Giovanni Pratesi (Florence, Italy) reported that the two-year results of the INNOVATION study (A multicentre, open-label, prospective, non-randomised study of the Cordis Incraft system in subjects with abdominal aortic aneurysms) confirm the “very promising results” of the one-year outcomes of the Incraft bifurcated stent graft system (Cordis). The results, presented at the Charing Cross Symposium 2014 (5-8 April, London, UK), showed that the system was not associated with any endoleaks at two years in patients undergoing endovascular aortic aneurysm repair (EVAR).
Pratesi stated that the Incraft system – showcased for the first time at the Charing Cross Symposium – has been designed to overcome the limitations of current stent grafts for the management of abdominal aortic aneurysms. He commented that it has an ultra-low profile delivery system and had the ability to be “customised during the procedure thanks to the bilateral in-situ length adjustment features”. Also, according to Pratesi, the graft offers the possibility of covering a wide range of anatomies with a minimum number of product codes.
The aim of the INNOVATION study was to assess the safety and efficacy of the Incraft system for the management of aortic abdominal aneurysms. The primary endpoint was technical success at one-month and the one-year safety endpoints included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks and maintenance of device integrity through one-year of follow-up. The main inclusion criteria included a proximal neck length of ≥15mm and up to 27mm in diameter, an access vessel large enough to accept the 14F outer diameter of the delivery catheter, and an aortic bifurcation >18mm in diameter.
The rate of technical success at one month was 97% (56 of 58 patients of the original 60 patients who were enrolled) and the rate of freedom from aneurysm enlargement was 100% at one year with the absence of both type I and III endoleaks in all patients.
Pratesti reported that two-year results confirmed these “very promising” early and one-year outcomes. He added that (at two years): “There were zero incidences of endoleaks (type I or type III), device- or procedure-related major adverse events, stent-graft migrations, or stent fractures.” He further said that there were also no incidences of aneurysm sac enlargement with sac shrinkage being observed in 45% of patients. However, one patient did develop a late limb ischaemia occlusion at day 666 due to sac contraction and limb confirmation change.
Pratesi concluded: “These excellent results are encouraging and suggest that the Cordis abdominal aortic aneurysm stent graft is a valuable alternative device with increased applicability over the broad spectrum of aorto-iliac anatomic configurations encountered in patients undergoing EVAR.”