Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for endovascular aortic aneurysm repair

Abstract

In patients with both normal and complex anatomy of the proximal aortic neck, the Endurant stent graft obtained acceptable results, with no difference in survival, morbidity, or reinterventions. However, there was a greater risk of type I endoleak when OL indications were applied. Longer term follow-up is required to evaluate the effectiveness of this endograft in preventing late aneurysm-related complications.

Endovascular Treatment of Abdominal Aortic Aneurysm: Application of the Chimney and Periscope Graft Technique in Juxta- and Pararenal Aneurysms

“…However, some devices perform quite well even if they do not meet the manufacturer's IFU, for example, when the minimal length of the proximal neck is below limit [ 35 ] . The critical concern remains the sealing and therefore the exclusion of the aneurysm, with the incidence of type I endoleaks and aneurysm-related complications in long term, such as sac enlargement or endotension [ 36 ] .…”

“…Using these techniques one should keep in mind that the intended use of aortic stentgrafts do not cover those techniques, and therefore this treatment is not recommended as standard when landing and sealing zones do not meet the requirements of the stentgraft's IFUs [ 7,9,35 ] .…”

Outcomes of EVAR with the endurant stent-graft system in patients with infrarenal ruptured abdominal aortic aneurysms: Is hostile anatomy a challenging factor?

“…Skepticism exists with regard to the safety and efficacy of this practice. There is insufficient high-level evidence in favor of or against performing standard endovascular aneurysm repair (EVAR) in patients with hostile neck anatomy [3][4][5].…”

Development of tissue‐engineered self‐expandable aortic stent grafts (Bio stent grafts) using in‐body tissue architecture technology in beagles

“…[4][5][6] Although significant improvements have been made in implantation techniques and medical devices, late complications such as stent graft migration and endoleaks still occur and represent important issues that need to be rectified. Most of these complications are caused by an angulated or short landing zone 7,87,8 -which is the nonaneurysmal cylindrical part of the aorta that is used for stent graft fixation-and/or a lack of adaptation to late aortic remodeling; therefore, stent grafts with landing zones that completely adapt to the native aorta would be ideal. Based on our previous experience with the implantation of tissue-engineered materials, we consider that stent grafts constructed using tissue-engineered materials may be able to easily adapt to native vessels soon after implantation.…”