Three-Year Experience with Modular Stent-Graft Devices for Endovascular AAA Treatment

Abstract

Purpose: To evaluate feasibility and present early results of endovascular abdominal aortic aneurysm (AAA) exclusion using modular stent-grafts. Methods: In a 3-year period ending July 1997, 201 patients were treated with self-expanding stent-grafts for AAAs with infrarenal necks ≥ 10 to 15 mm long and ≤ 32 mm wide; subtotal mural thrombus, calcification, and even angulation to some extent were acceptable, as were iliac arteries up to 18 mm wide. The patients were treated with either the Stentor/Vanguard device (178 cases) or the Talent endograft (23 cases). Follow-up on all patients was conducted at 3, 6, 12, 18, and 24 months. Results: The technical aneurysm exclusion rate was 89% (178/201). There were 18 primary endoleaks (9.0%; 2 proximal, 16 distal), 4 (2.0%) conversions to open surgery, and 1 (0.5%) failure to deploy the graft. Seven (3.5%) patients died in the perioperative period, 5 due to multiorgan failure early in the series and two of hemorrhagic complications. Five (2.5%) renal artery occlusions were encountered; in one case, the graft was removed after 3 weeks. Nineteen late endoleaks were found in follow-up, related primarily to the iliac limb graft extensions of the Stentor device, graft material problems, or unknown causes. To date, 10 primary and 13 secondary endoleaks have been treated endovascularly. Twenty (10.0%) graft-limb thromboses were treated either by thrombolysis, thrombectomy, or a femorofemoral bypass. Conclusions: Endovascular grafting is technically feasible and becomes easier with improvements of the introducer systems and the grafts. The seemingly high complication rate in this series is due to the liberal patient selection criteria.