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BackgroundSymptoms of breathlessness, fatigue, and ankle swelling are common in general practice but deciding which patients are likely to have heart failure is challenging.AimTo evaluate the performance of a clinical decision rule (CDR), with or without N-Terminal pro-B type natriuretic peptide (NT-proBNP) assay, for identifying heart failure.Design and settingProspective, observational, diagnostic validation study of patients aged >55 years, presenting with shortness of breath, lethargy, or ankle oedema, from 28 general practices in England.MethodThe outcome was test performance of the CDR and natriuretic peptide test in determining a diagnosis of heart failure. The reference standard was an expert consensus panel of three cardiologists.ResultsThree hundred and four participants were recruited, with 104 (34.2%; 95% confidence interval [CI] = 28.9 to 39.8) having a confirmed diagnosis of heart failure. The CDR+NT-proBNP had a sensitivity of 90.4% (95% CI = 83.0 to 95.3) and specificity 45.5% (95% CI = 38.5 to 52.7). NT-proBNP level alone with a cut-off ConclusionAt the low threshold of NT-proBNP

Aims Improving quality of life (QoL) in heart failure patients is a key management objective. Validated health‐related QoL (HR‐QoL) measurement tools have been incorporated into clinical trials but not routinely into daily practice. The aims of this study were to investigate the acceptability and feasibility of implementing validated HR‐QoL instruments into heart failure clinics and to examine the impact of patient characteristics on HR‐QoL. Methods and results One hundred and sixty‐three patients attending heart failure clinics at a UK tertiary centre were invited to complete three HR‐QoL assessments: the Minnesota Living with Heart Failure Questionnaire (MLHFQ); the EuroQoL 5D‐3L (EQ‐5D‐3L); and the Kansas City Cardiomyopathy Questionnaire (KCCQ) in that order. Data on patient demographics, co‐morbidities, New York Heart Association (NYHA) class, plasma B‐type natriuretic peptide (BNP), renal function, and left ventricular ejection fraction were recorded. 94% of patients attending clinic were willing to participate. The EQ‐5D‐3L had all questions answered by 92% of patients, compared with 86% and 51% for the MLHFQ and KCCQ, respectively. HR‐QoL significantly correlated with NYHA class using each tool (MLHFQ, r = 0.59; KCCQ, r = −0.61; EQ‐5D‐3L, r = −0.44, all P < 0.01). However, within each NYHA class, there was a widespread of HR‐QoL scores. There was no association between patient demographics, left ventricular ejection fraction, plasma B‐type natriuretic peptide, or renal function with HR‐QoL using any tool. Conclusions Health‐related QoL assessment by validated questionnaire was acceptable to patients and feasible to perform in routine practice. Although NYHA class correlated significantly with HR‐QoL scores, there was high variability in HR‐QoL within each NYHA class, highlighting its limitation as the sole assessment of HR‐QoL. Clinicians should encourage the assessment of HR‐QoL to facilitate patient‐centred care and make more specific use of HR‐QoL measurement tools.

Background—Current guidelines only recommend the use of an implantable cardioverter defibrillator (ICD) in patients with dilated cardiomyopathy (DCM) for the primary prevention of sudden cardiac death (SCD) in those with a left ventricular ejection fraction (LVEF)35%. Patients with a LVEF>35% also have low competing risks of death from non-sudden causes. Therefore, those at high-risk of SCD may gain longevity from successful ICD therapy. We investigated whether late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR) identified patients with DCM without severe LV systolic dysfunction at high-risk of SCD. Methods—We prospectively investigated the association between mid-wall late gadolinium enhancement (LGE) and the pre-specified primary composite outcome of SCD or aborted SCD amongst consecutive referrals with DCM and a LVEF≥40% to our center between January 2000 and December 2011, who did not have a pre-existing indication for ICD implantation. Results—Of 399 patients (145 women, median age 50 years, median LVEF 50%, 25.3% with LGE) followed for a median of 4.6 years, 18 of 101 (17.8%) patients with LGE reached the pre-specified end-point, compared to 7 of 298 (2.3%) without (HR 9.2; 95% CI 3.9-21.8; p5% compared to those without LGE were 10.6 (95%CI 3.9-29.4), 4.9 (95% CI 1.3-18.9) and 11.8 (95% CI 4.3-32.3) respectively. Conclusions—Mid-wall LGE identifies a group of patients with DCM and LVEF≥40% at increased risk of SCD and low-risk of non-sudden death who may benefit from ICD implantation.

Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way.

A substantial proportion of patients with heart failure have preserved left ventricular ejection fraction (HF-PEF). Previous studies have reported mixed results whether survival is similar to those patients with heart failure and reduced EF (HF-REF). We compared survival in patients with HF-PEF with that in patients with HF-REF in a meta-analysis using individual patient data. Preserved EF was defined as an EF epsilon 50. The 31 studies included 41 972 patients: 10 347 with HF-PEF and 31 625 with HF-REF. Compared with patients with HF-REF, those with HF-PEF were older (mean age 71 vs. 66 years), were more often women (50 vs. 28), and have a history of hypertension (51 vs. 41). Ischaemic aetiology was less common (43 vs. 59) in patients with HF-PEF. There were 121 [95 confidence interval (CI): 117, 126] deaths per 1000 patient-years in those with HF-PEF and 141 (95 CI: 138, 144) deaths per 1000 patient-years in those with HF-REF. Patients with HF-PEF had lower mortality than those with HF-REF (adjusted for age, gender, aetiology, and history of hypertension, diabetes, and atrial fibrillation); hazard ratio 0.68 (95 CI: 0.64, 0.71). The risk of death did not increase notably until EF fell below 40. Patients with HF-PEF have a lower risk of death than patients with HF-REF, and this difference is seen regardless of age, gender, and aetiology of HF. However, absolute mortality is still high in patients with HF-PEF highlighting the need for a treatment to improve prognosis.

Current European guidelines recommend prophylactic implantation of cardioverter defibrillators (ICDs) in patients with a reduced left ventricular ejection fraction (LVEF) who are not in NYHA class IV and have reasonable life expectancy. Cost and benefit implications of this recommendation have not been reported from a European perspective.Markov modelling estimated lifetime costs and effects [life years (LY) and quality-adjusted LY (QALY) gained] of prophylactic ICD implantation vs. conventional treatment, among patients with a reduced LVEF. Efficacy was estimated from a meta-analysis of mortality rates in the six primary prevention trials with inclusion criteria matching ACC/AHA/ESC Class I or IIa recommendations. Direct medical costs were estimated using Belgian national references. Costs and effects were discounted at 3 and 1.5% per annum, respectively. Probabilistic sensitivity and scenario analyses estimated the uncertainty around the incremental cost-effectiveness ratio. An ICD implantation increased the lifetime direct costs by euro 46,413. Estimated mean LY/QALY gained were 1.88/1.57, respectively. Probabilistic analysis estimated mean lifetime cost per QALY gained as euro 31,717 (95% CI: euro 19,760-euro 61,316). Cost-effectiveness was influenced most by ICD efficacy, time to replacement, utility, and patient age at implantation.In a European healthcare setting, prophylactic ICD implantation may be cost-effective if current guidelines for patients with a reduced LVEF are followed.