Treating severe aortoiliac occlusive disease (AIOD) at the aortic bifurcation
Restoring flow to a patient with stenosis at the aortoiliac bifurcation
Restoring flow in a patient with severe claudication and focal iliac calcification

Treating severe aortoiliac occlusive disease (AIOD) at the aortic bifurcation

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Case submitted by Jean Panneton, M.D.
Norfolk, Virginia

Challenge

• 73-year-old female presented with bilateral buttock, thigh, calf and foot claudication. 
• Femoral pulses not palpable bilaterally.
• Relevant patient history:
  • Breast cancer, hypertension, hyperlipidemia
  • Former heavy smoker
• Baseline ankle-brachial index (ABI) = 0.49 bilaterally.

Figure 1. Aortoiliac occlusive disease at aortic bifurcation.

Procedure

• Angiography revealed severe calcification of the bilateral common iliac arteries with anterior tibial and posterior tibial run-off to the right foot and posterior tibial run-off to the left foot (TASC II D lesion).
• Deployed two 6 x 39 mm GORE^® VIABAHN^® VBX Balloon Expandable Endoprostheses (VBX Stent Graft) simultaneously in a kissing stent technique (Figure 2).
• Follow-up angiogram showed successful deployment and brisk distal run-off (Figure 3).

Result

• Post-procedure follow-up revealed resolution of claudication symptoms. Right ABI = 1.01, Left ABI = 0.98.
• At six-year follow-up, patient remained asymptomatic with normal ABI bilaterally (Figure 4).

Figure 4. Six-year follow-up ABI. Left = 1.05, Right = 1.14.

Case takeaways

Complex AIOD can be managed via endovascular means with sustained long-term clinical durability. The COBEST trial demonstrated the benefits of using covered stents over bare metal stents for TASC II C and D aortoiliac lesions.¹ The Gore VBX FLEX Clinical Study evaluated the safety and effectiveness of the VBX Stent Graft for the treatment of AIOD with freedom from target lesion revascularization (fTLR) in kissing stents at one and three years, 96.6% and 92.1%, respectively.*

This case highlights the use of the VBX Stent Graft for the treatment of advanced calcific aortoiliac lesions as both safe and effective in appropriate patients with excellent long-term durability.

Restoring flow to a patient with stenosis at the aortoiliac bifurcation

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 

Case submitted by Masahiko Fujihara, M.D.
Osaka, Japan

Challenge

• 78-year-old female with severe intermittent claudication (Rutherford 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

Calcified nodule at the aortoiliac bifurcation

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 Devices (VBX Stent Graft) using 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

Result:

• The patient was discharged with a full ankle-brachial index recovery and no remaining symptoms.

Fully expanded GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis across the calcified segment

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.

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 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.

Focal calcification in the right CIA

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.
• Pre-dilated 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.

Result:

At discharge, the patient’s ABI was 1.0. At three-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

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