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In spring 2018, the American Heart Association convened the Value in Healthcare Summit to begin an important conversation about the challenges patients with cardiovascular disease face in accessing and deriving quality and value from the healthcare system. Following the summit and recognizing the collective momentum it created, the American Heart Association, in collaboration with the Robert J. Margolis Center for Health Policy at Duke University, launched the Value in Healthcare Initiative—Transforming Cardiovascular Care. Four areas of focus were identified, and learning collaboratives were established and proceeded to conduct concrete, actionable problem solving in 4 high-impact areas in cardiovascular care: Value-Based Models, Partnering with Regulators, Predict and Prevent, and Prior Authorization. The deliverables from these groups are being disseminated in 4 stand-alone articles, and their publication will initiate further work to test and evaluate each of these promising areas of reform. This article provides an overview of the initiative’s findings and highlights key cross-cutting themes for consideration as the initiative moves forward.

Background: Palliative use of continuous IV inotrope therapy has shown to improve quality of life and reduce hospital readmissions for patients with end-stage heart failure (HF) who are otherwise ineligible to receive advanced therapies. Administration of home inotrope therapy generally requires a hospice or home-health agency, placing this option out of reach for patients who lack funding. As such, underinsured patients are relegated to the difficult choice of either remaining in the hospital to receive IV inotropes, or going home without the therapy for as long as their symptoms allow. To address this issue at our large county safety-net hospital, we developed and implemented a patient self-administered home inotrope therapy program. Methods: A multidisciplinary team of physicians, pharmacists, nurses, and social workers was assembled to pilot the program. Eligible patients were provided with a peripherally inserted central venous catheter (PICC) and a portable infusion pump. They were then instructed on proper use of the pump, medication administration, medication bag changes, and IV line care using a nursing teach-back technique. After proper understanding was demonstrated, patients were discharged home with weekly follow up in heart failure clinic for PICC-care and medication exchanges. Results: During the initial 12 months of the program, 5 patients were deemed eligible for enrollment. Total hospitalized days for these patients was 277 (mean = 55.4 days) in the one year prior to enrollment and 12 (mean = 2.4 days) while enrolled for a cumulative period of 288 days (Figure 1). One patient was able to secure funding for advanced therapies, two patients died while enrolled, and two patients are currently enrolled and alive. Discussion: A self-administered home IV inotrope therapy program is a feasible alternative for palliation in unfunded patients with end-stage HF who are otherwise not candidates for advanced therapies, allowing for more days at home in the end of life. Thus far, the cost impact of the program has been mitigated by the cost savings for inpatient hospitalizations. Studies to assess patient-centered outcomes, and overall cost savings are ongoing.

Introduction: Out-of-pocket costs (OOPC) are a significant barrier to care and drive suboptimal medical therapy in ASCVD. Despite this, there is minimal attention paid to these costs in post-graduate education. To define a potential knowledge gap, we surveyed trainee understanding of OOPC. Methods: We surveyed Internal Medicine residents at a large academic program comprised of a large county safety-net hospital, a VA, and a private tertiary care hospital, about knowledge and practices surrounding patient OOPC. Residents rotate on services at all sites and the vast majority have primary care clinic at the county or VA hospital. Participants answered questions considering their most recent inpatient panel and their clinic patient panel. Familiarity was ranked on a 5-point Likert scale, and for the purposes of presentation, was divided into “Poor” and “Moderate or Better”. Non-parametric analysis was used to test differences between outpatients v inpatients and by year of training. Results: Of 159 residents, 106 (67%) responded. Familiarity with patient insurance status was moderate or better in 135 of 159 (85%). Moderate or better understanding of costs associated with medications (52% [83 of 159]), testing (19% [30 of 159]) and clinic visits (30% [48 of 159]) was less common. Respondents had higher familiarity with OOPC for clinic patients compared with their most recent inpatient panel: clinic visits (39% v 21% [62 v 33 of 159 p < 0.005]), testing (25.7% v 12.4% [41 v 20 of 159 p = 0.002]), and medications (62% v 42% [99 v 67 of 159 p Discussion: Our survey demonstrates that trainee familiarity with OOPC was low overall but modestly higher for established clinic patients, perhaps reflecting longitudinal experience with them or the heterogeneity of admitted patient funding status. Familiarity with patient OOPC was not an often-considered factor in decision making and did not significantly improve over years of training. This suggests an important gap in trainee education. Teaching greater familiarity with patient OOPC during residency can increase awareness of the financial realities of patients, enabling more patient-centered care.

Key Points Question Is implementation of a novel high-sensitivity cardiac troponin T protocol in patients with chest pain associated with less resource use and within acceptable safety parameters? Findings This cohort study of 31 543 emergency department encounters found that implementation of the protocol was associated with a shorter length of stay in the emergency department and a higher proportion of patients discharged. There was no difference in the rate of 30-day hospitalization for myocardial infarction or death. Meaning This or similar protocols that rapidly rule out myocardial infarction have the potential to reduce emergency department overcrowding and improve health care quality., This cohort study of patients at a large US safety net hospital examines the safety of and resource use associated with a new protocol for excluding myocardial infarction from diagnosis of patients with chest pains through the use of high-sensitivity troponin., Importance High-sensitivity cardiac troponin T (hs-cTnT) protocols for the evaluation of chest pain in the emergency department (ED) may reduce unnecessary resource use and overcrowding. Objective To determine whether the implementation of a novel hs-cTnT protocol, which incorporated troponin values drawn at 0, 1, and 3 hours after ED presentation and the modified HEART score (history, electrocardiogram, age, risk factors), was associated with improvements in resource use while maintaining safety. Design, Setting, and Participants This retrospective cohort study from Parkland Health and Hospital System, a large safety net hospital in Dallas, Texas, included data on 31 543 unique ED encounters in which patients underwent electrocardiographic and troponin testing from January 1, 2017, to October 16, 2018. The hs-cTnT protocol was implemented in December 2017. Main Outcomes and Measures Resource use outcomes included trends in ED dwell time, troponin to disposition decision time (the difference between the first troponin draw time and the time an order was placed for inpatient admission, admission to observation, or discharge), and final patient disposition. Safety outcomes included readmission for myocardial infarction and death. Results In 31 543 encounters, mean (SD) patient age was 54 (14.4) years and 14 675 patients (48%) were female. Department dwell time decreased by a mean of −1.09 (95% CI, −2.81 to 0.64) minutes per month in the preintervention period. The decline was steeper after the intervention (−4.69 [95% CI, −9.05 to −0.33] minutes per month) (P for interaction = .007). The troponin to disposition time was increasing in the preintervention period by 1.72 (95% CI, 1.08 to 2.36) minutes per month; postintervention, the mean difference increased more slowly (0.37 [95% CI, −1.25 to 1.99 minutes per month; P value for interaction = .007]). The proportion of patients discharged from the ED increased after the intervention (48% vs 54%, P

Objectives Patients with severe hyperlipidemia (low-density lipoprotein-cholesterol (LDL-C) ≥190 ​mg/dL) have a significantly increased risk of cardiovascular disease (CVD) and are more likely to have familial hypercholesterolemia (FH). We sought to determine how often health care providers recognize the implications of and adjust therapy for an LDL-C ≥190 ​mg/dL. Methods We conducted a retrospective review of patients with an LDL-C measurement in the medical record of a large health care system between November 2015 and June 2016. Patients were restricted to those with LDL-C ≥190 ​mg/dL and without secondary causes of dyslipidemia, with sensitivity analyses for those with LDL-C ≥220 ​mg/dL. Results Of 27,963 patients, 227 had LDL-C ≥190 ​mg/dL. Only 21% were on a statin at the time of LDL-C measurement. More than 90% had a follow-up clinic visit, but 41% had no change in treatment. FH was only included in the differential for 14%. The presence/absence of a family history of dyslipidemia, myocardial infarction, and premature CVD were documented in 26%, 29%, and 31%. Only 20.7% and 22.1% had documentation of the presence or absence of tendinous xanthomas or corneal arcus, respectively. Among those without prior specialist care (cardiologist or endocrinologist), only 13% were referred. These measures were only slightly better for those with LDL-C ≥220 ​mg/dL. Conclusion In a large health care system, the possibility of FH was rarely acknowledged in those with residual LDL-C ≥190 ​mg/dL, few were referred to specialists, and therapeutic adjustments were suboptimal. Additional efforts are required to understand barriers to improving the evaluation and management of patients with LDL-C ≥190 ​mg/dL.

This cross-sectional study assesses Medicare Part D and Medicaid spending on extended-release drug formulations and the potential savings associated with switching to generic immediate-release drug formulations., Key Points Question How much do Medicare and Medicaid spend on extended-release drug formulations, and what would be the potential savings associated with switching to immediate-release formulations? Findings In this cross-sectional study of 20 extended-release drugs, Medicare Part D and Medicaid spent a combined $3.1 billion in 2017. Switching to immediate-release drug formulations was associated with an estimated $2.6 billion reduction in spending in 2017 and a $13.7 billion reduction from 2012 to 2017. Meaning The findings suggest that substitution of therapeutically equivalent extended-release drug formulations with immediate-release formulations represents a possible option to reduce Medicare and Medicaid spending., Importance The United States spends more money on medications than any other country. Most extended-release drugs have not consistently shown therapeutic or adherence superiority, and switching these medications to less expensive, generic, immediate-release formulations may offer an opportunity to reduce health care spending. Objective To evaluate Medicare Part D and Medicaid spending on extended-release drug formulations and the potential savings associated with switching to generic immediate-release formulations. Design, Setting, and Participants This cross-sectional study used the 2012 to 2017 Medicare Part D Drug Event and Medicaid Spending and Utilization data sets to analyze 20 extended-release drugs with 37 Medicare formulations and 36 Medicaid formulations. Only cardiovascular, diabetes, neurologic, and psychiatric extended-release drugs saving at most 1 additional daily dose compared with their immediate-release counterparts were included. Extended-release drugs with therapeutic superiority were excluded. Analyses were conducted from January to December 2019. Main Outcomes and Measures Estimated Medicare Part D and Medicaid savings from switching extended-release to immediate-release drug formulations between 2012 and 2017. Results Of the 6252 drugs screened for eligibility from the 2017 Medicaid Drug Utilization database and the 2017 Medicare Part D database, 67 drugs with extended-release formulations that were identified in the Medicare data set (20 distinct drugs with 37 formulations [19 brand, 18 generic]) were included in the analysis. In 2017, Medicare Part D spent $2.2 billion and Medicaid spent $952 million (a combined $3.1 billion) on 20 extended-release drugs. Between 2012 and 2017, Medicare Part D and Medicaid spent $12 billion and $5.9 billion, respectively, on extended-release formulations. Switching from brand-name to generic extended-release formulations was estimated to be associated with a $247 million reduction in Medicare spending and $299 million reduction in Medicaid spending in 2017, whereas switching all brand-name and generic extended-release formulations to immediate-release formulations in both Medicare and Medicaid was estimated to reduce spending by $2.6 billion ($1.8 billion for Medicare and $836 million for Medicaid) in 2017. During the study period, the estimated spending reduction associated with switching all patients receiving extended-release formulations (brand name extended-release and generic extended-release) to generic immediate-release formulations was $13.7 billion ($8.5 billion from Medicare and $5.2 billion from Medicaid). Conclusions and Relevance The findings suggest that switching from extended-release drug formulations to therapeutically equivalent immediate-release formulations when available represents a potential option to reduce Medicare and Medicaid spending.

James L. Januzzi, Jr, MD, FACC, Chair Tariq Ahmad, MD, MPH, FACC Brendan Everett, MD, FACC William Hucker, MD, PHD Dharam J. Kumbhani, MD, SM, FACC Joseph E. Marine, MD, FACC Pamela B. Morris, MD, FACC Robert N. Piana, MD, FACC Sunil V. Rao, MD, FACC Marielle Scherrer-Crosbie, MD, PhD

BACKGROUND: Cardiovascular disease is a leading economic and medical burden in the United States (US). As an important risk factor for cardiovascular disease, hypertension represents a critical point of intervention. Less is known about longitudinal effects of neighborhood deprivation on blood pressure outcomes, especially in light of new hypertension guidelines. METHODS: Longitudinal data from the Dallas Heart Study facilitated multilevel regression analysis of the relationship between neighborhood deprivation, blood pressure change, and incident hypertension over a 9-year period. Factor analysis explored neighborhood perception, which was controlled for in all analyses. Neighborhood deprivation was derived from US Census data and divided into tertiles for analysis. Hypertension status was compared using pre-2017 and 2017 hypertension guidelines. RESULTS: After adjusting for covariates, including moving status and residential self-selection, we observed significant associations between residing in the more deprived neighborhoods and 1) increasing blood pressure over time and 2) incident hypertension. In the fully adjusted model of continuous blood pressure change, significant relationships were seen for both medium (SBP: β=4.81, SE=1.39, p=0.0005; DBP: β=2.61, SE=0.71, p=0.0003) and high deprivation (SBP: β=7.64, SE=1.55, p

Purpose: This study evaluated the comparative effectiveness of different pharmacist visit types on reducing readmission rates. Method: A single-center, retrospective cohort study was conducted from January 2015 to July 2017. Patients were 18 years or older with an index heart failure (HF) exacerbation admission. Upon hospital discharge, patients were seen in clinic by a clinical pharmacy specialist (CPS) with collaborative practice agreement (CPA) (High Intensity Bundle), medication therapy management (MTM) pharmacist without CPA (Low Intensity Bundle), or no pharmacist (Standard of Care [SOC]). The primary outcome was 30-day all-cause readmission rate. Secondary outcomes included rate of 30-day HF readmissions and average number of days until readmission in those who were readmitted. Results: Totally, 98 patients were included in the final analysis (35 High Intensity Bundle, 28 Low Intensity Bundle, and 35 SOC). The primary outcome of all-cause readmissions was lower in both the pharmacist groups compared with SOC (CPS 8.6% [3/35] vs SOC 25.7% [9/35], P = 0.046 and MTM 7.1% [2/28] vs SOC 25.7% [9/35], P = 0.057). Incremental differences were seen between visit types for the secondary outcome of 30-day HF readmissions (CPS 2.9% vs MTM 7.1% vs SOC 17.1%, P = 0.039). The average number of days until readmission was longer in the CPS versus the MTM and SOC (26.7 days vs 12.5 days vs 14.1 days, respectively). Conclusion: Post-hospital discharge pharmacist visits were associated with lower 30-day all-cause readmission. In particular, clinic visits with a Higher Intensity Bundle may be more effective in reducing HF readmissions. These exploratory findings warrant further investigation.

We describe the validation and implementation of the new 5th generation high sensitivity Troponin T assay (Roche Diagnostics®). In addition to the assay improved sensitivity, the numerical values, reporting units, reference intervals, and critical limits are markedly different. We describe the use of clinical correlation as the basis for implementation and validation of the fifth-generation hs-TnT assay at a large teaching county hospital.

BACKGROUND: Circulating natriuretic peptide (NP) levels are markedly lower in healthy men than women. A relative NP deficiency in men could contribute to their higher risk of hypertension and cardiovascular disease. Epidemiologic studies suggest testosterone may contribute to sex-specific NP differences. OBJECTIVES: We aimed to determine the effect of testosterone administration on NP levels using a randomized, placebo-controlled design. METHODS: 151 healthy men (aged 20–50 years) received goserelin acetate to suppress endogenous production of gonadal steroids, and anastrazole to suppress conversion of testosterone to estradiol. Subjects were randomized to placebo gel or 4 different doses of testosterone (1%) gel for 12 weeks. Serum N-terminal-pro-B-type natriuretic peptide (NT-proBNP) and total testosterone levels were measured at baseline and follow-up. RESULTS: Men who did not receive testosterone replacement (placebo gel group) after suppression of endogenous gonadal steroid production experienced a profound decrease in serum testosterone (median 540 to 36 ng/dl, p

Key Points Question How have trajectories of cardiovascular (CV) mortality among US counties varied over 35 years, and are county-level factors associated with this variation? Findings In this cross-sectional study, cardiovascular mortality declined in all groups from 1980 to 2014 in this cross-sectional analysis of 3133 US counties. Three unique phenogroups based on mortality trajectory were identified, with the difference between high- and low-mortality counties unchanged during the study period, and were associated with social, behavioral, and environmental characteristics at the county level. Meaning These findings suggest that despite an overall decline in CV mortality rates over the past 35 years, differences in health behavior patterns and other societal risk factors are associated with persistent CV mortality disparities at the county level., This cross-sectional study identifies clusters based on cardiovascular mortality trajectory among US counties and county-level social, demographic, environmental, and health-related risk factors that are associated with these clusters., Importance Cardiovascular (CV) mortality has declined for more than 3 decades in the US. However, differences in declines among residents at a US county level are not well characterized. Objective To identify unique county-level trajectories of CV mortality in the US during a 35-year study period and explore county-level factors that are associated with CV mortality trajectories. Design, Setting, and Participants This longitudinal cross-sectional analysis of CV mortality trends used data from 3133 US counties from 1980 to 2014. County-level demographic, socioeconomic, environmental, and health-related risk factors were compiled. Data were analyzed from December 2019 to September 2021. Exposures County-level characteristics, collected from 5 county-level data sets. Main Outcomes and Measures Cardiovascular mortality data were obtained for 3133 US counties from 1980 to 2014 using age-standardized county-level mortality rates from the Global Burden of Disease study. The longitudinal K-means approach was used to identify 3 distinct clusters based on underlying mortality trajectory. Multinomial logistic regression models were constructed to evaluate associations between county characteristics and cluster membership. Results Among 3133 US counties (median, 49.5% [IQR, 48.9%-50.5%] men; 30.7% [IQR, 27.1%-34.4%] older than 55 years; 9.9% [IQR, 4.5%-22.7%] racial minority group [individuals self-identifying as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, Pacific Islander, other, or multiple races/ethnicities]), CV mortality declined by 45.5% overall and by 38.4% in high-mortality strata (694 counties), by 45.0% in intermediate-mortality strata (1382 counties), and by 48.3% in low-mortality strata (1057 counties). Counties with the highest mortality in 1980 continued to demonstrate the highest mortality in 2014. Trajectory groups were regionally distributed, with high-mortality trajectory counties focused in the South and in portions of Appalachia. Low- vs high-mortality groups varied significantly in demographic (racial minority group proportion, 7.6% [IQR, 4.1%-14.5%]) vs 23.9% [IQR, 6.5%-40.8%]) and socioeconomic characteristics such as high-school education (9.4% [IQR, 7.3%-12.6%] vs 20.1% [IQR, 16.1%-23.2%]), poverty rates (11.4% [IQR, 8.8%-14.6%] vs 20.6% [IQR, 17.1%-24.4%]), and violent crime rates (161.5 [IQR, 89.0-262.4] vs 272.8 [IQR, 155.3-431.3] per 100 000 population). In multinomial logistic regression, a model incorporating demographic, socioeconomic, environmental, and health characteristics accounted for 60% of the variance in the CV mortality trajectory (R2 = 0.60). Sociodemographic factors such as racial minority group proportion (odds ratio [OR], 1.70 [95% CI, 1.35-2.14]) and educational attainment (OR, 6.17 [95% CI, 4.55-8.36]) and health behaviors such as smoking (OR for high vs low, 2.04 [95% CI, 1.58-2.64]) and physical inactivity (OR, 3.74 [95% CI, 2.83-4.93]) were associated with the high-mortality trajectory. Conclusions and Relevance Cardiovascular mortality declined in all subgroups during the 35-year study period; however, disparities remained unchanged during that time. Disparate trajectories were associated with social and behavioral risks. Health policy efforts across multiple domains, including structural and public health targets, may be needed to reduce existing county-level cardiovascular mortality disparities.

Background Whether the volume of coronavirus disease 2019 (COVID-19) hospitalizations is associated with outcomes has important implications for the organization of hospital care both during this pandemic and future novel and rapidly evolving high-volume conditions. Methods We identified COVID-19 hospitalizations at US hospitals in the American Heart Association COVID-19 Cardiovascular Disease Registry with ≥10 cases between January and August 2020. We evaluated the association of COVID-19 hospitalization volume and weekly case growth indexed to hospital bed capacity, with hospital risk-standardized in-hospital case-fatality rate (rsCFR). Results There were 85 hospitals with 15,329 COVID-19 hospitalizations, with a median hospital case volume was 118 (interquartile range, 57, 252) and median growth rate of 2 cases per 100 beds per week but varied widely (interquartile range: 0.9 to 4.5). There was no significant association between overall hospital COVID-19 case volume and rsCFR (rho, 0.18, P = .09). However, hospitals with more rapid COVID-19 case-growth had higher rsCFR (rho, 0.22, P = 0.047), increasing across case growth quartiles (P trend = .03). Although there were no differences in medical treatments or intensive care unit therapies (mechanical ventilation, vasopressors), the highest case growth quartile had 4-fold higher odds of above median rsCFR, compared with the lowest quartile (odds ratio, 4.00; 1.15 to 13.8, P = .03). Conclusions An accelerated case growth trajectory is a marker of hospitals at risk of poor COVID-19 outcomes, identifying sites that may be targets for influx of additional resources or triage strategies. Early identification of such hospital signatures is essential as our health system prepares for future health challenges.

Postacute myocardial infarction (AMI) readmissions are common among Medicare beneficiaries (≥65 years) and are associated with significant resource utilization. However, patterns of AMI readmissions for younger age groups in the United States are not known. In the Nationwide Readmissions Database, a nationally representative all-payer database of in-patient hospitalizations, we identified 212,171 index AMI hospitalizations in January to November 2013, weighted to represent 478,247 hospitalizations nationally (mean age 66.9 years, 38% women, 29% low income). This included 26,516 cases in the 18 to 44 age group, 183,703 in the 45 to 64 age group, and 268,027 in the ≥65 age group. The overall 30-day readmission rate was 14.5% and varied across age groups (9.7% [18 to 44], 11.2% [45 to 64], and 17.3% [≥65]). The cumulative cost of 30-day readmissions was $1.1 billion, of which $365 million was spent on those

Management of chronic diseases, such as heart failure, is a major public health problem. A standard approach to managing chronic diseases by medical community is to have a committee of experts develop guidelines that all physicians should follow. Due to their complexity, these guidelines are difficult to implement and are adopted slowly by the medical community at large. We have developed a physician advisory system that codes the entire set of clinical practice guidelines for managing heart failure using answer set programming. In this paper, we show how abductive reasoning can be deployed to find missing symptoms and conditions that the patient must exhibit in order for a treatment prescribed by a physician to work effectively. Thus, if a physician does not make an appropriate recommendation or makes a non-adherent recommendation, our system will advise the physician about symptoms and conditions that must be in effect for that recommendation to apply. It is under consideration for acceptance in TPLP.

Aims To investigate the obesity paradox and association of extreme obesity with long-term outcomes among older ST-segment elevation myocardial infarction (STEMI) patients. Methods and results Nineteen thousand four hundred and ninety-nine patients ≥65 years with STEMI surviving to hospital discharge in NCDR ACTION Registry-GWTG linked to Centers for Medicare and Medicaid Services outcomes between 2007 and 2012 were stratified by body mass index (BMI) (kg/m2) into normal weight (18.5–24.9), overweight (25–29.9), class I (30–34.9), class II (35–39.9), and class III/extreme obese (≥40) categories. Multivariable-adjusted associations were evaluated between BMI categories and mortality by Cox proportional hazards models, and days alive and out of hospital (DAOH) by generalized estimating equations, within 3 years after discharge. Seventy percent of patients were overweight/obese and 3% extremely obese. Normal weight patients were older and more likely to smoke; while extremely obese patients were younger and more likely to be female and black, with lower socioeconomic status and more comorbidity (P ≤ 0.001). A U-shaped association was observed between BMI categories and mortality: patients with class I obesity were at lowest risk, while normal weight [hazard ratio (HR) 1.30, 95% confidence interval (CI) 1.15–1.47] and extremely obese patients (HR 1.33, 95% CI 1.02–1.74) had higher mortality. Normal weight [odds ratio (OR) 0.79, 95% CI 0.68–0.90] and extremely obese (OR 0.73, 95% CI 0.54–0.99) individuals also had lower odds of DAOH. Conclusion Mild obesity is associated with lower long-term risk in older STEMI patients, while normal weight and extreme obesity are associated with worse outcomes. These findings highlight hazards faced by an increasing number of older individuals with normal weight or extreme obesity and cardiovascular disease.

In this issue of Diabetes Care , Divakaran et al. (1) report on patients from the Partners YOUNG-MI registry who suffered a first myocardial infarction (MI) at or before the age of 50 years. They describe diabetes prevalence and long-term cardiovascular outcomes stratified by diabetes status. Diabetes is a well-established risk factor for major adverse cardiovascular events (MACE) such as MI, stroke, or cardiovascular death. However, most existing data are in older patients. Thus, this article offers an opportunity to gain insight into an important and understudied population. The mean age of this study cohort was 44 years, 19% were women, and 73% were white. Patients were enrolled between 2000 and 2016, and median follow-up was just over 11 years. Of the 2,097 patients in this cohort, 416 (20%) had diabetes, 39 (2%) of whom had type 1 diabetes. In 81 patients (20% of the patients with diabetes, 4% of the overall cohort), this was a new diabetes diagnosis. Although young, the risk factor burden in these patients was substantial. Half the cohort reported current smoking, 9 in 10 carried a diagnosis of hyperlipidemia, and 1 in 4 reported a family history of premature cardiovascular disease. Despite this significant risk factor burden, the median atherosclerotic cardiovascular disease (ASCVD) 10-year risk score was just under 10% in study patients with diabetes. Despite the young age of this cohort, the cumulative incidence curves shown in Fig. 1 of the article show all-cause mortality >20% at 10 years in patients on insulin and >10% in patients with diabetes not on insulin. Cardiovascular mortality was ∼10% in patients with diabetes, over threefold higher than …

Importance In 2015, the US Food and Drug Administration approved 2 new medications for treatment of heart failure with reduced ejection fraction, sacubitril/valsartan and ivabradine. However, few national data are available examining their contemporary use and associated costs. Objective To evaluate national patterns of use of sacubitril/valsartan and ivabradine and associated therapeutic spending in Medicare Part D and Medicaid. Design, Setting, and Participants In this US nationwide claims-based study, we analyzed data from the Medicare Part D Prescription Drug Event and Medicaid Utilization and Spending data sets to compare national patterns of use of sacubitril/valsartan and ivabradine between 2016 and 2017. Main Outcomes and Measures Changes in total spending, per-beneficiary/claim spending, number of beneficiaries, and number of claims between 2016 and 2017 for sacubitril/valsartan and ivabradine. Results The number of Medicare beneficiaries prescribed sacubitril/valsartan increased from 35 423 to 90 606 (156% increase from 2016 to 2017). Medicare beneficiaries prescribed ivabradine increased from 15 856 to 23 213 (46% increase). In 2017, Medicare Part D spent $227 million and $7.3 million on sacubitril/valsartan and ivabradine, respectively. This represented increases of 241% and 59% compared with 2016 spending, respectively. The annual Medicare per-beneficiary spending on sacubitril/valsartan and ivabradine was $2512 and $2400. Parallel trends in use patterns and spending were observed among Medicaid beneficiaries. Conclusions and Relevance Although initial experiences suggested slow uptake after regulatory approval, these national data demonstrate an increase in use of sacubitril/valsartan and, to a lesser degree, ivabradine in the United States. Current annual per-beneficiary expenditures remain less than spending thresholds that have been reported to be cost-effective. Ongoing efforts are needed to promote high-value care while improving affordability and access to established and emerging heart failure therapies.

Type 2 diabetes mellitus is a progressive chronic disease and is an established risk factor for cardiovascular disease. Until recently, the cardiovascular safety and efficacy of antihyperglycemic drugs remained uncertain. However, after the changes in regulatory guidance in 2008, a wealth of data has been generated, expanding the focus of the treatment of diabetes from blood glucose control to the prevention of macro-and microvascular complications and improvement in mortality. This article will review cardiovascular outcome trials of antihyperglycemic agents and provide overview of ongoing trials.

Objective: Therapeutic drug monitoring (TDM) is the assessment of medication adherence by detection of a drug or its metabolites in blood or urine samples. TDM-guided feedback has been shown to improve medication adherence and subsequent blood pressure (BP) control in patients with resistant hypertension. Herein, we sought to evaluate the attitudes of patients with uncontrolled hypertension as well as their providers towards incorporating TDM in clinical practice. Methods: We conducted a qualitative study consisting of in-depth, cognitive interviews in 10 patients seen in Parkland General Cardiology and Internal Medicine Clinics with uncontrolled hypertension. The patients were asked a series of 9 standardized questions to elicit their attitudes towards TDM use in the management of hypertension after informed consent. In addition, 10 providers, including faculty, trainees, and pharmacists, were also interviewed, using the same questionnaire to evaluate their attitudes of incorporating TDM in hypertension management. Results: Of the patients interviewed, 90% (9 of 10) were supportive of TDM use in clinical practice. Similarly, 100% (10 of 10) of providers thought TDM was a good idea and should be used regularly. On subsequent questioning, 78% (7 of 9) of patients who felt TDM was a good idea expressed reservation that TDM could negatively impact the physician-patient relationship. Nonetheless, 86% (6 of 7) of these patients felt TDM could be a useful tool to identifying and solving non-adherence of antihypertensive drugs, if providers are mindful of patients’ unique circumstances. Amongst providers, 90% (9 of 10) felt TDM may negatively impact the physician-patient relationship, yet felt TDM could still be useful in addressing non-adherence. Conclusion: TDM was found to be well accepted amongst patients and providers, though between 80-90% of patients and providers still had concerns that TDM could negatively impact the physician-patient relationship. However, the majority of patients and providers believed that TDM could be an effective tool in identifying and solving barriers to adherence, if the providers are sensitive to the patients’ specific needs. Our survey suggested feasibility of adopting TDM in improving medication adherence.

Pharmacy refill data are frequently used to screen for medication non-adherence in clinical practice but its accuracy has not been validated against therapeutic drug monitoring (TDM) in patients with uncontrolled hypertension. Accordingly, we evaluated the accuracy of proportions of days covered (PDC) and medication possession ratio (MPR) in assessing non-adherence to cardiovascular medications against therapeutic drug monitoring (TDM) in patients with uncontrolled hypertension at outpatient clinics of Parkland Memorial Hospital. Patients who had blood pressure of >130/80 mmHg, were on ≥2 antihypertensive medications, and verbally reported full medication compliance were enrolled in the study after an informed consent. Plasma samples were obtained for measurement of 36 cardiovascular drugs including statins, using liquid chromatography mass spectrometry assay. Among 38 patients enrolled in our study, 21% (8/38 patients) were non-adherent to at least 1 antihypertensive medication, while 39% (12/31 patients) were non-adherent to statin drugs. The non-adherent patients were younger than the adherent patients (57.2±12.0 vs. 62.9±7.8, p=0.08), and were less likely to be African Americans (7/17 vs. 16/21, p2 =0.15, p=0.11 for PDC; r 2 =0.15, p=0.16 for MPR). Using a threshold of < 80%, low PDC has a sensitivity of 100% and a specificity of 63% in detecting medication non-adherence when compared to TDM. Similar results were obtained for MPR: sensitivity of 100% and specificity of 65%. While medication refill data may be a sensitive screening tool for medication non-adherence, it has limited specificity and availability when compared to TDM. Thus, TDM constitutes a more efficient and reliable way to assess medication non-adherence, which is crucial in optimizing cardiovascular risk factors in this indigent population.

Management of heart failure is a major challenge in health care. Optimal management of heart failure requires adherence to evidence-based clinical guidelines. The nearly 80-page guideline for heart failure management is very complex. As a result, clinical guidelines are difficult to implement and are adopted slowly by the medical community at large. In this paper we describe a heart failure treatment adviser system which automates the reasoning process required to comply with the heart failure management guideline. The system is able to correctly compute guideline- compliant treatment recommendations for a given patient. For each recommendation, justification is also given by the system. We illustrate the technical aspect of the implementation of the system as well as some primitive user interfaces associated with the system's core functionality. A simulated case is presented with system-generated recommendations and justifications.

Introduction: Serum magnesium levels ([Mg]) are often maintained at >2 mg/dl in hospital patients, especially those on cardiology services, despite a poor correlation between serum and total body Mg stores and lack of data supporting routine Mg repletion. Oral Mg oxide (MgO) is as effective as intravenous (IV) Mg sulfate (MgSO 4 ) at repleting Mg stores but is significantly more expensive. Objective: To determine the frequency and relative cost impact of IV versus oral Mg repletion. Methods: We queried our EHR for all instances in which Mg was administered within 24 hours after a serum [Mg] measurement among adults at a large, tertiary-care county hospital from 10/2016 to 10/2018, excluding obstetric and perioperative uses. The data collected included serum [Mg], route of administration, and patient location. Using the hospital medication cost for IV and oral Mg, we determined the potential cost savings of a change in route (medication costs only, not including administration costs). This quality improvement study was deemed exempt from IRB review. Results: Overall, there were 46,852 instances of Mg repletion. The IV route was used in 80% cases, of which 53% were for serum Mg ≥ 1.8 mg/dL. The mean serum [Mg] preceding repletion was 1.80 and 1.84 mg/dL for the IV and oral routes, respectively (p4 was $193,210 over 2 years. Conclusion: IV Mg repletion for mild hypomagnesemia was common. The mean serum [Mg] for patients treated by the IV versus oral routes were not meaningfully different, suggesting route differences are not driven by perceived severity of hypomagnesemia. Overall, the pattern of IV MgSO 4 use at our institution suggests widespread overuse with a substantial financial impact. We expect this pattern of use may be present at other institutions, and that cardiologists can play a lead role in reducing unnecessary testing. Further implementation studies of strategies to reduce IV use are warranted.

Background: Although social and functional determinants of health (SFDoH) are increasingly recognized to contribute to increased 30-day readmission risk for cardiovascular illnesses, most health systems lack individual-level data to enable individual risk stratification and targeted interventions to address these needs. We sought to determine whether electronic health record (EHR) data in SFDoH domains collected as a part of routine inpatient care from a safety-net hospital could be used to enhance prediction of 30-day readmissions beyond traditional clinical risk factors alone among underserved adults hospitalized with acute myocardial infarction (AMI). Methods: We used Epic EHR data on AMI hospitalizations from 2014-2017 in an urban safety-net hospital in Dallas to predict non-elective 30-day readmissions to any of 75 hospitals in north Texas, using a regional all-payer hospitalization database. We started with the AMI READMITS score, our previously validated model consisting of 7 clinical risk factors. Next, we derived and validated an enhanced model incorporating SFDoH predictors. EHR data for candidate SFDoH predictors included structured, semi-structured, and short free-text fields from demographics, encounter types, note types, and case manager, social worker, and nursing inpatient flowsheets. We selected novel predictors using stepwise backward selection with a threshold of p≤0.20, forcing in the composite AMI READMITS score. We conducted sensitivity analyses using forward selection, lasso regression, and random forest which resulted in similar models. We internally validated our final model using 5-fold cross-validation and compared model performance to the AMI READMITS score. Results: Of 1,071 hospitalizations, 154 (14.5%) were readmitted within 30 days. In addition to the composite AMI READMITS score, our final model included 9 SFDoH risk factors, including neighborhood poverty (aOR 1.39, 95% CI 0.91-2.14), address change in the past year (aOR 1.53, 95% CI 0.96-2.46), any opioid use in the past year (aOR 2.35, 95% CI 1.36-4.05), history of durable medical equipment use in the past year (aOR 1.70, 95% CI 1.02-2.82), and ADL impairments in feeding, bathing, and toileting in the past year (aOR 1.81 for all three impairments, 95% CI 0.99-3.29). The AMI READMITS+SFDoH model had better discrimination than AMI READMITS alone (optimism-corrected C-statistic 0.69 vs 0.62, p Conclusions: Incorporating existing EHR data on social and functional determinants of health improved readmission risk prediction after an AMI hospitalization in an urban underserved population.

Context: Poor adherence to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is associated with poor outcomes including stent thrombosis, rehospitalization, and mortality. Safety-net patients are at high risk for low adherence due to poor health literacy and financial constraints. Understanding and overcoming barriers to patient adherence to DAPT after PCI may reduce the risk of adverse outcomes in safety-net patients. Objective: A multidisciplinary team of Nurses, Pharmacists, Internal Medicine Residents, and Cardiologists designed and implemented a telephone-based intervention to improve adherence to DAPT after PCI at Parkland Health & Hospital System (PHHS), a safety-net hospital system in Dallas, Texas. Methods: Beginning 9/1/17, nurses from the Parkland Cardiac Catheterization Laboratory called all PCI patients 7, 30, and 90 days post-PCI. Patients were reminded of the importance of DAPT and asked if they had concerns about their medications. Specific issues that arose were handled by the multidisciplinary team via interventions such as: provision of vouchers for reduced-cost medications, change in pharmacy or medication to lower cost, appointment with Pharmacy or Cardiology clinicians to discuss medication, confirmation of active refills. The total number of patients with self-reported nonadherence was quantified, as was proportion of days covered (PDC) on DAPT at 6 months, defined as the total number of days filled in the first 6 months post-PCI divided by 180 days. Results: From 9/1/17 - 2/28/18, 189 patients underwent PCI at Parkland. Of these patients, 67% (127 of 189) were able to be contacted, with 10% (13 of 127) of contacted patients reporting problems with medications resulting in complete nonadherence and requiring intervention. Of the total treated patients, 65% (123 of 189) had prescriptions filled at PHHS pharmacies which allowed for manual calculation of adherence data and 72% (89 of 123) of these patients were successfully contacted. Median PDC was 94% at 6 months, with PDC >90% in 59% (72 of 123) of all patients and 62% (55 of 89) of successfully contacted patients. A historical control sample (N=154) who underwent PCI at Parkland from 1/1/16 - 8/31/17 and filled prescriptions at PHHS pharmacies had a median PDC of 92% at 6 months, with PDC >90% in 55% (84 of 154). There was no significant difference in median PDC (p=0.4) or proportion of patients with PDC >90% in either all-study (p=0.37) or successful contact (p=0.19) patient populations compared to this control. Conclusion: A telephone-based intervention allowed for identification and resolution of potentially catastrophic barriers to DAPT adherence in 1 in 10 contacted patients within 6 months post-PCI. However, it was unable to significantly improve medication adherence as measured by PDC, indicating that this adherence metric may not be an adequate measure of impact in this context.

Background Increased blood pressure ( BP ) variability and nondipping status seen on 24‐hour ambulatory BP monitoring are often observed in autonomic failure ( ATF ). Methods and Results We assessed BP variability and nocturnal BP dipping in 273 patients undergoing ambulatory BP monitoring at Southwestern Medical Center between 2010 and 2017. SD , average real variability, and variation independent of mean were calculated from ambulatory BP monitoring. Patients were divided into a discovery cohort (n=201) and a validation cohort (n=72). ATF was confirmed by formal autonomic function test. In the discovery cohort, 24‐hour and nighttime average real variability, SD , and variation independent of mean did not differ significantly between ATF (n=25) and controls (n=176, all P >0.05). However, daytime SD, daytime coefficient of variation, and daytime variation independent of mean of systolic BP ( SBP ) were all significantly higher in patients with ATF than in controls in both discovery and validation cohorts. Nocturnal BP dipping was more blunted in ATF patients than controls in both cohorts (both P SBP yielded a sensitivity of 77% and specificity of 82% in detecting ATF in the validation cohort, whereas nondipping status had a sensitivity of 80% and specificity of 44%. The area under the receiver operator characteristic of daytime SD SBP was greater than the area under the receiver operator characteristic of nocturnal SBP dipping (0.79 [0.66‐0.91] versus 0.73 [0.58‐0.87], respectively). Conclusions Daytime SD of SBP is a better screening tool than nondipping status in detecting autonomic dysfunction.

Ticagrelor is a cornerstone of modern antithrombotic therapy alongside aspirin in patients with acute coronary syndrome and after percutaneous coronary intervention. Adverse effects such as bleeding and dyspnea have been associated with premature ticagrelor discontinuation, which may limit any potential advantage of ticagrelor over clopidogrel. The randomized trials of ticagrelor captured adverse events, offering the opportunity to more precisely quantify these effects across studies. Therefore, a meta-analysis of 4 randomized clinical trials of ticagrelor conducted between January 2007 and June 2017 was performed to quantify the incidence and causes of premature ticagrelor discontinuation. Among 66,870 patients followed for a median 18 months, premature ticagrelor discontinuation was seen in 25%; bleeding was the most common cause of discontinuation followed by dyspnea. Versus the comparators, the relative risk of dyspnea-related discontinuation during follow-up was 6.4-fold higher, the relative risk of bleeding was 3.2-fold higher, and the relative risk of discontinuation due to any adverse event was 59% higher for patients receiving ticagrelor. Understanding these potential barriers to adherence to ticagrelor is crucial for informed patient-physician decision making and can inform future efforts to improve ticagrelor adherence. This review discusses the incidence, causes, and biological mechanisms of ticagrelor-related adverse effects and offers strategies to improve adherence to ticagrelor.

Objectives To investigate biotin interference on three cardiac troponin (cTn) assays and demonstrate a method to overcome biotin interference. Methods cTn levels were measured in (1) plasma from healthy volunteers on 10-mg daily biotin supplementation mixed with a plasma with known elevated troponin, (2) plasmas with known elevated cTn after mixing in reagent biotin to simulate supplementation, and (3) biotin-spiked plasma specimens pretreated with streptavidin-agarose beads. Results Daily biotin ingestion (10 mg) and studies simulating daily biotin use resulted in significant interference in the Gen5 cardiac troponin T (cTnT) assay; the contemporary Gen 4 cTnT and high-sensitivity cardiac troponin I (hs-cTnI) assays were unaffected. The biotin interference threshold was 31, 315, and more than 2,000 ng/mL for Gen5 cTnT, cTnT, and hs-cTnI assays, respectively. Streptavidin pretreatment blocked biotin interference in cTn assays. Conclusions Biotin interference is possible at plasma concentrations achievable by ingestion of over-the-counter supplements that may lead to delayed or missed diagnosis of myocardial injury with the Gen5 cTnT assay.

Key Points Question What factors are associated with observed trends in the in-hospital mortality rates in the United States during the first 9 months of the COVID-19 pandemic? Findings In this cohort study of 20 736 patients, in-hospital mortality rates decreased in the US between March and November 2020, even after accounting for the changing mix in patient age, sex, comorbidities, and disease severity at the time of admission. Hospital and intensive care unit length of stay and use of mechanical ventilation decreased over time, whereas the use of glucocorticoids and remdesivir increased. Meaning Changes in age, sex, comorbidities, and disease severity among patients with COVID-19 do not fully explain the decrease in the in-hospital mortality rates observed during the first 9 months of the COVID-19 pandemic., Importance In-hospital mortality rates from COVID-19 are high but appear to be decreasing for selected locations in the United States. It is not known whether this is because of changes in the characteristics of patients being admitted. Objective To describe changing in-hospital mortality rates over time after accounting for individual patient characteristics. Design, Setting, and Participants This was a retrospective cohort study of 20 736 adults with a diagnosis of COVID-19 who were included in the US American Heart Association COVID-19 Cardiovascular Disease Registry and admitted to 107 acute care hospitals in 31 states from March through November 2020. A multiple mixed-effects logistic regression was then used to estimate the odds of in-hospital death adjusted for patient age, sex, body mass index, and medical history as well as vital signs, use of supplemental oxygen, presence of pulmonary infiltrates at admission, and hospital site. Main Outcomes and Measures In-hospital death adjusted for exposures for 4 periods in 2020. Results The registry included 20 736 patients hospitalized with COVID-19 from March through November 2020 (9524 women [45.9%]; mean [SD] age, 61.2 [17.9] years); 3271 patients (15.8%) died in the hospital. Mortality rates were 19.1% in March and April, 11.9% in May and June, 11.0% in July and August, and 10.8% in September through November. Compared with March and April, the adjusted odds ratios for in-hospital death were significantly lower in May and June (odds ratio, 0.66; 95% CI, 0.58-0.76; P, This cohort study of patients included in the US American Heart Association COVID-19 Cardiovascular Disease Registry evaluates whether any changes in the in-hospital COVID-19 mortality rates during the first 9 months of the pandemic are associated with individual characteristics of patients with COVID-19.

Previous studies have demonstrated ethnic/racial differences in cardiorespiratory fitness (CRF). However, the relative contributions of body mass index (BMI), lifestyle behaviors, socioeconomic status (SES), cardiovascular (CV) risk factors, and cardiac function to these differences in CRF are unclear. In this study, we included 2,617 Dallas Heart Study participants (58.6% women, 48.6% black; 15.7% Hispanic) without CV disease who underwent estimation of CRF using a submaximal exercise test. We constructed multivariable-adjusted linear regression models to determine the association between race/ethnicity and CRF, which was defined as peak oxygen uptake (ml/kg/min). Black participants had the lowest CRF (blacks: 26.3 ± 10.2; whites: 29.0 ± 9.8; Hispanics: 29.1 ± 10.0 ml/kg/min). In multivariate analysis, both black and Hispanic participants had lower CRF after adjustment for age and gender (blacks: Std β = -0.15; p value ≤0.0001, Hispanics: Std β = -0.05, p value = 0.01; ref group: whites). However, this association was considerably attenuated for black (Std β = -0.04, p value = 0.03) and no longer significant for Hispanic ethnicity (p value = 0.56) after additional adjustment for BMI, lifestyle factors, SES, and CV risk factors. Additional adjustment for stroke volume did not substantially change the association between black race/ethnicity and CRF (Std β = -0.06, p value = 0.01). In conclusion, BMI, lifestyle, SES, and traditional risk factor burden are important determinants of ethnicity-based differences in CRF.

Background— Current guidelines recommend surgical revascularization (coronary artery bypass graft [CABG]) over percutaneous coronary intervention (PCI) in patients with diabetes mellitus and multivessel coronary artery disease. Few data are available describing revascularization patterns among these patients in the setting of non–ST-segment–elevation myocardial infarction. Methods and Results— Using Acute Coronary Treatment and Intervention Outcomes Network Registry–Get with the Guidelines (ACTION Registry–GWTG), we compared the in-hospital use of different revascularization strategies (PCI versus CABG versus no revascularization) in diabetes mellitus patients with non–ST-segment–elevation myocardial infarction who had angiography, demonstrating multivessel coronary artery disease between July 2008 and December 2014. Factors associated with use of CABG versus PCI were identified using logistic multivariable regression analyses. A total of 29 769 patients from 539 hospitals were included in the study, of which 10 852 (36.4%) were treated with CABG, 13 760 (46.2%) were treated with PCI, and 5157 (17.3%) were treated without revascularization. The overall use of revascularization increased over the study period with an increase in the proportion undergoing PCI (45% to 48.9%; P trend =0.0002) and no change in the proportion undergoing CABG (36.1% to 34.7%; p trend =0.88). There was significant variability between participating hospitals in the use of PCI and CABG (range: 22%–100%; 0%–78%, respectively; P value Conclusions— Among patients with diabetes mellitus and multivessel coronary artery disease presenting with non–ST-segment–elevation myocardial infarction, only one third undergo CABG during the index admission. Furthermore, the use of PCI, but not CABG, increased modestly over the past 6 years.

Objective To review the literature systematically to determine whether noninvasive or invasive risk stratification, such as with an electrophysiological study of patients with asymptomatic pre-excitation, reduces the risk of arrhythmic events and improves patient outcomes. Methods PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (all January 1, 1970, through August 31, 2014) were searched for randomized controlled trials and cohort studies examining noninvasive or invasive risk stratification in patients with asymptomatic pre-excitation. Studies were rejected for low-quality design or the lack of an outcome, population, intervention, or comparator of interest or if they were written in a language other than English. Results Of 778 citations found, 9 studies met all the eligibility criteria and were included in this paper. Of the 9 studies, 1 had a dual design–a randomized controlled trial of ablation versus no ablation in 76 patients and an uncontrolled prospective cohort of 148 additional patients–and 8 were uncontrolled prospective cohort studies (n=1,594). In studies reporting a mean age, the range was 32 to 50 years, and in studies reporting a median age, the range was 19 to 36 years. The majority of patients were male (range, 50% to 74%), and 250 ms) developed in 0% to 16%, malignant atrial fibrillation (shortest RR interval ≤250 ms) in 0% to 9%, and ventricular fibrillation in 0% to 2%, most of whom were children in the last case. Conclusions The existing evidence suggests risk stratification with an electrophysiological study of patients with asymptomatic pre-excitation may be beneficial, along with consideration of accessory-pathway ablation in those deemed to be at high risk of future arrhythmias. Given the limitations of the existing data, well-designed and well-conducted studies are needed.

Premature clopidogrel discontinuation is an important cause of stent thrombosis, myocardial infarction, and death after drug-eluting stent (DES) placement. Previous studies of clopidogrel nonadherence after DES placement have had short follow-up and have relied on self-reported adherence. All patients who underwent DES placement from January 2008 to December 2011 at a single safety-net hospital and received medications through the county-subsidized health plan were considered for inclusion; those with1-year follow-up were excluded. We retrospectively collected 1-year refill data from a large, closed pharmacy system. Our primary outcome was time to failure to obtain a clopidogrel refill, allowing a 5-day grace period. Our study cohort (n = 369) was 34% female, 39% Hispanic, 26% white, and 26% African-American; 26% identified Spanish as their primary language. The time to failure to obtain a clopidogrel refill was 153 days. Cumulative failure to obtain at least 1 refill was 23% for the first refill, increasing to 52% at 6 months and 68% at 1 year. Examining the proportion of days covered (PDC), 21% of patients had 100% coverage, whereas 34% had PDC80%. There were no independent predictors of nonadherence (PDC80%). In conclusion, we identified a high rate of clopidogrel nonadherence in a multiethnic urban poor patient population where clopidogrel was provided at discharge and at nominal cost thereafter. In this cohort, prediction models of nonadherence performed poorly. Novel strategies are needed to address this important problem.

Author(s): Writing Group Members; Mozaffarian, Dariush; Benjamin, Emelia J; Go, Alan S; Arnett, Donna K; Blaha, Michael J; Cushman, Mary; Das, Sandeep R; de Ferranti, Sarah; Despres, Jean-Pierre; Fullerton, Heather J; Howard, Virginia J; Huffman, Mark D; Isasi, Carmen R; Jimenez, Monik C; Judd, Suzanne E; Kissela, Brett M; Lichtman, Judith H; Lisabeth, Lynda D; Liu, Simin; Mackey, Rachel H; Magid, David J; McGuire, Darren K; Mohler, Emile R; Moy, Claudia S; Muntner, Paul; Mussolino, Michael E; Nasir, Khurram; Neumar, Robert W; Nichol, Graham; Palaniappan, Latha; Pandey, Dilip K; Reeves, Mathew J; Rodriguez, Carlos J; Rosamond, Wayne; Sorlie, Paul D; Stein, Joel; Towfighi, Amytis; Turan, Tanya N; Virani, Salim S; Woo, Daniel; Yeh, Robert W; Turner, Melanie B; American Heart Association Statistics Committee; Stroke Statistics Subcommittee

ObjectivesPrevious studies have implicated therapeutic drug monitoring (TDM), by measuring serum or urine drug levels, as a highly reliable technique for detecting medication non-adherence but the attitudes of patients and physicians toward TDM have not been evaluated previously. Accordingly, we solicited input from patients with uncontrolled hypertension and their physicians about their views on TDM.DesignProspective analysis of responses to a set of questions during semistructured interviews.SettingOutpatient clinics in an integrated health system which provides care for a low-income, uninsured population.ParticipantsPatients with uncontrolled hypertension with either systolic blood pressure of at least 130 mm Hg or diastolic blood pressure of at least 80 mm Hg despite antihypertensive drugs and providers in the general cardiology and internal medicine clinics.Primary and secondary outcome measuresAttitudes towards TDM and the potential impact on physician–patient relationship.ResultsWe interviewed 11 patients and 10 providers and discussed the findings with 13 community advisory panel (CAP) members. Of the patients interviewed, 91% (10 of 11) and all 10 providers thought TDM was a good idea and should be used regularly to better understand the reasons for poorly controlled hypertension. However, 63% (7 of 11) of patients and 20% of providers expressed reservations that TDM could negatively impact the physician–patient relationship. Despite some concerns, the majority of patients, providers and CAP members believed that if test results are communicated without blaming patients, the potential benefits of TDM in identifying suboptimal adherence and eliciting barriers to adherence outweighed the risks.ConclusionThe idea of TDM is well accepted by patients and their providers. TDM information if delivered in a non-judgmental manner, to encourage an honest conversation between patients and physicians, has the potential to reduce patient–physician communication obstacles and to identify barriers to adherence which, when overcome, can improve health outcomes.

The association of the Hospital Readmission Reduction Program (HRRP) with reductions in racial disparities in 30-day outcomes for myocardial infarction (MI), is unknown, including whether this varies by HRRP hospital penalty status.To assess temporal trends in 30-day readmission and mortality rates among black and nonblack patients discharged after hospitalization for acute MI at low-performing and high-performing hospitals, as defined by readmission penalty status after HRRP implementation.This observational cohort analysis used data from the multicenter National Cardiovascular Data Registry Chest Pain-MI Registry centers that were subject to the first cycle of HRRP, between January 1, 2008, and November 30, 2016. All patients hospitalized with MI who were included in National Cardiovascular Data Registry Chest Pain-MI Registry were included in the analysis. Data were analyzed from April 2018 to September 2019.Hospital performance category and race (black compared with nonblack patients). Centers were classified as high performing or low performing based on the excess readmission ratio (predicted to expected 30-day risk adjusted readmission rate) for MI during the first HRRP cycle (in October 2012).Thirty-day all-cause readmission and mortality rates.Among 753 hospitals that treated 155 397 patients with acute MI (of whom 11 280 [7.3%] were black), 399 hospitals (53.0%) were high performing. Thirty-day readmission rates declined over time in both black and nonblack patients (annualized 30-day readmission rate: 17.9% vs 20.8%). Black (compared with nonblack) race was associated with higher unadjusted odds of 30-day readmission in both low-performing and high-performing centers (odds ratios: before HRRP: low-performing hospitals, 1.14 [95% CI, 1.03-1.26]; P = .01; high-performing hospitals, 1.17 [95% CI, 1.04-1.32]; P = .01; after HRRP: low-performing hospitals, 1.23 [95% CI, 1.13-1.34]; P .001; high-performing hospitals, 1.25 [95% CI, 1.12-1.39]; P .001). However, these racial differences were not significant after adjustment for patient characteristics. The 30-day mortality rates declined significantly over time in nonblack patients, with stable (nonsignificant) temporal trends among black patients. Adjusted associations between race and 30-day mortality showed that 30-day mortality rates were significantly lower among black (compared with nonblack) patients in the low-performing hospitals (odds ratios: pre-HRRP, 0.79 [95% CI, 0.63-0.97]; P = .03; post-HRRP, 0.80 [95% CI, 0.68-0.95]; P = .01) but not in high-performing hospitals. Finally, the association between race and 30-day outcomes did not vary after the HRRP period began in either high-performing or low-performing hospitals.In this analysis, 30-day readmission rates among patients with MI declined over time for both black and nonblack patients. Differences in race-specific 30-day readmission rates persisted but appeared to be attributable to patient-level factors. The 30-day mortality rates have declined for nonblack patients and remained stable among black patients. Implementation of the HRRP was not associated with improvement or worsening of racial disparities in readmission and mortality rates.

Most guidelines have recommended lower home blood pressure (BP) threshold when clinic BP threshold of 140/90 mm Hg is used for diagnosis of hypertension. However, home BP thresholds to define hypertension have never been determined in the general population in the United States. We identified home BP thresholds for stage 1 (BP ≥130/80 mm Hg) hypertension using a regression-based approach in the DHS (Dallas Heart Study; n=5768) and the NCMH study (North Carolina Masked Hypertension; n=420). Home BP thresholds were also assessed using outcome-derived approach based on the composite of all-cause mortality or cardiovascular events in the DHS cohort. For this approach, BP thresholds were identified only for systolic BP because diastolic BP was not associated with the outcome. Among untreated participants, the regression-derived thresholds for home BP corresponding to clinic BP for stage 1 hypertension were 129/80 mm Hg in blacks, 130/80 mm Hg in whites, and 126/78 mm Hg in Hispanics, respectively. The results are similar in the North Carolina cohort. The 11-year composite cardiovascular and mortality events corresponding to clinic systolic BP >130 mm Hg were higher in blacks than in whites and Hispanics (13.3% versus 5.98% versus 5.52%, respectively). Using a race/ethnicity-specific composite outcome in the untreated DHS participants, the outcome-derived home systolic BP thresholds corresponding to stage 1 hypertension were 130 mm Hg in blacks, 129 mm Hg in whites, and 131 mm Hg in Hispanics, respectively. Our data based on both regression-derived and outcome approach support home BP threshold of 130/80 mm Hg for diagnosis of hypertension in blacks, whites, and Hispanics.

Neighborhood environment perception (NEP) has been associated with health outcomes. However, little is known about how NEP relates to routine healthcare utilization. This study investigated the relationship between NEP and independent subfactors with healthcare utilization behavior, as measured by self-reported (1) usual source of healthcare and (2) time since last routine healthcare check-up. We used cross-sectional data from the Dallas Heart Study, which features a diverse, probability-based sample of Dallas County residents ages 18 to 65. We used logistic regression modeling to examine the association of self-reported NEP and routine healthcare utilization. NEP was assessed via a questionnaire exploring residents' neighborhood perceptions, including violence, the physical environment, and social cohesion. Routine healthcare utilization was assessed via self-reported responses regarding usual source of care and time since last routine healthcare check-up. The analytic sample (N = 1706) was 58% black, 27% white, 15% Hispanic, 42% male, and had a mean age of 51 (SD = 10.3). Analysis of NEP by tertile demonstrated that younger age, lower income, and lower education were associated with unfavorable overall NEP (p trend

Background: Although hospitalization for acute decompensated heart failure (HF) is common and associated with poor outcomes and high costs, few evidence-based recommendations are available to guide patient management. Thus, management of inpatient HF remains heterogeneous. We evaluated if physician-specific self-reported HF practice patterns were associated with 2 important contributors to resource utilization: length of stay (LOS) and 30-day readmission. Methods and Results: A 5-point Likert scale survey was created to assess physician-specific HF discharge strategies and administered to all cardiologists and hospitalists at a single large academic teaching hospital. Practice patterns potentially impacting LOS and discharge decisions were queried, including use of physical examination findings, approaches to diuretic use and influence of kidney function. Likert scale responses are reported as means with any value above 3.00 considered more influential and any value below 3.00 considered less influential. Physician-specific LOS and 30-day readmission rates from July 1, 2015, to June 30, 2016, were extracted from the electronic record. We received survey responses and HF utilization metrics from 58 of 69 surveyed physicians (32 hospitalists and 26 cardiologists), encompassing 753 HF discharges over a 1-year period. Median LOS was 4.5 days (interquartile range, 4.0–5.8) and total 30-day readmission rate was 17.0% (128 unique readmissions). Physicians with below-median LOS placed less importance on observing a patient on oral diuretics for 24 hours before discharge (Likert 2.54 versus 3.30, P =0.01), reaching documented dry weight (Likert 2.93 versus 3.60, P =0.02), and complete resolution of dyspnea on exertion (Likert 3.64 versus 4.10, P =0.03) when compared with those above-median LOS. In contrast, no surveyed discharge practices were associated with physician-specific 30-day readmission. Conclusions: We identified specific inpatient HF discharge practice patterns that associated with shorter LOS but not with readmission rates. These may be targets for future interventions aimed at cost reduction; additional larger studies are needed for further exploration.

Management of heart failure is a major health care challenge. Healthcare providers are expected to use best practices described in clinical practice guidelines, which typically consist of a long series of complex rules. For heart failure management, the relevant guidelines are nearly 80 pages long. Due to their complexity, the guidelines are often difficult to fully comply with, which can result in suboptimal medical practices. In this paper, we describe a heart failure treatment adviser system that automates the entire set of rules in the guidelines for heart failure management. The system is based on answer set programming, a form of declarative programming suited for simulating human-style reasoning. Given a patient’s information, the system is able to generate a set of guideline-compliant recommendations. We conducted a pilot study of the system on 21 real and 10 simulated patients with heart failure. The results show that the system can give treatment recommendations compliant with the guidelines. Out of 187 total recommendations made by the system, 176 were agreed upon by the expert cardiologists. Also, the system missed eight valid recommendations. The reason for the missed and discordant recommendations seems to be insufficient information, differing style, experience, and knowledge of experts in decision-making that were not captured in the system at this time. The system can serve as a point-of-care tool for clinics. Also, it can be used as an educational tool for training physicians and an assessment tool to measure the quality metrics of heart failure care of an institution., This paper reports an artificial intelligence-based implementation of the American Heart Association's guidelines for heart failure.

Background: Most hypertension guidelines have recommended lower home than clinic BP thresholds based on epidemiological studies conducted in non-US populations. However, diagnostic thresholds to define home BP elevation have never been determined in the general population in the United States. Methods: We analyzed data from 2 US cohorts with home and clinic BP data in the same participants, the Dallas Heart Study (DHS, n=5,768) and the North Carolina Masked Hypertension study (NCMH, n = 420). Home BP thresholds for stage 1 (BP ≥ 130/80 mmHg) and stage 2 hypertension (BP ≥ 140/90 mmHg) were identified using a regression-based approach in both cohorts and an outcome-derived approach in the DHS cohort. The composite of all-cause mortality or a cardiovascular disease (CVD) event was used in the outcome-derived approach. For this approach, BP thresholds were identified only for systolic BP (SBP) as clinic diastolic BP (DBP) was not associated with the outcome. Results: Among untreated participants in DHS, the regression-derived thresholds for home BP corresponding to clinic BP for stage 1 and stage 2 hypertension were 130/81 and 137/88 mmHg in blacks and 127/79 and 135/86 mmHg in nonblacks, respectively. The results are virtually identical in the NCMH cohort. The 11-year composite CVD and mortality events corresponding to stage 1 (clinic SBP ≥ 130) and stage 2 (clinic SBP ≥ 140 mmHg) were higher in untreated blacks than untreated non-blacks [13.3 (11.06-15.54) and 17.59 (14.8-20.37)% vs. 6.78 (5.17-8.39) and 9.86 (6.94-12.77)%, respectively]. Using a race/ethnicity-specific composite outcome, the outcome-derived thresholds from the DHS for home SBP corresponding to stage 1 and stage 2 hypertension were 131 and 140 mmHg in untreated blacks and 130 and 139 mmHg in untreated nonblacks, respectively. Conclusions: Based on the regression-derived approach, we found home BP thresholds for stage 1 and 2 hypertension from both cohorts to be similar to the current ACC/AHA guidelines. The outcome-derived approach also identified similar home SBP thresholds for stage 1 hypertension but slightly higher home SBP thresholds for stage 2 hypertension than recommended guidelines.

Importance Health insurance is effective in preventing financial hardship from unexpected major health care events. However, it is also essential to assess whether vulnerable patients, particularly those from low-income families, are adequately protected from longitudinal health care costs for common chronic conditions such as atherosclerotic cardiovascular disease (ASCVD). Objective To examine the annual burden of total out-of-pocket health expenses among low-income families that included a member with ASCVD. Design, Setting, and Participants In this cross-sectional study of the Medical Expenditure Panel Survey from January 2006 through December 2015, all families with 1 or more members with ASCVD were identified. Families were classified as low income if they had an income under 200% of the federal poverty limit. Analyses began December 2017. Main Outcomes and Measures Total annual inflation-adjusted out-of-pocket expenses, inclusive of insurance premiums, for all patients with ASCVD. We compared these expenses against annual family incomes. Out-of-pocket expenses of more than 20% and more than 40% of family income defined high and catastrophic financial burden, respectively. Results We identified 22 521 adults with ASCVD, represented in 20 600 families in the Medical Expenditure Panel Survey. They correspond to an annual estimated 23 million or 9.9% of US adults with a mean (SE) age of 65 (0.2) years and included 10.9 million women (47.1%). They were represented in 21 million or 15% of US families. Of these, 8.2 million families (39%) were low income. The mean annual family income was $57 143 (95% CI, $55 377-$58 909), and the mean out-of-pocket expense was $4415 (95% CI, $3735-$3976). While financial burden from health expenses decreased throughout the study, even in 2014 and 2015, low-income families had 3-fold higher odds than mid/high–income families of high financial burden (21.4% vs 7.6%; OR, 3.31; 95% CI, 2.55-4.31) and 9-fold higher odds of catastrophic financial burden (9.8% vs 1.2%; OR, 9.35; 95% CI, 5.39-16.20), representing nearly 2 million low-income families nationally. Further, even among the insured, 1.6 million low-income families (21.8%) experienced high financial burden and 721 000 low-income families (9.8%) experienced catastrophic out-of-pocket health care expenses in 2014 and 2015. Conclusions and Relevance One in 4 low-income families with a member with ASCVD, including those with insurance coverage, experience a high financial burden, and 1 in 10 experience a catastrophic financial burden due to cumulative out-of-pocket health care expenses. To alleviate economic disparities, policy interventions must extend focus to improving not only access, but also quality of coverage, particularly for low-income families.

Background Readmissions after hospitalization for acute myocardial infarction ( AMI ) are common. However, the few currently available AMI readmission risk prediction models have poor‐to‐modest predictive ability and are not readily actionable in real time. We sought to develop an actionable and accurate AMI readmission risk prediction model to identify high‐risk patients as early as possible during hospitalization. Methods and Results We used electronic health record data from consecutive AMI hospitalizations from 6 hospitals in north Texas from 2009 to 2010 to derive and validate models predicting all‐cause nonelective 30‐day readmissions, using stepwise backward selection and 5‐fold cross‐validation. Of 826 patients hospitalized with AMI , 13% had a 30‐day readmission. The first‐day AMI model (the AMI “ READMITS ” score) included 7 predictors: renal function, elevated brain natriuretic peptide, age, diabetes mellitus, nonmale sex, intervention with timely percutaneous coronary intervention, and low systolic blood pressure, had an optimism‐corrected C‐statistic of 0.73 (95% confidence interval, 0.71–0.74) and was well calibrated. The full‐stay AMI model, which included 3 additional predictors (use of intravenous diuretics, anemia on discharge, and discharge to postacute care), had an optimism‐corrected C‐statistic of 0.75 (95% confidence interval, 0.74–0.76) with minimally improved net reclassification and calibration. Both AMI models outperformed corresponding multicondition readmission models. Conclusions The parsimonious AMI READMITS score enables early prospective identification of high‐risk AMI patients for targeted readmissions reduction interventions within the first 24 hours of hospitalization. A full‐stay AMI readmission model only modestly outperformed the AMI READMITS score in terms of discrimination, but surprisingly did not meaningfully improve reclassification.