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New ESC heart failure guidelines include distinct mid-range LVEF category

News - May 21, 2016

The European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure are published today in European Heart Journal and the European Journal of Heart Failure, and presented at Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure.

In the guidelines, heart failure (HF) is defined as ‘a clinical syndrome characterised by typical symptoms (e.g. breathlessness, ankle swelling and fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral edema) caused by a structural and/or functional cardiac abnormality, resulting in a reduced cardiac output and/or elevated intracardiac pressures at rest or during stress.’ Thus this definition is restricted to symptomatic HF.

During the general presentation of the guidelines at the ESC Heart Failure Congress, professor Adriaan Voors (Groningen, The Netherlands), Task Force Co-Chairperson, asked the audience to raise their hands at the left ventricular ejection fraction (LVEF) cut-off value they thought should be used for HF with reduced EF (HFrEF). Most answered <40 or <45%. The varying opinions illustrated the problem faced by the Guideline Task Force. Consequently, a new clinical category has been defined, namely those with mid-range EF (HFmrEF) with LVEF in the range of 40-49%. Distinct consideration of these patients is important due to different underlying aetiologies, demographics, co-morbidities. Patients appear to show a different phenotype as compared with real HFpEF and may have a different response to therapies.
A sizeable proportion of the HF population may fit into this category, possibly 10-20%. Professor Piotr Ponikowski (Wroclaw, Poland), Chairperson of the guidelines Task Force, said: “There are no evidence based treatments for patients with LVEF 40% or above. Many patients fall into the mid-range category and this should stimulate research into novel therapies.”

A new algorithm is introduced for the diagnosis of heart failure in the non-acute setting and is based on the evaluation of heart failure probability. “This algorithm will be more useful in clinical practice for general practitioners and other non-cardiologists faced with patients who may have heart failure,” said Professor Ponikowski. “It clearly defines when heart failure can be ruled out and when further tests are needed.” The algorithm includes cut-off values for natriuretic peptides to exclude heart failure (NT-proBNP> 125 pg/mL, BNP>35 pg/mL).

The 2016 guidelines include sacubitril/valsartan (LCZ696) for the first time. This drug is the first in the class of angiotensin receptor neprilysin inhibitors (ARNIs) and was shown in the PARADIGM-HF trial to be superior to the angiotensin-converting enzyme inhibitor (ACEI) enalapril for reducing the risk of death and hospitalisation in patients with heart failure with reduced ejection fraction who met strict inclusion and exclusion criteria.

Professor Piotr Ponikowski said: “The issue of how to include LCZ696 in the treatment algorithm generated a lot of discussion. We recommend that the drug should replace ACEIs in patients who fit the PARADIGM-HF criteria. The Task Force agreed that more data is needed before it can be recommended in a broader group of patients.”

Cardiac resynchronisation therapy (CRT) is now contraindicated in patients with a QRS duration less than 130 msec after the EchoCRT study found it may increase mortality in this group. This is a change from the 120 msec cut-off in the 2012 guidelines. The indications for CRT vary according to the presence or absence of left bundle branch block and QRS duration.

With regard to acute heart failure, early initiation of appropriate therapy along with identification of acute aetiology is stressed. The concept of ‘time to therapy’, adopted from acute coronary syndrome, is included in the guidelines for the first time. The algorithm dictates urgent diagnosis and treatment based on clinical presentation. “Acute heart failure is a life-threatening condition and earlier appropriate treatment may prevent organ damage,” said Professor Voors.

Adaptive servo-ventilation (ASV) is not recommended in patients with HFrEF and central sleep apnoea after mortality increased in the SERVE-HF trial. Professor Ponikowski said: “We took for granted that ASV benefitted these patients. The trial was a big surprise and ASV is now contraindicated in this situation.”

Novel recommendations to prevent or delay the onset of heart failure and prolong life include: treatment of hypertension, statins for patients with or at high risk of coronary artery disease, and empagliflozin (a sodium-glucose cotransporter 2, or SGLT2, inhibitor) for patients with type 2 diabetes.

Professor Voors said: “We have better ways to treat comorbidities that increase the risk of heart failure. Several drugs for diabetes were associated with a higher risk of deterioration of heart failure but now we have an SGLT2 inhibitor that reduces the risk of heart failure hospitalisations in high risk patients, although studies with SGLT2 inhibitors in patients with established heart failure are still lacking.”

The guidelines include structured recommendations with class of recommendation and level of evidence given to all the main elements of management from diagnosis, monitoring and therapies to postdischarge follow-up.
Professor Ponikowski: “Heart failure is becoming a preventable and treatable disease. Implementing the guidelines published today will give patients the best chance of a positive outcome.”

At the end of the session, Professor Ponikowski formulated 10 commandments as a take home summary of the new HF guidelines, which can be found elsewhere on this website.
 Presentation at ESC HF 2016 and press release
Find the guidelines online at Eur Heart J

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