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Challenge

  • A 70-year-old male on hemodialysis (HD) via a left brachiocephalic fistula created three years previous
  • One de-clotting procedure three months previous, where a cephalic arch stenosis was identified and treated successfully with balloon venoplasty
  • Increased venous pressures on HD two months later – therefore repeat procedure / intervention
Image
Before Cephalic arch stenosis


Image courtesy of Robert Jones, M.D. Used with permission.

Procedure

Direct left brachiocephalic fistula access. Venography demonstrated recurrent cephalic arch stenosis. Venoplasty to 7 mm with a high-pressure balloon and recoil stenosis. Upsizing of sheath access. Deployment of a 7 mm x 5 cm GORE® VIABAHN® Device, and post-dilatation.

Image
After deployment of GORE VIABAHN Endoprosthesis


Image courtesy of Robert Jones, M.D. Used with permission.

Result

A good result was achieved and the subclavian / axillary vein was not compromised. Follow up venography at three months demonstrated on-going patency.

Image
Fistulogram at 3 months


Image courtesy of R Jones, Interventional Radiologist, Birmingham, UK. Used with permission.

Case Takeaways 

  • Symptomatic and recoil cephalic arch stenosis requires a durable solution to restore and maintain patency  
  • Cephalic arch is a notoriously difficult area to treat in the dialysis circuit. High rates of treatment failure and recurrent stenosis are seen with venoplasty alone  
  • When venoplasty fails the GORE® VIABAHN® Device offers a durable solution as it conforms very well to the anatomical configuration of the arch without kinking  
  • It is possible to accurately deploy a GORE® VIABAHN® Device in the cephalic arch without significant compromise to the axillary vein
  • Device introduction from the fistula access (as opposed to femoral access) provides more precise control during deployment and allows more accurate positioning as the GORE® VIABAHN® Device deploys distal – proximal  
  • ESVS guidelines recommend that endovascular treatment with stent grafts should be considered for the treatment of cephalic arch stenosis (Recommendation 63)1

Related case study

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Treating a thrombosed arteriovenous (AV) access graft with the VIABAHN® Device

Submitted by Thomas Ward, M.D.

1. Schmidli, J. et al., Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS), European Journal of Vascular and Endovascular Surgery 2018 Jun;55(6):757-818 

IFU Consult instructions

Refer to Instructions for Use at eifu.goremedical.com or a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly 

INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of: 

  • de novo or restenotic lesions in the iliac arteries
  • de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
  • stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
  • popliteal artery aneurysms and isolated visceral artery aneurysms
  • traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) 

CONTRAINDICATIONS:

  • 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.
Product may not be available in all countries. Please check with your Gore representative for availability.