Use of a novel immediate access dialysis graft designed to prevent needle-related complications: A first-in-man case report

Currently, there is no vascular access that possesses all ideal qualities for hemodialysis access, but attributes particularly lacking include: ease of identification (cannulation zone), ease of access, resistance to stenosis, durable to repetitive cannulation, resistance to infection, resistance to acute needle-related injuries, and instant hemostasis. The overall value of these attributes could be appreciated in the reduction of complications (patient burden and suffering, which can also result in increased healthcare costs), and improved safety and durability. In this case report, we present a novel hemodialysis access graft that has the potential to provide the following benefits: it is designed to be self-sealing and immediately usable post implant, easy to identify, easy to access, has more durable cannulation zones, and protects from needle-related injuries. This case report describes the first-in-man use of this novel graft technology to replace a giant, thrombotic, and difficult-to-access arteriovenous fistula to provide the patient with a potentially safer and more durable access that does not require placement of a bridging dialysis catheter. This single-patient experience suggests that implantation and function of this novel graft as a hemodialysis access is feasible in a human subject with end-stage renal disease, and it suggests that the novel properties (i.e. immediate use, easy identification, easy use, cannulation zone durability, and protection from needle-related injuries) of this graft seem to function as intended.

An Unusual Case of an Epidermoid Cyst Eroding into an Arteriovenous Graft Resulting in Graft Loss

Arteriovenous grafts (AVG) are unfortunately vulnerable to infection given their nature of being a foreign body that is routinely accessed in a patient population that typically has multiple comorbidities. Management of AVG infections can become more complex when a patient has exhausted all options of hemodialysis access and gets an infection involving the AVG or a chronic wound in closed proximity. Herein, we present a case of an epidermoid cyst that caused breakdown of a thigh PTFE dialysis graft, which became infected and encapsulated the femoral anastomosis.

An immediate access dialysis graft designed to prevent needle-related complications: Results from the initial pre-clinical studies

Introduction: No technology has been specifically developed with the intent to reduce needle-related vascular access injuries; a significant source of complications and abandonment. We present the initial pre-clinical study results of a novel, self-sealing, immediate cannulation dialysis graft that aims to prevent needle-related complications; to promote safe, reliable needle access; to reduce catheter use; and could facilitate home hemodialyisis. Methods: The innovative graft design consists of two cannulation chambers with self-sealing properties and materials that prevent side and back wall needle puncture. Study and control grafts (expanded polytetrafluoroethylene) were implanted in one pig and 10 sheep in two studies over the course of 1 year. First cannulation occurred immediately post implant for all study grafts. Post-cannulation time to hemostasis, hematoma and seroma formation, infection, and patency were recorded. Results: The two studies account for nearly 60 weeks (average 6.4 weeks/graft) of study graft follow-up. In the ovine study, average study graft time to hemostasis was 27.3 s (standard deviation = 26.3, range = 0–120), and the control averaged 177.2 s (standard deviation = 113.4, range = 60–600), p < 0.0001. Secondary patency was 75% and 67% for the study and control grafts, respectively. Neither study nor control groups experienced seroma, graft infections, or deaths. Discussion: All novel grafts in the studies were implanted successfully and functioned as intended. There were no complications related to tunneling of the study graft and the chamber prevented back/side wall needle injury. This novel technology may help to mitigate these needle-related complications, while allowing for early/immediate cannulation which could also reduce catheter contact time.