Bovine Carotid Artery Biologic Graft and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

Not Applicable

Terminated

Interventions: Device: Bovine Carotid Artery Graft
Device: Expanded polytetrafluoroethylene Graft

Brief Summary: The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.

Detailed Description: Arteriovenous grafts (AVG) remain reliable substitutes for permanent hemodialysis access in scenarios that preclude the placement of arteriovenous fistulae. There is scarcity of evidence to support the current preference of synthetic conduits over biologic grafts in clinical practice. Advances in the design of AVG's warrant contemporary comparisons between synthetic and biologic AVG options. This is especially important as biologic conduits may confer an advantage by virtue of their inherent similarity to the native human vasculature.

The overall goal of this project is to compare one and two year patency (functional, primary, primary assisted and secondary), complication rates and re-intervention rates between BCA and standard ePTFE grafts. The investigators hypothesize that vascular patient who will receive the BCA graft will have improved patency as well as lower complication and re-intervention rates compared to the standard ePTFE graft.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Eligible to receive an Arterio-Venous-Fistula
Known allergic reaction or history of intolerance to any ePTFE or BCA components
Local infection at AVG placement site at the time of surgery
Patients with a bleeding disorder or who refuse blood transfusion
Patients with an active malignancy
Life expectancy less than 1 year
Pregnant women or those planning on becoming pregnant for the duration of the study

Arm && Interventions

Group	Intervention	Description
Bovine carotid Artery Graft	Bovine Carotid Artery Graft	The bovine carotid artery biological grafts (Artegraft®; Artegraft, Inc., North Brunswick, NJ) consist of a biological fibrous matrix processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant.
Expanded polytetrafluoroethylene (ePTFE)	Expanded polytetrafluoroethylene Graft	The ePTFE grafts used are the Flixene (Maquet-Atrium Medical, Hudson, NH), Advanta VXT (Maquet-Atrium), GORE-TEXStretch Vascular Graft For Vascular Access (W. L. Gore and Associates, Flagstaff, Ariz), or Venaflo (Bard Peripheral Vascular, Tempe, Ariz). The choice of graft used is at the surgeons' discretion. The graft it is offered in both large and small diameters, as well as thin-wall and rapidly-tapering designs for cases where arterial steal syndrome is a potential complication. A 6 mm graft featuring external supporting rings in 5 cm centered or 7 cm offset sections enables tight loop configurations and crossing the cubitus. A 4-7 mm tapered graft with 10 or 15 cm of removable rings allows for tailoring or exact placement of the ringed section.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Primary Graft Patency	Two years after Graft Placement	Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).
Percentage of Patients With Primary-Assisted Graft Patency	Two years after Graft Placement	Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.
Percentage of Patients With Secondary Graft Patency	Two years after Graft Placement	Secondary patency is defined as the interval from graft placement to graft failure.
Percentage of Patients With Functional Patency	Two years after Graft Placement	Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Surgical Site Infection	At 24 months after Graft Placement	The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.
Incidence of Pseudoaneurysms Formation at the Access Site	At 24 months after Graft Placement
Steal Syndrome	At 24 months after Graft Placement	Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.
Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft	At 24 months after Graft Placement	At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention