The VENOS-2 Early Feasibility Study: Six-Month Outcomes of the Velocity® Percutaneous Arteriovenous Fistula

Each of the two FDA approved systems used to create percutaneous arteriovenous fistulas (pAVFs) for hemodialysis successfully and safely create vascular access.  Unfortunately, many of these pAVFs require one or more subsequent unplanned procedures to allow successful use for hemodialysis, such as occlusion of deep venous flow or treatment of anastomotic stenosis.  Furthermore, special training is often required to facilitate cannulation at the dialysis unit.  The Velocity® pAVF (Venova Medical, Los Gatos, CA) was designed to create pAVFs with improved functional maturation and ease of cannulation.{1}

Materials and Methods:

VENOS-2 (NCT06712251) is a prospective, single-arm, feasibility study performed at 5 U.S. sites. Eligible participants had renal failure and suitable anatomy for pAVF creation. The primary effectiveness endpoint is physiologic maturation at 6 weeks (5 mm outflow vein diameter and flow volume > 500 mL/min), and secondary endpoints include functional use, catheter removal, patency, reinterventions, and patient satisfaction.

Results:

16 patients on dialysis and 7 pre-dialysis patients were enrolled.  Successful pAVFs were created in all patients with no procedure or device related serious adverse events.  Median follow-up was 173 days (IQR 79-179 days).  By 6 weeks, cephalic vein diameter increased from 3.6 ± 0.5 millimeter to 6.3 ± 0.6 millimeter, with mean brachial artery flow of 1177 ± 226 mL/min.  Physiologic maturation was achieved in 96% (22/23) at or before 6 weeks and was unassisted in 20/22 (91%). In the subgroup dialyzing with a catheter, 88% (14/16) achieved two-needle cannulation at 64 ± 52 days, facilitating early catheter removal.  Median basilic vein ligation or embolization was performed in 62% (10/16) before initial pAVF cannulation, allowing successful cephalic vein cannulation of all pAVFs without any dedicated in-center dialysis unit training. No subject required brachial vein coil embolization or angioplasty for anastomotic stenosis prior to initial cannulation.

Conclusion:

The Velocity® pAVF System safely achieved pAVFs in all patients with rapid physiologic maturation, favorable functional outcomes, ease of cannulation, and venous catheter removal. This feasibility study shows that it is a minimally invasive method that warrants further study.