Reprieve Cardiovascular's Reprieve System has shown promising results in managing acute decompensated heart failure (ADHF) patients with fluid volume overload. Data from a first-in-human study and the FASTR pilot trial indicate the system's potential to safely and effectively remove excess fluid and sodium, improve decongestion outcomes, and preserve kidney function.
The Reprieve System is designed to address the challenges of fluid management in ADHF, where precise diuretic administration is crucial to prevent readmissions without causing kidney damage. The system combines real-time physiological monitoring with automated recommendations to tailor treatment to each patient's needs.
First-in-Human Study
In a first-in-human, open-label, single-arm study (NCT03897842) conducted in Tbilisi, Georgia, ten patients with ADHF received Reprieve System therapy for a maximum of 72 hours. The results, presented at the Device Therapies in Heart Failure Conference in Munich, demonstrated:
- Average treatment duration of 18.3 hours
- Net fluid loss of 4.8 liters
- Average weight reduction of 4.8 kg
- Net sodium loss of 653 mmol
Notably, kidney function remained stable throughout the trial, with no patients experiencing acute kidney injury. The average serum creatinine level decreased, indicating effective decongestion without renal complications.
FASTR Pilot Trial
The FASTR pilot trial, a multicenter, randomized, controlled study, evaluated the Reprieve System against optimal diuretic therapy (ODT) in 96 patients hospitalized with acute heart failure and at least 10 lbs of volume overload. Top-line results, presented at the Technology and Heart Failure Therapeutics (THT) Annual Meeting, showed that the Reprieve System led to:
- Significantly greater sodium excretion (p<0.001)
- Higher total urine output (p<0.001)
- More weight loss (p=0.002)
There was no increase in decongestion-related adverse events, and a trend towards fewer increases in serum creatinine during treatment was observed. The risk of death or rehospitalization for heart failure through 3 months was numerically lower in the Reprieve System group, although not statistically significant (HR 0.64; 95% CI 0.31-1.30).
Clinical Implications
These findings suggest that the Reprieve System can address the challenges of ADHF treatment by removing a significant amount of sodium, improving decongestion outcomes, reducing renal injury risks, and potentially shortening hospital stays. As Piotr Ponikowski, professor of cardiology at Wroclaw Medical University, stated, "These initial findings demonstrate the potential of the Reprieve System to address the longstanding challenges of ADHF treatment... As heart failure management continues to evolve, this technology represents a significant step forward in developing precise, patient-centric approaches to decongestion management."
Future Directions
Reprieve Cardiovascular has received FDA approval to initiate the FASTR II randomized pivotal trial in the United States and Europe in the first half of 2025. This trial aims to further validate the Reprieve System's efficacy and safety and support a premarket approval submission.
Mark Pacyna, CEO of Reprieve Cardiovascular, noted, "With FDA approval to start the FASTR II randomized pivotal trial... we’re excited to begin the next phase of Reprieve’s development."
