A Novel Percutaneous Arteriovenous Fistula for Hemodialysis Access: One-Year Outcomes of the VENOS-1 First-In-Human...

Starting patients on hemodialysis (HD) with an arteriovenous fistula (AVF) and minimizing catheter contact time are major unmet needs for end-stage renal disease (ESRD) patients. Percutaneous arteriovenous fistulas (pAVFs) could address these needs, but current devices often result in flow loss to the brachial vein, requiring reinterventions for target vein maturation and initial clinical use. This study evaluated the technical feasibility and safety of a novel implant-based pAVF, designed to replicate surgical AVF anatomy by directing flow exclusively into the superficial venous system of the upper arm.

The VENOS-1 trial (NCT05757726) is a prospective, single-arm, open-label early feasibility study. The primary effectiveness outcome was procedural success and primary safety outcome measures were serious adverse device events and major reinterventions at 6 weeks. Secondary outcomes included physiologic maturation, defined as brachial artery flow ≥500 mL/min and venous outflow diameter ≥5 mm, reintervention rate, and functional use.

Ten HD patients were enrolled and average follow-up was 15.9 months. Mean age was 45.1 years (range=27-61) and the mean body mass index was 24.3 kg/m² (SD±9.2). Procedural success was 100%, with no serious adverse events or major reinterventions at 6 weeks. At 6 weeks, median brachial artery flow was 977 ml/min (interquartile range [IQR]±300), and cephalic vein diameter increased to 6.3 mm (SD±1.0 mm). Physiologic maturation was achieved in all patients without reintervention, on average by day 18 (range=13-40). Four subjects underwent ligation of the median basilic vein after reaching unassisted physiologic maturation to facilitate 2-needle inline cannulation of the upper-arm cephalic vein. Two percutaneous reinterventions were needed to maintain or restore patency across 10 subjects in the first 12 months. Access circuit primary patency at 1 year was 80%.

This first-in human study demonstrates that an implant-based technique is effective and safely creates an AVF for HD. By directing arterial flow into the superficial venous system, the device creates hemodynamic conditions that facilitate physiologic maturation without adjunctive procedures, an observation that will require confirmation in larger studies.Clinical ImpactThis first-in-human study demonstrates that an implant-based percutaneous arteriovenous fistula (AVF) can consistently achieve physiologic maturation without need for flow diversion from the deep venous system. Flow conditions in the superficial venous system drives maturation and creates physical exam findings in the cephalic vein needed for cannulation. This novel approach addresses limitations of earlier percutaneous arteriovenous fistula technologies by simplifying access creation and optimizing hemodynamics in the cannulation zone. Clinicians may benefit from expanded access options that reliably result in physiologic maturation and lowers procedural complexity, which together could reduce catheter exposure. If validated in larger studies, this technique has the potential to shift dialysis access practice by offering an additional access option that creates reliable maturation for initiating hemodialysis with an AVF.