Gillinov Lauren A, Wang Grace J, Goel Nicholas J, Catalano Michael A, Szeto Wilson Y, Kalapatapu Venkat R, Desai Nimesh D
Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, PA.
Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Pennsylvania, Philadelphia, PA.
J Vasc Surg. 2025 Sep;82(3):770-779.e2. doi: 10.1016/j.jvs.2025.05.038. Epub 2025 May 26.
Thoracic endovascular aortic repair (TEVAR) is the preferred treatment for descending thoracic aortic aneurysms, but long-term data are limited. This study assessed long-term results of TEVAR in early recipients of TEVAR devices who were enrolled in US Food and Drug Administration investigational device exemption clinical trials for aneurysm.
This was a single-center retrospective study including 179 patients enrolled in 14 clinical trials for TEVAR for descending thoracic aortic aneurysm between 2000 and 2019. The primary outcome was 10-year mortality. Secondary outcomes included a 30-day composite of death or a neurologic event, endoleak, reintervention, and aortic diameter on follow-up imaging. Descriptive statistics, Kaplan-Meier survival analysis, Cox proportional hazards models, and cumulative incidence functions with competing risk were used for analysis.
The median patient age was 74 years and median follow-up was 5.5 years. Aneurysm morphology was fusiform (n = 100 [55.9%]) or saccular (n = 70 [39.1%]), with median preoperative diameter of 60.0 mm. Survival at 1, 5, and 10 years was 91.1%, 62.8%, and 31.4%. Endoleak was observed in 58 patients (32.4%), and reintervention in 44 patients (24.6%). Neither endoleak nor reintervention was associated with all-cause mortality at 10 years. Increasing age and preoperative aneurysm diameter were independent predictors of mortality. A majority of patients (73.8%) had stable aneurysm sac at 5 years.
Although overall survival at 10 years was limited, early outcomes were favorable and most patients had stable aneurysm sac at 5 years. Endoleak and reintervention were not linked to long-term mortality, whereas age and preoperative aortic diameter predicted worse survival. In this older patient cohort, the durability of TEVAR remains a concern.
胸主动脉腔内修复术（TEVAR）是降主动脉瘤的首选治疗方法，但长期数据有限。本研究评估了参与美国食品药品监督管理局器械豁免临床试验的早期TEVAR装置接受者中TEVAR的长期结果。
这是一项单中心回顾性研究，纳入了2000年至2019年间参加14项降主动脉瘤TEVAR临床试验的179例患者。主要结局是10年死亡率。次要结局包括30天内死亡或神经系统事件的复合结局、内漏、再次干预以及随访影像学检查时的主动脉直径。采用描述性统计、Kaplan-Meier生存分析、Cox比例风险模型以及具有竞争风险的累积发病率函数进行分析。
患者中位年龄为74岁，中位随访时间为5.5年。动脉瘤形态为梭形（n = 100 [55.9%]）或囊状（n = 70 [39.1%]），术前中位直径为60.0 mm。1年、5年和10年生存率分别为91.1%、62.8%和31.4%。58例患者（32.4%）观察到内漏，44例患者（24.6%）进行了再次干预。10年内漏和再次干预均与全因死亡率无关。年龄增加和术前动脉瘤直径是死亡率的独立预测因素。大多数患者（73.8%）在5年时动脉瘤囊稳定。
尽管10年总体生存率有限，但早期结局良好，大多数患者在5年时动脉瘤囊稳定。内漏和再次干预与长期死亡率无关，而年龄和术前主动脉直径预示生存率较差。在这个老年患者队列中，TEVAR的耐久性仍然是一个问题。
