Comparative Effectiveness and Safety of Direct Oral Anticoagulants and Warfarin in Patients With Atrial Fibrillation and Chronic Liver Disease: A Nationwide Cohort Study.

BACKGROUND: The benefit-risk profile of direct oral anticoagulants (DOACs) compared with warfarin, and between DOACs in patients with atrial fibrillation (AF) and chronic liver disease is unclear. METHODS: We conducted a new-user, retrospective cohort study of patients with AF and chronic liver disease who were enrolled in a large, US-based administrative database between January 1, 2011, and December 31, 2017. We assessed the effectiveness and safety of DOACs (as a class and individually) compared with warfarin, and between DOACs in patients with AF and chronic liver disease. The primary outcomes were hospitalization for ischemic stroke/systemic embolism and hospitalization for major bleeding. Inverse probability treatment weights were used to balance the treatment groups on measured confounders. RESULTS: Overall, 10 209 participants were included, with 4421 (43.2%) on warfarin, 2721 (26.7%) apixaban, 2211 (21.7%) rivaroxaban, and 851 (8.3%) dabigatran. The incidence rates per 100 person-years for ischemic stroke/systemic embolism were 2.2, 1.4, 2.6, and 4.4 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. The incidence rates per 100 person-years for major bleeding were 7.9, 6.5, 9.1, and 15.0 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. After inverse probability treatment weights, the risk of hospitalization for ischemic stroke/systemic embolism was significantly lower between DOACs as a class (hazard ratio [HR], 0.64 [95% CI, 0.46-0.90]) or apixaban (HR, 0.40 [95% CI, 0.19-0.82]) compared with warfarin, but not significantly different between rivaroxaban versus warfarin (HR, 0.76 [95% CI, 0.47-1.21]) or rivaroxaban versus apixaban (HR, 1.73 [95% CI, 0.91-3.29]). Compared with warfarin, the risk of hospitalization for major bleeding was lower with DOACs as a class (HR, 0.69 [95% CI, 0.58-0.82]), apixaban (HR, 0.60 [95% CI, 0.46-0.78]), and rivaroxaban (HR, 0.79 [95% CI, 0.62-1.0]). However, the risk of hospitalization for major bleeding was higher for rivaroxaban versus apixaban (HR, 1.59 [95% CI, 1.18-2.14]). CONCLUSIONS: Among patients with AF and chronic liver disease, DOACs as a class were associated with lower risks of hospitalization for ischemic stroke/systemic embolism and major bleeding versus warfarin. However, the incidence of clinical outcomes among patients with AF and chronic liver disease varied between individual DOACs and warfarin, and in head-to-head DOAC comparisons.

Variations in antihypertensive medication treatment and blood pressure control among Veterans with HIV and existing hypertension.

BACKGROUND: Hypertension is a leading risk factor for cardiovascular disease among patients living with HIV (PLWH). Understanding the predictors and patterns of antihypertensive medication prescription and blood pressure (BP) control among PLWH with hypertension (HTN) is important to improve the primary prevention efforts for this high-risk population. We sought to identify important patient-level correlates for (e.g., race) and assess inter-facility variations in antihypertension medication prescriptions and BP control among Veterans living with HIV (VLWH) and HTN. METHODS: We studied VLWH with a diagnosis of HTN who received care in the Veterans Health Administration (VHA) from January 2018 to December 2019. We evaluated HTN treatment and blood pressure control across demographic variables, including race, and by medical comorbidities. Data were also compared among VHA facilities. Predictors of HTN treatment and control were assessed in two-level hierarchical multivariate logistic regression models to estimate odds ratios (ORs). The VHA facility random-effects parameters from the hierarchical models were used to calculate the median odds ratios to characterize the variation across the different VHA facilities. RESULTS: A total of 17,468 VLWH with HTN (mean age 61 years, 97% male, 54% Black, 40% White) who received care within the VHA facilities in 2018-2019 were included. 73% were prescribed antihypertension medications with higher prescription rates among Black versus White patients (75% vs. 71%) and higher prescription rates among patients with a history of cardiovascular disease, diabetes, and kidney disease (>80%), and those receiving antiretroviral therapy and with controlled HIV viral load (∼75%). Only 27% of VLWH with HTN had optimal BP control of systolic BP <130 mmHg and diastolic BP <80 mmHg, with a lower rate of control among Black versus White patients (24% v. 31%). In multivariate regression, Black patients had a higher likelihood of HTN medication prescription (OR 1.32, 95% CI: 1.22-1.42 used Table 3) but were less likely to have optimal BP control (OR 0.82; 0.76-0.88). Important correlates of antihypertensive prescription and optimal BP control included: number of outpatient visits, and histories of diabetes, coronary artery disease, and heart failure. There was about 10% variability in both antihypertensive prescription and BP control patterns between VHA facilities for patients with similar characteristics. There was increased inter-facility variation antihypertensive prescription among those with a history of heart failure and those not receiving antiretroviral therapy. CONCLUSION: In a retrospective analysis of large VHA data, we found that VLWH with HTN have suboptimal antihypertensive medication prescription and BP control. Black VLWH had higher HTN medication prescription rates but lower optimal BP control.

Hostility and prevalent diabetes among black adults: The Jackson Heart Study.

BACKGROUND AND AIMS: The relationship between hostility and the prevalence of diabetes mellitus (DM) among black adults was investigated using the Jackson Heart Study (JHS) cohort. We hypothesized that Cook-Medley Hostility scores will be positively related with the prevalence of DM. METHODS AND RESULTS: A total of 3232 black adults who completed at least one question for each of the three subscales of the Cook-Medley Hostility Scale and had data available regarding DM status were included. Using multivariate logistic regression, we studied the cross-sectional relationship between the overall Total Cook-Medley Hostility scores and individual subscales, hostile affect (n = 3232), aggression (n = 3119) and cynical distrust (n = 3085), with prevalent DM, adjusting for known DM confounders. Our population was 36% male with a mean age of 53.5 ± 0.9 years. In risk-factor adjusted models, each point higher in the overall Total Cook-Medley Hostility scores was associated with increased odds of having DM [Adjusted OR 1.02, 95%CI 1.00-1.04, P = 0.03]. Higher scores of cynicism were independently associated with prevalent DM [Adjusted OR 1.04, 95%CI 1.01-1.07, p = 0.021]. CONCLUSIONS: There was a positive relationship between overall hostility levels and prevalent DM. Future studies should investigate the extent to which additional social determinants may impact the relationship between hostile affect and prevalent DM.

Shared Medical Appointments in Heart Failure for Post Acute Care Follow-Up: A Randomized Controlled Trial.

BACKGROUND: Shared medical appointments (SMAs) in heart failure (HF) are medical visits where several patients with HF meet with multidisciplinary providers at the same time for efficient and comprehensive care. It is unknown whether HF-SMAs can improve overall and cardiac health status for high-risk patients with HF discharged from acute care. METHODS AND RESULTS: A 3-site, open-label, randomized-controlled-trial was conducted. Participants within 12 weeks of HF acute care (emergency-room/hospitalization) requiring intravenous diuretic therapy were randomized to receive either HF-SMA or usual HF clinical care (usual-care) on a 1:1 ratio. The HF-SMA team, which consisted of a nurse, nutritionist, psychologist, nurse practitioner and/or a clinical pharmacist, provided four 2-hour session HF-SMAs that met every other week for 8 weeks. Primary outcomes were the overall health status measured by European Quality of Life Visual Analog Scale and cardiac health status by Kansas City Cardiomyopathy Questionnaire, 180 days postrandomization. Of the 242 patients enrolled (HF-SMA n=117, usual-care n=125, mean age 69.3±9.4 years, 71.5% White patients, 94.6% male), 84% of participants completed the study (n=8 HF-SMA and n=9 usual-care patients died). After 180 days, both HF-SMA and usual-care participants had significant improvements from baseline in Kansas City Cardiomyopathy Questionnaire that were not statistically different. Only HF-SMA participants had significant improvements in European Quality of Life Visual Analog Scale (mean change = 7.2±15.8 in HF-SMA versus -0.4±19.0 points in usual-care, P < 0.001). CONCLUSIONS: Both HF-SMA and usual-care in participants with HF achieved significant improvements in cardiac health status, but only a team approach through HF-SMA achieved significant improvements in overall health status. Future larger studies are needed to evaluate hospitalization and death outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02481921.

Clinical Outcomes After Acute Coronary Syndromes or Revascularization Among People Living With HIV: A Systematic Review and Meta-Analysis.

Importance: Clinical outcomes after acute coronary syndromes (ACS) or percutaneous coronary interventions (PCIs) in people living with HIV have not been characterized in sufficient detail, and extant data have not been synthesized adequately. Objective: To better characterize clinical outcomes and postdischarge treatment of patients living with HIV after ACS or PCIs compared with patients in an HIV-negative control group. Data Sources: Ovid MEDLINE, Embase, and Web of Science were searched for all available longitudinal studies of patients living with HIV after ACS or PCIs from inception until August 2023. Study Selection: Included studies met the following criteria: patients living with HIV and HIV-negative comparator group included, patients presenting with ACS or undergoing PCI included, and longitudinal follow-up data collected after the initial event. Data Extraction and Synthesis: Data extraction was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Clinical outcome data were pooled using a random-effects model meta-analysis. Main Outcome and Measures: The following clinical outcomes were studied: all-cause mortality, major adverse cardiovascular events, cardiovascular death, recurrent ACS, stroke, new heart failure, total lesion revascularization, and total vessel revascularization. The maximally adjusted relative risk (RR) of clinical outcomes on follow-up comparing patients living with HIV with patients in control groups was taken as the main outcome measure. Results: A total of 15 studies including 9499 patients living with HIV (pooled proportion [range], 76.4% [64.3%-100%] male; pooled mean [range] age, 56.2 [47.0-63.0] years) and 1 531 117 patients without HIV in a control group (pooled proportion [range], 61.7% [59.7%-100%] male; pooled mean [range] age, 67.7 [42.0-69.4] years) were included; both populations were predominantly male, but patients living with HIV were younger by approximately 11 years. Patients living with HIV were also significantly more likely to be current smokers (pooled proportion [range], 59.1% [24.0%-75.0%] smokers vs 42.8% [26.0%-64.1%] smokers) and engage in illicit drug use (pooled proportion [range], 31.2% [2.0%-33.7%] drug use vs 6.8% [0%-11.5%] drug use) and had higher triglyceride (pooled mean [range], 233 [167-268] vs 171 [148-220] mg/dL) and lower high-density lipoprotein-cholesterol (pooled mean [range], 40 [26-43] vs 46 [29-46] mg/dL) levels. Populations with and without HIV were followed up for a pooled mean (range) of 16.2 (3.0-60.8) months and 11.9 (3.0-60.8) months, respectively. On postdischarge follow-up, patients living with HIV had lower prevalence of statin (pooled proportion [range], 53.3% [45.8%-96.1%] vs 59.9% [58.4%-99.0%]) and ß-blocker (pooled proportion [range], 54.0% [51.3%-90.0%] vs 60.6% [59.6%-93.6%]) prescriptions compared with those in the control group, but these differences were not statistically significant. There was a significantly increased risk among patients living with HIV vs those without HIV for all-cause mortality (RR, 1.64; 95% CI, 1.32-2.04), major adverse cardiovascular events (RR, 1.11; 95% CI, 1.01-1.22), recurrent ACS (RR, 1.83; 95% CI, 1.12-2.97), and admissions for new heart failure (RR, 3.39; 95% CI, 1.73-6.62). Conclusions and Relevance: These findings suggest the need for attention toward secondary prevention strategies to address poor outcomes of cardiovascular disease among patients living with HIV.

Improving pharmacist knowledge of oral chemotherapy in the community.

BACKGROUND: Approximately 10% of chemotherapy agents are administered orally, with anticipated annual growth of this practice. In the future, community pharmacy practitioners will potentially serve a larger role in the management of patients with cancer. OBJECTIVE: To improve pharmacist confidence, knowledge of oral chemotherapy agents, and dispensing behaviors through live continuing pharmacy education (CPE) programs. METHODS: A prospective cohort study of pharmacists attending live CPE programs in Rhode Island and Maine was conducted between March and May 2010. A survey was administered before and after the educational program; primary outcome measures included change in level of pharmacist confidence in oral chemotherapy knowledge, overall knowledge, and willingness to adjust behavior when dispensing oral chemotherapy agents in community pharmacy. RESULTS: Two hundred fifty-seven of the 410 pharmacists in attendance participated in the survey. Pharmacists significantly improved in confidence level, from no confidence to some confidence (p < 0.001). Counseling the family on the safe handling of oral chemotherapy increased from 37.1% pre-CPE program to 100% post-CPE program. Following the CPE program, behaviors such as (1) using a separate counting tray, (2) wearing gloves, and (3) requiring a double-check improved from 22.5%, 31.5%, and 29.4% baseline to 92.0%, 81.3%, and 81.8%, respectively. All responses to knowledge-based questions improved significantly. CONCLUSIONS: A live CPE program on oral chemotherapy designed to improve pharmacist confidence and knowledge, as well as inform about behaviors, is an effective method. Additional education to improve the knowledge of community-based practitioners to safely dispense and properly counsel patients receiving oral chemotherapy is required.

Benefits of a primary care clinic co-located and integrated in a mental health setting for veterans with serious mental illness.

INTRODUCTION: Efficacy trials have shown that primary care co-located in the mental health setting improves the receipt of high-quality medical care among people with serious mental illness. We tested whether implementation of such a program affected health service use and cardiovascular risk factor control among veterans with serious mental illness who had previously demonstrated limited primary care engagement. METHODS: We performed a cohort study of veterans enrolled in a co-located, integrated primary care clinic in the mental health outpatient unit through targeted chart review. Two successive 6-month periods in the year before and in the year following enrollment in the co-located primary care clinic were examined for primary care and emergency department use and for goal attainment of blood pressure, fasting blood lipids, body mass index (BMI), and, among patients with diabetes, hemoglobin A1c (HbA1c). We used repeated-measures logistic regression to analyze goal attainment and repeated measures Poisson regression to analyze service use. RESULTS: Compared with the period before enrollment, the 97 veterans enrolled in the clinic had significantly more primary care visits during 6 months and significantly improved goal attainment for blood pressure, low-density lipoprotein cholesterol, triglycerides, and BMI. Changes with regard to goal attainment for high-density lipoprotein cholesterol and HbA1c were not significant. CONCLUSION: Enrollment in a co-located, integrated clinic was associated with increased primary care use and improved attainment of some cardiovascular risk goals among veterans with serious mental illness. Such a clinic can be implemented effectively in the mental health setting.

Association between median household income, state Medicaid expansion status, and COVID-19 outcomes across US counties.

OBJECTIVE: To study the relationship between county-level COVID-19 outcomes (incidence and mortality) and county-level median household income and status of Medicaid expansion of US counties. METHODS: Retrospective analysis of 3142 US counties was conducted to study the relationship between County-level median-household-income and COVID-19 incidence and mortality per 100,000 people in US counties, January-20th-2021 through December-6th-2021. County median-household-income was log-transformed and stratified by quartiles. Multilevel-mixed-effects-generalized-linear-modeling adjusted for county socio-demographic and comorbidities and tested for Medicaid-expansion-times-income-quartile interaction on COVID-19 outcomes. RESULTS: There was no significant difference in COVID-19 incidence-rate across counties by income quartiles or by Medicaid expansion status. Conversely, for non-Medicaid-expansion states, counties in the lowest income quartile had a 41% increase in COVID-19 mortality-rate compared to counties in the highest income quartile. Mortality-rate was not related to income in counties from Medicaid-expansion states. CONCLUSIONS: Median-household-income was not related to COVID-19 incidence-rate but negatively related to COVID-19 mortality-rate in US counties of states without Medicaid-expansion.

Healthcare providers experiences with shared medical appointments for heart failure.

Shared medical appointments (SMAs) offer a means for providing knowledge and skills needed for chronic disease management to patients. However, SMAs require a time and attention investment from health care providers, who must understand the goals and potential benefits of SMAs from the perspective of patients and providers. To better understand how to gain provider engagement and inform future SMA implementation, qualitative inquiry of provider experience based on a knowledge-attitude-practice model was explored. Semi-structured interviews were conducted with 24 health care providers leading SMAs for heart failure at three Veterans Administration Medical Centers. Rapid matrix analysis process techniques including team-based qualitative inquiry followed by stakeholder validation was employed. The interview guide followed a knowledge-attitude-practice model with a priori domains of knowledge of SMA structure and content (understanding of how SMAs were structured), SMA attitude/beliefs (general expectations about SMA use), attitudes regarding how leading SMAs affected patients, and providers. Data regarding the patient referral process (organizational processes for referring patients to SMAs) and suggested improvements were collected to further inform the development of SMA implementation best practices. Providers from all three sites reported similar knowledge, attitude and beliefs of SMAs. In general, providers reported that the multi-disciplinary structure of SMAs was an effective strategy towards improving clinical outcomes for patients. Emergent themes regarding experiences with SMAs included improved self-efficacy gained from real-time collaboration with providers from multiple disciplines, perceived decrease in patient re-hospitalizations, and promotion of self-management skills for patients with HF. Most providers reported that the SMA-setting facilitated patient learning by providing opportunities for the sharing of experiences and knowledge. This was associated with the perception of increased comradery and support among patients. Future research is needed to test suggested improvements and to develop best practices for training additional sites to implement HF SMA.

Pharmacist-led group medical appointments for the management of type 2 diabetes with comorbid depression in older adults.

BACKGROUND: Depression is associated with poor glycemic control, increased number of microvascular and macrovascular complications, functional impairment, mortality, and 4.5 times higher total health care costs in patients with diabetes. Shared medical appointments (SMAs) may be an effective method to attain national guideline recommendations for glycemic control in diabetes for patients with depression through peer support, counseling, problem solving, and improved access to care. OBJECTIVE: To test the efficacy as assessed by attainment of a hemoglobin A(1c) (A1C) <7% of pharmacist-led group SMA visits, Veterans Affairs Multidisciplinary Education in Diabetes and Intervention for Cardiac Risk Reduction in Depression (VA-MEDIC-D), in patients with type 2 diabetes mellitus. METHODS: This was a randomized controlled trial of VA-MEDIC-D added to standard care versus standard care alone in depressed patients with diabetes with A1C >6.5%. VA-MEDIC-D consisted of 4 once-weekly, 2-hour sessions followed by 5 monthly 90-minute group sessions. Each SMA session consisted of multidisciplinary education and pharmacist-led behavioral and pharmacologic interventions for diabetes, lipids, smoking, and blood pressure. No pharmacologic interventions for depression were provided. The change in the proportion of participants who achieved an A1C <7% at 6 months was compared. RESULTS: Compared to standard care (n = 44), a lower proportion of patients in VA-MEDIC-D (n = 44) had systolic blood pressure (SBP) <130 mm Hg at baseline, but were similar in other cardiovascular risk factors and psychiatric comorbidity. The change in the proportion of participants achieving an A1C <7% was greater in the VA-MEDIC-D arm than in the standard care arm (29.6% vs 11.9%), with odds ratio 3.6 (95% CI 1.1 to 12.3). VA-MEDIC-D participants also achieved significant reductions in SBP, low-density lipoprotein cholesterol, and non-high-density lipoprotein (HDL) cholesterol from baseline, whereas significant reductions were attained only in non-HDL cholesterol with standard care. There was no significant change in depressive symptoms for either arm. CONCLUSIONS: Pharmacist-led group SMA visits are efficacious in attainment of glycemic control in patients with diabetes and depression without change in depression symptoms.

Required warfarin dose and time in therapeutic range in patients with diagnosed Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH).

Warfarin has been widely used to treat thromboembolism. The effect of nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), on warfarin dosing remains unknown. This study aims to examine the effects of NAFLD/NASH on the average daily dose (ADD) of warfarin and the time in therapeutic range (TTR). This is a retrospective study utilizing an administrative data. We included patients with at least 2 months of warfarin dispensing and two subsequent consecutive INR measures. The ADD of warfarin to achieve therapeutic range INR levels, and TTR were compared between patients with and without NAFLD/NASH in four subgroups of patients accounting for the presence of obesity and diabetes. Generalized linear models (GLM) with Propensity score (PS) fine stratification were applied to evaluate the relative differences (RD) of warfarin ADD and TTR (>60%) in four subgroups. A total of 430 NAFLD/NASH patients and 38,887 patients without NAFLD/NASH were included. The ADD and TTR, were not significant in the overall cohort between those with and without NAFLD/NASH. However, GLM results in patients without diabetes or obesity (N = 26,685) showed a significantly lower warfarin ADD (RD: -0.38; 95%CI: -0.74--0.02) and shorter TTR (OR: 0.71; 95%CI: 0.52-0.97) in patients diagnosed with NAFLD/NASH. The effects of NAFLD/NASH on warfarin dose or TTR were observed in patients without obesity and diabetes. Obesity and diabetes appear to be significant modifiers for the effects of NAFLD/NASH on warfarin dose and TTR.

Maintenance of risk factor control in diabetic patients with and without mental health conditions after discharge from a cardiovascular risk reduction clinic.

BACKGROUND: Diabetes and hypertension can be challenging to manage in patients with mental health conditions. While the effectiveness of a cardiovascular risk reduction clinic (CRRC) has been shown not to differ between those with and without mental health conditions, it is unknown whether patients with mental health conditions would differ in durability of success following discharge from the CRRC. OBJECTIVE: To determine the effect of mental health conditions on the maintenance of glycemic control and blood pressure control in patients with diabetes following successful completion of a CRRC program. METHODS: Patients were discharged from the CRRC when therapeutic goals of hemoglobin A(1c) (A1C) <7% and blood pressure <130/80 mm Hg were achieved. We performed a retrospective chart review of a cohort of 231 patients by quarterly intervals for A1C and systolic blood pressure (SBP), providing up to 3 years of data following discharge from the CRRC. We assessed the time to failure to maintain goal A1C and SBP following CRRC discharge for patients with diagnosed mental health conditions versus patients without mental health conditions. RESULTS: For patients with and without mental health conditions, 50% of those who had been discharged from the CRRC with an SBP goal of <130 mm Hg failed to maintain SBP by 1 quarter. The hazard ratio for failure to maintain SBP, with those without mental health conditions as the reference group, was 0.96 (95% CI 0.68 to 1.35). Overall, for patients with an A1C goal of <7%, the combined median time to failure was 3 quarters. Among patients without mental health conditions, 25% failed in 3 quarters, and of those with mental health conditions, 25% failed in 4 quarters (HR 0.91; 95% CI 0.50 to 1.66). CONCLUSIONS: There was no significant difference between diabetic patients with and without mental health conditions in maintenance of A1C and SBP after discharge from a CRRC. This provides further evidence that a CRRC is a viable approach to cardiovascular risk reduction in individuals with mental health conditions.

Pharmacist-led telehealth disease management program for patients with diabetes and depression.

INTRODUCTION: The aim of this study was to determine whether a pharmacist-led telehealth disease management program is superior to usual care of nurse-led telehealth in improving diabetes medication adherence, haemoglobin A1C (A1C), and depression scores in patients with concomitant diabetes and depression. METHODS: Patients with diabetes and depression were randomized to pharmacist-led or nurse-led telehealth. Veterans with type 1 or type 2 diabetes, an A1C ≥ 7.5%, diagnosis of depression, and access to a landline phone were invited to participate. Patients were randomized to usual care of nurse-led telehealth or pharmacist-led telehealth. Patients were shown how to use the telehealth equipment by the nurse or pharmacist. In the pharmacist-led group, the patients received an in-depth medication review in addition to the instruction on the telehealth equipment. RESULTS: After six months, the pharmacist-led telehealth arm showed significant improvements for cardiovascular medication adherence (14.0; 95% confidence interval (CI) 0.4 to 27.6), antidepressant medication adherence (26.0; 95% CI 0.9 to 51.2), and overall medication adherence combined (13.9; 95% CI 6.6 to 21.2) from baseline to six-month follow-up. There was a significant difference in A1C between each group at the six-month follow-up in the nurse-led telehealth group (6.9 ± 0.9) as compared to the pharmacist-led telehealth group (8.8 ± 2.0). There was no significance in the change in patient health questionnaire-9 (PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D) from baseline to follow-up in both groups. DISCUSSION: Pharmacist-led telehealth was efficacious in improving medication adherence for cardiovascular, antidepressants, and overall medications over a six-month period as compared to nurse-led telehealth. There was no significant improvement in overall depression scores.

Ambulatory Intravenous Diuretic Clinic Associated with Short-Term Risk Reduction in Mortality and Rehospitalizations in Patients Discharged with Heart Failure.

BACKGROUND: Data on effectiveness of ambulatory intravenous (IV) diuretic clinics for volume management in patients with heart failure to prevent rehospitalization and mortality are limited. Therefore, the primary goal of this research is to evaluate the effectiveness of an out- patient multidisciplinary IV diuretic clinic versus standard observational hospitalizations of less than 48 hours for decompensated heart failure on the time to rehospitalization or death. METHODS: A retrospective cohort study of patients with heart failure (n=90) at the Providence Veterans Affairs Medical Center was conducted. Patients were included in the analyses if they received at least one ambulatory IV diuretic clinic visit or an observational hospitalization of less than 48 hours for decompensated heart failure between January 1, 2014 and June 30, 2016. Using Cox proportional hazards modeling, we compared the time to any hospitalization or death between the IV clinic and the observational hospitalization cohort over 180 days of follow-up. RESULTS: In the ambulatory IV diuretic clinic group, 27 patients (mean age 78.3 ± 8.3 years) received a median of 3 (interquartile range [IQR] 2-12), IV diuretic treatments. In the comparison group, 63 patients (mean age 80.3 ± 11.0 years) were hospitalized for observation for 48 hours or less during the same time period. Adjusting for age and imbalances in baseline characteristics, left ventricular ejection fraction and enrollment in hospice care, the hazards of any hospitalization or death (HR 0.39, 95% confidence interval 0.19 to 0.83) were reduced for patients in the ambulatory IV diuretic clinic versus those in the observational hospitalization cohort. CONCLUSIONS: In patients with decompensated heart failure, an ambulatory IV diuretic clinic was associated with risk reduction of any rehospitalization or death over 180 days of follow up when compared to a strategy of observational hospitalization for less than 48 hours. Future research should prospectively analyze outpatient IV therapy in a larger and more diverse population.

Relationship Between Dietary Magnesium Intake and Incident Heart Failure Among Older Women: The WHI.

Background Women represent a large proportion of the growing heart failure (HF) epidemic, yet data are lacking regarding optimal dietary and lifestyle prevention strategies for them. Specifically, the association between magnesium intake and HF in a multiracial cohort of women is uncertain. Methods and Results We included 97 725 postmenopausal women from the WHI (Women's Health Initiative) observational studies and placebo arms of the hormone trial. Magnesium intake was measured at baseline by a 122-item validated food-frequency questionnaire and stratified into quartiles based on diet only, total intake (diet with supplements), and residual intake (calibration by total energy). Incident hospitalized HF (2153 events, median follow-up 8.1 years) was adjudicated by medical record abstraction. In Cox proportional hazards models, we evaluated the association between magnesium intake and HF adjusting for potential confounders. Analyses were repeated on a subcohort (n=18 745; median-follow-up, 13.2 years) for whom HF cases were subclassified into preserved ejection fraction (526 events), reduced ejection fraction (291 events) or unknown (168 events). Most women were white (85%) with a mean age of 63. Compared with the highest quartile of magnesium intake, women in the lowest quartile had an increased risk of incident HF, with adjusted hazard ratios of 1.32 (95% CI, 1.02-1.71) for diet only (P trend=0.03), 1.26 (95% CI, 1.03-1.56) for total intake, and 1.31 (95% CI, 1.02-1.67) for residual intake. Results did not significantly vary by race. Subcohort analyses showed low residual magnesium intake was associated with HF with reduced ejection fraction (hazard ratio, 1.81, lowest versus highest quartile; 95% CI, 1.08-3.05) but not HF with preserved ejection fraction. Conclusions Low magnesium intake in a multiracial cohort of postmenopausal women was associated with a higher risk of incident HF, especially HF with reduced ejection fraction.

Maintenance of cardiovascular risk goals in veterans with diabetes after discharge from a cardiovascular risk reduction clinic.

The authors evaluated maintenance of achieved cardiovascular risk control after discharge from a pharmacist-coordinated cardiovascular risk reduction clinic. Using data from 2001 to 2004 divided by financial quarters (ie, 3-month periods), the authors performed survival analysis of diabetic patients who had attained at least one cardiovascular risk goal in the clinic. Mean times to failure were 7.1 +/- 0.21 quarters for hemoglobin A1c, 7.6 +/- 0.29 quarters for low-density lipoprotein cholesterol (LDL-C), and 2.5 +/- 0.24 quarters for systolic blood pressure (SBP). Body mass index predicted glycemic control failure (hazard ratio [HR], 1.08; 95% confidence interval [CI], 1.01-1.15; P = .02), insulin use predicted LDL-C control failure (HR, 3.08; 95% CI, 1.15-8.22; P = .03), and baseline SBP predicted SBP control failure (HR, 1.02; 95% CI, 1.01-1.03; P = .0003). The authors found good durability of effect for most cardiovascular risk targets. Worse control at entry predicted failure after successful attainment of a cardiovascular goal. More sustained attention or booster interventions for patients with worse control at entry may be necessary.

Home-Based Cardiac Rehabilitation Alone and Hybrid With Center-Based Cardiac Rehabilitation in Heart Failure: A Systematic Review and Meta-Analysis.

Background Center-based cardiac rehabilitation (CBCR) has been shown to improve outcomes in patients with heart failure (HF). Home-based cardiac rehabilitation (HBCR) can be an alternative to increase access for patients who cannot participate in CBCR. Hybrid cardiac rehabilitation (CR) combines short-term CBCR with HBCR, potentially allowing both flexibility and rigor. However, recent data comparing these initiatives have not been synthesized. Methods and Results We performed a meta-analysis to compare functional capacity and health-related quality of life (hr-QOL) outcomes in HF for (1) HBCR and usual care, (2) hybrid CR and usual care, and (3) HBCR and CBCR. A systematic search in 5 standard databases for randomized controlled trials was performed through January 31, 2019. Summary estimates were pooled using fixed- or random-effects (when I2>50%) meta-analyses. Standardized mean differences (95% CI) were used for distinct hr-QOL tools. We identified 31 randomized controlled trials with a total of 1791 HF participants. Among 18 studies that compared HBCR and usual care, participants in HBCR had improvement of peak oxygen uptake (2.39 mL/kg per minute; 95% CI, 0.28-4.49) and hr-QOL (16 studies; standardized mean difference: 0.38; 95% CI, 0.19-0.57). Nine RCTs that compared hybrid CR with usual care showed that hybrid CR had greater improvements in peak oxygen uptake (9.72 mL/kg per minute; 95% CI, 5.12-14.33) but not in hr-QOL (2 studies; standardized mean difference: 0.67; 95% CI, -0.20 to 1.54). Five studies comparing HBCR with CBCR showed similar improvements in functional capacity (0.0 mL/kg per minute; 95% CI, -1.93 to 1.92) and hr-QOL (4 studies; standardized mean difference: 0.11; 95% CI, -0.12 to 0.34). Conclusions HBCR and hybrid CR significantly improved functional capacity, but only HBCR improved hr-QOL over usual care. However, both are potential alternatives for patients who are not suitable for CBCR.

Effectiveness of a multifactorial cardiovascular risk reduction clinic for diabetes patients with depression.

INTRODUCTION: Depression may attenuate the effects of diabetes interventions. Our ongoing Cardiovascular Risk Reduction Clinic simultaneously addresses hyperglycemia, hypertension, smoking, and hyperlipidemia. We examined the relationship between depression diagnosis and responsiveness to the Cardiovascular Risk Reduction Clinic. METHODS: We studied Cardiovascular Risk Reduction Clinic participants with diabetes who had a depression diagnosis and those with no mental health diagnosis. Our outcome measure was change in 20-year cardiovascular mortality risk according to the United Kingdom Prospective Diabetes Study (UKPDS) score. RESULTS: Of 231 participants, 36 (15.6%) had a depression diagnosis. Participants with a depression diagnosis had a higher baseline UKPDS score (56.8 [SD 21.3]) than participants with no mental health diagnosis (49.5 [SD 18.7], P = .04). After Cardiovascular Risk Reduction Clinic participation, mean UKPDS scores did not differ significantly (37.8 [SD 15.9] for no mental health diagnosis and 39.4 [SD 18.6] for depression diagnosis). Mean UKPDS score reduction was 11.6 [SD 15.6] for no mental health diagnosis compared with 18.4 [SD 15.9] for depression diagnosis (P = .03). Multivariable linear regression that controlled for baseline creatinine, number of Cardiovascular Risk Reduction Clinic visits, sex, and history of congestive heart failure showed significantly greater improvement in UKPDS score among participants with a depression diagnosis (beta = 6.0, P = .04) and those with more Cardiovascular Risk Reduction Clinic visits (beta = 2.1, P < .001). CONCLUSION: The Cardiovascular Risk Reduction Clinic program reduced cardiovascular disease risk among patients with diabetes and a diagnosis of depression. Further work should examine how depressive symptom burden and treatment modify the effect of this collaborative multifactorial program and should attempt to determine the durability of the effect.

Cognitive Function in Individuals with Normal Weight Obesity: Results from the Third National Health and Nutrition Examination Survey (NHANES III).

BACKGROUND/OBJECTIVE: Normal weight obesity (NWO) is associated with increased risk of metabolic syndrome, cardiovascular- and all-cause mortality. However, no data have been reported on the relationship between adiposity and cognitive performance in NWO. We therefore studied the association between cognitive function and body fat percentage (BF%) in NWO, using a representative sample of the United States population. METHODS: A cross-sectional study was performed using the nationwide 1988 to 1994 data set from the Third National Health and Nutrition Examination Survey. Cognitive function was measured by three validated cognitive tests: simple reaction time test (SRTT), symbol digit substitution test (SDST), and serial digit learning test (SDLT). The association between BF% and cognitive performance was evaluated in 2,039 adults aged 20-59 years and with a body mass index ranging from 18.5 to 24.9 kg/m2. Linear regression modeling was used to adjust for potential confounders. RESULTS: Increased BF% was significantly associated with poorer performance on SDLT in the entire study sample (coefficient [95% CI]: 0.15 [0.01, 0.29]) and with poorer performance on SDST in the age group 20-29 years (coefficient [95% CI]: 0.30 [0.10, 0.49]). Increased BF% did not significantly predict poorer performance on SRTT. CONCLUSION: Higher BF% is significantly associated with poorer cognitive function in a nationally representative sample of US adults with NWO. The identification of possible complications associated with increased adipose tissue underlines the need to measure body fat content in NWO individuals, whose metabolic and cognitive dysfunction could go undetected for years due to their young age and normal body weight.

Costs and effectiveness of pharmacist-led group medical visits for type-2 diabetes: A multi-center randomized controlled trial.

OBJECTIVES: The effectiveness and costs associated with addition of pharmacist-led group medical visits to standard care for patients with Type-2 Diabetes Mellitus (T2DM) is unknown. METHODS: Randomized-controlled-trial in three US Veteran Health Administration (VHA) Hospitals, where 250 patients with T2DM, HbA1c >7% and either hypertension, active smoking or hyperlipidemia were randomized to either (1) addition of pharmacist-led group-medical-visits or (2) standard care alone for 13 months. Group (4-6 patients) visits consisted of 2-hour, education and comprehensive medication management sessions once weekly for 4 weeks, followed by quarterly visits. Change from baseline in cardiovascular risk estimated by the UKPDS-risk-score, health-related quality-of-life (SF36v) and institutional healthcare costs were compared between study arms. RESULTS: After 13 months, both groups had similar and significant improvements from baseline in UKPDS-risk-score (-0.02 ±0.09 and -0.04 ±0.09, group visit and standard care respectively, adjusted p<0.05 for both); however, there was no significant difference between the study arms (adjusted p = 0.45). There were no significant differences on improvement from baseline in A1c, systolic-blood-pressure, and LDL as well as health-related quality-of-life measures between the study arms. Compared to 13 months prior, the increase in per-person outpatient expenditure from baseline was significantly lower in the group visit versus the standard care arm, both during the study intervention period and at 13-months after study interventions. The overall VHA healthcare costs/person were comparable between the study arms during the study period (p = 0.15); then decreased by 6% for the group visit but increased by 13% for the standard care arm 13 months post-study (p<0.01). CONCLUSIONS: Addition of pharmacist-led group medical visits in T2DM achieved similar improvements from baseline in cardiovascular risk factors than usual care, but with reduction in the healthcare costs in the group visit arm 13 months after completion compared to the steady rise in cost for the usual care arm. TRIAL REGISTRATION: NCT00554671 ClinicalTrials.gov.