Department of Vascular and Endovascular Surgery, Hospital Ottakring, Vienna, Austria.
Interact Cardiovasc Thorac Surg. 2021 Apr 8;32(3):460-466. doi: 10.1093/icvts/ivaa272.
The Medtronic Endurant II stent graft has recently received Conformité Européenne (CE) approval for the use in chimney endovascular aortic repair (ChEVAR) for the treatment for juxtarenal aortic aneurysms. The aim of this study was to assess the percentage of patients treated by fenestrated endovascular repair who would have been alternatively suitable for the treatment by the CE approved Medtronic ChEVAR.
Preoperative computed tomography scans of 100 patients who underwent fenestrated endovascular aortic repair (FEVAR) between April 2013 and February 2017 were retrospectively assessed for the applicability of the ChEVAR technique according to the Medtronic instructions for use. Eligibility criteria included an aortic neck diameter of 19-30 mm, a minimum infrarenal neck length of 2 mm, a total proximal sealing zone of at least 15 mm, thrombus in the aortic neck in ˂25% of the circumference, and maximum aortic angulations of 60° in the infrarenal, 45° in the suprarenal segment and ˂45° above the superior mesenteric artery.
According to CE-approved inclusion criteria, 19 individuals (19%) would have been eligible for ChEVAR. In 81 patients, at least 1 measure was found outside instructions for use: (i) excluding factor was detected in 26 patients, (ii) incongruous measures in 28 patients and in 27 patients, 3-5 measures were outside the instructions for use. The most frequently identified excluding factor was an insufficient infrarenal neck at ˂2 mm length (n = 63; 63%).
Patients with juxta- or pararenal aneurysm treated by FEVAR are in 19% of the cases alternatively suitable for the treatment by ChEVAR within CE-approved instructions for use. While ChEVAR is suitable in many emergency cases, FEVAR offers a broader applicability in an elective setting.
美敦力公司的 Endurant II 支架移植物最近获得了欧洲符合性（CE）认证，可用于治疗肾下型主动脉瘤的烟囱腔内血管修复术（ChEVAR）。本研究旨在评估通过开窗腔内血管修复术（FEVAR）治疗的患者中，有多少患者根据 CE 批准的美敦力 ChEVAR 使用说明，可选择采用该技术进行治疗。
回顾性评估了 2013 年 4 月至 2017 年 2 月期间接受 FEVAR 的 100 例患者的术前计算机断层扫描，以根据美敦力使用说明评估 ChEVAR 技术的适用性。入选标准包括主动脉颈直径 19-30mm、肾下颈长度至少 2mm、总近端密封区至少 15mm、主动脉颈内血栓 ˂25%周径、肾下、肾上和肠系膜上动脉以上的最大主动脉角分别为 60°、45°和 ˂45°。
根据 CE 批准的纳入标准，有 19 人（19%）符合 ChEVAR 的条件。在 81 例患者中，至少有 1 项指标超出了使用说明：（i）在 26 例患者中发现了排除因素；（ii）在 28 例患者中发现了不一致的指标；在 27 例患者中，有 3-5 项指标超出了使用说明。最常见的排除因素是肾下颈长度 ˂2mm（n=63；63%）。
通过 FEVAR 治疗的肾周或肾旁动脉瘤患者，根据 CE 批准的使用说明，有 19%的患者可选择采用 ChEVAR 进行治疗。虽然 ChEVAR 适用于许多急诊情况，但 FEVAR 在择期治疗中具有更广泛的适用性。
