Revisiting Transvenous Phrenic Nerve Stimulation in Central Sleep Apnoea and Heart Failure: Emerging Innovations in Clinical Trials Analysis.

Central sleep apnoea (CSA) is a common comorbidity in patients with heart failure. Due to its insidious and chronic nature, CSA often remains unrecognised. Patients with CSA typically present with symptoms, such as daytime fatigue, recurrent heart failure decompensations and cardiac arrhythmias.

Mechanistic Basis for Differential Effects of Interatrial Shunt Treatment in HFrEF vs HFpEF: The RELIEVE-HF trial.

Background: The RELIEVE-HF trial randomized 508 patients with heart failure (HF) to interatrial shunt-treatment vs placebo-procedure. Randomization was stratified into 2 patient groups with HF with reduced ejection fraction (HFrEF;LVEF≤40%) and HF with preserved EF (HFpEF;LVEF>40%). HF event rates (all-cause death, transplantation/LVAD, HF hospitalization/outpatient worsening) after shunt treatment during 2-year follow-up were directionally opposite: decreased by 51% in HFrEF, increased by 69% in HFpEF.

Impact of Baseline Anteroposterior Mitral Annular Dimensions on Clinical Outcomes after MitraClip for Secondary Mitral Regurgitation.

Background: In the randomized Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT; NCT01626079) trial, mitral transcatheter edge-to-edge repair (M-TEER) improved clinical outcomes in patients with severe secondary mitral regurgitation (MR). A prior post hoc analysis from the COAPT trial showed that increasing anteroposterior mitral annular diameter (APMAD) was the sole independent echocardiographic predictor of the composite endpoint of death or heart failure hospitalizations (HFH) at 2 years. Given the relationship between the mitral annulus and leaflets, we examined the association of baseline APMAD with long-term clinical outcomes.

Timing of Cardiac Resynchronization Therapy Following Stable Medical Therapy in Patients With Heart Failure.

Background: Guidelines' recommendations for cardiac resynchronization therapy (CRT) implantation in selected patients with heart failure (HF) exist. However, data on the best timing for CRT implantation after the achievement of stable medical therapy (SMT) and its association with outcomes are currently lacking.

Objectives: The aim of this study was to investigate the timing of CRT implantation after the achievement of SMT, associated patient profiles, and clinical outcomes in a real-world HF population.

iCARDIO Alliance Global Implementation Guidelines on Heart Failure 2025.

Inconsistencies in healthcare access, varying infrastructure, resource constraints and diverse local practices as well as practical and political issues restrict the global applicability of currently available guidelines. There is a need for universal recommendations that address the unique challenges faced by patients and healthcare providers worldwide. Our iCARDIO Alliance Global Implementation Guidelines emphasize the incorporation of novel therapies, while integrating standard of care with the most up-to-date evidence to enable clinicians to optimize patient care.

Race and Ethnicity in Heart Failure Trials: Time to Update Recommended Categories for Global Relevance.

Background: The collection of race and ethnicity data in clinical trials using standardized categories is recommended by the US Food and Drug Administration, although this is primarily for domestic reasons. The applicability and understanding of the categories in multinational trials are uncertain.

Methods: We analyzed patient-level data from 13 major heart failure trials, examining race and ethnicity data recorded by country, as recommended by the Food and Drug Administration: "American Indian or Alaska Native," "Asian," "Black or African American," "Native Hawaiian or Other Pacific Islander," and "White" for race and "Hispanic or Latino" as a minimum for ethnicity (with an expanded list of ethnicities available).

Cardiac resynchronization therapy for enabling guideline-directed medical therapy optimization in heart failure.

Aims: We aimed to assess whether cardiac resynchronization therapy (CRT) might serve as an enabler for guideline-directed medical therapy (GDMT) optimization.

Methods And Results: Patients with heart failure with reduced ejection fraction (HFrEF) enrolled in the Swedish Heart Failure Registry between January 2009 and August 2022 were considered. Patients receiving a CRT close to the index registration were the cases, whereas controls had not received a CRT despite having an indication.

Forward Flow in Patients With Heart Failure and Functional Mitral Regurgitation: The COAPT Trial.

Background: Heart failure (HF) is characterized by a reduction in forward cardiac output (forward flow), potentially worsened by functional mitral regurgitation (FMR). The impact of reduced forward flow in HF patients with FMR is uncertain, and the outcomes of mitral transcatheter edge-to-edge repair (TEER) according to forward flow levels have not been described.

Methods: This study assessed the change in baseline flow in patients with HF and FMR enrolled in the COAPT trial randomized to TEER plus guideline-directed medical therapy (GDMT) compared with GDMT alone.

Remote monitoring in heart failure: artificial intelligence and the use of remote speech analysis to detect worsening heart failure events.

Globally, heart failure (HF) is a leading cause of hospitalization and mortality, primarily among the elderly, and is estimated to affect more than 64 million individuals. Hospitalization for HF represents the largest part of overall medical care expenditures for HF, and hospitalization for HF is associated with high rates of in-hospital and post-discharge morbidity and mortality. Patients discharged from the hospital with a diagnosis of acute decompensated HF have an increased risk for clinical worsening, rehospitalization, and mortality.

Effect of pulmonary artery pressure-guided management on outcomes of patients with heart failure outside clinical trials: A systematic review and meta-analysis of real-world evidence with the CardioMEMS Heart Failure System.

Aims: Pulmonary artery pressure (PAP)-guided heart failure (HF) management using the CardioMEMS HF System improves patient outcomes in randomized controlled trials (RCTs). Our aim was to systematically assess its impact on outcomes of HF patients receiving the device in a non-RCT setting.

Methods And Results: PubMed, ClinicalTrials.

Impact of Natriuretic Peptide and Prior Hospitalization in Patients With Severe Mitral Regurgitation: COAPT Trial.

Background: The clinical significance of elevated baseline natriuretic peptide level and prior heart failure hospitalization (HFH) within the prior year in mitral transcatheter edge-to-edge repair outcomes is unclear. This analysis examined the impact of BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal pro-B-type natriuretic peptide) and prior HFH on outcomes in patients with severe secondary mitral regurgitation.

Methods: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was a randomized controlled trial of subjects assigned to mitral valve transcatheter edge-to-edge repair with the MitraClip device versus guideline-directed medical therapy alone.

Win ratio analysis of the REVERSE cardiac resynchronization trial.

Background: The novel win ratio statistic has emerged as a promising alternative end point for the comparison of 2 treatment groups on multiple end points simultaneously, but it has not been used for cardiac resynchronization therapy (CRT) trials. REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE; ClinicalTrials.gov identifier: NCT00271154) was the first multicenter, randomized CRT trial in mild heart failure (HF).

Remote pulmonary artery pressure-guided management of patients with heart failure: A clinical consensus statement of the Heart Failure Association (HFA) of the ESC.

Episodes of worsening heart failure (HF) are a major cause of unplanned hospitalizations. Their onset is usually preceded by an early increase in intracardiac pressures with subsequent worsening of symptoms due to congestion. Implantable devices allowing daily remote pulmonary artery pressure (PAP) monitoring are useful to identify early haemodynamic changes so that medical therapy can be adjusted at an early stage, before symptom onset, and HF-related hospitalizations be prevented.

Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure.

Background: Hemodynamically guided management of patients with chronic heart failure (HF), using a remote, ambulatory pulmonary artery (PA) pressure monitor, has been shown to reduce mortality and morbidity. These improved outcomes were associated with a reduction in PA pressure. However, several pivotal questions remain unanswered: do systolic, diastolic, or mean PA pressures each predict all-cause mortality? Do PA pressures predict mortality across the ejection fraction (EF) spectrum? Do increases or decreases in PA pressure over time predict increases or decreases in mortality?

Methods: Retrospective analyses of data from CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients; n=550), GUIDE-HF (Hemodynamic-GUIDEed management of Heart Failure; n=2358), US PAS (CardioMEMS HF System Post Approval Study; n=1200), and MEMS-HF (CardioMEMS Monitoring Study for Heart Failure; n=234) were performed, including all enrolled patients regardless of treatment assignments (Total N=4342).

Clinical phenotypes and outcomes associated with improved left ventricular ejection fraction after biventricular pacing.

Background: In some patients who receive a cardiac resynchronization therapy (CRT) device, the left ventricular ejection fraction (LVEF) does not improve.

Methods: We analyzed patients enrolled in the REVERSE, MADIT-CRT, and BLOCK-HF trials, restricting the analysis to those who received CRT. Characteristics of patients with or without improved LVEF were compared using two sample t-tests and Pearson's chi-square tests.

Cardiac rhythm devices in heart failure with reduced ejection fraction - role, timing, and optimal use in contemporary practice. European Journal of Heart Failure expert consensus document.

Guidelines for management of heart failure with reduced ejection fraction (HFrEF) emphasize personalized care, patient engagement, and shared decision-making. Medications and cardiac rhythm management (CRM) devices are recommended with a high level of evidence. However, there are significant disparities: patients who could benefit from devices are frequently referred too late or not at all.

Heart Rate Reduction Is Associated With Reverse Left Ventricular Remodeling and Mechanism-Specific Molecular Phenotypes in Dilated Cardiomyopathy.

Background: Heart rate (HR) affects heart failure outcomes, via uncertain mechanisms that may include left ventricular remodeling. However, in human ventricular myocardium, HR change has not been associated with a particular remodeling molecular phenotype.

Methods: Patients with nonischemic dilated cardiomyopathy (N=22) in sinus rhythm and refractory to β-blockade for both HR lowering and reverse remodeling were randomized 2:1 double-blind to the HCN4 (hyperpolarization-activated cyclic nucleotide-gated potassium channel 4) channel inhibitor ivabradine or placebo for 24 weeks treatment while maintaining target doses of β-blockers.

Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure: JACC Expert Panel From the HF-ARC.

Perturbations in kidney function are frequently encountered in heart failure (HF) across its spectrum in both chronic and acute settings with distinct implications for patient management and prognosis. Lack of consensus on the threshold for clinically meaningful changes in kidney function has led to heterogeneity in the clinical characteristics and background therapies of individuals enrolled in clinical trials, and in multiple aspects of trial design. A meaningful and collaborative interaction among the disciplines of cardiology and nephrology, clinical trialists, industry sponsors, and regulatory agencies is vital to the development of standardized definitions of changes in kidney function across HF settings.

Enhancing Sweat Rate for In-Hospital and Home-Based Decongestive Therapy.

Background: The interstitial fluid compartment is disproportionally expanded in heart failure (HF). Enhancing sweat rate removes fluids and sodium directly from the interstitial compartment.

Objectives: To study the feasibility and efficacy of direct interstitial decongestion in hospitalized HF patients.

Remote Monitoring in Heart Failure: Revolutionizing Patient Management and Outcomes.

Heart failure (HF) is a global health issue, contributing significantly to morbidity and mortality, particularly in North America. The management of HF is complex, requiring diligent monitoring to prevent decompensation and clinical progression. While there have been improvements in treating HF, it still leads to significant negative health outcomes and heavily contributes to the use of healthcare services.

Design and rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA-HF).

Aims: The interstitial space is the major compartment in which the excess fluid is located, forming peripheral congestion in acute decompensated heart failure (ADHF). The lymphatic system is responsible for the constant drainage of the compartment. In ADHF, the inefficiency of this system causes extravascular fluid accumulation, underscoring the crucial role of lymphatic system failure in ADHF's pathophysiology.

Management of acute decompensated valvular heart disease.

Worldwide, valvular heart disease (VHD) is a common cause of hospitalization for acute heart failure. In acute heart failure caused by VHD, symptoms result from rapid haemodynamic changes and subsequent decline in cardiac function, and if left untreated, leads to acute decompensation and cardiogenic shock. Current evidence remains scarce and recommendations regarding the management of acute heart failure caused by VHD are lacking in most recent international guidelines.

Applicability of heart failure clinical practice guidelines in low- and middle-income countries.

Aims: Clinical practice guidelines are commonly written by professional societies in high-income countries (HIC) with limited anticipation of implementation obstacles in other environments. We used heart failure (HF) guidelines as a paradigm to examine this concern, by conducting a survey to understand clinicians' ability to implement HF guidelines and their perceptions of the current HF guideline applicability in low- and middle-income countries (LMIC).

Methods And Results: An online survey of physicians in the database of the Translational Medicine Academy who treat HF patients was offered by email from 5 October to 27 November 2023, inquiring of participants' demographic information, experience, and views of HF guidelines as related to their practice.