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The aim of this study was to examine patterns of care and clinical outcomes among patients with heart failure with reduced ejection fraction (HFrEF) in the United States and Canada.

This study sought to use INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) results to evaluate sex differences in the use and clinical outcomes of left ventricular assist devices (LVAD).

Psychiatric comorbidities play a key role in patient selection for left ventricular assist devices (LVADs), but their impact on clinical outcomes is unknown.

IMPORTANCE: Left ventricular assist devices (LVADs) improve outcomes in patients with advanced heart failure, but little is known about the role of neurohormonal blockade (NHB) in treating these patients. OBJECTIVE: To analyze the association between NHB blockade and outcomes in patients with LVADs. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) included patients from more than 170 centers across the United States and Canada with continuous flow LVADs from 2008 to 2016 who were alive with the device in place at 6 months after implant. The data were analyzed between February and November 2019. EXPOSURES: Patients were stratified based on exposure to NHB and represented all permutations of the following drug classes: angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, and mineralocorticoid antagonists. MAIN OUTCOMES AND MEASURES: The outcomes of interest were survival at 4 years and quality of life at 2 years based on Kansas City Cardiomyopathy Questionnaire scores and a 6-minute walk test. RESULTS: A total of 12 144 patients in INTERMACS met inclusion criteria, of whom 2526 (20.8% ) were women, 8088 (66.6%) were white, 3024 (24.9%) were African American, and 753 (6.2%) were Hispanic; the mean (SD) age was 56.8 (12.9) years. Of these, 10 419 (85.8%) were receiving NHB. Those receiving any NHB medication at 6 months had a better survival rate at 4 years compared with patients not receiving NHB (56.0%; 95% CI, 54.5%-57.5% vs 43.9%; 95% CI, 40.5%-47.7%). After sensitivity analyses with an adjusted model, this trend persisted with patients receiving triple therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, β-blocker, and mineralocorticoid antagonist having the lowest hazard of death compared with patients in the other groups (hazard ratio, 0.34; 95% CI, 0.28-0.41). Compared with patients not receiving NHB, use of NHB was associated with a higher Kansas City Cardiomyopathy Questionnaire score (66.6; bootstrapped 95% CI, 65.8-67.3 vs 63.0; bootstrapped 95% CI, 60.1-65.8; P = .02) and a 6-minute walk test (1103 ft; bootstrapped 95% CI, 1084-1123 ft vs 987 ft; bootstrapped 95% CI, 913-1060 ft; P < .001). CONCLUSIONS AND RELEVANCE: Among patients with LVADs who tolerated NHB therapy, continued treatment was associated with improved survival and quality of life. The optimal heart failure regimen for patients after LVAD implant may be the initiation and continuation of guideline-directed medical therapy.

The purpose of this study was to examine outcomes after left ventricular assist device (LVAD) implantation in older adults (>75 years of age).

Background:Marital stress is associated with worse cardiac outcomes in young adults (≤55 years) with acute myocardial infarction (AMI), but whether psychosocial factors mediate this association remains largely unknown. We conducted a mediation analysis to investigate whether marital stress worsened quality of life (QoL) after AMI by increasing the likelihood of depression or low social support.Methods:There were 1,037 married/partnered AMI survivors aged 18-55 years enrolled in the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study (2008-2012) (67% women, mean age 47 years). Marital stress was measured by the Stockholm Marital Stress Scale at 1 month post-AMI; categorized as absent/moderate or severe. Depression (Patient Health Questionnaire-9 score ≥10), low social support (ENRICHD Social Support Instrument score ≤3 on ≥2 items and total score ≤18), and cardiac-specific QoL (Seattle Angina Questionnaire) were assessed at 1 year post-AMI. Natural direct and indirect effects of marital stress, depression, and low social support on QoL were estimated by causal mediation analysis with bias-corrected bootstrapped confidence intervals. Baseline QoL, sex, age, race, and socioeconomic factors (education, income, employment, and insurance status) were entered as covariates in all models.Results:There was a statistically significant direct effect from severe marital stress to lower 1-year cardiac-specific QoL after adjusting for covariates (Figure). Low social support and depression mediated 14.7% and 11.1% of the total relationship between marital stress and QoL, respectively; however, only the mediating effect through low social support was statistically significant.Conclusion:Marital stress was significantly associated with worse 1-year cardiac-specific QoL, and this effect was partially mediated by low social support. Interventions to decrease marital stress that also screen and provide resources for social support may help to improve AMI outcomes.

Introduction:Nationally representative data evaluating recent trends in racial and ethnic differences in prevalence and treatment of metabolic syndrome (MetS) are sparse.Methods:We evaluated 21-year trends in the prevalence and treatment of MetS and individual components in 21,602 adults, using data from the National Health and Nutrition Examination Surveys (NHANES) from 1999 to 2020. We used weighted linear regression to estimate time trends and compared these trends by race and ethnicity.Results:Among participants, the mean age was 47.7 (SD, 2.2) years; 51 % were female; 78 %, 12.7%, and 9.3% were White, Black, and Hispanic. From 1999 to 2020, the prevalence of MetS as well as the prevalences of elevated waist circumference and elevated fasting glucose increased significantly for Black, Hispanic, and White individuals (P<0.01 for all). The prevalences of elevated blood pressure and elevated triglyceride increased among Black individuals but did not change among Hispanic and White individuals. The use of antihypertensive, antihyperglycemic, and lipid-modifying medications also increased for all racial/ethnic subgroups. Racial/ethnic disparities in prevalence and treatment of MetS and individual components persisted throughout the study period. Compared with White individuals, Black individuals had higher use of antihypertensive medications but lower use of lipid-modifying medications (P<0.01 for all). Hispanic individuals had lower use of antihypertensive medications and lipid-modifying medications (P<0.01 for all). Across all racial/ethnic subgroups, less than 60% and 30% of people with medication indications received lipid-modifying and antihyperglycemic medications, respectively.Conclusions:Temporal trends suggest an increase in prevalence of MetS. There were persistent racial/ethnic disparities in use of antihypertensive, antihyperglycemic, and lipid-modifying medications among people with medication indications.

Introduction:Digital transformation of medical data present opportunities for novel approaches to manage patients with persistent hypertension (HTN).Methods:This qualitative study was a thematic analysis of clinician notes in the electronic health records of patients in the Yale New Haven Health System. Eligible patients were 18 to 85 years and had blood pressure >=160/100 mmHg at 5 or more consecutive outpatient visits between 1/1/2013 and 12/31/2018. 4,828 patients met criteria. We used conventional qualitative content analysis to develop a pragmatic framework of themes that distinguishes patients with persistent hypertension by their contributing factors. A random sample of 116 records were reviewed and analyzed when no new concepts emerge from analyses of subsequent data.Results:Of 116 patients, mean age was 64.5 (SD, 13.2) years; 55 % were female; 66 %, 21%, and 9% were White, Black, and Hispanic. The three themes emerged: (1) non-response to treatment, where patients were highly medically complex and biological resistance or secondary causes of HTN were significant components of their persistent HTN; (2) non-intensification of treatment, where issues such as provider specialty purview, competing medical priorities, patient preference, and concerns of white coat HTN contributed to treatment plans not being adjusted; (3) non-implementation of treatment plan, where varied concerns including a disconnect in patient education, difficulty obtaining medications, psychosocial barriers, or medication in tolerance caused appropriately escalated treatment plans to not be enacted.Conclusions:Our thematic analysis of patients’ medical records provides insights into actionable factors contributing to persistent HTN. These findings lay a foundation for designing digital tools for health systems to rapidly identify people with persistent HTN and connect them with targeted interventions at scale.

Background:Psychosocial stress is associated with worse cardiac outcomes, but little is known about the prognostic impact of marital stress in young adults (≤55 years) with acute myocardial infarction (AMI). We investigated the association between marital stress and 1-year health outcomes in young AMI survivors.Methods:We used data from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled people aged 18-55 years with AMI (2008-2012). Marital stress was assessed among married/partnered participants at 1 month post-AMI using the Stockholm Marital Stress Scale, categorized as absent/mild, moderate, and severe. Main outcomes were physical/mental health status, generic/disease-specific quality of life, angina, depressive symptoms, and all-cause readmission at 1 year post-AMI. Linear and logistic regression models were sequentially adjusted for baseline health status, demographics, and socioeconomic factors (including education level, income level, employment status, and insurance status).Results:Among the 1593 married/partnered participants in our study, more women reported severe marital stress than men (39.4% vs 30.4%, p=0.001). Having severe marital stress was associated with worse physical and mental health, lower generic and cardiovascular-specific quality of life, more angina and depressive symptoms, and 1.48 times higher all-cause readmission at 1 year post-AMI. These associations remained significant after adjusting for baseline health score and patient demographics (Table Model 1), but they attenuated and became non-significant when further adjusting for socioeconomic factors (Model 2).Conclusion:Marital stress was associated with worse health outcomes in young AMI patients, which can be partially mediated by socioeconomic factors. Further research is needed to understand this complex relationship and potential causal pathway associated with these findings.

Background:Health-related expenditures due to diabetes mellitus (DM) are rising in the US. Medication nonadherence is associated with worse health outcomes, particularly among individuals with DM who require uninterrupted treatment. We sought to determine whether patients with DM in the US report cost-related nonadherence (CRN), a potential consequence of rising drug costs.Methods:We used the National Health Interview Survey (2013-18), a nationally representative study, to identify participants with and without self-reported DM. Participants were considered to have experienced CRN if during the preceding year they reported skipping doses, taking less medication, or delaying filling a prescription to save money.Results:Of the 20,326 participants with DM, a weighted 14% (or 3 million annually) experienced CRN, including 9.5% skipping doses, 9.9% taking less medicine, and 11.8% delaying prescription filling to save money. Compared to those without DM (N=145,186), participants with DM reported a higher prevalence of CRN, with the largest differences being observed among non-elderly adults (Figure). Among non-elderly adults with DM, a weighted 19.4% (or 2.3 million annually) reported CRN. In multivariable logistic regression models, the main drivers of CRN among participants with DM were lack of insurance (OR 4.34, 95% CI 3.49, 5.39), younger age (OR 3.43, 95% CI 2.65, 4.44), low income (OR 1.82, 95% CI 1.58, 2.09), use of insulin (OR 1.19, 95% CI 1.04, 1.35), and unfavorable risk factor profile (OR 1.53, 95% CI 1.21, 1.93) (Table).Conclusion:In the US, 1 in 7 adults with DM reported CRN, and the burden was highest among non-elderly adults. Cost represents a serious barrier for therapy adherence among individuals with DM in the US, particularly among the most vulnerable. Removing financial barriers to accessing medications may improve adherence to essential therapies among individuals with DM, and ultimately improving outcomes.

Introduction:Reducing overall rates of and the racial/ethnic differences in obesity is a public health priority in the US. However, it is unknown how the racial/ethnic differences in different adiposity measures changed in the US population over recent decadesMethods:Using data from the National Health and Nutrition Examination Survey 1999-2018, we determined trends in the racial/ethnic differences of several adiposity measures and whether race/ethnicity moderates the associations between these measures and all-cause mortality. Adiposity measures included overweight (body mass index [BMI] of 25.0-29.9 kg/m2), overall obesity (BMI ≥30.0 kg/m2), abdominal obesity (waist circumference [WC] ≥88 cm for women or ≥102 cm for men), and high body fat (body fat mass percentage [FM] ≥35% for women or ≥25% for men).Results:The study included 49,629 adults aged 18-79 years (mean age 45.3 [SD, 17.9] years, 51.3% women), of whom 12.5% were Black, 15.5% were Latino/Hispanic, and 72.0% were White. Between 1999 and 2018, Latino/Hispanic people had a higher prevalence of overweight, overall obesity, abdominal obesity, and high body fat than White people. The gaps between Latino/Hispanic and White people significantly increased for all adiposity measures (P<0.01 for all measures) during this time. Black people had a higher prevalence of overweight, overall obesity, and abdominal obesity, but a similar prevalence of high body fat compared with White people. There were no significant changes in the gaps between Black and White people for any adiposity measures. For all adiposity measures, the associations between adiposity measures and mortality did not differ by race/ethnicity.Conclusions:Racial/ethnic differences in the prevalence of overweight, overall obesity, abdominal obesity, and high body fat persisted or increased over 20 years, with the differences increasing between Latinos/Hispanics and Whites and not changing between Blacks and Whites.

Introduction:Black and Hispanic adults have poorer hypertension control compared with White adults in the US. Less is known about the country’s progress in eliminating disparities in awareness and treatment of hypertension and whether these differences explain the difference in hypertension control.Methods:We assessed 20-year trends in racial/ethnic differences in awareness, use of medication, and whether these differences help explain racial/ethnic difference in blood pressure (BP) control in the US population, using data from 59,204 hypertensive adults enrolled in the National Health and Nutrition Examination Survey (1999-2018).Results:For all 3 racial groups (White, Black, and Hispanic), hypertension awareness, treatment, and control rates increased between 1999-2013, and then declined between 2014-2018. Although Black adults had a lower BP control rate (odds ratio: 0.77 [0.70-0.85]) compared with White adults, they had a higher awareness rate (1.30 [1.13-1.46]), a similar overall treatment rate (1.07 [0.94-1.19]) and received more intensive antihypertensive therapy (OR for combination therapy 1.32 [1.19-1.45]). Hispanic adults had a significantly lower BP control rate (0.68 [0.59-0.77]), awareness rate (0.76 [0.65-0.85]), overall treatment rate (0.65 [0.55-0.74]) and received less intensive therapy compared with Black and White adults. From 1999-2018, the racial/ethnic differences in awareness, treatment, and BP control persisted and were more pronounced among younger (<60 years of age), male, and lower income adults. Lower awareness and treatment were associated with lower BP control in Hispanics, but not in Blacks.Conclusions:Although Blacks had higher level of awareness and received more intensive antihypertensive therapy, Hispanics were less aware and treated than White. Racial/ethnic differences in awareness and treatment partially explain difference in hypertension control for Hispanics, but not for Blacks.

Introduction:The impact of respiratory failure on patients undergoing left ventricular assist device (LVAD) implantation is not well understood, especially since these patients were excluded from landmark clinical trials.Hypothesis:We assessed the hypothesis that immediate pre- and post-implant respiratory failure is associated with worse outcomes in advanced heart failure patients undergoing LVAD implantation.Methods:We included all patients in the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were implanted with continuous-flow LVADs from 2008 to 2016.Results:Of the 16,362 patients who underwent continuous-flow LVAD placement, 906 (5.5%) required pre-implant intubation within 48 hours prior to implantation, and 1,001 (6.1%) patients developed respiratory failure within 1-week after implantation. A higher proportion of patients requiring pre-implant intubation were INTERMACS Profile 1, required mechanical circulatory support, and presented with cardiac arrest or myocardial infarction (P<0.001, all). At 1-year, 54.3% of patients intubated pre-implant were alive, 20.1% had been transplanted, and 24.2% died (Figure). After multivariable analysis, both pre-implant intubation (Hazard ratio [HR]; 1.24, 95% Confidence Interval [CI], 1.06-1.45; P=0.007) and respiratory failure within 1-week (HR 2.60; 95% CI, 2.31-2.92; P<0.001) were associated with higher all-cause 1-year mortality. Among INTERMACS Profile 1 patients, pre-implant intubation incurred additional risk of death at 1-year (HR 1.67; 95% CI, 1.40-2.00; p<0.001).Conclusions:Respiratory failure both prior to and immediately after LVAD implantation identifies an advanced heart failure population with significantly worse 1-year mortality. This data might be helpful in counseling patients and their families about expectations regarding life with an LVAD.

Background:Left ventricular assist devices (LVADs) improve outcomes in patients with advanced heart failure (HF), but little is known about the role of neurohormonal blockade (NHB) in the clinical management of these patients.Objective:We sought to evaluate the association between NHB and survival in patients with chronic LVADs.Methods:We conducted a retrospective cohort analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and included patients implanted with their first continuous flow LVAD between 2008-2016. We examined survival probability from 6 months to 4 years after implantation based on exposure to different combinations of NHB: angiotensin converting enzyme inhibitors or angiotensin receptor blockers (ACEi/ARB), beta blockers (BB), and mineralocorticoid antagonists (MRA).Results:A total of 12,200 patients met inclusion criteria of which 10,419 were on NHB. Use of any NHB was associated with significantly better survival at 4 years compared with those not on any form of NHB (hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.59-0.75; p<0.001.) Kaplan-Meier survival analysis revealed that patients on triple therapy with an ACEi/ARB, BB, and MRA or dual therapy with an ACEi/ARB and MRA had better survival compared to any other therapy (71.0%, CI 67.4-74.7 versus 55.0%, CI 53.0-57.1; HR 0.60, CI 0.53-0.68; p<0.001) (Figure). After adjusting for change in medication group over time, demographics, comorbidities, and NYHA class, patients on triple therapy had the lowest risk of death compared to patients not on NHB (HR 0.36, CI 0.30-0.42; p<0.001).Conclusion:Use of NHB is associated with improved survival among patients with chronic LVADs. Our results suggest the potential for synergy between intensive NHB and mechanical unloading for patients with advanced HF.Figure.Kaplan-Meier survival curve based on medication group at 6 months post-LVAD implantation (A) and number at risk (B).

Background:The growing out-of-pocket costs among patients with diabetes mellitus (DM) represents a serious risk of financial hardship for Americans. In this study, we describe the national burden of financial hardship from medical bills among non-elderly individuals with DM, and its association with financial distress, food security, cost-related medication non-adherence (CRN), and rates of foregone/delayed medical care.Research Design and Methods:We used the National Health Interview Survey data from 2013 to 2017, including individuals from 18 to 64 years old with a self-reported history of diabetes.Results:of 164,696 surveyed individuals, 123,706 were 18-64 years of age and 8,967 reported having DM, representing 13.1 million non-elderly adults annually across the United States. Mean age was 51.6 years (SD 10.3) and 49.1% were female. An estimated of 5.4 million (41.1%) were part of families that reported having financial hardship from medical bills, with 2 million (15.6%) reporting an inability to pay medical bills at all. In multivariate analyses, individuals who were uninsured had 2.26 (95% CI, 1.82 - 2.81) and 3.22 (95% CI, 2.61 - 3.97) higher odds of having any financial hardship from medical bills and being unable to pay bills at all, respectively. Non-Hispanic Blacks and those with low income or high-comorbidity burden were also at higher risk of such outcomes. When comparing the graded categories of financial hardship from medical bills, there was a stepwise increase in the prevalence of high financial distress, food insecurity, CRN, and foregone/delayed medical care, reaching 70.5%, 49.4%, 49.5%, and 74% among those unable to pay bills, respectively (Figure).Conclusions:Our results highlight that a substantial proportion of non-elderly DM patients and their families in the United States struggle with medical bills and its deleterious unintended consequences.

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