Sacubitril/Valsartan in Real-Life Practice: Experience in Patients with Advanced Heart Failure and Systematic Review.

PURPOSE: Sacubitril/valsartan reduced heart failure (HF) admissions and cardiovascular mortality in the PARADIGM-HF trial. However, real-life studies are scarce comparing daily practice patients with those of the trial. The aim of our study was to analyze the efficacy and safety of the drug in an advanced heart failure cohort and to review systematically the previous real-life studies published to date. METHODS: We performed a retrospective analysis of consecutive patients prescribed sacubitril/valsartan in a single tertiary HF clinic between September 2016 and February 2018. HF admissions before and after the initiation of the drug were assessed in a paired fashion. A systematic review of real-life studies published to date was also conducted. RESULTS: Sacubitril/valsartan was started in 108 patients who were in a more advanced NYHA class and more frequently treated with mineral receptor antagonists, internal cardiac defibrillator, and cardiac resynchronization therapy than in the PARADIGM-HF trial. After a 6-month follow-up, we observed a significant reduction in the HF hospitalizations, median levels of NT-proBNP, and need for levosimendan ambulatory perfusion. Likewise, we found a significant improvement in mean LVEF and end diastolic left ventricle diameter. Regarding safety, sacubitril/valsartan was well-tolerated without any severe adverse effect. CONCLUSION: Sacubitril/valsartan in real-life is prescribed to a more advanced HF population, which could be responsible for the difficulties in reaching high doses of the drug. However, after a 6-month follow-up, sacubitril/valsartan significantly reduces HF hospitalization and induces cardiac reverse remodeling, without remarkable adverse events.

A Simple Score to Identify Super-Responders to Sacubitril/Valsartan in Ambulatory Patients With Heart Failure.

INTRODUCTION: Sacubitril/valsartan (SV) promotes cardiac remodeling and improves prognosis in patients with heart failure (HF). However, the response to the drug may vary between patients and its implementation in daily clinical practice has been slower than expected. Our objective was to develop a score predicting the super-response to SV in HF outpatients. METHODS: This is a retrospective analysis of 185 consecutive patients prescribed SV from two tertiary hospitals between September 2016 and February 2018. Super-responder was defined as a patient taking the drug and (i) without HF admissions, death, or heart transplant, and (ii) with a ≥50% reduction in NT-proBNP levels and/or an increase of ≥10 points in LVEF in a 12-month follow-up period after starting SV. Clinical, echocardiographic, ECG, and biochemical variables were used in a logistic regression analysis to construct a score for super-response to SV which was internally validated using bootstrap method. RESULTS: Out of 185 patients, 65 (35%) fulfilled the super-responder criteria. Predictors for super-response to SV were absence of both previous aldosterone antagonist and diuretic treatment, NYHA I-II class, female gender, previous 1-year HF admission, and sinus rhythm. An integrating score distinguished a low- (<25%), intermediate- (∼46%), and high-probability (>80%) for 1-year super-response to SV. The AUC for the model was 0.72 (95%CI: 0.64-0.80), remaining consistent after internal validation. CONCLUSION: One-third of our patients presented a super-response to SV. We propose an easy-to-calculate score to predict super-response to SV after 1-year initiation based on variables that are currently assessed in clinical practice.

Prevalencia e implicaciones pronósticas de los trastornos del sueño en la insuficiencia cardiaca crónica / Prevalence and prognostic implications of sleep disorders in patients with chronic heart failure

Objetivos. Evaluar la prevalencia e implicaciones pronosticas de los trastornos del sueño en pacientes con insuficiencia cardiaca crónica atendidos en una unidad de Insuficiencia Cardiaca hospitalaria. Método. Se realizó un estudio observacional, descriptivo y prospectivo. Ámbito: Unidad de Insuficiencia Cardiaca del Hospital de la Santa Creu i Sant Pau. Participantes: pacientes atendidos por primera vez en la Unidad entre abril de 2014 y noviembre de 2014. Variables: se realizó una evaluación de los trastornos del sueño mediante el cuestionario Insomnia Severity Index8,9 modificado. Se obtuvieron datos sociodemográficos, clínicos y farmacológicos de la historia clínica del paciente. Se evaluó la aparición de eventos adversos en el seguimiento (hospitalización por insuficiencia cardiaca o muerte de causa cardiovascular). Análisis: las variables cualitativas se describieron en forma de porcentajes y las cuantitativas en forma de media y desviaciones estándares. Resultados. La muestra total fue de 68 pacientes con una media de edad de 68 ± 12 años; un 59 % de los pacientes fueron varones. La etiología de la insuficiencia cardiaca fue en un 37 % de causa no isquémica, en un 40 % de causa isquémica, en el 10 % valvular y en un 13 % de otras etiologías. Los trastornos del sueño estaban presentes en el 48.5 % del total de la muestra (33 pacientes). Los pacientes con trastornos del sueño presentaron mayor incidencia de efectos adversos cardiovasculares en el seguimiento (21 % frente a 0 %; p < 0.05). Conclusiones. La prevalencia de los trastornos del sueño es alta en pacientes con insuficiencia cardiaca y se asocia a un peor pronóstico clínico (AU)

Objectives. To evaluate the prevalence and prognostic implications of sleep disorders in patients with chronic heart failure treated in a hospital’s Heart Failure Unit. Method. An observational, descriptive and prospective study. The study was carried out in Hospital de la Santa Creu i Sant Pau Heart Failure Unit, Barcelona. Participants consisted of patients arriving to the Unit for the first time between April and November 2014. An assessment of sleeping disorders was performed using the modified questionnaire Insomnia Severity Index8,9. Patient’s sociodemographic, clinical and pharmacological data was obtained from their medical history. Adverse events during follow-up, (hospitalization due to heart failure and/or cardiovascular death), were assessed. In the analysis, qualitative variables were described as percentages and quantitative variables as mean and standard deviations. Results. The total sample consisted of 68 patients with a mean age of 68 ± 12 years. 59 % of patients were male. The etiological cause of heart failure was: in 37 % of the cases non-ischemic, 40 % ischemic, 10 % valvular and 13 % presented other etiologies. Sleep disorders were present in 48.5 % of the total sample (33 patients). Patients with sleep disorders had a higher incidence of cardiovascular adverse effects during the follow-up: 21 % vs 0 %; p <0.05. Conclusions. The prevalence of sleep disorders is high in patients with heart failure and is associated with a worse clinical prognosis (AU)