Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF).

Acute decompensated heart failure is a common problem and is frequently associated with diuretic resistance from cardiorenal syndrome. We present the first in human use of the JuxtaFlow Renal Assist Device (RAD) to treat congestion in patients admitted to the hospital with acute decompensated heart failure. In an open-label single-arm trial, patients admitted with acute decompensated heart failure who were diuretic resistant underwent placement of the RAD catheter system and received treatment for 24 hours with RAD. The primary endpoints were safety metrics (safe use of the device) and markers of hematuria. Secondary endpoints included markers of efficacy, including 24 hour urine output and biomarkers of renal function. Seven patients underwent an implant of the RAD catheter system, with six patients successfully completing the protocol. Among patients who completed the protocol, no structural abnormalities were identified on renal ultrasound. Significant improvements in 24 hour urine output and sodium excretion were noted despite a small sample size. The volume optimization incorporating negative pressure diuresis in heart failure (VOID-HF) trial demonstrated the early feasibility of the RAD catheter system, with six of seven patients completing the protocol. Further studies are indicated to determine if this novel therapy is a safe and effective addition to current standards of care.