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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 - 07/12/23

Doi : 10.1016/j.ahj.2023.11.008 
Gianluigi Savarese, MD PhD a, b, #, , Paolo Gatti, MD a, #, Lina Benson, MSc a, Marianna Adamo, MD c, Ovidiu Chioncel, MD d, Maria G. Crespo-Leiro, MD PhD e, Stefan D. Anker, MD PhD f, Andrew J.S. Coats, MD PhD g, Gerasimos Filippatos, MD PhD h, Mitja Lainscak, MD PhD i, Theresa McDonagh, MD PhD j, Alexandre Mebazaa, MD PhD k, l, Marco Metra, MD PhD c, Massimo F. Piepoli, MD PhD m, Giuseppe M.C. Rosano, MD PhD n, Frank Ruschitzka, MD PhD o, Petar Seferovic, MD PhD p, Maurizio Volterrani, MD PhD q, Aldo P. Maggioni, MD PhD r, Lars H. Lund, MD PhD a, b
a Division of Cardiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden 
b Heart and Vascular and Neuro Theme, Karolinska University Hospital, Stockholm, Sweden 
c Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Italy 
d Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', University of Medicine Carol Davila, Bucharest, Romania 
e Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Complexo Hospitalario Universitario A Coruna, CHUAC, INIBIC, UDC, CIBERCV, La Coruna, Spain 
f Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany 
g Heart Research Institute, Sydney, Australia 
h Heart Failure Unit, Department of Cardiology, University Hospital Attikon, National and Kapodistrian Univeristy of Athens, Athens, Greece 
i Division of Cardiology, Murska Sobota, Murska Sobota and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia 
j King's College Hospital, London, UK 
k UMR 942 Inserm – MASCOT; University of Paris, Paris, France 
l Department of Anesthesia-Burn-Critical Care, APHP Saint Louis Lariboisière University Hospitals, Paris, France 
m Clinical Cardiology, IRCCS Policlinico San Donato, University of Milan, Milan, Italy 
n IRCCS San Raffaele Cassino, Cassino, Italy 
o University Hospital, Clinic of Cardiology, Zürich, Switzerland 
p University of Belgrade Faculty of Medicine, Belgrade, Serbia 
q IRCCS San Raffaele Pisana, Rome, Italy 
r ANMCO Research Center, He 1 art Care Foundation, Firenze, Italy 

⁎⁎Reprint requests: Gianluigi Savarese, MD, PhD Division of Cardiology, Department of Medicine Karolinska Institutet Norrbacka S3:00, 171 76 Stockholm, Sweden.Division of CardiologyDepartment of Medicine Karolinska InstitutetNorrbacka S1:02Stockholm171 76Sweden

ABSTRACT

Aims

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.

Methods and results

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.

Conclusions

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.

Il testo completo di questo articolo è disponibile in PDF.

Graphical abstract

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).



Image, graphical abstract

Il testo completo di questo articolo è disponibile in PDF.

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© 2023  The Author(s). Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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