LAUSR

BACKGOUND - Thoracic endovascular aortic repair (TEVAR) has radically transformed the treatment of descending thoracic aortic aneurysms. However, when aneurysms involve the aortic arch in the region of the left subclavian artery, branch vessel preservation must be considered. Branched aortic endografts provide a new option to maintain branch patency. METHODS - Six investigative sites enrolled 31 patients in a non-randomized, prospective investigational device exemption (IDE) feasibility trial of a single branched aortic endograft for ; management of aneurysms that include the distal aortic arch. The GORE® TAG® Thoracic ; Branch Endoprosthesis (TBE; W.L. Gore & Associates, Inc., Flagstaff, AZ) an investigational device, allows graft placement proximal to the left subclavian artery and incorporates a single side branch for left subclavian perfusion. RESULTS - All 31 (100%) patients had a successful implantation of the investigational device in landing zone 2. Men slightly outnumbered women (51.6%). Average age of 74.1 +/- 10.4 years. Aneurysm morphology was fusiform in 12 and saccular in 19, with a mean maximum aortic diameter of 54.8 +/- 10.9 mm. Mean follow up for the cohort is 25.2 +/- 11.1 months; patient outcomes are reported here at 1 month and 1 year. At one month, side branch patency was 100% and freedom from core lab reported device related endoleak (type I and III) was 96.7% without 30-day death or permanent paraplegia. One patient experienced a procedure-related stroke. Through one year, there have been five patient deaths, none device or procedure-related (CEC adjudicated); one thoracic re-intervention; no conversions; no reported aneurysm growth (Core lab), and one loss of side branch patency diagnosed of the left subclavian artery in an asymptomatic individual by CT imaging at 6 months with no reported subsequent adverse events due to loss of patency. Endoleaks were Core lab reported in five patients at 12 months (two type II and three were indeterminate). CONCLUSIONS - This IDE feasibility study reports the preliminary study results of a single side branch endograft to treat patients with proximal descending thoracic aortic aneurysms.