Heart failure (HF) societies around the world have agreed on the following new universal definition of HF: “a clinical syndrome with symptoms and/or signs caused by a structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion.”
They have also proposed a revised classification of HF into 4 categories according to left ventricular ejection fraction (LVEF):
- HF with reduced ejection fraction (HFrEF): HF with LVEF ≤40%
- HF with mildly reduced ejection fraction (HFmrEF): HF with LVEF 41–49% (a change from “mid-range” to “mildly reduced”)
- HF with preserved ejection fraction (HFpEF): HF with LVEF ≥50%
- HF with improved ejection fraction (HFimpEF): HF with a baseline LVEF ≤40%, a ≥10 point increase from baseline LVEF, and a second measurement of LVEF >40%
Expanded indication for sacubitril/valsartan
Data from the PARADIGM-HF (NCT01035255) and PARAGON-HF (NCT01920711) trials demonstrated that patients with HFmrEF and HFpEF may still benefit from sacubitril/valsartan. In light of this new evidence, the US Food and Drug Administration expanded the indication for sacubitril/valsartan to “reduce the risk of cardiovascular death and hospitalization for HF in adult patients with chronic HF.” It further noted that the benefits of sacubitril/valsartan are most evident in patients with a “below normal” LVEF, thus avoiding any reference to a specific category of LVEF2. This important change will allow patients who suffer from HF even in the absence of an overt reduction in LVEF to access the drug.
Many specialists feel that the cut-off of 50% LVEF as suggested by some HF guidelines to define a normal LVEF is too low, especially for women (whose LVEF is normally higher than that of men). Echocardiography guidelines define normal LVEF as >55%. Changing the threshold of a below-normal from <50% to <55% will reduce the risk of depriving patients with HF and a LVEF of 50%of potentially life-saving therapies.
Rigid definitions may reduce the proportion of patients who qualify for proven treatments for HF. Instead, adapting nomenclature to reflect clinical realities will facilitate access of patients with HF to potentially life-saving therapies.
Get our free eBook, Cardiology Best Practices, for a comprehensive look at the top position papers, consensus reports and more cardiology news important for daily practice.
Author: Kelly Schoonderwoerd
Original article: Lam and Solomon. JACC June 2021;77(25):3217-25.