Endovascular treatment of chronic superficial femoral artery (SFA) occlusion for limb salvage
A case study using the GORE® VIABAHN® Endoprosthesis with PROPATEN 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
Image: Proximal SFA disease and mid-SFA occlusion
Image courtesy of James Persky, M.D. 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
Image: Post-placement of three 5 mm VIABAHN® Devices
Image courtesy of James Persky, M.D. 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
Image: Post-placement of three 5 mm VIABAHN® Devices
Image courtesy of James Persky, M.D. 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
* As used by Gore, PROPATEN Bioactive Surface refers to Gore's proprietary CBAS® Heparin Surface.
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.
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.