Results of a prospective multicenter trial of CTAG thoracic endograft.

ABSTRACT

OBJECTIVE: As thoracic aortic aneurysms (TAAs) are more frequently being treated with endografts, the anatomic challenges of the thoracic aorta have led to design modifications of endografts. The Conformable GORE TAG (CTAG) device (W. L. Gore & Associates, Flagstaff, Ariz) was specifically designed to be more conformable in tortuous anatomy, more resistant to compression, and more accommodating to various aortic diameters compared with the original GORE TAG device. This prospective, multicenter study evaluated the safety and effectiveness of the CTAG endograft in the repair of descending TAA. METHODS: This was a prospective, multicenter regulatory study with a primary end point of freedom from major device event through 1 month after treatment. Two-year outcomes included aneurysm-related morbidity (endoleaks and morphology changes), aneurysm-related mortality, and all-cause mortality. RESULTS: Fifty-one patients were enrolled between October 2009 and October 2010, with at least one endograft implanted in 50 patients. After the regulatory study successfully completed its primary end point and expanded to a continued-access phase, 15 additional patients were enrolled in the continued-access arm of the study from February 2011 until September 2011, for a total treatment group of 66 patients for the early results and 65 patients for the long-term clinical results with imaging evaluation. There was one 30-day death (1.5%), two patients (3%) with spinal cord ischemia, and two central strokes (3%) ≤30 days. Five patients (7.6%) died ≤1 year; 1 of ascending aortic aneurysm rupture, 2 of cardiac disease, and 2 of respiratory failure. The core laboratory adjudicated 1-month imaging in 60 patients (92.3%), where nine endoleaks (15.0%) were identified (1 type Ia, 4 type II, and 4 indeterminate). Forty-five patients (69.2%) had 2-year imaging with five endoleaks (11.1%; two type II and three indeterminate), and one patient had a distal aortic dilatation that required a secondary intervention. At 2 years, 20 of 38 imaged patients (52.6%) had aneurysm shrinkage ≥5 mm, 15 (39.5%) had no change in diameter, and three patients (7.9%) had an increase in aneurysm diameter of ≥5 mm. There were no conversions, fractures, compressions, or aneurysm ruptures of the treated segment through 2 years. CONCLUSIONS: This next-generation thoracic endograft has a low rate of major device events through 2 years, with no graft compressions or device failures. The data for this new endograft demonstrate favorable outcomes and confirm low risks for treatment for patients with TAA. Follow-up will be continued for 5 years.