Improving TRansitions ANd outcomeS for heart FailurE patients in home health CaRe (I-TRANSFER-HF): a type 1 hybrid effectiveness-implementation trial: study protocol.

BACKGROUND: Some of the most promising strategies to reduce hospital readmissions in heart failure (HF) is through the timely receipt of home health care (HHC), delivered by Medicare-certified home health agencies (HHAs), and outpatient medical follow-up after hospital discharge. Yet national data show that only 12% of Medicare beneficiaries receive these evidence-based practices, representing an implementation gap. To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits combined with an early outpatient medical visit post-discharge, among HF patients receiving HHC. METHODS: This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF in partnership with four geographically diverse dyads of hospitals and HHAs ("hospital-HHA" dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome), and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHA dyads will be randomized to cross over from a baseline period of no intervention to the intervention in a randomized sequential order. Medicare claims data from each dyad and from comparison dyads selected within the national dataset will be used to ascertain outcomes. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF's implementation using a mixed-methods approach and is guided by the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0). Qualitative interviews will be conducted with key stakeholders across the hospital-HHA dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. DISCUSSION: As the first pragmatic trial of promoting timely HHC and outpatient follow-up in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the implementation of HHC nationally. TRIAL REGISTRATION: This trial has been registered on ClinicalTrials.Gov (#NCT06118983). Registered on 10/31/2023, https://clinicaltrials.gov/study/NCT06118983?id=NCT06118983&rank=1 .

Heart Failure in Older People Part 2: Guideline-Directed Medical Therapy.

Heart failure is a common cardiovascular disease that affects older people and has a high rate of mortality. Treatment for heart failure has evolved in the past 10 years to include novel evidence-based agents as well as changes in how medications are initiated and up-titrated. Despite evidence of the importance of using four guideline-directed medications, older people are often undertreated with these lifesaving therapies. Senior care pharmacists play an important role in heart failure management among older people by providing therapeutic recommendations; monitoring therapeutic interventions; and educating patients, caregivers, and/ or providers.

Feasibility of a digital palliative care intervention (Convoy-Pal) for older adults with heart failure and multiple chronic conditions and their caregivers: a waitlist randomized control trial.

BACKGROUND: Although older adults with heart failure (HF) and multiple chronic conditions (MCC) frequently rely on caregivers for health management, digital health systems, such as patient portals and mobile apps, are designed for individual patients and often exclude caregivers. There is a need to develop approaches that integrate caregivers into care. This study tested the feasibility of the Social Convoy Palliative Care intervention (Convoy-Pal), a 12-week digital self-management program that includes assessment tools and resources for clinical palliative care, designed for both patients and their caregivers. METHODS: A randomized waitlist control feasibility trial involving patients over 65 years old with MCC who had been hospitalized two or more times for HF in the past 12 months and their caregivers. Descriptive statistics were used to evaluate recruitment, retention, missing data, self-reported social functioning, positive aspects of caregiving, and the acceptability of the intervention. RESULTS: Of 126 potentially eligible patients, 11 were ineligible and 69 were deceased. Of the 46 eligible patients, 31 enrolled in the trial. Although 48 caregivers were identified, only 15 enrolled. The average age was 76.3 years for patients and 71.6 years for caregivers, with most participants being non-Hispanic White. Notably, 4% did not have access to a personal mobile device or computer. Retention rates were 79% for intervention patients, 57% for intervention caregivers, and 60% for control participants. Only 4.6% of survey subscales were missing, aided by robust technical support. Intervention patients reported improved social functioning (SF-36: 64.6 ± 25.8 to 73.2 ± 31.3) compared to controls (64.6 ± 27.1 to 67.5 ± 24.4). Intervention caregivers also reported increased positive perceptions of caregiving (29.5 ± 5.28 to 35.0 ± 5.35) versus control caregivers (29.4 ± 8.7 to 28.0 ± 4.4). Waitlist control participants who later joined the Convoy-Pal program showed similar improvements. The intervention was well-rated for acceptability, especially regarding the information provided (3.96 ± .57 out of 5). CONCLUSIONS: Recruiting informal caregivers proved challenging. Nonetheless, Convoy-Pal retained patients and collected meaningful self-reported outcomes, showing potential benefits for both patients and caregivers. Given the importance of a patient and caregiver approach in palliative care, further research is needed to design digital tools that cater to multiple simultaneous users. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04779931. Date of registration: March 3, 2021.

Evaluating the predictive efficacy of real-time 3D echocardiography in cardiac resynchronization therapy.

BACKGROUND: The aim of this study is to assess the predictive efficacy of real-time three-dimensional echocardiography (RT-3DE) and QRS wave duration in determining the response to cardiac resynchronization therapy (CRT) and assessing left ventricular systolic function pre- and post-CRT device implantation. METHOD: A total of 51 patients with heart failure undergoing CRT at the Second Affiliated Hospital of Nantong University between January 1, 2013, and October 31, 2020, were enrolled in this study. Traditional two-dimensional echocardiography and RT-3DE were performed pre and post-CRT, with QRS wave width data from electrocardiograms and additional clinical information collected. Patients were categorized into CRT responder (n = 36) and CRT non-responder (n = 15) groups based on their response to CRT device implantation. Comparative analyses were conducted on the general characteristics of both groups, as well as the predictive efficacy of RT-3DE and QRS wave width for CRT responsiveness and left ventricular systolic function. Data on the standard deviation (Tmsv16-SD, Tmsv12-SD, Tmsv6-SD) and maximum difference (Tmsv16-Dif, Tmsv12-Dif, Tmsv6-Dif) of left ventricular end-systolic volume (LVESV) at segments 16, 12, and 6, as well as QRS wave width, were collected and analyzed. RESULTS: The indicators Tmsv6-Dif, Tmsv12-Dif, Tmsv16-Dif, Tmsv6-SD, Tmsv12-SD, Tmsv16-SD, and QRS wave width exhibited significantly higher values in the CRT responder group when compared to the CRT non-responder group (P < 0.05). Among these, Tmsv16-SD demonstrated superior predictive performance for post-CRT response, with a sensitivity of 88.9%, specificity of 80.0%, and a diagnostic cut-off value of 6.19%. This predictive capability exceeded that of the conventional indicator, QRS wave width. CONCLUSION: RT-3DE enables accurate prediction of post-CRT patient response and significantly facilitates quantitative assessment of CRT therapy efficacy.

Myocardial Revascularization in Heart Failure: A State-of-the-Art Review.

Patients with heart failure (HF) and underlying coronary artery disease (CAD) have a substantially higher risk of mortality compared with those with HF from other causes. However, identifying individuals with HF for whom revascularization is likely to improve prognosis is a complex clinical decision. Revascularization is likely beneficial for patients with CAD-predominant symptoms, such as those with acute myocardial infarction or stable ischemic heart disease with refractory angina. However, for patients with HF-predominant symptoms, characterized by dyspnea without acute myocardial infarction or refractory angina, the benefits of revascularization are less clear. This state-of-the-art review summarizes the outcomes, clinical trials, and therapeutic approaches for patients with both CAD and HF, and proposes a therapeutic algorithm to guide the diagnosis and comprehensive workup of these complex patients.

Non-invasive remote ischemic preconditioning for patients with heart failure undergoing cardiac catheterization: a network meta-analysis of randomized controlled trials.

OBJECTIVE: This study aimed to evaluate the efficacy of six non-invasive remote ischemic preconditioning (RIPC) interventions during the nursing care of patients with heart failure (HF) prior to cardiac catheterization. METHODS: A comprehensive search of nine Chinese and English online databases was conducted from the date of their inception to June 2023 to identify randomized controlled trials (RCTs) investigating RIPC in patients with HF prior to cardiac catheterization. Two independent investigators screened the articles, extracted data, and assessed their quality. The risk of bias was evaluated using the Cochrane risk-of-bias tool, and a network meta-analysis was conducted using R software. RESULTS: Four trials involving 511 patients with a low risk of bias were included in the analysis. Six non-invasive RIPC interventions were identified, all demonstrating effectiveness in reducing the incidence of contrast-induced acute kidney injury (CI-AKI). Among these, Intervention F (applying up to 50 mmHg above the resting systolic pressure for 5 min to the dominant leg or upper limb, repeated three times with an 18-minute interval) was deemed optimal, although the timing of the procedure was not specified. Intervention D (applying up to 200 mmHg pressure to the upper limb for 5 min, repeated four times with 5-minute intervals, within 45 min prior to cardiac catheterization, ) was considered suboptimal. CONCLUSION: Although Intervention D was recommended as the preferred option, none of the four trials examined its impact on the cardiac function of patients with HF. Large-scale, multi-center RCTs are required, with outcome indicators including cardiac function and the occurrence of CI-AKI, to better understand the therapeutic effects of RIPC on HF and reduce the incidence of CI-AKI. This will provide a more robust foundation for clinical practice.

Geometric Changes in Mitral Valve Apparatus during Long-term Cardiac Resynchronization Therapy as Assessed with Cardiac CT.

Purpose To assess long-term geometric changes of the mitral valve apparatus using cardiac CT in individuals who underwent cardiac resynchronization therapy (CRT). Materials and Methods Participants from a randomized controlled trial with cardiac CT examinations before CRT implantation and at 6 months follow-up (Clinicaltrials.gov identifier NCT01323686) were invited to undergo an additional long-term follow-up cardiac CT examination. The geometry of the mitral valve apparatus, including mitral valve annulus area, A2 leaflet angle, tenting height, and interpapillary muscle distances, were assessed. Geometric changes at the long-term follow-up examination were reported as mean differences (95% CI), and the Pearson correlation test was used to assess correlation between statistically significant geometric changes and left ventricular (LV) volumes and function. Results Thirty participants (mean age, 68 years ± 9 [SD]; 25 male participants) underwent cardiac CT imaging after a median long-term follow-up of 9.0 years (IQR, 8.4-9.4). There were reductions in end-systolic A2 leaflet angle (-4° [95% CI: -7, -2]), end-systolic tenting height (-1 mm [95% CI: -2, -1]), and end-systolic and end-diastolic interpapillary muscle distances (-4 mm [95% CI: -6, -2]) compared with pre-CRT implantation values. The mitral valve annulus area remained unchanged. LV end-diastolic and end-systolic volumes decreased (-68 mL [95% CI: -99, -37] and -67 mL [95% CI: -96, -39], respectively), and LV ejection fraction increased (13% [95% CI: 7, 19]) at the long-term follow-up examination. Changes in interpapillary muscle distances showed moderate to strong correlations with LV volumes (r = 0.42-0.72; P < .05), while A2 leaflet angle and tenting height were not correlated to LV volumes or function. Conclusion Among the various geometric changes in the mitral valve apparatus after long-term CRT, the reduction in interpapillary muscle distances correlated with LV volumes while the reduced A2 leaflet angle and tenting height did not correlate with LV volumes. Keywords: Mitral Valve Apparatus, Cardiac Resynchronization Therapy, Cardiac CT Supplemental material is available for this article. © RSNA, 2024.

Health Care Usage During the COVID-19 Pandemic and the Adoption of Telemedicine: Retrospective Study of Chronic Disease Cohorts.

BACKGROUND: The COVID-19 pandemic accelerated telehealth adoption across disease cohorts of patients. For many patients, routine medical care was no longer an option, and others chose not to visit medical offices in order to minimize COVID-19 exposure. In this study, we take a comprehensive multidisease approach in studying the impact of the COVID-19 pandemic on health care usage and the adoption of telemedicine through the first 12 months of the COVID-19 pandemic. OBJECTIVE: We studied the impact of the COVID-19 pandemic on in-person health care usage and telehealth adoption across chronic diseases to understand differences in telehealth adoption across disease cohorts and patient demographics (such as the Social Vulnerability Index [SVI]). METHODS: We conducted a retrospective cohort study of 6 different disease cohorts (anxiety: n=67,578; depression: n=45,570; diabetes: n=81,885; kidney failure: n=29,284; heart failure: n=21,152; and cancer: n=35,460). We used summary statistics to characterize changes in usage and regression analysis to study how patient characteristics relate to in-person health care and telehealth adoption and usage during the first 12 months of the pandemic. RESULTS: We observed a reduction in in-person health care usage across disease cohorts (ranging from 10% to 24%). For most diseases we study, telehealth appointments offset the reduction in in-person visits. Furthermore, for anxiety and depression, the increase in telehealth usage exceeds the reduction in in-person visits (by up to 5%). We observed that younger patients and men have higher telehealth usage after accounting for other covariates. Patients from higher SVI areas are less likely to use telehealth; however, if they do, they have a higher number of telehealth visits, after accounting for other covariates. CONCLUSIONS: The COVID-19 pandemic affected health care usage across diseases, and the role of telehealth in replacing in-person visits varies by disease cohort. Understanding these differences can inform current practices and provides opportunities to further guide modalities of in-person and telehealth visits. Critically, further study is needed to understand barriers to telehealth service usage for patients in higher SVI areas. A better understanding of the role of social determinants of health may lead to more support for patients and help individual health care providers improve access to care for patients with chronic conditions.

Effects of home disease management strategies based on the dyadic illness management theory on elderly patients with chronic heart failure and informal caregivers' physical and psychological outcomes: protocol of a randomized controlled trial.

BACKGROUND: Currently, most elderly chronic heart failure (CHF) patients go home for rehabilitation after certain treatment in hospitals. However, the results of their rehabilitation at home are not satisfactory. According to studies, dyadic treatments can increase the efficiency of home rehabilitation, enhance both partners' quality of life, lessen the caregiver's load of care, and alleviate the strain of medical resources. Thus, the aim of our research is to design a study protocol that included elderly CHF patients and their informal caregivers as an intervention unit and to explore the impact of the protocol on their health and physical outcomes. METHODS: This is a prospective randomized controlled trial conducted in a triple-A hospital. In total, 80 elderly CHF patients and informal caregivers (80 dyads) will be recruited with informed consent. Based on the randomized numbers, they are divided into a control group (40 dyads) and an intervention group (40 dyads), subjects in the control group will receive usual care, and subjects in the intervention group will receive a home-based disease management program based on the Theory of Dyadic Illness Management on the basis of the control group. The duration of the intervention is 3 months, and the follow-up is 6 months. Data is collected at enrolment, 3 months after the intervention, and 3 months after the end of the intervention. The primary outcome is patients' quality of life and readmission. Secondary outcomes include patients' self-management behaviors, anxiety, and depression and caregivers' quality of life and care burden. DISCUSSION: This study focuses on whether this home-based disease management program can improve the quality of life of elderly patients with CHF, reduce the readmission rate, enhance their self-management capacity, reduce negative emotions, and reduce the burden of informal caregivers. It can provide a new perspective on home management and cardiac rehabilitation of heart failure disease in the elderly, as well as alleviate problems such as the burden of healthcare resources. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCRT2300068026. Registered on 3 February 2023, manuscript Version: 1.0,  https://www.chictr.org.cn/ .

Dual Training in Interventional Cardiology: The Next Frontier.

Dual training in Interventional Cardiology (IC) with other cardiac subspecialties such as Advanced Heart Failure and Transplant Cardiology (AHFTC) and Critical Care Cardiology (CCC) is becoming a pathway for trainees to acquire a needed skill set to deliver comprehensive care for increasingly complex patients in the intensive care unit and catheterization laboratory settings. The makeup of these training pathways varies depending on several factors, with the resultant role of the specialist reflecting this reality. Herein, we review the merits to combined fellowship training for the Interventional Cardiologist, the ideal structure of programs to facilitate this, and how the faculty position for such a unique specialist can enhance a program.

Incidence and predictors of unplanned 30-day hospital readmissions among heart failure patients in Ethiopia: a 5-year retrospective cohort study.

The burden of heart failure increases over time and is a leading cause of unplanned readmissions worldwide. In addition, its impact has doubled in countries with limited health resources, including Ethiopia. Identifying and preventing the possible contributing factors is crucial to reducing unplanned hospital readmissions and improving clinical outcomes. The study aimed to assess the incidence and predictors of 30-day unplanned readmission among heart failure patients at selected South Wollo general hospitals in 2022. A hospital-based retrospective cohort study design was employed from January 1, 2016, to December 30, 2020. The data was collected from 572 randomly selected medical records using data extraction checklists. Data were entered in Epi-Data version 4.6 and analyzed with Stata version 17. The Kaplan-Meier and log-rank tests were used to estimate and compare the survival failure time. A Cox proportional hazard analysis was used to identify the predictors of readmission. The statistical significance level was declared at a p-value < 0.05 with an adjusted odds ratio and a 95% confidence interval. A total of 151 (26.40%) heart failure patients were readmitted within 30 days of discharge. Among the study participants, 302 (52.8%) were male, and 370 (64.7%) were rural residents. The mean age was 45.8 ± 14.1 SD years. In the multivariate Cox proportional hazards analysis being an age (> 65 years) (AHR: 3.172, 95% CI:.21, 4.55, P = 0.001), rural in residency (AHR: 2.47, 95%CI: 1.44, 4.24, P = 0.001), Asthma or Chronic Obstructive Pulmonary Disease (AHR: 1.62, 95% CI: 1.11, 2.35, P = 0.012), HIV/AIDS (AHR: 1.84, 95%CI: 1.24, 2.75, P = 0.003), Haemoglobin level 8-10.9 g/dL (AHR: 6.20, 95% CI: 3.74, 10.28, P = 0.001), and Mean platelet volume > 9.1 fl (AHR: 2.08, 95% CI: 1.27, 3.40, P = 0.004) were identified as independent predictors of unplanned hospital readmission. The incidence of unplanned hospital readmission was relatively high among heart failure patients. Elderly patients, rural residency, comorbidity, a higher mean platelet volume, and a low hemoglobin level were independent predictors of readmission. Working on these factors will help reduce the hazards of unplanned hospital readmission.

Health-related quality of life and self-care in heart failure patients under telecare-insights from the randomized, prospective, controlled AMULET trial.

Introduction: The growing population of heart failure (HF) patients places a burden on the healthcare system. Patient-centered outcomes such as health-related quality of life (HRQoL) and self-care behaviors are key elements of modern HF management programs. Thus, optimized strategies to improve these outcomes are sought. Purpose: To assess the effects of a new model of medical telecare on HRQoL and self-care in patients with HF (the AMULET study). Methods: The study was prospective, randomized, open-label, and controlled with two parallel groups: telecare and standard care. In the telecare group, HF nurses performed patient clinical assessments with telemedical support by a cardiologist and provided education focused on the prevention of HF exacerbation. In the standard care group, patients were followed according to standard practices in the existing healthcare system. At the baseline and at 12 months, HRQoL was assessed using the Short Form 36 (SF-36) questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLwHF). The level of self-care was assessed with the 12-item standardized European Heart Failure Self-care Behavior Scale (EHFScBS-12). Results: In the overall study group, 79% of the subjects were male, the mean age was 67 ± 14 years, and 59% of the subjects were older than 65 years of age. The majority of the subjects (70%) had a left ventricular ejection fraction below 40%. After 12 months, statistically significant increases in physical component of the SF-36 (43.3 vs. 47.4 for telecare vs. 43.4 vs. 46.6 for standard care) and mental component of SF-36 (58.4 vs. 62 for telecare vs. 60.4 vs. 64.2 for standard care) were noted, with no intergroup differences. However, patients receiving telecare showed improvement in specific domains, such as physical functioning, role-physical, bodily pain, vitality, social functioning, role-emotional, and mental health. There was a significant decrease in MLwHF (29 vs. 35.0; lower is better) at follow-up for both groups. Telecare patients had a statistically significant decrease in EHFScBS-12 (lower is better) at 12 months. Conclusion: AMULET outpatient telecare, which is based on nurse-led non-invasive assessments supported by specialist teleconsultations, improved the HRQoL and self-care of HF patients after an episode of acute HF.

Implementing a Medicines at Transitions Intervention (MaTI) for patients with heart failure: a process evaluation of the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial.

BACKGROUND: Heart failure is a major global health challenge incurring a high rate of mortality, morbidity and hospitalisation. Effective medicines management at the time of hospital discharge into the community could reduce poor outcomes for people with heart failure. Within the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) programme, the Medicines at Transitions Intervention (MaTI) was co-designed to improve such transitions, with a cluster randomised controlled trial to test effectiveness. The MaTI includes a patient toolkit and transfer of discharge medicines information to community pharmacy. This paper aims to determine the degree to which the intervention was delivered, and identify barriers and facilitators experienced by staff for the successful implementation of the intervention. METHODS: The study was conducted in six purposively selected intervention sites. A mixed-methods design was employed using hospital staff interviews, structured and unstructured ward observations, and routine trial data about adherence to the MaTI. A parallel mixed analysis was applied. Qualitative data were analysed thematically using the Framework method. Data were synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research (CFIR). RESULTS: With limited routines of communication between ward staff and community pharmacy, hospital staff found implementing community pharmacy-related steps of the intervention challenging. Staff time was depleted by attempts to bridge system barriers, sometimes leading to steps not being delivered. Whilst the introduction of the patient toolkit was often completed and valued as important patient education and a helpful way to explain medicines, the medicines discharge log within it was not, as this was seen as a duplication of existing systems. Within the CFIR the most applicable constructs were identified as 'intervention complexity' and 'cosmopolitanism' based on how well hospitals were networked with community pharmacies, and the availability of hospital resources to facilitate this. CONCLUSION: The MaTI was generally successfully implemented, particularly the introduction of the toolkit. However, implementation involving community pharmacy was more challenging and more effective communication systems are needed to support wider implementation. TRIAL REGISTRATION: 11/04/2018 ISRCTN66212970. https://www.isrctn.com/ISRCTN66212970 .