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腹主动脉腔内修复术的试验之外:一项15年单中心经验,比较新一代与旧一代覆膜支架。

Abdominal aortic endografting beyond the trials: a 15-year single-center experience comparing newer to older generation stent-grafts.

作者信息

Verzini Fabio, Isernia Giacomo, De Rango Paola, Simonte Gioele, Parlani Gianbattista, Loschi Diletta, Cao Piergiorgio

机构信息

1 Vascular and Endovascular Surgery Unit, Hospital S. Maria della Misericordia, University of Perugia, Italy.

出版信息

J Endovasc Ther. 2014 Jun;21(3):439-47. doi: 10.1583/13-4599MR.1.

Abstract

PURPOSE

To evaluate the late results of endovascular aneurysm repair (EVAR) with the endografts currently in use and compare outcomes to older devices.

METHODS

Clinical, demographic, and imaging data on consecutive patients undergoing elective EVAR from January 1997 to December 2011 at a single center were retrieved from an electronic database and reviewed. Newer stent-grafts (NSG) were defined as those introduced after 2004 (second-generation Excluder and Anaconda) or currently in use without modifications (Zenith, Endurant). Of the 1412 consecutive patients (1290 men; mean age 73 years) who underwent elective EVAR in a tertiary university hospital, 882 were treated with NSGs and 530 with older stent-grafts (OSGs).

RESULTS

In the NSG group, the abdominal aortic aneurysms (AAA) were larger (55.7 vs. 53.2 mm, p<0.0001) and the patients were older (p<0.0001) and less frequently smokers or had pulmonary disease, while hypertension and diabetes were more frequent (all p<0.0001). Thirty-day mortality was 0.8% in the NSG group vs. 1.1% in the OSG group (p=NS). Follow-up ranged from 1 to 174 months (mean 54.1±42.4); the OSG patients had longer mean follow-up compared to the NSG group (80.2±47.9 vs. 38.4±29.1 months, p<0.0001). All-cause survival rates were comparable in both groups. Freedom from late conversion (96.1% vs. 89.1% at 7 years, p<0.0001) or reintervention (83.6% vs. 74.2% at 7 years, p=0.015) and freedom from AAA diameter growth >5 mm (p=0.022) were higher in the NSG group. In adjusted analyses, the use of a new-generation device was a negative independent predictor of reintervention [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49 to 0.93, p=0.015] and aneurysm growth (HR 0.63, 95% CI 0.45 to 0.89, p=0.010).

CONCLUSION

Newer-generation endografts can perform substantially better than the older devices. In the long term, incidences of reintervention, conversion, and AAA growth are decreased in patients treated with devices currently in use. However, the need for continuous surveillance is still imperative for all endografts.

摘要

目的

评估目前使用的血管内动脉瘤修复术(EVAR)的远期疗效,并将结果与较旧的器械进行比较。

方法

从电子数据库中检索并回顾了1997年1月至2011年12月在单一中心接受择期EVAR的连续患者的临床、人口统计学和影像学数据。较新的支架型人工血管(NSG)定义为2004年后引入的(第二代Excluder和Anaconda)或目前未经改良使用的(Zenith、Endurant)。在一家三级大学医院接受择期EVAR的1412例连续患者(1290例男性;平均年龄73岁)中,882例接受了NSG治疗,530例接受了较旧的支架型人工血管(OSG)治疗。

结果

在NSG组中,腹主动脉瘤(AAA)更大(55.7对53.2mm,p<0.0001),患者年龄更大(p<0.0001),吸烟或患有肺部疾病的频率更低,而高血压和糖尿病更常见(均p<0.0001)。NSG组30天死亡率为0.8%,OSG组为1.1%(p=无显著性差异)。随访时间为1至174个月(平均54.1±42.4);与NSG组相比,OSG组患者的平均随访时间更长(80.2±47.9对38.4±29.1个月,p<0.0001)。两组的全因生存率相当。NSG组免于晚期转换(7年时为96.1%对89.1%,p<0.0001)或再次干预(7年时为83.6%对74.2%,p=0.015)以及免于AAA直径增长>5mm(p=0.022)的比例更高。在多因素分析中,使用新一代器械是再次干预[风险比(HR)0.67,95%置信区间(CI)0.49至0.93,p=0.015]和动脉瘤生长(HR为0.63,95%CI为0.45至0.89,p=0.010)的负独立预测因素。

结论

新一代血管内移植物的性能明显优于旧器械。从长期来看,使用目前器械治疗的患者再次干预、转换和AAA生长的发生率降低。然而,对所有血管内移植物进行持续监测仍然至关重要。

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