GORE® VIABAHN® Device family
Case Studies
Join the next generation of care in the treatment of aortoiliac occlusive disease
Restoring flow to a patient with stenosis at the aortoiliac bifurcation
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Case submitted by Masahiko Fujihara, M.D.
Challenge
- A 78-year-old female with severe intermittent claudication (Rutherford category 3)
- Bilateral common iliac artery stenosis (TASC II D lesions) originating at the aortic bifurcation
- Relevant patient history:
- Hypertension, hyperlipidemia, prior bilateral carotid artery stenosis
Procedure
- Gained bilateral access in the common femoral arteries
- Crossed lesions on both the left and right with .014” guidewires
- Dilated with a 2 mm diameter percutaneous transluminal angioplasty (PTA) balloon to allow for intravascular ultrasound examination
- Pre-dilation with 5 mm balloons in kissing balloon technique
- Exchanged to .035” stiff guidewires and 7 Fr long sheaths
- Deployed two 7 mm x 79 mm GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis using a kissing stent technique
- Due to significant calcification, post-dilated first with two 8 mm x 40 mm PTA balloons
- Sequential post-dilation of VBX Stent Grafts proximally with a 10 mm x 20 mm PTA balloon followed by final post-dilation with kissing 8 mm x 40 mm PTA balloons
- Confirmed successful result using intravascular ultrasound and angiography
Results
- The patient was discharged with a full ankle-brachial index recovery and no remaining symptoms.
Case takeaways
The VBX Stent Graft provides durable outcomes in highly calcified lesions. The performance of the VBX Stent Graft allows device customization to the anatomy (6-11 mm for 7 mm x 79 mm device) and provides radial strength to achieve luminal gain while potentially mitigating the risk of rupture and perforation.
Images courtesy of Masahiko Fujihara, M.D. Used with permission.
Restoring flow in a patient with severe claudication and focal iliac calcification
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
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.
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 x 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 x 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 x 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.
Results
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.
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
Images courtesy of Chris Metzger, M.D. Used with permission.
- 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.
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
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface
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.
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 found in 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.