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Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)
Alex M Parker1, Vincent G Bird2, Shweta Bansal3
1From the Division of Cardiovascular Medicine, University of Florida, Gainesville, Florida.
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|April 29, 2025
Summary
The JuxtaFlow Renal Assist Device (RAD) shows early promise in treating diuretic-resistant acute decompensated heart failure. This novel therapy improved urine output and sodium excretion in a small trial, suggesting potential for managing heart failure congestion.
Area of Science:
- Cardiology
- Nephrology
- Medical Devices
Background:
- Acute decompensated heart failure (ADHF) frequently involves diuretic resistance due to cardiorenal syndrome.
- Managing fluid overload in ADHF patients with diuretic resistance remains a clinical challenge.
Purpose of the Study:
- To evaluate the safety and feasibility of the JuxtaFlow Renal Assist Device (RAD) for treating congestion in diuretic-resistant ADHF patients.
- To assess the efficacy of RAD in improving urine output and renal function markers.
Main Methods:
- An open-label, single-arm trial (VOID-HF) involving seven patients with ADHF and diuretic resistance.
- RAD catheter system implantation for 24-hour treatment, with primary safety endpoints (hematuria) and secondary efficacy endpoints (urine output, renal biomarkers).
Main Results:
- Six of seven patients completed the protocol without structural renal abnormalities on ultrasound.
- Significant improvements in 24-hour urine output and sodium excretion were observed.
- The RAD system demonstrated early feasibility in this patient cohort.
Conclusions:
- The JuxtaFlow RAD shows early feasibility for managing congestion in diuretic-resistant ADHF.
- Further research is warranted to establish the safety and efficacy of RAD as a potential treatment option.
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