Long-term outcomes of thoracic endovascular aortic repair for descending thoracic aortic aneurysms based on pooled results from FDA clinical trials.

IF 3.9 2区 医学 Q1 PERIPHERAL VASCULAR DISEASE
Lauren A Gillinov, Grace J Wang, Nicholas J Goel, Michael A Catalano, Wilson Y Szeto, Venkat R Kalapatapu, Nimesh D Desai
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引用次数: 0

Abstract

Objective: Thoracic endovascular aortic repair is the preferred treatment for descending thoracic aortic aneurysms, but long-term data are limited. This study assessed long-term results of thoracic endovascular aortic repair in early recipients of thoracic endovascular aortic repair devices who were enrolled in FDA investigational device exemption clinical trials for aneurysm.

Methods: This was a single-center retrospective study including 179 patients enrolled in 14 clinical trials for thoracic endovascular aortic repair for descending thoracic aortic aneurysm between 2000 and 2019. The primary outcome was ten-year mortality. Secondary outcomes included a 30-day composite of death or 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.

Results: Median 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 millimeters. Survival at one, five, and ten 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 ten years. Increasing age and preoperative aneurysm diameter were independent predictors of mortality. A majority of patients (73.8%) had stable aneurysm sac at five years.

Conclusions: While overall survival at ten years was limited, early outcomes were favorable and most patients had stable aneurysm sac at five 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, durability of thoracic endovascular aortic repair remains a concern.

基于FDA临床试验汇总结果的胸降性主动脉瘤血管内修复的长期预后
目的:胸主动脉血管内修复术是治疗胸降动脉瘤的首选方法,但长期数据有限。本研究评估了早期接受胸腔血管内主动脉修复装置的患者的长期效果,这些患者参加了美国食品药品监督管理局(FDA)关于动脉瘤的试验性器械豁免临床试验。方法:这是一项单中心回顾性研究,纳入了2000年至2019年期间进行胸降性主动脉瘤血管内修复术的14项临床试验的179例患者。主要结果是10年死亡率。次要结局包括30天的死亡或神经事件、内漏、再干预和随访成像的主动脉直径。使用描述性统计、Kaplan-Meier生存分析、Cox比例风险模型和具有竞争风险的累积发生率函数进行分析。结果:中位年龄74岁,中位随访5.5年。动脉瘤形态为梭状(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(32.4%)患者出现Endoleak, 44例(24.6%)患者出现再干预。再干预与10年全因死亡率均无相关性。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。结论:虽然10年的总生存率有限,但早期结果是有利的,大多数患者在5年时有稳定的动脉瘤囊。Endoleak和再干预与长期死亡率无关,而年龄和术前主动脉直径预测较差的生存率。在这个老年患者队列中,胸腔血管内主动脉修复术的持久性仍然是一个值得关注的问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.70
自引率
18.60%
发文量
1469
审稿时长
54 days
期刊介绍: Journal of Vascular Surgery ® aims to be the premier international journal of medical, endovascular and surgical care of vascular diseases. It is dedicated to the science and art of vascular surgery and aims to improve the management of patients with vascular diseases by publishing relevant papers that report important medical advances, test new hypotheses, and address current controversies. To acheive this goal, the Journal will publish original clinical and laboratory studies, and reports and papers that comment on the social, economic, ethical, legal, and political factors, which relate to these aims. As the official publication of The Society for Vascular Surgery, the Journal will publish, after peer review, selected papers presented at the annual meeting of this organization and affiliated vascular societies, as well as original articles from members and non-members.
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