一个单一的中心长期跟踪Nellix内血管动脉瘤密封系统
Sven R Mathisen1, Simen T Berge2
1Department of Vascular Surgery, Innlandet Hospital Trust, Hamar, Norway.
概括
对于腹腔大动脉动脉瘤 (AAA) 的内血管动脉瘤密封 (EVAS) 的长期结果显示,设备故障率增加. 在EVAS治疗后,认真监测患者至关重要.
科学领域:
- 血管外科 血管外科
- 血管内干预 血管内干预
- 动脉瘤治疗的方法
背景情况:
- 内血管动脉瘤密封 (EVAS) 为腹腔大动脉瘤 (AAA) 修复提供了一种微创的方法.
- 对于EVAS设备的长期临床性能数据对于了解耐用性和患者结果至关重要.
研究的目的:
- 评估Nellix EVAS系统在治疗腹腔大动脉瘤 (AAA) 的长期临床性能和安全性.
- 评估设备的耐用性,不需要干预,以及EVAS后的存活率.
主要方法:
- 一项观察性,前性,单中心研究包括117名接受EVAS初级AAA修复的患者.
- 关键的终点包括技术成功,器件故障,开放式手术转换,二次干预,囊裂和死亡率,平均随访时间为6.2年.
主要成果:
- 主要技术成功率为100%. 然而,在七年内,没有Nellix设备故障的比例为36%,而没有开放式手术转换的比例为59%.
- 二次囊裂的累积发病率为9.4%,动脉瘤相关死亡率为12%. 平均存活时间为4年.
- 二次干预率为每100人/年11.4人.
结论:
- 对EVAS的长期随访表明,设备故障和并发症的发生率很高.
- 在内血管AAA治疗后,特别是在新设备技术下,严格监测是强制性的.
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