GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is not authorized for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts in Canada.

A case study using the VIABAHN® Device 

 

Challenge 

  • 77-year-old female with end-stage renal disease on hemodialysis via a right upper extremity axillary artery to axillary vein ePTFE loop graft
  • Presented after unsuccessful attempt at dialysis due to an occluded graft
  • Relevant patient history:
    • Access was created four months prior to presentation
    • Venogram performed two months prior to presentation for pulsatility and recirculation demonstrated venous anastomotic tenosis, for which drug-eluting balloon venoplasty was performed
Angiogram

Image: Balloon angioplasty during clot maceration of a thrombosed upper arm graft reveals tight stricture at the venous anastomosis. The same lesion was previously treated two months prior.

Images courtesy of Thomas Ward, M.D. Used with permission.  

Procedure 

  • Initial ultrasound images demonstrated the length of the graft to be occluded. Antegrade and retrograde access was obtained.
  • Pharmacological thrombolysis was performed with 4 mg tPA followed by balloon maceration across the length of the graft
  • Contrast was injected via the antegrade sheath, demonstrating persistent moderate stenosis
  • Given short-term recurrence and graft occlusion, an 8 mm x 7.5 cm VIABAHN® Device was deployed to treat the recurrent venous anastomotic stenosis 
Angiogram

Image: Persistent stenosis at the venous anastomosis after balloon angioplasty.

Images courtesy of Thomas Ward, M.D. Used with permission.

Result

  • Completion AV graft venogram demonstrated the graft and venous outflow stent to be widely patent
  • A brisk thrill was palpated
  • Patient had successful hemodialysis immediately following the procedure and dialysis access circuit remains patent 
Angiogram

Image: Brisk thrill re-established after placement of 8 mm x 7.5 cm VIABAHN® Device.

Images courtesy of Thomas Ward, M.D. Used with permission. 

Case Takeaways

  • The VIABAHN® Device remains an excellent option for percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft
  • In this patient with short-term recurrent stenosis after drug-eluting balloon venoplasty, use of the VIABAHN® Device aided in re-establishing access circuit patency

 

See additional clinical information

Related case study

 

Management of vascular graft stenosis in a patient with recurrent thrombosis

Submitted by Daniel V. Patel, M.D.
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The outcomes and observations reported are based on individual case experience and the patients treated. The steps described here may not be complete, and are not intended to be a replacement for the Instructions for Use (IFU) or the education, training and professional judgment of health care providers (HCP). HCPs remain solely responsible for making decisions about patient care and the use of medical technologies.

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.

INDICATIONS FOR USE IN CANADA: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries. 

CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with PROPATEN 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 PROPATEN 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.

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