Australia & New Zealand Society of Vascular Surgeons

Objective The Talent endovascular graft has been used in the treatment of abdominal aortic aneurysms in over 20,000 patients worldwide, however information regarding the results of its use has been limited. This report describes the experience with 368 patients with abdominal aortic aneurysms treated at 4 medical centers as part of an investigator sponsored – Investigational Device Exemption trial. Methods Patients with abdominal aortic aneurysms were enrolled at 4 sites over a 32-month period from January 1999 to July 2001. All patients had an infrarenal AAA treated with the Talent endovascular graft. Repair was performed using transrenal stent fixation under epidural (362/368 patients, 98.3%), local (4/368 patients, 1.1%) or general (2/368 patients, 0.5%) anesthesia. Average aortic diameters were: Aneurysm 6.2 ± 1.2 cm, proximal aortic fixation site 2.6 ± 0.4 cm, distal iliac fixation site 1.4 ± 0.6 cm. Bifurcated grafts were used in 276/366 patients (75%), aortouniiliac in 57/366 patients (16%) and tube aortoaortic in 33/366 (9%). Multiple comorbid medical conditions were present in all patients (average 4.7 conditions / patient). Mean age was 75.8 yrs; 85% were male. Follow-up ranged from 2 -33months (mean, 7.3 months). Results Endovascular graft deployment was accomplished in 366 of 368 patients. In the 263 patients followed for at least 6 months after endovascular repair AAA diameter decreased by 5mm or more in 83 (32%); it remained unchanged (change <5mm) in 157 (60%) and increased by 5mm or more in 23 (8.7%). Major morbidity occurred in 46/368 patients (12.5%); minor morbidity occurred in 31/368 (8.4%). The 30-day mortality rate was 1.9%. Secondary procedures were performed in 32 patients (8.7%). Late rupture occurred in 2 patients and late deaths unrelated to AAA occurred in 32 patients (8.7%) during follow-up. The primary technical success rate for all patients was 93.4%. The 30-day primary procedural success rate was 73.3%. The 30-day secondary procedural success rate was significantly higher and was 85.8%. CT scan was performed within 1 month postoperatively in 349 patients. An endoleak was present in 43/349 (12.3%). These were comprised of 10 (2.9%) attachment site (type I), 31 (8.9%) retrograde side-branch (type II) and 2 (0.6%) transgraft (type III). Conclusions These mid-term findings demonstrate a high degree of technical and procedural success, achieved in a patient population with extensive comorbid medical illnesses with low peri-operative morbidity and mortality rates. Further follow-up will be necessary to determine the effectiveness of the Talent endograft for the long-term treatment of AAA.