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. 2023 Apr 24;8(4):394-402.
doi: 10.1016/j.jacbts.2023.02.010. eCollection 2023 Apr.

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

Robert Zymliński  1   2 , Jan Biegus  1   2 , Marc Vanderheyden  3 , Piotr Gajewski  1   2 , Riet Dierckx  3 , Jozef Bartunek  3 , Piotr Ponikowski  1   2
Affiliations

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

Robert Zymliński et al. JACC Basic Transl Sci. .

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 ± 4.7 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).

Keywords: acute heart failure; device therapy; diuretic resistance; insufficient response; venous congestion.

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Conflict of interest statement

This study was supported by Revamp Medical. Research plan, and clinical testing was performed by staff with no financial interest in Revamp Medical. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
The Concept and Visualization of Doraya Catheter CVP = central venous pressure.
Figure 2
Figure 2
The Changes in CVP of Individual Patients Before and After the Procedure CVP = central venous pressure.
Figure 3
Figure 3
The Changes in Heart Rate of Individual Patients Before and After the Procedure Bpm = beats/min.
Figure 4
Figure 4
The Changes in Systolic Blood Pressure of Individual Patients Before and 48 Hours After the Procedure
Figure 5
Figure 5
The Changes in Urine Output Rate of Individual Patients Before and During the Procedure
Figure 6
Figure 6
The Changes in Dyspnea of Individual Patients Before and 48 Hours After the Procedure
Figure 7
Figure 7
The Changes in Edema Score of Individual Patients Before and 48 Hours After the Procedure
See this image and copyright information in PMC

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References

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