2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure PDF
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2021
Theresa A. McDonagh, Marco Metra
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2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. The document provides guidelines for health professionals to aid in the diagnosis and treatment of heart failure, outlining various disease and risk factors.
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ESC GUIDELINES European Heart Journal (2021) 42, 35993726 doi:10.1093/eurheartj/ehab368 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure With the special contribution of the Heart Failure Association (HFA) of the ESC Authors/Task Force Members: Theresa A. McDon...
ESC GUIDELINES European Heart Journal (2021) 42, 35993726 doi:10.1093/eurheartj/ehab368 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure With the special contribution of the Heart Failure Association (HFA) of the ESC Authors/Task Force Members: Theresa A. McDonagh* (Chairperson) (United Kingdom), Marco Metra * (Chairperson) (Italy), Marianna Adamo (Task Force Coordinator) (Italy), Roy S. Gardner (Task Force Coordinator) (United Kingdom), Andreas Baumbach (United Kingdom), Michael Böhm (Germany), Haran Burri (Switzerland), Javed Butler (United States of America), Jelena Celutkien e_ (Lithuania), Ovidiu Chioncel (Romania), John G.F. Cleland (United Kingdom), Andrew J.S. Coats (United Kingdom), Maria G. Crespo-Leiro (Spain), Dimitrios Farmakis (Greece), Martine Gilard (France), Stephane Heymans * Corresponding authors: The two chairpersons contributed equally to the document. Theresa McDonagh, Cardiology Department, King’s College Hospital, Denmark Hill, London, SE5 9RS, United Kingdom. Tel: þ44 203 299 325, E-mail: [email protected]; Marco Metra, Institute of Cardiology, ASST Spedali Civili di Brescia and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy. Tel: þ39 303 07221, E-mail: [email protected] Author/Task Force Member affiliations: listed in Author information. ESC Clinical Practice Guidelines Committee (CPG): listed in the Appendix. ESC subspecialty communities having participated in the development of this document: Associations: Association for Acute CardioVascular Care (ACVC), Association of Cardiovascular Nursing & Allied Professions (ACNAP), European Association of Cardiovascular Imaging (EACVI), European Association of Preventive Cardiology (EAPC), European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Heart Rhythm Association (EHRA), Heart Failure Association (HFA). Councils: Council of Cardio-Oncology, Council on Basic Cardiovascular Science, Council on Valvular Heart Disease. Working Groups: Adult Congenital Heart Disease, Cardiovascular Pharmacotherapy, Cardiovascular Regenerative and Reparative Medicine, Cardiovascular Surgery, e-Cardiology, Myocardial and Pericardial Diseases, Myocardial Function. Patient Forum The content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only. No commercial use is authorized. No part of the ESC Guidelines may be translated or reproduced in any form without written permission from the ESC. Permission can be obtained upon submission of a written request to Oxford University Press, the publisher of the European Heart Journal and the party authorized to handle such permissions on behalf of the ESC ([email protected]). Disclaimer: The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their publication. The ESC is not responsible in the event of any contradiction, discrepancy and/or ambiguity between the ESC Guidelines and any other official recommendations or guidelines issued by the relevant public health authorities, in particular in relation to good use of healthcare or therapeutic strategies. Health professionals are encouraged to take the ESC Guidelines fully into account when exercising their clinical judgment, as well as in the determination and the implementation of preventive, diagnostic or therapeutic medical strategies; however, the ESC Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient’s health condition and in consultation with that patient and, where appropriate and/or necessary, the patient’s caregiver. Nor do the ESC Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient’s case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations. It is also the health professional’s responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription. C the European Society of Cardiology 2021. All rights reserved. This article has been co-published with permission in the European Heart Journal and European Journal of Heart Failure. V The articles are identical except for minor stylistic and spelling differences in keeping with each journal’s style. Either citation can be used when citing this article. For permissions, please email [email protected]. Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) 3600 ESC Guidelines (Netherlands), Arno W. Hoes (Netherlands), Tiny Jaarsma (Sweden), Ewa A. Jankowska (Poland), Mitja Lainscak (Slovenia), Carolyn S.P. Lam (Singapore), Alexander R. Lyon (United Kingdom), John J.V. McMurray (United Kingdom), Alexandre Mebazaa (France), Richard Mindham (United Kingdom), Claudio Muneretto (Italy), Massimo Francesco Piepoli (Italy), Susanna Price (United Kingdom), Giuseppe M.C. Rosano (United Kingdom), Frank Ruschitzka (Switzerland), Anne Kathrine Skibelund (Denmark), ESC Scientific Document Group All experts involved in the development of these guidelines have submitted declarations of interest. These have been compiled in a report and published in a supplementary document simultaneously to the guidelines. The report is also available on the ESC website www.escardio.org/guidelines For the Supplementary Data which include background information and detailed discussion of the data that have provided the basis for the guidelines see European Heart Journal online Online publish-ahead-of-print 27 August 2021................................................................................................................................................................................................... Keywords Guidelines heart failure natriuretic peptides ejection fraction diagnosis pharmacotherapy neuro-hormonal antagonists cardiac resynchronization therapy mechanical circulatory support transplantation arrhythmias comorbidities hospitalization multidisciplinary management advanced heart failure acute heart failure Table of contents 1 Preamble...................................................... 3607 2 Introduction................................................... 3609 2.1 What is new.............................................. 3609 3 Definition, epidemiology and prognosis......................... 3612 3.1 Definition of heart failure.................................. 3612 3.2 Terminology.............................................. 3612 3.2.1 Heart failure with preserved, mildly reduced, and reduced ejection fraction............................................ 3612.............................. 3.2.2 Right ventricular dysfunction........................... 3.2.3 Other common terminology used in heart failure....... 3.2.4 Terminology related to the symptomatic severity of heart failure................................................ 3.3 Epidemiology and natural history of heart failure............ 3.3.1 Incidence and prevalence............................... 3.3.2 Aetiology of heart failure.............................. 3.3.3 Natural history and prognosis.......................... 4 Chronic heart failure........................................... 4.1 Key steps in the diagnosis of chronic heart failure........... 3613 3613 3613 3613 3613 3614 3614 3614 3614 Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 Document Reviewers: Rudolf A. de Boer (CPG Review Coordinator) (Netherlands), P. Christian Schulze (CPG Review Coordinator) (Germany), Magdy Abdelhamid (Egypt), Victor Aboyans (France), Stamatis Adamopoulos (Greece), Stefan D. Anker (Germany), Elena Arbelo (Spain), Riccardo Asteggiano (Italy), Johann Bauersachs (Germany), Antoni Bayes-Genis (Spain), Michael A. Borger (Germany), Werner Budts (Belgium), Maja Cikes (Croatia), Kevin Damman (Netherlands), Victoria Delgado (Netherlands), Paul Dendale (Belgium), Polychronis Dilaveris (Greece), Heinz Drexel (Austria), Justin Ezekowitz (Canada), Volkmar Falk (Germany), Laurent Fauchier (France), Gerasimos Filippatos (Greece), Alan Fraser (United Kingdom), Norbert Frey (Germany), Chris P. Gale (United Kingdom), Finn Gustafsson (Denmark), Julie Harris (United Kingdom), Bernard Iung (France), Stefan Janssens (Belgium), Mariell Jessup (United States of America), Aleksandra Konradi (Russia), Dipak Kotecha (United Kingdom), Ekaterini Lambrinou (Cyprus), Patrizio Lancellotti (Belgium), Ulf Landmesser (Germany), Christophe Leclercq (France), Basil S. Lewis (Israel), Francisco Leyva (United Kingdom), Ales Linhart (Czech Republic), Maja-Lisa Løchen (Norway), Lars H. Lund (Sweden), Donna Mancini (United States of America), Josep Masip (Spain), Davor Milicic (Croatia), Christian Mueller (Switzerland), Holger Nef (Germany), Jens-Cosedis Nielsen (Denmark), Lis Neubeck (United Kingdom), Michel Noutsias (Germany), Steffen E. Petersen (United Kingdom), Anna Sonia Petronio (Italy), Piotr Ponikowski (Poland), Eva Prescott (Denmark), Amina Rakisheva (Kazakhstan), Dimitrios J. Richter (Greece), Evgeny Schlyakhto (Russia), Petar Seferovic (Serbia), Michele Senni (Italy), Marta Sitges (Spain), Miguel Sousa-Uva (Portugal), Carlo G. Tocchetti (Italy), Rhian M. Touyz (United Kingdom), Carsten Tschoepe (Germany), Johannes Waltenberger (Germany/Switzerland) 3601 ESC Guidelines 3616 3617 3617 3619 3619 3619 3619 3619 3620 3621 3621 3621 3621 3622 3622 3623 3623 3623 3623 3623 3624 3624 3624 3625 3626 3626 3626 3626 3626 3627 3628 3628 3628 3629 3629 3629 3629 3629 3629 3629 3630 3630............................................................................................................................................................................. 8 Heart failure with preserved ejection fraction................... 8.1 The background to heart failure with preserved ejection fraction....................................................... 8.2 Clinical characteristics of patients with heart failure with preserved ejection fraction.................................... 8.3 The diagnosis of heart failure with preserved ejection fraction....................................................... 8.4 Treatment of heart failure with preserved ejection fraction.. 9 Multidisciplinary team management for the prevention and treatment of chronic heart failure................................ 9.1 Prevention of heart failure................................. 9.2 Multidisciplinary management of chronic heart failure....... 9.2.1 Models of care........................................ 9.2.2 Characteristics and components of a heart failure management programme................................... 9.3 Patient education, self-care and lifestyle advice.............. 9.4 Exercise rehabilitation..................................... 9.5 Follow-up of chronic heart failure.......................... 9.5.1 General follow-up..................................... 9.5.2 Monitoring with biomarkers........................... 9.6 Telemonitoring............................................ 10 Advanced heart failure........................................ 10.1 Epidemiology, diagnosis, and prognosis.................... 10.2 Management............................................. 10.2.1 Pharmacological therapy and renal replacement....... 10.2.2 Mechanical circulatory support....................... 10.2.3 Heart transplantation................................ 10.2.4 Symptom control and end-of-life care................. 11 Acute heart failure............................................ 11.1 Epidemiology, diagnosis and prognosis.................... 11.2 Clinical presentations..................................... 11.2.1 Acute decompensated heart failure................... 11.2.2 Acute pulmonary oedema............................ 11.2.3 Isolated right ventricular failure....................... 11.2.4 Cardiogenic shock................................... 11.3 Management............................................. 11.3.1 General aspects...................................... 11.3.2 Oxygen therapy and/or ventilatory support........... 11.3.3 Diuretics............................................ 11.3.4 Vasodilators......................................... 11.3.5 Inotropes............................................ 11.3.6 Vasopressors........................................ 11.3.7 Opiates.............................................. 11.3.8 Digoxin.............................................. 11.3.9 Thromboembolism prophylaxis...................... 11.3.10 Short-term mechanical circulatory support.......... 11.3.11 Pre-discharge assessment and post-discharge management planning....................................... 12 Cardiovascular comorbidities................................. 12.1 Arrhythmias and conduction disturbances................. 12.1.1 Atrial fibrillation...................................... 12.1.2 Ventricular arrhythmias.............................. 12.1.3 Symptomatic bradycardia, pauses and atrio-ventricular block...................................................... 12.2 Chronic coronary syndromes............................. 12.2.1 Medical therapy...................................... 12.2.2 Myocardial revascularization.......................... 3630 3630 3630 3630 3631 3633 3633 3633 3633 3633 3633 3636 3636 3636 3636 3636 3637 3637 3639 3639 3639 3643 3644 3644 3644 3646 3646 3647 3647 3647 3649 3649 3650 3652 3654 3655 3655 3655 3656 3656 3656 3657 3657 3657 3657 3660 3660 3660 3661 3662 Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 4.2 Natriuretic peptides....................................... 4.2.1 Use in the non-acute setting........................... 4.3 Investigations to determine the underlying aetiology of chronic heart failure........................................... 5 Heart failure with reduced ejection fraction..................... 5.1 The diagnosis of heart failure with reduced ejection fraction. 5.2 Pharmacological treatments for patients with heart failure with reduced ejection fraction.......................... 5.2.1 Goals of pharmacotherapy for patients with heart failure with reduced ejection fraction........................ 5.2.2 General principles of pharmacotherapy for heart failure with reduced ejection fraction........................ 5.3 Drugs recommended in all patients with heart failure with reduced ejection fraction...................................... 5.3.1 Angiotensin-converting enzyme inhibitors.............. 5.3.2 Beta-blockers......................................... 5.3.3 Mineralocorticoid receptor antagonists................ 5.3.4 Angiotensin receptor-neprilysin inhibitor............... 5.3.5 Sodium-glucose co-transporter 2 inhibitors............ 5.4 Other drugs recommended or to be considered in selected patients with heart failure with reduced ejection fraction.............................................. 5.4.1 Diuretics.............................................. 5.4.2 Angiotensin II type 1 receptor blockers................. 5.4.3 If-channel inhibitor.................................... 5.4.4 Combination of hydralazine and isosorbide dinitrate.... 5.4.5 Digoxin............................................... 5.4.6 Recently reported advances from trials in heart failure with reduced ejection fraction........................ 5.5 Strategic phenotypic overview of the management of heart failure with reduced ejection fraction..................... 6 Cardiac rhythm management for heart failure with reduced ejection fraction................................................. 6.1 Implantable cardioverter-defibrillator....................... 6.1.1 Secondary prevention of sudden cardiac death......... 6.1.2 Primary prevention of sudden cardiac death............ 6.1.3 Patient selection for implantable cardioverterdefibrillator therapy........................................ 6.1.4 Implantable cardioverter-defibrillator programming..... 6.1.5 Subcutaneous and wearable implantable cardioverter-defibrillators.................................. 6.2 Cardiac resynchronization therapy......................... 6.3 Devices under evaluation.................................. 7 Heart failure with mildly reduced ejection fraction.............. 7.1 The diagnosis of heart failure with mildly reduced ejection fraction....................................................... 7.2 Clinical characteristics of patients with heart failure with mildly reduced ejection fraction........................... 7.3 Treatments for patients with heart failure with mildly reduced ejection fraction...................................... 7.3.1 Angiotensin-converting enzyme inhibitors.............. 7.3.2 Angiotensin receptor II type 1 receptor blockers....... 7.3.3 Beta-blockers......................................... 7.3.4 Mineralocorticoid receptor antagonists................ 7.3.5 Angiotensin receptor-neprilysin inhibitor............... 7.3.6 Other drugs.......................................... 7.3.7 Devices............................................... 3602 3662 3662 3664 3664 3666 3666 3666 3666 3666 3667 3668 3668 3668 3669 3670 3671 3671 3672 3672 3672 3672 3675 3675 3675 3675 3675 3677 3677 3677 3681 3682 3682 3682 3682 3682 3682 3682 3682 3682 3685 3685 3686 3688 3689 3690 3693 3694 3694 3694 3695 List of recommendations Recommended diagnostic tests in all patients with suspected chronic heart failure................................... 3617.. Recommendations for specialized diagnostic tests for selected.... patients with chronic heart failure to detect reversible/treatable.... causes of heart failure............................................ 3618.. Pharmacological treatments indicated in patients with.... (NYHA class IIIV) heart failure with reduced ejection fraction.. (LVEF 30 kg/m2), Hypertensive (use of >_2 antihypertensive medications), atrial Fibrillation (paroxysmal or persistent), Pulmonary hypertension (Doppler Echocardiographic estimated Pulmonary Artery Systolic Pressure >35 mmHg), Elderly (age >60 years), Filling pressure (Doppler Echocardiographic E/e0 >9) (score) Glycated haemoglobin 3606 LVEDP LVEF LVESD LVH LVNC LVOT LVOTO MADIT-CRT MADIT-II MAGGIC MCS MEK MI MITRA-FR MMR MR MRA MRI mRNA MR-proANP MT MV mWHO MYPC NICM NKX2-5 NP NSAID NSVT NT-proBNP NYHA o.d OMT OSA PA PaO2 PARADIGM-HF pCO2 PCI PCR PCWP PEP-CHF PET PKP2 Left ventricular end-diastolic pressure Left ventricular ejection fraction Left ventricular end-systolic diameter Left ventricular hypertrophy Left ventricular non-compaction Left ventricular outflow tract Left ventricular outflow tract obstruction Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (trial) Multicenter Automatic Defibrillator Implantation Trial II (trial) Multicenter Automatic Defibrillator Implantation Trial Reduce Inappropriate Therapy (trial) Meta-Analysis Global Group in Chronic Heart Failure Mechanical circulatory support Mitogen-activated protein kinase Myocardial infarction Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation (trial) Mismatch repair Mitral regurgitation Mineralocorticoid receptor antagonist Magnetic resonance imaging Messenger ribonucleic acid Mid-regional pro-atrial natriuretic peptide Medical therapy Mitral valve Modified World Health Organization Myosin-binding protein C Non-ischaemic cardiomyopathy NK2 transcription factor related, locus 5 Natriuretic peptide Non-steroidal anti-inflammatory drug Non-sustained ventricular tachycardia N-terminal pro-B-type natriuretic peptide New York Heart Association Omne in die (once daily) Optimal medical therapy Obstructive sleep apnoea Pulmonary artery Partial pressure of oxygen Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure (trial) Partial pressure of carbon dioxide Percutaneous coronary intervention Polymerase chain reaction Pulmonary capillary wedge pressure Perindopril in Elderly People with Chronic Heart Failure (trial) Positron emission tomography Plakophilin 2............................................................................................................................................................................ PLN PPCM PREVEND PV PVC PVI pVO2 QI QOL QRS RAAS RACE II RAFT RASi RATE-AF RBM20 RCT REMATCH REVERSE REVIVED RNA RRT RV RVAD RVEDP SARS-CoV-2 SAVR SBP SCN5a SCORED SENIORS SERVE-HF SGLT2 S-ICD SMR SPECT Phospholamban Peripartum cardiomyopathy Prevention of REnal and Vascular ENd-stage Disease (trial) Pulmonary vein Premature ventricular contraction Pulmonary vein isolation Peak exercise oxygen consumption Quality indicator Quality of life Q, R, and S waves of an ECG Renin-angiotensin-aldosterone system Rate Control Efficacy in Permanent Atrial Fibrillation: a Comparison between Lenient versus Strict Rate Control II (trial) Resynchronization/Defibrillation for Ambulatory Heart Failure Trial (trial) Renin-angiotensin system inhibitor Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (trial) Ribonucleic acid binding motif 20 Randomized controlled trial Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (trial) REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (trial) REVascularization for Ischaemic VEntricular Dysfunction (trial) Ribonucleic acid Renal replacement therapy Right ventricular/ventricle Right ventricular assist device Right ventricular end-diastolic pressure Severe acute respiratory syndrome coronavirus 2 Surgical aortic valve replacement Systolic blood pressure Sodium channel alpha subunit 5 Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (trial) Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalizations in Seniors with Heart Failure (trial) Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure (trial) Sodium-glucose co-transporter 2 Subcutaneous implantable cardioverterdefibrillator Secondary mitral regurgitation Single-photon emission computed tomography Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 MADIT-RIT ESC Guidelines 3607 ESC Guidelines SpO2 SR STEMI STICH STICHES STS-PROM TSAT TSH TTN TTR UK US VAD Val-HeFT VEGF VERTIS-CV VEST VKA VO2 VPB vs. VV interval WARCEF wtTTR-CA XL 1 Preamble Guidelines summarize and evaluate available evidence with the aim of assisting health professionals in proposing the best management strategies for an individual patient with a given condition. Guidelines and their recommendations should facilitate decision making of health professionals in their daily practice. However, the final decisions concerning an individual patient must be made by the responsible health professional(s) in consultation with the patient and caregiver as appropriate. A great number of guidelines have been issued in recent years by the European Society of Cardiology (ESC), as well as by other............................................................................................................................................................................. societies and organizations. Because of their impact on clinical practice, quality criteria for the development of guidelines have been established in order to make all decisions transparent to the user. The recommendations for formulating and issuing ESC Guidelines can be found on the ESC website (https://www.escardio.org/ Guidelines). The ESC Guidelines represent the official position of the ESC on a given topic and are regularly updated. In addition to the publication of Clinical Practice guidelines, the ESC carries out the EURObservational Research Programme of international registries of cardiovascular (CV) diseases and interventions which are essential to assess diagnostic/therapeutic processes, use of resources and adherence to guidelines. These registries aim at providing a better understanding of medical practice in Europe and around the world, based on high-quality data collected during routine clinical practice. Furthermore, the ESC has developed and embedded in this document a set of quality indicators (QIs), which are tools to evaluate the level of implementation of the guidelines and may be used by the ESC, hospitals, healthcare providers and professionals to measure clinical practice as well as used in educational programmes, alongside the key messages from the guidelines, to improve quality of care and clinical outcomes. The Members of this Task Force were selected by the ESC, including representation from its relevant ESC sub-specialty groups, in order to represent professionals involved with the medical care of patients with this pathology. Selected experts in the field undertook a comprehensive review of the published evidence for management of a given condition according to ESC Clinical Practice Guidelines (CPG) Committee policy. A critical evaluation of diagnostic and therapeutic procedures was performed, including assessment of the riskbenefit ratio. The level of evidence and the strength of the recommendation of particular management options were weighed and graded according to predefined scales, as outlined below. The experts of the writing and reviewing panels provided declaration of interest forms for all relationships that might be perceived as real or potential sources of conflicts of interest. Their declarations of interest were reviewed according to the ESC declaration of interest rules and can be found on the ESC website (http://www.escardio.org/ guidelines) and have been compiled in a report and published in a supplementary document simultaneously to the guidelines. This process ensures transparency and prevents potential biases in the development and review processes. Any changes in declarations of interest that arise during the writing period were notified to the ESC and updated. The Task Force received its entire financial support from the ESC without any involvement from the healthcare industry. The ESC CPG supervises and coordinates the preparation of new guidelines. The Committee is also responsible for the endorsement process of these Guidelines. The ESC Guidelines undergo extensive review by the CPG and external experts. After appropriate revisions the guidelines are signed-off by all the experts involved in the Task Force. The finalized document is signed-off by the CPG for publication in the European Heart Journal. The guidelines were developed after careful consideration of the scientific and medical knowledge and the evidence available at the time of their dating. The task of developing ESC Guidelines also includes the creation of educational tools and implementation programmes for the recommendations including condensed pocket guideline versions, summary slides, summary cards for non-specialists and an electronic version for digital applications (smartphones, etc.). These versions are abridged and thus, Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 SZC T2DM TAVI TFT t.i.d. TKI TMEM43 TNNT TR TRPM4 Transcutaneous oxygen saturation Sinus rhythm ST-elevation myocardial infarction Surgical Treatment for Ischemic Heart Failure (trial) Extended follow-up of patients from the STICH trial Society of Thoracic Surgeons Predicted Risk of Mortality Sodium zirconium cyclosilicate Type 2 diabetes mellitus Transcatheter aortic valve implantation Thyroid function test Ter in die (three times a day) Tyrosine kinase inhibitor Transmembrane protein 43 Troponin-T Tricuspid regurgitation Transient receptor potential cation channel subfamily M member 4 Transferrin saturation Thyroid-stimulating hormone Titin Transthyretin United Kingdom United States Ventricular assist device Valsartan Heart Failure Trial (trial) Vascular endothelial growth factor Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease (trial) Vest Prevention of Early Sudden Death Trial (trial) Vitamin K antagonist Oxygen consumption Ventricular premature beat Versus Interventricular delay interval Warfarin and Aspirin in Reduced Cardiac Ejection Fraction (trial) Wild-type transthyretin cardiac amyloidosis Extended release 3608 Classes of recommendations Class I Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, effective. Class II Conflicting evidence and/or a divergence of opinion about the usefulness/ efficacy of the given treatment or procedure. Weight of evidence/opinion is in favour of usefulness/efficacy. Should be considered Class IIb Usefulness/efficacy is less well established by evidence/opinion. May be considered Evidence or general agreement that the Is not recommended given treatment or procedure is not useful/effective, and in some cases may be harmful. ©ESC 2021 Is recommended or is indicated Class IIa Class III Table 2 Wording to use Levels of evidence Level of evidence A Data derived from multiple randomized clinical trials or meta-analyses. Level of evidence B Data derived from a single randomized clinical trial or large non-randomized studies. Level of evidence C Consensus of opinion of the experts and/or small studies, retrospective studies, registries. for more detailed information, the user should always access to the full text version of the guidelines, which is freely available via the ESC website and hosted on the European Heart Journal website. The National Cardiac Societies of the ESC are encouraged to endorse, adopt, translate and implement all ESC Guidelines. Implementation programmes are needed because it has been shown that the outcome of disease may be favourably influenced by the thorough application of clinical recommendations. Health professionals are encouraged to take the ESC Guidelines fully into account when exercising their clinical.............................. judgment, as well as in the determination and the implementation of preventive, diagnostic, or therapeutic medical strategies. However, the ESC Guidelines do not override in any way whatsoever the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient’s health condition and in consultation with that patient or the patient’s caregiver where appropriate and/or necessary. It is also the health professional’s responsibility to verify the rules and regulations applicable in each country to drugs and devices at the time of prescription. Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 Classes of recommendations Definition ©ESC 2021 Table 1 ESC Guidelines 3609 ESC Guidelines 2 Introduction 2.1 What is new In addition to the recommendations listed below, the following table lists some new concepts compared with the 2016 version. New concepts A change of the term ‘heart failure with mid-range ejection fraction’ to ‘heart failure with mildly reduced ejection fraction’ (HFmrEF). A new simplified treatment algorithm for HFrEF. The addition of a treatment algorithm for HFrEF according to phenotypes. Modified classification for acute HF. Updated treatments for most non-cardiovascular comorbidities Updates on cardiomyopathies including the role of genetic testing and new treatments. The addition of key quality indicators. HF = heart failure. ESC 2021 including diabetes, hyperkalaemia, iron deficiency, and cancer. New recommendations Recommendations Class Recommendations for the diagnosis of HF Right heart catheterization should be considered in patients where HF is thought to be due to constrictive pericarditis, restrictive cardiomyopathy, congenital heart disease, and high output states. Right heart catheterization may be considered in selected patients with HFpEF to confirm the diagnosis. IIa IIb Recommendations for treatment of chronic HF HFrEF Dapagliflozin or empagliflozin are recommended for patients with HFrEF to reduce the risk of HF hospitalization and I death. Vericiguat may be considered in patients in NYHA class IIIV who have had worsening HF despite treatment with an ACE-I (or ARNI), a beta-blocker and an MRA to reduce the risk of IIb CV mortality or HF hospitalization. HFmrEF An ACE-I may be considered for patients with HFmrEF to reduce the risk of HF hospitalization and death. An ARB may be considered for patients with HFmrEF to reduce the risk of HF hospitalization and death. A beta-blocker may be considered for patients with HFmrEF to reduce the risk of HF hospitalization and death. An MRA may be considered for patients with HFmrEF to reduce the risk of HF hospitalization and death. Sacubitril/valsartan may be considered for patients with HFmrEF to reduce the risk of HF hospitalization and death. IIb IIb IIb IIb IIb HFpEF Screening for, and treatment of, aetiologies, and CV and nonCV comorbidities are recommended in patients with HFpEF I (see relevant sections of this document). Prevention and monitoring Self-management strategies are recommended to reduce the risk of HF hospitalization and mortality. I Either home-based and/or clinic-based programmes improve outcomes and are recommended to reduce the risk of HF hospitalization and mortality. Influenza and pneumococcal vaccinations should be considered in order to prevent HF hospitalizations. A supervised, exercise-based, cardiac rehabilitation programme should be considered in patients with more severe I IIa IIa disease, frailty, or with comorbidities. Non-invasive HTM may be considered for patients with HF in order to reduce the risk of recurrent CV and HF hospitalizations and CV death. IIb Recommendations for management of patients with advanced HF Patients being considered for long-term MCS must have good compliance, appropriate capacity for device handling and psy- I chosocial support. Continued Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 The aim of this ESC Guideline is to help health professionals manage people with heart failure (HF) according to the best available evidence. Fortunately, we now have a wealth of clinical trials to help us select the best management to improve the outcomes for people with HF; for many, it is now both preventable and treatable. This guideline provides practical, evidence-based recommendations. We have revised the format of the previous 2016 ESC HF Guidelines1 to make each phenotype of HF stand-alone in terms of its diagnosis and management. The therapy recommendations mention the treatment effect supported by the class and level of evidence and are presented in tables. For HF with reduced ejection fraction (HFrEF), the tabular recommendations focus on mortality and morbidity outcomes. Where there are symptomatic benefits, these are highlighted in the text and/or in the web appendices. Detailed summaries of the trials underpinning the recommendations are available in the web appendices. For diagnostic indications, we have suggested investigations that all patients with HF should receive, and investigations that can be targeted to specific circumstances. As diagnostic tests have rarely been subject to randomized controlled trials (RCTs), most of the evidence would be regarded as level C. However, that does not mean that there has not been appropriate rigorous evaluation of diagnostic tests. In this guideline, we have decided to focus on the diagnosis and treatment of HF, not on its prevention. Management of CV risk and many CV diseases [especially systemic hypertension, diabetes mellitus, coronary artery disease, myocardial infarction (MI), atrial fibrillation (AF), and asymptomatic left ventricular (LV) systolic dysfunction] will reduce the risk of developing HF, which is addressed by many other ESC Guidelines and in section 9.1 of the current guideline.27 This guideline is the result of a collaboration between the Task Force (including two patient representatives), the reviewers, and the ESC CPG Committee. As such, it is a consensus/majority opinion of the experts consulted in its development............................................................................................................................................................................. 3610 ESC Guidelines I with advanced HF, refractory to medical/device therapy and who do not have absolute contraindications. Continuous inotropes and/or vasopressors may be considered in patients with low cardiac output and evidence of organ hypo- IIb perfusion as bridge to MCS or heart transplantation. Recommendations for management of patients after HF hospitalization It is recommended that patients hospitalized for HF be carefully evaluated to exclude persistent signs of congestion before discharge and to optimize oral treatment. It is recommended that evidence-based oral medical treat- I An early follow-up visit is recommended at 12 weeks after discharge to assess signs of congestion, drug tolerance, and start and/or uptitrate evidence-based therapy. I Recommendations for management of patients with HF and atrial fibrillation Long-term treatment with an oral anticoagulant should be considered for stroke prevention in AF patients with a IIa CHA2DS2-VASc score of 1 in men or 2 in women. Recommendations for management of patients with HF and CCS CABG should be considered as the first-choice revascularization strategy, in patients suitable for surgery, especially if they have diabetes and for those with multivessel disease. IIa In LVAD candidates needing coronary revascularization, CABG should be avoided, if possible. IIa Coronary revascularization may be considered to improve outcomes in patients with HFrEF, CCS, and coronary anatomy suitable for revascularization, after careful evaluation of the individual risk to benefit ratio, including coronary anatomy (i.e. proximal stenosis >90% of large vessels, stenosis of left main or proximal LAD), comorbidities, life expectancy, and patient’s perspectives. IIb PCI may be considered as alternative to CABG, based on Heart Team evaluation, considering coronary anatomy, IIb comorbidities, and surgical risk. Recommendations for management of patients with HF and valvular heart disease Aortic valve intervention, TAVI or SAVR is recommended in patients with HF and severe high-gradient aortic stenosis to reduce mortality and improve symptoms. I It is recommended that the choice between TAVI and SAVR be made by the Heart Team, according to individual patient preference and features including age, surgical risk, clinical, anatomical and procedural aspects, weighing the risks and I benefits of each approach. Percutaneous edge-to-edge mitral valve repair should be considered in carefully selected patients with secondary mitral regurgitation, not eligible for surgery and not needing coronary IIa revascularization, who are symptomatic despite OMT and who fulfil criteria to achieve a reduction in HF hospitalizations. Percutaneous edge-to-edge mitral valve repair may be considered to improve symptoms in carefully selected patients with secondary mitral regurgitation, not eligible for surgery and not needing coronary revascularization, who are highly symptomatic despite OMT and who do not fulfil criteria for reducing HF hospitalization. IIb Continued Recommendations for management of patients with HF and diabetes SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with T2DM at risk of CV events to reduce hospitalizations for HF, major CV events, end-stage renal dysfunction, and CV death. I SGLT2 inhibitors (dapagliflozin, empagliflozin, and sotagliflozin) are recommended in patients with T2DM and HFrEF to reduce hospitalizations for HF and CV death. The DPP-4 inhibitor saxagliptin is not recommended in patients with HF. I III Recommendations for management of patients with HF and iron deficiency It is recommended that all patients with HF are periodically screened for anaemia and iron deficiency with a full blood I count, serum ferritin concentration, and TSAT. Intravenous iron supplementation with ferric carboxymaltose should be considered in symptomatic HF patients recently hospitalized for HF and with LVEF 35 (SR) or >105 (AF) pg/mL PA systolic pressure >35 mmHg Sensitivity 54%, specificity 85% for the presence of HFpEF by invasive TR velocity at resta >2.8 m/s exercise testing259,261 AF = atrial fibrillation; BNP = B-type natriuretic peptide; E/e’ratio = early filling velocity on transmitral Doppler/early relaxation velocity on tissue Doppler; HFpEF = heart failure with preserved ejection fraction; LA = left atrial; LV = left ventricular; NP = natriuretic peptide; NT-proBNP = N-terminal pro-B-type natriuretic peptide; PA = pulmonary artery; SR = sinus rhythm; TR = tricuspid regurgitation. Note: The greater the number of abnormalities present, the higher the likelihood of HFpEF. a Only commonly used indices are listed in the table; for less commonly used indices refer to the consensus document of the ESC/HFA.259 ESC 2021 of 13 had lower sensitivity (46%) but higher specificity (86%).71,259,274 Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 *Of note, patients with a history of overtly reduced LVEF (_50%, should be considered to have recovered HFrEF or ‘HF with improved LVEF’ (rather than HFpEF). Continued treatment for HFrEF is recommended in these patients.271 It is not known whether starting HF therapy in patients with recovered LVEF is beneficial. Patients with HFpEF tend to have stable trajectory of LVEF over time.272 However, in those who develop a clinical indication for a repeat echo during follow-up, around one third have a decline in LVEF.273 In the presence of AF, the threshold for LA volume index is >40 mL/m2. Exercise stress thresholds include E/e0 ratio at peak stress >_15 or tricuspid regurgitation (TR) velocity at peak stress >3.4 m/s.275 LV global longitudinal strain _15 mmHg (at rest) or >_25 mmHg (with exercise) or LV.... end-diastolic pressure >_16 mmHg (at rest) is generally considered.. diagnostic.266 However, instead of an exercise PCWP cut-off, some.... have used an index of PCWP to cardiac output for the invasive diag.. nosis of HFpEF260,276. Recognizing that invasive haemodynamic exer.... cise testing is not available in many centres worldwide, and is.. associated with risks, its main use is limited to the research setting. In.... the absence of any disease-modifying treatments, the current guide.. lines do not mandate gold standard testing in every patient to make.... the diagnosis, but emphasize that the greater the number of objective.... non-invasive markers of raised LV filling pressures (Table 9), the.. higher the probability of a diagnosis of HFpEF........... 8.4 Treatment of heart failure with.. preserved ejection fraction.... To date, no treatment has been shown to convincingly reduce.... mortality and morbidity in patients with HFpEF, although improve.. ments have been seen for some specific phenotypes of patients.... within the overall HFpEF umbrella. However, none of the large.. RCTs conducted in HFpEF have achieved their primary endpoints..... These include PEP-CHF (perindopril),277 CHARM-Preserved (can.. desartan),245 I-PRESERVE (irbesartan),278 TOPCAT (spironolac.... tone),246 DIG-Preserved (digoxin),279 and PARAGON-HF.. (sacubitril/valsartan)13 (see Supplementary Table 12 for the details.... about these and additional trials). Hospitalizations for HF were.. reduced by candesartan and spironolactone and there was a trend.... towards reduction with sacubitril/valsartan, although as these trials.. were neutral for their primary endpoints, these are hypothesis.... generating findings only. Although nebivolol significantly reduced.. the combined primary endpoint of all-cause mortality or CV hospi.... tal admission in the SENIORS trial, this trial included only 15% with.. an LVEF >50%.119,249 Trials targeting the nitric oxide-cyclic guano... sine monophosphate pathway have also failed to improve exercise 3632 ESC Guidelines Recommendations Screening for, and treatment of, aetiologies, and cardiovascular and non-cardiovascular comorbidities is recommended in patients with HFpEF Classa I Levelb C Diuretics are recommended in congested patients with HFpEF in order to alleviate symptoms and signs.137 HFpEF = heart failure with preserved ejection fraction. a Class of recommendation. b Level of evidence. I C ESC 2021 (see relevant sections of this document). Table 10 Risk factors for the development of heart failure and potential corrective actions Risk factors for heart failure Preventive strategies Sedentary habit Regular physical activity Cigarette smoking Cigarette smoking cessation Obesity Physical activity and healthy diet 286 Excessive alcohol intake General population: no/light alcohol intake is beneficial Patients with alcohol-induced CMP should abstain from alcohol Influenza Influenza vaccination Microbes (e.g. Trypanosoma Early diagnosis, specific antimicrobial cruzi, Streptococci) therapy for either prevention and/or treatment Cardiotoxic drugs (e.g., anthracyclines) Cardiac function and side effect monitoring, dose adaptation, change of chemotherapy Chest radiation Hypertension Cardiac function and side effect monitoring, dose adaptation Lifestyle changes, antihypertensive Dyslipidaemia Healthy diet, statins Diabetes mellitus Physical activity and healthy diet, SGLT2 inhibitors CAD Lifestyle changes, statin therapy ESC 2021 therapy CAD = coronary artery disease; CMP = cardiomyopathy; SGLT2 = sodium-glucose co-transporter 2. Recommendations for the primary prevention of heart failure in patients with risk factors for its development Recommendations Classa Levelb I A I A I A I C Treatment of hypertension is recommended to prevent or delay the onset of HF, and to prevent HF hospitalizations.287290 Treatment with statins is recommended in patients at high risk of CV disease or with CV disease in order to prevent or delay the onset of 291,292 HF, and to prevent HF hospitalizations. SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with diabetes at high risk of CV disease or with CV disease in order to prevent HF hospitalizations.293297 Counselling against sedentary habit, obesity, cigarette smoking, and alcohol abuse is recommended to prevent or delay the onset of HF.298302 CV = cardiovascular; HF = heart failure; SGLT2 = sodium-glucose co-transporter 2. a Class of recommendation. b Level of evidence. ESC 2021 Recommendations for the treatment of patients with heart failure with preserved ejection fraction............................................................................................................................................................................ Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 capacity or QOL in HFpEF, e.g. NEAT-HFpEF,280 INDIE-HFpEF,281 VITALITY-HFpEF,282 and CAPACITY-HFpEF (praliciguat).283 Despite the lack of evidence for specific disease-modifying therapies in HFpEF, as the vast majority of HFpEF patients have underlying hypertension and/or CAD, many are already treated with ACE-I/ ARB, beta-blockers, or MRAs. In the PARAGON-HF study at baseline, more than 86% of patients were on ACE-I/ARBs, 80% were on beta-blockers, and more than 24% were on MRAs.13 The Task Force acknowledge that the treatment options for HFpEF are being revised as this guideline is being published. We note that the Food and Drug Administration (FDA) has endorsed the use of sacubitril/valsartan and spironolactone in those with an LVEF ‘less than normal’. These statements relate to patients within both the HFmrEF and HFpEF categories. For sacubitril/valsartan, this decision was based on the subgroup analysis from the PARAGON-HF study, which showed a reduction in HF hospitalizations in those with an LVEF 2 kg in 3 days, patients may increase Provide individualized information to support self-management such as: their diuretic dose and/or alert their healthcare team. Living with HF Psychological issues To be able to live a good life with HF. To be able to seek help in case of psychological problems Regularly communicate information on disease, treatment options and self-care. such as depressive symptoms, anxiety or low mood Regularly discuss the need for support. which may occur in the course of the HF trajectory. Treat or referral to specialist for psychological support when necessary. Continued Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 To be able to prevent malnutrition and know how to eat 3636 ESC Guidelines Table 12 Continued Education topic Goal for the patient and caregiver Professional behaviour and educational tools Family and informal To be able to ask for support. Discuss the preference of caregiver/family involvement. caregivers Involve patients and caregivers in a respectful way. ESC 2021 To recognise that the carer or family members may be greatly affected and need to seek help. CMP = cardiomyopathy; CV = cardiovascular; HF = heart failure. a 1 unit is 10 mL of pure alcohol (e.g., 1 glass of wine, 1=2 pint of beer, 1 measure of spirit). Providing information in a variety of formats that take into account educational grade and health literacy. Consider approaches with active roles for patients and caregivers such as ‘ask-tell-ask’, ‘teach back’, or motivational interviewing. Reinforce messages at regular time intervals. Recognizing barriers to communication (language, social skills, cognition, anxiety/depression, hearing or visual challenges). Recommending ‘HFmatters.org’. Offer help and guidance to use it and offer discussion of questions arising. Inviting patients to be accompanied by a family member or friend. Key topics to include are recommended in Table 12. 9.4 Exercise rehabilitation There is consistent evidence that physical conditioning by exercise training improves exercise tolerance, and health-related QOL in patients with HF. Clinical trials and meta-analyses in people with HFrEF show that exercise rehabilitation improves exercise capacity and QOL. Several meta-analyses also show that it reduces all-cause and HF hospitalizations, although uncertainty persists about its effects on mortality.322328 The effect on hospitalization is seen in those who are highly adherent to the exercise programme.329 Highintensity interval training, in patients who are able and willing, may improve peak oxygen consumption (VO2).330,331 Supervised Recommendations for exercise rehabilitation in patients with chronic heart failure Recommendations Classa Levelb I A IIa C Exercise is recommended for all patients who are able in order to improve exercise capacity, QOL, and reduce HF hospitalization.c 324328,335337 tion programme should be considered in patients with more severe disease, frailty, or with comorbidities.95,324327,338 HF = heart failure; QOL = quality of life. a Class of recommendation. b Level of evidence. c In those who are able to adhere to the exercise programme. ESC 2021 A supervised, exercise-based, cardiac rehabilita-.... exercise-based rehabilitation should be considered in those who are.. frail, who have more severe disease or comorbidities.95.... Physical conditioning also improves exercise capacity and.. QOL.332335 No data on HFmrEF are available, but benefits.... observed in the other groups of HF should also apply to this group....... 9.5 Follow-up of chronic heart failure.... 9.5.1 General follow-up.. This is a relatively understudied area. Patients with HF, even if symp.... toms are well controlled and stable, require follow-up to ensure con.. tinued optimization of therapy, to detect asymptomatic progression of.... HF or its comorbidities and to discuss any new advances in care. These.. guidelines recommend follow-up at intervals no longer than 6 months.... to check symptoms, heart rate and rhythm, BP, full blood count, elec.... trolytes, and renal function. For patients recently discharged from hos.. pital, or in those undergoing uptitration of medication, follow-up.... intervals should be more frequent. Whether such stable patients need.. to be followed-up by cardiologists is uncertain. Some studies suggest.... that follow-up in primary care may be appropriate.303,339 However,.. uptake of evidence-based interventions is poor in many settings340,104.... and several studies suggest that care and follow-up provided by HF.. specialists, and use of quality improvement registries can lead to higher.... rates of optimal therapy and improved outcomes.341343.. An ECG should be done annually to detect QRS prolongation344.... as such patients may become candidates for CRT. Furthermore, it.. may identify conduction disturbances and AF..... Serial echocardiography is generally not necessary, although an.. echocardiogram should be repeated if there has been a deterioration.... in clinical status. An echocardiogram is also advised 36 months after.. optimization of standard therapies for HFrEF to determine the need.... for addition of newer pharmacological agents and implanted devices....... 9.5.2 Monitoring with biomarkers.. Trials investigating the use of biomarkers (particularly BNP and/or.... NT-proBNP) to guide pharmacotherapy for HFrEF have produced.. conflicting results.345352 They are undoubtedly good prognostic.... markers.72,353,354 Conceptually, it is not clear what a biomarker.. supported strategy might offer in addition to assiduous application of.... guideline-recommended therapy. Current evidence, therefore, does.. not support the routine measurement of BNP or NT-proBNP to.... guide titration of therapy....... 9.6 Telemonitoring.... Telemonitoring enables patients to provide, remotely, digital health.. information to support and optimize their care. Data such as Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 QOL or prognosis; however, providing this information has become a key component of education for self-care. General educational approaches include: 3637 ESC Guidelines ESC 2021.. Thus, non-invasive HTM may be considered for patients with HF.... in order to reduce the risk of recurrent CV and HF hospitalizations.... and CV death; further evidence on management guided by implanted.. systems is awaited.374......... Recommendations for telemonitoring...... Recommendations Classa Levelb.... Non-invasive HTM may be considered for.... patients with HF in order to reduce the risk of IIb B.. recurrent CV and HF hospitalizations and CV.. 374.. death..... Monitoring of pulmonary artery pressure using a.. wireless haemodynamic monitoring system may.. IIb B.. be considered in symptomatic patients with HF.. in order to improve clinical outcomes.372.... CV = cardiovascular; HF = heart failure; HTM = home telemonitoring; LVEF = left.... ventricular ejection fraction... Class of recommendation... Level of evidence................. 10 Advanced heart failure...... 10.1 Epidemiology, diagnosis, and.... prognosis.... Many patients with HF progress into a phase of advanced HF, charac.. terized by persistent symptoms despite maximal therapy.375377 The.... prevalence of advanced HF is increasing due to the growing number.. of patients with HF, ageing of the population, and better treatment.... and survival of HF. Prognosis remains poor, with a 1-year mortality.. ranging from 25% to 75%.378380.... The updated HFA-ESC 2018 criteria for the definition of advanced.. HF are reported in Table 13.376 A severely reduced LVEF is common.... but not required for a diagnosis of advanced HF as it may develop in.. patients with HFpEF as well. In addition to the reported criteria,.... extra-cardiac organ dysfunction due to HF (e.g. cardiac cachexia,.. liver or kidney dysfunction) or type II pulmonary hypertension.... may be present, but are not required for the definition of advanced.. HF.376.... The Interagency Registry for Mechanically Assisted Circulatory.... Support (INTERMACS) profiles, developed to classify patients.. with a potential indication for durable MCS devices, describes.... clinical parameters and characteristics consistent with a need for.. advanced therapies (Table 14).381 This classification has also been.... shown to be useful in estimating the prognosis of patients under.. going urgent heart transplantation382 or LV assist device (LVAD).... implantation,383 and for risk assessment in ambulatory advanced.. HF patients.384.. Prognostic stratification is important to identify the ideal time for.... referral to an appropriate centre (i.e. one capable of providing.... advanced HF therapies), to properly convey expectations to patients.. and families, and to plan treatment and follow-up strategies a b Downloaded from https://academic.oup.com/eurheartj/article/42/36/3599/6358045 by guest on 08 April 2024 symptoms, weight, heart rate, and BP, can be collected frequently, stored in an electronic health record and used to guide patients (directly or through a healthcare professional), to adjust therapy or to seek further advice. Home telemonitoring (HTM) can help maintain quality of care, facilitate rapid access to care when needed, reduce patient travel costs, and minimize the frequency of clinic visits.355 Enforced cessation of face-to-face consultations in many countries during the recent COVID-19 pandemic have highlighted some of the potential advantages of HTM.356 Trials of HTM are diverse. Patients are usually required to make measurements and, as for many other aspects of HF management, adherence may be incomplete. HTM may be provided as a local, regional, or national service. Systems that focus on optimizing management rather than detecting and managing medical emergencies need only to be staffed during standard working hours. Some systems are designed also to offer support at any time requested by the patient. The comparative effectiveness and cost effectiveness of each strategy is uncertain. Systems that focus on continuous optimization of care (a health maintenance approach) rather than trying to anticipate and manage episodes of worsening (a strategy that is plagued by a large number of false-positive alerts), appear more successful.357 HTM is an efficient method for providing patient education and motivation and aiding delivery of care, but it should be adapted to work in synergy with existing healthcare provision.358 A Cochrane systematic review conducted in 2017 identified 39 relevant trials of HTM, largely based on assessments of symptoms, weight, heart rate and rhythm, and BP and found that HTM was associated with a reduction in all-cause mortality of 20% and HF hospitalization of 37%.359 Since then, several neutral trials and at least one positive trial have been published.357,360364 These are unlikely to change the positive results of the systematic review. Importantly, if social distancing and the ‘green’ agenda are important, HTM only needs to show that it is not inferior to contemporary methods of delivering care to be an appropriate means of supporting care.356 Whether wearable technologies for monitoring heart rate and rhythm or lung congestion (bio-impedance or lung radar) offer additional benefits to conventional HTM described above is uncertain.365367 Many implanted therapeutic devices can provide, wirelessly and remotely, information either on the device itself (generator and lead function), arrhythmias, or on patient physiology (heart rate, activity, heart sounds, bio-impedance). There is strong evidence that monitoring can detect device malfunction earlier than by conventional monitoring and that it may be useful for detecting arrhythmias such as AF. However, there is little evidence that device monitoring reduces admissions for HF or mortality.368370,371 Devices that only provide a monitoring function are also available. Implantable loop-recorders can be injected subcutaneously and used to monitor heart rate and rhythm, activity, and bio-impedance. Monitoring devices can also be placed in the pulmonary artery to monitor pressure wirelessly, although the external reader required to detect the device signal is rather bulky and requires patient cooperation. A rise in diastolic pulmonary artery pressure may be one of the earliest signs of congestion. A preliminary, but fairly substantial, trial showed a reduction in the risk of recurrent HF hospitalization.372 A much larger trial has completed recruitment (GUIDE-HF).373 3638 Table 13 ESC Guidelines Criteria for definition of advanced heart failure All the following criteria must be present despite optimal medical treatment: 1. Severe and persistent symptoms of heart failure [NYHA class III (advanced) or IV]. 2. Severe cardiac dysfunction defined by at least one of the following: LVEF
