Benveniste Glen L, Tjahjono Richard, Chen Oliver, Verhagen Hence J M, Böckler Dittmar, Varcoe Ramon L
Ashford Vascular Clinic, Adelaide, South Australia, Australia.
Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Ann Vasc Surg. 2020 Aug;67:265-273. doi: 10.1016/j.avsg.2020.02.020. Epub 2020 Mar 20.
Registry studies have shown that the Endurant stent graft is associated with low rates of all-cause and aneurysm-related mortality when used for the endovascular treatment of abdominal aortic aneurysm (AAA). However, many were limited by length of follow-up and all had a proportion of patients lost to follow-up. The aim of this study is to report results from a large, real-world experience using Endurant, utilizing methods to ensure complete ascertainment of mortality.
This study describes a large, single vascular unit experience using the Endurant stent graft in consecutive patients treated between August 2008 and March 2019.
One-hundred eighty patients (mean age 76.0 ± 8.6 years; 90% male) with mean AAA diameter of 57.5 ± 10.5 mm underwent endovascular aneurysm repair (EVAR). Technical success was achieved in all cases. At median follow-up of 55.0 months (interquartile range 29.8-79.0), 51 (28.3%) patients had died. Kaplan-Meier estimate of 5-year overall survival and freedom from aneurysm-related death was 71.6% and 99.4%, respectively. Lower survival rates were observed in patients who underwent EVAR at age ≥80 years (59.2% vs. 78.3%, P < 0.01) and with aneurysm diameter ≥70 mm (55.6% vs. 73.8%, P = 0.03). Thirteen endoleaks (7.2%; 4 type 1A, 2 type 1B, 7 type 2) were observed during follow-up (mean time from implantation 8.7 ± 4.2, range 1-52 months). Eleven patients (6.1%) required secondary intervention for limb occlusion (n = 7), endoleak (n = 3), and restenosis (n = 1). Patients treated within (n = 104; 57.8%) and outside (n = 76; 42.2%) the manufacturer's instructions for use (IFU) had similar rates of endoleak (7 [6.7%] vs. 6 [7.9%]; P = 0.76), secondary re-intervention (7 [6.7%] vs. 4 [5.3%]; P = 0.74) and overall-survival (72 [69.2%] vs. 55 [72.3%]; P = 0.46).
Results from this real-world study of consecutive patients treated for AAA using the Endurant stent graft demonstrate that it is safe and effective, with excellent long-term outcomes for anatomy that falls both inside and outside IFU recommendations.
登记研究表明，Endurant支架型人工血管用于腹主动脉瘤（AAA）的血管内治疗时，全因死亡率和动脉瘤相关死亡率均较低。然而，许多研究受随访时间限制，且均有一定比例的患者失访。本研究旨在报告使用Endurant的大型真实世界经验结果，采用确保完全确定死亡率的方法。
本研究描述了2008年8月至2019年3月期间，在一个大型单一血管单元对连续患者使用Endurant支架型人工血管的经验。
180例患者（平均年龄76.0±8.6岁；90%为男性）接受了血管内动脉瘤修复术（EVAR），AAA平均直径为57.5±10.5mm。所有病例均取得技术成功。中位随访55.0个月（四分位间距29.8 - 79.0），51例（28.3%）患者死亡。Kaplan-Meier法估计的5年总生存率和无动脉瘤相关死亡生存率分别为71.6%和99.4%。年龄≥80岁接受EVAR的患者生存率较低（59.2%对78.3%，P<0.01），动脉瘤直径≥70mm的患者生存率也较低（55.6%对73.8%，P = 0.03）。随访期间观察到13例内漏（7.2%；4例1A型，2例1B型，7例2型）（植入后平均时间8.7±4.2个月，范围1 - 52个月）。11例（6.1%）患者因肢体闭塞（n = 7）、内漏（n = 3）和再狭窄（n = 1）需要二次干预。在制造商使用说明书（IFU）范围内（n = 104；57.8%）和范围外（n = 76；42.2%）接受治疗的患者，内漏发生率（7[6.7%]对6[7.9%]；P = 0.76）、二次再干预率（7[6.7%]对4[5.3%]；P = 0.74）和总生存率（72[69.2%]对55[72.3%]；P = 0.46）相似。
这项对使用Endurant支架型人工血管治疗AAA的连续患者的真实世界研究结果表明，该支架型人工血管安全有效，对于符合和不符合IFU建议的解剖结构均有出色的长期效果。
