Outcome and Safety of Aorfix™ Stent Graft in Highly Angulated Necks – A Prospective Observational Study (Arbiter 2)

Abstract

The results of this study support the continued application of the Aorfix™ graft to the highly angulated neck.

Early results of the Endurant endograft system in patients with friendly and hostile infrarenal abdominal aortic aneurysm anatomy

“…Interestingly, the incidence of loss of proximal sealing length has been reported to be higher (6.7%) with the Aorfix stent graft. 20 The higher incidence of type I endoleak in our cohort might be explained by the severe proximal neck angulation (all patients with type I endoleak had severely angulated infrarenal neck, 84°/82°/73°) since no loss of distance from renal to graft was observed. Notably, the incidence of type Ia endoleak was 33% (2/6) in the subgroup of patients with Ͼ80°proximal neck angulation.…”

“…A recent report evaluating 30 patients with angulated anatomies (all with neck angle Ͼ60°, including 63% with neck angle Ͼ75°) treated with the Aorfix stent graft, achieved lower clinical success (92.6%) within the first 6 months after the operation, with two recurrent type Ia endoleaks being reported. 20 Moderate (40%-59%) to severe (Ͼ60%) angulation of the proximal aneurysm neck has been demonstrated to be associated with acute or late adverse events following EVAR despite an adequate proximal aortic length (Ͼ20 mm) and, probably, regardless of the type of the endograft used. 14 Furthermore, previous reports have shown that endovascular treatment of aneurysms with an angulated neck Ͼ60°is commonly associated with adjunctive procedures, such as giant Palmaz (Cordis, Miami Lakes, Fla) stent or cuff placement to achieve proximal seal.…”

“…24 Furthermore, stringent morphologic criteria have been used to select patients for EVAR and have been found to be of importance to achieve durable results. 9,12,25 The ever expanding use of EVAR and the fact that a significant proportion of patients with hostile aneurysm anatomy receive endovascular treatment, 3,19,20,[26][27][28] emphasizes the need for advanced endograft devices.…”

“…Other anatomical limitations, such as a very short proximal neck and severe angulation of the iliac arteries have also been described. Cumulative clinical experience and technical advances with the evolution of newer more flexible stent graft devices 3,5,[7][8][9]19,20 have all been working together to circumvent adverse aneurysm morphologies, with a view to expanding the applications of endovascular treatments for aortic aneurysms. Recently, late generation stent grafts, like the Endurant (Medtronic Cardiovascular, Santa Rosa, Calif) device, have been developed to overcome complex aortic morphologies and improve EVAR outcomes.…”

“…Recently, late generation stent grafts, like the Endurant (Medtronic Cardiovascular, Santa Rosa, Calif) device, have been developed to overcome complex aortic morphologies and improve EVAR outcomes. [3][4][5][6][7][8][9][10][11]19,20 A prospective, multicenter, controlled trial experience revealed that the Endurant system was associated with no postoperative aneurysm ruptures or aneurysm-related mortalities at 1 year and with no mortalities from any cause at 30 days. It is currently under review by the FDA for premarket approval.…”