Endovascular repair of the thoracic aorta in the post-FDA approval era

Abstract

Endovascular repair of thoracic aortic disease is rapidly progressing as an alternative to open surgical therapy. In March of 2005, the Gore TAG thoracic endoprosthesis (W. L. Gore & Associates, Inc, Flagstaff, Ariz) received Food and Drug Administration (FDA) approval for the treatment of descending thoracic aortic aneurysms. Subsequently, off-label use of the technology expanded to include additional thoracic aortic diseases. The purpose of this study was to examine whether the outcomes with this device changed after the inclusion and exclusion criteria of FDA-controlled trials no longer governed patient selection. A retrospective analysis was performed on all patients who underwent endovascular repair of the thoracic aorta with the Gore TAG device at our institution between March 23, 2005, and September 8, 2006. Fifty consecutive patients with a broad range of aortic pathologic conditions were included in the study. The results in this group compared with those of the phase II trial included the following: length of stay, 7.5 versus 7.6 days (P = .97); intensive care unit stay, 3.7 versus 2.6 days (P = .61); 30-day mortality, 2.0% versus 1.5% (P = .68); spinal cord injury, 2% versus 3% (P = .89); stroke, 4% versus 4% (P = .67); early endoleaks, 26% versus 4% (P < .01); and late endoleaks, 18% versus 7% (P = .08). At 1 year, overall survival was 92% compared with 82% in the phase II trial. In the post-FDA approval era, endovascular stent-graft therapy is frequently applied to patients with more challenging thoracic aortic anatomy and a wide range of pathologic conditions. Our results in this group are similar to outcomes reported for patients with descending thoracic aortic aneurysm exclusively.