Kidney Week

Abstract: SA-OR44

Midterm Outcomes of a Novel First-in-Human Percutaneous Arteriovenous Fistula

Session Information

• Dialysis Vascular Access: Research Advances
  October 26, 2024 | Location: Room 8, Convention Center
  Abstract Time: 05:40 PM - 05:50 PM

Category: Dialysis

• 803 Dialysis: Vascular Access

Authors

• Hentschel, Dirk M., Brigham and Women's Hospital, Boston, Massachusetts, United States

Dirk M. Hentschel, MD, FASN

• Shahverdyan, Robert, Asklepios Kliniken Hamburg GmbH, Hamburg, Hamburg, Germany

Robert Shahverdyan, MD

• van der Burg, Erik, Venova Medical, Los Gatos, California, United States

Erik van der Burg, MS

• Vartanian, Shant M., University of California San Francisco, San Francisco, California, United States

Shant M. Vartanian, MD

Background

Percutaneous arteriovenous fistulas (pAVF) can address barriers to starting hemodialysis with an AVF. Commercial devices often lose flow into the deep venous system, requiring reinterventions for effective cannulation. A novel implant-based pAVF was developed to create a single outflow AVF between the proximal radial artery and the cubital perforating vein, mimicking surgical AVF anatomy. The objectives of this study were to establish technical feasibility and safety.

Methods

The VENOS-1 trial (NCT 05757726) is a prospective, single-arm, early feasibility study. The primary endpoint is procedural success, and the primary safety endpoints are serious adverse device events and major reinterventions at 6 weeks. Secondary endpoints included physiologic maturation (flow > 500 ml/min and vein d. > 5 mm), reintervention rate, and functional maturation.

Results

Ten ESRD patients were enrolled with follow-up to 6 months. The average age was 45.1 yrs (range 27-61) and the BMI 24.3 kg/m² (SD ± 9.2). Procedural success was 100% with no safety events at 6 weeks. Mean brachial artery flow was 972 ml/min (SD ± 229 ml/min), and upper arm vein diameter increased to 6.3 mm (SD ± 1.0 mm). Physiologic maturation was achieved in all patients, on average by day 18 (range 13-40). No reinterventions were needed prior to maturation. Four of 10 patients achieved unassisted cannulation by 6 weeks, and two-needle cannulation of the cephalic vein was achieved in 70% of subjects by 6 months.

Conclusion

Mid-term results show this novel pAVF is highly effective at creating, maturing, and supporting early clinical use of a proximal forearm AVF. The method promotes rapid maturation without needing subsequent flow-diverting procedures and avoids thermal injury. These results suggest this novel pAVF could lead to more optimal starts in the HD population and warrants study in a larger patient population.

Angiogram showing an AVF from the radial artery to the cubital perforating vein, without flow into the deep veins. The arrow denotes implant location. A. Early antegrade filling of the pAVF. B. Late retrograde flow from the radial artery into the CPV.

Funding

• Commercial Support – Venova Medical