1-Year Outcomes of Endovascular Repair of Zone 0/1 Aortic Arch Lesions with a Thoracic Branched Endoprosthesis.

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.