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

Abstract

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.

Keywords: Immediate access; arteriovenous graft; cannulation chamber; catheter time; early cannulation; end-stage renal disease; graft injury; home dialysis; needle injury; needle protection; self-sealing.

Conflict of interest statement

Declaration of conflicting interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.M.G. is a current employee of InnAVasc Medical, the company developing the technology reported in this manuscript. S.M.G. is co-inventor of the technology, founder of the company, and owns stock in InnAVasc. J.R.R. and K.A.I. are investigators in InnAVasc’s current clinical study and their site receives payments from InnAVasc related to the conduct of clinical research. J.R.R. and K.A.I. have no additional relevant conflicts of interest to disclose.

Figures

Figure 1.

Rendering of the InnAVasc Graft (Gen. 1.0) “straight” configuration. The chambers are designed with a raised cannulation zone indicator on top to denote the safe cannulation zone. If the dialysis needle is placed in this zone it cannot penetrate through the back or sidewall of the graft and the needle tip will remain in the flow lumen. Note the flattened bottom of the chamber to provide orientation and to prevent rotation in the tunnel. The chambers are closer together in the “straight” configuration so as to allow for placement in a straight or soft “C” geometry in the upper arm (consistent with the configuration in this case report). The chambers are arranged further apart in the looped configuration (not shown) to allow for adequate placement in a looped geometry in the upper or lower arm.

Figure 2.

(a) InnAVasc Graft immediately post implant. 16ga dialysis needles have been placed into each cannulation chamber during the operation to perform a completion angiogram. (b) Completion angiogram performed while in the operating room to verify proper placement of the graft and to, rule out any technical graft abnormalities such as kinking or twisting.

Figure 3.

(a) Case report subject with giant, aneurysmal, thrombogenic fistula prior to InnAVasc Graft placement. (b) Subject 3 weeks post InnAVasc Graft placement and use (approximately nine punctures per chamber). (c) Subject 10 months post InnAVasc Graft placement and use (approximately 120 punctures per chamber). (d) Angiogram of InnAVasc Graft after 10 months of use for hemodialysis (~120 punctures per chamber) without evidence of hematoma, seroma, intragraft defects, or pseudoaneurysm formation.