目的:在这项前瞻性美国研究器械豁免试验中,我们评估了Thoraflex混合装置(Terumo主动脉)用于冷冻大象躯干技术修复升主动脉的安全性和1年临床结局,主动脉弓,胸主动脉降.
方法:对于试验,涉及12个美国网站,65例没有破裂的患者被纳入主要研究组,9例患者被纳入破裂组。所有患者都接受了升主动脉的开放手术修复,主动脉弓,在动脉瘤和/或夹层的情况下,胸主动脉下降。主要终点为无主要不良事件(MAE),定义为永久行程,永久性截瘫/截瘫,意外主动脉相关再手术(不包括出血再手术),或全因死亡率。
结果:在主要研究组中,2例患者在1年内失访。一年的MAE自由度为81%(51/63)。7例患者(11%)死亡(包括2例在30天或出院前),3名患者(5%)患有永久性中风,3例(5%)发生永久性截瘫/截瘫。26名患者(41%)接受了计划的延期手术,包括22例血管内手术,中位数为122(四分位间距,64-156)天。在主动脉破裂组中,2例患者在1年内失访。一年的MAE自由度为71%(5/7)。一名患者(14%)死亡,2例患者(29%)有永久性卒中,没有人患有永久性截瘫/截瘫。破裂组未进行任何延伸程序。
结论:使用ThoraflexHybrid装置的一年结果是可以接受的。长期数据对于评估这些维修的耐久性是必要的。
OBJECTIVE: In this prospective US investigational device exemption
trial, we assessed the safety and 1-year clinical outcomes of the Thoraflex Hybrid device (Terumo Aortic) for the frozen elephant trunk technique to repair the ascending aorta, aortic arch, and descending thoracic aorta.
METHODS: For the
trial, which involved 12 US sites, 65 patients without rupture were recruited into the primary
study group, and 9 patients were recruited into the rupture group. All patients underwent open surgical repair of the ascending aorta, aortic arch, and descending thoracic aorta in cases of aneurysm and/or dissection. The primary end point was freedom from major adverse events (MAE), defined as permanent stroke, permanent paraplegia/paraparesis, unanticipated aortic-related reoperation (excluding reoperation for bleeding), or all-cause mortality.
RESULTS: In the primary
study group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 81% (51/63). Seven patients (11%) died (including 2 before 30 days or discharge), 3 patients (5%) suffered permanent stroke, and 3 (5%) developed permanent paraplegia/paraparesis. Twenty-six patients (41%) underwent planned extension procedures, including 22 endovascular procedures within a median of 122 (interquartile range, 64-156) days. In the aortic rupture group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 71% (5/7). One patient (14%) died, 2 patients (29%) had permanent stroke, and none had permanent paraplegia/paraparesis. No extension procedures were performed in the rupture group.
CONCLUSIONS: One-year results with the Thoraflex Hybrid device are acceptable. Long-term data are necessary to assess the durability of these repairs.