“Real World” Thoracic Endografting: Results With the Gore TAG Device 2 Years After U.S. FDA Approval

Abstract

The Gore TAG thoracic endoprosthesis (W. L. Gore and Associates, Flagstaff, AZ) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of thoracic aortic aneurysms on March 23, 2005, and remains the only FDA approved thoracic device to date. We present our experience with the TAG device for the 2 years post-approval to better characterize "real world" use and results outside the clinical trial setting. Between March 23, 2005, and March 23, 2007, n = 91 thoracic endograft procedures were performed at our institution. Of these, n = 83 (91%) utilized the TAG device and form the basis of this report. Indications for endovascular repair were: fusiform or saccular aneurysm (n = 43; 52%), acute or chronic dissection (n = 30; 36%), acute or chronic traumatic transection (n = 7; 8%), and false aneurysm after prior aortic surgery (n = 3; 4%). A "hybrid" approach involving carotid-carotid bypass (n = 2), stage I elephant trunk procedure (n = 3), aortic arch debranching (n = 7), or complete visceral debranching (n = 5) was required in 20% of patients to create an adequate landing zone. Primary technical success rate was 98.8% (n = 82/83). Thirty-day rates of mortality and permanent stroke were both 3.6% (n = 3 each). Permanent paraparesis/paraplegia rate was 2.4% (n = 2). The 30-day rate of vascular or device-related complications requiring additional endovascular or open procedures was 7.2% (n = 6). During a mean duration of follow-up of 14 +/- 8 months (range 0-28), there was one late death from aneurysm rupture (1.2%) and one late conversion to open repair (1.2%). "Real world" utilization of the TAG device includes high rates of off-label use (nearly 50%) and "hybrid" techniques (20%) for the treatment of multiple pathologic entities of the thoracic and thoracoabdominal aorta. Regardless, short to mid-term results appear promising. Longer follow-up is needed to determine the durability of this approach.