Transcatheter Renal Venous Decongestion (TRVD^TM) for the Management of Acute Decompensated Heart Failure (ADHF)

Background

The main reason for hospitalization in ADHF is congestion rather than low cardiac output, and the encapsulated kidneys are particularly vulnerable to congestion: increased renal venous pressure (RVP) has been shown to impair renal blood flow and function and worsen diuretic responsiveness. Renal dysfunction in ADHF increases in-hospital death rate 7-fold and length of stay 3-fold.

Methods

We selectively reduce RVP in order to mechanically unload the kidneys, improve renal perfusion and function, and promote fluid and sodium removal. To this end, we developed the Transcatheter Renal Venous Decongestion (TRVD) System, including two self-expandable flow-pumps that are easily deployed in the renal veins through 8.5Fr steerable introducer sheaths. The system was tested in a controlled porcine model where caval venous pressure was raised using an inflatable balloon, comparing urine output and sodium excretion in one treated kidney to that of the untreated kidney (internal control). The system was then introduced for clinical testing in a First-in-Man study in 11 patients with ADHF.

Results

Animal experiments: Urine output at baseline was similar, 22 ± 1 ml/10 min and 21 ± 4 ml/10 min, respectively (n.s.). During increased venous pressure, urine output was 29 ± 10 ml/10 min in treated kidneys, but fell to 10 ± 4 ml/10 min in untreated kidneys (p < 0.02 to baseline; p < 0.002 to treatment).

Human data: [Updated human data will be shown as of the time of the presentation].

Conclusion

TRVD shows favorable effects on urine output, sodium excretion and diuretic responsiveness (clinically) and has therefore the potential to become an important interventional tool in the treatment of patients with ADHF.