Abstract
Lowering elevated central venous pressure may reduce renal dysfunction in acute heart failure (AHF) patients. The Doraya catheter lowers renal venous pressure by creating a gradient in the inferior vena cava below the renal veins. Here, we present a first-in-human feasibility study of the Doraya catheter performed on 9 AHF patients. We assessed the safety, feasibility, and acute clinical (hemodynamic and renal) effects of transient Doraya catheter deployment when added to the standard diuretic-based regimen in AHF patients with a poor diuretic response. The procedures decreased central venous pressure from 18.4 ± 3.8 mm Hg to 12.4 ± 4.7mmHg (P< 0.001) and improved mean diuresis and clinical signs of congestion. No device-related serious adverse events were observed. Thus, Doraya catheter deployment was safe and feasible in AHF patients. (FirstIn Human Study of the Doraya Catheter for the Treatment of AHF Patients; NCT03234647).
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