Sex differences in long-term outcomes following acute heart failure hospitalization: Findings from the Get With The Guidelines-Heart Failure registry.

AIMS: Sex differences in long-term outcomes following hospitalization for heart failure (HF) across ejection fraction (EF) subtypes are not well described. In this study, we evaluated the risk of mortality and rehospitalization among males and females across the spectrum of EF over 5 years of follow-up following an index HF hospitalization event. METHODS AND RESULTS: Patients hospitalized with HF between 1 January 2006 and 31 December 2014 from the American Heart Association's Get With The Guidelines-Heart Failure registry with available 5-year follow-up using Medicare Part A claims data were included. The association between sex and risk of mortality and readmission over a 5-year follow-up period for each HF subtype (HF with reduced EF [HFrEF, EF ≤40%], HF with mildly reduced EF [HFmrEF, EF 41-49%], and HF with preserved EF [HFpEF, EF >50%]) was assessed using adjusted Cox models. The effect modification by the HF subtype for the association between sex and outcomes was assessed by including multiplicative interaction terms in the models. A total of 155 670 patients (median age: 81 years, 53.4% female) were included. Over 5-year follow-up, males and females had comparably poor survival post-discharge; however, females (vs. males) had greater years of survival lost to HF compared with the median age- and sex-matched US population (HFpEF: 17.0 vs. 14.6 years; HFrEF: 17.3 vs. 15.1 years; HFmrEF: 17.7 vs. 14.6 years for age group 65-69 years). In adjusted analysis, females (vs. males) had a lower risk of 5-year mortality (adjusted hazard ratio [aHR] 0.89, 95% confidence interval [CI] 0.87-0.90, p < 0.0001), and the risk difference was most pronounced among patients with HFrEF (aHR 0.87, 95% CI 0.85-0.89; pinteraction [sex*HF subtype] = 0.04). Females (vs. males) had a higher adjusted risk of HF readmission over 5-year follow-up (aHR 1.06, 95% CI 1.04-1.08, p < 0.0001), with the risk difference most pronounced among patients with HFpEF (aHR 1.11, 95% CI 1.07-1.14; pinteraction [sex*HF subtype] = 0.001). CONCLUSIONS: While females (vs. males) had lower adjusted mortality, females experienced a significantly greater loss in survival time than the median age- and sex-matched US population and had a greater risk of rehospitalization over 5 years following HF hospitalization.

Effects of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors on cardiovascular and kidney outcomes in Asian versus White patients with type 2 diabetes mellitus.

BACKGROUND: The study aimed to assess the treatment effects of the two medications on cardiovascular and kidney outcomes in Asian compared with White patients with type 2 diabetes mellitus (T2DM). METHODS: MEDLINE, EMBASE, and CENTRAL were searched up to October 31, 2022. We included the trials that assessed the effects of glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium-glucose cotransporter-2 inhibitors (SGLT2i) versus placebo in Asian and White patients with T2DM on major adverse cardiovascular events (MACE) and kidney outcomes. The Bucher method was used to perform an indirect comparison for estimating the differences in treatment effects of GLP-1 RA and SGLT2i between Asian versus White patients. Interaction tests were also performed for treatment-by-race to assess the potential effect modification by race. RESULTS: We included 22 publications from 13 randomized trials. For MACE, there were no differences in treatment effects of GLP-1 RA (HR = 0.84, 95% CI: 0.68-1.04) or SGLT2i (HR = 0.90, 95% CI: 0.72-1.13) in Asian versus White patients. No differences in treatment effects of SGLT2i on kidney outcomes in Asian versus White patients were found (HR = 1.01, 95% CI: 0.75-1.36). There was no significant effect modification by race on cardiovascular and kidney outcomes. CONCLUSIONS: There were no significant differences in treatment effects of GLP-1 RA or SGLT2i for MACE between Asian and White patients with T2DM. Likewise, no significant differences in treatment effects of SGLT2i on kidney outcomes were found between Asian and White patients.

Remote Patient Monitoring for Patients with Heart Failure: Sex- and Race-based Disparities and Opportunities.

Remote patient monitoring (RPM), within the larger context of telehealth expansion, has been established as an effective and safe means of care for patients with heart failure (HF) during the recent pandemic. Of the demographic groups, female patients and black patients are underenrolled relative to disease distribution in clinical trials and are under-referred for RPM, including remote haemodynamic monitoring, cardiac implantable electronic devices (CIEDs), wearables and telehealth interventions. The sex- and race-based disparities are multifactorial: stringent clinical trial inclusion criteria, distrust of the medical establishment, poor access to healthcare, socioeconomic inequities, and lack of diversity in clinical trial leadership. Notwithstanding addressing the above factors, RPM has the unique potential to reduce disparities through a combination of implicit bias mitigation and earlier detection and intervention for HF disease progression in disadvantaged groups. This review describes the uptake of remote haemodynamic monitoring, CIEDs and telehealth in female patients and black patients with HF, and discusses aetiologies that may contribute to inequities and strategies to promote health equity.

Utilization of Implantable Cardioverter Defibrillators Among Patients with a Left Ventricular Assist Device: Insights From a National Database.

The trends of implantable cardioverter defibrillator (ICD) use in patients with a durable left ventricular assist device (LVAD) remain uncertain. We used the National Inpatient Sample to identify hospitalizations between 2009 and 2018 in which patients received a new LVAD or had a pre-existing one. Procedure codes were then used to identify hospitalizations in which a new ICD was implanted. In 34,113 hospitalizations for new and/or replacement LVADs, an ICD was implanted in 1297 (3.8%). The rate of ICD implantation along with an LVAD declined from 2009 to 2018 (annual percent change: -23.2%; P-trend < 0.001). Independent factors associated with concurrent ICD implantation in patients receiving LVAD were younger age, White (compared with Black) race, and in-hospital cardiac arrest. Concurrent ICD implantation was associated with a longer hospital stay (adjusted mean difference: 4.48 days) and higher inflation-adjusted costs (adjusted mean difference: $31,679), but lower in-hospital mortality rates (adjusted odds ratio: 0.29; P < 0.001), compared with LVAD placement alone. Amongst 95,583 hospitalizations of patients with a pre-existing LVAD, an ICD was placed in 616 (0.64%). There was no change in the rate of ICD implantation from 2009 to 2018 in patients with a pre-existing LVAD (annual percent change: -10.34%; P = 0.18).

Relation of Extracardiac Vascular Disease and Outcomes in Patients With Diabetes (1.1 Million) Hospitalized for Acute Myocardial Infarction.

The association between vascular disease and outcomes of patients with acute myocardial infarction (AMI) has not been well-defined in the diabetes mellitus (DM) population. All patients with DM presenting with AMI between October 2015 and December 2018 in the National Inpatient Sample database were stratified by number and site of extracardiac vascular comorbidity (cerebrovascular [CVD], renovascular, neural, retinal and peripheral [PAD] diseases). Multivariable logistic regression was used to determine the adjusted odds ratios (aORs) of in-hospital adverse outcomes and procedures. Of 1,116,670 patients with DM who were hospitalized for AMI, 366,165 had ≥1 extracardiac vascular comorbidity (32.8%). Patients with vascular disease had an increased aOR for mortality (aOR 1.05, 95% confidence interval [CI] 1.04 to 1.07), major adverse cardiovascular and cerebrovascular events (MACCEs) (aOR 1.19, 95% CI 1.18 to 1.21), stroke (aOR 1.72, 95% CI 1.68 to 1.76), and major bleeding (aOR 1.11, 95% CI 1.09 to 1.13) and had lower odds of receiving coronary angiography (CA) (aOR 0.90, 95% CI 0.90 to 0.91) and percutaneous coronary intervention (PCI) (aOR 0.82, 95% CI 0.82 to 0.83) than patients without extracardiac vascular disease. Patients with PAD had the highest odds of mortality (aOR 1.29, 95% CI 1.27 to 1.32), whereas patients with CVD had the greatest odds of MACCEs, stroke, and major bleeding (aOR 1.82, 95% CI 1.78 to 1.87, aOR 4.25, 95% CI 4.10 to 4.40, and aOR 1.51, 95% CI 1.45 to 1.57, respectively). Patients with DM presenting with AMI and concomitant extracardiac vascular disease were more likely to develop clinical outcomes and less likely to undergo CA or PCI. Patients with PAD had the highest risk of mortality, whereas patients with CVD had the greatest risk of MACCEs, stroke, and major bleeding.

The LENT index predicts 30 day outcomes following hospitalization for heart failure.

AIMS: The LE index (Length of hospitalization plus number of Emergent visits ≤6 months) predicts 30 day all-cause readmission or death following hospitalization for heart failure (HF). We combined N-terminal pro-B type natriuretic peptide (NT-proBNP) levels with the LE index to derive and validate the LENT index for risk prediction at the point of care on the day of hospital discharge. METHODS AND RESULTS: In this prospective cohort sub-study of the Patient-centred Care Transitions in HF clinical trial, we used log-binomial regression models with LE index and either admission or discharge NT-proBNP as the predictors and 30 day composite all-cause readmission or death as the primary outcome. No other variables were added to the model. We used regression coefficients to derive the LENT index and bootstrapping analysis for internal validation. There were 772 patients (mean [SD] age 77.0 [12.4] years, 49.9% female). Each increment in the LE index was associated with a 25% increased risk of the primary outcome (RR 1.25, 95% CI 1.16-1.35; C-statistic 0.63). Adjusted for the LE index, every 10-fold increase in admission and discharge NT-proBNP was associated with a 48% (RR 1.48; 95% CI 1.10, 1.99; C-statistic 0.64; net reclassification index [NRI] 0.19) and 56% (RR 1.56; 95% CI 1.08, 2.25; C-statistic 0.64; NRI 0.21) increased risk of the primary outcome, respectively. The predicted probability of the primary outcome increased to a similar extent with incremental LENT, regardless of whether admission or discharge NT-proBNP level was used. CONCLUSIONS: The point-of-care LENT index predicts 30 day composite all-cause readmission or death among patients hospitalized with HF, with improved risk reclassification compared with the LE index. The performance of this simple, 3-variable index - without adjustment for comorbidities - is comparable to complex risk prediction models in HF.

Variations in stepped-wedge cluster randomized trial design: Insights from the Patient-Centered Care Transitions in Heart Failure trial.

The stepped-wedge (SW) cluster randomized controlled trial, in which clusters cross over in a randomized sequence from control to intervention, is ideal for the implementation and testing of complex health service interventions. In certain cases however, implementation of the intervention may pose logistical challenges, and variations in SW design may be required. We examine the logistical and statistical implications of variations in SW design using the optimization of the Patient-Centered Care Transitions in Heart Failure trial for illustration. We review the following complete SW design variations: a typical SW design; an SW design with multiple clusters crossing over per period to achieve balanced cluster sizes at each step; hierarchical randomization to account for higher-level clustering effects; nested substudies to measure outcomes requiring a smaller sample size than the primary outcomes; and hybrid SW design, which combines parallel cluster with SW design to improve efficiency. We also reviewed 3 incomplete SW design variations in which data are collected in some but not all steps to ease measurement burden. These include designs with a learning period that improve fidelity to the intervention, designs with reduced measurements to minimize collection burden, and designs with early and late blocks to accommodate cluster readiness. Variations in SW design offer pragmatic solutions to logistical challenges but have implications to statistical power. Advantages and disadvantages of each variation should be considered before finalizing the design of an SW randomized controlled trial.

Early Unplanned Readmissions After Admission to Hospital With Heart Failure.

Hospital readmissions remain a continued challenge in the care of patients with heart failure (HF). This study aims to examine the rates, temporal trends, predictors and causes of 30-day unplanned readmissions after admission with HF. Patients hospitalized with a primary or secondary diagnosis of HF in the U.S. Nationwide Readmission Database were included. We examined the incidence, trends, predictors and causes of unplanned all-cause readmissions at 30-days. A total of 2,635,673 and 8,342,383 patients were included in the analyses for primary and secondary diagnoses of HF, respectively. The 30-day unplanned readmission rate was 15.1% for primary HF and 14.6% for secondary HF. Predictors of readmission in primary HF included renal failure (OR 1.27 (1.25 to 1.28)), cancer (OR 1.26 (1.22 to 1.29)), receipt of circulatory support (OR 2.81 (1.64 to 4.81)) and discharge against medical advice (OR 2.29 (2.20 to 2.39)). In secondary HF, the major predictors were receipt of circulatory support (OR 1.43 (1.12 to 1.84)) and discharge against medical advice (OR 2.01 95%CI (1.95 to 2.07)). In primary HF 52.4% of patients were readmitted for a noncardiac cause while for secondary HF 73.9% were readmitted for a noncardiac cause. For secondary HF, the strongest predictor of readmission was discharge against medical advice (OR 2.06 95%CI 2.01 to 2.12, p < 0.001). Early unplanned readmissions are common among patients hospitalized with HF, and a majority of readmissions are due to causes other than HF. Our results highlight the need to better manage comorbidities in patients with HF.

Transitional care quality indicators to assess quality of care following hospitalisation for chronic obstructive pulmonary disease and heart failure: a systematic review protocol.

INTRODUCTION: The period following hospitalisation for chronic obstructive pulmonary disease (COPD) or heart failure (HF)-when patients transition between settings and clinicians-is one of high risk. Transitional care services that bridge the gap from hospital to home can improve outcomes, but there are no widely accepted indicators to assess their quality. METHODS AND ANALYSIS: In this systematic review, we will summarise transitional care quality indicators, and describe their associations with clinical, patient-reported and cost outcomes. We will search MEDLINE, Embase, CINAHL and HealthSTAR, as well as grey literature and reference lists of included articles. We will screen all studies published between January 1990 and October 2019 that test an intervention that aims to improve the hospital-to-home transition for patients with COPD and/or HF; and measure at least one process (eg, medication errors), clinical (eg, hospital readmissions) or patient-reported (eg, health-related quality of life) outcome which will serve as a transitional care quality indicator . We will include randomised controlled trials, cohort studies, cross-sectional studies, interrupted time series studies and before-after studies. We will extract data in duplicate and classify transitional care quality indicators as structural, process-related or outcome-related. When possible, we will assess associations between transitional care quality indicators and clinical outcomes. In anticipation of conceptual and statistical heterogeneity, we will provide a qualitative synthesis and narrative review of the results. ETHICS AND DISSEMINATION: This review will provide a list of transitional care quality indicators and their associations with clinical outcomes. These results can be used by hospitals, administrators and clinicians for assessing the quality of transitional care provided to patients with COPD and HF. The findings can also be used by policy-makers to assess and incentivise transitional care quality. We will disseminate results through publications, social media releases and presentations. PROSPERO REGISTRATION NUMBER: This study is registered on PROSPERO.

The Use of Text Messaging to Improve the Hospital-to-Community Transition in Acute Coronary Syndrome Patients (Txt2Prevent): Intervention Development and Pilot Randomized Controlled Trial Protocol.

BACKGROUND: Acute coronary syndrome, including acute myocardial infarction (AMI), is one of the leading causes for hospitalization, with AMI 30-day readmission rates around 20%. Supporting patient information needs and increasing adherence to recommended self-management behaviors during transition from hospital to home has the potential to improve patient outcomes. Text messages have been effective in other interventions and may be suitable to provide support to patients during this transition period. OBJECTIVE: The goal of this study is to pilot test a text messaging intervention program (Txt2Prevent) that supports acute coronary syndrome patients for 60 days postdischarge. The primary objective is to compare self-management, as measured by the Health Education Impact Questionnaire, between patients receiving only usual care versus those who receive usual care plus the Txt2Prevent intervention. The secondary objectives are to compare medication adherence, health-related quality of life, self-efficacy, health care resource use (and associated costs), all-cause and cardiovascular disease (CVD) readmission, and all-cause and CVD mortality rates between the 2 groups. The third objective is to assess acceptability of the text messaging intervention and feasibility of the study protocol. METHODS: This is a randomized controlled trial with blinding of outcome assessors. The Txt2Prevent program includes automated text messages to patients about standard follow-up care, general self-management, and healthy living. The content of the text messages was informed by and developed based on interviews with patients, discharge materials, theoretical domains of behavior, and a clinical advisory group composed of patients, clinicians, and researchers. We will recruit 76 consecutive cardiac in-patients with acute coronary syndrome who are treated with either medical management or percutaneous coronary intervention from a hospital in Vancouver, Canada. RESULTS: Assessments at baseline will include measures for demographic information, self-management, health-related quality of life, and self-efficacy. Assessments at follow-up will include medication adherence, readmissions, health care resource use, and mortality in addition to the reassessment of baseline measures. Baseline assessments are done in-person while follow-up assessments are completed through a combination of mailed packages and phone calls. Semistructured interviews with participants will also be performed to better understand participant experiences managing their condition and with the text messages. CONCLUSIONS: This study will determine preliminary efficacy, feasibility, and acceptability of the Txt2Prevent program to support acute coronary syndrome patients in the transition to home following hospital discharge. The results of this study will be used to inform a larger trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02336919; https://clinicaltrials.gov/ct2/show/NCT02336919 (Archived by WebCite at http://www.webcitation.org/6qMjEqo6O).