Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, WA.
Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, WA.
Ann Vasc Surg. 2021 Jan;70:481-490. doi: 10.1016/j.avsg.2020.06.032. Epub 2020 Jun 27.
First-generation "off-the-shelf" branched endovascular stent grafts are in development for treatment of thoracoabdominal aortic aneurysms (TAAAs). Prior studies have assessed eligibility rates among highly selected cohorts of patients referred for endovascular treatment, and the broader applicability of these devices to all patients with TAAA is unknown. The aims of this study were to assess the overall suitability of the 3 commercial 4-branched devices with or without adjunct procedure(s) in an unselected cohort of patients with TAAA and to identify areas for improvement in the next generation of devices.
A retrospective review of three-dimensional centerline reconstructions of contrast-enhanced computed tomography (CT) imaging was performed in consecutive patients with TAAA seen between 2013 and 2017. All patients with contrast-enhanced CT imaging were included, regardless of prior evaluation for suitability for endovascular repair. Eligibility for a device was assessed based on instructions for use (IFU) from the device manufacturer along with prespecified anatomic criteria. Adjunct procedures were defined as carotid-subclavian revascularization, target vessel endovascular intervention, and iliac conduit/revascularization.
Of 165 patients with TAAA, 122 had CT scans adequate for study inclusion. Eighteen patients (14.8%) were eligible for at least 1 device by IFU, and 41 (33.6%) could have been made eligible for at least 1 device by an adjunct procedure. Sixty-three (51.6%) were not eligible for any device within IFU even with adjunct procedures, including 31 of 32 patients with TAAA due to dissection. The most common reasons for ineligibility were perivisceral flow channel diameter <20 mm (n = 43) and an inadequate proximal seal zone (n = 29). Women were significantly less likely to be eligible for an off-the-shelf device (P = 0.03) and were more likely to require an iliac procedure to become eligible (P = 0.006). Almost none of the patients with dissection could receive a device even if adjunct procedures were used.
Over half of patients with TAAA could not be made eligible for an off-the-shelf device based on manufacturers' criteria, even with adjunct procedures. Women and patients with TAAA due to dissection had higher rates of ineligibility. These data demonstrate that custom fenestrated devices and low-profile devices are needed to expand eligibility for endovascular repair of TAAA.
第一代“现成”分支型血管内支架移植物正在开发中，用于治疗胸腹主动脉瘤（TAAA）。先前的研究评估了接受血管内治疗的高度选择患者队列中的入选率，而这些设备对所有 TAAA 患者的广泛适用性尚不清楚。本研究的目的是评估在 TAAA 患者的未选择队列中，使用或不使用辅助手术，这 3 种商业 4 分支设备的总体适用性，并确定下一代设备的改进领域。
对 2013 年至 2017 年间连续就诊的 TAAA 患者的增强 CT 成像的三维中心线重建进行回顾性分析。所有接受增强 CT 成像的患者均包括在内，无论其是否进行过血管内修复的适用性评估。根据设备制造商的使用说明（IFU）以及预定的解剖标准评估设备的适用性。辅助手术定义为颈动脉-锁骨下血管重建术、靶血管血管内介入术和髂血管重建术。
在 165 例 TAAA 患者中，有 122 例 CT 扫描结果适合研究纳入。根据 IFU，18 例（14.8%）至少有 1 种设备符合入选标准，41 例（33.6%）至少有 1 种设备可通过辅助手术符合入选标准。即使使用辅助手术，63 例（51.6%）也不符合任何设备的标准，包括 32 例 TAAA 患者中有 31 例因夹层而不符合标准。不符合标准的最常见原因是内脏周围血流通道直径<20mm（n=43）和近端密封区不足（n=29）。女性使用“现成”设备的可能性显著降低（P=0.03），更有可能需要髂部手术才能符合条件（P=0.006）。即使使用辅助手术，几乎没有夹层患者可以接受设备。
根据制造商的标准，超过一半的 TAAA 患者不符合“现成”设备的标准，即使使用辅助手术也是如此。女性和因夹层而患有 TAAA 的患者不符合标准的比例较高。这些数据表明，需要定制的开窗设备和低剖面设备来扩大 TAAA 血管内修复的适应证。
