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LATE-BREAKING CLINICAL TRIAL: Pivotal Results Of The Medtronic Vascular Talent™ Thoracic Stent Graft System For Patients With Thoracic Aortic Disease. The VALOR Trial

Ronald M. Fairman¹, Mark Farber², Christopher Kwolek³, Alan Matsumoto⁴, Edward H. Garrett⁵, Gregorio Sicard, MD⁶, Manish Mehta⁷, Rodney White⁸, Alan Lumsden⁹, W. Anthony Lee¹⁰, J. Michael Tuchek¹¹, Frank Criado.^12
1University of Pennsylvania, Philadelphia, Pa; ²University of North Carolina Chapel Hill, Chapel Hill, N.C.; ³Massachusetts General Hospital, Boston, Mass.; ⁴University of Virginia Health System, Charlottesville, Va.; ⁵Cardiovascular Surgery Clinic, PLLC, Memphis, Tenn.; ⁶Washington University School of Medicine, St. Louis, Mo.; ⁷Albany Medical College, Albany, N.Y.; ⁸Harbor UCLA Medical Center, Los Angeles, Calif.; ⁹Baylor College of Medicine, Houston, Texas; ¹⁰University of Florida, Gainesville, Fla.; ¹¹Loyola University Medical Center, Maywood, Ill.; ¹²Union Memorial Hospital, Baltimore, Md.

OBJECTIVES: The objective of this report is to disclose the 30 day and 12 month results of the Medtronic Vascular Talent™ Thoracic Stent Graft System for patients with thoracic aortic aneurysms who are considered candidates for open surgical repair and who are at low to moderate risk for surgery (0, 1, 2) per the modified SVS/AAVS criteria.  The aneurysm had to be at least 20 mm distal to the left common carotid and 20 mm proximal to the celiac artery, have a proximal and distal non-aneurysmal aortic neck diameter between 18-42 mm and proximal and distal non-aneurysmal aortic necks lengths of at least 20 mm.

METHODS: The study was a prospective, non-randomized, multi-center, pivotal trial conducted at 38 sites. Enrollment occurred between December 2003 and June 2005.  Standard follow-up interval examinations were prescribed at 1 month, 6 months, 1 year and annually thereafter. Outcomes were summarized by descriptive statistics and hypothesis tests.

RESULTS: Of the 195 enrolled subjects, 4 subjects withdrew their consent, 1 was lost to follow-up and 31 subjects died, leaving 159 subjects at 12 month follow-up. The mean patient age was 70.2 years, 59% were male, and 83% were white. The mean maximum aneurysm diameter was 55.5 ± 11.6 mm and the mean aneurysm length was 121.4±72.7 mm. The mean number of Talent™ Thoracic Stent Graft components implanted in 194 treated subjects was 2.7±1.3 devices per subject. Twenty-five percent (25%) 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% of subjects, and access was achieved with an iliac conduit in 21.1% of treated patients. 33.5% of patients had the bare spring segment of the most proximally implanted device in zones 1 or 2 of the aortic arch. 194 patients (99.5%) had successful vessel access by the delivery device and 194 (99.5%) had the Talent™ Thoracic Stent Graft successfully deployed at the intended site in the aorta. The average procedure length was 154.2 minutes, the mean estimated blood loss was 371.2 ml, the average ICU stay was 2.0 days, and the average length of stay was 6.4 days. All cause mortality at 12 months was 16.1%. Successful Aneurysm Treatment, defined as no aneurysm growth greater than 5 mm at the 12 month follow-up visit when compared to the 1 month follow-up visit AND absence of a Type I endoleak for which a secondary procedure was performed before, at or as a result of the 12 month follow-up visit was 89.2%. The 30 day results included perioperative mortality (2.1%), paraplegia (1.5%) and stroke (3.6%). The 12 month results included aneurysm-related mortality (3.1%), conversion to open surgery (0.5%), target aneurysm rupture (0.5%), stent graft migration >10 mm (3.9%), endoleak (12.2%), secondary procedures for endoleak (6.5%), serious Major Adverse Events (MAE) (42.7%), stent graft patency (100%), stable or decreasing aneurysm diameter (91.5%) and loss of stent graft integrity (4 patients). There were no instances of bare spring flip or perforation of the aorta by a graft component.

CONCLUSIONS: The Pivotal VALOR trial results demonstrate highly favorable preliminary and 12 month outcomes using the Medtronic Talent™ Thoracic Stent Graft System in patients with thoracic aortic aneurysms who were considered candidates for open surgical repair.