Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure.

AIMS: Hypertonic saline solution (HSS) plus intravenous (IV) loop diuretic appears to enhance the diuretic response in patients hospitalized for heart failure (HF). The efficacy and safety of this therapy in the ambulatory setting have not been evaluated. We aimed to describe the design and baseline characteristics of the SALT-HF trial participants. METHODS AND RESULTS: 'Efficacy of Saline Hypertonic Therapy in Ambulatory Patients with HF' (SALT-HF) trial was a multicenter, double-blinded, and randomized study involving ambulatory patients who experienced worsening heart failure (WHF) without criteria for hospitalization. Enrolled patients had to present at least two signs of volume overload, use ≥ 80 mg of oral furosemide daily, and have elevated natriuretic peptides. Patients were randomized 1:1 to treatment with a 1-h infusion of IV furosemide plus HSS (2.6-3.4% NaCl depending on plasmatic sodium levels) versus a 1-h infusion of IV furosemide at the same dose (125-250 mg, depending on basal loop diuretic dose). Clinical, laboratory, and imaging parameters were collected at baseline and after 7 days, and a telephone visit was planned after 30 days. The primary endpoint was 3-h diuresis after treatment started. Secondary endpoints included (a) 7-day changes in congestion data, (b) 7-day changes in kidney function and electrolytes, (c) 30-day clinical events (need of IV diuretic, HF hospitalization, cardiovascular mortality, all-cause mortality or HF-hospitalization). RESULTS: A total of 167 participants [median age, 81 years; interquartile range (IQR), 73-87, 30.5% females] were randomized across 13 sites between December 2020 and March 2023. Half of the participants (n = 82) had an ejection fraction >50%. Most patients showed a high burden of comorbidities, with a median Charlson index of 3 (IQR: 2-4). Common co-morbidities included diabetes mellitus (41%, n = 69), atrial fibrillation (80%, n = 134), and chronic kidney disease (64%, n = 107). Patients exhibited a poor functional NYHA class (69% presenting NYHA III) and several signs of congestion. The mean composite congestion score was 4.3 (standard deviation: 1.7). Ninety per cent of the patients (n = 151) presented oedema and jugular engorgement, and 71% (n = 118) showed lung B lines assessed by ultrasound. Median inferior vena cava diameter was 23 mm, (IQR: 21-25), and plasmatic levels of N-terminal-pro-B-type natriuretic peptide (NTproBNP) and antigen carbohydrate 125 (CA125) were increased (median NT-proBNP 4969 pg/mL, IQR: 2508-9328; median CA125 46 U/L, IQR: 20-114). CONCLUSIONS: SALT-HF trial randomized 167 ambulatory patients with WHF and will determine whether an infusion of hypertonic saline therapy plus furosemide increases diuresis and improves decongestion compared to equivalent furosemide administration alone.

Papel del Doppler de la vena femoral en pacientes con insuficiencia cardiaca aguda: resultados de un estudio multicéntrico prospectivo / Role of the femoral vein doppler in acute heart failure patients: results from a prospective multicentric study

Antecedentes y objetivo El objetivo de nuestro estudio es definir el papel de la ecografía Doppler pulsada (PW-Doppler) de la vena femoral común en la evaluación de la dilatación de la vena cava inferior (VCI), la probabilidad de hipertensión pulmonar, la insuficiencia tricuspídea y la excursión sistólica del plano anular tricuspídeo (TAPSE). Métodos Se trata de un estudio prospectivo en dos hospitales en 74 pacientes ingresados con insuficiencia cardiaca aguda. Se realizó ecografía PW-Doppler de vena femoral común, ecocardiografía y evaluación de la VCI en el momento del ingreso, así como PW-Doppler y ecografía de VCI al alta hospitalaria. Resultados La detección de un flujo pulsátil (138 exploraciones) tuvo una curva ROC excelente para la detección de VCI mayor de 2cm (AUC 0,931, Sn95%, Sp 90%, VPP 93%, VPN 94%) con una odds ratio (OR) de 211,2 (intervalo de confianza del 95% 48,13-926,72). La pulsatilidad del flujo también tuvo el mayor rendimiento en la detección de la hipertensión pulmonar (AUC 0,8, Sn 95%, Sp 64%, VPP 84%, VPN 84%) y en la detección de la insuficiencia tricuspídea moderada-grave (AUC 0,79, Sn 95%, Sp 67%, VPP 88%, VPN 78%). Si el flujo es continuo, podemos descartar razonablemente una disminución del TAPSE (VPN 89%). Conclusión La detección del flujo PW-Doppler de vena femoral común puede ser una ventana alternativa para la detección de una dilatación de la VCI de 2cm, TR significativa y la probabilidad de hipertensión pulmonar elevada en la insuficiencia cardiaca aguda. También permite descartar razonablemente la disfunción del ventrículo derecho en casos de normalidad en estos pacientes (AU)

Background and objective The aim of our study is to define the role of Pulsed-Doppler (PW-Doppler) Ultrasound of the common femoral vein in the assessment of dilatation Inferior Vena Cava (IVC), probability of Pulmonary Hypertension (PH), Tricuspid Regurgitation (TR), and Tricuspid annular plane systolic excursion (TAPSE). Methods This is a prospective two-hospital study in 74 patients admitted with acute heart failure (AHF). We performed PW-Doppler ultrasound of the common femoral vein, Point of Care cardiac ultrasonography and assessment of the IVC at the time of admission, as well as PW-Doppler and ultrasound of the IVC at hospital discharge. Results The detection of a pulsatile flow (138 scans) had an excellent ROC curve for the detection of IVC greater than 2cm (AUC 0.931, Sn 95%, Sp 90%, PPV 93%, NPV 94%) with an Odds Ratio (OR) of 211.2 (95% confidence interval 48.13-926.72). The pulsatility of the flow also had the highest performance in the detection of PH (AUC 0.8, Sn 95%, Sp 64%, PPV 84%, NPV 84%) and in the detection of moderate-severe TR (AUC 0.79, Sn 95%, Sp 67%, PPV 88%, NPV 78%). If the flow is continuous, we can reasonably rule out diminished TAPSE (NPV 89%). Conclussion Detection of PW-Doppler flow of the common femoral vein may be an alternative window for the detection of an IVC dilation of 2cm, significant TR, and the likelihood of high PH in acute heart failure. It also allows us to reasonably rule out dysfunction of the right ventricle in cases of normality in these patients (AU)

Role of the femoral vein doppler in acute heart failure patients: results from a prospective multicentric study.

BACKGROUND AND OBJECTIVE: The aim of our study is to define the role of Pulsed-Doppler (PW-Doppler) Ultrasound of the Common Femoral Vein (CFV) in the assessment of dilatation Inferior Vena Cava (IVC), probability of Pulmonary Hypertension (PH), Tricuspid Regurgitation (TR), and Tricuspid annular plane systolic excursion (TAPSE). METHODS: This is a prospective two-hospital study in 74 patients admitted with acute heart failure (AHF). We performed PW-Doppler ultrasound of the common femoral vein, Point of Care (POC) cardiac ultrasonography and assessment of the IVC at the time of admission, as well as PW-Doppler and ultrasound of the IVC at hospital discharge. RESULTS: The detection of a pulsatile flow (138 scans) had an excellent ROC curve for the detection of IVC greater than 2cm (AUC 0.931, Sn 95%, Sp 90%, PPV 93%, NPV 94%) with an Odds Ratio (OR) of 211.2 (95% confidence interval 48.13-926.72). The pulsatility of the flow also had the highest performance in the detection of PH (AUC 0.8, Sn 95%, Sp 64%, PPV 84%, NPV 84%) and in the detection of moderate-severe TR (AUC 0.79, Sn 95%, Sp 67%, PPV 88%, NPV 78%). If the flow is continuous, we can reasonably rule out diminished TAPSE (NPV 89%). CONCLUSSION: Detection of PW-Doppler flow of the CFV may be an alternative window for the detection of an IVC dilation of 2cm, significant TR, and the likelihood of high PH in acute heart failure. It also allows us to reasonably rule out dysfunction of the right ventricle in cases of normality in these patients.

Miocarditis y miocardiopatía inflamatoria confirmadas por biopsia endomiocárdica: perfil clínico y pronóstico / Endomyocardial biopsy-confirmed myocarditis and inflammatory cardiomyopathy: clinical profile and prognosis

Introducción y objetivos La biopsia endomiocárdica (BEM) es la única técnica capaz de establecer el diagnóstico etiológico de pacientes con miocarditis o miocardiopatía inflamatoria (MI). El objetivo de este estudio es conocer el perfil clínico, la evolución y los factores pronósticos de los pacientes con sospecha de miocarditis o MI sometidos a BEM. Métodos Se analizaron retrospectivamente las características clínicas, los hallazgos histológicos y la evolución de todos los pacientes con sospecha de miocarditis o MI sometidos a BEM entre 1997 y 2019 en un hospital terciario español. Se evaluó el rendimiento del diagnóstico histológico mediante los criterios de Dallas frente a los criterios inmunohistoquímicos (IHQ). Resultados Se realizó BEM a 99 pacientes (el 67% varones; edad, 42± 15 años; fracción de eyección media, 34±14%). El 28% presentaba miocarditis o MI confirmada por criterios de Dallas y el 54% aplicando los criterios IHQ (p <0,1). Se diagnosticaron 47 miocarditis linfocitarias, 6 miocarditis eosinofílicas, 3 sarcoidosis y 1 miocarditis de células gigantes. Tras una mediana de seguimiento de 18 meses, 23 pacientes (23%) precisaron trasplante cardiaco o asistencia ventricular o fallecieron. El 21% de los pacientes con miocarditis confirmada mediante IHQ precisó trasplante cardiaco o asistencia o falleció, frente al 7% de aquellos sin inflamación (p=0,056). La fracción de eyección ≤ 30%, un diámetro telediastólico del ventrículo izquierdo ≥60mm y una clase NYHA III-IV iniciales se asociaron con peor pronóstico, especialmente en presencia de inflamación. Conclusiones La BEM permite establecer un diagnóstico etiológico en más de la mitad de los casos de sospecha de miocarditis o MI cuando se emplean técnicas IHQ. La inflamación confirmada por IHQ añade valor pronóstico y permite identificar a los pacientes con mayor probabilidad de sufrir complicaciones (AU)

Introduction and objectives Endomyocardial biopsy (EMB) is the only technique able to establish an etiological diagnosis of myocarditis or inflammatory cardiomyopathy (ICM). The aim of this study was to analyze the clinical profile, outcomes, and prognostic factors of patients with suspected myocarditis/ICM undergoing EMB. Methods We retrospectively analyzed the clinical characteristics, histological findings, and follow-up data of all patients with suspected myocarditis or ICM who underwent EMB between 1997 and 2019 in a Spanish tertiary hospital. The diagnostic yield was compared using the Dallas criteria vs immunohistochemical criteria (IHC). Results A total of 99 patients underwent EMB (67% male; mean age, 42±15 years; mean left ventricular ejection fraction [LVEF], 34%±14%). Myocarditis or ICM was confirmed in 28% with application of the Dallas criteria and in 54% with the IHC criteria (P <.01). Lymphocytic myocarditis was diagnosed in 47 patients, eosinophilic myocarditis in 6, sarcoidosis in 3, and giant cell myocarditis in 1 patient. After a median follow-up of 18 months, 23 patients (23%) required heart transplant (HTx), a left ventricular assist device (LVAD), and/or died. Among the patients with IHC-confirmed myocarditis, 21% required HTx/LVAD or died vs 7% of those without inflammation (P=.056). The factors associated with a worse prognosis were baseline LVEF ≤ 30%, left ventricular end-diastolic diameter ≥ 60mm, and NYHA III-IV, especially in the presence of inflammation. Conclusions EMB allows an etiological diagnosis in more than half of patients with suspected myocarditis/ICM when IHC techniques are used. IHC-confirmed inflammation adds prognostic value and helps to identify patients with a higher probability of developing complications (AU)

Diferencias de género en la titulación de fármacos de pacientes con insuficiencia cardiaca y fracción de eyección reducida del ensayo ETIFIC / Gender differences in drug titration among heart failure patients with reduced ejection fraction in the ETIFIC trial

Introducción y objetivos El tratamiento óptimo disminuye la mortalidad y hospitalizaciones por insuficiencia cardiaca (IC) en pacientes con IC y fracción de eyección reducida. En los ensayos clínicos las mujeres estuvieron infrarrepresentadas y no fueron evaluadas específicamente. Este estudio buscó comparar la seguridad y efectividad de titulación (ajuste de dosis) de fármacos en mujeres y varones. Métodos Estudio post hoc de género del ensayo aleatorizado multicéntrico ETIFIC. Se incluyeron pacientes hospitalizados con IC de novo y fracción de eyección reducida. Proceso estructurado de titulación en unidades de IC. Objetivo principal: la dosis relativa media de bloqueadores beta (% de la dosis objetivo) alcanzada por mujeres frente a varones. Objetivos secundarios: dosis relativas medias de otros fármacos de IC, eventos adversos y resultados clínicos a 6 meses. Resultados Se incluyeron 320 pacientes, 83 (25,93%) mujeres y 237 (74,06%) varones. (76 frente a 213 analizados). Media±desviación estándar de dosis relativa de bloqueadores beta mujeres frente a varones: 62,08±30,72% frente a 64,4±32,77%; diferencia −2,32%; IC95%, −10,58-5,94; p=0,580, antagonistas del receptor de mineralocorticoides 79,85±27,72% comparado con 67,29±31,43%; p=0,003, sin diferencias significativas en dosificación de otros fármacos. El análisis multivariante no encontró diferencias significativas. Mortalidad cardiovascular 1 (1,20%) frente a 3 (1,26%), p=1 y 0 hospitalizaciones por IC (0,00%) frente a 10 (4,22%), p=0,125. Conclusiones En un análisis post hoc del ensayo ETIFIC de titulación en IC no encontramos diferencias de género significativas en dosificación, mortalidad cardiovascular y hospitalizaciones por IC (AU)

Introduction and objectives Optimal medical therapy decreases mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. Women have been underrepresented in clinical trials and not specifically evaluated. This study aimed to compare the safety and effectiveness of drug titration in women vs men. Methods This post hoc gender study of the ETIFIC multicenter randomized trial included hospitalized patients with new-onset HF with reduced ejection fraction and New York Heart Association II-III and no contraindications to beta-blockers. A structured 4-month titration process was implemented in HF clinics. The primary endpoint was the mean relative dose (% of target dose) of beta-blockers achieved by women vs men. Secondary endpoints included the mean relative doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists, adverse events, and other clinical outcomes at 6 months. Results A total of 320 patients were included, 83 (25.93%) women and 237 (74.06%) men (76 vs 213 analyzed). The mean±standard deviation of the relative doses achieved by women vs men were as follows: beta-blockers 62.08%±30.72% vs 64.4%±32.77%, with a difference of−2.32% (95%CI,−10.58-5.94), P = .580; and mineralocorticoid receptor antagonists 79.85%±27.72% vs 67.29%±31.43%, P =.003. No other differences in drug dosage were found. Multivariate analysis showed nonsignificant differences. CV mortality was 1 (1.20%) vs 3 (1.26%), P=1, and HF hospitalizations 0 (0.00%) vs 10 (4.22%), P=.125. Conclusions In a post hoc analysis from the HF-titration ETIFIC trial, we found nonsignificant gender differences in drug dosage, cardiovascular mortality, and HF hospitalizations (AU)