These midterm findings show a high degree of technical and procedural success achieved in a patient population with extensive comorbid medical illnesses with low perioperative morbidity and mortality rates. Further follow-up study will be necessary to determine the effectiveness of the Talent endograft for the long-term treatment of AAA.
Twenty-nine patients underwent placement of the Teramed Ariba Endovascular Graft System (Maple Grove, Minn) as part of a European Feasibility study (14 patients) and a US phase I trial (15 patients). Salient features of this modular endograft system include a crimped seamless polyester bifurcation graft supplied in three diameters and three iliac limb lengths, three types of nitinol stents including a suprarenal stent with aortic barbs, a flexible delivery system capable of controlled incremental sheath retraction, a flexible tapered lead balloon, and a telescoping technique for adjusting the length of graft coverage during surgery over a range of 3 cm. Twenty-eight of the 29 patients met the primary objective of this evaluation, which was to confirm the safety of the system, defined as the absence of major device-related adverse events and type I, III, or IV endoleaks within 1 month of implantation. Three major adverse events occurred within 1 month of discharge: renal failure, which was related to deployment of the device close to the renal arteries; pulmonary edema, which was related to the procedure but not the device; and peripheral ischemia, which was related to the patient's pre-existing condition. Seven patients had type II endoleaks noted by means of computed tomography scanning at 1 month; the endoleaks were identified by means of angiography and classified at the time of surgery. There were no deaths, aneurysm ruptures, stent-graft migrations, stent fractures, graft ruptures, graft thromboses, or surgical conversions at 1 month. This early clinical experience indicates that the Ariba Bifurcated Endovascular System can be safely implanted.
This study was performed to evaluate the efficacy of a balloon-expandable Palmaz stent common iliac artery occluder device for endovascular stent-graft repair of aortoiliac aneurysms. Eighty-four patients (79 men, 5 women; age range 60-95 yr; mean age, 76 yr) with aortoiliac aneurysms underwent endovascular stent-graft repair. The repair consisted of a stent-graft extending from the abdominal aorta to the iliac or common femoral artery, a cross-femoral bypass graft, and an endovascular arterial occluder device within the contralateral common iliac artery. The occluder device consisted of a 5-cm segment of 6-mm diameter polytetrafluoroethylene (PTFE) graft with a purse-string suture occluding the leading end and a Palmaz stent sutured to the trailing end. The occluder device was delivered through a 17F catheter via an arteriotomy. Eighty-three of the 84 patients received aortic endografts. In one case, infrarenal aortic rupture occurred during deployment of the aortic stent requiring conversion to an open surgical repair. Initial technical success for occluder device insertion was achieved in 78 of the remaining 83 patients. Failure to advance the occluder device delivery sheath through a diseased iliac artery occurred in one patient. Common iliac artery rupture occurred during balloon expansion and occluder device deployment in two patients. Two patients required additional coil embolization of the common iliac artery adjacent to the occluder device at the time of stent-graft insertion to correct incomplete iliac occlusion. Delayed occluder device-related complications included one patient with a postoperative iliac endoleak who required percutaneous coil embolization and one patient with a postoperative iliac endoleak in whom a contained aortic aneurysm rupture developed that was treated by surgical ligation of the common iliac artery. Use of the Palmaz stent-based iliac artery occluder device is an effective technique to induce common iliac artery thrombosis to facilitate endoluminal stent-graft aneurysm repair.
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