Abstract 14026: Intermittent Occlusion of the Superior Vena Cava Reduces Estimated Stressed Blood Volume in Patients With Acutely Decompensated Heart Failure

Abstract

BACKGROUND: Stressed blood volume (SBV) refers to intravascular volume that produces hydrostatic pressure and contributes to congestion in acutely decompensated heart failure (ADHF). The VENUS HF Early Feasibility Study (EFS) is the first clinical trial testing intermittent occlusion of the superior vena cava (SVC) with the preCARDIA system, a catheter mounted balloon and pump console, to improve decongestion in ADHF. We hypothesized that preCARDIA therapy reduces SBV in ADHF. Methods: In a multicenter, prospective, single-arm exploratory safety and feasibility trial, 32 patients with ADHF were assigned to preCARDIA therapy for 24 hours. Invasive hemodynamics were measured before, immediately after, and for 3 hours after preCARDIA treatment. SBV was estimated (eSBV) using the hemodynamic simulator, Harvi, with heart rate (HR), cardiac output (CO), central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), systolic and diastolic systemic arterial and pulmonary artery (PA) pressures, and left ventricular ejection fraction (LVEF) from 27 enrolled subjects. Results: Mean LVEF was 28±13%. Freedom from device or procedure related major adverse events was observed in 96% (n=26/27) of patients. Compared to pre-treatment values, CVP, PCWP, and PA pressures were significantly reduced, while systemic mean arterial pressures, HR and CO remained unchanged (Table 1). Daily urine output (2.6±1.9 vs 5.2±3.8 L, p=0.0072) and net fluid balance (-1.7±1.4 vs -3.4±2.6 L/24hr, p=0.0098) improved with 24-hours of treatment. Compared to pre-treatment values, eSBV decreased by 22% or -709±551 mL/70kg from baseline to 3 hours after treatment completion (3217±426 vs 2507±694 mL/70kg, p<0.000001). Conclusions: We report for the first time that intermittent SVC occlusion using the preCARDIA system reduced estimated stressed blood volume in patients with ADHF. These results support future studies characterizing the clinical utility of the preCARDIA system.