seattle Angina Questionnaire summary scores were worse in patients with rehospitalizations for UA (mean difference, -10.1; 95% confidence interval, -12.4 to -7.9) and unplanned revascularization (mean difference, -5.7; 95% confidence interval, -8.8 to -2.5) when compared with patients without such rehospitalizations. Similarly, EuroQol-5D Visual Analog Scale scores were worse among patients with such readmissions. Individual Seattle Angina Questionnaire domains indicated worse 1-year angina and quality of life outcomes among patients rehospitalized for UA or unplanned revascularization.Conclusions: Within the first year after acute myocardial infarction, rehospitalizations for UA and unplanned revascularization are associated with worse health status. These findings highlight the impact of such events from a patient's perspective, beyond their economic impact and support the use of UA and unplanned revascularization as elements of composite end points. [ABSTRACT FROM AUTHOR]

Background: Under-recognition of angina by physicians may result in undertreatment with revascularization or medications that could improve patients' quality of life. We sought to describe characteristics associated with under-recognition of patients' angina.Methods and Results: Patients with coronary disease from 25 US cardiology outpatient practices completed the Seattle Angina Questionnaire before their clinic visit, quantifying their frequency of angina during the previous month. Immediately after the clinic visit, physicians independently quantified their patients' angina. Angina frequency was categorized as none, monthly, and daily/weekly. Among 1257 patients, 411 reported angina in the previous month, of whom 173 (42%) were under-recognized by their physician, defined as the physician reporting a lower frequency category of angina than the patient. In a hierarchical logistic model, heart failure (odds ratio, 3.06, 95% confidence interval, 1.89-4.95) and less-frequent angina (odds ratio for monthly angina [versus daily/weekly], 1.69; 95% confidence interval, 1.12-2.56) were associated with greater odds of under-recognition. No other patient or physician factors were associated with under-recognition. Significant variability across physicians (median odds ratio, 2.06) was observed.Conclusions: Under-recognition of angina is common in routine clinical practice. Although patients with less-frequent angina and those with heart failure more often had their angina under-recognized, most variation was unrelated to patient and physician characteristics. The large variation across physicians suggests that some physicians are more accurate in assessing angina frequency than others. Standardized prospective use of a validated clinical tool, such as the Seattle Angina Questionnaire, should be tested as a means to improve recognition of angina and, potentially, improve appropriate treatment of angina. [ABSTRACT FROM AUTHOR]

Background: Although patients with diabetes mellitus experience high rates of adverse events after acute myocardial infarction (AMI), including death and recurrent ischemia, some diabetic patients are likely at low risk, whereas others are at high risk. We sought to develop prediction models to stratify risk after AMI in patients with diabetes mellitus.Methods and Results: We developed prediction models for long-term mortality and angina among 1613 patients with diabetes mellitus discharged alive after AMI from 24 US hospitals and then validated the models in a separate, multicenter registry of 786 patients with diabetes mellitus. Event rates in the derivation cohort were 27% for 5-year mortality and 27% for 1-year angina. Parsimonious prediction models demonstrated good discrimination (c-indices=0.78 and 0.69, respectively) and excellent calibration. Within the context of the predictors we estimated, the strongest predictors for mortality were higher creatinine, not working at the time of the AMI, older age, lower hemoglobin, left ventricular dysfunction, and chronic heart failure. The strongest predictors for angina were angina burden in the 4 weeks before the AMI, younger age, history of prior coronary bypass graft surgery, and non-white race. The lowest and highest deciles of predicted risk ranged from 4% to 80% for mortality and 12% to 59% for angina. The models also performed well in external validation (c-indices=0.78 and 0.73, respectively).Conclusions: We found a wide range of risk for adverse outcomes after AMI in diabetic patients. Predictive models can identify patients with diabetes mellitus for whom closer follow-up and aggressive secondary prevention strategies should be considered. [ABSTRACT FROM AUTHOR]

Background: Although rapid response teams have been widely promoted as a strategy to reduce unexpected hospital deaths, most studies of rapid response teams have not adjusted for secular trends in mortality before their implementation. We examined whether implementation of a rapid response team was associated with a reduction in hospital mortality after accounting for preimplementation mortality trends.Methods: Among 56 hospitals in Get With The Guidelines-Resuscitation linked to Medicare, we calculated the annual rates of case mix-adjusted mortality for each hospital during 2000 to 2014. We constructed a hierarchical log-binomial regression model of mortality over time (calendar-year), incorporating terms to capture the effect of rapid response teams, to determine whether implementation of rapid response teams was associated with reduction in hospital mortality that was larger than expected based on preimplementation trends, while adjusting for hospital case mix index.Results: The median annual number of Medicare admissions was 5214 (range, 408-18 398). The median duration of preimplementation and postimplementation period was 7.6 years (≈2.5 million admissions) and 7.2 years (≈2.6 million admissions), respectively. Hospital mortality was decreasing by 2.7% annually during the preimplementation period. Implementation of rapid response teams was not associated with a change in mortality during the initial year (relative risk for model intercept, 0.98 [95% CI, 0.94-1.02]; P=0.30) or in the mortality trend (relative risk for model slope, 1.01 per year [95% CI, 0.99-1.02]; P=0.30). Among individual hospitals, implementation of a rapid response team was associated with a lower-than-expected mortality at only 4 (7.1%) and higher-than-expected mortality at 2 (3.7%) hospitals.Conclusions: Among a large and diverse sample of US hospitals, we did not find implementation of rapid response teams to be associated with reduction in hospital mortality. Studies are needed to understand best practices for rapid response team implementation, to ensure that hospital investment in these teams improves patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Despite calls to expand measurement of acute myocardial infarction (AMI) outcomes to include symptom burden, little has been done to describe hospital-level variation in this patient-centered outcome, or its association with mortality. Understanding the relationship between symptoms and longer-term mortality could inform the importance of these outcomes for monitoring quality of care.Methods and Results: Among 4316 patients with AMI treated at 24 hospitals participating in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) study, we assessed risk-standardized 1-year symptom burden as measured by the Seattle Angina Questionnaire Angina Frequency Score and mortality attributed to the hospital that provided AMI care. Median odds ratios were used to assess outcome variation and reflect the relative odds of an outcome for 2 patients with identical covariates at different, randomly selected, hospitals. We then evaluated the correlation between hospital-level mortality and angina. Finally, we determined the extent to which variation in mortality and angina was explained by achievement of AMI performance measures. We observed hospital variation in risk-adjusted 1-year mortality (range, 4.9%-8.6%; median odds ratio, 1.30; P=0.01) and angina (range, 17.7%-29.4%; median odds ratio, 1.34; P<0.001). At the hospital level, mortality and angina at 1 year were weakly correlated (r=0.40; 95% confidence interval, 0.00-0.68; P=0.05). Accounting for the quality of AMI care did not attenuate variation in risk-adjusted 1-year mortality or angina.Conclusions: Symptom burden and mortality vary at the hospital level after AMI and are only weakly correlated. These findings suggest that symptom burden should be considered a separate quality domain that is not well captured by current quality metrics. [ABSTRACT FROM AUTHOR]

The article presents a study which examined (AMI) patients in the first 48 hours admitted to U.S. hospitals from 2000 to 2008, to identify glucose variability (GV) metrics that are most predictive of in-hospital mortality and examine whether GV provides additional prognostic information above and beyond mean blood glucose (BG). Mean BG remains an independent predictor of in-hospital death, even in models adjusting for GV and multiple patient characteristics.

The article discusses a study on the relationship between levels of serum potassium and in-hospital mortality in patients with acute myocardial infarction (AMI) in the era of widespread use of β-blocker and reperfusion therapy. The study used information on 38,689 patients with AMI included in the Health Facts database of Cerner Corp. in the U.S. The occurrence of ventricular fibrillation, ventricular flutter or cardiac arrest in 1707 patients during hospitalization is discussed. AMI patients with postadmission serum potassium levels between 3.5 and less than 4.5 milliequivalents per liter (mEq/L) were found to have the lowest mortality.

The article focuses on a study which evaluated the association between automated external defibrillators (AEDs) use and survival for in-hospital cardiac arrest. The researchers examined 11,695 hospitalized patients who experienced cardiac arrests between January 1, 2000 to August 26, 2008 at U.S. hospitals following the introduction of AEDs on general and hospital wards. Study results indicated that hospitalized patients with cardiac arrest and use of AED were not associated with improved survival.

Background: Prior studies have associated low social support (SS) with increased rehospitalization and mortality after acute myocardial infarction. However, relatively little is known about whether similar patterns exist for other outcomes, such as health status and depressive symptoms, and whether these patterns vary by sex.Methods and Results: Using data from 2411 English- or Spanish-speaking patients with acute myocardial infarction enrolled in a 19-center prospective study, we examined the association of SS (low, moderate, high) with health status (angina, disease-specific quality of life, general physical and mental functioning) and depressive symptoms over the first year of recovery. Overall and sex-stratified associations were evaluated using mixed-effects Poisson and linear regression, adjusting for site, baseline health status, baseline depressive symptoms, and demographic and clinical factors. Patients with the lowest SS (relative to those with the highest) had increased risk of angina (relative risk, 1.27; 95% confidence interval [CI], 1.10, 1.48); lower disease-specific quality of life (mean difference [beta]=-3.33; 95% CI, -5.25, -1.41), lower mental functioning (beta=-1.72; 95% CI, -2.65, -0.79), and more depressive symptoms (beta=0.94; 95% CI, 0.51, 1.38). A nonsignificant trend toward lower physical functioning (beta=-0.87; 95% CI, -1.95, 0.20) was observed. In sex-stratified analyses, the relationship between SS and outcomes was stronger for women than for men, with a significant SS-by-sex interaction for disease-specific quality of life, physical functioning, and depressive symptoms (all P<0.02).Conclusions: Lower SS is associated with worse health status and more depressive symptoms over the first year of acute myocardial infarction recovery, particularly for women. [ABSTRACT FROM AUTHOR]

The article presents a study which examines the glucose normalization among patients with acute myocardial infarction in the U.S. It states that high blood glucose levels on hospital admission have connection with increased mortality in patients with acute myocardial infarction. It concludes that glucose normalization after hospital admission is associated with better survival in hyperglycemic patients with acute myocardial infarction whether or not they receive insulin therapy. It highlights the need for effective strategy on intentional glucose lowering with insulin therapy.

Background: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown.Methods: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients' baseline health status accounted for variability in outcomes, the proportion of variability (R2) explained by sequentially adding these variables to the model was quantified.Results: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients' baseline KCCQ-OS score (R2=25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume.Conclusions: There is moderate variation across sites in their patients' achievement of health status benefits from TMVr, with patient's baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr. [ABSTRACT FROM AUTHOR]

The article discusses a prospective cohort study that examines whether providing doctors with patients' pre-procedural risk of bleeding improve the use of bleeding avoidance strategies. Study highlights include the number of U.S. centres that participated in the study, bias, confounding, and other reasons for caution, and generalisability to other populations.

We used data from 1,344 patients enrolled in the Prospective Registry Evaluating Myocardial Infarction: Events and Recovery study to examine the adoption of drug-eluting stents (DESs) and the effect of the release of the Food and Drug Administration’s preliminary public health notification, which raised concerns about DES safety. Overall, there was a dramatic increase in the use of DESs over the study period, from 32% in April 2003 to 81% in March 2004. The notification issued on October 29, 2003 was associated with a 26% relative decrease in DES use. By January 2004, DES use had returned to the prenotification rate and continued to increase thereafter. In conclusion, the Food and Drug Administration’s notification had a modest but temporary effect on clinical practice. [Copyright &y& Elsevier]

Objectives: The objective of this study was to compare the consistency in appropriate use criteria (AUC) ratings among a broad range of practicing cardiologists and the AUC Technical Panel. Background: AUC for coronary revascularization have been developed by selected experts. Methods: Before AUC publication, 85 cardiologists from 10 U.S. institutions assessed the appropriateness of coronary revascularization for 68 indications that had been evaluated by the AUC Technical Panel. Each indication was classified as appropriate, uncertain, or inappropriate, based on the physician group''s median rating. Rates of concordance between the physician group and the AUC Technical Panel (i.e., same appropriateness category assignment) and rates of nonagreement within the physician group (≥25% of panelists'' ratings outside the group''s appropriateness category assessment) were determined. Results: Overall concordance between the 2 groups was 84%. Among indications classified as appropriate by the AUC Technical Panel, concordance between the 2 groups was excellent (94% [34 of 36]); however, nonagreement within the physician group was 44% (16 of 36). Among indications classified as uncertain, there was 73% (16 of 22) concordance between the 2 groups. Among inappropriate indications, concordance was moderate (70% [7 of 10]), but nonagreement occurred frequently (70% [7 of 10]). Moreover, there was substantial variation in appropriateness ratings between individual physicians and the AUC Technical Panel (weighted kappa range: 0.05 to 0.76). Conclusions: Although there was good concordance in assessments of appropriateness for coronary revascularization between physicians and the AUC Technical Panel, nonagreement within the physician group was common and there was marked variation in ratings between individual physicians and the AUC Technical Panel. [Copyright &y& Elsevier]

Background: Caregivers of patients with advanced heart failure may experience burden in providing care, but whether changes in patient health status are associated with caregiver burden is unknown., Methods: This observational study included older patients (60-80 years old) receiving advanced surgical heart failure therapies and their caregivers at 13 US sites. Patient health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (range, 0-100; higher scores are better). Caregiver burden was assessed using the Oberst Caregiving Burden Scale, which measures time on task (OCBS-time) and task difficulty (OCBS-difficulty; range, 1-5; lower scores are better). Measurements occurred before surgery and 12 months after in 3 advanced heart failure cohorts: patients receiving long-term left ventricular assist device support; heart transplantation with pretransplant left ventricular assist device support; and heart transplantation without pretransplant left ventricular assist device support. Multivariable linear regression was used to identify predictors of change in OCBS-time and OCBS-difficulty at 12 months., Results: Of 162 caregivers, the mean age was 61.0±9.4 years, 139 (86%) were female, and 140 (86%) were the patient's spouse. At 12 months, 99 (61.1%) caregivers experienced improved OCBS-time, and 61 (37.7%) experienced improved OCBS-difficulty (versus no change or worse OCBS). A 10-point higher baseline 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (β=-0.09 [95% CI, -0.14 to -0.03]; P <0.001) and OCBS-difficulty (β=-0.08 [95% CI, -0.12 to -0.05]; P <0.001). Each 10-point improvement in the 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (β=-0.07 [95% CI, -0.12 to -0.03]; P =0.002) and OCBS-difficulty (β=-0.09 [95% CI, -0.12 to -0.06]; P <0.001)., Conclusions: Among survivors at 12 months, baseline and change in patient health status were associated with subsequent caregiver time on task and task difficulty in dyads receiving advanced heart failure surgical therapies, highlighting the potential for serial 12-item Kansas City Cardiomyopathy Questionnaire assessments to identify caregivers at risk of increased burden., Registration: URL: https://www.clinicaltrials.gov; unique identifier: NCT02568930., Competing Interests: Dr Grady is the principal investigator of grants from the National Heart, Lung, and Blood Institute; receives speaker fees from the American Heart Association; and served on the Board of Directors for the International Society for Heart and Lung Transplantation. Dr Spertus is the principal investigator of grants from Myokardia and Janssen; is a consultant to Myokardia, Bristol Meyers Squibb, Merck, Novartis, Pfizer, and Janssen; serves on the Scientific Advisory Board of United Healthcare and the Board of Directors for Blue Cross Blue Shield of Kansas City; and owns the copyright to the Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and Peripheral Artery Questionnaire. The other authors report no conflicts.

Background: Heart failure is a common and devastating complication of type 2 diabetes (T2D). Prompt recognition of heart failure may avert hospitalization, facilitate use of guideline-directed therapies, and impact choice of T2D medications. We sought to determine the rate and factors associated with heart failure documentation in T2D patients with evidence of volume overload requiring loop diuretics., Methods: DCR is an on-going, prospective US registry of outpatient T2D patients from > 5000 cardiology, endocrinology, and primary care clinicians (current analysis used data from 2013-2019). Among T2D patients receiving loop diuretics, we examined the rate of chart documentation of heart failure. We used a 3-level hierarchical logistic regression model (patients nested within physician within practice) to examine factors associated with heart failure diagnosis., Results: Among 1,322,640 adults with T2D, 225,125 (17.0%) were receiving a loop diuretic, of whom 91,969 (40.9%) had documentation of heart failure. Male sex, lower body mass index, atrial fibrillation, chronic kidney disease, and coronary artery disease were associated with greater odds of heart failure diagnosis. After accounting for patient factors, patients seen by cardiologists were the most likely to have HF documented followed by PCPs and then endocrinologists., Conclusions: Among US outpatients with T2D, 17% of patients had evidence of volume overload-defined by loop diuretic prescription-of whom fewer than half had a clinical diagnosis of heart failure. While there may be non-heart failure indications for loop diuretics, our data suggest that a substantial proportion of T2D patients may have unrecognized heart failure and therefore could be missing opportunities for targeted therapies that could alter the clinical course of heart failure.

Background: Many clinical investigations depend on participant self-report as a principal method of identifying health care events. If self-report is used as the trigger to collect and adjudicate medical records, any event that is not reported by the patient will be missed by the investigators, reducing the power of the study and misrepresenting the risk of its participants. We sought to determine the rates and predictors of underreporting hospitalization events during the follow-up period of a prospective study of patients hospitalized with an acute myocardial infarction., Methods and Results: The TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status) registry, a longitudinal multicenter cohort study of people with acute myocardial infarction in the United States, queried patients for hospitalization events during interviews at 1, 6, and 12 months. To validate these self-reports, medical records for all events at every hospital where the patient reported receiving care were acquired for adjudication, not just those for the reported events. Of the 4340 participants in TRIUMPH, 1209 (28%) reported at least one hospitalization. After medical records abstraction and adjudication, we identified 1086 hospitalizations from 639 participants (60.2±12 years of age, 38.2% women). Of these hospitalizations, 346 (31.9%) were underreported by the participants. Rates of underreporting ranged from 22.5% to 55.6% based on different patient characteristics. The odds of underreporting were highest for those not currently working (adjusted odds ratio, 1.66 [95% CI, 1.04-2.63]), lowest for those married (adjusted odds ratio, 0.50 [95% CI, 0.33-0.76]), and increased the longer the elapsed time between the admission and the patient's follow-up interview (adjusted odds ratio per month, 1.16 [95% CI, 1.08-1.24]). There was a substantial within-individual variation on the accuracy of reporting., Conclusions: Hospitalizations after acute myocardial infarction are commonly underreported in interviews and should not be used alone to determine event rates in clinical studies.

Background Effective management of cardiovascular risk factors is the foundation of secondary prevention in coronary artery disease. The physician under whose sphere these are managed can vary, primary care physicians, cardiologists, or both, and the optimal management strategy for risk factor control is unknown. Methods and Results The APPEAR (Angina Prevalence and Provider Evaluation of Angina Relief) study was a cross-sectional cohort study of outpatients with coronary artery disease (stable angina, percutaneous coronary intervention, coronary artery bypass grafting, or myocardial infarction) from 25 US cardiology practices. After each patient visit, providers noted who managed each risk factor. Blood pressure and lipid levels were recorded from charts. We compared adherence to guideline-directed risk factor control between management strategies (primary care physician alone, cardiologist alone, or comanaged). Among 1259 outpatients with coronary artery disease (mean [SD] age, 71 [11.1] years; 69% men), blood pressure and lipid management strategy varied. Mean blood pressure was 127.9/72.3 mm Hg, with 74% of patients at <140/90 mm Hg and 46% at <130/80 mm Hg. Mean low-density lipoprotein was 83.5 mg/dL, with 75% of patients at <100 mg/dL and 91% on appropriate statin therapy. Patients managed by cardiologists alone tended to have higher rates of risk factor control for both blood pressure and lipids, even after adjusting for covariates. Conclusions Although comanagement has shown benefit in some clinical situations, we found that risk factor control in patients with coronary artery disease tended to be poorer when care was shared between cardiologists and primary care physicians. Further research is needed to better define which conditions are best comanaged and how to more effectively comanage patients in the fractured US healthcare system.

The use of prasugrel and ticagrelor as part of dual antiplatelet therapy is increasing in patients after percutaneous coronary intervention (PCI). Accordingly, we aimed to evaluate their prescription patterns in the National Cardiovascular Data Registry (NCDR) Practice Innovation and Clinical Excellence (PINNACLE) registry. We analyzed patients enrolled in NCDR PINNACLE registry from January 2013 to March 2015 who underwent PCI with drug-eluting stent and were prescribed dual antiplatelet therapy. All patients received aspirin. The primary study outcome was a 3-level variable denoting the second antiplatelet agent prescribed: (1) clopidogrel, (2) prasugrel, or (3) ticagrelor. Baseline characteristics were compared among the 3 groups. Odds ratios and 95% credible intervals were calculated from a nested hierarchical Bayesian logistic regression models to identify independent predictors of prescription of antiplatelet medications, incorporating practice and provider as random effects. Our study cohort consisted of 26,710 patients during our study period January 2013 to March 2015. Seventy nine percent of patients were prescribed clopidogrel, 12% prasugrel, and 11% ticagrelor. Patients aged ≥75 years, women, history of tobacco use, Peripheral Arterial Disease (PAD), hypertension, diabetes, previous vascular complication, heart failure, and stroke/transient ischemic attack were more likely to be on clopidogrel than prasugrel or ticagrelor. The relative percentages of ticagrelor and prasugrel were higher in patients with history of myocardial infarction, compared with those without myocardial infarction. In summary, our study highlights the prescription patterns associated with prescription of antiplatelet agents after PCI. We found that both ticagrelor and prasugrel were mostly prescribed per the current practice guidelines, thus reflecting appropriate guideline adherence by practices in NCDR PINNACLE registry., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: This study sought to examine depression prevalence among chronic total occlusion (CTO) patients and compared symptom improvement among depressed and nondepressed patients after percutaneous coronary intervention (PCI)., Background: Depression in cardiovascular patients is common, but its prevalence among CTO patients and its association with PCI response is understudied., Methods: Among 811 patients from the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated change in health status between baseline and 1-year post-PCI, as measured by the Seattle Angina Questionnaire (SAQ) and the Rose Dyspnea Score. Depression was defined using the Personal Health Questionnaire-8. The independent association between health status and depression following PCI was assessed using multivariable regression., Results: Among the 811 patients, 190 (23%) screened positive for major depression, of whom 6.3% were on antidepressant therapy at intervention. Depressed patients experienced more baseline angina, but by 1-year post-PCI they experienced greater improvements than nondepressed patients (change in SAQ Summary: 31.4 ± 22.4 vs. 24.2 ± 20.0; p < 0.001). After adjustment, baseline depressed patients had more improvement in health status (adjusted difference in SAQ Summary improvement, depressed vs. nondepressed: 5.48 ± 1.81; p = 0.003)., Conclusions: Depression is common among CTO PCI patients, but few were treated with antidepressants at baseline. Depressed patients had more severe baseline angina and significant improvement in health status after PCI. (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion [OPEN-CTO]; NCT02026466)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Long-term exposure to particulate matter <2.5 µm in diameter (PM 2.5 ) and ozone has been associated with the development and progression of cardiovascular disease and, in the case of PM 2.5 , higher cardiovascular mortality. Whether exposure to PM 2.5 and ozone is associated with patients' health status and quality of life is unknown. We used data from 2 prospective myocardial infarction (MI) registries to assess the relationship between long-term PM 2.5 and ozone exposure with health status outcomes 1 year after an MI., Methods and Results: TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction) and PREMIER (Prospective Registry Evaluating Myocardial Infarction: Events and Recovery) enrolled patients presenting with MI at 31 US hospitals between 2003 and 2008. One year later, patients were assessed with the disease-specific Seattle Angina Questionnaire, and 5-year mortality was assessed with the Centers for Disease Control's National Death Index. Individual patients' exposures to PM 2.5 and ozone over the year after their MI were estimated from the Environment Protection Agency's Fused Air Quality Surface Using Downscaling tool that integrates monitoring station data and atmospheric models to predict daily air pollution exposure at the census tract level. We assessed the association of exposure to ozone and PM 2.5 with 1-year health status and mortality over 5 years using regression models adjusting for age, sex, race, socioeconomic status, date of enrollment, and comorbidities. In completely adjusted models, higher PM 2.5 and ozone exposure were independently associated with poorer Seattle Angina Questionnaire summary scores at 1-year (β estimate per +1 SD increase =-0.8 [95% CI, -1.4 to -0.3; P=0.002] for PM 2.5 and -0.9 [95% CI, -1.3 to -0.4; P<0.001] for ozone). Moreover, higher PM 2.5 exposure, but not ozone, was independently associated with greater mortality risk (hazard ratio =1.13 per +1 SD [95% CI, 1.07-1.20; P<0.001])., Conclusions: In our study, greater exposure to PM 2.5 and ozone was associated with poorer 1-year health status following an MI, and PM 2.5 was associated with increased risk of 5-year death.

Background Although admission heart rate predicts higher mortality after acute myocardial infarction ( AMI ), less is known about discharge heart rate. We tested the hypothesis that higher discharge heart rate after AMI is related to increased long-term mortality independent of admission heart rate, and assessed whether β blockers modify this relationship. Methods and Results In 2 prospective US multicenter registries of AMI , we evaluated the associations of discharge and admission heart rate with 3-year mortality using Cox models. Among 6576 patients with AMI , discharge heart rate was modestly associated with initial heart rate ( r=0.28), comorbidities, and infarct severity. In this cohort, 10.7% did not receive β blockers at discharge. After full adjustment for demographic, psychosocial, and clinical covariates, discharge heart rate (hazard ratio [HR]=1.14 per 10 beats per minute [bpm]; 95% CI =1.07-1.21 per 10 bpm) was more strongly associated with risk of death than admission heart rate (HR=1.05 per 10 bpm; 95% CI=1.02-1.09 per 10 bpm) when both were entered in the same model ( P=0.043 for comparison). There was a significant interaction between discharge heart rate and β-blocker use ( P=0.004) on mortality, wherein risk of death was markedly higher among those with high discharge heart rate and not on β blockers (HR=1.35 per 10 bpm; 95% CI=1.19-1.53 per 10 bpm) versus those with a high discharge heart rate and on β blockers at discharge (HR=1.10 per 10 bpm; 95% CI=1.03-1.17 per 10 bpm). Conclusions Higher discharge heart rate after AMI was more strongly associated with 3-year mortality than admission heart rate, and the risk associated with higher discharge heart rate was modified by β blockers at discharge. These findings highlight opportunities for risk stratification and intervention that will require further investigation.

An exercise ankle-brachial index (ABI) test can provide further insight into the functional significance of peripheral artery disease (PAD). The variability in its use, associated patient factors and its relation to patients' symptoms are unknown. From the international PORTRAIT registry, we identified 1131 patients with PAD. We fit a hierarchical logistic regression model, adjusting for patient factors, country and site, to examine predictors of and variation in ordering exercise ABI testing. We also examined the associations between test components and health status as quantified by the Peripheral Artery Questionnaire (PAQ) using semi-parametric regression methods. Testing was ordered in 22% in the United States versus 80% in the Netherlands and 90% in Australia. Testing was likely to be performed if the patient was male, younger, had typical symptoms and a higher resting ABI, with substantial variability across sites (median odds ratio=5.9, 95% CI: 3.2-19.5). Adjusting for country and site, the resting ABI and all exercise ABI metrics were associated with the PAQ Physical Limitation score. In addition, important components of the test, namely time to onset of claudication, pain-free walking distance (PFWD), and maximum walking distance (MWD), were also associated with PAQ Symptoms and Summary scores. More importantly, even after adjusting for resting ABI, a patient with a post-exercise ABI of 0.29 (25th percentile), compared to 0.61 (75th percentile), achieved 4.4 (95% CI: 0.4-8.4, p=0.031) points less on the PAQ Physical Limitation score. Exercise ABI test use is remarkably variable, and less used in the United States. Its data, specifically PFWD and MWD, might help in objectively assessing the impact of PAD on patients' functioning and quality of life.

Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Methods and Results Among 13 351 patients who underwent TAVR at 252 US sites between November 9, 2011 and June 30, 2015, the rate of poor outcome at 1 year after TAVR was 38.9%, which was because of death in 20.7% and poor quality of life or quality of life decline in 18.2%. The rate of poor outcome has decreased slightly over time, from 42.0% in 2012 to 37.8% in 2015 ( P for trend=0.076). The original TAVR poor outcome risk model did not calibrate well on this population. We then reestimated the intercept and coefficients in the model and retested model performance, after which it performed well (both overall and in subgroups), with a C index 0.65 and excellent calibration. Conclusions In a large cohort of unselected patients in the United States, we found that while a substantial minority of patients continue to have a poor outcome after TAVR, outcomes have slowly improved over time. After recalibration, the TAVR poor outcome risk model performed well. This model could potentially be used before TAVR to help patients have appropriate expectations of recovery.

Background: In patients with coronary artery disease (CAD), low diastolic blood pressure (DBP) is associated with increased risk of myocardial infarction, but its association with angina is unknown., Objectives: The goal of this study was to examine the association of low DBP and angina in patients with CAD., Methods: The study assessed the frequency of angina (measured by using the Seattle Angina Questionnaire-Angina Frequency score) according to DBP in patients with known CAD from 25 U.S. cardiology clinics. Hierarchical logistic regression was used to test the association between DBP and angina, with a spline term for DBP to assess nonlinearity., Results: Among 1,259 outpatients with CAD, 411 (33%) reported angina in the prior month, with higher rates in the lowest DBP quartile (40 to 64 mm Hg: 37%). In the unadjusted model, DBP was associated with angina with a J-shaped relationship (p = 0.017, p for nonlinearity = 0.027), with a progressive increase in odds of angina as DBP decreased below ∼70 to 80 mm Hg. This association remained significant after sequential adjustment for demographic characteristics (p = 0.002), comorbidities (p = 0.002), heart rate (p = 0.002), systolic blood pressure (p = 0.046), and antihypertensive antianginal medications (p = 0.045)., Conclusions: In patients with chronic CAD, there seemed to be an association between lower DBP and increased odds of angina. If validated, these findings suggest that clinicians should consider less aggressive blood pressure control in patients with CAD and angina., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Some studies suggest that female practitioners are more likely to provide guideline-concordant care than male practitioners; however, little is known about the role of practitioner gender in cardiology., Objective: The aim of the study was to measure the association between practitioner gender and adherence to the cardiovascular performance measures in the American College of Cardiology's ambulatory Practice Innovation and Clinical Excellence Registry., Methods: Patients with at least 1 outpatient visit with a unique practitioner were included. Among eligible patients, adherence to 7 guideline-supported performance measures for coronary artery disease, heart failure, and atrial fibrillation over 12 months after registry entry was compared by practitioner gender using hierarchical models adjusting for practitioner type (physicians vs advance practice practitioners) and number of visits., Results: The study cohort included 1493 individual practitioners who saw 769 139 patients; 80% of practitioners were men. Male practitioners were more often physicians compared with female practitioners (98.2% vs 43.7%, P < .01). Accounting for practitioner category and visit frequency, guideline adherence rates were similar by practitioner gender for all measures with the exception of marginally higher rates for coronary artery disease performance measures for male practitioners compared with female practitioners (antiplatelet: rate ratio [RR] = 1.06; 95% confidence interval [CI], 1.03-1.09; β-blockers: RR = 1.06; 95% CI, 1.01-1.10; and lipid-lowering drug: RR = 1.07; 95% CI, 1.04-1.10) and atrial fibrillation (oral anticoagulants: RR = 1.05; 95% CI, 1.01-1.09)., Conclusion: Male practitioners marginally outperformed their female counterparts in ambulatory practices enrolled in a voluntary cardiovascular performance improvement registry program. Overall low adherence to some performance measures suggests room for improvement among all practitioners.

Importance: The 2013 American College of Cardiology/American Heart Association (ACC/AHA) Cholesterol Management Guideline recommends moderate-intensity to high-intensity statin therapy in eligible patients., Objective: To examine adoption of the 2013 ACC/AHA guideline in US cardiology practices., Design, Setting, and Participants: Among 161 cardiology practices, trends in the use of moderate-intensity to high-intensity statin and nonstatin lipid-lowering therapy (LLT) were analyzed before (September 1, 2012, to November 1, 2013) and after (February 1, 2014, to April 1, 2015) publication of the 2013 ACC/AHA guideline among 4 mutually exclusive risk groups within the ACC Practice Innovation and Clinical Excellence Registry. Interrupted time series analysis was used to evaluate for differences in trend in use of moderate-intensity to high-intensity statin and nonstatin LLT use in hierarchical logistic regression models. Participants were a population-based sample of 1 105 356 preguideline patients (2 431 192 patient encounters) and 1 116 472 postguideline patients (2 377 219 patient encounters). Approximately 97% of patients had atherosclerotic cardiovascular disease (ASCVD)., Exposures: Moderate-intensity to high-intensity statin and nonstatin LLT use before and after publication of the 2013 ACC/AHA guideline., Main Outcomes and Measures: Time trend in the use of moderate-intensity to high-intensity statin and nonstatin LLT., Results: In the study cohort, the mean (SD) age was 69.6 (12.1) years among 1 105 356 patients (40.2% female) before publication of the guideline and 70.0 (11.9) years among 1 116 472 patients (39.8% female) after publication of the guideline. Although there was a trend toward increasing use of moderate-intensity to high-intensity statins overall and in the ASCVD cohort, such a trend was already present before publication of the guideline. No significant difference in trend in the use of moderate-intensity to high-intensity statins was observed in other groups. The use of moderate-intensity to high-intensity statin therapy was 62.1% (before publication of the guideline) and 66.6% (after publication of the guideline) in the overall cohort, 62.7% (before publication) and 67.0% (after publication) in the ASCVD cohort, 50.6% (before publication) and 52.3% (after publication) in the cohort with elevated low-density lipoprotein cholesterol levels (ie, ≥190 mg/dL), 52.4% (before publication) and 55.2% (after publication) in the diabetes cohort, and 41.9% (before publication) and 46.9% (after publication) in the remaining group with 10-year ASCVD risk of 7.5% or higher. In hierarchical logistic regression models, there was a significant increase in the use of moderate-intensity to high-intensity statins in the overall cohort (4.8%) and in the ASCVD cohort (4.3%) (P < .01 for slope for both). There was no significant change for other risk cohorts. Nonstatin LLT use remained unchanged in the preguideline and postguideline periods in the hierarchical logistic regression models for all of the risk groups., Conclusions and Relevance: Adoption of the 2013 ACC/AHA Cholesterol Management Guideline in cardiology practices was modest. Timely interventions are needed to improve guideline-concordant practice to reduce the burden of ASCVD.

Background: Prior studies have demonstrated that patients with high-risk acute myocardial infarction (AMI) are less likely to receive guideline-directed medications during hospitalisation. It is unknown if this paradox persists following discharge. We aimed to assess if persistence with guideline-directed medications post discharge varies by patients' risk following AMI., Methods: Data were analysed from two prospective, multicentre US AMI registries. The primary outcome was persistence with all prescribed guideline-directed medications (aspirin, β-blockers, statins, angiotensin-antagonists) at 1, 6 and 12 months post discharge. The association between risk and medication persistence post discharge was assessed using multivariable mixed-effect models., Results: Among 6434 patients with AMI discharged home, 2824 were considered low-risk, 2014 intermediate-risk and 1596 high-risk for death based upon their Global Registry of Acute Coronary Event (GRACE) 6-month risk score. High-risk was associated with a lower likelihood of receiving all appropriate therapies at discharge compared with low-risk patients (relative risk (RR) 0.90; 95% CI 0.87 to 0.94). At 12 months, the rate of persistence with all prescribed therapies was 61.5%, 57.9% and 45.9% among low-risk, intermediate-risk and high-risk patients, respectively. After multivariable adjustment, high-risk was associated with lower persistence with all prescribed medications (RR 0.87; 95% CI 0.82 to 0.92) over follow-up. Similar associations were seen for individual medications. Over the 5 years of the study, persistence with prescribed therapies post discharge improved modestly among high-risk patients (RR 1.05; 95% CI 1.03 to 1.08 per year)., Conclusions: High-risk patients with AMI have a lower likelihood of persistently taking prescribed medications post discharge as compared with low-risk patients. Continued efforts are needed to improve the use of guideline-directed medications in high-risk patients., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: After left ventricular assist device (LVAD) placement for advanced heart failure, increased cerebral perfusion should result in improved cognitive function. However, stroke (a well-known LVAD complication) and subclinical cerebral ischemia may result in transient or permanent cognitive decline. We sought to describe the incidence and predictors of cognitive decline after LVAD using a valid, sensitive assessment tool., Methods and Results: Among 4419 patients in the Interagency Registry for Mechanically Assisted Circulatory Support who underwent LVAD implantation between May 2012 and December 2013, cognitive function was assessed in 1173 patients with the Trail Making B Test before LVAD and at 3, 6, and 12 months. The test detects several forms of cognitive impairment, including subclinical stroke. Cognitive decline was defined as a clinically important increase during follow-up using a moderate Cohen d effect size of 0.5×baseline SD (32 s). The cumulative incidence of cognitive decline in the year after LVAD implantation, treating death and transplantation as competing risks, was 29.2%. In adjusted analysis, older age (≥70 versus <50 years; hazard ratio, 2.24; 95% confidence interval 1.46-3.44; P(trend)<0.001) and destination therapy (hazard ratio, 1.42; 95% confidence interval, 1.05-1.92) were significantly associated with greater risk of cognitive decline., Conclusions: Cognitive decline occurs commonly in patients in the year after LVAD and is associated with older age and destination therapy. These results could have important implications for patient selection and improved communication of risks before LVAD implantation. Additional studies are needed to explore the association between cognitive decline and subsequent stroke, health status, and mortality in patients after LVAD., (© 2015 American Heart Association, Inc.)

Background: As new techniques emerge to quantify patients' health status, new opportunities are created to validate patient-reported outcome questionnaires. The Seattle Angina Questionnaire (SAQ), a widely used coronary artery disease-specific health status tool, has not been validated against daily records of angina frequency and sublingual nitroglycerin (SL NTG) use. Additional evidence supporting the validity of the SAQ could justify its broader use as an outcome for clinical studies designed to evaluate treatments that may improve patients' symptoms, function, and quality of life., Methods and Results: We used data from 917 patients with type 2 diabetes mellitus, coronary artery disease, and stable angina from the multinational Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina (TERISA) trial. The number of angina episodes and SL NTG used were recorded and transmitted daily using an electronic diary. In cross-sectional analyses, there was a strong relationship between the 2 SAQ angina frequency questions (ie, frequency of angina and SL NTG use) and the corresponding diary responses, with correlation coefficients of -0.64 for angina frequency (95% confidence interval,-0.68 to -0.60) and -0.69 for SL NTG use (95% confidence interval, -0.73 to -0.66). Longitudinally, changes in SAQ angina frequency scores from day 1 to week 8 also correlated with changes in angina frequency (-0.42; 95% confidence interval, -0.48 to -0.30) and SL NTG use by diary (-0.38; 95% confidence interval, -0.43 to -0.32) over the corresponding time period. Correlations were similar when stratified by age, sex, or geography., Conclusions: In a multinational cohort of patients with stable angina, the SAQ angina frequency domain was significantly correlated, both cross sectionally and longitudinally, with daily diary entries of angina frequency and SL NTG use. These data further support the validity of the SAQ angina frequency domain across a broad spectrum of patients with stable angina., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT01425359., (© 2014 American Heart Association, Inc.)

Objectives: We aimed to compare quality of life benefits of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) with non-CTO PCI., Background: Data quantifying the benefits of PCI of CTO are inconsistent., Methods: We leveraged a 10-center prospective PCI registry including Seattle Angina Questionnaire (SAQ) assessment at the time of PCI and in follow-up. We propensity matched attempted CTO PCIs with up to 10 non-CTO PCIs. The primary analysis compared changes between baseline and 6 months in SAQ Physical Limitation (PL), Quality of Life (QoL); Angina Frequency (AF) scores as well as the Rose Dyspnea scores (RDS) and the EQ5D Visual Analogue Scale (VAS). Noninferiority was assessed for quality of life changes between CTO and non-CTO PCI., Results: In 3,303 patients enrolled, 167 single-vessel CTOs were attempted; 147 (88%) were matched with 1,616 non-CTO PCI. Baseline PL (73.0 vs. 77.4, P = 0.039) and VAS (66.4 vs. 70.8, P = 0.005) scores were lower for CTO. There was no difference in AF, QoL, or RDS scores. At 6-month follow-up, all SAQ scores improved (P < 0.05 vs. baseline for all) and were equivalent for CTO and Non-CTO (P = NS for all). VAS scores remained lower for CTO, but improved in both groups (P < 0.05 vs. baseline for both). Formal noninferiority testing demonstrated that CTO PCI was not inferior to non-CTO PCI (P ≤ 0.02 for all)., Conclusions: Symptoms, function, QoL, and dyspnea improve to the same degree following CTO PCI as compared with non-CTO PCI. Symptom relief supports CTO PCI to improve patients' quality of life., (© 2013 Wiley Periodicals, Inc.)

Background: The objective of this study is to examine practice-level variation in rates of guideline-recommended treatment for outpatients with heart failure and reduced ejection fraction, and to examine the association between treatment variation and practice site, independent of patient factors., Methods and Results: Cardiology practices participating in the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence registry from July 2008 to December 2010 were evaluated. Practice rates of treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and β-blockers and an optimal combined treatment measure were determined for patients with heart failure and reduced ejection fraction and no documented contraindications. Multivariable hierarchical regression models were adjusted for demographics, insurance status, and comorbidities. A median rate ratio was calculated for each therapy, which describes the likelihood that the treatment of a patient with given comorbidities would differ at 2 randomly selected practices. We identified 12 556 patients from 45 practices. The unadjusted practice-level prescription rates ranged from 44% to 100% for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (median, 85%; interquartile range, 75%-89%), from 49% to 100% for β-blockers (median, 92%; interquartile range, 83%-95%), and from 37% to 100% for optimal combined treatment (median, 79%; interquartile range, 66%-85%). The adjusted median rate ratio was 1.11 (95% confidence interval, 1.08-1.18) for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers therapy, 1.08 (95% confidence interval, 1.05-1.15) for β-blockers therapy, and 1.17 (1.13-1.26) for optimal combined treatment., Conclusions: Variation in the use of guideline-recommended medications for patients with heart failure and reduced ejection fraction exists in the outpatient setting. Addressing practice-level differences may be an important component of improving quality of care for patients with heart failure and reduced ejection fraction.

Background: Despite the growing epidemic of heart failure with preserved ejection fraction (HFpEF), no valid measure of patients' health status (symptoms, function, and quality of life) exists. We evaluated the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated measure of HF with reduced EF, in patients with HFpEF., Methods and Results: Using a prospective HF registry, we dichotomized patients into HF with reduced EF (EF≤ 40) and HFpEF (EF≥50). The associations between New York Heart Association class, a commonly used criterion standard, and KCCQ Overall Summary and Total Symptom domains were evaluated using Spearman correlations and 2-way ANOVA with differences between patients with HF with reduced EF and HFpEF tested with interaction terms. Predictive validity of the KCCQ Overall Summary scores was assessed with Kaplan-Meier curves for death and all-cause hospitalization. Covariate adjustment was made using Cox proportional hazards models. Internal reliability was assessed with Cronbach's α. Among 849 patients, 200 (24%) had HFpEF. KCCQ summary scores were strongly associated with New York Heart Association class in both patients with HFpEF (r=-0.62; P<0.001) and HF with reduced EF (r=-0.55; P=0.27 for interaction). One-year event-free rates by KCCQ category among patients with HFpEF were 0 to 25=13.8%, 26 to 50=59.1%, 51 to 75=73.8%, and 76 to 100=77.8% (log rank P<0.001), with no significant interaction by EF (P=0.37). The KCCQ domains demonstrated high internal consistency among patients with HFpEF (Cronbach's α=0.96 for overall summary and ≥0.69 in all subdomains)., Conclusions: Among patients with HFpEF, the KCCQ seems to be a valid and reliable measure of health status and offers excellent prognostic ability. Future studies should extend and replicate our findings, including the establishment of its responsiveness to clinical change.

Background: Elevated blood glucose is associated with higher mortality in patients with acute myocardial infarction (AMI). Although clinical guidelines recommend targeted glucose control in this group, clinical trials have yielded inconclusive results. Our objective was to understand how this lack of evidence impacts the management of severe hyperglycemia in routine practice., Methods: We examined insulin use among 4,297 AMI admissions with a mean hospitalization blood glucose of ≥200 mg/dL across 55 US hospitals from 2000 to 2008. Temporal trends and interhospital variation in 2 measures of insulin use during hospitalization-any (subcutaneous, intravenous [IV], short acting, long acting) and IV insulin-were examined using hierarchical Poisson regression models., Results: Of the 4,297 admissions, 2,618 (61%) received any insulin and 538 (13%) received IV insulin. After multivariable adjustment, a slight increase in insulin use was observed per admission year (relative risk [RR] 1.06, 95% CI 1.01-1.11). There was a modest (albeit nonsignificant) increase in IV insulin use seen before May 2004 (RR 1.18, 95% CI 0.96-1.47), with no significant change thereafter (RR 0.99, 95% CI 0.92-1.09). Marked variability in insulin use was observed across hospitals (median rate ratio 1.5 [any insulin] and 1.8 [IV insulin]), which did not change over time., Conclusions: Insulin use among patients with AMI and severe hyperglycemia has remained low over the past decade, with substantial and persistent interhospital variation. These observations reflect marked clinical uncertainty with regard to glucose management in AMI, underscoring the imperative for a definitive clinical trial in this field., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objectives: Overcoming racial differences in acute coronary syndrome (ACS) outcomes is a strategic goal for U.S. health care. Genetic polymorphisms in the adrenergic pathway seem to explain some outcome differences by race in other cardiovascular diseases treated with β-adrenergic receptor blockade (BB). Whether these genetic variants are associated with survival among ACS patients treated with BB, and if this differs by race, is unknown., Background: β-adrenergic receptor blockade after ACS is a measure of quality care, but the effectiveness across racial groups is less clear., Methods: A prospective cohort of 2,673 ACS patients (2,072 Caucasian; 601 African-American) discharged on BB from 22 U.S. hospitals were followed for 2 years. Subjects were genotyped for polymorphisms in ADRB1, ADRB2, ADRA2C, and GRK5. We used proportional hazards regression to model the effect of genotype on mortality, stratified by race and adjusted for baseline factors., Results: The overall 2-year mortality rate was 7.5% for Caucasians and 16.7% for African Americans. The prognosis associated with different genotypes in these BB-treated patients differed by race. In Caucasians, ADRA2C 322-325 deletion carriers had significantly lower mortality as compared with homozygous individuals lacking the deletion (hazard ratio: 0.46; confidence interval [CI]: 0.21 to 0.99; p = 0.047; race × genotype interaction p = 0.053). In African Americans, the ADRB2 16R allele was associated with significantly increased mortality (hazard ratio for RG vs. GG: 2.10; CI: 1.14 to 3.86; RR vs. GG: 2.65; CI: 1.38 to 5.08; p = 0.013; race × genotype interaction p = 0.096)., Conclusions: Adrenergic pathway polymorphisms are associated with mortality in ACS patients receiving BB in a race-specific manner. Understanding the mechanism by which different genes impact post-ACS mortality differently in Caucasians and African Americans might illuminate opportunities to improve BB therapy in these groups., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Previous studies have described an "obesity paradox" with heart failure, whereby higher body mass index (BMI) is associated with lower mortality. However, little is known about the impact of obesity on survival after acute myocardial infarction., Methods: Data from 2 registries of patients hospitalized in the US with acute myocardial infarction between 2003-2004 (PREMIER) and 2005-2008 (TRIUMPH) were used to examine the association of BMI with mortality. Patients (n=6359) were categorized into BMI groups (kg/m(2)) using baseline measurements. Two sets of analyses were performed using Cox proportional hazards regression with fractional polynomials to model BMI as categorical and continuous variables. To assess the independent association of BMI with mortality, analyses were repeated, adjusting for 7 domains of patient and clinical characteristics., Results: Median BMI was 28.6. BMI was inversely associated with crude 1-year mortality (normal, 9.2%; overweight, 6.1%; obese, 4.7%; morbidly obese; 4.6%; P <.001), which persisted after multivariable adjustment. When BMI was examined as a continuous variable, the hazards curve declined with increasing BMI and then increased above a BMI of 40. Compared with patients with a BMI of 18.5, patients with higher BMIs had a 20% to 68% lower mortality at 1 year. No interactions between age (P=.37), sex (P=.87), or diabetes mellitus (P=.55) were observed., Conclusions: There appears to be an "obesity paradox" among patients after acute myocardial infarction such that higher BMI is associated with lower mortality, an effect that was not modified by patient characteristics and was comparable across age, sex, and diabetes subgroups., (Copyright © 2012 Elsevier Inc. All rights reserved.)

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 © 2011 Elsevier Inc. All rights reserved.)

Background: Black patients with myocardial infarction (MI) have worse outcomes than white patients, including higher mortality rates, more angina, and worse quality of life. The Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) study was designed to examine whether racial differences in socioeconomic, clinical, genetic, metabolic, biomarker, or treatment characteristics mediate observed disparities in outcomes., Methods and Results: Between April 11, 2005, and December 31, 2008, 31 567 patients with MI were prospectively screened; 6152 had an eligible MI, and 4340 (71%) were enrolled from 24 US centers. Consenting patients had detailed chart abstractions of their medical history and processes of inpatient care, supplemented with a detailed baseline interview. Detailed genetic and metabolic data were obtained at hospital discharge in 2979 (69%) and 3013 patients (69%), respectively. In a subset of patients, blood and urine samples were obtained at 1 month (obtained in 27% of survivors) and blood samples at 6 months (obtained in 19% of survivors). Centralized follow-up interviews sought to quantify patients' postdischarge care and outcomes, with a focus on their health status (symptoms, function, and quality of life). At 1, 6, and 12 months, 23%, 27%, and 24%, respectively, were lost to follow-up. Vital status was available for 99% of patients at 12 months., Conclusions: TRIUMPH is a novel MI registry with detailed information on patients' sociodemographic, clinical, treatment, health status, metabolic, and genetic characteristics. The wealth of patient data collected in TRIUMPH will provide unique opportunities to examine factors that may mediate racial differences in mortality and health status after MI and the complex interactions between genetic and environmental determinants of post-MI outcomes.

Objectives: We examined compliance with performance measures for 14,464 patients enrolled from July 2008 through June 2009 into the American College of Cardiology's PINNACLE (Practice Innovation And Clinical Excellence) program to provide initial insights into the quality of outpatient cardiac care., Background: Little is known about the quality of care of outpatients with coronary artery disease (CAD), heart failure, and atrial fibrillation, and whether sex and racial disparities exist in the treatment of outpatients., Methods: The PINNACLE program is the first, national, prospective office-based quality improvement program of cardiac patients designed, in part, to capture, report, and improve outpatient performance measure compliance. We examined the proportion of patients whose care was compliant with established American College of Cardiology, American Heart Association, and American Medical Association-Physician Consortium for Performance Improvement (ACC/AHA/PCPI) performance measures for CAD, heart failure, and atrial fibrillation., Results: There were 14,464 unique patients enrolled from 27 U.S. practices, accounting for 18,021 clinical visits. Of these, 8,132 (56.4%) had CAD, 5,012 (34.7%) had heart failure, and 2,786 (19.3%) had nonvalvular atrial fibrillation. Data from the PINNACLE program were feasibly collected for 24 of 25 ACC/AHA/PCPI performance measures. Compliance with performance measures ranged from being very low (e.g., 13.3% of CAD patients screened for diabetes mellitus) to very high (e.g., 96.7% of heart failure patients with blood pressure assessments), with moderate (70% to 90%) compliance observed for most performance measures. For 3 performance measures, there were small differences in compliance rates by race or sex., Conclusions: For more than 14,000 patients enrolled from 27 practices in the outpatient PINNACLE program, we found that compliance with performance measures was variable, even after accounting for exclusion criteria, suggesting an important opportunity to improve the quality of outpatient care., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In 2007, a multispecialty society task force published a clinical expert consensus document (CECD) on carotid stenting (CAS), containing recommendations for appropriate patient selection and quality of care. The CECD also inspired creation of a large, national registry of carotid revascularization, the Carotid Artery Revascularization and Endarterectomy (CARE) registry. Our goal here was to investigate whether initial CAS procedures submitted to CARE conformed to CECD recommendations, and examine their clinical outcomes., Methods: We analyzed CAS procedures for the period January 1, 2005 through December 31, 2008. These were grouped into those that conformed to CECD recommendations [CECD(+), n = 4,636, 79.8%] and those that did not [CECD(-), n = 1,168, 20.2%]., Results: The CECD(+) patients were older than CECD(-) patients (71.5 +/- 10.3 vs. 67.6 +/- 10.3 years, P = 0.001, respectively), and more frequently had chronic kidney disease (46.9% vs. 17.8%, P = 0.001), chronic lung disease (33.0% vs. 12.4%, P = 0.001), ejection fraction

Context: Racial differences in survival have not been previously studied after in-hospital cardiac arrest, an event for which access to care is not likely to influence treatment., Objectives: To estimate racial differences in survival for patients with in-hospital cardiac arrests and examine the association of sociodemographic and clinical factors and the admitting hospital with racial differences in survival., Design, Setting, and Patients: Cohort study of 10,011 patients with cardiac arrests due to ventricular fibrillation or pulseless ventricular tachycardia enrolled between January 1, 2000, and February 29, 2008, at 274 hospitals within the National Registry of Cardiopulmonary Resuscitation., Main Outcome Measures: Survival to hospital discharge; successful resuscitation from initial arrest and postresuscitation survival (secondary outcome measures)., Results: Included were 1883 black patients (18.8%) and 8128 white patients (81.2%). Rates of survival to discharge were lower for black patients (25.2%) than for white patients (37.4%) (unadjusted relative rate [RR], 0.73; 95% confidence interval [CI], 0.67-0.79). Unadjusted racial differences narrowed after adjusting for patient characteristics (adjusted RR, 0.81 [95% CI, 0.75-0.88]; P < .001) and diminished further after additional adjustment for hospital site (adjusted RR, 0.89 [95% CI, 0.82-0.96]; P = .002). Lower rates of survival to discharge for blacks reflected lower rates of both successful resuscitation (55.8% vs 67.4% for whites; unadjusted RR, 0.84 [95% CI, 0.81-0.88]) and postresuscitation survival (45.2% vs 55.5% for whites; unadjusted RR, 0.85 [95% CI, 0.79-0.91]). Adjustment for the hospital site at which patients received care explained a substantial portion of the racial differences in successful resuscitation (adjusted RR, 0.92 [95% CI, 0.88-0.96]; P < .001) and eliminated the racial differences in postresuscitation survival (adjusted RR, 0.99 [95% CI, 0.92-1.06]; P = .68)., Conclusions: Black patients with in-hospital cardiac arrest were significantly less likely to survive to discharge than white patients, with lower rates of survival during both the immediate resuscitation and postresuscitation periods. Much of the racial difference was associated with the hospital center in which black patients received care.