European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2022
Three-year follow-up of aortic arch endovascular stent grafting with the Nexus device: results from a prospective multicentre study.
Многоцентровое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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D'Onofrio Augusto, Lachat Mario, Mangialardi Nicola, Antonello Michele, Schelzig Hubert, Chaykovska Lyubov, Hill Andrew, Holden Andrew, Lindsay Thomas, Ten Tan Kong, Orrico Matteo, Ronchey Sonia, Greener Gabby Elbaz, Hayes Paul, Lorenzoni Giulia, Gerosa Gino, Planer David
Аннотация
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.
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.