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 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*,† 

Challenge 

  • 48-year-old male with end stage renal disease secondary to hypertensive nephrosclerosis and diabetic nephropathy  
    • Relevant patient history:  
      • Diabetes mellitus, chronic anemia, paroxysmal atrial fibrillation, coronary artery disease, hypertension, hyperlipidemia, COPD, tobacco use  
      • Left brachioaxillary arteriovenous (AV) graft 4-7 mm implanted June 26, 2018. Two revisions, April 8, 2019 and August 23, 2019, each with an BD® ULTRASCORE® Focused Forced PTA Balloon followed by a 9 mm x 40 mm BD® LUTONIX® 035 Drug Coated Balloon PTA Catheter  
  • Presented after two failed percutaneous transluminal angioplasty (PTA) revisions of the venous anastomosis of an arteriovenous graft, preventing successful hemodialysis. 
Fistulography with recurrent stenosis noted at venous outflow anastomosis.

Image: Fistulography with recurrent stenosis noted at venous outflow anastomosis.

Images courtesy of Nicolas Mouawad, M.D. Used with permission.

Procedure 

  • Planned definitive treatment with outflow stenting  
  • Advanced the TERUMO® RADIFOCUS® GLIDEWIRE® ADVANTAGE .035" Guidewire across the target lesion (Left image) 
  • Pre-dilated the stenotic lesion with an 8 x 40 mm MEDTRONIC EVERCROSS PTA BALLOON Catheter (Left image) 
  • Placed a 9 mm x 5 cm .035" guidewire compatible low profile VIABAHN® Device (Right image) 
  • Post-dilated with a 9 x 40 mm MEDTRONIC EVERCROSS PTA BALLOON Catheter PTA (Right image) 
Combined angiogram

Left image: Lesion preparation with pre-dilatation using 8 x 40 mm noncompliant balloon.  

Right image: Post-PTA outflow fistulography in preparation for VIABAHN® Device deployment. 

Images courtesy of Nicolas Mouawad, M.D. Used with permission. 

Result

Excellent outflow without any recurrent complication at eight months post-intervention. 

Fistulogram following stent deployment with complete resolution of stenosis

Image: Fistulogram following stent deployment with complete resolution of stenosis. 

Images courtesy of Nicolas Mouawad, M.D. Used with permission. 

Case takeaways

The outcome of this case aligns to the well-established findings that the VIABAHN® Device offers value through reduced frequency of repeat interventions as compared to PTA.1 

Enhanced access and visibility in challenging anatomies is enabled by a low profile and radiopaque markers on the proximal and distal ends of the device.

At eight months post-placement, the VIABAHN® Device has exceeded results achieved with prior PTA treatments; primary patency of the stent graft is maintained, with no circuit reinterventions post VIABAHN® Device placement to date. 

 

Diagram of GORE VIABAHN Endoprosthesis results
See additional clinical information

Related case studies

* 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. 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

BD, LUTONIX and ULTRASCORE are trademarks of Becton, Dickinson and Company. 

MEDTRONIC and EVERCROSS are trademarks of Medtronic, Inc. 

TERUMO and RADIFOCUS are trademarks of Terumo Medical Corporation. 

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 market 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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