Working Paper Article Version 1 This version is not peer-reviewed

Impact of Sacubitril/Valsartan on Indication of Implantable Cardioverter Defibrillator, Left Ventricle Ejection Fraction and Biomarkers: Data From a Real Life Cohort in Heart Failure With Reduced Ejection Fraction

Version 1 : Received: 26 April 2021 / Approved: 5 May 2021 / Online: 5 May 2021 (10:30:13 CEST)

How to cite: Morgado García de Polavieja, J.I.; Sigismondi, A.; Ortiz Cruces, S.; Díaz Fernández, J.F. Impact of Sacubitril/Valsartan on Indication of Implantable Cardioverter Defibrillator, Left Ventricle Ejection Fraction and Biomarkers: Data From a Real Life Cohort in Heart Failure With Reduced Ejection Fraction. Preprints 2021, 2021050029 Morgado García de Polavieja, J.I.; Sigismondi, A.; Ortiz Cruces, S.; Díaz Fernández, J.F. Impact of Sacubitril/Valsartan on Indication of Implantable Cardioverter Defibrillator, Left Ventricle Ejection Fraction and Biomarkers: Data From a Real Life Cohort in Heart Failure With Reduced Ejection Fraction. Preprints 2021, 2021050029

Abstract

Background: our purpose is to assess the effectiveness and safety of sacubitril/valsartan (SV) in “real-world” patients with heart failure and reduced ejection fraction (HFrEF), including a broader spectrum of patients than those in clinical trials and evaluating variables not previously described in the literature. Methods: real-world study in HFrEF patients (N:204), both in and out-patients, who started SV between October 2017 and December 2018. We performed a prospective analysis with a 12-month follow-up. The study outcomes were effectiveness and safety, measured by individual parameters and combined endpoints, comparing the pre and post practice periods. Results: at the end of follow-up, an improvement of left ventricle ejection fraction (LVEF): 29.8% vs 33.7; p<0.0001, a decrease in NT-proBNP levels (3928 pg/mL vs 2902 pg/mL; p=0.012), number of hospital admissions (141 vs 35; p<0.0001) and percentage of patients with implantable cardioverter defibrillator (ICD) indication (79.9% vs 49.5%; p<0.0001) were observed. Of our population, 81.3% met a combined efficacy endpoint (defined by increase of LVEF, reduction of hospital admission or improvement in functional class). No differences were observed in parameters regarding safety. Conclusions: Sacubitril/valsartan has brought about a revolution in the therapeutic management of HFrEF patients and its use may raise questions about what is considered "optimal medical therapy" prior to implantation of cardiac devices.

Keywords

Heart failure with reduced ejection fraction; Real-life practice; Sacubitril/valsartan; Left ventricular ejection fraction recovery; Implantable cardioverter defibrillator

Subject

Medicine and Pharmacology, Immunology and Allergy

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