Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Ga.
Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pa.
J Vasc Surg. 2021 Nov;74(5):1491-1498. doi: 10.1016/j.jvs.2021.04.063. Epub 2021 May 20.
The Gore conformable TAG thoracic endoprosthesis (CTAG) was engineered to enhance conformability in the thoracic aorta and has demonstrated greater deployment accuracy and wall apposition than the original TAG device. The Food and Drug Administration approved the CTAG in 2011 based on the 1-year results of the pivotal trial for the CTAG device. In the present report, we have documented the outcomes for those patients through 5 years.
The CTAG aneurysm study was a prospective, multicenter trial that assessed the safety and effectiveness of the CTAG device as treatment of descending thoracic aortic aneurysms. Follow-up imaging assessments consisted of radiographs and computed tomography at annual intervals through 5 years. A core imaging laboratory was used to assess the aneurysm size, device integrity, and endoleaks.
A total of 66 patients were enrolled (51 pivotal arm patients and 15 continued access patients) from October 2009 through September 2011. The baseline characteristics, procedural characteristics, and outcomes through 2 years were reported previously. Through 5 years, five patients (7.6%) had required device-related reintervention (one type Ia endoleak or contained rupture of the descending thoracic aorta, one type Ib endoleak, two indeterminate endoleaks, and one thoracic aortic pseudoaneurysm). Four patients (6.1%) had died of aneurysm-related causes, with one death occurring within 30 days of the index procedure. A total of 24 patients (36.3%) had died during the 5-year study period. Seven patients (10.6%) had experienced stroke or transient ischemic attack through 5 years, with one early stroke (postoperative day 28). Prosthesis or intercomponent migration was observed in six patients (9.1%) through 5 years; however, no patient had developed a type III junctional endoleak. No stent-graft fracture or compression was observed through 5 years. At 5 years, 14 patients (50.0%) showed sac regression, 5 (17.9%) showed sac expansion, and 9 (32.1%) showed sac stability using on a 5-mm threshold for change.
Thoracic endovascular aortic repair with the CTAG device was associated with low rates of aneurysm-related mortality and reintervention through 5 years. Proximal endoleak was rare, and most patients showed sac regression or stability at 5 years after the initial thoracic endovascular aortic repair.
戈尔顺应性 TAG 胸主动脉内修复假体（CTAG）旨在提高胸主动脉的顺应性，与原始 TAG 装置相比，其具有更高的置放精度和贴壁效果。美国食品和药物管理局（FDA）于 2011 年基于 CTAG 装置的关键试验 1 年结果批准了该产品。在本报告中，我们通过 5 年的随访，记录了这些患者的治疗结果。
CTAG 动脉瘤研究是一项前瞻性、多中心临床试验，评估了 CTAG 装置治疗降主动脉瘤的安全性和有效性。通过 5 年的定期随访，对患者进行影像学评估，包括每年一次的 X 线和 CT 检查。使用一个核心影像学实验室来评估动脉瘤大小、器械完整性和内漏情况。
2009 年 10 月至 2011 年 9 月期间，共纳入 66 例患者（51 例来自关键试验组，15 例来自继续准入试验组）。基线特征、手术特点和 2 年的治疗结果已在先前的报告中描述。通过 5 年的随访，5 例患者（7.6%）需要进行器械相关的再次干预（1 例为 I 型内漏或降主动脉破裂，1 例为 Ib 型内漏，2 例不确定型内漏，1 例胸主动脉假性动脉瘤）。4 例患者（6.1%）因动脉瘤相关原因死亡，其中 1 例死亡发生在索引手术 30 天内。5 年研究期间共有 24 例患者（36.3%）死亡。7 例患者（10.6%）在 5 年内发生了卒中和短暂性脑缺血发作，其中 1 例为早期卒中（术后第 28 天）。6 例患者（9.1%）在 5 年内出现了移植物或移植物之间的迁移，但没有患者发生 III 型交界性内漏。5 年内没有观察到支架移植物断裂或压迫。5 年时，14 例患者（50.0%）显示瘤腔缩小，5 例（17.9%）显示瘤腔扩张，9 例（32.1%）显示瘤腔稳定，以 5mm 为阈值判断变化。
采用 CTAG 装置进行胸主动脉腔内修复术，5 年内与较低的动脉瘤相关死亡率和再干预率相关。近端内漏罕见，大多数患者在初次胸主动脉腔内修复术后 5 年内显示瘤腔缩小或稳定。
