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.

Outcomes of a multidisciplinary mechanical circulatory support network in cardiogenic shock in a centre without heart transplant program: A successful interprofessional coordination model.

BACKGROUND AND OBJECTIVE: Cardiogenic shock (CS) mortality remains very high and mechanical circulatory support (MCS) may provide an effective alternative of treatment in selected patients. The aim of this study is to analyse the results of a multidisciplinary team care program (including anaesthesiologists, cardiologists, cardiothoracic surgeons, and intensivists) in CS patients who required MCS, in a tertiary centre without a heart transplant (HT) program. METHODS: Prospective observational study that sought to analyse the characteristics and survival to discharge predictors in a consecutive CS patients cohort treated with MCS. RESULTS: A total of 48 patients were included. Mean age was 61 ± 14 years. Before MCS, 45.8% of the patients presented with cardiac arrest. A 54.2% 30-day survival and 45.8% overall survival to discharge, was found. Age and vasoactive-inotropic score were independent predictors of mortality. CONCLUSIONS: A multidisciplinary team-care based MCS program in CS patients is feasible and may achieve favourable results in a centre without HT program.

Impact of Diabetes Mellitus and Frailty on Long-Term Outcomes in Elderly Patients with Acute Coronary Syndromes.

OBJECTIVES: Diabetes mellitus (DM) and frailty are common in older patients with acute coronary syndromes (ACS). No data exists about its prognostic impact on long-term outcomes and their possible interaction in this setting. DESIGN: Observational prospective study. SETTING: Multicenter registry conducted in 44 hospitals in Spain. PARTICIPANTS: Consecutive patients with ACS aged 80≥years. MEASUREMENTS: A comprehensive geriatric evaluation was performed during hospitalization, including frailty assessment by the FRAIL score. The impact of DM and frailty on the incidence of mortality/readmission at 24 months was analysed by a Cox regression model. RESULTS: A total of 498 patients were included (mean age 84.3 years). Prevalence of previous DM was 199/498 (40.0%). The rate of frail patients was 135/498 (27.1%). The incidence of mortality/readmission was higher frail patients (HR 2.49) (both p<0.001). In contrast, DM was not significantly associated to a higher rate of outcomes (HR 1.23, p=0.060) in the whole cohort. Among non-frail patients, patients with DM had a similar incidence of mortality or readmission (p=0.959). In contrast, among frail patients, DM was significantly associated with a higher incidence of events (HR 1.51, p=0.034). CONCLUSIONS: Unlike frailty status, DM was not associated to poorer long-term outcome in elderly patients with ACS. Among frail patients the presence of DM seems to provide additional prognostic information.