Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: The VALOR trial
Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: The VALOR trial
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DOI：
10.1016/j.jvs.2008.03.061
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发表时间：
2008-09-01
影响因子：
4.3
通讯作者：
Tuchek, J. Michael
中科院分区：
文献类型：
--
作者：
Fairman, Ronald M.;Criado, Frank;Tuchek, J. Michael
目的：本报告总结了使用美敦力血管人才胸主动脉覆膜支架系统（美敦力血管，圣罗莎，加利福尼亚州）对被认为适合开放手术修复的胸主动脉瘤 (TAA) 患者进行血管内治疗的 30 天和 12 个月的结果。 方法：该研究是一项前瞻性、非随机、多中心、关键试验，在 38 个站点。登记发生在2003年12月至2005年6月之间。标准随访间隔检查规定为1个月、6个月、1年以及此后每年一次。将这些血管内结果与来自三个卓越中心的回顾性开放手术数据进行比较。结果。美敦力血管人才胸主动脉覆膜支架系统治疗胸主动脉瘤的评估（VALOR）试验招募了 195 名患者，其中 189 名患者被确定为回顾性开放手术受试者。与开放手术组相比，VALOR测试组的年龄和性别分布相似，但TAA尺寸较小。患者平均接受了 2.7 +/- 1.3 个覆膜支架组件。植入的近端覆膜支架组件中 25% 的直径 < 26 mm 或 > 40 mill。 5.2% 的患者在初次支架移植手术前进行了左锁骨下动脉血运重建。 21.1% 的患者使用了髂导管。在 33.5% 的患者中，最近植入装置的裸露弹簧段位于主动脉弓的 1 区或 2 区。 194 名患者 (99.5%) 的血管通路和覆膜支架在预定部位成功展开。 30 天 VALOR 结果包括围手术期死亡率 2.1%；重大不良事件，41%；截瘫发生率1.5%；截瘫，7.2%；和中风，3.6%。 12 个月的 VALOR 结果包括全因死亡率 16.1%；动脉瘤相关死亡率，3.1%；转为开放手术，0.5%；目标动脉瘤破裂，0.5%；覆膜支架迁移>10mm，3.9%；内漏（12.2%），覆膜支架通畅，100%；动脉瘤直径稳定或减小，91.5%；四名患者的覆膜支架完整性丧失。没有发生与部署相关的事件或移植部件造成的主动脉穿孔。与开放式相比，Talent 胸主动脉覆膜支架在急性手术结果 (P < .001)、30 天主要不良事件 (41% vs 84.4%，P < .001)、围手术期死亡率 (2% vs 8%，P < .01) 和 12 个月动脉瘤相关死亡率 (3.1% vs 11.6%，P < .002) 方面表现出统计学上优越的性能 结论：关键的 VALOR 12 个月试验结果表明，对于被视为开放手术修复候选者的 TAA 患者，美敦力 Talent 胸腔覆膜支架系统是一种安全有效的血管内治疗方法，可作为开放手术的替代方案。
Objective: This report summarizes the 30-day and 12-month results of endovascular treatment using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) for patients with thoracic aortic aneurysms (TAA) who are considered candidates for open surgical repair.Methods: The study was a prospective, nonrandomized, multicenter, pivotal trial conducted at 38 sites. Enrollment occurred between December 2003 and June 2005. Standard follow-up interval examinations were prescribed at I month, 6 months, 1 year, and annually thereafter. These endovascular results were compared with retrospective open surgical data from three centers of excellence.Results. The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial enrolled 195 patients, and 189 were identified as retrospective open surgical subjects. Compared with the open surgery group, the VALOR test group had similar age and sex distributions, but had a smaller TAA size. Patients received a mean number of 2.7 +/- 1.3 stent graft components. The diameters of 25% of the proximal stent graft components implanted were < 26 mm or > 40 mill. Left subclavian artery revascularization was performed before the initial stent graft procedure in 5.2% of patients. Iliac conduits were used in 21.1% of patients. In 33.5% of patients, the bare spring segment of the most proximally implanted device was in zones 1 or 2 of the aortic arch. In 194 patients (99.5%), vessel access and stent graft deployment were successful at the intended site. The 30-day VALOR results included perioperative mortality, 2.1%; major adverse advents, 41%; incidence of paraplegia, 1.5%; paraparesis, 7.2%; and stroke, 3.6%. The 12-month VALOR results included all-cause mortality, 16.1%; aneurysm-related mortality, 3.1%; conversion to open surgery, 0.5%; target aneurysm rupture, 0.5%; stent graft migration > 10 mm, 3.9%; endoleak (12.2%), stent graft patency, 100%; stable or decreasing aneurysm diameter, 91.5%; and loss of stent graft integrity, four patients. No deployment-related events or perforation of the aorta by a graft component occurred. The Talent Thoracic Stent Graft showed statistically superior performance with respect to acute procedural outcomes (P < .001), 30-day major adverse events (41% vs 84.4%, P < .001), perioperative mortality (2% vs 8%, P < .01), and 12-month aneurysm-related mortality (3.1% vs 11.6%, P < .002) vs open surgery.Conclusions: The pivotal VALOR 12-month trial results demonstrate that the Medtronic Talent Thoracic Stent Graft System is a safe and effective endovascular therapy as an alternative to open surgery in patients with TAA who were considered candidates for open surgical repair.