Updated European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure have been published.1
The 2016 guidelines include for the first time the new drug sacubitril/valsartan (previously known as LCZ696). This is the first drug 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 (ACE) inhibitor enalapril for reducing the risk of death and hospitalisation in patients with heart failure with reduced ejection fraction (HFREF) who met strict inclusion and exclusion criteria.
Professor Piotr Ponikowski (Chairperson of the ESC Guidelines Task Force), said: “The issue of how to include LCZ696 in the treatment algorithm generated a lot of discussion. We recommend that the drug should replace ACE inhibitors 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”.
New heart failure category
The guidelines also include a new category of heart failure with mid-range ejection fraction (HFMREF), added for patients with a left ventricular ejection fraction (LVEF) ranging from 40–49%. This category sits between HFREF, defined as LVEF <40%, and heart failure with preserved ejection fraction (HFPEF), defined as LVEF >50%. Explaining the new category, Professor Ponikowski said there were currently no evidence-based treatments for patients with a LVEF of 40% or above. “Many patients fall into the mid-range category and this should stimulate research into novel therapies,” he added.
Other changes in the new guidelines include:
- Cardiac resynchronisation therapy (CRT) is now contraindicated in patients with a QRS duration of <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.
- The concept of ‘time is muscle’ in acute heart failure is included for the first time and demands urgent diagnosis and treatment.
- A new algorithm for the diagnosis of heart failure in the non-acute setting 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.”
- Adaptive servo-ventilation (ASV) is not recommended in patients with HFREF and central sleep apnoea after mortality increased in the SERVE-HF trial. “We took for granted that ASV benefitted these patients. The trial was a big surprise and ASV is now contraindicated in this situation,” said Professor Ponikowski.
- Novel recommendations to prevent or delay the onset of heart failure and prolong life. These include: treatment of hypertension, statins for patients with or at high risk of coronary artery disease, and empagliflozin (a sodium-glucose cotransporter 2 [SGLT2] inhibitor) for patients with type 2 diabetes. Professor Adriaan A Voors, Task Force Co-Chairperson explained: “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.”
Speaking at the launch, Professor Ponikowski concluded: “Heart failure is becoming a preventable and treatable disease. Implementing the guidelines published today will give patients the best chance of a positive outcome”.
1. Ponikowski P, Voors AA, Anker SD, et al. on behalf of authors/task force members. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2016 published online 20 May 2016. http://dx.doi.org/10.1093/eurheartj/ehw128