医学
外科
主动脉弓
支架
冲程(发动机)
截瘫
四分位间距
心肌梗塞
心脏病学
主动脉
机械工程
精神科
工程类
脊髓
作者
Augusto D’Onofrio,Mário Lachat,Nicola Mangialardi,Michele Antonello,Hubert Schelzig,Lyubov Chaykovska,Andrew Hill,Andrew Holden,Thomas F. Lindsay,Kiat Tsong Tan,Matteo Orrico,Silvia Ronchey,Gabby Elbaz-Greener,Paul D. Hayes,Giulia Lorenzoni,Gino Gerosa,David Planer
标识
DOI:10.1093/ejcts/ezac561
摘要
Abstract OBJECTIVES Endovascular aortic arch stent grafting with branched devices has shown initial promising results. The aim of this prospective, multicentre study was to evaluate 3-year outcomes of aortic arch stent grafting with NEXUS® Aortic Arch Stent Graft System (Nexus), a single-branch, bi-modular, off-the-shelf aortic arch stent graft system in high-risk patients. METHODS Patients treated with Nexus, either under the feasibility clinical study or as compassionate use procedures in 5 centres, were included in this study. The primary end point was overall survival. The secondary end points included the incidence of procedure-related unplanned intervention, stroke, paraplegia and endoleak. Clinical and radiologic follow-up was performed at each study site at 30 days, 6 months and on a yearly basis thereafter up to 3 years postoperatively. RESULTS We analysed data from a total of 28 patients. The overall median follow-up was 1132 (interquartile range: 809–1537). There were no device or procedure-related deaths between 1 and 3 years. Overall survival at 1 and 3 years was 89% and 71%, respectively. The cumulative incidence of unplanned reintervention at 1 and 3 years was 11% and 29%, respectively. There were no reports of stroke, paraplegia, aneurysm rupture, myocardial infarction or new aortic valve insufficiency. In this study’s 1–3 year follow-up period, 1 type Ib (4%), 1 type II (4%) and 2 type III (8%; between Nexus’ distal end and Thoracic endovascular aortic repair (TEVAR) extensions) endoleak were detected. CONCLUSIONS Endovascular aortic arch exclusion with the single-branch, off-the-shelf Nexus system provides promising clinical and radiologic results at 3-year follow-up in a high-risk patient cohort.
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