Ten-year single-center outcomes following endovascular repair for abdominal aortic aneurysm using the INCRAFT device.

ABSTRACT

OBJECTIVE: This study aimed to report the long-term outcomes beyond 10 years of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms using the low-profile INCRAFT device. METHODS: This was a single-center, retrospective cohort study of all patients undergoing EVAR using the INCRAFT device as part of the regulatory trial between 2012 and 2013. Primary endpoint was aneurysm-related death. Secondary endpoints were all-cause death, reintervention, late open conversion, and aneurysm status (shrinkage, stable, and growth). RESULTS: Thirty patients with a mean age of 71.8 ± 7.7 years were included in this study. The median aneurysm diameter at EVAR was 54.5 mm (interquartile range, 53-56.8 mm). All abdominal aortic aneurysms in this study were treated following the device's instructions for use. At index EVAR, the INCRAFT device was successfully implanted in all patients using a percutaneous approach under local anesthesia. No patients experienced major adverse events or procedure-related complications 30 days after EVAR. During the median follow-up of 125 months (interquartile range, 98-131 months) with follow-up rates of 100% at 5 years and 96.7% at 10 years, aneurysm-related mortality was 0%, and freedom from all-cause mortality was 82.9% at 5 years and 75.3% at 10 years. Reintervention was required in 10 patients with 15 procedures. Sac growth was observed in 11 patients (36.7%), six of whom eventually required late open conversion; five of these patients underwent open aneurysmorrhaphy with stent graft preservation, and one underwent open surgical repair with endograft explantation. Late rupture was identified in one case, where type Ia endoleak led to rupture at 69 months, and open repair was successfully performed. Freedom from reintervention was 89.0% at 5 years but declined to 60.9% at 10 years; freedom from late open conversion was 100% at 5 years but declined to 70.8% at 10 years. CONCLUSIONS: Long-term outcomes of the INCRAFT stent graft showed no aneurysm-related deaths. However, sac growth occurred persistently throughout the follow-up period, resulting in a relatively high rate of reinterventions in the later periods, which highlights the importance of lifelong postoperative surveillance and appropriate reinterventions when indicated.