在标准EVAR中使用TREO设备的现实世界经验:来自德国多中心研究的150个病例的中期结果
Sebastian Zerwes1, Ana-Maria Ciura1, Hans-Henning Eckstein2
1Clinic for vascular and endovascular surgery, Medizinische Fakultät, Universität of Augsburg, Germany.
VASA. Zeitschrift fur Gefasskrankheiten
|September 10, 2024
概括
该TREO装置显示了在现实环境中治疗腹腔大动脉动脉瘤 (AAA) 的可行性,中期结果与现有数据可比. 在使用说明 (IFU) 中和外观察到并发症和重新干预.
科学领域:
- 血管外科 血管外科
- 血管内动脉瘤修复 (EVAR) 进行.
背景情况:
- 该TREO设备用于治疗腹腔大动脉动脉瘤 (AAA).
- 关于TREO装置中期结果的现实数据有限.
研究的目的:
- 在未被选中的患者中分析TREO装置的中期结果.
- 评估使用说明 (IFU) 内外的结果.
主要方法:
- 在2017年1月至2020年11月期间接受治疗的150名患者的多中心,回顾性分析.
- 主要结局包括技术成功,死亡率和内移植并发症.
- 二次结果评估了动脉瘤/与程序相关的重新干预.
主要成果:
- 技术成功率在IFU内部为99%,在IFU之外为92% (p=0.08).
- 30天死亡率为2%,整体死亡率为5%.
- 25%的患者 (35/150) 发生了内皮瘤,主要是II型 (33/35).
- 13%的患者 (19/150) 需要进行二次干预.
结论:
- 在现实环境中,TREO设备似乎可用于AAA治疗,包括非标签使用.
- 中期并发症和重新干预率与已公布的数据一致.
- 标准EVAR与严重的不良事件有关,强调需要仔细选择设备.
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