Update on the talent aortic stent-graft: A preliminary report from United States phase I and II trials

Purpose: Phase I and phase II trials were conducted to determine the safety and efficacy of the Talent aortic stent-graft (Medtronic World Medical, Su nrise, Fla) in the treatment of infrarenal abdominal aortic aneurysms (AAA) . This is a preliminary report of the technical results and 30-day clinical outcome of these trials. Methods: Multicenter prospective trials were conducted to test the Talent s tent-graft in high-risk and low-risk patient populations with AAA, includin g phase I feasibility and phase II clinical trials. The low-risk study incl uded concurrent surgical controls. Results: In the phase I trial, deployment success was achieved in 92% (23/2 5 patients), and initial technical success was 78% (18/23 implants without endoleak). The 30-day technical success rate was 96%, with six endoleaks th at resolved spontaneously (without need for further intervention); and the 30-day mortality rate was 12% (3/25 patients). The phase II high-risk trial demonstrated a deployment success of 94% (119/127 patients) and an initial technical success of 86% (102/119 implants). The 30-day technical success rate was 96%, and the all-day mortality rate was 1.5% (2/127 patients). The phase II low-risk trial included a first-generation and a second-generatio n Talent stent-graft. Deployment success rates were 97% and 99%, respective ly, and technical success rates at 30 days were 97% and 96%, respectively. The 30-day mortality rate was 2% in the phase II low-risk first-generation device trial, and the adverse-event rate was 20%. Corresponding figures for the second-generation device were 0% and 1.8%, respectively. Conclusion: The Talent stent-graft fan be deployed successfully and achieve s endovascular exclusion in a large proportion of patients with AAA. Morbid ity and mortality rates are acceptable. One-year clinical results and the c omparison with concurrent surgical control subjects remain to be evaluated.