Developing a Multilevel Polypill Implementation Bundle for Patients With Heart Failure With Reduced Ejection Fraction.

New heart failure guidelines offer a changing landscape

A polypill containing all 4 classes of guideline-directed medical therapy for heart failure with reduced ejection fraction (HFrEF) has been proposed to change the heart failure treatment paradigm. The acceptability, appropriateness, and feasibility of a HFrEF polypill-based strategy are unknown. The purpose of this study was to elicit patients' and providers' priorities in the design of HFrEF polypills. From April 2023 to December 2023, we conducted a convergent parallel mixed-methods study at Washington University in St. Louis, the University of California, San Francisco, and the American College of Cardiology. We administered physician surveys containing adapted implementation outcome measures to elicit physicians' perspectives on the acceptability, feasibility, and appropriateness of a HFrEF polypill (Likert scale ranging from 1 [low] to 5 [high]). We used a purposive sampling frame to select patients and physicians for in-depth interviews. Using semi-structured interview guides, we elicited participants' perspectives on current HFrEF care, HFrEF polypill design, and supportive strategies. The Consolidated Framework for Implementation Research v2.0 guided thematic analysis. Of the 214 survey respondents across the United States, physicians agreed that HFrEF polypills are highly acceptable (mean [SD], 4.2 [0.7]), highly appropriate (4.1 [0.8]), and highly feasible (4.1 [0.7]). Key themes from 9 patient and 22 provider interviews included the following: (1) current determinants of HFrEF care, including medication adherence, variations in clinical practice, and health care access, (2) provider-level differences in preferred HFrEF polypill design, (3) cost and equity considerations in the implementation of HFrEF polypills, and (4) research priorities for evaluating polypill effectiveness and implementation. A HFrEF polypill-based strategy was viewed as highly acceptable, appropriate, and feasible by patients and physicians. Participants described key priorities in HFrEF polypill design, titratability, and potential impacts on health equity that will directly inform future randomized controlled trials.

Temporal trends in the outcomes of acute heart failure: between consolatory evidences and real progress.

IntroductionA four-drug regimen of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) is underused, in part due to prescriber inertia and low patient adherence. Although fixed-dose...

Racial disparities in guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) have not been fully documented in a community setting. In the ARIC Surveillance Study (2005-2014), we examined racial differences in GDMT at discharge, its temporal trends, and the prognostic impact among individuals with hospitalized HFrEF, using weighted regression models to account for sampling design. Optimal GDMT was defined as beta blockers (BB), mineralocorticoid receptor antagonist (MRA) and ACE inhibitors (ACEI) or angiotensin II receptor blockers (ARB). Acceptable GDMT included either one of BB, MRA, ACEI/ARB or hydralazine plus nitrates (H-N). Of 16,455 (unweighted n = 3,669) HFrEF cases, 47% were Black. Only ~ 10% were discharged with optimal GDMT with higher proportion in Black than White individuals (11.1% vs. 8.6%, p < 0.001). BB use was > 80% in both racial groups while Black individuals were more likely to receive ACEI/ARB (62.0% vs. 54.6%) and MRA (18.0% vs. 13.8%) than Whites, with a similar pattern for H-N (21.8% vs. 10.1%). There was a trend of decreasing use of optimal GDMT in both groups, with significant decline of ACEI/ARB use in Whites (- 2.8% p < 0.01) but increasing H-N use in both groups (+ 6.5% and + 9.2%, p < 0.01). Only ACEI/ARB and BB were associated with lower 1-year mortality. Optimal GDMT was prescribed in only ~ 10% of HFrEF patients at discharge but was more so in Black than White individuals. ACEI/ARB use declined in Whites while H-N use increased in both races. GDMT utilization, particularly ACEI/ARB, should be improved in Black and Whites individuals with HFrEF.

A polypill-based implementation strategy has been proposed to increase rates of guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction. This has the potential to improve mortality and morbidity in India and undertreated populations globally. We conducted a convergent parallel mixed methods study integrating quantitative data from stakeholder surveys using modified implementation science outcome measures and qualitative data from key informant in-depth interviews. Our objective was to explore physician, nurse, pharmacist, and patient perspectives on a HFrEF polypill implementation strategy in India from January 2021 to April 2021. Quantitative and qualitative data were integrated to develop an Implementation Research Logic Model. Among 69 respondents to the stakeholder survey, there was moderate acceptability (mean [SD] 3.8 [1.0]), appropriateness (3.6 [1.0]), and feasibility (3.7 [1.0]) of HFrEF polypill implementation strategy. Participants in the key-informant in-depth interviews (n = 20) highlighted numerous relative advantages of the HFrEF polypill innovation including potential to simplify medication regimens and improve patient adherence. Key relative disadvantages elucidated, include concerns about side effects and interruption of multiple GDMT medications due to polypill discontinuation for side effects or hospitalizations. Based on this data, the proposed implementation strategies in the Implementation Research Logic Model include 1) HFrEF polypills, 2) HFrEF polypill initiation, titration, and maintenance protocols, and 3) HFrEF polypill laboratory monitoring protocols for safety which we postulate will lead to desired clinical and implementation outcomes through multiple mechanisms including increased medication adherence to a single pill. This study demonstrates that a HFrEF polypill-based implementation strategy is considered acceptable, feasible, and appropriate among healthcare providers in India. We identified contextually relevant determinants, strategies, mechanism, and outcomes outlined in an Implementation Research Logic Model to inform future research to improve heart failure care in South Asia.

Introduction: Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) improves clinical outcomes and quality of life. Optimizing GDMT in the hospital is associated with greater long-term use in HFrEF. Hypothesis: A multidisciplinary virtual HF intervention improves GDMT optimization among patients with HFrEF admitted for any cause. Methods: In this pilot randomized, controlled study, consecutive patients with HFrEF admitted to non-cardiology medicine services for any cause were identified at Duke Hospital between May to September 2021. Major exclusions were end-stage renal disease, hemodynamic instability, and hospice care. Patients were randomized to a clinician-level virtual peer-to-peer consult intervention providing GDMT recommendations and information on medication costs vs. usual care. Primary endpoints included 1) proportion of patients with new GDMT initiation or use, and 2) changes to HF optimal medical therapy (OMT) scores which included target dosing (range 0-9). Results: Of 242 patients identified, 91 (38%) were eligible and randomized to intervention (N=52) or usual care (N=39). Baseline characteristics were similar between intervention and usual care (mean age 63 vs. 67 years, 23% vs. 26% female, 46% vs. 49% Black, mean EF 33% vs. 31%). GDMT use on admission was also similar. There were greater proportions of patients with GDMT initiation or continuation with the intervention compared with usual care ( Figure 1 ). After adjusting for OMT score on admission, changes to OMT score at discharge were higher for the intervention group compared with usual care (+0.44 vs. -0.31, absolute difference +0.75, adjusted estimate 0.86 ± 0.42; p=0.041). Conclusions: Among eligible patients with HFrEF hospitalized for any cause on non-cardiology services, a multidisciplinary pilot virtual HF consultation increased new GDMT initiation and dose optimization at discharge.

Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) improves clinical outcomes and quality of life. Optimizing GDMT in the hospital is associated with greater long-term use in HFrEF. This study aimed to describe the efficacy of a multidisciplinary virtual HF intervention on GDMT optimization among patients with HFrEF admitted for any cause. In this pilot randomized, controlled study, consecutive patients with HFrEF admitted to noncardiology medicine services for any cause were identified at a large academic tertiary care hospital between May to September 2021. Major exclusions were end-stage renal disease, hemodynamic instability, concurrent COVID-19 infection, and current enrollment in hospice care. Patients were randomized to a clinician-level virtual peer-to-peer consult intervention providing GDMT recommendations and information on medication costs versus usual care. Primary end points included (1) proportion of patients with new GDMT initiation or use and (2) changes to HF optimal medical therapy scores which included target dosing (range, 0-9). Of 242 patients identified, 91 (38%) were eligible and randomized to intervention (N=52) or usual care (N=39). Baseline characteristics were similar between intervention and usual care (mean age 63 versus 67 years, 23% versus 26% female, 46% versus 49% Black, mean ejection fraction 33% versus 31%). GDMT use on admission was also similar. There were greater proportions of patients with GDMT initiation or continuation with the intervention compared with usual care. After adjusting for optimal medical therapy score on admission, changes to optimal medical therapy score at discharge were higher for the intervention group compared with usual care (+0.44 versus -0.31, absolute difference +0.75, adjusted estimate 0.86±0.42; P=0.041). Among eligible patients with HFrEF hospitalized for any cause on noncardiology services, a multidisciplinary pilot virtual HF consultation increased new GDMT initiation and dose optimization at discharge.

Comparative Effectiveness of Dosing of Medical Therapy for Heart Failure: From the CHAMP-HF Registry

Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction.

A novel algorithm for rapid sequence optimization of guideline directed medical therapy for heart failure with reduced ejection fraction

Clinician perceptions and reasons for non-use of guideline-directed medical therapy for heart failure with reduced ejection fraction in the United States

Background The four pharmacological pillars of heart failure—an angiotensin receptor-neprilysin inhibitor (ARNi), a beta blocker, a mineralocorticoid receptor antagonist (MRA), and a sodium-glucose cotransporter 2 inhibitor (SGLT2i)—must be started for all patients with heart failure with reduced ejection fraction (HFrEF) in accordance with the most recent guidelines [1]. Low dosages of multiple pillars are more beneficial than greater doses of one medication, according to new research. It has been shown that starting all four pharmacological pillars at once offers better protection than starting only one or a few pillars [2–5]. Notwithstanding the encouraging outcomes of several trials, a number of restrictions can prohibit the prescription of more medications beyond the medical therapy guided by guidelines. Methodology A retrospective observational study was conducted on patients diagnosed with Heart Failure with Reduced Ejection Fraction (HFrEF). Patients who presented to our hospital and received an HFrEF diagnosis during a 7-month period from January 2024 to September 2024 were incorporated into this study. A total of 150 HFrEF patients were included. Cardiologists collaborated meticulously to manually annotate and validate the data, encompassing clinical conditions (contraindications) and co-morbidities. Any limitations pertinent to each patient were documented in their respective reports, and this data was subsequently collected and tabulated. Conclusion Starting all four of the pharmacological pillars of heart failure at the same time produces better results than starting only one or a few pillars at a time. The most recent guidelines recommend the initiation of all four pillars for patients with HFrEF. However, numerous limitations may necessitate the initiation of fewer than four pillars of heart failure, deviating from guideline-directed medical therapy.Percentage of patients per pillarLimitations to GDMT for HFrEF

Outpatient Management of Guideline-Directed Medical Therapy for Heart Failure Using Telehealth: A Comparison of In-Office, Video, and Telephone Visits

Strong evidence supports the importance of rapid sequence or simultaneous initiation of quadruple guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) for substantially reducing risk of mortality and hospitalization. Barring absolute contraindications for each individual medication, employing the strategy of rapid sequence, simultaneous, and/or in-hospital initiation at the time of HF diagnosis best ensures patients with HFrEF have the opportunity to benefit from proven medications and achieve large absolute risk reductions for adverse clinical outcomes. However, despite guideline recommendations supporting this approach, implementation in clinical practice remains persistently low, with less than one-fifth of eligible patients being prescribed the quadruple GDMT regimen. Additionally, for heart failure with mildly reduced or preserved ejection fraction (HFpEF), sodium-glucose co-transporter 2 inhibitors (SGLT2i) and non-steroidal mineralocorticoid receptor antagonists (MRA)constitute foundational therapy for all eligible patients with significant clinicalbenefits within just weeks of medication initiation. Nonetheless, the burden of symptoms, functional limitations, and hospitalizations remains substantial for many of these patients, even with SGLT2iand non-steroidal MRA therapy. Additional evidence supports consideration of adjunctive therapies for HF with EF > 40% that can be tailored to the patient phenotype, including glucagon-like peptide-1 receptor agonists (GLP-1 RA) for patients with obesity, as well as angiotensin receptor-neprilysin inhibitors (ARNI) for patients with EF below normal. This article reviews the evidence-based sequencing of GDMT for HF across the spectrum of EF, emphasizing the rationale and benefits of early up-front initiation of quadruple medical therapy for HFrEF, rapid initiation of SGLT2i for HF regardless of EF, and prompt phenotype-specific tailored approach to adjunctive therapies for HF with EF > 40%.