The JuxtaFlow® Renal Assist Device: A Novel Potentially Renoprotective Technology Associated with Reduced Low Urine Oxygen Burden in a Swine CPB Model
Stafford-Smith M MD1,3 ·
Thomson S MD2,3 ·
Coles S BS3 ·
Tucker BJ PhD3
1Dept Anesthesiology, Duke Univ Med Ctr, Durham, NC ·
2Dept Medicine, UCSD, San Diego, CA ·
33ive Labs, LLC, Roswell, GA
Introduction
- The JuxtaFlow Renal Assist Device (JF-RAD) delivers mild negative pressure to the renal pelvises through ureteral catheters connected trans-urethrally to a pump.
- JF-RAD augments GFR, diuresis, and natriuresis in volume-overload patients with cardiorenal syndrome, but its effects on acute kidney injury (AKI) are unclear.
- AKI is a common complication of cardiac surgery, associated with low urine oxygen (puO₂) levels, potentially related to renal medullary hypoxia.
- We assessed potential renoprotection from continuous bilateral JF-RAD negative pressure treatment (Tx) in a mock cardiac surgery swine CPB model, using low puO₂ as an AKI early biomarker.
Methods
- IACUC approved — nine 50–65 kg female pigs, general endotracheal anesthesia, arterial line monitoring
- Bilateral JF-RAD catheter placement (cystoscopic): −15 mmHg (Tx) vs. no negative pressure (control)
- Periop periods: baseline (120 min) → CPB with heparin, left thoracotomy, ~120 min (incl. Xclamp & cardioplegia) → postCPB (120 min)
- Continuous q60sec bilateral puO₂ measurements via JF-RAD catheters
- Low puO₂ thresholds: <40 mmHg and <35 mmHg — expressed as degree-duration AKI early biomarkers (mmHg·min); p < 0.05 considered significant
Device Overview
JuxtaFlow® Renal Assist Device with bilateral ureteral catheters (coiled end) connected trans-urethrally to a negative-pressure pump targeting the renal pelvises
Standardized per-animal collection across periop periods: standard vitals, CPB flow, hematocrit, electrolytes, ABG, creatinine clearance, urine output (JF-RAD + Foley), urinalysis, serum/urine IL-6, and q60sec puO₂
Primary Finding — Low puO₂ Burden (< 40 mmHg)
Low puO₂ burden per animal (mmHg·min) — lower is better | p < 0.02 (primary analysis)
Key Results
- 9 pigs completed protocol (Tx n=5, Control n=4); 1 Tx animal excluded (puO₂ started 80 min late due to technical difficulties)
- Standard measures were similar between groups; no left/right kidney puO₂ differences
- Trends toward improved renal function in Tx group: ↑ urine output, creatinine clearance, sodium excretion
- Each group had 9 low puO₂ episodes, but Tx episodes were considerably shorter (avg. 30 vs. 57 min), resulting in significantly reduced low puO₂ burden
- Episodes were most frequent in the postCPB period and were both unilateral and bilateral
- No evidence of important hematuria following catheter placement + heparin anticoagulation + CPB
- Similar findings observed at the <35 mmHg threshold analysis
Conclusions
Future Directions
These intriguing findings suggest JF-RAD negative pressure treatment may have renoprotective potential and support further investigation in the context of cardiac surgery with CPB, particularly for patients with high AKI risk.