Long-term outcome after Talent endograft implantation for aneurysms of the abdominal aorta: a multicenter retrospective study.

BACKGROUND: The development of newer-generation endografts for the endovascular treatment of abdominal aortic aneurysms has resulted in considerable improvements in clinical performance. However, long-term outcome data are still scarce. To assess long-term clinical and radiographic outcomes after use of the Talent stent graft, a retrospective analysis was performed that was based on 165 patients treated with this endograft in Germany between October 1996 and December 1998. METHODS: Data were collected according to the recommendation of the ad hoc committee for standardized reporting practices in vascular surgery and were evaluated statistically by using univariate and multivariate analyses. RESULTS: A total of 165 patients were treated with a Talent endograft in 9 German centers before December 31, 1998. Most were asymptomatic (94.5%), male (97.6%), and treated with a bifurcated graft (86.7%). Two patients (1.2%) died within 30 days, and 28 (17%) died during the follow-up period. The cause of death was aneurysm rupture in one case. Survival was 95.4% +/- 1.7% at 1 year, 89% +/- 2.6% at 2 years, 78.1% +/- 3.6% at 5 years, and 76.2% +/- 4.1% at 7 years. Patients classified as American Society of Anesthesiologists grade IV had a significantly lower survival rate (24.9%) than those classified as American Society of Anesthesiologists grade II and III (91.9% and 77.3%). During a mean follow-up period of 53.2 +/- 20.1 months (range, 1-84 months), 47 secondary procedures were performed in 31 patients (18.8%). Kaplan-Meier estimates showed a freedom from secondary intervention of 94.7% +/- 1.8%, 81.7% +/- 3.3%, and 77.4% +/- 3.6% at 1, 3, and 7 years, respectively. The reason for secondary treatment was endograft thrombosis in 10 patients (6.1%), persisting primary endoleak in 9 (5.5%), late secondary endoleak in 6 (3.6%), graft migration in 3 (1.8%), aneurysm rupture in 2 (1.2%), and graft infection in 1 (0.6%). Device migration (> or =10 mm) occurred in seven patients (4.2%). Other graft changes, such as graft kinking (n = 4; 2.4%), fracture of metallic stents (n = 2; 1.2%), erosion of the longitudinal bar (n = 2; 1.2%), or modular component separation (n = 1; 0.6%), were rare. Follow-up computed tomographic imaging revealed a decrease of the maximum aneurysm sac diameter (>5 mm) in 106 (64.2%) patients and an increase in 14 (8.5%) patients. The mean aneurysm diameter significantly decreased (P < .001). Of the factors recorded at baseline, only endoleaks showed a significant correlation with the risk of aneurysm increase during follow-up (P < .001). Adverse anatomy (neck diameter >28 mm, neck length <15 mm, and '5 patent aortic branches) did not adversely influence the aneurysm shrinkage rate, the risk for a secondary procedure, or the clinical success rate. A significantly higher rate of clinical success (P < .05) was observed in patients older than 65 years of age. CONCLUSIONS: Implantation of the Talent endograft device is a safe and effective alternative to open surgery for exclusion of abdominal aortic aneurysm. In comparison with first-generation grafts, the device showed superior durability for as long as 5 to 7 years after implantation. Even if prototypes of the Talent device were implanted in this study, the graft was also successfully used in most patients, even in those with adverse anatomy. Because improvements of the endograft have been made to address connecting bar breaks, a lower incidence of graft limb occlusion can be expected in the future.

Incidence of renal infarctions after transrenal stent placement in an animal model.

PURPOSE: To evaluate the incidence and appearance of renal infarctions after transrenal stent placement in an animal model. METHODS: An aortic stent was placed via a femoral approach in 20 female Merino sheep. Ten animals had intentional coverage of one renal ostium with the bare struts, 1 sheep had both renal artery ostia covered, and the other 9 sheep had no stent impingement on the renal orifices. Animals were sacrificed after 3 to 12 months (mean 6) for gross pathological and histological evaluation. Infarction locations and patterns were evaluated and correlated to stent placement. RESULTS: Of the 40 renal arteries, coverage was proven at autopsy in 12 cases; the remaining 28 arteries were free of any stent overlay. Overall, 14 (35%) renal infarctions were detected; 7 were found in the 12 arteries with a transrenal stent (58.3% incidence in covered renal arteries). By comparison, the other 7 infarctions were found in the 28 unaffected arteries (25% incidence in noncovered renal arteries; p = 0.04). All infarctions appeared to be well-defined punctate lesions. CONCLUSIONS: A transrenal stent position in the abdominal aorta is related to increased renal infarctions in an animal model.

Complications after endovascular treatment of thoracic aortic aneurysms.

PURPOSE: To retrospectively determine the value of stent-graft repair of descending thoracic aortic aneurysms by analyzing the results and complications. METHODS: From May 1997 to July 2002, 45 patients (33 men; mean age 69 years, range 31-88) received endovascular treatment for thoracic aortic aneurysms. In 11 patients, emergency treatment was necessary for a contained rupture. The medical records of these patients were reviewed to gather data on the procedures, immediate results, complications, mortality, and survival in follow-up. RESULTS: In all cases, the stent-grafts were successfully implanted. In 15 (33%) cases, the subclavian artery was covered by the stent-graft without complications. There was no paraparesis/paraplegia; 2 (4.4%) patients suffered a stroke intraoperatively. The in-hospital mortality was 2.2% (n=1); 3 (6.7%) patients died within 30 days. Primary endoleaks occurred in 8 (17.8%) cases. Procedural success (technical success without endoleak or death) was 80% (93.3% after primary endoleak repair). During follow-up, 2 (4.4%) secondary endoleaks developed. All endoleaks were treated successfully or sealed spontaneously (n=2). At a mean 24-month follow-up (range 1-62), 84% of patients were alive. CONCLUSIONS: The endovascular treatment of thoracic aortic aneurysms appears to be safe and effective, with lower morbidity and mortality than in conventional open operations. For these reasons, endovascular treatment should be administered whenever possible.

Endovascular stent-graft repair of ruptured aortic aneurysms.

PURPOSE: To demonstrate the endovascular approach to the management of ruptured abdominal aortic aneurysms (AAA). METHODS: From 1995 to 2001, 24 patients (21 men; mean age 69 years, range 26-92) underwent emergency endovascular treatment for ruptured AAA. The average interval between onset of symptoms and admission to the hospital was 8.0 hours; the mean time between admission and the operation was 2.3 hours. No suprarenal occluding catheter was used. The stent-graft configurations were 19 bifurcated, 4 tube, and 1 aortomonoiliac. RESULTS: Stent-graft placement was successful in 23 (96%) cases. Failed limb extension deployment prompted conversion to open surgery in the remaining patient. One case was converted to open surgery. Mean duration of treatment was 122 minutes. Three (12.5%) patients died in-hospital. The median hospital stay was 12 days. The rate of endoleaks (all type I) was 16.7%. The overall technical success rate was 77%. The 3-year actuarial survival rate was 75%. CONCLUSIONS: Our experience shows excellent results in emergency patients with ruptured AAAs treated with endovascular surgery. In order to verify these promising results, a broader-scale clinical study must be conducted.