Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)

CHF, as defined by the American College of Cardiology and the American Heart Association, is "a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood." These patients will often develop congestion that may require urgent hospitalization, especially if pulmonary congestion is present. However, congestion can be difficult to assess, especially when symptoms are mild, or in patients nearing discharge from an HF hospitalization.8 Increased cardiac filling pressures, including the CVP, often silently precede the appearance of congestive symptoms by days resulting in hepatic congestion.

Invasive methods, such as RHC, remain the gold standard method of measuring CVP, offering accurate and direct hemodynamic data. However, RHC requires specialized training and invasive vascular access and is associated with procedural risks including bleeding, infection, arrhythmia, and patient discomfort.

Echocardiography is the most common non-invasive adjunct tool for estimating CVP and assessing cardiac function. It evaluates indirect parameters, right atrial size, IVC diameter, and collapsibility to detect elevated CVP.

LSM by VCTE™ has emerged as a novel non-invasive approach to detecting elevated CVP indirectly. Liver elastography relies on imaging techniques to assess LSM, with high values equating to increased stiffness. While this was developed to assess fibrosis in chronic liver diseases, LSM also reflects increased CVP and hepatic congestion. Multiple studies have shown promising correlations between increased liver stiffness and invasively measured CVP, indicating a potential clinical strategy for detecting hemodynamic congestion non-invasively.

Given these considerations, the current clinical investigation aims to evaluate the 13.3 kPa cutoff performance of LSM with FibroScan (Echosens, Paris, France) to diagnose elevated CVP (\>10 mm Hg).

• Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of elevated CVP (>10 mm Hg) [Time frame: at Day 0]
• Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of abnormal IVC diameter [Time frame: at Day 0]
• Logistic regression model to identify clinical, laboratory, and echocardiographic factors associated with LSM/CVP discordance. [Time frame: at Day 0]
• Correlation between LSM and echocardiographic parameters evaluated with Pearson or Spearman correlation coefficients [Time frame: at Day 0]
• Correlation between LSM and NT-proBNP evaluated with Pearson or Spearman correlation coefficients [Time frame: at Day 0]
• Correlation between LSM and CA-125 evaluated with Pearson or Spearman correlation coefficients [Time frame: at Day 0]
• Correlation between LSM and clinical parameters evaluated with Pearson or Spearman correlation coefficients [Time frame: at Day 0]
• Proportion of individuals correctly identified for the diagnosis of elevated CVP (>10 mm Hg) compared between LSM, echocardiography parameter and NT-proBNP using DeLong's test for correlated ROC curves [Time frame: at Day 0]