Nienaber Christoph A, Yuan Xun, Aboukoura Mohamad, Blanke Philip, Jakob Rudolf, Janosi Rolf Alexander, Lovato Luigi, Riambau Vincent, Trebacz Jaroslaw, Trimarchi Santi, Zipfel Burkhart, van den Berg Jos C
Department of Cardiology, University Hospital Rostock, Rostock, Germany; Cardiology and Aortic Centre, Royal Brompton and Harefield Hospital, Harefield, United Kingdom; Department of Cardiology, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, United Kingdom.
Cardiology and Aortic Centre, Royal Brompton and Harefield Hospital, Harefield, United Kingdom; Department of Cardiology, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, United Kingdom.
Ann Thorac Surg. 2020 Nov;110(5):1572-1579. doi: 10.1016/j.athoracsur.2020.02.029. Epub 2020 Mar 20.
The ASSIST (A multicentre Study in Survivors of type B aortic dissection undergoing Stenting) study compared both 1-year outcomes and evolution of true and false lumen (eg, remodeling) in patients with complicated type B aortic dissection subjected to thoracic endovascular aortic repair (TEVAR) with distal true lumen scaffolding by self-expanding nitinol open stent in comparison with TEVAR alone.
The ASSIST study was a multicenter prospective single-arm study comparing clinical and imaging data from 39 consecutive patients (59.4 ± 13 years of age) who received TEVAR and the JOTEC E-XL open stent with data from matched control subjects treated with TEVAR alone based on 1:1 propensity score matching. Clinical data were collected by an independent Contract Research Organization (CRO) and computed tomography images were subjected to blinded core-lab analysis.
There were no differences in baseline demographics, clinical profiles, morphological data, procedural details, and in-hospital and 1-year outcomes between groups. Differences emerged with regard to evolution of both true lumen distal to stent graft, false lumen over the entire length of dissection, and remodeling (P < .001). At 1 year, TEVAR with the E-XL stent revealed false lumen thrombosis at the level of celiac trunk in 53.8% vs 17.9% with TEVAR alone (P = .004). Kaplan-Meier survival analysis indicated favorable clinical outcomes with the additional E-XL stent.
TEVAR for acute complicated type B aortic dissection proved to be safe and promoted remodeling of the stent grafted thoracic aorta. Additional scaffolding of the true lumen distal to TEVAR with a self-expanding stent supported distal true lumen expansion, false lumen regression, and thrombosis, with evidence of improved distal remodeling at 1 year.
ASSIST(B型主动脉夹层支架置入幸存者多中心研究)研究比较了接受胸主动脉腔内修复术(TEVAR)并使用自膨式镍钛诺开放式支架进行远端真腔支架置入的复杂B型主动脉夹层患者与单纯接受TEVAR治疗的患者的1年结局以及真腔和假腔的演变情况(如重塑)。
ASSIST研究是一项多中心前瞻性单臂研究,将39例连续患者(年龄59.4±13岁)接受TEVAR和JOTEC E-XL开放式支架的临床和影像数据与基于1:1倾向评分匹配的单纯接受TEVAR治疗的匹配对照受试者的数据进行比较。临床数据由独立的合同研究组织(CRO)收集,计算机断层扫描图像进行盲法核心实验室分析。
两组之间在基线人口统计学、临床特征、形态学数据、手术细节以及住院期间和1年结局方面均无差异。在支架移植物远端的真腔演变、整个夹层长度的假腔以及重塑方面出现了差异(P<.001)。1年时,使用E-XL支架的TEVAR显示腹腔干水平的假腔血栓形成率为53.8%,而单纯TEVAR为17.9%(P=.004)。Kaplan-Meier生存分析表明,额外使用E-XL支架具有良好的临床结局。
对于急性复杂B型主动脉夹层,TEVAR被证明是安全的,并促进了支架置入胸主动脉的重塑。使用自膨式支架对TEVAR远端的真腔进行额外支架置入可支持远端真腔扩张、假腔消退和血栓形成,并有证据表明1年时远端重塑得到改善。