Mayo Clinic, Phoenix, AZ.
Mayo Clinic, Jacksonville, FL.
Ann Vasc Surg. 2022 Nov;87:225-230. doi: 10.1016/j.avsg.2022.04.046. Epub 2022 May 17.
The purpose of this study was to evaluate the association between aortic endograft diameter and long-term outcomes following endovascular aneurysm repair (EVAR) performed in accordance with manufacturer instructions for use (IFU).
A retrospective review of consecutive patients undergoing on-IFU EVAR (2000-2018) was performed to facilitate a comparative analysis of long-term patient outcomes based on device diameter. "Large diameter" devices were defined as >34 mm. The primary outcome of interest was freedom from sac expansion throughout long-term follow-up. Analyses included standard bivariate analyses, Kaplan-Meier with log-rank comparison, and Cox proportional hazards multivariate analysis.
A total of 1,099 underwent on-IFU EVAR from 2000-2018. Follow-up data were available for 980 patients. Of these, 75 patients (7.6%) were treated with >34-mm devices. There were no significant differences in demographics or comorbidities between the 2 groups, although preoperative abdominal aortic aneurysm size was greater in patients undergoing implantation of >34-mm devices (58 ± 8.5 mm vs. 56 ± 17.4 mm; P = 0.05). Median follow-up was 10.3 years. Patients with grafts >34 mm had reduced freedom from sac expansion throughout follow-up (P = 0.038). There were no significant differences in reintervention rates, open conversion, or rupture when stratified by graft diameter. A multivariate Cox regression identified patient age, preoperative abdominal aortic aneurysm size, need for reintervention, and use of >34-mm endografts as independent factors associated with expansion.
The use of large diameter aortic endografts is associated with higher rates of sac expansion during long-term follow-up. Although there is undoubtedly a role for large diameter graft use in selected patients, it is important to recognize that these devices were typically approved post hoc without the same regulatory scrutiny of smaller endografts. These findings underscore the importance of ongoing surveillance for patients treated with >34-mm grafts, irrespective of compliance with manufacturer IFU.
本研究旨在评估根据制造商使用说明（IFU）进行血管内动脉瘤修复（EVAR）后，主动脉内移植物直径与长期结果之间的关系。
对连续接受 IFU-EVAR（2000-2018 年）的患者进行回顾性分析，以根据设备直径对长期患者结局进行比较分析。“大直径”设备定义为>34mm。主要观察终点为长期随访过程中瘤囊无扩张。分析包括标准双变量分析、对数秩检验的 Kaplan-Meier 分析和 Cox 比例风险多变量分析。
2000-2018 年共 1099 例患者接受 IFU-EVAR。980 例患者获得随访数据。其中，75 例（7.6%）患者使用>34mm 设备治疗。两组患者的人口统计学和合并症无显著差异，尽管植入>34mm 设备的患者术前腹主动脉瘤更大（58±8.5mm 比 56±17.4mm；P=0.05）。中位随访时间为 10.3 年。随访期间，使用>34mm 移植物的患者瘤囊扩张的无复发生存率降低（P=0.038）。按移植物直径分层，再干预率、开放转换或破裂率无显著差异。多变量 Cox 回归分析确定患者年龄、术前腹主动脉瘤大小、再干预需求和使用>34mm 内移植物是与扩张相关的独立因素。
长期随访期间，大直径主动脉内移植物的使用与瘤囊扩张的发生率较高相关。尽管在某些患者中大直径移植物的使用无疑具有一定作用，但重要的是要认识到，这些设备通常是在事后获得批准的，而没有对较小移植物进行同样的监管审查。这些发现强调了对接受>34mm 移植物治疗的患者进行持续监测的重要性，而不论其是否符合制造商 IFU。
