Anatomic suitability for commercially available percutaneous arteriovenous fistula creation systems

The Food and Drug Administration recently approved two percutaneous arteriovenous fistula creation systems: the Ellipsys vascular access (EL) system and WavelinQ EndoAVF (WQ) system. Although the initial clinical trials of each system have demonstrated a high success rate, little detail on anatomic suitability was provided. We sought to determine the real-world applicability of the EL and WQ systems by studying them in a single representative cohort.

All patients receiving a first-time arteriovenous access consultation at a single Veterans Affairs institution underwent extensive vein mapping of the bilateral upper extremities. Anatomic suitability was assessed in accordance with the manufacturer's instructions for use (IFU), and clinical usability was determined using additional published anatomic guidelines. The suitability for radiocephalic fistula (RCF) creation was also assessed. To estimate how often these systems would be used in practice, a clinical algorithm was created, with a preference for RCF creation, followed by percutaneous arteriovenous fistula (pAVF) creation, surgical fistula creation at the elbow, and, finally, graft placement.

During the study period, 116 upper extremities were measured in 58 male patients. Per the IFU, the rate of extremity suitability was 93% and 52% for the WQ and EL systems, respectively (P < .0001). In the same population, 32% of the extremities had acceptable anatomy for RCF creation. The overall clinical usability of these systems using more recent published guidelines was 55% for the WQ system and 44% for the EL system (P = .09). The usability of both pAVF systems was most limited by the size of the deep perforating cubital vein. The proximity of the antecubital perforator vein and proximal radial artery additionally limited EL usability. Based on the clinical algorithm, initial access creation would have been RCF creation for 31% of the cohort, followed by the WQ (32%), the EL (23%), surgical fistula creation at the elbow (18%), and graft placement (17%).

Anatomic suitability was greater for WQ than for EL when considering only the IFU. Once the full requirements for pAVF creation were considered, we found no significant differences in usability between the two systems. Anatomic analysis showed that pAVF creation can constitute a substantial part of a hemodialysis access practice.