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Home > Vascular Annual Meeting^® > LB3. Five-year Outcomes of the Medtronic Talent AAA...

LB3. Five-year Outcomes of the Medtronic Talent AAA Stent-Graft Pivotal IDE Trial

Luis A. Sanchez, for the investigators of the Talent eLPS IDE Trial
Washington University School of Medicine, St. Louis, MO

OBJECTIVES: The Talent Enhanced Low Profile (eLPS) Trial led to the approval of the Talent AAA Stent Graft in the US. The objective was to demonstrate the acute & long-term safety and effectiveness of EVAR using the Talent graft. At 1 year, stent-graft outcomes were compared with open surgery historical controls (SVS Lifeline IDE Registry). 

METHODS: Between 2/02 & 4/03, 166 patients (91.6% male, mean age 74.1 years) received the Talent graft at 13 US centers. Inclusion criteria included a AAA ≥4.0 cm in diameter and a proximal neck length of >5 mm with a diameter >14 mm and <32 mm. Post procedure evaluation involved plain films & CTA before discharge, at 30 days, 1 year, and yearly to 5 years. Data from the SVS open repair IDE registry contained comparable data for 243 patients (81.5% male, mean age 70.1 years) out to 1 year.  Aneurysm related mortality (ARM) was defined as death that occurred within 1 month of  the index  procedure to treat the AAA, from AAA rupture, or from any procedure intended to treat the AAA.

RESULTS: The EVAR population was older & sicker than the open repair population, with higher rates of arrhythmia (44.0% vs 11.5%), CHF (28.3% vs 4.9%), HTN (83.7% vs 66.7%), and PVD (46.4% vs 15.6%). EVAR was superior to open repair for all periprocedural outcomes: mean procedure duration (167.3 min vs 196.4 min, P <.001), blood transfusion (18.2% vs 56.8%, P <.001), median ICU stay (19.3 h vs 74.3 h, P <.001), and mean hospital stay (3.6 d vs 8.2 d, P <.001). Freedom from MAE was better for EVAR at 30 days (89.2% vs 44.0%, P <.001) & 1 year (81.3% vs 42.4%, P <.001). Freedom from ARM was superior for EVAR at 1 year (98.2% vs 96.7%) and was 96.5% for EVAR at 5 years. Freedom from aneurysm rupture and conversion to surgery at 5 years was 98.2% and 99.1% respectively. One device migration was reported by the core lab at 1 year and 4 additional ones by the sites between 2 & 5 years;1 required a 2ry procedure.  A total of 28 new and persistent Type I & III endoleaks were reported through 5 years; 9 required a 2ry procedure. 

CONCLUSIONS:  The Talent eLPS Pivotal trial showed excellent safety and effectiveness when compared to open surgical repair at 1 year. Durability & effectiveness of endovascular repair is maintained to 5 years. ARM at 5 years was low in a population that included patients with more challenging anatomical characteristics than other AAA IDE trials.

AUTHOR DISCLOSURES: L.A. Sanchez, Consultant: Medtronic Vascular, Cook Medical, W.L. Gore & Associates, Inc, Aptus.