US multicenter trials of endoprostheses for the endovascular treatment of descending thoracic aneurysms

Abstract

Since the first report of endovascular therapy for descending thoracic aortic pathology in 1994 by Dake et al, the advent of commercially available devices has been relatively slow. This is primarily due to the relatively lower volume of thoracic aortic aneurysms as compared with infrarenal aortic aneurysms. Technical and anatomic challenges in thoracic endografting, such as proximity of the great vessels and tortuosity around the arch, also pose a challenge. In addition, a larger device profile and hostile hemodynamic forces complicate the technical aspect of the deployment procedure. With broadened applications for endovascular treatment of thoracic pathology worldwide, including aortic dissections, aneurysmal degeneration of chronic dissections, traumatic ruptures, and penetrating ulcers, there has been an increased focus on the development of thoracic endoprostheses. As many as 12 thoracic endografts are currently available for commercial use in Europe. In the United States, only one thoracic endoprosthesis, the Gore Thoracic Aortic Graft (TAG) device (W.L. Gore and Associates, Flagstaff, Ariz), has gained US Food and Drug Administration (FDA) approval for treatment of descending thoracic aortic aneurysms (DTAs) and is commercially available. Two other devices are undergoing US multicenter trials: the TX2 device (Cook, Bloomington, Ind) and the Talent stent graft (Medtronic AVE, Sunrise, Fla). This chapter provides an update on these three devices and the available data on the US trials.