Case submitted by Chris Metzger, M.D.

Kingsport, Tennessee

Challenge 

  • A 57-year-old male with severe intermittent claudication (Rutherford category 3).
  • TASC II B lesion in the right common iliac artery (CIA) and focal iliac calcification.
  • Relevant patient history:
    • Current smoker with hypertension, hyperlipidemia and previous diagnosis of peripheral artery disease in the right limb that was treated with medication.
    • Baseline ankle-brachial index (ABI) = 0.76. 
VBX Prelmplant


Focal calcification in the right CIA.  
Images courtesy of Chris Metzger, M.D. Used with permission. 

Procedure

  • Started with bilateral access, identified focal lesion in the distal right CIA that was ~80% stenosed.
  • Angiography showed robust multi-vessel distal runoff down to the foot.
  • Predilated with a 5 × 20 mm ABBOTT® ARMADA PTA Balloon, observed presence of calcification nodule that prevented full dilatation of the percutaneous transluminal angioplasty (PTA) balloon.
  • Delivered and deployed an 8 mm × 39 mm GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft).
  • Slight residual stenosis observed following VBX Stent Graft deployment.
  • Post-dilatation performed using a 7 × 20 mm ABBOTT® ARMADA PTA Balloon inflated to 14 atm (near rated burst pressure).
  • Final angiogram showed complete restoration of patency in the right CIA with good distal outflow. 
Left Coronary
Abdomen


GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis deployment and post-dilatation.
Images courtesy of Chris Metzger, M.D. Used with permission. 

Result

At discharge, the patient’s ABI was 1.0. At 3-year follow-up, ABI was measured at 0.99 and patient was Rutherford 0 with no report of pain/discomfort or problems with mobility.

Complete restoration of patency


Complete restoration of patency.
Images courtesy of Chris Metzger, M.D. Used with permission. 

Case Takeaways 

Calcified lesions present challenges in endovascular treatment of aortoiliac occlusive disease, including an increased risk of rupture. The VBX Stent Graft provides a barrier that mitigates concerns about neointimal hyperplasia and provides high radial strength to restore patency in even the most calcified lesions.1 

  1. Bismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal study of a next-generation balloon-expandable stent-graft for treatment of iliac occlusive disease. Journal of Endovascular Therapy 2017;24(5):629-637.

Procedural outcomes based on usage of legacy GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. (BXA catalogue numbers).

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 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.

ABBOTT and ARMADA are trademarks of Abbott Vascular. 

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 

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of:  

  • de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation;  
  • de novo or restenotic lesions in the visceral arteries;  
  • isolated visceral, iliac, and subclavian artery aneurysms; or  
  • 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).  

The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for use as a bridging stent in branched and fenestrated endovascular aortic aneurysm repair with the following: 

  • Approved for use branched aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and polypropylene suture with branch diameters of 6/8 mm and lengths of 18/21 mm.  
  • Approved for use fenestrated aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and fenestrations with polypropylene suture ranging in diameter from 6–8 mm. 

CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.

 

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis with Reduced Profile:

INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of: 

  • de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation;  
  • de novo or restenotic lesions in the visceral arteries;  
  • isolated visceral, iliac, and subclavian artery aneurysms; or
  • 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: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 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.
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