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. 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). 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. 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.

中文翻译：

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使用 INCRAFT 装置对腹主动脉瘤进行血管内修复后的十年单中心结果

本研究旨在报告使用低调 INCRAFT 装置对腹主动脉瘤进行血管内动脉瘤修复 (EVAR) 10 年以上的长期结果。这是一项单中心、回顾性队列研究，研究对象为 2012 年至 2013 年间所有使用 INCRAFT 装置接受 EVAR 的患者，作为监管试验的一部分。主要终点是动脉瘤相关死亡。次要终点是全因死亡、再次干预、晚期开放性转换和动脉瘤状态（缩小、稳定和生长）。本研究纳入了 30 名平均年龄为 71.8 ± 7.7 岁的患者。 EVAR 时的中位动脉瘤直径为 54.5 毫米（四分位数范围，53-56.8 毫米）。本研究中的所有腹主动脉瘤均按照设备的使用说明进行治疗。在指数 EVAR 时，INCRAFT 装置在局部麻醉下通过经皮方法成功植入所有患者体内。 EVAR 后 30 天，没有患者出现重大不良事件或手术相关并发症。在中位随访 125 个月（四分位距，98-131 个月）期间，5 年随访率为 100%，10 年随访率为 96.7%，动脉瘤相关死亡率为 0%，并且没有全因死亡率5 年死亡率为 82.9%，10 年死亡率为 75.3%。 10 名患者需要进行 15 次手术重新干预。 11 名患者 (36.7%) 观察到囊生长，其中 6 名患者最终需要晚期开放转换；其中 5 名患者接受了保留支架移植物的开放式动脉瘤成形术，1 名患者接受了内移植物移植的开放式手术修复术。 1例发现晚期破裂，69个月时Ia型内漏导致破裂，成功进行开放式修复。 5 年时免于再次干预的比例为 89.0%，但 10 年时降至 60.9%； 5 年时免于后期开放转换的比例为 100%，但 10 年时降至 70.8%。 INRAFT 覆膜支架的长期结果显示没有与动脉瘤相关的死亡。然而，囊生长在整个随访期间持续发生，导致后期的再干预率相对较高，这凸显了术后终身监测和有指征时适当再干预的重要性。