{Reference Type}: Multicenter Study
{Title}: Three-year follow-up of aortic arch endovascular stent grafting with the Nexus device: results from a prospective multicentre study.
{Author}: D'Onofrio A;Lachat M;Mangialardi N;Antonello M;Schelzig H;Chaykovska L;Hill A;Holden A;Lindsay T;Ten Tan K;Orrico M;Ronchey S;Greener GE;Hayes P;Lorenzoni G;Gerosa G;Planer D;
{Journal}: Eur J Cardiothorac Surg
{Volume}: 63
{Issue}: 1
{Year}: 12 2022 2
{Factor}: 4.534
{DOI}: 10.1093/ejcts/ezac561
{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.