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Aims: Heart failure (HF), a global pandemic affecting millions of individuals, calls for adequate predictive guidance for improved therapy. Congestion, a key factor in HF‐related hospitalizations, further underscores the need for timely interventions. Proactive monitoring of intracardiac pressures, guided by pulmonary artery (PA) pressure, offers opportunities for efficient early‐stage intervention, since haemodynamic congestion precedes clinical symptoms. Methods: The BioMEMS study, a substudy of the MONITOR‐HF trial, proposes a multifaceted approach integrating blood biobank data with traditional and novel HF parameters. Two additional blood samples from 340 active participants in the MONITOR‐HF trial were collected at baseline, 3‐, 6‐, and 12‐month visits and stored for the BioMEMS biobank. The main aims are to identify the relationship between temporal biomarker patterns and PA pressures derived from the CardioMEMS‐HF system, and to identify the biomarker profile(s) associated with the risk of HF events and cardiovascular death. Conclusion: Since the prognostic value of single baseline measurements of biomarkers like N‐terminal pro‐B‐type natriuretic peptide is limited, with the BioMEMS study we advocate a dynamic, serial approach to better capture HF progression. We will substantiate this by relating repeated biomarker measurements to PA pressures. This design rationale presents a comprehensive review on cardiac biomarkers in HF, and aims to contribute valuable insights into personalized HF therapy and patient risk assessment, advancing our ability to address the evolving nature of HF effectively. [ABSTRACT FROM AUTHOR]

Aims: High left ventricular filling pressure increases left atrial volume and causes myocardial fibrosis, which may decrease with spironolactone. We studied clinical and proteomic characteristics associated with left atrial volume indexed by body surface area (LAVi), and whether LAVi influences the response to spironolactone on biomarker expression and clinical variables. Methods and results: In the HOMAGE trial, where people at risk of heart failure were randomized to spironolactone or control, we analysed 421 participants with available LAVi and 276 proteomic measurements (Olink) at baseline, month 1 and 9 (mean age 73 ± 6 years; women 26%; LAVi 32 ± 9 ml/m2). Circulating proteins associated with LAVi were also assessed in asymptomatic individuals from a population‐based cohort (STANISLAS; n = 1640; mean age 49 ± 14 years; women 51%; LAVi 23 ± 7 ml/m2). In both studies, greater LAVi was significantly associated with greater left ventricular masses and volumes. In HOMAGE, after adjustment and correction for multiple testing, greater LAVi was associated with higher concentrations of matrix metallopeptidase‐2 (MMP‐2), insulin‐like growth factor binding protein‐2 (IGFBP‐2) and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) (false discovery rates [FDR] <0.05). These associations were externally replicated in STANISLAS (all FDR <0.05). Among these biomarkers, spironolactone decreased concentrations of MMP‐2 and NT‐proBNP, regardless of baseline LAVi (pinteraction > 0.10). Spironolactone also significantly reduced LAVi, improved left ventricular ejection fraction, lowered E/e', blood pressure and serum procollagen type I C‐terminal propeptide (PICP) concentration, a collagen synthesis marker, regardless of baseline LAVi (pinteraction > 0.10). Conclusion: In individuals without heart failure, LAVi was associated with MMP‐2, IGFBP‐2 and NT‐proBNP. Spironolactone reduced these biomarker concentrations as well as LAVi and PICP, irrespective of left atrial size. [ABSTRACT FROM AUTHOR]

Background: We hypothesize that Alzheimer's disease (AD)-related pathology may accelerate cognitive decline in patients with cardiovascular diseases. Objective: To investigate the association between blood-based biomarkers of AD, astrocyte activation, and neurodegeneration and cognitive decline. Methods: From the multi-center Heart-Brain study, we included 412 patients with heart failure, carotid occlusive disease or vascular cognitive impairment (age:68.6±9.0) and 128 reference participants (65.7±7.5). Baseline amyloid-β42/40 (Aβ42/40), phosphorylated-tau181 (pTau181), glial fibrillary acidic protein (GFAP), and neurofilament light (NfL) were determined using SiMoA (Quanterix). Memory, attention, language, and executive functioning were evaluated (follow-up:2.1±0.3 years). We applied linear mixed models with terms for biomarker, time and biomarker*time interactions, adjusted for age, sex, education, and site, to assess associations between biomarkers and cognitive decline. Results: Among patients, Aβ42/40 was not associated with cognitive performance at baseline. However, lower Aβ42/40 was associated with steeper decline in global cognition (β±SE:0.04±0.02). Higher pTau181 was associated with worse baseline performance on global cognition (–0.14±0.04) and memory (–0.31±0.09) and with steeper decline in global cognition (–0.07±0.02), memory (–0.09±0.04), attention (–0.05±0.02), and language (–0.10±0.03). Higher GFAP was associated with worse baseline performance on global cognition (–0.22±0.05), memory (–0.43±0.10), attention (–0.14±0.06), language (–0.15±0.05), and executive functioning (–0.15±0.05) and steeper decline in global cognition (–0.05±0.01). Higher NfL was associated with worse baseline performance on global cognition (–0.16±0.04), memory (–0.28±0.09), attention (–0.20±0.06), and executive functioning (-0.10±0.04), but was not associated with performance over time. In reference participants, no associations were found. Conclusions: Our findings suggest that blood-based biomarkers of AD-related pathology predict cognitive decline in patients with cardiovascular diseases. [ABSTRACT FROM AUTHOR]

Introduction: Heart failure is a serious burden on health care systems due to frequent hospital admissions. Early recognition of outpatients at risk for clinical deterioration could prevent hospitalization. Still, the role of signs and symptoms in monitoring heart failure patients is not clear. The heart failure coach is a web-based telemonitoring application consisting of a 9-item questionnaire assessment of heart failure signs and symptoms and developed to identify outpatients at risk for clinical deterioration. If deterioration was suspected, patients were contacted by a heart failure nurse for further evaluation. Methods: Heart failure coach questionnaires completed between 2015 and 2018 were collected from 287 patients, completing 18,176 questionnaires. Adverse events were defined as all-cause mortality, heart failure- or cardiac-related hospital admission or emergency cardiac care visits within 30 days after completion of each questionnaire. Multilevel logistic regression analyses were performed to assess the association between the heart failure coach questionnaire items and the odds of an adverse event. Results: No association between dyspnea and adverse events was observed (odds ratio 1.02, 95% confidence interval 0.79–1.30). Peripheral edema (odds ratio 2.21, 95% confidence interval 1.58–3.11), persistent chest pain (odds 2.06, 95% confidence interval 1.19–3.58), anxiety about heart failure (odds ratio 2.12, 95% confidence interval 1.44–3.13), and extensive struggle to perform daily activities (odds ratio 2.23, 95% confidence interval 1.38–3.62) were significantly associated with adverse outcome. Discussion: Regular assessment of more than the classical signs and symptoms may be helpful to identify heart failure patients at risk for clinical deterioration and should be an integrated part of heart failure telemonitoring programs. [ABSTRACT FROM AUTHOR]

Background: Diuretic resistance is common and results in poor outcome. Spot urine sodium (UrNa) is suggested as a tool to tailor diuretics and improve efficacy of therapy. We prospectively evaluate the prevalence of diuretic resistance, predictors of low spot-UrNa and the prognostic value of spot-UrNa in an unselected ADHF population., Methods: Patients admitted for ADHF and treated with iv diuretics were included. Spot-UrNa was collected 2 h after administration of an IV diuretic bolus. The main endpoint was a composite of HF re-hospitalizations and all-cause mortality at 90 days follow-up., Results: 143 patients were included in this study (median age 81 [75 - 85] years, 55 % male), of which 50 % were newly diagnosed with HF. Low spot-UrNa was independently associated with worse renal function, low serum sodium, and systolic blood pressure, previous loop diuretic and SGLT2i use and loop diuretic administered dose. Both absolute spot-UrNa (HR 0.87, 95 % CI 0.79 - 0.95, P=0.003 per 10 mmol/L increase) and a urinary sodium ≥ 100 mmol/l (HR=0.51, 95 % CI 0.27 - 0.97, P=0.04) significantly predicted the composite endpoint. This association was no longer significant after correction for confounders. Patients with low spot-UrNa attained longer IV diuretic treatment and a higher cumulative IV diuretic dose., Conclusions: Spot-UrNa is prevalent and occurs more often in patients with more progressed cardio-renal disease. Spot-UrNa significantly predicts 90-day HF hospital-free survival in ADHF. Further studies are needed evaluating the effect of UrNa guided diuretic treatment on clinical endpoints., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [R.R.J.K. reports research grants from the Dutch Heart Foundation and Netherlands Heart Institute; personal consultancy fees from Novartis Pharma and Bayer; and personal lecture fees from Novartis Pharma and Bayer. H.P.B.L.R. has declared grants from Roche Diagnostics and Vifor Pharma; consulting fees from Boehringer-Ingelheim, Roche Diagnostics and Novartis; lecture payment from Boehringer-Ingelheim, AstraZeneca, Novo Nordisk, Novartis and Vifor Pharma; Participation on a Data Safety Monitoring Board of Advisory Board for Roche Diagnostics, Vifor Pharma and CeleCor Therapeutics; and leadership roles in IHI project iCARE4CVD (no. 101112022) and Interreg-NEW supported project PASSIN-HF NWE702. S.S.W. has received grants from Cardio Research Limburg, Boehringer Ingelheim, Astrazeneca and Roche Diagnostics; Consulting fees from Boehringer Ingelheim and Roche Diagnostics; lecture payment from Boehringer Ingelheim, Novartis, AstraZeneca and Roche diagnostics and is a board member of the WCN (Dutch Scientific Cardiology Network) and Stichting Perfusie. T.L. has received an unrestricted grant from AstraZeneca]., (© 2024 The Authors.)

Background and Aims: In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups., Methods: The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronization therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life-, clinical-, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented., Results: The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were non-significant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = .03; adjusted Pinteraction = .33) and diabetics (Pinteraction = .01; adjusted Pinteraction = .06) were observed. However, these interaction effects did not persist after adjusting for multiple testing., Conclusions: This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions' selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence. The new Medical Device Regulation is more stringent than its predecessor, yet its scope does not span all intended uses and several difficulties remain. The European Society of Cardiology Regulatory Affairs Committee set up a Task Force to explore existing assessment frameworks and clinical and cost-effectiveness evidence. This knowledge was used to propose criteria with which HCPs could evaluate mHealth solutions spanning diagnostic support, therapeutics, remote follow-up and education, specifically for cardiac rhythm management, heart failure and preventive cardiology. While curated national libraries of health apps may be helpful, their requirements and rigour in initial and follow-up assessments may vary significantly. The recently developed CEN-ISO/TS 82304-2 health app quality assessment framework has the potential to address this issue and to become a widely used and efficient tool to help drive decision-making internationally. The Task Force would like to stress the importance of co-development of solutions with relevant stakeholders, and maintenance of health information in apps to ensure these remain evidence-based and consistent with best practice. Several general and domain-specific criteria are advised to assist HCPs in their assessment of clinical evidence to provide informed advice to patients about mHealth utilization., Competing Interests: Conflict of interest: G.B. declares payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, Boston, Boehringer Ingelheim, Daiichi-Sankyo, Janssen, Sanofi. L.N. reports grants or contracts through her institution from Daiichi Sankyo; under 1000 USD personal honoraria from Pfizer-BMS. A.G.F. reports grant support from the European Union Horizon Europe programme for the CORE MD project (agreement 965246); being the Chairman, Regulatory Affairs Committee, Biomedical Alliance in Europe. F.D. Reports being a task force member for the European Society of Cardiology; support for attending meetings and/or travel by the BSI/TeamNB as a technical specialist; fiduciary role in Team NB as a technical specialist from BSI. A.B. reports Abiomed scientific grant (76445733); royalties or licences from Seerling Ltd; Support for attending meetings and/or travel from Pfizer for the ESC congress 2023; being a member of the Librexia ACS trial steering committee. E.G.C. reports a grant in the form of a <1K€ payment to his institution from the Advisory Board on digital Health of Medtronic USA; honoraria for presentations or educational events (total <10k€) from Servier, Summeet Srl, Dynamicom Education Srl, UVET GBT Spa, Sanofi; support for attending meetings and/or travel from the European Society of Cardiology. R.C. declares personal payments for lectures, presentations, speakers bureaus, manuscript writing or educational events from Boehringer Ingelheim, Servier, Novartis, BerlinChemie, Zentiva, Viatris, Pfizer, Astra Zeneca; support for attending meetings and/or travel from Novartis Berlin-Chemie, Astra Zeneca, Boehringer Ingelheim; participation on a Data Safety Monitoring Board or Advisory Board for Boehringer Ingelheim; receipt of drug samples from Astra Zeneca and Boehringer Ingelheim. D.A.L. declares grants or contracts to her institution from Bristol-Myers Squibb and Pfizer; consulting fees from Bristol-Myers Squibb (BMS) and Boehringer Ingelheim; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, BMS-Pfizer, Boehringer Ingelheim. G.R. declares consulting fees paid to the University no value transfer from Astra Zeneca, Bayer, Boehringer Ingelheim, Vifor, Menarini; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events to the university no value transfer from Astra Zeneca, Bayer, Boehringer Ingelheim, Vifor, Menarini; support for attending meetings and/or travel from Fondazione Menarini, Servier, Astra Zeneca. P.H declares Horizon Europe Label2Enable project payments to the Leiden University Medical center and to be the lead expert of CEN-ISO/TS 82304-2 with no financial ties or royalties for CEN TC251; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events covered by Label2Enable project; payment for expert testimony for the Advanced and Active Living project for project reviews; support for attending meetings and/or travel from, the American Society of Clinical Oncology in 2019 as a patient advocate; being the unpaid initiator and driver of two health apps in oncology (ReMind app and Goings-On app). R.A. reports <100 € of royalties or licences from Springer-Verlag GmbH; a 750 EUR payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from the Univers Formazione SRL Roma; participation on a Data Safety Monitoring Board or Advisory Board of Resilience Trial. H.P.B.LR. declares support for the present manuscript in the form of INTERREG-NWE project NWE702; PASSION-HF grants to his institution; grants or contracts from Dutch Heart Foundation CVON 2018-28, ZONMW IMDI 104022004, Vifor Pharma, and Roche Diagnostics to his institution; consulting fees from Novartis Pharma, Boehringer-Ingelheim, AstraZeneca, Roche Diagnostics, Vifor Pharma to his institution; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events to his institution from Novartis, Roche Diagnostics; payment for expert testimony to his institution from Novartis; being on Committee on pharmacological treatment of the Dutch Society of Cardiology. K.M.R. declares payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Biosense Webster; support for attending meetings and/or travel to/from the European Heart Rhythm Association; being on the board of the European Heart Rhythm Association. E.T.L. declares a professional personal contract (2019–today) as a Senior Consultant with the IRCCS Policlinico San Donato and a professional personal contract (2003–today) as a Senior Consultant with the Italian National Health System—Lombardy Region, support for attending meetings and/or travel to/from the Japanese Heart Rhythm Society (July 2023). M.R.C. Reports having been the chair of the ESC Digital Health Committee in the period 2018–2022; being employed by AstraZeneca. G.P. declares honorariums for lectures from Omron Health Care and Somnomedics. P.S. declares payment or honorariums for educational events from Novartis and Polpharma. R.C.A. declares payment for lectures made to his institution by Abbot and Boston Scientific. CP declares honorariums for educational cardio-oncology presentations from Amgen and Beigene. P.D., S.C., A.S., C.O.M., B.B., M.S., H.K., declare no conflict of interest for this contribution., (© European Society of Cardiology 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Heart failure (HF) is a common cause of mortality and (re)hospitalizations. The NWE-Chance project explored the feasibility of providing hospitalizations at home (HH) supported by a newly developed digital health platform. The aim of this study was to explore the perceived usability by healthcare professionals (HCPs) of a digital platform in addition to HH for HF patients., Methods and Results: A prospective, international, multicentre, single-arm interventional study was conducted. Sixty-three patients and 22 HCPs participated. The HH consisted of daily home visits by the nurse and use of the platform, consisting of a portable blood pressure device, weight scale, pulse oximeter, a wearable chest patch to measure vital signs (heart rate, respiratory rate, activity level, and posture), and an eCoach for the patient. Primary outcome was usability of the platform measured by the System Usability Scale halfway and at the end of the study. Overall usability was rated as sufficient (mean score 72.1 ± 8.9) and did not differ between the measurements moments (P = 0.690). The HCPs reported positive experiences (n = 7), negative experiences (n = 13), and recommendations (n = 6) for the future. Actual use of the platform was 79% of the HH days., Conclusion: A digital health platform to support HH was considered usable by HCPs, although actual use of the platform was limited. Therefore, several improvements in the integration of the digital platform into clinical workflows and in defining the precise role of the digital platform and its use are needed to add value before full implementation., Registration: clinicaltrials.gov NCT04084964., Competing Interests: Conflict of interest: The authors declare that there is no conflict of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aims: Current heart failure (HF) guidelines recommend to prescribe four drug classes in patients with HF with reduced ejection fraction (HFrEF). A clear challenge exists to adequately implement guideline-directed medical therapy (GDMT) regarding the sequencing of drugs and timely reaching target dose. It is largely unknown how the paradigm shift from a serial and sequential approach for drug therapy to early parallel application of the four drug classes will be executed in daily clinical practice, as well as the reason clinicians may not adhere to new guidelines. We present the design and rationale for the real-world TITRATE-HF study, which aims to assess sequencing strategies for GDMT initiation, dose titration patterns (order and speed), intolerance for GDMT, barriers for implementation, and long-term outcomes in patients with de novo, chronic, and worsening HF., Methods and Results: A total of 4000 patients with HFrEF, HF with mildly reduced ejection fraction, and HF with improved ejection fraction will be enrolled in >40 Dutch centres with a follow-up of at least 3 years. Data collection will include demographics, physical examination and vital parameters, electrocardiogram, laboratory measurements, echocardiogram, medication, and quality of life. Detailed information on titration steps will be collected for the four GDMT drug classes. Information will include date, primary reason for change, and potential intolerances. The primary clinical endpoints are HF-related hospitalizations, HF-related urgent visits with a need for intravenous diuretics, all-cause mortality, and cardiovascular mortality., Conclusions: TITRATE-HF is a real-world multicentre longitudinal registry that will provide unique information on contemporary GDMT implementation, sequencing strategies (order and speed), and prognosis in de novo, worsening, and chronic HF patients., (© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)