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Abstract: SA-PO018

Endovascular Nephrectomy in Swine for Evaluation of Implantable Devices for Renal Replacement Therapy

Session Information

  • Bioengineering
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Bioengineering

  • 300 Bioengineering

Authors

  • Moyer, Jarrett, University of California San Francisco, San Francisco, California, United States
  • Wilson, Mark W., University of California San Francisco, San Francisco, California, United States
  • Santandreu, Ana, University of California San Francisco, San Francisco, California, United States
  • Chen, Caressa, University of California San Francisco, San Francisco, California, United States
  • Hu, Dean, Outset Medical, San Jose, California, United States
  • Kerdok, Amy, Outset Medical, San Jose, California, United States
  • Porock, Edward, University of California San Francisco, San Francisco, California, United States
  • Wright, Nathan, University of California San Francisco, San Francisco, California, United States
  • Ly, Jimmy, University of California San Francisco, San Francisco, California, United States
  • Blaha, Charles, University of California San Francisco, San Francisco, California, United States
  • Frassetto, Lynda A., University of California San Francisco, San Francisco, California, United States
  • Fissell, William Henry, Vanderbilt University Medical Center, Nashville, Tennessee, United States
  • Vartanian, Shant M., University of California San Francisco, San Francisco, California, United States
  • Roy, Shuvo, University of California San Francisco, San Francisco, California, United States
Background

Silicon nanopore membranes (SNM) are efficient blood-compatible membranes that enable novel approaches to renal replacement therapy (RRT). Previously, arteriovenous SNM hemodialyzers (SNMHD) were patent and effectively cleared solutes after retroperitoneal implant in healthy swine. Renal arterial embolization is a non-invasive approach to near-total nephrectomy that preserves retroperitoneal anatomy for subsequent device implants. An established embolization-to-implantation protocol is key to therapeutic investigation of implantable RRT devices.

Methods

A Yucatan minipig underwent staged bilateral renal artery embolization with PVA particles and microcoils to induce renal failure. The right renal artery was embolized until contrast stagnation on fluoroscopy. After a 2-week recovery, 50% of the left renal arterial system was embolized. The animal received intermittent hemodialysis (HD) with the Tablo HD System for 35 days and began daily aspirin (325 mg). A small-scale arteriovenous SNMHD prototype was then implanted in the right retroperitoneum. SNMHD dialysate catheters were tunneled externally for connection to a dialysate recirculation pump. The animal resumed HD in parallel to SNMHD testing for 7 days. SNMHD clearance was determined by intermittent sampling of the recirculating dialysate.

Results

Staged embolization successfully induced kidney failure. Embolization, subsequent HD sessions and retroperitoneal SNMHD implantation were well-tolerated. The animal developed anemia (nadir hematocrit 25%), which improved after darbepoetin injection. A chronic venous catheter inserted for HD access was replaced once for tip thrombosis prior to SNMHD implant. Creatinine and urea clearance through the SNMHD were 76-105 mL/min/m2 and 140-165 mL/min/m2, respectively. No albumin was detected in the dialysate.

Conclusion

We successfully piloted an embolization-to-implantation protocol enabling the first implant of a SNMHD in a swine renal failure model. Normalized creatinine and urea clearance measured in the SNMHD may translate to a fully-implantable clinical-scale device. This pilot establishes a path toward therapeutic testing of the clinical-scale SNMHD and other implantable RRT devices.

Funding

  • NIDDK Support – Outset Medical