Thrombosed AV grafts
Not indicated for use in Canada.
Arteriovenous (AV) access grafts that have thrombosed are often associated with worse outcomes than those that are stenosed1
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The 2019 KDOQI guidelines for vascular access specify a target goal of ≤ three interventions annually to maintain access2:
- In support of achieving this goal, KDOQI recommends stent grafts in preference to angioplasty alone for recurrent thrombotic AV access lesions.
There are a limited number of randomized trials to help guide evidence-based treatment decisions for patients with thrombosed grafts
- In the Gore REVISE Clinical Study, 43% of patients in the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*† arm of the study enrolled with a thrombosed graft.1
Before
Treatment of stenosis at the venous anastomosis of a synthetic graft.
Images courtesy of Thomas Ward, M.D. Used with permission.
After
Post-placement of 8 mm x 7.5 cm GORE® VIABAHN® Endoprosthesis.
Images courtesy of Thomas Ward, M.D. Used with permission.
The GORE® VIABAHN® Endoprosthesis has proven success when treating thrombosed grafts1, 2
Proven patency
- Exceeded KDOQI minimum guidelines for three-month circuit primary patency for thrombotic patients (48%) whereas percutaneous transluminal angioplasty (PTA) did not (39%).1,2
- Increased primary patency in thrombosed grafts of both the target lesion and the circuit by ~50% when compared to PTA at six months.1
Fewer reinterventions
- Lowered the mean number of interventions over two years by 40% in thrombosed grafts.3
AV access maintenance challenges
- The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface† has proven success in the most challenging AV access cases, including early PTA failures, lesions at points of flexion, and in thrombosed grafts.
* As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.
† Also referred to as the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in some regions.
- Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. Journal of Vascular Surgery 2016;64(5):1400-1410.e1. http://www.sciencedirect.com/science/article/pii/S0741521416301756
- Lok CE, Huber TS, Lee T, et al; KDOQI Vascular Access Guideline Work Group. KDOQI Clinical Practice Guideline for Vascular Access: 2019 update. American Journal of Kidney Diseases 2020;75(4)Supplement 2:S1-S164.
- Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and economic benefits of stent grafts in dysfunctional and thrombosed hemodialysis access graft circuits in the REVISE Randomized Trial. Journal of Vascular & Interventional Radiology 2019;30(2):203-211.e4.
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
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