The Annals of thoracic surgery · 2026
1-Year Outcomes of Endovascular Repair of Zone 0/1 Aortic Arch Lesions with a Thoracic Branched Endoprosthesis.
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Brinkman William T, Shutze William P, Gable Dennis R, Sweet Matthew P, Burke Christopher R, Dake Michael D, Matsumura Jon S, Lee Jason T, Ohki Takao, Atkins Marvin D, Leshnower Bradley G, Patel Himanshu J
Аннотация
BACKGROUND: The GORE® TAG® Thoracic Branch Endoprosthesis (TBE) pivotal non-randomized, multicenter, prospective trial evaluated 1-year outcomes in patients at high risk for open surgical repair undergoing aortic arch and descending thoracic aorta endovascular repair (Zone 0/1).
METHODS: Endpoints evaluated from endovascular procedure through 12 months included aortic-related death, disabling stroke, permanent paraplegia or paraparesis, new onset renal failure, and unanticipated reintervention. Core-lab identified endpoints included aortic rupture or enlargement (≥5 mm), Type I/III endoleak, device integrity, device migration, fistula, patency, and new dissection.
RESULTS: The 77 enrolled patients had aneurysm (n=50), dissection (n=24), or other isolated lesion types (n=3); 90.9% had a Zone 0 proximal stent landing zone. Patients were a mean age of 70.8±10.8 years, 66.2% male, and 57.1% white and all had the aortic and side branch component implanted. Technical success was 94.8%. Early outcomes to 12 months included 8 (10.4%) aortic-related deaths, 6 (7.8%) disabling strokes (all aneurysm cohort), 4 (5.2%) unanticipated reintervention, 2 (2.6%) aortic ruptures, and 1 (1.3%) renal failure. Type IA/IB or Type III endoleaks occurred in 6 (7.8%) patients. Loss of side branch patency occurred in 1 (1.3%) patient. There was no permanent paraplegia or paraparesis or loss of device integrity or migration. A total of five patients had aortic enlargement; none required reintervention.
CONCLUSIONS: Early data from this prospective investigation of the TBE device in Zone 0/1 applications signals that the device is a reasonable therapeutic alternative in patients with appropriate anatomy deemed high risk for open arch surgery.
METHODS: Endpoints evaluated from endovascular procedure through 12 months included aortic-related death, disabling stroke, permanent paraplegia or paraparesis, new onset renal failure, and unanticipated reintervention. Core-lab identified endpoints included aortic rupture or enlargement (≥5 mm), Type I/III endoleak, device integrity, device migration, fistula, patency, and new dissection.
RESULTS: The 77 enrolled patients had aneurysm (n=50), dissection (n=24), or other isolated lesion types (n=3); 90.9% had a Zone 0 proximal stent landing zone. Patients were a mean age of 70.8±10.8 years, 66.2% male, and 57.1% white and all had the aortic and side branch component implanted. Technical success was 94.8%. Early outcomes to 12 months included 8 (10.4%) aortic-related deaths, 6 (7.8%) disabling strokes (all aneurysm cohort), 4 (5.2%) unanticipated reintervention, 2 (2.6%) aortic ruptures, and 1 (1.3%) renal failure. Type IA/IB or Type III endoleaks occurred in 6 (7.8%) patients. Loss of side branch patency occurred in 1 (1.3%) patient. There was no permanent paraplegia or paraparesis or loss of device integrity or migration. A total of five patients had aortic enlargement; none required reintervention.
CONCLUSIONS: Early data from this prospective investigation of the TBE device in Zone 0/1 applications signals that the device is a reasonable therapeutic alternative in patients with appropriate anatomy deemed high risk for open arch surgery.