Abstract

BACKGROUND: Urine sodium excretion identifies risk for short and long-term adverse events in acutely decompensated heart failure (ADHF). The VENUS HF Early Feasibility Study is testing whether intermittent occlusion of the superior vena cava (SVC) with the preCARDIA system, a catheter mounted balloon and pump console, improves decongestion in ADHF. We hypothesized that preCARDIA therapy increases natriuresis 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. Urine output and urine electrolytes were measured from a spot urine sample before, immediately after, and for 24 hours after preCARDIA treatment in 13 patients. Results: 32 patients were enrolled and received the preCARDIA system. Thirteen patients had complete urine electrolytes available for analysis. Compared to pre-treatment values, total daily urine output increased (1.9±0.8 vs. 4.2±1.5 L/day, p<0.001) and net fluid balance improved (-1.2±0.8 vs. -2.6±1.4 L/day, p=0.01) with treatment. Compared to pre-treatment, urine sodium (U-Na: 64±26 vs 97±24 mEq/L, p=0.0008) and U-Na/urine creatinine (U-Na/U-Cr: 1.7±1.3 vs 5.3±3.9 mmol/mg p=0.024) increased with treatment (Figure). Improved daily urine output and net fluid balance persisted 24 hours after treatment (1.9±0.8 vs 4.4±1.5 L p=0.0001; -1.2±0.8 vs -3.2±1.5 L/24h p=0.0003, respectively). Both U-Na and U-Na/U-Cr remained increased 24 hours after device removal (90 mEq/L, p=0.01; 3.93±2.8 p=0.026). Treatment increased fractional excretion of U-Na (2.08±1.87% vs. 4.22±2.72% p=0.05). No change in potassium excretion was observed. Conclusions: We report for the first time that intermittent SVC occlusion using the preCARDIA system to reduce congestion may increase urinary sodium excretion in ADHF. Future studies will further test the clinical utility of the preCARDIA system.

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