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Longevity on dialysis depends on reliable vascular access1

Percutaneous transluminal angioplasty (PTA) presents significant limitations when treating arteriovenous (AV) access lesions. In fact, with each successive PTA procedure, patency rates diminish.2,3


As PTA effectiveness diminishes, intervention frequency increases2,3

In 1 survey, 57% of hemodialysis patients cited "the time dialysis takes out of my life" as their biggest frustration.4 Where possible, minimizing the frequency of access-related procedures may help optimize the patient experience.
 

New peer perspectives

Hear fellow physicians share their perspectives on PTA and the potential to improve the dialysis experience for patients.

 

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      PTA as a first-line treatment can be helpful, but with recoil and the challenges we see with these patients, you really need to come up with something more definitive.

      Nicolas Mouawad, M.D.

      Breaking the stenosis cycle

      "Repeatedly reinjuring the vessel with angioplasty stimulates an injury-healing cycle, potentially leading to more exuberant neointimal hyperplasia and more rapid or severe restenosis."

      Theodore Saad, M.D.

      In treatment of > 50% AVG stenosis, the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*,† had nearly 50% higher primary patency at 6 months than PTA alone.3
      Target lesion2
      AVG circuit2
      Image
      relative improvement over PTA

      47%

      relative improvement over PTA

      48%

      relative improvement over PTA

      Changing course in stenosis with thrombosis

       

      "The challenge of treating a graft-vein anastomosis stenosis in a thrombosed access with PTA alone is the risk for recurrent short-term thrombosis."

      Daniel Patel, M.D.

       
      Thrombosed graft lesions treated with the VIABAHN® Device required fewer reinterventions and drove lower costs versus PTA at 2 years.5
      Reinterventions5
      nurse-black

      40% fewer reiterventions5

      Image
      Reinterventions chart

      Fewer reinterventions resulted in $11,943 savings (on average) in reinterventions costs per patient: $19,322 vs. $31,265 (P < .001)

      Total costs5
      lowering-costs-red

      18% reduction in total lesion treatment costs5

      Image
      Reinterventions total costs chart

      Compared to total 2-year treatment costs with PTA only ($37,206), treatment with the VIABAHN® Device ($30,329) becomes more cost-effective at 15-months post-placement, generating $6,977 in total cost savings per patient.

      Key KDOQI Recommendations:1

      KDOQI recommends stent graft use in preference to angioplasty alone for recurrent clinically significant AVG stenosis and thrombotic AVG lesions.1

      hospital-black

      Stent grafts in preference to angioplasty alone

      for recurrent clinically significant stenotic and recurrent thrombotic AVG lesions.

      target-idea-black

      Target goal of ≤ 3 interventions

      annually to maintain the access.

      Not allowed

      Avoid use of bare metal stents

      for the treatment of significant AVG and AVF stenotic lesions


      * 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.

      1. 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. https://www.ajkd.org/article/S0272-6386(19)31137-0/fulltext
      2. 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
      3. Kanterman RY, Vesely TM, Pilgram TK, Guy BW, Windus DW, Picus D. Dialysis access grafts: anatomic location of venous stenosis and results of angioplasty. Radiology 1995;195(1):135-139.
      4. Dialysis Access TAC, Physician and Patients Quantitative Research Report, April 2019. n=104
      5. 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.https://www.jvir.org/article/S1051-0443(18)31772-X/fulltext
      IFU Consult instructions

      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

      INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. 

      CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.