- BACKGROUND: The Terumo Aortic Global Endovascular Registry (TiGER) was established to monitor the real-world performance of Terumo Aortic endografts. Reported here are the two-year outcomes of this multi-center experience with the TREO® Abdominal Stent Graft System for the treatment of infrarenal abdominal aortic aneurysms.
METHODS: Between November 2019 and September 2024, 330 subjects (90.3% male; mean age 73.8±7.3 years) were treated with a TREO® Abdominal Stent Graft System at 23 sites across seven European countries. Subjects received elective (N.=312) or emergency (N.=18) endovascular aortic repair.
RESULTS: Technical success was achieved at 97.3% (318/327). Failures were due to inability to advance the device (N.=2), stent-graft kinking or twisting (N.=3), type Ia endoleak (N.=2), concomitant type Ia and Ib endoleak (N.=1), and type IIIa endoleak (N.=1). The concomitant type Ia and Ib endoleak resulted in a contained rupture, treated successfully by open reconstruction. FourBACKGROUND: The Terumo Aortic Global Endovascular Registry (TiGER) was established to monitor the real-world performance of Terumo Aortic endografts. Reported here are the two-year outcomes of this multi-center experience with the TREO® Abdominal Stent Graft System for the treatment of infrarenal abdominal aortic aneurysms.
METHODS: Between November 2019 and September 2024, 330 subjects (90.3% male; mean age 73.8±7.3 years) were treated with a TREO® Abdominal Stent Graft System at 23 sites across seven European countries. Subjects received elective (N.=312) or emergency (N.=18) endovascular aortic repair.
RESULTS: Technical success was achieved at 97.3% (318/327). Failures were due to inability to advance the device (N.=2), stent-graft kinking or twisting (N.=3), type Ia endoleak (N.=2), concomitant type Ia and Ib endoleak (N.=1), and type IIIa endoleak (N.=1). The concomitant type Ia and Ib endoleak resulted in a contained rupture, treated successfully by open reconstruction. Four deaths (1.2%) occurred within 30 days of the procedure. During a mean follow-up of 464.3±362.4 days, an additional ten subjects experienced a type I/III endoleak, four of which had reinterventions to address the observation. There were ten subjects (3.0%) with limb occlusions, of which one subject required three reinterventions to address limb occlusion. Overall survival at two years was 85.3±3.8%.
CONCLUSIONS: Initial results from this real-world, multi-center registry showed the safe and effective use of the TREO® Abdominal Stent Graft System for treatment of infrarenal abdominal aortic aneurysms. Long-term outcomes from TiGER are necessary to validate the durability of these results.…
