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Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.
Annals of Vascular Surgery 2024 March 15
OBJECTIVE: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation.
METHODS: Across 34 investigative sites, 9 patients with BTAI requiring left subclavian artery coverage were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion.
RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up is planned. All participants had grade 3 BTAI. All procedures took place between 2018-2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 minutes (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection or thrombosis) through 12 months of follow-up.
CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for definitive assessment of the device safety and durability in traumatic aortic injuries.
METHODS: Across 34 investigative sites, 9 patients with BTAI requiring left subclavian artery coverage were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion.
RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up is planned. All participants had grade 3 BTAI. All procedures took place between 2018-2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 minutes (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection or thrombosis) through 12 months of follow-up.
CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for definitive assessment of the device safety and durability in traumatic aortic injuries.
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