Safety, Feasibility of Controllable Decrease of Vena Cava Pressure by Doraya Catheter in Heart Failure

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 +/- 4.7 mm Hg (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. (First In Human Study of the Doraya Catheter for the Treatment of AHF Patients; NCT03234647)(c) 2023 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Automated summary

Lowering elevated central venous pressure can reduce renal dysfunction in AHF patients. The Doraya catheter creates a pressure gradient to lower renal venous pressure. A feasibility study was performed on 9 AHF patients to evaluate the acute clinical effects of using the Doraya catheter in addition to standard diuretic-based regimen. The deployment of the Doraya catheter was safe and feasible, reducing central venous pressure and improving diuresis and signs of congestion.