This morning, at the Controversies in Dialysis Access (CiDA) 2024 meeting (3–5 October, Washington D.C., USA), Robert Shahverdyan (Hamburg, Germany) gave a presentation sharing the one-year results of the VENOS-1 first-in-human study, which examined the Velocity (Venova Medical) percutaneous arteriovenous fistula (pAVF) system.
Beginning by outlining the background of pAVFs, Shahverdyan pointed out that, whilst there are currently two US Food and Drug Administration (FDA) approved devices available—WavelinQ (BD) and Ellipsys (Medtronic)—the lack of worldwide adoption was, in his opinion, a “missed opportunity” that has led to decreased usage of pAVFs over the past couple of years. After outlining his algorithm for the use of pAVFs and sharing some of his own experiences and results with their use from the last six years, Shahverdyan conceded that the main challenges with pAVFs are the issues with cannulation and a high rate of reinterventions (such as flow directing procedures and/or juxtaanastomotic stenosis angioplasties), which consecutively increase the costs for pAVFs.
Following on from this, he stated that what was needed from the next generation of pAVFs was a revaluation of cost-effectiveness, fewer interventions after pAVF creation, and an improved procedural efficiency without compromising on efficacy.
A device that he feels fulfils this brief is Velocity—the “generation 2.0 pAVF”. Shahverdyan stated that it is able to replicate surgical AVF anatomy, via its optimal geometry that allows for ideal flow conditions to support fast maturation, and a low incidence of anastomotic stenosis thanks to the endothelium being shielded from turbulence, inflammation or thermal injury.
The first-in-human trial for this device, VENOS-1, commenced in 2023, with enrolment being completed by October of the same year. It consisted of two cohorts; with the last cohort of 10 patients treated by the updated and final design, and now completed the final one-year follow-up visits. All 10 procedures were technically successful, with all of them being performed under regional anaesthesia. There were no serious adverse events at six weeks, as well as no instances of hand ischaemia.
What was interesting is that the ultrasound findings showed that there was a 1:1 relationship between arterial flow and superficial venous flow, confirming a targeted AVF flow, and that 100% of the pAVFs matured within six weeks, with no re-interventions needed to reach this endpoint. The trial results also demonstrated 80% of primary patency years at one year, with only two re-interventions for the entire cohort in the first year, including a single angioplasty for a juxtaanastomotic stenosis at day 242.
With that, Shahverdyan concluded that the Velocity pAVF system demonstrates the least inflammatory way of creating an AVF with the implant shielding the juxtaanastomotic segment from turbulence and developing a stenosis, improving maturation rates, adding that a VENOS-2 US-based early feasibility study is planed to start end of 2024.
