ESC Guidelines PDF

ESC Guidelines 3609 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 eje...

ESC Guidelines 3609 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 II!IV 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 UNAM user on 02 July 2023 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.2!7 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............................................................................................................................................................................. ESC Guidelines 3610 with advanced HF, refractory to medical/device therapy and I 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 1!2 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 UNAM user on 02 July 2023 *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 ESC Guidelines 3632 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 Chest radiation Cardiac function and side effect monitoring, dose adaptation Hypertension Lifestyle changes, antihypertensive Dyslipidaemia Healthy diet, statins Diabetes mellitus Physical activity and healthy diet, SGLT2 inhibitors CAD Lifestyle changes, statin therapy chemotherapy 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.287!290 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 HF, and to prevent HF hospitalizations.291,292 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.293!297 Counselling against sedentary habit, obesity, cigarette smoking, and alcohol abuse is recommended to prevent or delay the onset of HF.298!302 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 UNAM user on 02 July 2023 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