%0 Multicenter Study
%T Three-year follow-up of aortic arch endovascular stent grafting with the Nexus device: results from a prospective multicentre study.
%A D'Onofrio A
%A Lachat M
%A Mangialardi N
%A Antonello M
%A Schelzig H
%A Chaykovska L
%A Hill A
%A Holden A
%A Lindsay T
%A Ten Tan K
%A Orrico M
%A Ronchey S
%A Greener GE
%A Hayes P
%A Lorenzoni G
%A Gerosa G
%A Planer D
%J Eur J Cardiothorac Surg
%V 63
%N 1
%D 12 2022 2
%M 36484696
%F 4.534
%R 10.1093/ejcts/ezac561
%X 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.<BR>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.<BR>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.<BR>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.