Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, Wash.
Division of Vascular Surgery and Endovascular Therapeutics, Department of Surgery, University of Louisville, Louisville, Ky.
J Vasc Surg. 2020 Jun;71(6):1851-1857. doi: 10.1016/j.jvs.2019.05.070. Epub 2020 Feb 1.
The purpose of this study was to report the updated results of a prospective, multicenter, nonrandomized, single-arm investigational device exemption study conducted at 17 sites in the United States to assess safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injury (BTAI).
The primary safety end point was 30-day all-cause mortality and aortic injury-related mortality. The primary effectiveness end point was 30-day device success. Additional outcomes evaluated included major adverse events and imaging findings including aortic injury healing, graft patency, and device integrity as analyzed by the core laboratory on follow-up computed tomography imaging through 5 years.
A total of 50 patients with BTAI were enrolled in the TRANSFIX study between January 2013 and May 2014. Mean follow-up was 21 months (range, 0.6-35 months). The 30-day mortality was 2% (n = 1), and it was unrelated to the aortic repair or study device. Five deaths occurred after 30 days, and one was considered procedure related. Freedom from all-cause and BTAI-related mortality was 89.3% and 97.6%, respectively, at 2 years. Aortic injury healing was noted in 96% at 2 years. An incidental finding of thrombus formation within the stent graft, most commonly at the distal aspect of the study device, occurred in 15 patients (30%; 12 by core laboratory, 3 by site) and was confirmed in 13 patients (26%). None of these patients were noted to have clinical sequelae on most recent follow-up.
The updated results from the TRANSFIX study continue to show low rates of aortic injury-related mortality and major adverse events during follow-up. However, findings of in-graft thrombus have resulted in the manufacturer's voluntary removal of the BTAI indication for this device. Caution should be exercised in appropriate and accurate device sizing and planning (eg, limiting graft oversizing) as well as in regular, lifelong follow-up evaluation.
本研究旨在报告在美国 17 个地点进行的一项前瞻性、多中心、非随机、单臂研究的最新结果，该研究使用 Zenith Alpha 胸主动脉覆膜支架（库克医疗公司，印第安纳州布鲁明顿）评估治疗钝性胸主动脉损伤（BTAI）的安全性和有效性。
主要安全性终点为 30 天全因死亡率和主动脉损伤相关死亡率。主要有效性终点为 30 天器械成功率。其他评估的结果包括主要不良事件和影像学发现，包括主动脉损伤愈合、移植物通畅性以及通过核心实验室在 5 年内进行的随访 CT 成像分析的器械完整性。
2013 年 1 月至 2014 年 5 月期间，共有 50 例 BTAI 患者入组 TRANSFIX 研究。平均随访时间为 21 个月（0.6-35 个月）。30 天死亡率为 2%（n=1），与主动脉修复或研究器械无关。5 例死亡发生在 30 天后，其中 1 例被认为与手术相关。2 年时全因死亡率和 BTAI 相关死亡率分别为 89.3%和 97.6%。2 年时，96%的患者主动脉损伤愈合。15 例患者（30%；12 例经核心实验室，3 例经术者）发现支架内血栓形成，最常见于研究器械的远端，13 例患者（26%）经证实存在该情况。在最近的随访中，这些患者均无明显的临床后遗症。
TRANSFIX 研究的更新结果继续显示，在随访期间，主动脉损伤相关死亡率和主要不良事件发生率较低。然而，移植物内血栓形成的发现导致制造商自愿取消该器械治疗 BTAI 的适应证。在进行适当和准确的器械尺寸选择和规划（例如，限制移植物过度扩张）以及定期、终身随访评估时应谨慎。
