Case Studies for GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System
Confidence in hostile aortic neck anatomy
A case study using the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System.
Experience proven precision in EVAR
See how the EXCLUDER® Conformable device enables precise placement and maximum aortic neck seal in an angulated, short neck.
Case submitted by James R. Ballard, MD
Bend, Oregon
Challenge
- 72-year-old male presented with saccular abdominal aortic aneurysm (AAA).
- Steep-angled proximal aortic neck and short aortic neck length with bilateral tortuous iliac arteries (Figure 1 and 2).
- Infrarenal aortic neck length: 12mm
- Measured using centerline. Right and left renal arteries take off roughly on the same level.
- Intraoperative challenge:
- Due to the steep AP angulation of aortic neck, remove parallax to obtain visualization of the renal arteries.
Procedure
- Common femoral arteries accessed with typical endovascular techniques.
- Advanced an 18 Fr GORE® DRYSEAL Flex Introducer Sheath on right side over an Amplatz Super Stiff™ Guidewire (long floppy tip), followed by a 32x14x14 EXCLUDER® Conformable AAA Endoprosthesis.
- Advanced a 12 Fr sheath on left side, followed by an angiographic catheter placement in the infrarenal aorta. Aortography demonstrated the previously described steep, short aortic neck (Video 1).
- EXCLUDER® Conformable Device was placed more proximally than final target position, then primary deployment was initiated over stiff portion of the wire (Video 2). No angulation control was used during primary deployment.
- EXCLUDER® Conformable Device was reconstrained and repositioned, moving distally towards target position (Video 3).
- The contralateral gate of the EXCLUDER® Conformable Device was crossed toward patient right and was cannulated from the left. An 18x14 GORE® EXCLUDER® AAA Contralateral Limb Endoprosthesis was advanced into contralateral gate and deployed.
- Deployment of the ipsilateral leg EXCLUDER® Conformable Device was completed, and device was removed from the patient. A 16x14 GORE® EXCLUDER® AAA Contralateral Limb Endoprosthesis was advanced on patient right side into ipsilateral limb of the EXCLUDER® Conformable Device and deployed.
- Six Heli-FX™ EndoAnchor™ devices were prophylactically placed in the proximal aortic neck.
Procedure Videos
Results
Technical success was achieved and can be seen on completion angiography, demonstrating infrarenal neck seal and fixation in a highly angulated, short neck infrarenal AAA.
Case takeaways
- Due to the highly-angulated neck, sizing the EXCLUDER® Conformable Trunk-Ipsilateral Device using the maximum aortic neck diameter on centerline (instead of average diameter), ensured the device selected is based off of the widest part of the lumen, reducing the risk of undersizing, which has been associated with type 1a endoleaks.
- Orienting the EXCLUDER® Conformable Trunk-Ipsilateral Device toward the left side of the patient aided in keeping the device high on the right side at the level of the renal arteries. Each time the device was reconstrained and pulled down, the device stayed high on the right while pulling down on the ipsilateral side toward patient left to achieve orthogonality.
- In this case, the proximal portion of the EXCLUDER® Conformable Device was carefully ballooned to ensure fixation of the stent graft infrarenally. According to the IFU, for angulated proximal aortic necks, ballooning the proximal region of the trunk is at the discretion of the physician.
- The unique multi-stage deployment and reconstraining mechanism of the EXCLUDER® Conformable Device allowed for starting deployment more proximally, then repositioning the device. These device features allowed for precise placement at the target position, achieving maximum aortic neck seal.
Related Pages
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
INDICATIONS FOR USE: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below: Adequate iliac/femoral access; Infrarenal aortic neck treatment diameter range of 16-32 mm and a minimum aortic neck length of 10 mm; Proximal aortic neck angulation ≤ 90°; Iliac artery treatment diameter range of 8-25 mm and iliac distal vessel seal zone length of at least 10 mm. Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components are intended to be used after deployment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired.
CONTRAINDICATIONS: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is contraindicated in: patients with known sensitivities or allergies to the device materials. All components of the GORE® EXCLUDER® Conformable Endoprosthesis contain expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), nitinol (nickel-titanium alloy) and gold. Patients with systemic infection who may be at increased risk of endovascular graft infection.