Impact of Sacubitril/Valsartan on Clinical and Echocardiographic Parameters in Heart Failure Patients With Reduced Ejection Fraction: Data From a Real Life 2-year Follow-Up Study

Abstract

Heart failure (HF) represents a widespread health problem characterized by high morbidity and mortality. Sacubitril/Valsartan (sac/val) has improved clinical prognosis in patients affected by HF with reduced ejection fraction (HFrEF). The aim of this study was to evaluate the effectiveness and durability of sac/val treatment on the clinical, hemodynamic and echocardiographic parameters, in real-life consecutive HFrEF outpatients, evaluated up to 2-years of follow-up. We collected 300 repeated observations over time in 60 patients suffering of HFrEF and symptomatic despite optimal drug therapy. Patients with left ventricular ejection fraction (LVEF) <35 and II-III NYHA functional class were considered. All patients underwent to clinical-instrumental and laboratory determinations and Minnesota Living with HF Questionnaire (MLHFQ) every 6 months until 24 months to evaluate possible clinical benefits and adverse events. During a 2-year follow-up period and through a 6-monthly control of the study variables both clinical, hemodynamic, biochemical and echocardiographic parameters significantly improved, in particular cardiac index (CI), both atrial and ventricular volumes and global longitudinal strain (GLS). Furthermore, there was a reduction of NT-proBNP levels and betterment of renal function and NYHA functional class, demonstrating the efficacy and durability of sac/val treatment. In a multiple linear mixed model the longitudinal evolutions of CI were associated to concomitant changes of GLS and E/e’ ratio. Our study, contemplating the collection of 300 repeated observations in 60 patients, provides a complete and detailed demonstration of sac/val effects, showing effectiveness, safety and effect durability of the treatment every 6 months up to 2-years of follow-up with significant improvement of several clinical, hemodynamic and echocardiographic parameters in HFrEF outpatients.

Long Term Metabolic Effects of Sacubitril/Valsartan in Non-Diabetic and Diabetic Patients With Heart Failure Reduced Ejection Fraction: A Real Life Study

“…In this longitudinal-observational, single-center study, considering 90 HFrEF patients with optimal medical therapy but still symptomatic, sac/val treatment demonstrated efficacy, safety and durability every 6 months up to 30 months of follow-up, with an important improvement in clinical and echocardiographic parameters confirming previous evidence ( Armentaro et al, 2021 ). Notably, sac/val showed also a significant betterment in renal function, glycometabolic state and insulin sensitivity parameters and this effect was particularly noticeable in T2DM patients who represented about 67% of the entire population.…”

“…A secondary analysis of the PARADIGM-HF trial has shown a beneficial effects of sac/val on renal function with patients treated with sac/val exhibiting lower decline in renal function than those treated with enalapril, an improvement that was more pronounced in diabetic patients compared to non-diabetics ( Packer et al, 2018 ). Accordingly, a 24-month follow-up real-life study has demonstrated the efficacy and durability of sac/val treatment in patients with HFrEF not only in terms of clinical, haemodynamic and echocardiographic parameters but also regarding the renal function ( Armentaro et al, 2021 ). Data on the improvement of metabolic parameters with sac/val treatment, in particular in diabetic patients, derive mainly from post-hoc analysis of the large clinical trials.…”

Haemodynamic Effects of Sacubitril/Valsartan Initiation in Outpatients with Chronic Heart Failure

“…In addition, we observed a significant reduction of sPAP after start of S/V therapy. A similar finding was reported from other observational studies [ 6 , 35 , 37 , 39 , 40 ].…”

“…Thus, results may not be transferable to patients with stable chronic HFrEF. A recent observational study of 60 outpatients with HFrEF reported a significant increase in cardiac index as determined by echocardiography after up to 2 years of S/V treatment [ 40 ]. However, as the first follow-up assessment of cardiac index was performed 6 months after therapy initiation, the study does not provide any data on short-term haemodynamic effects of S/V.…”

Effects of sacubitril/valsartan on both metabolic parameters and insulin resistance in prediabetic non-obese patients with heart failure and reduced ejection fraction

“…According to previous studies ( 37 – 40 ), in our patients, we also observed that treatment with sac/val significantly improve left ventricular (LV) remodeling and function parameters. Sac/val treatment was associated with a reduction in LAV and end-systolic and end-diastolic LV volumes; together with this, also diastolic function parameters were improved, with an E/A ratio increase and E/e′ reduction, thus showing a lowering of intraventricular filling pressure.…”