Groupe Hospitalier Pellegrin, Bordeaux, France.
Groupe Hospitalier Pellegrin, Bordeaux, France.
Eur J Vasc Endovasc Surg. 2020 Jul;60(1):16-25. doi: 10.1016/j.ejvs.2020.02.005. Epub 2020 Mar 14.
A significant decrease in aneurysm related survival is observed at long term follow up after infrarenal endovascular aneurysm repair (EVAR) compared with open repair. Therefore, longer term results with new generation endografts are essential. The aim of this post-approval French multicentre prospective observational study (EPI-ANA-01) was to evaluate the technical success and five year mortality and secondary intervention rates of the third generation Anaconda endograft.
From June 2012 to October 2013, 176 consecutive unruptured infrarenal abdominal aortic aneurysms were included (160 male patients, mean age 75.3 ± 8.4 years). Survival, freedom from type Ia endoleak, limb events, and re-interventions were estimated using the Kaplan-Meier method. Anatomical and clinical characteristics were compared according to the occurrence of migration, conversion, adverse limb events, endoleak, and sac enlargement.
The primary technical and clinical success rates were 98.3% and 94.9%, respectively. A hostile neck was identified in 33.9% of patients and 10.7% were treated outside instructions for use (IFU). An early post-operative (≤30 days) mortality rate of 1.7% was observed. At one and five years, respectively, the overall survival rate was 94.9% and 65.9% (aneurysm related in four patients [2.3%]) and the clinical success rate was 90.9% and 70.6%. Secondary interventions were performed in 35 of 176 patients (19.9%). The overall limb occlusion rate was 7.9% and the aneurysm sac diameter decreased significantly (pre-operative diameter 53.9 ± 8.6 mm vs. 42.3 ± 14.7 mm at five years; p < .001). Patients treated outside the instructions for use (IFU) had significantly higher rates of migration, surgical conversion, and aneurysm sac expansion (p = .03).
The Anaconda endograft provides high technical success and satisfactory five year aneurysm exclusion and clinical success rates. However, implantation outside the IFU should be avoided, as it leads to significantly worse outcomes, and caution over the risk of limb occlusion and distal embolisation should be observed.
与开放修复相比，腹主动脉瘤腔内修复术（EVAR）后长期随访发现与动脉瘤相关的生存率显著降低。因此，新代内植物的长期结果至关重要。本项法国多中心前瞻性观察研究（EPI-ANA-01）的目的是评估第三代 Anaconda 覆膜支架的技术成功率以及五年死亡率和二级干预率。
2012 年 6 月至 2013 年 10 月，连续纳入 176 例未破裂的肾下腹主动脉瘤患者（160 例男性患者，平均年龄 75.3±8.4 岁）。使用 Kaplan-Meier 方法估计生存、无 Ia 型内漏、肢体事件和再干预率。根据迁移、转换、不良肢体事件、内漏和瘤腔增大的发生情况，比较解剖学和临床特征。
主要技术和临床成功率分别为 98.3%和 94.9%。33.9%的患者存在颈部不良解剖，10.7%的患者超出使用说明（IFU）进行治疗。观察到术后早期（≤30 天）死亡率为 1.7%。分别在 1 年和 5 年时，总生存率分别为 94.9%和 65.9%（4 例患者因动脉瘤相关原因死亡[2.3%]），临床成功率分别为 90.9%和 70.6%。176 例患者中有 35 例（19.9%）接受了二级干预。总体肢体闭塞率为 7.9%，瘤腔直径明显减小（术前直径 53.9±8.6mm 与 5 年后的 42.3±14.7mm；p<.001）。超出 IFU 治疗的患者迁移、手术转换和瘤腔扩张的发生率显著更高（p=0.03）。
Anaconda 覆膜支架具有较高的技术成功率和令人满意的五年动脉瘤封闭和临床成功率。然而，应避免超出 IFU 进行植入，因为这会导致更差的结果，并应注意肢体闭塞和远端栓塞的风险。
