OBJECTIVES: Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. We report three-year outcomes of a single-branched thoracic endograft, following previous publication of perioperative and one-year outcomes.DESIGN: This is a multicenter feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion.METHODS: The first study arm enrolled patients with intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery incorporation (LSA, zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularization of the remaining aortic arch vessels. Outcomes at three years are reported.RESULTS: The cohort comprised forty patients (31 zone 2, 9 zone 0/1). The majority were male (52%). Mean follow up was 1408±552 days in the zone 2 and 1187±766 days in the zone 0/1 cohort. During 3-year follow-up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from reintervention was 97% at 1 and 3 years but there were two side branch occlusions. Two patients had aneurysm enlargement >5mm without documented endoleak or reintervention. Freedom from mortality at 1 and 3 years was 90% and 84%. In the zone 0/1 arm there were no reinterventions, loss of branch patency, or aneurysm enlargement at 3 years. Cerebrovascular events occurred in three patients during follow-up, two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow-up period, both unrelated to the procedure or the aneurysm.CONCLUSIONS: Initial 3-year results of the TBE device for endovascular repair of arch aneurysms show favorable patency and durability with low rates of graft-related complications.
View details for DOI 10.1016/j.ejvs.2022.08.003
View details for PubMedID 35970335