Three-year Follow Up of Aortic Arch Endovascular Stent-Grafting with the Nexus device. Results from a Prospective Multi-Centre Study


 
 
 Endovascular aortic arch stent-grafting (ASG) with branched devices has shown initial promising results. The aim of this prospective, multicenter study was to evaluate 3-year outcomes of ASG with NEXUS® Aortic Arch Stent Graft System (Nexus) (Endospan, Herzlia, Israel), 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 five centers, were included in this study. The primary endpoint was overall survival. The secondary endpoints 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 analyzed 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-year. Overall survival at 1 and 3-year was 89% and 71%, respectively. 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, one type Ib (4%), one type II (4%) and two type III (8%; between Nexus’ distal end and 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.
