Abstract：
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.
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.
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.
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.
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.
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.
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.
摘要：
背景：带有分支装置的血管内主动脉弓支架移植（ASG）已显示出初步的有希望的结果。这个前瞻性的目标，多中心研究是评估使用NEXUS®主动脉弓支架移植系统（Nexus）的ASG的3年结局（Endanspan，Herzlia,以色列),一个单一的分支，双模块化，高危患者的现成主动脉弓支架移植系统。
方法：接受Nexus治疗的患者，根据可行性临床研究或作为五个中心的同情使用程序，包括在这项研究中。主要终点是总生存期。次要终点包括手术相关的非计划干预的发生率，中风,截瘫和内漏。在30天时在每个研究地点进行临床和放射学随访。6个月，此后每年最多3年。
结果：我们分析了28例患者的数据。总体中位随访时间为1132（四分位距：809-1537）。在1至3年之间没有与设备或手术相关的死亡。1年和3年的总生存率分别为89%和71%。分别。1年和3年非计划再干预的累积发生率为11％和29％，分别。没有中风的报告,截瘫,动脉瘤破裂,心肌梗死或新的主动脉瓣关闭不全。在本研究的1-3年随访期内，一种Ib型(4%)，检测到一种II型(4%)和两种III型(8%;在Nexus'远端和TEVAR延伸之间)内漏。
结论：单支主动脉弓腔内排除，现成的Nexus系统在高风险患者队列中进行3年随访时提供了有希望的临床和放射学结果.
方法：接受Nexus治疗的患者，根据可行性临床研究或作为五个中心的同情使用程序，包括在这项研究中。主要终点是总生存期。次要终点包括手术相关的非计划干预的发生率，中风,截瘫和内漏。在30天时在每个研究地点进行临床和放射学随访。6个月，此后每年最多3年。
结果：我们分析了28例患者的数据。总体中位随访时间为1132（四分位距：809-1537）。在1至3年之间没有与设备或手术相关的死亡。1年和3年的总生存率分别为89%和71%。分别。1年和3年非计划再干预的累积发生率为11％和29％，分别。没有中风的报告,截瘫,动脉瘤破裂,心肌梗死或新的主动脉瓣关闭不全。在本研究的1-3年随访期内，一种Ib型(4%)，检测到一种II型(4%)和两种III型(8%;在Nexus'远端和TEVAR延伸之间)内漏。
结论：单支主动脉弓腔内排除，现成的Nexus系统在高风险患者队列中进行3年随访时提供了有希望的临床和放射学结果.
