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Heart transplantation remains the gold standard treatment for end-stage heart failure patients without contraindications. However, limited donor availability and long wait times have created a need for left ventricular assist devices (LVAD) to be used as a bridge to transplantation in appropriately selected patients. Improvements in LVAD technology have resulted in improved short- and long-term outcomes, further supporting the use of these devices for a bridge-to-transplant (BTT) indication. LVAD utilization as BTT exhibits notable disparities worldwide, mainly due to variations in organ availability, allocation policies, and financial constraints. Although Europe has experienced a consistent increase in the use of LVAD for this purpose, the United Network for Organ Sharing 2018 policy amendment resulted in a significant reduction in the number of LVADs used for BTT in the US. To overcome this issue, modifications in the US allocation policy to consider factors such as days on device support, age, and type of complications may be necessary to potentially increase implantation rates.The authors provide an overview comparing the current state of heart transplantation in the US and Europe, with a particular focus on how distinct allocation policies and organ availability impact medical practices. Additionally, the review will examine critical aspects ranging from patient selection and pre-implantation optimization to post-transplant outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes. Methods and analysis: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles. Discussion: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early. Trial registration: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022. [ABSTRACT FROM AUTHOR]

The current practice of atrial fibrillation ablation (AFA) as a treatment option for atrial fibrillation (AF) in patients with heart failure (HF) across Europe, their clinical profiles and outcomes is still undefined. The European Society of Cardiology (ESC) led a prospective observational registry of consecutive patients undergoing AFA, in 27 member countries. The subgroup of patients with HF, followed-up for 1 year, was analyzed and the results are reported. Of the 3582 AF patients in the Registry, 537 (14.9%) had HF. Diabetes, hypertension, hypercholesterolemia, CHA 2 DS 2 -VASc score ≥ 2, structural heart disease and persistent AF were more common in HF than non-HF patients (all p < 0.001). However the in-hospital complications were less frequent in HF patients (5.0% vs. 8.2% p = 0.01). Both in-hospital and 1-year outcomes, including 1-year AF recurrence (15.4%) and repeat ablations (9.5%), were similar in both groups. We subdivided HF patients according to their left ventricular ejection fraction (EF) at baseline into reduced (HFrEF, <40%), mid-range (HFmEF, 40–49%), or preserved EF (HFpEF, ≥ 50%). Most patients were HFpEF (n 375, 77%), 72 (15%) were HFmEF and 8% HFrEF. The most frequent underlying conditions in HFpEF were hypertension and ischemic heart disease, while those most common in HFmEF and HFrEF were valvular and dilated cardiomyopathy. In routine care in Europe, HF patients represent a minority of patients undergoing AFA, and most belong to the HFpEF phenotype. The limited clinical research on AFA HFpEF patients is reflected by the uncertainty expressed in the current AF Guidelines and Expert statements. • A survey conducted by the ESC in 27 member countries evaluated the practice use of atrial fibrillation ablation. • 3582 ablated patients were enrolled, 537 with HF, 77% of which had preserved left ventricular ejection fraction (LVEF≥50%). • In contrast most randomized clinical research trials focused on HF with reduced LVEF (35-40%). • Such asymmetry in evidence may account for some inconsistency in current Guidelines. [ABSTRACT FROM AUTHOR]

Type 2 diabetes mellitus (T2DM) is common in patients with heart failure (HF) and associated with considerable morbidity and mortality. Significant advances have recently occurred in the treatment of T2DM, with evidence of several new glucose-lowering medications showing either neutral or beneficial cardiovascular effects. However, some of these agents have safety characteristics with strong practical implications in HF [i.e. dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RA), and sodium-glucose co-transporter type 2 (SGLT-2) inhibitors]. Regarding safety of DPP-4 inhibitors, saxagliptin is not recommended in HF because of a greater risk of HF hospitalisation. There is no compelling evidence of excess HF risk with the other DPP-4 inhibitors. GLP-1 RAs have an overall neutral effect on HF outcomes. However, a signal of harm suggested in two small trials of liraglutide in patients with reduced ejection fraction indicates that their role remains to be defined in established HF. SGLT-2 inhibitors (empagliflozin, canagliflozin and dapagliflozin) have shown a consistent reduction in the risk of HF hospitalisation regardless of baseline cardiovascular risk or history of HF. Accordingly, SGLT-2 inhibitors could be recommended to prevent HF hospitalisation in patients with T2DM and established cardiovascular disease or with multiple risk factors. The recently completed trial with dapagliflozin has shown a significant reduction in cardiovascular mortality and HF events in patients with HF and reduced ejection fraction, with or without T2DM. Several ongoing trials will assess whether the results observed with dapagliflozin could be extended to other SGLT-2 inhibitors in the treatment of HF, with either preserved or reduced ejection fraction, regardless of the presence of T2DM. This position paper aims to summarise relevant clinical trial evidence concerning the role and safety of new glucose-lowering therapies in patients with HF. [ABSTRACT FROM AUTHOR]

Objective: The long-term predictive value of the new proposed algorithm in the updated 2016 guidelines of the European Association of Cardiovascular Imaging to assess diastolic dysfunction (DD) in patients with heart failure with preserved ejection fraction (HFpEF) has not been validated.Methods: The analysis included 451 patients who were diagnosed with HFpEF as confirmed via echocardiography. The endpoints were mortality and hospitalization for HF. The Kaplan-Meier curves and Cox regression models were generated to determine the risk of all-cause mortality based on the 2016 and 2009 DD grading algorithm, respectively. We evaluated the net reclassification index of outcomes on the basis of 2009 DD grade after abiding by the 2016 recommendations.Results: After a follow-up of 2976 days, 119 patients (26.4%) died. According to the 2016 DD grading, grade III DD was associated with a significantly higher risk of mortality (hazard ratio [HR], 2.209; 95% CI 1.144-4.266) and HF hospitalization (HR, 2.047; 95% CI 1.348-3.870), as compared with grade I DD. Grade II DD was also associated with a higher risk of mortality (HR, 1.538; 95% CI 1.313-1.924). However, only grade III DD was independently associated with worse mortality based on 2009 DD grading. The net reclassification index for mortality increased significantly after grading by 2016 algorithm (10.6%, p < 0.001).Conclusions: The 2016 DD grading algorithm showed improved prognostic value of long-term mortality in patients with HFpEF. Based on the findings of the study, the appropriate grading of DD is important in the prognostication of patients with HFpEF.Key Points: • The application of the 2016 European Association of Cardiovascular Imaging recommendations diastolic dysfunction (DD) grading algorithm improves the predictive value for mortality. • Our analysis suggests DD grades II and III based on 2016 guidelines is associated with poor outcomes as compared with grade I. The echocardiographic indices of the new algorithm should be obtained and applied to effectively evaluate DD. [ABSTRACT FROM AUTHOR]

Aim: To provide reliable survival estimates for people with chronic heart failure and explain variation in survival by key factors including age at diagnosis, left ventricular ejection fraction, decade of diagnosis, and study setting.Methods and Results: We searched in relevant databases from inception to August 2018 for non-interventional studies reporting survival rates for patients with chronic or stable heart failure in any ambulatory setting. Across the 60 included studies, there was survival data for 1.5 million people with heart failure. In our random effects meta-analyses the pooled survival rates at 1 month, 1, 2, 5 and 10 years were 95.7% (95% confidence interval 94.3-96.9), 86.5% (85.4-87.6), 72.6% (67.0-76.6), 56.7% (54.0-59.4) and 34.9% (24.0-46.8), respectively. The 5-year survival rates improved between 1970-1979 and 2000-2009 across healthcare settings, from 29.1% (25.5-32.7) to 59.7% (54.7-64.6). Increasing age at diagnosis was significantly associated with a reduced survival time. Mortality was lowest in studies conducted in secondary care, where there were higher reported prescribing rates of key heart failure medications. There was significant heterogeneity among the included studies in terms of heart failure diagnostic criteria, participant co-morbidities, and treatment rates.Conclusion: These results can inform health policy and individual patient advanced care planning. Mortality associated with chronic heart failure remains high despite steady improvements in survival. There remains significant scope to improve prognosis through greater implementation of evidence-based treatments. Further research exploring the barriers and facilitators to treatment is recommended. [ABSTRACT FROM AUTHOR]

The prevalence of end stage heart failure and patients that could benefit from heart transplantation requires expansion of the donor pool, relying on the transplant community to continually re-evaluate and expand the use of marginal donor organs. Introduction of new technologies such as the Paragonix SherpaPak Cardiac Transport System (CTS) aids in this shift. We seek to analyze the impact of the CTS system on recipient outcomes who receive extended criteria organs in the GUARDIAN Heart Registry. Between October 2015-August 2022 , 761 adults from 9 US centers receiving donor hearts utilizing either CTS (N=419) or conventional ice storage (ICE, N=342) were analyzed from the GUARDIAN Heart registry using summary statistics. A modified EXPAND OCS Trial criteria was used to delineate cohorts of extended criteria donors, which included 176 CTS and 132 ICE (see Table). Forty percent of the total US donors in the registry population met the extended criteria definition. There were few baseline differences among recipients in the 2 cohorts, most notably both distance traveled and total ischemic time was significantly greater in CTS, and significantly more donor hearts in the CTS cohort had >4 hours total ischemia time, although baseline VAD was higher in the ICE cohort. Post-transplant MCS utilization and New ECMO/VAD was significantly reduced, and the rate of severe PGD was significantly reduced by over 50% in hearts preserved using CTS. Survival between cohorts was similar. This subgroup analysis demonstrates that SherpaPak CTS can be safely used to utilize extended criteria donors, with low severe PGD rates. This is encouraging toward use of extended criteria donors in European transplant programs, though further clinical evaluation in Europe is warranted. [ABSTRACT FROM AUTHOR]

Objectives: Value of information (VOI) analysis provides information on opportunity cost of a decision in healthcare by estimating the cost of reducing parametric uncertainty and quantifying the value of generating additional evidence. This study is an application of the VOI methodology to the problem of choosing between home telemonitoring and nurse telephone support over usual care in chronic heart failure management in the Netherlands. Methods: The expected value of perfect information (EVPI) and the expected value of partially perfect information (EVPPI) analyses were based on an informal threshold of €20K per quality-adjusted life-year. These VOI-analyses were applied to a probabilistic Markov model comparing the 20-year costs and effects in three interventions. The EVPPI explored the value of decision uncertainty caused by the following group of parameters: treatment-specific transition probabilities between New York Heart Association (NYHA) defined disease states, utilities associated with the disease states, number of hospitalizations and ER visits, health state specific costs, and the distribution of patients per NYHA group. We performed the analysis for two population sizes in the Netherlands—patients in all NYHA classes of severity, and patients in NYHA IV class only. Results: The population EVPI for an effective population of 2,841,567 CHF patients in All NYHA classes of severity over the next 20 years is more than €4.5B, implying that further research is highly cost-effective. In the NYHA IV only analysis, for the effective population of 208,003 patients over next 20 years, the population EVPI at the same informal threshold is approx. €590M. The EVPPI analysis showed that the only relevant group of parameters that contribute to the overall decision uncertainty are transition probabilities, in both All NYHA and NYHA IV analyses. Conclusions: Results of our VOI exercise show that the cost of uncertainty regarding the decision on reimbursement of telehealth interventions for chronic heart failure patients is high in the Netherlands, and that future research is needed, mainly on the transition probabilities. [ABSTRACT FROM AUTHOR]

Introduction: Readmissions are a recognised challenge for providers of healthcare and incur financial penalties in a growing number of countries. However, the scale of unscheduled hospital contacts including attendances at emergency departments that do not result in admission is not well known. In addition, little is known about the route to readmission for patients recently discharged from an emergency hospital stay. Methods: This is an observational study of national hospital administration data for England. In this retrospective cohort study, we tracked patients for 30 days after discharge from an emergency admission for heart failure (HF) or chronic obstructive pulmonary disorder (COPD). Results: The majority of patients (COPD:79%; HF:75%) had no unscheduled contact with secondary health care within 30 days of discharge. Of those who did have unscheduled contact, the most common first unscheduled contact was emergency department (ED) attendance (COPD:16%; HF:18%). A further 5% of COPD patients and 4% of HF patients were admitted for an emergency inpatient stay, but not through the ED. A small percentage of patients (COPD:<1%, HF:2%) died without any known contact with secondary care. ED conversion rates at first attendance for both COPD and HF were high: 75% and 79% respectively. A quarter of patients who were not admitted during this first ED attendance attended the ED again within the 30-day follow-up period, and around half (COPD:56%; HF:63%) of these were admitted at this point. Patients who live alone, had an index admission which included an overnight stay and were comorbid had higher odds of being admitted through the ED than via other routes. Conclusion: While the majority of patients did not have unscheduled contact with secondary care in the 30 days after index discharge, many patients attended the ED, often multiple times, and many were admitted to hospital, not always via the ED. More frail patients were more likely to be admitted through the ED, suggesting a possible area of focus as discharge bundles are developed. [ABSTRACT FROM AUTHOR]

Importance: Heart failure with preserved ejection fraction (HFpEF) lacks effective treatments. Based on preclinical studies, neladenoson bialanate, a first-in-class partial adenosine A1 receptor agonist, has the potential to improve several heart failure-related cardiac and noncardiac abnormalities but has not been evaluated to treat HFpEF.Objectives: To determine whether neladenoson improves exercise capacity, physical activity, cardiac biomarkers, and quality of life in patients with HFpEF and to find the optimal dose.Design, Setting, and Participants: Phase 2b randomized clinical trial conducted at 76 centers in the United States, Europe, and Japan. Patients (N = 305) with New York Heart Association class II or III HFpEF with elevated natriuretic peptide levels were enrolled between May 10, 2017, and December 7, 2017 (date of final follow-up: June 20, 2018).Interventions: Participants were randomized (1:2:2:2:2:3) to neladenoson (n = 27 [5 mg], n = 50 [10 mg], n = 51 [20 mg], n = 50 [30 mg], and n = 51 [40 mg]) or matching placebo (n = 76) for 20 weeks of treatment.Main Outcomes and Measures: The primary end point was change in 6-minute walk test distance from baseline to 20 weeks (minimal clinically important difference, 40 m). Key safety measures included bradyarrhythmias and adverse events. To evaluate the effects of varying doses of neladenoson, a multiple comparison procedure with 5 modeling techniques (linear, Emax, 2 variations of sigmoidal Emax, and quadratic) was used to evaluate diverse dose-response profiles.Results: Among 305 patients who were randomized (mean age, 74 years; 160 [53%] women; mean 6-minute walk test distance, 321.5 m), 261 (86%) completed the trial and were included in the primary analysis. After 20 weeks of treatment, the mean absolute changes from baseline in 6-minute walk test distance were 0.2 m (95% CI, -12.1 to 12.4 m) for the placebo group; 19.4 m (95% CI, -10.8 to 49.7 m) for the 5 mg of neladenoson group; 29.4 m (95% CI, 3.0 to 55.8 m) for 10 mg of neladenoson group; 13.8 m (95% CI, -2.3 to 29.8 m) for 20 mg of neladenoson group; 16.3 m (95% CI, -1.1 to 33.6 m) for 30 mg of neladenoson group; and 13.0 m (95% CI, -5.9 to 31.9 m) for 40 mg of neladenoson group. Because none of the neladenoson groups achieved the clinically relevant 40-m increase in 6-minute walk test distance from baseline, an optimal dose of neladenoson was not identified. There was no significant dose-response relationship for the change in 6-minute walk test distance among the 5 different dose-response models (P = .05 for Emax; P = .18 for quadratic; P = .21 for sigmoidal Emax 1; P = .39 for linear; and P = .52 for sigmoidal Emax 2). Serious adverse events were similar among the neladenoson groups (61/229 [26.6%]) and the placebo group (21/76 [27.6%]).Conclusions and Relevance: Among patients with HFpEF, there was no significant dose-response relationship detected for neladenoson with regard to the change in exercise capacity from baseline to 20 weeks. In light of these findings, novel approaches will be needed if further development of neladenoson for the treatment of patients with HFpEF is pursued.Trial Registration: ClinicalTrials.gov Identifier: NCT03098979. [ABSTRACT FROM AUTHOR]

Aim: Serelaxin is a recombinant human relaxin-2 hormone, which confers receptor-mediated vasodilatation in a tissue-specific fashion. The RELAX-AHF-EU study assessed the effect of serelaxin when added to standard-of-care (SoC) therapy on worsening heart failure (WHF)/all-cause death through Day 5 in patients hospitalised for acute heart failure (AHF) in Europe.Methods and Results: This multicentre, prospective, randomised, open-label, blinded-endpoint validation study enrolled hospitalised AHF patients and randomised (2:1) eligible patients (mild-to-moderate renal impairment and systolic blood pressure ≥ 125 mmHg) within 16 h of presentation with signs/symptoms of AHF, to receive 48 h intravenous infusion of 30 μg/kg/day serelaxin + SoC or SoC alone. The primary endpoint was adjudicated WHF/all-cause death through Day 5. Of 3183 patients targeted, 2666 were randomised when the study was terminated early by the sponsor due to the neutral results of the pivotal RELAX-AHF-2 study. Adjudicated WHF/all-cause death through Day 5 was significantly reduced in the serelaxin + SoC vs. SoC group (5.0% vs. 6.9%; hazard ratio 0.71; 95% confidence interval 0.51-0.98; P = 0.0172) (absolute risk reduction 1.9%, number needed to treat 53). The difference between treatment groups was not significant for WHF/all-cause death/heart failure rehospitalisation through Day 14 and length of hospital stay. A significantly smaller proportion of patients in the serelaxin + SoC vs. SoC group experienced persistent heart failure signs/symptoms at each visit until Day 4, or renal deterioration through Day 5 (all P ≤ 0.01). Overall incidence of treatment-emergent adverse events was comparable between treatment groups. Hypotension and decrease in haemoglobin/haematocrit were more frequent in the serelaxin + SoC group.Conclusion: When added to SoC, serelaxin reduced adjudicated WHF or all-cause death through Day 5 in AHF patients. The results from this open-label study should be considered in the context of the totality of the double-blind, randomised evidence on serelaxin in AHF. [ABSTRACT FROM AUTHOR]

This paper provides a practical clinical application of guideline recommendations relating to the inpatient monitoring of patients with acute heart failure, through the evaluation of various clinical, biomarker, imaging, invasive and non-invasive approaches. Comprehensive inpatient monitoring is crucial to the optimal management of acute heart failure patients. The European Society of Cardiology heart failure guidelines provide recommendations for the inpatient monitoring of acute heart failure, but the level of evidence underpinning most recommendations is limited. Many tools are available for the in-hospital monitoring of patients with acute heart failure, and each plays a role at various points throughout the patient's treatment course, including the emergency department, intensive care or coronary care unit, and the general ward. Clinical judgment is the preeminent factor guiding application of inpatient monitoring tools, as the various techniques have different patient population targets. When applied appropriately, these techniques enable decision making. However, there is limited evidence demonstrating that implementation of these tools improves patient outcome. Research priorities are identified to address these gaps in evidence. Future research initiatives should aim to identify the optimal in-hospital monitoring strategies that decrease morbidity and prolong survival in patients with acute heart failure. [ABSTRACT FROM AUTHOR]

Background: Cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure and is strongly recommended for such patients by guidelines. A European Society of Cardiology (ESC) CRT survey conducted in 2008-2009 showed considerable variation in guideline adherence and large individual, national and regional differences in patient selection, implantation practice and follow-up. Accordingly, two ESC associations, the European Heart Rhythm Association and the Heart Failure Association, designed a second prospective survey to describe contemporary clinical practice regarding CRT.Methods and Results: A survey of the clinical practice of CRT-P and CRT-D implantation was conducted from October 2015 to December 2016 in 42 ESC member countries. Implanting centres provided information about their hospital and CRT service and were asked to complete a web-based case report form collecting information on patient characteristics, investigations, implantation procedures and complications during the index hospitalisation. The 11 088 patients enrolled represented 11% of the total number of expected implantations in participating countries during the survey period; 32% of patients were aged ≥75 years, 28% of procedures were upgrades from a permanent pacemaker or implantable cardioverter-defibrillator and 30% were CRT-P rather than CRT-D. Most patients (88%) had a QRS duration ≥130 ms, 73% had left bundle branch block and 26% were in atrial fibrillation at the time of implantation. Large geographical variations in clinical practice were observed.Conclusion: CRT Survey II provides a valuable source of information on contemporary clinical practice with respect to CRT implantation in a large sample of ESC member states. The survey permits assessment of guideline adherence and demonstrates variations in patient selection, management, implantation procedure and follow-up strategy. [ABSTRACT FROM AUTHOR]

Aims: Recurrent hospitalizations are a major part of the disease burden in heart failure (HF), but conventional analyses consider only the first event. We compared the effect of sacubitril/valsartan vs. enalapril on recurrent events, incorporating all HF hospitalizations and cardiovascular (CV) deaths in PARADIGM-HF, using a variety of statistical approaches advocated for this type of analysis.Methods and Results: In PARADIGM-HF, a total of 8399 patients were randomized and followed for a median of 27 months. We applied various recurrent event analyses, including a negative binomial model, the Wei, Lin and Weissfeld (WLW), and Lin, Wei, Ying and Yang (LWYY) methods, and a joint frailty model, all adjusted for treatment and region. Among a total of 3181 primary endpoint events (including 1251 CV deaths) during the trial, only 2031 (63.8%) were first events (836 CV deaths). Among a total of 1195 patients with at least one HF hospitalization, 410 (34%) had at least one further HF hospitalization. Sacubitril/valsartan compared with enalapril reduced the risk of recurrent HF hospitalization using the negative binomial model [rate ratio (RR) 0.77, 95% confidence interval (CI) 0.67-0.89], the WLW method [hazard ratio (HR) 0.79, 95% CI 0.71-0.89], the LWYY method (RR 0.78, 95% CI 0.68-0.90), and the joint frailty model (HR 0.75, 95% CI 0.66-0.86) (all P < 0.001). The effect of sacubitril/valsartan vs. enalapril on recurrent HF hospitalizations/CV death was similar.Conclusions: In PARADIGM-HF, approximately one third of patients with a primary endpoint (time-to-first) experienced a further event. Compared with enalapril, sacubitril/valsartan reduced both first and recurrent events. The treatment effect size was similar, regardless of the statistical approach applied. [ABSTRACT FROM AUTHOR]

Background: In nonrandomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%.Methods: REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise.Results: A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control (P=0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group (P=0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the control group (P=1.0).Conclusions: In patients with HF and EF ≥40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation.Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT02600234. [ABSTRACT FROM AUTHOR]

Despite improvements in medical therapy and device-based treatment, heart failure (HF) continues to impose enormous burdens on patients and health care systems worldwide. Alterations in autonomic nervous system (ANS) activity contribute to cardiac disease progression, and the recent development of invasive techniques and electrical stimulation devices has opened new avenues for specific targeting of the sympathetic and parasympathetic branches of the ANS. The Heart Failure Association of the European Society of Cardiology recently organized an expert workshop which brought together clinicians, trialists and basic scientists to discuss the ANS as a therapeutic target in HF. The questions addressed were: (i) What are the abnormalities of ANS in HF patients? (ii) What methods are available to measure autonomic dysfunction? (iii) What therapeutic interventions are available to target the ANS in patients with HF, and what are their specific strengths and weaknesses? (iv) What have we learned from previous ANS trials? (v) How should we proceed in the future? [ABSTRACT FROM AUTHOR]

Aims: Mineralocorticoid receptor antagonists (MRAs) are recommended (unless contraindicated) to all patients with heart failure with reduced ejection fraction (HFrEF). However, MRAs are still largely underused in routine clinical practice. This study aims to describe the determinants and pattern of use of MRAs in HFrEF.Methods and Results: BIOSTAT-CHF is a European multicentre, prospective study which enrolled patients suboptimally treated with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARBs) and/or beta-blockers, with the aim of optimizing guideline-based use of these agents. From the original 2516 subjects, this retrospective post hoc analysis included the 1325 patients with an indication for MRA therapy (i.e. left ventricular ejection fraction ≤35%, estimated glomerular filtration rate ≥30 mL/min/1.73 m2 , K+ ≤5.0 mmol/L). The mean age was 66.1 ± 12.2 years. At baseline an MRA was prescribed to 741 (56%) patients. Patients who were prescribed MRAs at baseline were younger, more often male, had higher body mass index, lower sodium, higher proportion of hypertension history and ACEi/ARB prescription (all P < 0.05). Of the 1049 patients who completed the baseline plus the 9 month visit, 585 (56%) had an MRA prescribed at baseline and 662 (63%) had an MRA prescribed at 9 months. Among the 585 patients with MRA at baseline, 91 (16%) had discontinued therapy and among the 461 (44%) patients without MRA at baseline 168 (36%) had initiated therapy subsequently. MRA discontinuation was more likely in subjects with higher left ventricular ejection fraction and NYHA class III/IV (P < 0.05 for both). MRA prescription both at baseline and 9 months was not associated with the outcome of death or heart failure hospitalization (adjusted hazard ratio 1.02, 95% confidence interval 0.66-1.58; P = 0.93).Conclusions: In this prospective observational study across Europe, MRAs were largely under-prescribed and frequently discontinued. Owing to these dynamic changes, outcome inferences are inconclusive. [ABSTRACT FROM AUTHOR]

Aims: To identify differences in clinical epidemiology, in-hospital management and 1-year outcomes among patients hospitalized for acute heart failure (AHF) and enrolled in the European Society of Cardiology Heart Failure Long-Term (ESC-HF-LT) Registry, stratified by clinical profile at admission.Methods and Results: The ESC-HF-LT Registry is a prospective, observational study collecting hospitalization and 1-year follow-up data from 6629 AHF patients. Among AHF patients enrolled in the registry, 13.2% presented with pulmonary oedema (PO), 2.9% with cardiogenic shock (CS), 61.1% with decompensated heart failure (DHF), 4.8% with hypertensive heart failure (HT-HF), 3.5% with right heart failure (RHF) and 14.4% with AHF and associated acute coronary syndromes (ACS-HF). The 1-year mortality rate was 28.1% in PO, 54.0% in CS, 27.2% in DHF, 12.8% in HT-HF, 34.0% in RHF and 20.6% in ACS-HF patients. When patients were classified by systolic blood pressure (SBP) at initial presentation, 1-year mortality was 34.8% in patients with SBP <85 mmHg, 29.0% in those with SBP 85-110 mmHg, 21.2% in patients with SBP 110-140 mmHg and 17.4% in those with SBP >140 mmHg. These differences tended to diminish in the months post-discharge, and 1-year mortality for the patients who survived at least 6 months post-discharge did not vary significantly by either clinical profile or SBP classification.Conclusion: Rates of adverse outcomes in AHF remain high, and substantial differences have been found when patients were stratified by clinical profile or SBP. However, patients who survived at least 6 months post-discharge represent a more homogeneous group and their 1-year outcome is less influenced by clinical profile or SBP at admission. [ABSTRACT FROM AUTHOR]

Aims: Although hypokalaemia is common among patients with heart failure (HF), the prognostic significance of baseline hypokalaemia and hypokalaemia during follow-up in HF patients receiving a mineralocorticoid receptor antagonist (MRA) remains uncertain.Methods and Results: Results of the EMPHASIS-HF trial in patients (n = 2737) with HF and reduced EF with mild symptoms, randomized to eplerenone or placebo, were analysed with regard to the presence or occurrence of hypokalaemia (serum K+ <4.0 mmol/L) and the risk of cardiovascular death or hospitalization for HF (primary endpoint). Median follow-up was 21 months. Baseline hypokalaemia and hypokalaemia during follow-up were common occurrences (19.6% and 40.6%, respectively). Hypokalaemia during follow-up was associated with worse outcomes in multivariable analyses [hazard ratio (HR) 1.26, 95% confidence interval (CI) 1.05-1.52, P = 0.01] without evidence of interaction with eplerenone. In contrast, baseline hypokalaemia was associated with outcomes in the placebo group (HR 1.37, 95% CI 1.05-1.79, P = 0.02) but not in the eplerenone group (HR 0.87, 95% CI 0.62-1.23, P = 0.44; P for interaction = 0.04). Concurrently, eplerenone was found to be more protective in patients with baseline hypokalaemia vs. patients without baseline hypokalaemia compared with placebo (HR 0.44, 95% 0.30-0.64, P < 0.0001 vs. 0.69, 95% CI 0.57-0.83, P = 0.0001; P for interaction = 0.04). In patients without baseline hypokalaemia, eplerenone use decreased the rate of hypokalaemia during follow-up (HR 0.69, 95% CI 0.59-0.80, P < 0.001). A potassium level >4.0 mmol/L at 1 month after randomization mediated 26.0% (0.6-51.4%) of the eplerenone treatment effect (P = 0.04).Conclusion: In HF patients receiving optimal therapy but not treated with eplerenone, baseline hypokalaemia was associated with worse outcomes. Conversely, hypokalaemia amplified the treatment effect of eplerenone. [ABSTRACT FROM AUTHOR]

Aims: The 'obesity paradox' is consistently observed in patients with heart failure (HF). We investigated the relationship of body surface area (BSA) to mortality and hospitalizations in patients with chronic HF.Methods and Results: Data from the outpatient cohort of the observational, prospective, Heart Failure Long-Term Registry of the Heart Failure Association of the European Society of Cardiology was analysed in order to evaluate the prognostic significance of BSA in chronic HF. A total of 9104 chronic HF patients (age 64.8 ± 13.4 years; 71.6% males) were enrolled. Mortality during 1-year follow-up was observed in 718 of 8875 (8.1%) patients. A progressive, inverse relationship between all-cause mortality and BSA levels was observed; the adjusted hazard ratio (HR) for 1-year mortality was 1.823 [95% confidence interval (CI) 1.398-2.376], P < 0.001 for the lowest quartile of BSA <1.78 m(2) , and 1.255, 95% CI 1.000-1.576, P = 0.05 for the middle two quartiles (1.78 ≤BSA ≤2.07 m(2) ), compared with the highest quartile (BSA >2.07 m(2) ). For each increase of 0.1 m(2) in BSA, an adjusted HR of 0.908 (95% CI 0.870-0.948), P < 0.001 for mortality was calculated. HF hospitalizations were not associated with BSA subgroup distribution. In both genders, subjects within the lowest BSA quartile (males <1.84 m(2) and females <1.64 m(2) ) had significantly higher mortality rates during follow-up (log-rank P < 0.0001). However, the stepwise association with mortality was more distinct in males.Conclusions: Total and cardiovascular mortality, but not HF hospitalizations was inversely associated with BSA levels in chronic HF patients. BSA may serve as a prognostic indicator for adverse outcome in HF patients. [ABSTRACT FROM AUTHOR]

Recent advances in care and management of heart failure have improved outcome, largely as a result of the developing evidence basis for medications, implantable devices and the organization of heart failure follow-up. Such developments have also increased the complexity of delivering and coordinating care. This has led to a change to the way in which heart failure services are organized and to the traditional role of the heart failure nurse. Nurses in many countries now provide a range of services that include providing care for patients with acute and with chronic heart failure, working in and across different sectors of care (inpatient, outpatient, community care, the home and remotely), organising care services around the face-to-face and the remote collection of patient data, and liaising with a wide variety of health-care providers and professionals. To support such advances the nurse requires a skill set that goes beyond that of their initial education and training. The range of nurses' roles across Europe is varied. So too is the nature of their educational preparation. This heart failure nurse curriculum aims to provide a framework for use in countries of the European Society of Cardiology. Its modular approach enables the key knowledge, skills, and behaviours for the nurse working in different care settings to be outlined and so facilitate nursing staff to play a fuller role within the heart failure team. [ABSTRACT FROM AUTHOR]

Aims: It remains unclear if early administration of i.v. nesiritide in patients hospitalized with acute heart failure (AHF) is associated with improved clinical outcomes.Methods and Results: We analysed data from 7007 patients enrolled in ASCEND-HF to examine the associations between time to treatment with study medication (nesiritide or placebo) and clinical endpoints: (i) moderate to marked dyspnoea relief on a 7-point Likert scale at 6 h; (ii) 30-day all-cause mortality or re-hospitalization; and (iii) 30-day all-cause mortality. The median time to study drug administration was 16.7 h (25th, 75th percentiles = 6.5, 23.1), with significant regional variation (e.g. median of 13.0 h in Asia-Pacific vs. 18.4 h in North America). After risk adjustment, each hour delay in study medication after the first 10 h from initial hospital presentation was associated with modestly reduced odds of dyspnoea relief [(adjusted odds ratio (OR) 0.98, 95% confidence interval (CI) 0.98-0.99; P < 0.0001]. Every hour delay in study medication was associated with modestly higher all-cause mortality or re-hospitalization (unadjusted OR 1.01, 95% CI 1.01-1.02; P < 0.001) due to pre-randomization therapies and known predictors of 30-day outcomes (adjusted P = 0.12). There was no significant association between time to study drug and all-cause mortality (P > 0.08).Conclusion: In a large international AHF trial, time to treatment with study medication varied markedly across regions. Earlier administration of study medication was associated with modestly better dyspnoea relief, but not 30-day clinical outcomes. The association between timing of treatment with study medication and study endpoints may have implications for the interpretation of AHF studies and future trial design. [ABSTRACT FROM AUTHOR]

Aims: Despite major improvements in pharmacological and device treatments, heart failure remains a syndrome with high morbidity and mortality, poor quality of life, and high health-care costs. Given the extensive heterogeneity among patients with heart failure, substantial differences in the response to therapy can be expected. We hypothesize that individualized therapy is an essential next step to improve outcomes in patients with heart failure.Methods: The BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF) included 2516 patients with worsening signs and/or symptoms of heart failure from 11 European countries, who were considered to be on suboptimal medical treatment. Another 1738 patients from Scotland were included in a validation cohort. Overall, both patient cohorts were well matched. The majority of patients were hospitalized for acute heart failure, and the remainder presented with worsening signs and/or symptoms of heart failure at outpatient clinics. Approximately half of the patients were in New York Heart Association class III, and 7% vs 34% of patients of the index vs validation cohort had heart failure with preserved ejection fraction. According to study design, all patients used diuretics, but owing to the inclusion criteria of both cohorts, patients were not on optimal, evidence-based medical therapy. In the follow-up phase, uptitration to guideline-recommended doses was encouraged.Conclusion: By using a novel systems biology approach, incorporating demographics, biomarkers, genome-wide analysis, and proteomics, a model that predicts response to therapy will be developed, which should be instrumental in developing alternative therapies for patients with suboptimal response to currently recommended therapies and thus further improve care for patients with heart failure. [ABSTRACT FROM AUTHOR]

Aim& Methods: One critical factor enhancing the implementation of successful diagnostic and therapeutic strategies into clinical practice is awareness among the lay public. We describe awareness in a contemporary, multinational convenience sample of subjects attending the Heart Failure Awareness (HFA) Day Initiatives in 2013.Results: We analysed 2,438 subjects (Germany 33%, Lithuania 42%, Romania 8%, Slovenia 17%) : 53% were female, 58% were aged >60 years, 11% (had) worked in the medical sector, 82% heard about HF before. Shortness of breath and tiredness were correctly identified as symptoms of heart failure in 71% and 61%, but only 52% recognized swelling of feet and legs as a clinical sign; 31% considered heart failure a normal symptom of old age, and only 38% realized the particularly poor prognosis after a heart failure related hospitalization. Subjects who had heard about heart failure before had a lower prevalence of common misbeliefs about HF.Conclusion: In subjects participating in the HFA Day initiative 2013, the level of awareness was unsatisfactory, and important misconceptions remain. The educational and awareness activities for both the population at large and also for decision makers should be broadened and intensified. [ABSTRACT FROM AUTHOR]

Aims In heart failure ( HF), exercise training programmes ( ETPs) are a well-recognized intervention to improve symptoms, but are still poorly implemented. The Heart Failure Association promoted a survey to investigate whether and how cardiac centres in Europe are using ETPs in their HF patients. Methods and results The co-ordinators of the HF working groups of the countries affiliated to the European Society of Cardiology ( ESC) distributed and promoted the 12-item web-based questionnaire in the key cardiac centres of their countries. Forty-one country co-ordinators out of the 46 contacted replied to our questionnaire (89%). This accounted for 170 cardiac centres, responsible for 77 214 HF patients. The majority of the participating centres (82%) were general cardiology units and the rest were specialized rehabilitation units or local health centres. Sixty-seven (40%) centres [responsible for 36 385 (48%) patients] did not implement an ETP. This was mainly attributed to the lack of resources (25%), largely due to lack of staff or lack of financial provision. The lack of a national or local pathway for such a programme was the reason in 13% of the cases, and in 12% the perceived lack of evidence on safety or benefit was cited. When implemented, an ETP was proposed to all HF patients in only 55% of the centres, with restriction according to severity or aetiology. Conclusions With respect to previous surveys, there is evidence of increased availability of ETPs in HF in Europe, although too many patients are still denied a highly recommended therapy, mainly due to lack of resources or logistics. [ABSTRACT FROM AUTHOR]

Aims The purpose of this study was too describe the associated baseline features of AF patients with heart failure ( HF) with reduced and preserved ejection fraction ( HFrEF and HFpEF). Secondly, we assessed symptomatic status and their clinical correlates. Finally, we examined independent predictors for 'heart failure' at the 1-year follow-up period. Methods and results A survey of European cardiologists from nine countries, participating in the EURObservational Research Programme Pilot survey on Atrial Fibrillation ( EORP-AF Pilot), was carried out. Of the whole cohort of 2972 patients, 1411 (47.5%) had a diagnosis of HF. Of the AF patients with HF, oral anticoagulants were prescribed to 82.1% and antiarrhythmic drugs in 36.7%. Independent predictors of HFpEF were high body mass index, high heart rate, high systolic blood pressure, low diastolic blood pressure, high CHA2DS2-VASc score, and absence of chronic kidney disease, sleep apnoea, or ischaemic cardiomyopathy. On multivariate stepwise regression analysis, independent predictors of the development of HF were mode of AF presentation, diuretic use, prior HF, COPD, and valvular disease. At 1 year, HF was associated with a greater risk of all-cause mortality (log-rank test, P < 0.001). When HFrEF was compared with HFpEF at 1 year, crude rates were significant for the composite endpoint of 'stroke/thrombo-embolism/transient ischaemic attack and death' (15.9% vs. 11.1%, P = 0.043). Conclusion We provide insights into the clinical characteristics and outcomes in AF patients with HF, who were managed by European cardiologists. Despite a high prevalence of oral anticoagulant use, 1-year mortality and morbidity remained high in AF patients with HF, whether HFrEF or HFpEF. Such patients require a holistic approach to cardiovascular risk management. [ABSTRACT FROM AUTHOR]

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) was founded on 10 December 2009 with the initiative of Roland Hetzer (Deutsches Herzzentrum Berlin, Berlin, Germany) and Jan Gummert (Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany) with 15 other founding international members. It aims to promote scientific research to improve care of end-stage heart failure patients with ventricular assist device or a total artificial heart as long-term mechanical circulatory support. Likewise, the organization aims to provide and maintain a registry of device implantation data and long-term follow-up of patients with mechanical circulatory support. Hence, EUROMACS affiliated itself with Dendrite Clinical Systems Ltd to offer its members a software tool that allows input and analysis of patient clinical data on a daily basis. EUROMACS facilitates further scientific studies by offering research groups access to any available data wherein patients and centres are anonymized. Furthermore, EUROMACS aims to stimulate cooperation with clinical and research institutions and with peer associations involved to further its aims. EUROMACS is the only European-based Registry for Patients with Mechanical Circulatory Support with rapid increase in institutional and individual membership. Because of the expeditious data input, the European Association for Cardiothoracic Surgeons saw the need to optimize the data availability and the significance of the registry to improve care of patients withmechanical circulatory support and its potential contribution to scientific intents; hence, the beginning of their alliance in 2012. This first annual report is designed to provide an overview of EUROMACS' structure, its activities, a first data collection and an insight to its scientific contributions. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVAD) improve two-year survival and quality of life in patients with advanced heart failure. Following the MOMENTUM 3 study, Heartmate 3 (HM3) LVAD is the only device approved in the US and Europe. Data for event-free survival beyond two years on HM 3 is limited. The aim of this study was to assess the adverse event profile in patients who survive more than 2 years on support. We retrospectively reviewed all patients who received a HM3 LVAD at our center between 5/8/2015-10/29/2018. Patients who were alive two years following LVAD implant and were still on LVAD support were included in the study and followed for an additional two years. Patient outcomes including hospitalizations over the subsequent two years of follow-up were recorded (between year 2 and 4). Event percent per year (EPPY) was calculated for each of these outcomes. 127 patients received an LVAD during the study period with a 2 year survival rate of 85.1%. Within the first 2 years, 19 patients died, 39 patients were transplanted, and 13 transferred institutions or were lost to follow up. 56 patients remained on support and were included in this analysis and followed for an additional 2 years. The average age was 61 ± 14, 81% were male. Of those 56 patients, 50 patients were alive on support 4 years after LVAD implant (89%) (3 died and 3 patients underwent transplant). Between years 2 and 4 years from HM 3 implant, 51% were hospitalized. The most common causes of hospitalization were ADHF (0.142 EPPY), drive line infection (DLI) (.0268 EPPY) and GI bleed (0.0089 EPPY). In patients surviving 2 years on HM3 LVAD support the overall survival rate for additional 2 years is excellent. However, half of the patients will be hospitalized during long-term support, highlighting the need for more studies of medical management to prevent complications in this cohort of patients. [ABSTRACT FROM AUTHOR]

Aims: Heart failure (HF) patients increasingly receive device therapy, either an implantable cardioverter defibrillator (ICD) or a biventricular pacemaker, also called cardiac resynchronization therapy (CRT), or a CRT device with an ICD (CRT-D). However, epidemiological data on the use of device therapy in Europe are limited. [ABSTRACT FROM PUBLISHER]

BACKGROUND: It is important to assess the self-care behavior of patients with heart failure. However, in Japan, there is no valid and reliable scale for this purpose. The European Heart Failure Self-Care Behavior Scale (EHFScBS) is used to measure the self-care behavior of heart failure patients. The purpose of this study was to translate the EHFScBS into Japanese and evaluate its validity and reliability. METHODS AND RESULTS: A convenience sample of 116 outpatients with heart failure completed the Japanese version of the EHFScBS. Confirmatory factor analysis demonstrated the one-dimensionality of the scale. The Japanese version of the EHFScBS was significantly correlated with another scale, which was considered to evaluate the concept linked with the self-care behavior theoretically. These confirm its construct validity. Cronbach's alpha was 0.71, suggesting that internal consistency was satisfactory. Test-retest reliability was evaluated. The intraclass correlation coefficient of the scale was 0.69 and weighted kappa for individual items was 0.33-0.87, suggesting that test-retest reliability is adequate. CONCLUSIONS: The Japanese version of the EHFScBS was showed acceptable validity and reliability. It can be used to evaluate self-care behavior of Japanese patients with heart failure. [ABSTRACT FROM AUTHOR]

Background: Levosimendan, a novel calcium sensitiser, improves cardiac performance and symptoms without increasing oxygen consumption, and decreases the mortality of patients with low-output heart failure. Aims: To estimate the cost-effectiveness of intravenous treatment with levosimendan compared with dobutamine in patients with severe low-output heart failure. Methods: This economic evaluation was based on a European clinical trial (LIDO), in which 203 patients with severe heart failure randomly received a 24 h infusion with either levosimendan or dobutamine. Survival and resource utilisation data were collected for 6 months; survival was extrapolated assuming a mean additional lifetime of 3 years based on data from the Cooperative North Scandinavian Enalapril Survival Study trial. Costs were based on study drug usage and hospitalisation in the 6-month follow-up. A sensitivity analysis on dosage of drug and duration of survival was performed. Results: The mean survival over 6 months was 157±52 days in the levosimendan group and 139±64 days in the dobutamine group (P<0.01). When extrapolated up to 3 years, the gain in life expectancy was estimated at 0.35 years (discounted at 3%). Levosimendan increased the mean cost per patient by €1108, which was entirely due to the cost of the study drug. The incremental cost per life-year saved (LYS) was €3205 at the European level; in the individual countries the cost per LYS ranged between €3091 and €3331. The result was robust in the sensitivity analysis. Conclusions: Although the patients in the levosimendan group were alive for more days and thus at risk of hospitalisation for longer, there was no increase in hospitalisation or hospitalisation costs with levosimendan treatment. The cost per LYS using levosimendan compares favourably with other cost-effectiveness analyses in cardiology. [Copyright &y& Elsevier]

Presents a study that compared the life span of heart failure patients taking a comprehensive beta-blocker drug and a traditional selective version in several European countries. Therapeutic use of the beta-blocker drug Carvedilol for hypertension; Type of metropolol used in the study; Information on the number of U.S. citizens diagnosed with heart failure.