A case study using the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*,† 

Challenge

  • 83-year-old female with ischemic gangrene of right great toe (Rutherford 6)
  • Relevant patient history:
    • Diabetes, hypertension, dyslipidemia, obesity, coronary artery disease, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease (COPD)
    • Ankle-brachial index (ABI) supra-systemic due to calcified tibial arteries
    • Pulse volume recordings demonstrated femoropopliteal occlusive disease
Angiogram

Image: Proximal SFA disease and mid-SFA occlusion 

Image courtesy of James Persky, MD. Used with permission.

Procedure

  • Contralateral approach to right SFA (March 05, 2013)
  • Lesion crossed using straight TERUMO GLIDEWIRE® Guidewire, followed by placement of SPECTRANETICS® QUICK‑CROSS Support Catheter
  • Percutaneous transluminal angioplasty (PTA) with 5 mm angioplasty balloon
Angiogram

Image: Post-placement of three 5 mm VIABAHN® Devices

Image courtesy of James Persky, MD. Used with permission.

Result

  • Proximal device placed successfully at the ostium of the SFA
  • Correct sizing with 5 mm device
  • Excellent radiographic result
  • Patient’s ulcer healed after intervention
  • Stent graft patent through most recent available follow-up over 18 months post-procedure
Angiogram

Image: Post-placement of three 5 mm VIABAHN® Devices

Image courtesy of James Persky, MD. Used with permission. 

Case Takeaways 

  • Limb salvage by endoluminal bypass in Rutherford 6 limb
  • While initial PTA demonstrated a good result, diabetic patients have diffuse disease and the arteriogram understates the plaque burden in these patients
  • Cover healthy-to-healthy to the extent possible 

We opt for greater stent coverage beyond the segment of disease. We also employ oblique views of the take-off of the SFA so we can treat the diseased artery at the take-off of the SFA without compromising flow in the profunda femoris artery. 

James Persky, M.D., Cleveland, Ohio

See additional clinical information

* 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.

TERUMO and GLIDEWIRE® are trademarks of Terumo Medical Corporation.

SPECTRANETICS® and QUICK CROSS are trademarks of Spectranetics 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 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 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.

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