Vascular Surgery Unit, University Hospital Virgen de las Nieves, Granada, Spain.
Department of Surgery, University of Granada, Granada, Spain.
J Endovasc Ther. 2023 Dec;30(6):867-876. doi: 10.1177/15266028221102658. Epub 2022 Jun 23.
The widespread adoption of endovascular aneurysm repair (EVAR) as preferred treatment modality for abdominal aortic aneurysm (AAA) has enlarged the number of patients needing open surgical conversion (OSC). The relationship between adherence to Instructions For Use (IFU) and EVAR long-term outcomes remains controversial. The aim of this study is to compare preoperative differences and postoperative outcomes between EVAR patients not adjusted to IFU and adjusted to IFU who underwent OSC.
This multicenter retrospective study reviewed 33 explanted EVARs between January 2003 and December 2019 at 14 Vascular Units. Patients were included if OSC occurred >30 days after implantation and excluded if explantation was performed to treat an endograft infection, aortic dissection, or traumatic transections. Variables analyzed included baseline characteristics, adherence to IFU, implant and explant procedural details, secondary reinterventions, and postoperative outcomes.
Fifteen explanted patients (15/33, 45.5%) were identified not accomplished to IFU (out-IFU) at initial EVAR vs 18 explanted patients adjusted (in-IFU). During follow-up, a mean of 1.73±1.2 secondary reinterventions were performed, with more type I endoleaks treated in the subgroup out-IFU: 16.7% vs 6.3% in-IFU patients and more type III endoleaks (8.3% vs 0%). Patients out-IFU had shorter mean interval from implant to explant: 47.60±28.8 months vs 71.17±48. Type II endoleak was the most frequent indication for explantation. Low-flow endoleaks (types II, IV, V) account for 44% of indications for OSC in subgroup of patients in-IFU, compared with 13.3% in patients out-IFU and high-flow endoleaks (types I and III) were the main indication for patients out-IFU (33.3% vs 16.7% in-IFU). Total endograft explantation was performed in 57.5% of cases (19/33) and more suprarenal clamping was required in the subgroup out-IFU. Overall, 30-day mortality rate was 12.1% (4/33): 20% for patients out-IFU and 5.6% in-IFU.
In our experience, type II endoleak is the most common indication for conversion and differences have been found between patients treated outside IFU with explantation taking place earlier during follow-up, mainly due to high-flow endoleaks and with higher mortality in comparison with patients adjusted to IFU. Ongoing research is required to delve into these differences.
腹主动脉瘤（AAA）血管内修复术（EVAR）作为首选治疗方法的广泛采用，扩大了需要开放手术转换（OSC）的患者数量。遵守使用说明（IFU）与 EVAR 长期结果之间的关系仍存在争议。本研究旨在比较未根据 IFU 调整和根据 IFU 调整的接受 OSC 的 EVAR 患者的术前差异和术后结果。
这是一项多中心回顾性研究，纳入了 2003 年 1 月至 2019 年 12 月在 14 个血管单位进行的 33 例 EVAR 术后患者。如果在植入后 >30 天进行 OSC，则将患者纳入研究，如果进行 OSC 是为了治疗移植物感染、主动脉夹层或创伤性横断，则将患者排除在外。分析的变量包括基线特征、对 IFU 的依从性、植入物和取出程序细节、二级再干预和术后结果。
15 例（15/33，45.5%）在初始 EVAR 时未达到 IFU（out-IFU），18 例接受 OSC 的患者符合 IFU（in-IFU）。在随访期间，平均进行了 1.73±1.2 次二级再干预，out-IFU 亚组中治疗更多的 I 型内漏：16.7%比 in-IFU 患者的 6.3%，III 型内漏更多（8.3%比 0%）。out-IFU 患者的植入物到取出物的平均时间间隔更短：47.60±28.8 个月 vs 71.17±48. 类型 II 内漏是最常见的取出物指征。在 in-IFU 患者亚组中，低流量内漏（类型 II、IV、V）占 OSC 指征的 44%，而 out-IFU 患者为 13.3%，高流量内漏（类型 I 和 III）是 out-IFU 患者的主要指征（33.3%比 in-IFU 患者的 16.7%）。57.5%的病例（19/33）进行了总移植物取出，out-IFU 亚组需要更多的肾上极夹闭。总体而言，30 天死亡率为 12.1%（4/33）：out-IFU 患者为 20%，in-IFU 患者为 5.6%。
根据我们的经验，类型 II 内漏是转换的最常见指征，并且在未根据 IFU 治疗的患者中发现了与根据 IFU 治疗的患者之间的差异，这些差异主要与高流量内漏有关，并且与根据 IFU 治疗的患者相比，死亡率更高。需要进一步的研究来深入研究这些差异。
