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.

Prevalence and prognostic impact of subclinical pulmonary congestion at discharge in patients with acute heart failure.

AIMS: Residual pulmonary congestion at hospital discharge can worsen the outcomes in patients with heart failure (HF) and can be detected by lung ultrasound (LUS). The aim of this study was to analyse the prevalence of subclinical pulmonary congestion at discharge and its impact on prognosis in patients admitted for acute HF. METHODS AND RESULTS: This is a post-hoc analysis of the LUS-HF trial. LUS was performed by the investigators in eight chest zones with a pocket device. Physical exam was subsequently performed by the treating physicians. Primary outcome was a combined endpoint of rehospitalization, unexpected visit for HF worsening or death at 6- month follow-up. Subclinical pulmonary congestion at discharge was defined as the presence of ≥5 B-lines in LUS in absence of rales in the auscultation employing the area under the ROC curve. At discharge, 100 patients (81%) did not show clinical signs of pulmonary congestion. Of these, 41 had ≥5 B-lines. Independent factors related with the presence of subclinical pulmonary congestion were anaemia, higher New York Heart Association (NYHA) class, and N terminal pro brain natriuretic peptide (NT-proBNP). After adjusting by propensity score analysis including age, renal insufficiency, atrial fibrillation, NYHA class, NT-proBNP levels, clinical congestion, and the trial intervention, the presence of subclinical pulmonary congestion at discharge was a risk factor for the occurrence of the primary outcome (hazard ratio 2.63; 95% confidence interval: 1.08-6.41; P = 0.033). CONCLUSIONS: Up to 40% of patients considered 'dry' according to pulmonary auscultation presents subclinical congestion at hospital discharge that can be detected by LUS and implies a worse prognosis at 6- month follow-up. Comorbidities, high values of natriuretic peptides, and higher NYHA class are the factors related with its presence.

Lung ultrasound-guided treatment in ambulatory patients with heart failure: a randomized controlled clinical trial (LUS-HF study).

AIMS: Lung ultrasound (LUS) is a useful tool with which to assess subclinical pulmonary congestion and to stratify the prognosis of patients with heart failure (HF). The aim of this study was to evaluate whether an LUS-guided follow-up protocol improves the outcomes of patients with HF. METHODS AND RESULTS: In this single-blind clinical trial, 123 patients admitted for HF were randomized to either a standard follow-up (n = 62, control group) or a LUS-guided follow-up (n = 61, LUS group). The primary endpoint was a composite of urgent visit, hospitalization for worsening HF and death during follow-up. Visits were scheduled at 14, 30, 90 and 180 days after discharge. Treating physicians were encouraged to modify diuretic therapy in accordance with the number of B-lines recorded by LUS. The mean ± standard deviation (SD) age of the patients was 69 ± 12 years and 72% were male. The mean ± SD left ventricular ejection fraction was 39 ± 14%. The hazard ratio for the primary outcome in the LUS group was 0.518 [95% confidence interval (CI) 0.268-0.998; P = 0.049], mainly resulting from a decrease in the number of urgent visits for worsening HF. The number of patients needed to treat to avoid an event was 5 (95% CI 3-62). Other secondary endpoints such as N-terminal pro-B-type natriuretic peptide reduction were not achieved. The safety parameters were similar in the two groups. Patients in the LUS group received more loop diuretics [51 (91%) vs. 42 (75%); P = 0.02] and showed an improvement in the distance achieved in the 6-min walking test [60 m (interquartile range: 29-125 m) vs. 37 m (interquartile range: 5-70 m); P = 0.023]. CONCLUSIONS: Tailored LUS-guided diuretic treatment of pulmonary congestion in this proof-of-concept study reduced the number of decompensations and improved walking capacity in patients with HF. LUS is a non-invasive, safe and easy-to-use technique with potential clinical applicability to guide pulmonary congestion treatment in patients with HF.

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.

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)