European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure have recently been published in the 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.The 2016 guidelines include LCZ696 (Entresto) for this 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 (HFrEF) who met strict inclusion and exclusion criteria.
Professor Piotr Ponikowski, Chairperson of the 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 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.”
The guidance also includes a recommendation for the treatment of iron deficiency with ferric carboxymaltose (Ferinject) in patients with systolic heart failure.
Iron deficiency is a common comorbidity in heart failure associated with a worse prognosis and management of comorbidities is a key component of the holistic care of patients with heart failure. In Europe, one in two patients with congestive heart failure (CHF) has iron deficiency. Many studies have described iron deficiency, with or without anaemia, as an independent risk-factor for mortality, poor exercise capacity and low quality of life.
Per ESC Guidelines heart failure 2016, ferritin and transferrin saturation (TSAT) are included in the recommended diagnostic tests for the initial assessment of a patient with newly diagnosed heart failure. Treatment is recommended when ferritin is <100 µg/L, or ferritin is between 100-299 µg/L and TSAT <20%.
These treatment recommendations are based exclusively on the findings of two double-blind, placebo-controlled clinical trials of ferric carboxymaltose in patients with CHF and iron deficiency - FAIR-HF and CONFIRM-HF. The benefits of ferric carboxymaltose treatment in these studies demonstrated significant improvements in heart failure symptoms, exercise capacity and quality of life.
The ESC Guidelines HF 2016 also mention that treatment of these patients with ferric carboxymaltose for up to 52 weeks also showed reduced hospitalisation rates, based on the results of a meta-analysis.
Theresa McDonagh, Professor of Heart Failure and Consultant Cardiologist, Kings College London, UK, stated: "Iron deficiency is a debilitating condition which can place a huge burden on a patient's day-to-day life. Approximately 1 out of 2 patients with chronic heart failure have iron deficiency, which is a condition associated with impaired functional capacity, reduced quality of life and a greater risk of mortality."
Heart failure is one of the most cost-intensive chronic diseases, therefore, it is important that treatments for iron deficiency are both efficacious and cost-effective. Results from a recent German health-economic analysis of ferric carboxymaltose in patients with CHF and iron deficiency - also presented at the HFA 2016 congress in Florence - showed that, compared with no iron therapy, treatment with ferric carboxymaltose demonstrated a minimal net budget impact. Treatment with ferric carboxymaltose also resulted in improved symptoms and New York Heart Association (NYHA) functional class, and reduced hospitalisation rates, in comparison with no iron therapy.
In addition, a new category of heart failure with mid-range ejection fraction (HFmrEF) has been added for patients with a left ventricular ejection fraction (LVEF) ranging from 40 to 49%. It sits between HFrEF, defined as LVEF less than 40%, and heart failure with preserved ejection fraction (HFpEF), defined as LVEF above 50%.
A new algorithm is also 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.”