Abstract: PO2535
Enhancing Decongestion in Cardiorenal Syndrome by Renal Negative Pressure Diuresis: A First in-Human Experience
Session Information
- Late-Breaking Clinical Trials Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Fluid, Electrolyte, and Acid-Base Disorders
- 902 Fluid, Electrolyte, and Acid-Base Disorders: Clinical
Authors
- Kazory, Amir, University of Florida College of Medicine, Gainesville, Florida, United States
- Parker, Alex Michael, University of Florida, Gainesville, Florida, United States
- Bird, Vincent G., University of Florida, Gainesville, Florida, United States
- McMichael, Brittany, Sentara Healthcare Inc, Norfolk, Virginia, United States
- Baran, David A., Sentara Healthcare Inc, Norfolk, Virginia, United States
Background
Inadequate decongestion is the driver of adverse outcomes in acute decompensated heart failure (ADHF). Accumulating data points to renal venous congestion as the key mechanism underlying cardiorenal syndrome and diuretic resistance. Herein, we present the initial experience with a novel device that utilizes negative pressure in the renal pelvis to enhance diuresis (i.e. renal negative pressure diuresis [rNPD]).
Methods
rNPD involves endoscopic delivery of a ureteral catheter. Its proximal portion is placed in the renal pelvis to deliver controlled negative pressure via a specially designed vacuum pump. Patients with ADHF and diuretic resistance underwent rNPD for 24 hours. Several parameters including GFR, urine output, and natriuresis were measured 24 hours before and 24 hours after rNPD (72-hour study period).
Results
The current proof-of-concept study includes 3 patients from 2 centers meeting strict inclusion and exclusion criteria. Mean serum creatinine levels were 1.86 and 1.82 mg/dL before and after intervention respectively. rNPD resulted in a significant improvement in net fluid balance from -198 to -1775 ml/24 hours (an almost 8-fold effect) [figure-1] and a 156% increase in urinary sodium excretion (from 148 to 378 mmol/24 hours). No complications were observed.
Conclusion
After successful animal studies, this proof-of-concept study is the first in-human experience confirming the salutary impact of applying negative pressure in the renal pelvis of patients with ADHF and diuretic resistance. rNPD resulted in an impressive improvement in net negative fluid balance associated with exponential increase in natriuresis without any notable adverse effect.
Funding
- Commercial Support – 3iveLabs