Lee Joonpyo, Oh Pyung Chun, Jang Albert Youngwoo, Ahn Chul-Min, Choi Donghoon, Ko Young-Guk, Kang Woong Chol
Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
Division of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
J Endovasc Ther. 2024 Feb 27:15266028241232915. doi: 10.1177/15266028241232915.
Endovascular aneurysm repair (EVAR) has been used worldwide to treat abdominal aortic aneurysms (AAAs). Outcomes after EVAR within and outside the instruction for use (IFU) remain controversial. We analyzed long-term outcomes of EVAR within-the-IFU compared with that outside-the-IFU and baseline clinical/anatomical characteristics that influence outcomes of EVAR.
The study included 546 patients who underwent EVAR for infrarenal AAA from 1997 to 2021 at 2 Korean medical centers. The primary endpoint was graft-related adverse events (GRAEs), including type 1 or 3 endoleak, reintervention (included open conversion), aneurysm sac enlargement, aneurysm-related mortality (ARM), rupture, stent-graft migration, and stent thrombotic occlusion.
The patients who underwent EVAR outside the IFU were 287 (52.6%). A neck angle of >60° was most common outside the IFU criteria (n=146, 50.9%). This study revealed that patients outside the IFU had a higher rate of GRAEs compared with patients within the IFU (hazard ratio [HR]: 1.879; 95% confidence interval [CI]: 1.045-2.386). A neck angle of >60° was a significant risk factor for GRAEs (adjusted HR: 2.229; 95% CI: 1.418-3.503), type 1 or 3 endoleak (adjusted HR: 2.640; 95% CI: 1.343-5.189), and reintervention (adjusted HR: 1.891; 95% CI: 1.055-3.388).
Our study revealed EVAR with outside the IFU was associated with increased GRAEs, mainly attributed to endoleak and ARM, compared with EVAR with within the IFU. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak, and reintervention.
Our study revealed endovascular aneurysm repair (EVAR) with outside-the-instruction for use (IFU) was associated with increased graft-related adverse events (GRAEs) compared with EVAR with within-the-IFU. In the low-risk population, the incidence of GRAEs and Aneurysm related mortality were higher in the outside-the-IFU group rather than within-the-IFU group. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak and reintervention.
血管内动脉瘤修复术（EVAR）已在全球范围内用于治疗腹主动脉瘤（AAA）。在使用说明书（IFU）范围内和范围外进行EVAR后的结果仍存在争议。我们分析了在IFU范围内与范围外进行EVAR的长期结果以及影响EVAR结果的基线临床/解剖学特征。
该研究纳入了1997年至2021年在韩国两家医疗中心接受肾下AAA的EVAR治疗的546例患者。主要终点是移植物相关不良事件（GRAEs），包括1型或3型内漏、再次干预（包括开放转换）、动脉瘤囊扩大、动脉瘤相关死亡率（ARM）、破裂、支架移植物迁移和支架血栓闭塞。
在IFU范围外接受EVAR的患者有287例（52.6%）。颈角>60°在IFU标准范围外最为常见（n = 146，50.9%）。本研究表明，与IFU范围内的患者相比，IFU范围外的患者发生GRAEs的比率更高（风险比[HR]：1.879；95%置信区间[CI]：1.045 - 2.386）。颈角>60°是GRAEs（调整后HR：2.229；95%CI：范围外接受EVAR与IFU范围内接受EVAR相比，与GRAEs增加相关，主要归因于内漏和ARM。此外，严重的颈角成角是GRAEs、1型或3型内漏以及再次干预的独立危险因素。
我们的研究表明，与IFU范围内的血管内动脉瘤修复术（EVAR）相比，在使用说明书（IFU）范围外进行的EVAR与移植物相关不良事件（GRAEs）增加相关。在低风险人群中，IFU范围外组的GRAEs和动脉瘤相关死亡率的发生率高于IFU范围内组。此外，严重的颈角成角是GRAEs、1型或3型内漏以及再次干预的独立危险因素。 1.418 - 3.503）、1型或3型内漏（调整后HR：2.640；95%CI：1.343 - 5.189）和再次干预（调整后HR：1.891；95%CI：1.055 - 3.388）的显著危险因素。
我们的研究表明，与IFU范围内接受EVAR相比，在IFU
