The Vanderbilt Heart and Vascular Institute (VHVI) is part of a clinical trial to treat patients with acute decompensated heart failure (ADHF) using an innovative new device.
ADHF is a medical emergency in which the heart suddenly fails to pump enough blood, causing excess fluid to rapidly back up in the body. Symptoms include difficulty breathing, leg or feet swelling, and fatigue. Patients with such symptoms often require unplanned visits to the doctor, emergency room or hospital.
The Reprieve System, an investigational, automated medical device, is designed to safely and precisely manage fluid overload for patients in the hospital. It works by continuously monitoring urine output and providing personalized diuretic therapy, aiming to remove excess fluid while reducing the risk of kidney injury and hospital readmissions.
“There is an increasing population of patients who suffer from heart failure and one of the greatest challenges in the care of these patients is keeping them decongested, allowing them to stay out of the hospital,” said Aniket Rali, MD, Associate Professor of Medicine and Anesthesiology and co-director of the medical cardiovascular intensive care unit. “Despite best attempts, heart failure patients often experience decompensation requiring hospitalization. During these hospitalizations, the focus is on rapid and effective decongestion using intravenous medications. Conventional treatment algorithms rely on frequent laboratory tests, which take time to result, and clinical interventions based on this data. Hence, this space is ripe for innovation and automation.”
A recent patient in the trial is Thomas Williams. His use of the device helped him undergo efficient diuresis and get released from the hospital after a recent episode of decompensated heart failure.
Rali said the device has the potential to reduce the length of stay for ADHF patients by measuring their response to diuretic medication in real time using algorithms, allowing the process of removing fluid to be more efficient than the standard method.
“Any time you require clinicians to wait on laboratory results and respond to that data, it is time consuming and may lead to delays in clinical decisions,” he said. “This device uses time-tested algorithms in a single, integrated smart console that includes the right number of guardrails to ensure safety. The fact that VHVI was chosen for this trial is truly a reflection of our research enterprise and the clinical expertise we have.”
Zachary Cox, PharmD, heart failure clinical pharmacy specialist, said the average length of stay for ADHF patients is about seven days, and the device could reduce length of stay. He also stressed the minimally invasive nature of the device.
“Many of our devices are implantable, and require a trip to the ICU, but the interesting aspect of this device is that it is not implantable and sits at the bedside in a regular patient room,” said Cox, Adjunct Professor of Medicine at Vanderbilt Health and a Professor in the Department of Pharmacy Practice at Lipscomb University. “So, the risk is lower because it’s non-invasive, and it is using the same medications that we would otherwise administer manually.”
