German Aortic Center Hamburg, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.
German Aortic Center Hamburg, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.; Department of Vascular Surgery, Hospital, LMU Munich, Munich, Germany.
Ann Vasc Surg. 2022 Jul;83:212-221. doi: 10.1016/j.avsg.2021.12.006. Epub 2021 Dec 22.
Fenestrated endovascular aneurysm repair (F-EVAR) has allowed successful treatment of patients with complex aortic aneurysms. Custom-made devices (CMDs) are manufactured by companies and tailored to the patient's anatomy to incorporate target vessels, while there is also the "off label" alternative with the devices modified by a surgeon in the operating room: surgeon-modified FEVAR (sm-FEVAR). This study aims to present and compare technical durability of CMDs- and sm-FEVAR for complex abdominal and thoracoabdominal aortic pathologies.
A retrospective cohort study was undertaken including all consecutive patients treated with sm- or CMD-FEVAR during a 3-year period in a single center. Only cases with at least 3 reno-visceral target vessels were included. Primary outcomes were technical success, and freedom from endoleak (EL) (Ia or III; all branch related) and re-intervention during follow-up period. Mortality and morbidity were also recorded.
Thirty-two sm-FEVAR patients (81,3% male) and 79 CMD-FEVAR patients (77,2% male) were included. Indication for sm-FEVAR was exclusively urgent, while all CMD- FEVAR were elective. Technical success was similar in sm-FEVAR (100%) and CMD-FEVAR (98,7%) (P = 0.523). Mean follow-up was 16.3 ± 13 and 20 ± 17.3 months for sm-FEVAR and CMD- FEVAR, respectively (P = 0.28). The freedom from EL Ia rate was 91.7% [standard error (SE) 5.7%] at 12 months in sm-FEVAR, while it was 97.7% (SE 2.2%) and 92.3% (SE 4.3%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.69). The freedom from EL III rate was 95.5% (SE 4.4%) and 88% (SE 8.2%) at 12 and 24 months, respectively in sm-FEVAR, while it was 92.1% (SE 3.8%) and 89.2% (SE 4.7%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.68). The freedom from re-intervention rate was 91.6% (SE 5.7%) and 84.6% (SE 8.6%) at 12 and 24 months, respectively in sm-FEVAR, while it was 91.7% (SE 4%) and 83.4% (SE 5.9%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.90). The survival rate was 87.5% (5.8%) and 76.3% (7.9%) at 1 and 12 months, respectively in sm-FEVAR, while it was 93.7% (2.7%) at 1 month in CMD-FEVAR without any other death during FU period. No bridging stent occlusions were noted during follow-up period in any patient.
Sm-FEVAR offers good technical success and mid-term clinical outcomes in urgent cases of complex aortic pathologies. Its durability is acceptable and comparable to CMD-FEVAR with a relatively low re-intervention rate.
开窗型腔内血管修复术（F-EVAR）已经成功治疗了复杂主动脉瘤患者。定制型设备（CMDs）由公司制造，并根据患者的解剖结构进行定制，以纳入目标血管，同时还有一种“超适应证”的替代方案，即由外科医生在手术室中对设备进行修改：外科医生修改的 F-EVAR（sm-FEVAR）。本研究旨在介绍并比较复杂腹主动脉和胸腹主动脉病变中使用 CMDs 和 sm-FEVAR 的技术耐久性。
这是一项回顾性队列研究，纳入了在一个中心的 3 年内接受 sm-FEVAR 或 CMD-FEVAR 治疗的所有连续患者。仅纳入至少有 3 个肾-内脏目标血管的病例。主要结局是技术成功率，以及在随访期间无内漏（EL）（Ia 或 III；所有分支相关）和再次干预的发生率。还记录了死亡率和发病率。
纳入了 32 例 sm-FEVAR 患者（81.3%为男性）和 79 例 CMD-FEVAR 患者（77.2%为男性）。sm-FEVAR 的适应证均为紧急情况，而所有 CMD-FEVAR 均为择期。sm-FEVAR 的技术成功率为 100%，CMD-FEVAR 为 98.7%（P=0.523）。sm-FEVAR 和 CMD-FEVAR 的平均随访时间分别为 16.3±13 和 20±17.3 个月（P=0.28）。sm-FEVAR 中，EL Ia 发生率在 12 个月时为 91.7%（标准误差 5.7%），而在 CMD-FEVAR 中，12 个月和 24 个月时分别为 97.7%（标准误差 2.2%）和 92.3%（标准误差 4.3%）（P=0.69）。sm-FEVAR 中，EL III 发生率在 12 个月时为 95.5%（标准误差 4.4%），在 24 个月时为 88%（标准误差 8.2%），而在 CMD-FEVAR 中，12 个月和 24 个月时分别为 92.1%（标准误差 3.8%）和 89.2%（标准误差 4.7%）（P=0.68）。sm-FEVAR 中，再次干预的发生率在 12 个月和 24 个月时分别为 91.6%（标准误差 5.7%）和 84.6%（标准误差 8.6%），而在 CMD-FEVAR 中，12 个月和 24 个月时分别为 91.7%（标准误差 4%）和 83.4%（标准误差 5.9%）（P=0.90）。sm-FEVAR 的生存率在 1 个月和 12 个月时分别为 87.5%（5.8%）和 76.3%（7.9%），而在 CMD-FEVAR 中，1 个月时的生存率为 93.7%（无死亡率），在随访期间无其他死亡。在任何患者中，均未发现支架桥接闭塞。
sm-FEVAR 在复杂主动脉病变的紧急情况下提供了良好的技术成功率和中期临床结果。其耐久性可接受，与 CMD-FEVAR 相当，再次干预率相对较低。
