Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
J Vasc Surg. 2011 Feb;53(2):293-8. doi: 10.1016/j.jvs.2010.08.078. Epub 2010 Nov 4.
Since the introduction of endovascular aneurysm repair (EVAR), long-term follow-up studies reporting single-device results are scarce. In this study, we focus on EVAR repair with the Talent stent graft (Medtronic, Santa Rosa, Calif).
Between July 2000 and December 2007, 365 patients underwent elective EVAR with a Talent device. Patient data were gathered prospectively and evaluated retrospectively. By American Society of Anesthesiologists category, 74% were categories III and IV. Postoperative computed tomography (CT) scanning was performed before discharge, at 3, 12 months, and yearly thereafter. Data are presented according to reporting standards for EVAR.
The mean proximal aortic neck diameter was 27 mm (range, 16-36 mm), with a neck length <15 mm in 31% (data available for 193 patients). Deployment of endografts was successful in 361 of 365 patients (99%). Initially, conversion to laparotomy was necessary in four patients. Primary technical success determined by results from computed tomography (CT) scans before discharge was achieved in 333 patients (91%). Proximal type I endoleaks were present in 28 patients (8%) during follow-up, and 14 of these patients needed additional treatment for type I endoleak. The 30-day mortality for the whole Talent group was 1.1% (4 of 365). Follow-up to 84 months is reported for 24 patients. During follow-up, 122 (33%) patients died; in nine, death was abdominal aortic aneurysm (AAA)-related (including 30-day mortality). Kaplan-Meier estimates revealed primary clinical success rates of 98% at 1 year, 93% at 2 years, 88% at 3 years, 79% at 4 years, 64% at 5 years, 51% at 6 years, and 48% at 7 years. Secondary interventions were performed in 73 of 365 patients (20%). Ten conversions for failed endografts were performed. Life-table yearly risk for AAA-related reintervention was 6%, yearly risk for conversion to open repair was 1.1%, yearly risk for total mortality was 8.9%, and yearly risk for AAA-related mortality was 0.8%.
Initially, technical success of endovascular aneurysm repair (EVAR) using the Talent endograft is high, with acceptable yearly risk for AAA-related mortality and conversion. However, a substantial amount of mainly endovascular reinterventions is necessary during long-term follow-up to achieve these results.
自血管内动脉瘤修复术（EVAR）引入以来，报告单一器械结果的长期随访研究较为少见。在本研究中，我们专注于使用 Talent 支架移植物（美敦力，圣罗莎，加利福尼亚州）进行 EVAR 修复。
2000 年 7 月至 2007 年 12 月，365 例患者接受了 Talent 装置的择期 EVAR。前瞻性收集患者数据并进行回顾性评估。根据美国麻醉师协会分类，74%为 III 类和 IV 类。术后在出院前、3 个月、12 个月和此后每年进行计算机断层扫描（CT）检查。根据 EVAR 的报告标准提供数据。
近端主动脉颈直径的平均值为 27 毫米（范围，16-36 毫米），颈长<15 毫米的占 31%（193 例患者数据可用）。365 例患者中有 361 例（99%）成功植入支架移植物。最初，有 4 例患者需要转为剖腹手术。根据出院前 CT 扫描的结果，333 例（91%）患者达到了主要技术成功。在随访期间，28 例（8%）患者出现了近端 I 型内漏，其中 14 例患者需要额外治疗 I 型内漏。整个 Talent 组的 30 天死亡率为 1.1%（365 例中的 4 例）。24 例患者报告了 84 个月的随访。在随访期间，122 例（33%）患者死亡；其中 9 例与腹主动脉瘤（AAA）相关（包括 30 天死亡率）。Kaplan-Meier 估计显示，1 年时主要临床成功率为 98%，2 年时为 93%，3 年时为 88%，4 年时为 79%，5 年时为 64%，6 年时为 51%，7 年时为 48%。365 例患者中有 73 例（20%）接受了二次干预。10 例移植物失败患者进行了转换。AAA 相关再干预的年风险为 6%，转为开放修复的年风险为 1.1%，总死亡率的年风险为 8.9%，AAA 相关死亡率的年风险为 0.8%。
最初，使用 Talent 支架移植物进行血管内动脉瘤修复（EVAR）的技术成功率较高，可接受的与 AAA 相关的死亡率和转换率。然而，在长期随访中需要进行大量主要的血管内再干预，才能达到这些结果。
