Journal Article

Left ventricular ejection fraction digit bias and reclassification of heart failure with mildly reduced vs reduced ejection fraction based on the 2021 definition and classification of heart failure

Coats, Andrew J.S., Ruschitzka, Frank, Crespo-Leiro, Maria G., Volterrani, Maurizio, Savarese, Gianluigi, Gatti, Paolo, Lainscak, Mitja, Filippatos, Gerasimos, Anker, Stefan D., Seferovic, Petar, Adamo, Marianna, Lund, Lars H., McDonagh, Theresa, Benson, Lina, Rosano, Giuseppe M.C., Chioncel, Ovidiu, Maggioni, Aldo P., Mebazaa, Alexandre, Piepoli, Massimo F., Metra, Marco

2024

Overview

Aims were to evaluate (1) reclassification of patients from heart failure with mildly reduced (HFmrEF) to reduced (HFrEF) ejection fraction when an EF = 40% was considered as HFrEF, (2) role of EF digit bias, ie, EF reporting favouring 5% increments; (3) outcomes in relation to missing and biased EF reports, in a large multinational HF registry. Of 25,154 patients in the European Society of Cardiology (ESC) HF Long-Term registry, 17% had missing EF and of those with available EF, 24% had HFpEF (EF≥50%), 21% HFmrEF (40%-49%) and 55% HFrEF (<40%) according to the 2016 ESC guidelines´ classification. EF was “exactly” 40% in 7%, leading to reclassifying 34% of the HFmrEF population defined as EF = 40% to 49% to HFrEF when applying the 2021 ESC Guidelines classification (14% had HFmrEF as EF = 41% to 49% and 62% had HFrEF as EF≤40%). EF was reported as a value ending with 0 or 5 in ∼37% of the population. Such potential digit bias was associated with more missing values for other characteristics and higher risk of all-cause death and HF hospitalization. Patients with missing EF had higher risk of all-cause and CV mortality, and HF hospitalization compared to those with recorded EF. Many patients had reported EF = 40%. This led to substantial reclassification of EF from old HFmrEF (40%-49%) to new HFrEF (≤40%). There was considerable digit bias in EF reporting and missing EF reporting, which appeared to occur not at random and may reflect less rigorous overall care and worse outcomes. Graph of heart failure ejection fraction subpopulation prevalence with the percentage of reclassification due to change in definition from 2016 to 2021 with the cumulative incidence of outcomes by ejection fraction subtype and graph of ejection fraction measurement distribution with Kaplan-Meier curves of outcomes by digit bias. Legend: Cardiovascular death (CVD), ejection fraction (EF), heart failure (HF), heart failure with preserved ejection fraction (HFpEF), heart failure with mildly reduced ejection fraction (HFmrEF), heart failure with reduced ejection fraction (HFrEF). [Display omitted]

• Publisher: Elsevier Inc,Elsevier Limited,Elsevier
• Subject: Bias / Body mass index / Cardiology / Cause of Death / Chronic obstructive pulmonary disease / Classification / Congestive heart failure / Ejection fraction / Expected values / Females / Guidelines / Heart Failure / Hospitalization / Humans / Ischemia / Life Sciences / Patients / Prognosis / Reclassification / Stroke Volume / Ventricle / Ventricular Function, Left