Inferior vena cava and lung ultrasound-guided therapy in acute heart failure (CAVAL US-AHF study): a randomized controlled trial

Abstract

Abstract Background The 90-day readmission rate for hospitalized patients with acute heart failure (AHF) ranges from 25% to 30%, mostly due to persistent congestion at discharge. Since the optimal assessment of decongestion has not been clearly defined, there is an opportunity to implement new tools to identify subclinical congestion to guide treatment. Purpose To evaluate whether inferior vena cava (IVC) and pulmonary ultrasound (CAVAL US)-guided therapy in patients with AHF reduces subclinical congestion at discharge. A secondary objective was to investigate whether CAVAL US-guided therapy leads to improved outcomes al 90 days. Methods In this single-center, single-blind, randomized controlled trial, adult patients with AHF were randomized within 24 hours of hospital admission to the CAVAL US-guided strategy or clinically-guided decongestive therapy. A quantitative ultrasound protocol was used and patients were stratified into 3 groups according to the degree of congestion. All patients underwent lung and IVC ultrasound and were blinded to group allocation. The treating medical team was blinded to the results of the ultrasound evaluation in the control group and adjusted the treatments in the intervention group according to an individualized therapeutic algorithm. The primary endpoint was the presence of more than 5 B-lines and/or an increase in IVC diameter with and without collapsibility at discharge. The secondary endpoints were the composite of HF readmission, unplanned visit for worsening HF or death at 90 days and pro-B-type natriuretic peptide (NT-proBNP) reduction at discharge in %. Results Sixty patients were randomized to CAVAL US (n=30) or control (n=30). The mean age was 76.7±13 years, 68.3% were male and the mean left ventricular ejection fraction was 44% ± 15. The primary outcome occurred in 4 patients (13.3%) in the CAVAL US group and 20 patients (66.6%) in the control group (p<.001). A reduction in HF readmission, unplanned visit for worsening HF or death at 90 days was seen in the CAVAL US group (13.3% vs 36.7%; log rank p=0.038). Other secondary endpoints such as NT-proBNP reduction at discharge showed a non-statistically significant reduction in the CAVAL US group (48% IQR 27-67 vs 37% -3-59; p=0.09). The mean hospital stay was 4.5±5 days in the CAVAL US group and 3.3±1.6 days in the control group (p=0.26), with a trend toward higher total furosemide use in the CAVAL US group (170 mg IQR 120-240 vs 120 mg IQR 80-200, p=0.08). Safety outcomes were similar in both groups (p>0.05). Conclusion IVC and lung ultrasound-guided therapy in AHF patients significantly reduced subclinical congestion at discharge. CAVAL US-AHF provides evidence for the use of a simple, safe and non-invasive technique to guide decongestive therapy during hospitalization for AHF, that reduced the risk of HF readmission, unplanned visit for worsening HF, or death at 90 days without prolonging hospital stay.Subclinical congestion at dischargeKM secondary endpoint