Heart Failure Association of the European Society of Cardiology Quality of Care Centres Programme: design and accreditation document

Heart failure (HF) is the major contributor to cardiovascular morbidity and mortality. Given its rising prevalence, the costs of HF care can be expected to increase. Multidisciplinary management of HF can improve quality of care and survival. However, specialized HF programmes are not widely available in most European countries. These circumstances underlie the suggestion of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) for the development of quality of care centres (QCCs). These are defined as health care institutions that provide multidisciplinary HF management at all levels of care (primary, secondary and tertiary), are accredited by the HFA/ESC and are implemented into existing health care systems. Their major goals are to unify and improve the quality of HF care, and to promote collaboration in education and research activities. Three types of QCC are suggested: community QCCs (primary care facilities able to provide non‐invasive assessment and optimal therapy); specialized QCCs (district hospitals with intensive care units, able to provide cardiac catheterization and device implantation services), and advanced QCCs (national reference centres able to deliver advanced and innovative HF care and research). QCC accreditation will require compliance with general and specific HFA/ESC accreditation standards. General requirements include confirmation of the centre's existence, commitment to QCC implementation, and collaboration with other QCCs. Specific requirements include validation of the centre's level of care, service portfolio, facilities and equipment, management, human resources, process measures, quality indicators and outcome measures. Audit and recertification at 4–6‐year intervals are also required. The implementation of QCCs will evolve gradually, following a pilot phase in selected countries. The present document summarizes the definition, major goals, development, classification and crucial aspects of the accreditation process of the HFA/ESC QCC Programme.     

Clinical practice update on heart failure 2019: pharmacotherapy,procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology

The European Society of Cardiology (ESC) has published a series of guidelines on heart failure (HF) over the last 25 years, most recently in 2016. Given the amount of new information that has become available since then, the Heart Failure Association (HFA) of the ESC recognized the need to review and summarise recent developments in a consensus document. Here we report from the HFA workshop that was held in January 2019 in Frankfurt, Germany. This expert consensus report is neither a guideline update nor a position statement, but rather a summary and consensus view in the form of consensus recommendations. The report describes how these guidance statements are supported by evidence, it makes some practical comments, and it highlights new research areas and how progress might change the clinical management of HF. We have avoided re‐interpretation of information already considered in the 2016 ESC/HFA guidelines. Specific new recommendations have been made based on the evidence from major trials published since 2016, including sodium–glucose co‐transporter 2 inhibitors in type 2 diabetes mellitus, MitraClip for functional mitral regurgitation, atrial fibrillation ablation in HF, tafamidis in cardiac transthyretin amyloidosis, rivaroxaban in HF, implantable cardioverter‐defibrillators in non‐ischaemic HF, and telemedicine for HF. In addition, new trial evidence from smaller trials and updated meta‐analyses have given us the chance to provide refined recommendations in selected other areas. Further, new trial evidence is due in many of these areas and others over the next 2 years, in time for the planned 2021 ESC guidelines on the diagnosis and treatment of acute and chronic heart failure.     

Clinical trials update from the European Society of Cardiology–Heart Failure meeting 2015: AUGMENT‐HF,TITRATION, STOP‐HF,HARMONIZE, LION HEART,MOOD‐HF,and renin–angiotensin inhibitors in patients with heart and renal failure

This article provides an overview on the key trials relevant to the pathophysiology, prevention, and treatment of heart failure (HF) presented at the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) annual meeting held in Seville, Spain in May 2015. Trials reported include AUGMENT‐AF (myocardial injections of calcium‐alginate hydrogel), a propensity score‐matched study of renin–angiotensin system antagonists in patients with HF and severe renal dysfunction, HARMONIZE (sodium zirconium cyclosilicate used to bind potassium), TITRATION, comparing two regimes for introducing LCZ696, STOP‐HF, a trial of intramyocardial stromal cell‐derived factor‐1, MOOD‐HF (escitalopram for patients with heart failure and depression), and LION HEART, a trial of intermittent levosimendan therapy. Unpublished reports should be considered as preliminary, since analyses may change in the final publication.     

National Heart Failure Registry,India: Design and methods

ObjectiveHeart failure (HF) has emerged as a global public health problem that affects both low and high-income countries. The high HF burden and the need for resource-intensive treatments often lead to health system crisis in resource-poor settings. Data on prevailing practice patterns and long-term clinical outcomes of HF are scarce from the low and middle-income countries. Nationally representative HF data from India are not available.MethodsThe National Heart Failure Registry (NHFR) is a multicentric, hospital-based registry of HF patients from 53 centers across India. Consecutive patients admitted with the diagnosis of acute decompensated HF satisfying the European Society of Cardiology (ESC) 2016 criteria will be enrolled into the registry from January 2019 to December 2019. Each participating center is expected to contribute 200 patients into the registry (i.e., more than 10,000 HF patients from India). We are collecting demographics, clinical, laboratory, imaging, and other diagnostic data at baseline from all registered patients in the registry by using a structured document. Additionally, we are collecting the details of treatment practices and the usage of guideline-directed therapy from all participants. We intend to obtain the in-hospital, 3-months, 6-months and one-year outcome data on mortality, cause of death, and repeated hospitalization events.ConclusionsIn summary, NFHR will be the first nationally representative HF registry aimed at providing crucial information on prevailing etiology, distribution and current practices in the management of HF.     

Hospital Management of Acute Decompensated Heart Failure

Heart failure (HF) is one of the leading causes of hospitalizations for elderly adults in the United States. One in 5 Americans will be >65 years of age by 2050. Because of the high prevalence of HF in this group, the number of Americans requiring hospitalization for this disorder is expected to rise significantly. We reviewed the most recent and ongoing studies and recommendations for the management of patients hospitalized due to decompensated HF. The Acute Decompensated Heart Failure National Registry, together with the 2013 American College of Cardiology Foundation and American Heart Association heart failure guidelines, earlier retrospective and prospective studies including the Diuretic Optimization Strategies Evaluation (DOSE), the Trial of Intensified vs Standard Medical Therapy in the Elderly Patients With Congestive Heart Failure (TIME-CHF), the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE–HF), the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT) and the Comparison of Medical, Pacing and Defibrillation Therapies in Heart Failure (COMPANION) trial were reviewed for current practices pertaining to these patients. Gaps in our knowledge of optimal use of patient-specific information (biomarkers and comorbid conditions) still exist.     

Clinical trials update: IMPROVEMENT-HF, COPERNICUS, MUSTIC, ASPECT-II, APRICOT and HEART

Important new studies relevant to the field of heart failure reported at the annual congress of the European Society of Cardiology (ESC), held in Amsterdam in August 2000, are reviewed. The IMPROVEMENT of Heart Failure survey investigated the knowledge and perceptions of over 1300 primary care physicians from 14 ESC member nations and the actual practice in over 11000 of their patients. Guidelines and clinical practice were compared. The survey suggested, in this large sample, that the quality of care was higher than previous smaller surveys have suggested but have also identified important deficiencies in knowledge and management that should be rectified. The COPERNICUS study demonstrated that carvedilol was remarkably well tolerated even in patients with very severe heart failure and that treatment was associated with a substantial reduction in mortality even among patients that would conventionally not be considered, by many, for beta-blocker therapy. The MUSTIC trial suggested that cardiac resynchronisation using biventricular pacing improved patients symptomatically whether or not the patient was in atrial fibrillation. Morbidity and mortality studies of cardiac resynchronisation are now underway. The ASPECT-II and APRICOT-II studies investigated the role of warfarin, aspirin and their combination for the long-term management of myocardial infarction. One interpretation of the data from these studies is that the combination of aspirin and warfarin is about as effective as warfarin alone but with a much higher incidence of side effects. Warfarin alone appeared superior to aspirin alone. In summary, the annual congress of the ESC provided important new information for clinical practice and, to date, was, by far, the most important cardiology congress in the world this year.     

Management of heart failure patients with COVID‐19: a joint position paper of the Chinese Heart Failure Association & National Heart Failure Committee and the Heart Failure Association of the European Society of Cardiology

The coronavirus disease 2019 (COVID‐19) pandemic of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is causing considerable morbidity and mortality worldwide. Multiple reports have suggested that patients with heart failure (HF) are at a higher risk of severe disease and mortality with COVID‐19. Moreover, evaluating and treating HF patients with comorbid COVID‐19 represents a formidable clinical challenge as symptoms of both conditions may overlap and they may potentiate each other. Limited data exist regarding comprehensive management of HF patients with concomitant COVID‐19. Since these issues pose serious new challenges for clinicians worldwide, HF specialists must develop a structured approach to the care of patients with COVID‐19 and be included early in the care of these patients. Therefore, the Heart Failure Association of the European Society of Cardiology and the Chinese Heart Failure Association & National Heart Failure Committee conducted web‐based meetings to discuss these unique clinical challenges and reach a consensus opinion to help providers worldwide deliver better patient care. The main objective of this position paper is to outline the management of HF patients with concomitant COVID‐19 based on the available data and personal experiences of physicians from Asia, Europe and the United States.     

Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases

Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. Generally accepted standards exist for DMC composition and operational conduct. However, some relevant issues are not specifically addressed in current guidance documents, resulting in uncertainties regarding optimal approaches for communication between the DMC, steering committee, and sponsors, release of information, and liability protection for DMC members. The Heart Failure Association (HFA) of the European Society of Cardiology (ESC), in collaboration with the Clinical Trials Unit of the European Heart Agency (EHA) of the ESC convened a meeting of international experts in DMCs for cardiovascular and cardiometabolic clinical trials to identify specific issues and develop steps to resolve challenges faced by DMCs.The main recommendations from the meeting relate to methodological consistency, independence, managing conflicts of interest, liability protection, and training of future DMC members. This paper summarizes the key outcomes from this expert meeting, and describes the core set of activities that might be further developed and ultimately implemented by the ESC, HFA, and other interested ESC constituent bodies. The HFA will continue to work with stakeholders in cardiovascular and cardiometabolic clinical research to promote these goals.     

Heart Failure Association of the European Society of Cardiology Specialist Heart Failure Curriculum

It is well established that organized care of heart failure patients, including specialist management by cardiologists, improves patient outcomes. In response to this, other national training bodies (the UK and the USA) have developed heart failure subspecialty curricula within their Cardiology Training Curricula. In addition, European Society of Cardiology (ESC) subspecialty curricula exist for Interventional Cardiology and Heart Rhythm Management. The purpose of this heart failure curriculum is to provide a framework which can be used as a blueprint for training across Europe. This blueprint mirrors other ESC curricula. Each section has three components: the knowledge required, the skills which are necessary, and the professionalism (attitudes and behaviours) which should be attained. The programme is designed to last 2 years. The first year is devoted to the specialist heart failure module. The second year allows completion of the optional modules of advanced imaging, device therapy for implanters, cardiac transplantation, and mechanical circulatory support. The second year can also be devoted to continuation of specialist heart failure training and/or research for those not wishing to continue with the advanced modules.     

Clinical trials update from the European Society of Cardiology Heart Failure Meeting 2010: TRIDENT 1, BENEFICIAL,CUPID, RFA‐HF,MUSIC, DUEL,handheld BNP,phrenic nerve stimulation,CHAMPION and CABG with CRT study

This article provides information and a commentary on key trials relevant to the pathophysiology, prevention and treatment of heart failure (HF) presented at the annual meeting of the Heart Failure Association of the European Society of Cardiology held in Berlin. Unpublished reports should be considered as preliminary, since analyses may change in the final publication. Tonapofylline failed to show efficacy and was associated with an approximately 1% increased risk of seizures in patients with acute decompensated heart failure (ADHF) and renal dysfunction in TRIDENT. Results from BENEFICIAL do not support the use of alagebrium, an advanced glycation end‐product breaker, in clinically stable patients with relatively mild HF symptoms. CUPID showed encouraging preliminary results for augmentation of SERCA2a enzyme activity by gene transfection in patients with severe HF. The RFA‐HF study did not provide convincing evidence for the use of radiofrequency ablation for atrial fibrillation but was underpowered. A wearable, multi‐sensor patch showed potential for detecting impending HF decompensation in MUSIC. A comparison of low‐intensity oral diuretic therapy in patients hospitalized with ADHF suggested that torasemide was superior to furosemide in DUEL. The use of point‐of‐care B‐type natriuretic peptide and echocardiography failed to improve the rate of correct HF diagnosis in primary care. Phrenic nerve stimulation improved symptoms of sleep apnoea in a small study of patients with HF and central sleep apnoea. The use of a novel implantable pulmonary artery pressure monitoring system to guide patient management improved outcomes in the CHAMPION study. A study to evaluate a combined coronary artery bypass grafting (CABG) and epicardial cardiac resynchronization therapy implantation procedure reduced mortality compared with CABG alone.     

New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment

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.     

Thrombo-embolism and antithrombotic therapy for heart failure in sinus rhythm. A joint consensus document from the ESC Heart Failure Association and the ESC Working Group on Thrombosis

Chronic heart failure (HF) with either reduced or preserved ejection fraction is common and remains an extremely serious disorder with a high mortality and morbidity. Many complications related to HF can be related to thrombosis. Epidemiological and pathophysiological data also link HF to an increased risk of thrombosis, leading to the clinical consequences of sudden death, stroke, systemic thrombo-embolism, and/or venous thrombo-embolism. This consensus document of the Heart Failure Association (EHFA) of the European Society of Cardiology (ESC) and the ESC Working Group on Thrombosis reviews the published evidence and summarizes 'best practice', and puts forward consensus statements that may help to define evidence gaps and assist management decisions in everyday clinical practice. In HF patients with atrial fibrillation, oral anticoagulation is recommended, and the CHA(2)DS(2)-VASc and HAS-BLED scores should be used to determine the likely risk-benefit ratio (thrombo-embolism prevention vs. risk of bleeding) of oral anticoagulation. In HF patients with reduced left ventricular ejection fraction who are in sinus rhythm there is no evidence of an overall benefit of vitamin K antagonists (e.g. warfarin) on mortality, with risk of major bleeding. Despite the potential for a reduction in ischaemic stroke, there is currently no compelling reason to use warfarin routinely for these patients. Risk factors associated with increased risk of thrombo-embolic events should be identified and decisions regarding use of anticoagulation individualized. Patient values and preferences are important determinants when balancing the risk of thrombo-embolism against bleeding risk. New oral anticoagulants that offer a different risk-benefit profile compared with warfarin may appear as an attractive therapeutic option, but this would need to be confirmed in clinical trials.     

Clinical trials update from the European Society of Cardiology Heart Failure meeting 2011: TEHAF, WHICH, CARVIVA, and atrial fibrillation in GISSI-HF and EMPHASIS-HF

This article provides information and a commentary on key trials relevant to the pathophysiology, prevention, and treatment of heart failure (HF) presented at the European Society of Cardiology Heart Failure meeting held in Gothenburg, Sweden in May 2011. Unpublished reports should be considered as preliminary, since analyses may change in the final publication. In the TEHAF study, use of the Health Buddy^® monitoring system failed to reduce the number of HF admissions compared with usual care but a subgroup of patients with more recently diagnosed HF may have benefited. In the WHICH study, some reductions in the rate of hospital stay were observed in patients who underwent a nurse‐led home‐based intervention programme following a hospital admission for an acute HF exacerbation, compared with patients who were followed in a specialized outpatient clinic. Results from CARVIVA‐HF suggest that ivabradine alone or in combination with carvedilol is safe and effective for improving exercise capacity and quality of life in HF patients on optimized angiotensin‐converting enzyme inhibitor therapy. In the GISSI‐HF study there was no difference in atrial fibrillation (AF) occurrence between the n‐3 polyunsaturated fatty acids and placebo groups. In EMPHASIS‐HF the incidence of new onset AF or flutter was reduced in patients with mild HF randomized to eplerenone compared with placebo.     

Documento de consenso y recomendaciones sobre cuidados paliativos en insuficiencia cardiaca de las Secciones de Insuficiencia Cardiaca y Cardiología Geriátrica de la Sociedad Española de Cardiología

Heart failure is a complex entity, with high morbidity and mortality. The clinical course and outcome are uncertain and difficult to predict. This document, instigated by the Heart Failure and Geriatric Cardiology Working Groups of the Spanish Society of Cardiology, addresses various aspects related to palliative care, where most cardiovascular disease will eventually converge. The document also establishes a consensus and a series of recommendations with the aim of recognizing and understanding the need to implement and progressively apply palliative care throughout the course of the disease, not only in the advanced stages, thus improving the care provided and quality of life. The purpose is to improve and adapt treatment to the needs and wishes of each patient, who must have adequate information and participate in decision-making.     

Heart failure as a general pandemic in Asia

Heart failure (HF) is an epidemic in healthcare worldwide, including Asia. It appears that HF will become more serious in the near future, with the epidemiological transition and ageing of the population. However, in contrast to Western countries, information on HF epidemiology is still limited in Asia, particularly in South Asia. In this review, we will briefly summarize available information regarding the current and future burden of HF in Asia, which indicates the importance of both primary prevention of underlying diseases of HF and secondary prevention, including management of ischaemic HF, HF with preserved EF, and HF in the elderly.     

CRT Survey II: a European Society of Cardiology survey of cardiac resynchronisation therapy in 11 088 patients—who is doing what to whom and how?

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.     

Worsening of chronic heart failure: definition,epidemiology, management and prevention. A clinical consensus statement by the Heart Failure Association of the European Society of Cardiology

Episodes of worsening symptoms and signs characterize the clinical course of patients with chronic heart failure (HF). These events are associated with poorer quality of life, increased risks of hospitalization and death and are a major burden on healthcare resources. They usually require diuretic therapy, either administered intravenously or by escalation of oral doses or with combinations of different diuretic classes. Additional treatments may also have a major role, including initiation of guideline-recommended medical therapy (GRMT). Hospital admission is often necessary but treatment in the emergency service or in outpatient clinics or by primary care physicians has become increasingly used. Prevention of first and recurring episodes of worsening HF is an essential component of HF treatment and this may be achieved through early and rapid administration of GRMT. The aim of the present clinical consensus statement by the Heart Failure Association of the European Society of Cardiology is to provide an update on the definition, clinical characteristics, management and prevention of worsening HF in clinical practice.     

Clinical trials update from the European Society of Cardiology heart failure meeting 2009: CHANCE,B‐Convinced,CHAT, CIBIS‐ELD,and Signal‐HF

This paper provides information and a commentary on trials relevant to the pathophysiology, prevention, and treatment of heart failure presented at the annual meeting of the Heart Failure Association of the European Society of Cardiology held in Nice. The CHANCE study showed a substantial reduction in morbidity and mortality in a randomized controlled trial (RCT) of a multidisciplinary management programme for patients with chronic heart failure in Russia. Data from the B‐Convinced study, also an RCT, suggest that continuation of beta‐blocker (BB) therapy in patients hospitalized with worsening heart failure may be associated with improved outcomes when compared with treatment discontinuation. The CHAT study suggests that telephone support can improve prognosis in heart failure patients living in remote rural locations. CIBIS‐ELD showed that titration of BBs to target doses in older patients with heart failure is more difficult; but tolerance levels were similar for bisoprolol and carvedilol. Signal‐HF randomized elderly heart failure patients to treatment guided by NT‐proBNP levels or usual care, and showed no effect of NT‐proBNP‐guided treatment on outcomes.     

The autonomic nervous system as a therapeutic target in heart failure: a scientific position statement from the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology

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?