Ronald M. Fairman, MD, professor of surgery, chief of the division of vascular surgery at the Hospital of the University of Pennsylvania in Philadelphia and National Principal Investigator, reported the results of this prospective, non-randomized, multi-center, pivotal trial conducted at 38 sites. A total of 195 patients were enrolled in the VALOR Trial and 189 patients were identified as retrospective open surgical subjects. Endovascular enrollment occurred between December 2003 and June 2005 and endovascular results were compared with retrospective open surgical data from three centers of excellence.
The mean number of Talent™ Thoracic Stent Graft components implanted was 2.7 ± 1.3 devices per patient. Twenty-five percent of the proximal main Talent™ Thoracic Stent Graft components implanted had diameters smaller than 26 mm or larger than 40 mm. Left subclavian artery revascularization was performed prior to the initial stent graft procedure in 5.2 percent of patients, and iliac conduits were utilized in 21.1 percent of patients. Thirty-three percent of patients had the bare spring segment of the most proximally implanted device in zones 1 or 2 of the aortic arch. One hundred and ninety-four patients (99.5 percent) had successful vessel access and deployment of the Talent™ Thoracic Stent Graft at the intended site.
The 30 day VALOR results included perioperative mortality (2.1 percent), major adverse advents (41 percent), incidence of paraplegia (1.5 percent), paraparesis (7.2 percent), and stroke (3.6 percent). The 12 month VALOR results included all-cause mortality (16.1 percent), aneurysm-related mortality (3.1 percent), conversion to open surgery (0.5 percent), target aneurysm rupture (0.5 percent), stent graft migration > 10 mm (3.9 percent), endoleak (12.2 percent), stent graft patency (100 percent), stable or decreasing aneurysm diameter (91.5 percent) and loss of stent graft integrity (four patients). There were no instances of deployment-related events or perforation of the aorta by a graft component.
According to Dr. Fairman, "The Talent Thoracic Stent Graft showed statistically superior performance with respect to acute procedural outcomes (p<0.001), 30 day major adverse events (41 percent vs. 84.4 percent, p<0.001), peri-operative mortality (2 percent vs. 8 percent, p<0.01), and 12 month aneurysm-related mortality (3.1 percent vs. 11.6 percent, p<0.002) when compared to open surgery."
The submission of these Pivotal trial results lead to FDA approval of the Talent Thoracic Stent Graft System for treatment of thoracic aortic aneurysms in June, 2008.