Savarese Gianluigi, Gatti Paolo, Benson Lina, Adamo Marianna, Chioncel Ovidiu, Crespo-Leiro Maria G, Anker Stefan D, Coats Andrew J S, Filippatos Gerasimos, Lainscak Mitja, McDonagh Theresa, Mebazaa Alexandre, Metra Marco, Piepoli Massimo F, Rosano Giuseppe M C, Ruschitzka Frank, Seferovic Petar, Volterrani Maurizio, Maggioni Aldo P, Lund Lars H
Division of Cardiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden; Heart and Vascular and Neuro Theme, Karolinska University Hospital, Stockholm, Sweden.
Division of Cardiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Am Heart J. 2024 Jan;267:52-61. doi: 10.1016/j.ahj.2023.11.008. Epub 2023 Nov 15.
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.
旨在评估：（1）当射血分数（EF）=40%被视为射血分数降低的心衰（HFrEF）时，从轻度降低射血分数的心衰（HFmrEF）重新分类为射血分数降低的心衰（HFrEF）的患者情况；（2）EF数字偏差的作用，即EF报告倾向于以5%的增量递增；（3）在一个大型跨国心衰注册研究中，与缺失和有偏差的EF报告相关的结局。
在欧洲心脏病学会（ESC）心衰长期注册研究的25154例患者中，17%的患者EF值缺失，在有可用EF值的患者中，根据2016年ESC指南分类，24%为射血分数保留的心衰（HFpEF，EF≥50%），21%为轻度降低射血分数的心衰（HFmrEF，40%-49%），55%为射血分数降低的心衰（HFrEF，<40%）。7%的患者EF“恰好”为40%，在应用2021年ESC指南分类时，这导致将34%被定义为EF=40%至49%的HFmrEF人群重新分类为HFrEF（14%的患者HFmrEF时EF为41%至49%，62%的患者HFrEF时EF≤40%）。约37%的人群EF报告值以数字结尾为0或5。这种潜在的数字偏差与其他特征的更多缺失值以及全因死亡和心衰住院的更高风险相关。与有记录EF值的患者相比，EF值缺失的患者全因和心血管死亡率以及心衰住院风险更高。
许多患者报告EF=40%。这导致EF从旧的HFmrEF（40%-49%）大幅重新分类为新的HFrEF（≤40%）。EF报告中存在相当大的数字偏差以及EF报告缺失，这似乎并非随机发生，可能反映了整体护理不够严格以及结局更差。
