Contemporary American and European Guidelines for Heart Failure Management: JACC: Heart Failure Guideline Comparison.

This review serves to compare contemporary clinical practice recommendations for the management of heart failure (HF), as codified in the 2021 European Society of Cardiology (ESC) guideline, the 2022 American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) guideline, and the 2023 focused update of the 2021 ESC document. Overall, these guidelines aim to solidify significant advances throughout the HF continuum since the publication of previous full guideline iterations (2013 and 2016 for the ACC/AHA and ESC, respectively). All guidelines provide new recommendations for an increasingly complex landscape of HF care, with focus on primary HF prevention, HF stages, rapid initiation and optimization of evidence-based pharmacotherapies, overlapping cardiac and noncardiac comorbidities, device-based therapies, and management pathways for special groups of patients, including those with cardiac amyloidosis. Importantly, the ACC/AHA/HFSA document features special emphasis on HF risk prediction and screening, cost/value, social determinants of health, and health care disparities. The review discusses major similarities and differences between these recent guidelines and guideline updates, as well as their potential downstream implications for clinical care.

Incidence, risk assessment and prevention of sudden cardiac death in cardiomyopathies.

Cardiomyopathies are a significant contributor to cardiovascular morbidity and mortality, mainly due to the development of heart failure and increased risk of sudden cardiac death (SCD). Despite improvement in survival with contemporary treatment, SCD remains an important cause of mortality in cardiomyopathies. It occurs at a rate ranging between 0.15% and 0.7% per year (depending on the cardiomyopathy), which significantly surpasses SCD incidence in the age- and sex-matched general population. The risk of SCD is affected by multiple factors including the aetiology, genetic basis, age, sex, physical exertion, the extent of myocardial disease severity, conduction system abnormalities, and electrical instability, as measured by various metrics. Over the past decades, the knowledge on the mechanisms and risk factors for SCD has substantially improved, allowing for a better-informed risk stratification. However, unresolved issues still challenge the guidance of SCD prevention in patients with cardiomyopathies. In this review, we aim to provide an in-depth discussion of the contemporary concepts pertinent to understanding the burden, risk assessment and prevention of SCD in cardiomyopathies (dilated, non-dilated left ventricular, hypertrophic, arrhythmogenic right ventricular, and restrictive). The review first focuses on SCD incidence in cardiomyopathies and then summarizes established and emerging risk factors for life-threatening arrhythmias/SCD. Finally, it discusses validated approaches to the risk assessment and evidence-based measures for SCD prevention in cardiomyopathies, pointing to the gaps in evidence and areas of uncertainties that merit future clarification.

Mortality, Outcomes, Costs, and Use of Medicines Following a First Heart Failure Hospitalization: EVOLUTION HF.

BACKGROUND: There are few contemporary data on outcomes, costs, and treatment following a hospitalization for heart failure (hHF) in epidemiologically representative cohorts. OBJECTIVES: This study sought to describe rehospitalizations, hospitalization costs, use of guideline-directed medical therapy (GDMT) (renin-angiotensin system inhibitors, sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors), and mortality after hHF. METHODS: EVOLUTION HF (Utilization of Dapagliflozin and Other Guideline Directed Medical Therapies in Heart Failure Patients: A Multinational Observational Study Based on Secondary Data) is an observational, longitudinal cohort study using data from electronic health records or claims data sources in Japan, Sweden, the United Kingdom, and the United States. Adults with a first hHF discharge between 2018 and 2022 were included. The 1-year event rates per 100 patient-years (ERs) for death and rehospitalizations (with a primary diagnosis of heart failure (HF), chronic kidney disease [CKD], myocardial infarction, stroke, or peripheral artery disease) were calculated. Hospital health care costs were cumulatively summarized. Cumulative GDMT use was assessed using Kaplan-Meier estimates. RESULTS: Of 263,525 patients, 28% died within the first year post-hHF (ER: 28.4 [95% CI: 27.0-29.9]). Rehospitalizations were mainly driven by HF (ER: 13.6 [95% CI: 9.8-17.4]) and CKD (ER: 4.5 [95% CI: 3.6-5.3]), whereas the ERs for myocardial infarction, stroke, and peripheral artery disease were lower. Health care costs were predominantly driven by HF and CKD. Between 2020 and 2022, use of renin-angiotensin system inhibitors, sacubitril/valsartan, beta-blockers, and mineralocorticoid receptor antagonists changed little, whereas uptake of sodium-glucose cotransporter-2 inhibitors increased 2- to 7-fold. CONCLUSIONS: Incident post-hHF rehospitalization risks and costs were high, and GDMT use changed little in the year following discharge, highlighting the need to consider earlier and greater implementation of GDMT to manage risks and reduce costs.

Optimizing outcomes in heart failure: 2022 and beyond.

Although the development of therapies and tools for the improved management of heart failure (HF) continues apace, day-to-day management in clinical practice is often far from ideal. A Cardiovascular Round Table workshop was convened by the European Society of Cardiology (ESC) to identify barriers to the optimal implementation of therapies and guidelines and to consider mitigation strategies to improve patient outcomes in the future. Key challenges identified included the complexity of HF itself and its treatment, financial constraints and the perception of HF treatments as costly, failure to meet the needs of patients, suboptimal outpatient management, and the fragmented nature of healthcare systems. It was discussed that ongoing initiatives may help to address some of these barriers, such as changes incorporated into the 2021 ESC HF guideline, ESC Heart Failure Association quality indicators, quality improvement registries (e.g. EuroHeart), new ESC guidelines for patients, and the universal definition of HF. Additional priority action points discussed to promote further improvements included revised definitions of HF 'phenotypes' based on trial data, the development of implementation strategies, improved affordability, greater regulator/payer involvement, increased patient education, further development of patient-reported outcomes, better incorporation of guidelines into primary care systems, and targeted education for primary care practitioners. Finally, it was concluded that overarching changes are needed to improve current HF care models, such as the development of a standardized pathway, with a common adaptable digital backbone, decision-making support, and data integration, to ensure that the model 'learns' as the management of HF continues to evolve.

How can we optimise health technology assessment and reimbursement decisions to accelerate access to new cardiovascular medicines?

Regulatory approvals of, and subsequent access to, innovative cardiovascular medications have declined. How much of this decline relates to the final step of gaining reimbursement for new treatments is unknown. Payers and health technology assessment (HTA) bodies look beyond efficacy and safety to assess whether a new drug improves patient outcomes, quality of life, or satisfaction at a cost that is affordable compared to existing treatments. HTA bodies work within a limited healthcare budget, and this is one of the reasons why only half of newly approved drugs are accepted for reimbursement, or receive restricted or "optimised" recommendations from HTA bodies. All stakeholders have the common goal of facilitating access to safe, effective, and affordable treatments to appropriate patients. An important strategy to expedite this is providing optimal data. This is demonstrably facilitated by early (and ongoing) discussions between all stakeholders. Many countries have formal programmes to provide collaborative regulatory and HTA advice to developers. Other strategies include aligning regulatory and HTA processes, increasing use of real-world evidence, formally defining the decision-making process, and educating stakeholders on the criteria for positive decision making. Industry should focus on developing treatments for unmet medical needs, seek early engagement with HTA and regulatory bodies, improve methodologies for optimal price setting, develop internal systems to collaborate with national and international stakeholders, and conduct post-approval studies. Patient involvement in all stages of development, including HTA, is critical to capture the lived experience and priorities of those whose lives will be impacted by new treatment approvals.

Outcomes and Resource Utilization in Patients Hospitalized with Gastrointestinal Bleeding Complicated by Types 1 and 2 Myocardial Infarction.

BACKGROUND: Types 1 and 2 myocardial infarction (MI) may occur in the setting of gastrointestinal bleeding (GIB). There is a paucity of data pertinent to the contemporary prevalence and impact of types 1 and 2 MI following GIB. We examined clinical profiles and the prognostic impact of both MI types on outcomes of patients hospitalized with GIB. METHODS: The 2018 Nationwide Readmission Database was queried for patients hospitalized for the primary diagnosis of GIB and had concomitant diagnoses of type 1 or type 2 MI. Baseline characteristics, in-hospital mortality, resource utilization, and 30-day all-cause readmissions were compared among groups. RESULTS: Of 381,867 primary GIB hospitalizations, 2902 (0.75%) had type 1 MI and 3963 (1.0%) had type 2 MI. GIB patients with type 1 and type 2 MI had significantly higher in-hospital mortality compared to their counterparts without MI (adjusted odds ratios [aOR]: 4.72, 95% confidence interval [CI] 3.43-6.48; and aOR: 2.17, 95% CI 1.48-3.16, respectively). Both types 1 and 2 MI were associated with higher rates of discharge to a nursing facility (aOR of type 1 vs. no MI: 1.65, 95% CI 1.45-1.89, and aOR of type 2 vs no MI: 1.37, 95% CI 1.22-1.54), longer length of stay, higher hospital costs, and more 30-day all-cause readmissions (aOR of type 1 vs no MI: 1.22, 95% CI 1.08-1.38; aOR of type 2 vs no MI: 1.17, 95% CI 1.05-1.30). CONCLUSION: Types 1 and 2 MI are associated with higher in-hospital mortality and resource utilization among patients hospitalized with GIB in the United States.

Patient Characteristics and Outcomes of Type 2 Myocardial Infarction During Heart Failure Hospitalizations in the United States.

BACKGROUND: Type 2 myocardial infarction (MI) is increasingly diagnosed in patients with heart failure (HF). A paucity of data exists pertinent to the contemporary prevalence and impact of type 2 MI in patients with HF. We studied the patient profiles and the prognostic impact of type 2 MI on outcomes of HF hospitalizations. METHODS: The Nationwide Readmission Database 2018 was queried for patients with HF hospitalizations with and without type 2 MI. Baseline characteristics, inpatient outcomes, and 30-day all-cause readmissions between both cohorts were compared. RESULTS: Of 1,072,674 primary HF hospitalizations included in the study, 28,813 (2.7%) had type 2 MI. Patients with type 2 MI were more likely to be males (56.5% vs 51.6%; P < .001) and had a higher prevalence of hypertension (94% vs 92.2%; P < .001), prior myocardial infarction (17.1% vs 14.9%; P < .001), anemia (9.1% vs 8.1%; P < .001), chronic kidney disease (55.7% vs 49.4%; P < .001), neurological disorders (9.4% vs 7.3%; P < .001), and weight loss (7.3% vs 5.6%; P < .001). Compared with their counterparts without type 2 MI, patients with HF with type 2 MI had significantly higher in-hospital mortality (adjusted odds ratio [aOR], 1.53; 95% confidence interval [CI], 1.37-1.72), hospital costs (adjusted parameter estimate, $1785; 95% CI, 1388-2182), discharge to nursing facility (aOR, 1.22; 95% CI, 1.15-1.29), longer length of stay (adjusted parameter estimate, 0.53; 95% CI, 0.42-0.64), and rate of 30-day all-cause readmissions (aOR, 1.06; 95% CI, 1.01-1.12). CONCLUSION: Type 2 MI in patients hospitalized with HF is associated with higher mortality and resource utilization in the United States.

Heart Failure Site-Based Research in the United States: Results of the Heart Failure Society of America Research Network Survey.

OBJECTIVES: This study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the United States. BACKGROUND: Improvements in the current capability, potential, and deficiencies of the HF clinical research infrastructure in the United States are needed in order to enhance efficiency and impact. METHODS: The Heart Failure Society of America (HFSA) distributed an electronic survey regarding HF clinical trial activity for the purpose of understanding the barriers that exist to conducting high-quality HF clinical research. RESULTS: Overall, 1,794 HFSA members were queried, and 434 members (24%) completed surveys, whereas a total of 7,589 individuals with interest in HF were queried, and 615 completed surveys. Of the respondents, 410 (67%) were actively engaged in HF research and 120 (20%) were interested in research. Most respondents, 270, were physicians (44%); 311 of the total (76% of the total and 80% of physicians) practiced in academic institutions; 333 respondents (81%) had served as principal investigators and 73 (18%) as site coordinators. Respondents active in clinical research usually participated in 1 to 5 trials and enrolled 1 to 20 patients annually. Institutional review board (IRB) approval typically required 3 months, and contract completion required 3 to 6 months per site. The greatest barriers to research were insufficient site budgets, delay in contracting, inability to find participants meeting trial entry criteria, and unavailability of qualified study coordinators. CONCLUSIONS: Many U.S. clinical research sites are constrained by budgetary, staffing, and contractual issues. The HFSA Research Network seeks to unify interested sites and deconstruct barriers to permit high-value HF research.

Role of Biomarkers for the Prevention, Assessment, and Management of Heart Failure: A Scientific Statement From the American Heart Association.

BACKGROUND AND PURPOSE: Natriuretic peptides have led the way as a diagnostic and prognostic tool for the diagnosis and management of heart failure (HF). More recent evidence suggests that natriuretic peptides along with the next generation of biomarkers may provide added value to medical management, which could potentially lower risk of mortality and readmissions. The purpose of this scientific statement is to summarize the existing literature and to provide guidance for the utility of currently available biomarkers. METHODS: The writing group used systematic literature reviews, published translational and clinical studies, clinical practice guidelines, and expert opinion/statements to summarize existing evidence and to identify areas of inadequacy requiring future research. The panel reviewed the most relevant adult medical literature excluding routine laboratory tests using MEDLINE, EMBASE, and Web of Science through December 2016. The document is organized and classified according to the American Heart Association to provide specific suggestions, considerations, or contemporary clinical practice recommendations. RESULTS: A number of biomarkers associated with HF are well recognized, and measuring their concentrations in circulation can be a convenient and noninvasive approach to provide important information about disease severity and helps in the detection, diagnosis, prognosis, and management of HF. These include natriuretic peptides, soluble suppressor of tumorgenicity 2, highly sensitive troponin, galectin-3, midregional proadrenomedullin, cystatin-C, interleukin-6, procalcitonin, and others. There is a need to further evaluate existing and novel markers for guiding therapy and to summarize their data in a standardized format to improve communication among researchers and practitioners. CONCLUSIONS: HF is a complex syndrome involving diverse pathways and pathological processes that can manifest in circulation as biomarkers. A number of such biomarkers are now clinically available, and monitoring their concentrations in blood not only can provide the clinician information about the diagnosis and severity of HF but also can improve prognostication and treatment strategies.

Heart Failure in Women.

Heart failure is an important cause of morbidity and mortality in women, and they tend to develop it at an older age compared to men. Heart failure with preserved ejection fraction is more common in women than in men and accounts for at least half the cases of heart failure in women. When comparing men and women who have heart failure and a low left ventricular ejection fraction, the women are more symptomatic and have a similarly poor outcome. Overall recommendations for guideline-directed medical therapies show no differences in treatment approaches between men and women. Overall, women are generally underrepresented in clinical trials for heart failure. Further studies are needed to shed light into different mechanisms, causes, and targeted therapies of heart failure in women.

The Assessment of Stent Effectiveness Using a Wearable Beamforming MEMS Microphone Array System.

Studies involving turbulent flow have been carried out in many parts of the cardiovascular system, and it has been widely reported that turbulence related to stenosis (narrowing) of arteries creates audible sounds, which may be analyzed to yield information about the nature and severity of the blockage. Results so far indicate that the high frequency content of the sounds generally increases with the degree of stenosis. In this paper, we designed and built an MEMs microphone array and a signal acquisition board to improve the detection of coronary occlusions using an approach based on the recording and analysis of isolated diastolic heart sounds associated with turbulent blood flow in occluded coronary arteries. The nonlinear dynamic analysis method based on approximate entropy has been proposed for the analysis of diastolic heart sounds from patients with single coronary occlusions, before and after stent placement procedures. The nonlinear dynamic analysis (approximate entropy) measures of the diastolic heart sounds recorded from eight patients with single coronary occlusions and two normal subjects were estimated. In addition, a spectral analysis based on the fast Fourier transform was used to estimate the energy content of the recorded signals. Results suggest the presence of high nonlinear (approximate entropy) values of diastolic heart sounds associated with coronary artery disease ([Formula: see text]) as well as significant differences in the energy content of the heart sound signals above and below 150 Hz ([Formula: see text]).

Diagnosis and management of acute heart failure.

Acute heart failure (AHF) is a life threatening clinical syndrome with a progressively increasing incidence in general population. Turkey is a country with a high cardiovascular mortality and recent national statistics show that the population structure has turned to an 'aged' population.As a consequence, AHF has become one of the main reasons of admission to cardiology clinics. This consensus report summarizes clinical and prognostic classification of AHF, its worldwide and national epidemiology, diagnostic work-up, principles of approach in emergency department,intensive care unit and ward, treatment in different clinical scenarios and approach in special conditions and how to plan hospital discharge.

Provider Type and Quality of Outpatient Cardiovascular Disease Care: Insights From the NCDR PINNACLE Registry.

BACKGROUND: The current number of physicians will not be sufficient to accommodate 30 to 40 million Americans expected to secure health coverage with Affordable Care Act implementation. One proposed solution is to use advanced practice providers (APPs) (nurse practitioners and physician assistants). OBJECTIVES: This study sought to determine whether there were clinically meaningful differences in the quality of care delivered by APPs versus physicians in a national sample of cardiology practices. METHODS: Within the American College of Cardiology's PINNACLE Registry, we compared quality of coronary artery disease (CAD), heart failure, and atrial fibrillation care delivered by physicians and APPs for outpatient visits between January 1, 2012, and December 31, 2012. We performed hierarchical regression adjusting for provider sex; panel size; duration of participation in registry; and patient's age, sex, insurance, number of outpatient visits, history of hypertension, diabetes, myocardial infarction, and percutaneous coronary intervention or coronary artery bypass grafting in the preceding 12 months. RESULTS: We included 883 providers (716 physicians and 167 APPs) in 41 practices who cared for 459,669 patients. Mean number of patients seen by APPs (260.7) was lower compared with that seen by physicians (581.2). Compliance with most CAD, heart failure, and atrial fibrillation measures was comparable, except for a higher rate of smoking cessation screening and intervention (adjusted rate ratio: 1.14; 95% confidence interval: 1.03 to 1.26) and cardiac rehabilitation referral (rate ratio: 1.40; 95% confidence interval: 1.16 to 1.70) among CAD patients receiving care from APPs. Compliance with all eligible CAD measures was low for both (12.1% and 12.2% for APPs and physicians, respectively) with no significant difference. Results were consistent when comparing practices with both physicians and APPs (n = 41) and physician-only practices (n = 49). CONCLUSIONS: Apart from minor differences, a collaborative care delivery model, using both physicians and APPs, may deliver an overall comparable quality of outpatient cardiovascular care compared with a physician-only model.

Establishment of a transcatheter aortic valve program and heart valve team at a Veterans Affairs facility.

BACKGROUND: The US Food and Drug Administration recently approved a transcatheter aortic valve for patients for whom open heart surgery is prohibitively risky. METHODS: A multidisciplinary heart valve team partnered with administration to launch a transcatheter aortic valve replacement (TAVR) program. Clinical registries were used to show robust valve caseloads and outcomes at our Veterans Affairs (VA) facility and to project future volumes. A TAVR business plan was approved by the VA leadership as part of a multiphase project to upgrade and expand our surgical facilities. RESULTS: The heart valve team completed a training program that included simulations and visits to established TAVR centers. Patients were evaluated and screened through a streamlined process, and the program was initiated successfully. CONCLUSIONS: Establishing a TAVR program at a VA facility requires a multidisciplinary team with experience in heart valve and endovascular therapies and a supportive administration willing to invest in a sophisticated infrastructure.