Postmarket Clinical Experience with the INCRAFT AAA Stent Graft System for Challenging Access Routes

Background The INCRAFT system is a new device that has become available in Europe in September 2014 after the announcement of the 2-year results of the INNOVATION trial. However, no data in the “real-world” practice exist. Herein, we report our early series of consecutive patients treated with the INCRAFT after its launch on the market. Methods Prospectively collected data of patients enrolled in the INNOVATION trial (group IT) and consecutive patients from CE Mark approval to April 2015 (group CM) were retrospectively evaluated and compared. Main outcomes were any device- or procedure-related major adverse event (MAE) within 30 days and survival and reinterventions during follow-up. Results Seventeen patients were included in group IT (median follow-up [95% CI]; 60.4 months [55–63]), and 24 patients were in group CM (12.5 [6.6–13.5]). The patients' comorbidities were comparable between the groups. The average diameter of aortic bifurcation and the bilateral external iliac arteries was significantly smaller in group CM. Adjunctive interventions for iliac artery disease were performed in 8 patients (33%) in group CM, whereas no adjunctive was required in group IT. MAEs within 30 days were not significantly different between 2 groups. Survival and reintervention rates were also equivalent after a median follow-up of 13 months. Conclusions Compared to our patients recruited for the INNOVATION trial, the patients after CE Mark approval had significantly more challenging access routes reflecting the difficulties of “real-world” conditions. Despite frequent adjunctive procedures in group CM, the early performance of the endograft was encouraging so far. Long-term surveillance of those patients remains mandatory.