In accordance with the policy on clinical practice guidelines established by the Executive Committee of the Spanish Society of Cardiology,1 the current article discusses the most notable and novel aspects of the European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of acute and chronic heart failure (HF).2 The aim of the guidelines is to update our knowledge of the diagnosis and treatment of HF based on the best clinical evidence available.

The most important developments are listed in Table 1

Although the clinical definition of HF based on the presence of specific symptoms and signs is unchanged, the guidelines stress the importance of HF detection and diagnosis in the asymptomatic or largely symptomless phase because appropriate therapy can reduce disease progression and mortality.

The main development is undoubtedly the introduction of the concept of HF with mid-range ejection fraction (EF) (HFmrEF). This new entity, placed between the well-established HF with reduced EF (HFrEF) and HF with preserved EF (HFpEF), occupies the gray area of individuals with an EF between 40% and 49%. According to the authors, the demarcation of this group and its identification in the clinic should help to promote research into the underlying causes of HF in this type of patient, improve our understanding of its pathophysiology, and intensify the search for better treatment strategies. However, this classification appears arbitrary and, thus far, lacks clinical significance.

Data on HF epidemiology and hospitalization indicate the decreased incidence of HFrEF and the parallel increased incidence of patients with HFpEF. The latter phenomenon is mainly due to the following underlying risk factors: population aging and weight gain, greater detection of HF in women, and increased hypertension prevalence.

Because the diagnostic suspicion relies on symptoms and signs of congestion, medical history and physical examination continue to be vital for the syndromic diagnosis of HF. The document presents an interesting table aimed at physicians attending non-acute patients. This table summarizes both the most typical and less frequent signs and symptoms of HF, which should be known by all physicians. Three complementary pillars of the syndromic diagnosis of HF now supplement medical history: electrocardiography (ECG), determination of natriuretic peptide levels, and echocardiography. The use and systematic application of these methods are well demonstrated in a new diagnostic algorithm. This algorithm places special emphasis on the use of echocardiography to differentiate HFrEF, HFmrEF, and HFpEF. Particular attention is paid to the diagnosis of this last entity because it is the most common form of HF in elderly patients with multiple comorbidities and has a poorly defined therapeutic behavior. The diagnosis of HFpEF requires all of the following:

• •

  Presence of symptoms and signs of HF.

• •

  EF ≥ 50% (40%-49% for HFmrEF).

• •

  Elevated levels of B-type natriuretic peptide (BNP) (> 35 pg/mL) or N-terminal pro-B-type natriuretic peptide (NTproBNP) (> 125 pg/ml).

• •

  Objective echocardiographic evidence of other cardiac functional (E/e’ ratio) or structural (left ventricular hypertrophy, left atrial volume) alterations.

For the first time, the definition of HFrEF and HFmrEF requires the presence of elevated levels of natriuretic peptides, reflecting the importance of these proteins as a diagnostic tool in HF.

An important aspect mentioned in the guidelines is the difficulty of HF diagnosis in patients with atrial fibrillation (AF), particularly in terms of BNP and NTproBNP levels, because the cutoff levels for these peptides should be higher in patients with this condition.

Imaging tests should only be performed when deemed necessary for diagnosis or treatment. For example, a simple chest X-ray is useful in the emergency department but is of little to no use in non-acute patients.

As mentioned above, echocardiography is the method of choice for determining systolic and diastolic function in patients with HF.

Cardiac magnetic resonance is recognized as the gold standard for the evaluation of the volume, mass, and EF of both ventricles. It is the leading alternative to echocardiography (particularly for imaging the right ventricle) and the method of choice for patients with complex congenital heart disease. It is the best imaging method to detect myocardial fibrosis and for the diagnosis of amyloidosis, sarcoidosis, hemochromatosis, Chagas disease, and Fabry disease.

Single-photon emission computed tomography (SPECT), positron emission tomography (PET), and noninvasive coronary angiography with multidetector computed tomography (MDCT) can be useful in specific situations. Notably, most of these recommendations, even the class I recommendations, have a level of evidence of C.

This section considers the evidence available on a fact well proven in clinical trials: control of HF risk factors can delay or even stop the natural course of the disease. The recommendations table in this section shows a list of available strategies for the primary prevention of HF involving the general systematic control of risk factors by both pharmacological and nonpharmacological approaches. The most relevant innovation in this section is that the new inhibitors of the renal tubule sodium-glucose cotransporter should be considered in the treatment of diabetes mellitus to prevent or delay HF development and reduce mortality (class IIa, level of evidence B).

Pharmacological treatment of HF is a field undergoing continuous development and is the main reason for the improved prognosis and quality of life of patients. However, there are priority research needs for acute HF, HFpEF, and HFmrEF.

The CRT recommendations have been updated for patients with LVEF ≤ 35% who are symptomatic despite OMT and in sinus rhythm, without any differentiation according to their NYHA function class (II-IV). Cardiac resynchronization therapy is not recommended in patients with a QRS duration < 130ms (class III, level of evidence A) and, conversely, is indicated for patients with complete left bundle branch block (LBBB) and a QRS duration ≥ 130ms. If the patient has LBBB and QRS > 150ms, the recommendation is class I, level of evidence A, whereas the recommendation becomes class I, level of evidence B if the QRS is between 130 and 149ms. It is difficult to explain why a class I recommendation has been maintained for a QRS between 130 and 149ms because both subgroup analyses of the large CRT studies and the 2 metaanalyses mentioned in the guidelines as the basis for this indication show no survival benefit in patients in this range of QRS duration.

In the current American guidelines from the ACC/AHA, this approach received a type IIa recommendation in this population.12

If there is no LBBB, CRT should be considered for patients with QRS ≥ 150ms (class IIa, level of evidence B), with a more limited indication (class IIb, level of evidence B) for a QRS duration from 130 to 149ms. Thus, the guidelines reflect the validity of the ongoing controversy regarding whether the indication for CRT should be based only on the duration of QRS or whether it should include its morphology.

For patients with AF and HFrEF (EF < 35%), in NYHA III-IV despite OMT, and with QRS > 130ms, CRT should be considered if it can achieve close to 100% biventricular capture (class IIa, level of evidence B). Implantation of a CRT device is also recommended if a pacemaker is indicated due to heart block, independent of baseline rhythm (class I, level of evidence A).

Implantable cardioverter-defibrillators (ICDs) are indicated for secondary prevention in patients with an estimated survival less than 1 year (class I, level of evidence A). The guidelines recommend with a class I indication their use for primary prevention in patients with HF and reduced systolic function (EF < 35%) despite OMT (3 months) who are in functional class II-III. However, different levels of evidence are recognized in patients with ischemic cardiomyopathy (level of evidence A) vs nonischemic dilated cardiomyopathy (level of evidence B). The recent release of the results of the DANISH study,13 subsequent to the publication of these guidelines, will mean a drastic change in the indication for ICDs in patients with nonischemic cardiomyopathy: this randomized trial, whose primary endpoint was mortality, showed no benefit from ICD implantation in this patient group (although subgroups of patients < 59 years do appear to benefit). Thus, the use of ICD for primary prevention in nonischemic cardiomyopathy would be relegated to select individuals, more in accordance with a class IIb indication.

The guidelines expand the section dedicated to acute HF (AHF) compared with the previous edition. Its initial characterization can be performed using the Nohria classification. This system is based on the presence or absence of signs or symptoms of congestion—pulmonary or systemic— (patients “wet” or “dry”) and peripheral hypoperfusion (patients “cold” or “warm”). These categories are combined to give 4 clinical profiles used to outline the initial drug therapy.

The pillars of the initial diagnosis continue to be medical history and physical examination, together with a series of additional tests— chest X-ray, ECG (due to its very high negative predictive value), and laboratory variables (all class I, level of evidence C).14 Determination of natriuretic peptide levels is recommended in all patients with acute dyspnea and suspected AHF15 (class I, level of evidence A). In this case, the cutoff points are higher for the diagnosis of AHF than for the diagnosis of chronic HF. Echocardiography is recommended in the first 48hours but should be performed immediately in patients with hemodynamic instability or suspected life-threatening conditions (class I, level of evidence C).

Immediate care is based on noninvasive monitoring of blood pressure (BP), HR (ECG), and oxygenation (pulse oximetry) (all class I, level of evidence C). Invasive monitoring using pulmonary artery catheterization may be considered for patients with symptoms refractory to therapy, above all if they have hypotension with hypoperfusion (class IIb, level of evidence C). Patients with AHF should ideally be transferred to hospitals with a cardiology service and coronary or intensive care unit. Patients with respiratory failure or hemodynamic instability should be transferred to facilities able to provide respiratory and cardiocirculatory support and specific therapy should be started as soon as possible (class IIa, level of evidence B).

After the initial evaluation and stabilization, the guidelines recommend subsequent identification of the potential causative or precipitating factors of the decompensation. For this purpose, the use is recommended of the mnemonic rule CHAMP (corresponding to the initials of acute Coronary syndrome, Hypertension emergency, Arrhythmia, acute Mechanical cause, and Pulmonary embolism) to direct patients with a diagnosis to undergo immediate specific treatment or otherwise initiate the diagnostic work-up and general treatment.

The initial treatment guidelines include the recommendation to avoid oxygen supplementation in normoxic patients (class I, level of evidence C) and the performance of arterial blood gas in patients with pulmonary edema and COPD (class IIa, level of evidence B). Noninvasive ventilation (class IIa, level of evidence B) should be considered from the beginning for patients with respiratory failure, whereas intubation is to be reserved for patients with persistent respiratory failure (class I, level of evidence C). The use of morphine or opiates is more restricted than in previous guidelines; their systematic use is not recommended but they can be specifically considered to alleviate dyspnea and anxiety in acutely dyspneic patients (class IIb, level of evidence B).

The guidelines recommend the identification and prioritization of the remaining drug therapy based on the characterization of the initial clinical-hemodynamic profile of the patient. Most patients have symptomatic HF and treatment involves the use of diuretics to alleviate the congestion, as well as vasodilators in patients with a suitable BP. Intravenous loop diuretics are indicated to reduce congestion and alleviate symptoms in all of the above patients (class I, level of evidence C). The initial dose should be the lowest that has the desired clinical effect, beginning with 20-40mg furosemide i.v. (or equivalent) for patients with de novo AHF or chronic HF without previous diuretic treatment and at least the equivalent of the oral dose in those on long-term diuretic therapy (class I, level of evidence B), whether via bolus or perfusion (class I, level of evidence B). Vasodilator therapy (nitrates, sodium nitroprusside, nesiritide) should be considered for all patients with AHF and systolic BP > 90mmHg (class IIa, level of evidence B) and as primary therapy in patients with hypertensive AHF (class IIa, level of evidence B), in conjunction with blood pressure monitoring if intravenously administered. Patients with cardiogenic shock should be treated with inotropic agents and, when necessary, vasopressors. Mechanical circulatory support should be considered in patients with refractory disease.

When permitted by the hemodynamic conditions and contraindication status of the patient, chronic treatment that modifies the HF course (ACEIs, beta-blockers, and MRAs) should be continued in patients already receiving them (class I, level of evidence C).

The criteria for hospital discharge are clinical and hemodynamic stability, including normovolemia obtained with evidence-based treatment, stable renal function for at least 24hours prior to discharge, and receipt of education focused on self-care advice. The other key aspect is follow-up during the high-risk phase. Ideally, the management process will include patients in management and follow-up programs before their discharge and involve coordination with the primary care team, with check-ups by a general practitioner in the first week and by a cardiologist linked to the hospital within 2 weeks after discharge. Patients with chronic HF should undergo follow-up with a multidisciplinary team.

The guidelines present various novel aspects related to mechanical circulatory support (MCS) that will be useful in clinical practice.

In the first place, the INTERMACS scale is included as a table. Using this table, as an aid to decision-making, the survival of stages IV ambulatory (INTERMACS 4 and 5) can be compared with the survival estimated via the different risk scores.

Similarly, the guidelines mention the SAVE (Survival After Venoarterial Extracorporeal Membrane Oxygenation [ECMO]) risk score, which can help to calculate expected survival in patients receiving ECMO for refractory cardiogenic shock.

Another considerably useful aspect is the inclusion of eligibility criteria for implantation of a left MCS. These criteria reveal a development, namely, MCS contraindication due to the presence of combined severe right ventricular dysfunction and severe tricuspid regurgitation. A noteworthy aspect is the replacement of the MCS recommendation as “bridge to heart transplantation” (class I, level of evidence B) by the indication “bridge to transplant indication” (class IIa, level of evidence C). We agree that the scientific literature is yet to prove a universal benefit of MCS in patients on the transplant waiting list, but the cumulative experience with these devices in this setting reveals excellent results. Accordingly, we believe that it would be more appropriate to not replace the MCS indication as bridge to heart transplantation but to change it to a IIa class of recommendation with level of evidence B, as also concluded in the 2013 HF guidelines of the ACCF/AHA.12

Moreover, MCS systems should be considered as “destination therapy” for patients ineligible for transplantation, with a IIa class of recommendation, level of evidence B, because their benefit vs medical therapy has been shown in randomized trials. However, in Spain, this recommendation currently has limited applicability because the Spanish National Health System has widespread funding problems.

Finally, there was no recommendation regarding the implantation of temporary MSC devices in patients with cardiogenic shock. Regarding this aspect, the guidelines are particularly confusing because, although they recognize that MSC can be useful as a “bridge to decision”, the document states they it cannot be recommended as a treatment with proven efficacy for cardiogenic shock because no randomized studies or metaanalyses have shown its benefit. This statement contrasts with the indication for temporary ventricular assistance in patients with cardiogenic shock in the above-mentioned 2013 guidelines of the ACCF/AHA, which awarded it a IIa class of recommendation, level of evidence B.

The main heart transplant-related innovation is the inclusion of the new indications and contraindications for heart transplant agreed by the International Society for Heart and Lung Transplantation (ISHLT),16 which represent an adaptation of the guidelines to clinical practice. These changes concern the contraindications, 2 in particular. The first is the assertion that once severe pulmonary hypertension is classified as irreversible, we should consider the use of ventricular support. The second is the removal of the restriction on a history of treated neoplasm within 5 years prior to transplant, with the guidelines also recommending joint evaluation with oncology specialists. In addition, the guidelines explain that some contraindications are transient and treatable, noting that, with strict management, patients with HIV, hepatitis, Chagas disease, or tuberculosis can be considered suitable transplant candidates.

The guidelines stress that the key to the success of the HF management programs is ensuring continuity of care and thus list its characteristics and constituent elements. But perhaps the most novel aspect is the inclusion of the distinct roles that the professionals involved in HF management should play to help patients to acquire the necessary skills for self-management.

We consider it positive that the guidelines recommend that patients with HF perform aerobic exercise (class I, level of evidence A), independent of LVEF, because most Spanish cardiology services still lack cardiac rehabilitation programs and their implementation will be stimulated by these types of recommendations.

Another notable aspect is the benefit of correct discharge planning because programs incorporating early postdischarge follow-up drastically reduce the readmission rate.17

Finally, it is surprising that the recommendation that patients with stable HF and OMT be referred to primary care is classified as class IIb, level of evidence B, when the randomized studies behind this recommendation failed to find significant differences between primary care follow-up and specialized care,18,19 suggesting that this approach should be classified as class IIa, level of evidence A.

This is 1 of the main challenges in the treatment of patients with HF and 1 of the sections with the least available evidence.

The aim of such care is to alleviate the symptoms and improve the quality of life of patients with refractory HF. The guidelines list a series of points that acts as a checklist to ensure that physicians remember oft-overlooked aspects. This approach not only covers medication, but also anticipated desires and emotional support to patients and their carers. Nonetheless, the available evidence is insufficient to establish concrete recommendations.

Lacking is the discussion of certain palliative therapies that can improve the quality of life of these patients, such as intermittent inotropic infusion and peritoneal dialysis.

Finally, the new guidelines introduce some risk scores that help health care staff to monitor symptoms and quality of life in palliative care, an interesting inclusion because these tools are also useful for the evaluation of therapy effectiveness.

The section on comorbidities has improved both in length and depth, particularly in some of its subsections. This expansion underlines their importance, as shown in the table reproduced and summarized here (Table 2). Notably, the guidelines have included for the first time intravenous treatment with ferric carboxymaltose for symptomatic patients with HFrEF and absolute or functional iron deficiency to improve symptoms, exercise capacity, and quality of life (class IIa, level of evidence A).

The new ESC guidelines for HF for 2016 are immensely useful. Despite the numerous gaps in evidence on certain aspects of HF diagnosis and treatment, the new findings and concrete practical recommendations are clearly presented, with most recommendations based on a high level of evidence. The presentation of a table at the end of the guidelines with the essential messages about what to do and what not to do is particularly valuable.

Although intense dissemination of the new recommendations is required, we predict that their application will have a positive impact on the quality and efficiency of care of patients with HF.

None declared.