Transcatheter Anastomosis Connector System for Vascular access Graft Placement: Results from a First-in-human Pilot Study

Abstract

Purpose A lengthy healing and maturation period follows standard surgical preparation of a permanent arteriovenous access, often requiring or extending use of a venous catheter (VC) for hemodialysis. The InterGraft™ Anastomotic Connector System was developed for minimally invasive anastomosis of an arteriovenous graft (AVG). The venous and arterial InterGraft™ connectors are designed to provide optimized flow dynamics and may result in reduction of AVG stenosis. This pilot study evaluated placement procedure success, patency and safety of the InterGraft™ connectors. Methods Nine AVGs were implanted in nine patients currently receiving dialysis with a VC. The study allowed use of both connectors (n = 5) or use of the venous connector with a sutured arterial anastomosis (n = 4). Monthly ultrasound examinations were performed throughout the six-month follow-up. AVG angiography was performed at five months. Endpoints included procedure success (acceptable graft flow at end of procedure, without significant bleeding or need for emergent surgery), patency, and device-related major adverse events. Results Procedure success was attained in all patients. AVGs were used for dialysis within 17 days, on average, and VCs were removed. Three patients exited the study early for reasons unrelated to the InterGraft™ connectors. The remaining six patients had patent grafts: two with assisted and four with unassisted patency. AVG flow rates were greater than 1 L/minute. No dilatations or aneurysms were observed by angiography. There were no device-related major adverse events. Conclusions The InterGraft™ connectors can be safely and successfully used for AVG anastomoses, with acceptable near-term patency. Further clinical evaluation is warranted.