A multicenter experience with the Talent endovascular graft for the treatment of abdominal aortic aneurysms.

Objective: The Talent endovascular graft has been used in the treatment of abdominal aortic aneurysms (AAAs) in more than 13,000 patients worldwide. However, information regarding the results of its use has been limited. This report describes the experience with 368 patients with AAAs who underwent treatment at four medical centers as part of an investigator-sponsored investigational device exemption trial.

Methods: Patients with AAAs were enrolled at four sites during a 32-month period from January 1999 to July 2001. All patients underwent treatment for infrarenal AAA with the Talent endovascular graft. Repair was performed with transrenal stent fixation under epidural (362/368 patients; 98.3%), local (4/368 patients; 1.1%), or general (2/368 patients; 0.5%) anesthesia. The average diameters were: maximum aortic aneurysm, 6.2 +/- 1.2 cm; proximal aortic fixation site, 2.6 +/- 0.4 cm; and distal iliac fixation site, 1.4 +/- 0.6 cm. Bifurcated grafts were used in 276 of 366 patients (75%), aortouniiliac in 57 of 366 patients (16%), and tube aortoaortic in 33 of 366 patients (9%). Multiple comorbid medical conditions were present in all patients (average, 4.7 conditions/patient). The mean age was 75.8 years, and 85% of the patients were male. Follow-up period ranged from 2 to 33 months (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 5 mm or more in 83 patients (32%); diameter remained unchanged (change < 5 mm) in 157 patients (60%) and increased by 5 mm or more in 23 patients (8.7%). Major morbidity occurred in 46 of 368 patients (12.5%), and minor morbidity occurred in 31 of 368 (8.4%). The 30-day mortality rate was 1.9%. Secondary procedures were performed in 32 patients (8.7%). Late rupture occurred in two patients, and late deaths unrelated to AAA occurred in 32 patients (8.7%) during the follow-up period. 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 at 85.8%. Computed tomographic scan was performed within 1 month after surgery in 349 patients. An endoleak was present in 43 of 349 patients (12.3%). These endoleaks were comprised of 10 attachment site (type I; 2.9%), 31 retrograde side-branch (type II; 8.9%), and two transgraft (type III; 0.6%).

Conclusion: These midterm findings show a high degree of technical and procedural success achieved in a patient population with extensive comorbid medical illnesses with low perioperative morbidity and mortality rates. Further follow-up study will be necessary to determine the effectiveness of the Talent endograft for the long-term treatment of AAA.