Long-term Results With the Talent Thoracic Stent Graft in the VALOR Trial

Abstract

This report evaluates the 5-year outcomes of thoracic endovascular aneurysm repair (TEVAR) using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients considered candidates for open surgical repair. The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial was a prospective, nonrandomized, multicenter, pivotal study conducted at 38 sites. Between December 2003 and June 2005, VALOR enrolled 195 patients (mean age, 70.2 ± 11.1 years) who were at low or moderate risk (0, 1, and 2) by the modified Society for Vascular Surgery and American Association for Vascular Surgery criteria. The patients had fusiform thoracic aortic aneurysms (TAA) or focal saccular TAA/penetrating atherosclerotic ulcers, or both. Standard follow-up interval examinations were conducted at 1 month, 6 months, 1 year, and annually thereafter. At 5 years, freedom from aneurysm-related mortality (ARM) was 96.1%, freedom from all-cause mortality was 58.5%, freedom from aneurysm rupture was 97.1%, and freedom from conversion to surgery was 97.1%. ARM occurred in only one patient after the first year. Four patients were converted to open surgery during the 5 years, 2 due to endoleak, 1 due to aneurysm enlargement, and 1 due to perigraft infection. Four patients experienced aneurysm rupture. From 1 month to 5 years, stent graft migration >5 mm was documented in eight patients. There were eight patients with loss of stent graft integrity, all of which occurred after 2 years. The rate of type I endoleak was 4.6% up to 1 month, 6.3% from 1 month to 1 year, and 3.8% during year 5. The rate of type III endoleak was 1.3% ≤1 month, 1.9% from 1 month to 1 year, and 1.9% during year 5. Through 5 years, 30 patients underwent additional endovascular procedures. Through 5 years of follow-up in patients who were candidates for open surgical repair, TEVAR using the Talent Thoracic Stent Graft System demonstrated sustained protection from ARM, aneurysm rupture, and conversion to surgery, as well as durable stent graft performance.