The GORE® Conformable TAG® Thoracic Endoprosthesis (CTAG) was engineered to enhance conformability in the thoracic aorta and has demonstrated greater deployment accuracy and wall apposition than the original TAG device. FDA approval was granted in 2011 based on the 1-year results of the pivotal trial for the GORE® Conformable TAG® device. This report documents outcomes in those patients through 5 years.
The Conformable GORE TAG Aneurysm Study was a prospective, multicenter trial that assessed the safety and effectiveness of the CTAG device as treatment for patients with descending thoracic aortic aneurysms. Follow-up imaging assessments consisted of x-ray and CT imaging at yearly intervals through 5-years. A core imaging laboratory was used to assess aneurysm size, device integrity, and endoleaks.
A total of 66 patients were enrolled (51 pivotal arm patients, 15 continued access patients) from October 2009 through September 2011. Baseline characteristics, procedural characteristics, and outcomes through 2 years were published previously. Through 5 years, 5 patients (7.6%) underwent device-related reintervention (1 type Ia endoleak/contained rupture of the descending thoracic aorta, 1 type 1b endoleak, 2 indeterminate endoleaks, and 1 thoracic aortic pseudoaneurysm). Four patients (6.1%) died of aneurysm-related causes, with 1 death occurring within 30 days of index procedure. A total of 24 patients (36.3%) died during the 5-year study. Seven patients (10.6%) experienced stroke or transient ischemic attack through 5 years, with 1 early stroke (POD 28). Prosthesis or intercomponent migration was observed in 6 (9.1%) patients through 5 years; however, no patient developed a Type III junctional endoleak. No stent-graft fracture or compression was observed through 5 years. At 5 years, 14 patients (50.0%) showed sac regression and 5 patients (17.9%) showed sac expansion; 9 patients (32.1%) showed sac stability based on a 5 mm threshold of change.
Thoracic EndoVascular Aortic Repair (TEVAR) with the CTAG device is associated with low rates of aneurysm-related mortality and reintervention through 5 years. Proximal endoleak was rare and a majority of patients showed sac regression or stability 5 years after initial TEVAR.

Copyright © 2021. Published by Elsevier Inc.

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