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Early cannulation prosthetic graft (Flixene™) for arteriovenous access
A Frederick Schild1, Earl S Schuman, Karlene Noicely
11Florida International University Herbert Wertheim College of Medicine, Miami, FL, USA. afschild@fiu.edu
The Journal of Vascular Access
|February 15, 2011
Summary
The novel Flixene™ graft allows early hemodialysis (HD) access within 72 hours, proving safe and effective for patients unsuitable for fistulas. This vascular graft maintains patency and reduces complications like pseudoaneurysms.
Area of Science:
- Vascular Surgery
- Nephrology
- Biomaterials Science
Background:
- Autologous fistulas are the preferred hemodialysis (HD) access, but vascular grafts are necessary for patients with unsuitable vessels.
- Conventional vascular grafts require 2-3 weeks for maturation before access, and their structure can lead to complications from repeated cannulation.
- Existing grafts are not optimized for early cannulation, increasing reliance on HD catheters and associated risks.
Purpose of the Study:
- To evaluate the safety and efficacy of the Flixene™ graft for early cannulation (24-72 hours) in patients with failed fistula attempts.
- To assess if the Flixene™ graft maintains patency rates comparable to existing polytetrafluoroethylene (PTFE) grafts.
- To determine if the Flixene™ graft's design reduces the incidence of pseudoaneurysms and seromas.
Main Methods:
- A prospective, two-center study involving 33 patients who received 33 Flixene™ grafts.
- Evaluation of graft efficacy, post-operative complications, patency rates, and ease of cannulation.
- Documentation of dialysis center complications related to early cannulation, with a six-month follow-up period.
Main Results:
- Successful access was achieved in all 33 patients within 72 hours, with 29 patients accessed within 24 hours.
- Overall primary patency at six months was 49%, and primary-assisted patency was 80%.
- No pseudoaneurysms or seromas were observed at the six-month follow-up; complications were typical for graft access.
Conclusions:
- The Flixene™ graft enables successful early cannulation in all patients, serving as a viable alternative for those unable to receive an arteriovenous fistula.
- Six-month patency rates for the Flixene™ graft are comparable to those reported for other PTFE grafts.
- The Flixene™ graft design effectively prevents pseudoaneurysm and seroma formation, offering an advantage over traditional grafts and potentially reducing the need for HD catheters.
