Key result
GORE Excluder Conformable achieves 100% technical success in unruptured AAAs with hostile neck anatomy.
Why the study?
Abdominal aortic aneurysms with hostile neck anatomy are associated with increased perioperative risk and mortality, and many patients are unsuitable for standard EVAR or high-risk for open surgery.
Does the GORE Excluder Conformable AAA endoprosthesis provide safe and effective repair in patients with non-ruptured AAAs demonstrating hostile neck anatomy?
Observational (n=24)
No
Does the GORE Excluder Conformable AAA endoprosthesis provide safe and effective repair in patients with non-ruptured AAAs demonstrating hostile neck anatomy?
The conformable aortic stent-graft demonstrated 100% primary technical success and 12-month survival in patients with unruptured AAAs and hostile neck anatomy, though 21% required re-intervention.
Supports feasibility in hostile-neck AAA; leaves open durability, safety, and broader applicability pending larger trials.
Objectives Abdominal aortic aneurysms (AAAs) demonstrating hostile neck anatomy (HNA) are associated with increased perioperative risk and mortality. A number of these patients are not suitable for standard endovascular aneurysm repair (EVAR) and are high risk for open surgery. We present our experience with the first implantations in Scotland of a novel conformable aortic stent-graft designed to overcome some of the challenges of HNAs. Methods From May 2018 to March 2022, 24 consecutive patients with non-ruptured AAAs demonstrating HNAs (neck length < 15 mm, or angulation > 60°) were treated with GORE Excluder Conformable AAA endoprosthesis (CLEVAR) (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) at a Scottish vascular centre. We assessed clinical outcomes and technical success of CLEVAR during deployment, primary admission and the post-operative period at 3- and 12-month clinical follow-up alongside CT angiography. Results Twenty-four patients (20 males, mean age 75.6) were included. Primary technical success of proximal seal zones and CLEVAR deployment (no type 1/3 endoleaks, no conversion to open repair, AAA excluded and patient leaving theatre alive) was achieved in 100% of patients. All patients were alive and clinically stable at 3- and 12-month follow-up. There were five patients requiring re-intervention; at the 3-month follow-up, one patient (4.2%) developed a type 1b endoleak requiring graft limb extension, one patient developed a right common femoral artery dissection requiring open repair and one patient required a limb extension of the right iliac limb due to risk of developing a type 1b endoleak. At the 12-month follow-up, two patients required embolization of type 2 endoleaks and no patients demonstrated type 1 or type 3 endoleaks. Conclusions: In-hospital and post-operative 3- and 12-month clinical and angiographic outcomes demonstrate safety and efficacy with CLEVARs in treating unruptured AAAs with HNA. Further research involving larger heterogenous sample sizes is warranted to determine long-term clinical outcomes.
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Lee et al. (2022) conducted an observational in Abdominal aortic aneurysms with hostile neck anatomy (n=24). GORE Excluder Conformable AAA endoprosthesis (CLEVAR) was evaluated on Primary technical success of proximal seal zones and CLEVAR deployment. The GORE Excluder Conformable AAA endoprosthesis achieved 100% primary technical success in 24 patients with unruptured abdominal aortic aneurysms and hostile neck anatomy.
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