Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, Wash.
Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, Wash.
J Vasc Surg. 2021 Sep;74(3):823-831.e1. doi: 10.1016/j.jvs.2021.01.042. Epub 2021 Feb 14.
The Terumo aortic (TA) Treo device (Terumo, Somerset, NJ) is an endograft with unique features that lends itself to fenestrated endovascular aneurysm repair (FEVAR), including a low device profile, a wide amplitude stent design, and an increased interstent distance. We have described our initial experience with the Treo device for FEVAR to treat short neck and juxtarenal abdominal aortic aneurysms.
As part of an ongoing physician-sponsored investigational device exemption clinical trial (ClinicalTrials.gov identifier, NCT01538056), subjects were prospectively enrolled and underwent elective FEVAR using a variety of devices. Demographic and procedural details were collected. The data from subjects treated specifically with the Treo device from November 3, 2016 to May 2, 2019 were collected and analyzed.
Of a cohort of 161 patients who had undergone elective FEVAR, 46 had been treated with the TA Treo device. Most patients were men (70%), with a mean age of 75 years and high rates of hypertension (74%), hyperlipidemia (83%), coronary artery disease (33%), and chronic obstructive pulmonary disease (33%). The mean aneurysm size was 66 mm, the mean preoperative infrarenal neck length was 5 mm, and the mean final seal zone length was 45 mm. The average hospital and intensive care unit lengths of stay were 2.4 and 1.5 days, respectively. A total of 129 fenestrations were created for 44 superior mesenteric and 85 renal arteries (2.8 fenestrations per patient). Technical success, defined as successful implantation of the device with all target vessels preserved, was 98% (45 of 46), with only one renal artery not successfully preserved. The mean follow-up period was 598 days. During the study period, 18 endoleaks were detected (17 type II and 1 type III), with one patient with a type III endoleak requiring reintervention. Three subjects had died within 30 days, one of intracranial hemorrhage, one of respiratory failure, and one of ischemic colitis. The graft modification times for the TA Treo were significantly shorter (43 minutes) than those for other commercially available devices (Cook Zenith, 55 minutes; Medtronic Endurant, 54 minutes; P < .0001).
Our institution has reported exclusive worldwide experience using the TA Treo device for FEVAR. This device provides for a highly efficient and technically successful procedure for most patients. The procedural and fluoroscopy times were low even in the setting of high complexity. The technical success rates and simplification of the FEVAR procedure have made this approach a preferred technique for most patients at our institution.
Terumo 主动脉 (TA) Treo 装置（Terumo，新泽西州萨默塞特）是一种具有独特特性的血管内移植物，非常适合进行开窗式血管内动脉瘤修复术（fenestrated endovascular aneurysm repair，FEVAR），包括设备的低轮廓、宽幅度支架设计和增加的支架间距离。我们已经描述了我们使用 Treo 装置治疗短颈和肾周腹主动脉瘤的初步经验。
作为一项正在进行的医师赞助的调查性器械豁免临床试验（ClinicalTrials.gov 标识符，NCT01538056）的一部分，前瞻性地招募了受试者，并使用各种装置进行了选择性 FEVAR。收集了人口统计学和程序细节。收集并分析了 2016 年 11 月 3 日至 2019 年 5 月 2 日期间专门使用 Treo 装置治疗的受试者的数据。
在接受选择性 FEVAR 的 161 例患者中，有 46 例使用了 TA Treo 装置。大多数患者为男性（70%），平均年龄为 75 岁，高血压（74%）、高血脂（83%）、冠心病（33%）和慢性阻塞性肺疾病（33%）的发病率很高。平均动脉瘤大小为 66mm，术前肾下颈长度为 5mm，最终密封区长度为 45mm。平均住院和重症监护病房住院时间分别为 2.4 天和 1.5 天。总共创建了 129 个 fenestrations 用于 44 个肠系膜上动脉和 85 个肾动脉（每个患者 2.8 个 fenestrations）。技术成功率定义为所有目标血管均成功植入的成功率为 98%（45/46），只有 1 个肾动脉未成功保留。平均随访时间为 598 天。在研究期间，检测到 18 个内漏（17 个 II 型和 1 个 III 型），其中 1 例 III 型内漏需要再次介入治疗。3 例患者在 30 天内死亡，1 例死于颅内出血，1 例死于呼吸衰竭，1 例死于缺血性结肠炎。TA Treo 的移植物修改时间明显短于其他市售设备（Cook Zenith，55 分钟；Medtronic Endurant，54 分钟；P<.0001）。
我们机构报告了独家的全球经验，使用 TA Treo 装置进行 FEVAR。该装置为大多数患者提供了高效且技术上成功的手术。即使在高复杂性的情况下，手术和透视时间也很低。技术成功率和 FEVAR 手术的简化使该方法成为我们机构大多数患者的首选技术。
