Midterm Results of Endovascular Aneurysm Repair Using the Endurant Stent-Graft According to the Instructions for Use vs. Off-Label Conditions

Abstract

Off-label use of the Endurant stent-graft was associated with a greater but acceptable risk of type I endoleak. Otherwise, there was no difference between the IFU and off-label groups as regards survival, graft thrombosis, or reintervention.

Outcomes of Endurant stent graft in narrow aortic bifurcation

“…19 Globally, patients operated on in off-label conditions with Endurant stent graft have no statistically significant different early and midterm results with respect to those patients who have undergone treatment according to the instructions for use. 6,9 Off-label use of Endurant stent graft was associated with only a greater but acceptable risk of type I endoleak; this risk remained stable during the follow-up. 9 The focus on this new-generation device was always on the proximal aortic neck, except for one study in which the outcomes of this graft were evaluated in terms of limb occlusion.…”

“…6,9 Off-label use of Endurant stent graft was associated with only a greater but acceptable risk of type I endoleak; this risk remained stable during the follow-up. 9 The focus on this new-generation device was always on the proximal aortic neck, except for one study in which the outcomes of this graft were evaluated in terms of limb occlusion. 20 van Zeggeren et al 20 reported that Endurant endograft occlusion occurred in 4.0% of about 500 unselected patients at a median follow-up of 1.7 years; a technical justification for occlusion has been found by a board of experts for about 60% of patients.…”

“…2,3 Several publications demonstrated the good outcomes of this endograft with either normal or complex anatomy of the proximal aortic neck (hostile neck). [4][5][6][7][8][9] In particular, some reports focused on the feasibility and the effectiveness of this endograft even outside the instructions for use (offlabel situation). 6,9,10 However, the morphologic complexity of an AAA is also located in the distal abdominal aorta.…”

“…[4][5][6][7][8][9] In particular, some reports focused on the feasibility and the effectiveness of this endograft even outside the instructions for use (offlabel situation). 6,9,10 However, the morphologic complexity of an AAA is also located in the distal abdominal aorta. A distal abdominal aorta with a diameter of <20 mm configures a narrow distal aortic bifurcation, representing a criterion of exclusion from standard endovascular aortic repair.…”

The PROTAGORAS study to evaluate the performance of the Endurant stent graft for patients with pararenal pathologic processes treated by the chimney/snorkel endovascular technique

“…In our institutions, the Endurant device is the preferable abdominal endovascular endoprosthesis for standard EVAR. 13,15 In addition, we have to underline that at least for the moment, use of the Endurant device for the chimney technique is outside of the instructions for use of the device. This should be considered in elective cases with the option to use other techniques.…”