Torsello Giovanni, Osada Nani, Florek Hans-Joachim, Horsch Svante, Kortmann Helmut, Luska Guenter, Scharrer-Pamler Reinhard, Schmiedt Walther, Umscheid Thomas, Wozniak Gernold
St Franziskus-Hospital, Münster, Germany.
J Vasc Surg. 2006 Feb;43(2):277-84; discussion 284. doi: 10.1016/j.jvs.2005.09.037.
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.
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.
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.
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.
新一代用于腹主动脉瘤血管内治疗的移植物的发展已使临床性能有了显著改善。然而，长期结果数据仍然匮乏。为评估使用Talent覆膜支架的长期临床和影像学结果，我们进行了一项回顾性分析，该分析基于1996年10月至1998年12月期间在德国接受该移植物治疗的165例患者。
根据血管外科标准化报告实践特设委员会的建议收集数据，并采用单变量和多变量分析进行统计学评估。
1998年12月31日前，德国9个中心共对165例患者植入了Talent移植物。大多数患者无症状（94.5%），为男性（97.6%），且接受分叉移植物治疗（86.7%）。2例患者（1.2%）在30天内死亡，28例（17%）在随访期间死亡。死亡原因1例为动脉瘤破裂。1年生存率为95.4%±1.7%，2年生存率为89%±2.6%，5年生存率为78.1%±3.6%，7年生存率为76.2%±4.1%。美国麻醉医师协会分级为IV级的患者生存率（24.9%）显著低于分级为II级和III级的患者（91.9%和77.3%）。在平均53.2±20.1个月（范围1 - 84个月）的随访期内，31例患者（18.8%）进行了47次二次手术。Kaplan - Meier估计显示，1年、3年和7年无二次干预的概率分别为94.7%±1.8%、81.7%±3.3%和77.4%±3.6%。二次治疗的原因包括移植物血栓形成10例（6.1%）、持续性原发性内漏9例（5.5%）、晚期继发性内漏6例（3.6%）、移植物移位3例（1.8%）、动脉瘤破裂2例（1.2%）和移植物感染1例（0.6%）。7例患者（4.2%）发生了移植物移位（≥10 mm）。其他移植物改变，如移植物扭结（n = 4；2.4%）、金属支架断裂（n = 2；1.2%）、纵杆侵蚀（n = 2；1.2%）或组件分离（n = 1；0.6%）则较为罕见。随访计算机断层扫描成像显示，106例（64.2%）患者的最大动脉瘤囊直径减小（>5 mm），14例（8.5%）患者增大。平均动脉瘤直径显著减小（P <.001）。在基线记录的因素中，只有内漏与随访期间动脉瘤增大的风险显著相关（P <.001）。不良解剖结构（颈部直径>28 mm、颈部长度<15 mm和≥5支开放主动脉分支）并未对动脉瘤缩小率、二次手术风险或临床成功率产生不利影响。65岁以上患者的临床成功率显著更高（P <.05）。
植入Talent移植物装置是用于排除腹主动脉瘤的开放手术的一种安全有效的替代方法。与第一代移植物相比，该装置在植入后长达5至7年显示出更好的耐用性。即使本研究中植入的是Talent装置的原型，该移植物在大多数患者中也成功使用，即使是那些具有不良解剖结构的患者。由于已对移植物进行改进以解决连接杆断裂问题，预计未来移植物肢体闭塞的发生率会降低。
