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

Area of Science:

• Cardiology
• Nephrology
• Medical Devices

Background:

• Elevated central venous pressure contributes to renal dysfunction in acute heart failure (AHF).
• Standard diuretic therapy may be insufficient in some AHF patients, necessitating alternative approaches.
• The Doraya catheter aims to reduce renal venous pressure by altering inferior vena cava pressure gradients.

Purpose of the Study:

• To assess the safety and feasibility of the Doraya catheter in AHF patients.
• To evaluate the acute hemodynamic and renal effects of Doraya catheter deployment.
• To determine the impact of the Doraya catheter on diuretic response and clinical congestion in AHF.

Main Methods:

• A first-in-human feasibility study involving 9 AHF patients.
• Transient deployment of the Doraya catheter as an adjunct to standard diuretic therapy.
• Assessment of central venous pressure, diuresis, renal function, and adverse events.

Main Results:

• Successful reduction in central venous pressure from 18.4 ± 3.8 mm Hg to 12.4 ± 4.7 mm Hg (P < 0.001).
• Improvement in mean diuresis and resolution of clinical signs of congestion.
• No device-related serious adverse events were reported, indicating a favorable safety profile.

Conclusions:

• Doraya catheter deployment is safe and feasible in AHF patients.
• The device effectively lowers central venous pressure and improves clinical outcomes.
• This technology offers a potential new therapeutic option for AHF with diuretic resistance.