髂支血管腔内修复装置非适应证使用的对比研究
Comparison Study of Iliac Branch Endoprosthesis when Used on and off Label.
作者信息
Rodriguez Limael E, Eun John C, Calkins Ryan T, Carroll Adam M, Malgor Emily A, Wohlauer Max V, Nehler Mark R, Jacobs Donald L, Malgor Rafael D
机构信息
Division of Vascular Surgery, Department of Surgery, University of Colorado Anschutz School of Medicine at Denver, Aurora, CO.
Division of Vascular Surgery, Department of Surgery, University of Colorado Anschutz School of Medicine at Denver, Aurora, CO.
出版信息
Ann Vasc Surg. 2023 Feb;89:28-35. doi: 10.1016/j.avsg.2022.03.015. Epub 2022 Mar 24.
BACKGROUND
The aim of this study is to compare how instructions for use (IFU) affected perioperative and intermediate term outcomes for common iliac artery aneurysms (CIAA) treated with the Gore Excluder iliac branch endoprosthesis (IBE).
METHODS
A retrospective analysis was performed of all patients treated at two affiliated academic centers from September 2016 to May 2020. Outcomes were compared between IFU and nonIFU IBE cases. Criteria for nonIFU included: (1) use with a nonGore aortic endoprosthesis (n = 10), (2) isolated IBE (n = 3), and (3) requiring nondedicated covered stents for additional extension into a more suitable landing zone in the ipsilateral internal iliac artery or one of its branches (n = 11). Perioperative and intermediate term data were collected for both groups. The primary end points were free from the major adverse event (MAE) at 30 days and primary effectiveness at 1 year.
RESULTS
A total of 51 CIAA (39 patients) were treated with an IBE. Overall, 15 patients were treated under IFU and 24 under nonIFU. The IFU group mean age was older (72 vs. 67 years, P = 0.03), and males (97%) were primarily treated. Comorbidities were similar except nonIFU had more patients with previous endovascular abdominal aortic aneurysm repair on presentation (0 vs. 4 cases, P = 0.04). Procedure (178 vs. 264 min, P = 0.02) and fluoroscopy (52 vs. 74 min, P = 0.04) times were longer in the nonIFU group. Technical success was 100% for both groups, and there was no difference in device related reintervention at 30 days (0 vs. 1, P = 0.44). There was no MAE in either group at 30 days. Intervention for any endoleak was similar between the groups (2 vs. 3, P = 0.94). Percent CIAA sac regression was similar between the groups (19% vs. 18%, P = 0.21). There was no difference for primary effectiveness at 1 year (93% vs. 92%, P = 0.85). There was one death per group at one year not related to an aortic or iliac cause.
CONCLUSIONS
In properly selected patients with complex anatomy, IBE can be used with nondedicated aortic and internal iliac components with good early term outcomes.
背景
本研究的目的是比较使用说明（IFU）如何影响使用戈尔髂支型腔内修复装置（IBE）治疗的髂总动脉瘤（CIAA）的围手术期和中期结果。
方法
对2016年9月至2020年5月在两个附属医院中心接受治疗的所有患者进行回顾性分析。比较IFU和非IFU IBE病例的结果。非IFU的标准包括：（1）与非戈尔主动脉腔内修复装置联合使用（n = 10），（2）孤立性IBE（n = 3），以及（3）需要非专用覆膜支架进一步延伸至同侧髂内动脉或其分支中更合适的着陆区（n = 11）。收集两组的围手术期和中期数据。主要终点是30天时无主要不良事件（MAE）和1年时的主要有效性。
结果
共有51例CIAA（39例患者）接受了IBE治疗。总体而言，15例患者在IFU下接受治疗，24例在非IFU下接受治疗。IFU组的平均年龄更大（72岁对67岁，P = 0.03），主要治疗男性患者（97%）。除了非IFU组在就诊时有更多既往接受过腹主动脉瘤腔内修复的患者外（0例对4例，P = 0.04），合并症相似。非IFU组的手术时间（178分钟对264分钟，P = 0.02）和透视时间（52分钟对74分钟，P = 0.04）更长。两组的技术成功率均为100%，30天时与装置相关的再次干预无差异（0例对1例，P = 0.44）。两组在30天时均无MAE。两组间因任何内漏进行的干预相似（2例对3例，P = 0.94）。两组间CIAA瘤囊缩小百分比相似（19%对18%，P = 0.21）。1年时的主要有效性无差异（93%对92%，P = 0.85）。每组在1年时有1例死亡，与主动脉或髂动脉原因无关。
结论
在解剖结构复杂的合适患者中，IBE可与非专用的主动脉和髂内组件一起使用，早期结果良好。
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