Department of Vascular Surgery, Scientific Institute H. San Raffaele, Vita-Salute University, Milan, Italy.
J Endovasc Ther. 2011 Jun;18(3):338-49. doi: 10.1583/10-3340.1.
To compare the midterm results of endovascular treatment of thoracic aortic aneurysms and ulcers in patients who received either a 1-component or 2-component Zenith TX2 stent-graft.
Data were gathered from a prospectively maintained registry for the Zenith TX2 pivotal trial. Among 158 patients who underwent thoracic endovascular aortic repair (TEVAR) between March 2004 and July 2006, 64 received a 1-component stent-graft (group 1) and 94 patients a 2-component device (group 2).
In group 2, there were more men (79% vs. 63%; p = 0.03), and the patients had more diagnosed (p<0.01) and previously repaired (p<0.01) abdominal aortic aneurysms. Aneurysms in group 2 were significantly larger in both diameter (63 vs. 56 mm, p<0.01) and length (157 vs. 113 mm, p<0.01). Percent of thoracic aorta covered by the stent-graft was greater in group 2 (80% vs. 50%, p<0.01). Patients in group 2 had a significantly longer operation time (124±48 vs. 100±39 minutes, p<0.01) and significantly increased estimated blood loss during the procedure (248±359 vs. 169±139 mL, p = 0.05). Procedural success at 30 days was 95% in group 1 and 85% in group 2 (p = 0.06). Postoperative paraplegia and paraparesis were not observed in group 1, but 9 patients in group 2 (p = 0.01) were affected. Treatment success, endoleak, migration, secondary intervention rate, and all-cause and aneurysm-related mortality were not significantly different between the groups at 30 days, 1 year, and 2 years.
TEVAR using 1 or 2 TX2 components has similar results in terms of mortality and midterm treatment success. Patients treated with 2 components showed increased perioperative morbidity, including paraplegia, which may be related to the greater extent of graft coverage required in this patient group, as well as to male gender, previous aortic repair, longer operating time, and increased blood loss.
比较腔内治疗胸主动脉瘤和溃疡患者使用 1 组件或 2 组件 Zenith TX2 支架移植物的中期结果。
数据来自 2004 年 3 月至 2006 年 7 月 Zenith TX2 关键试验的前瞻性维护登记处。在 158 例接受胸主动脉腔内修复术（TEVAR）的患者中，64 例接受 1 组件支架移植物（组 1），94 例接受 2 组件装置（组 2）。
在组 2 中，男性更多（79%比 63%；p=0.03），并且更多患者诊断出（p<0.01）和以前修复过（p<0.01）的腹主动脉瘤。组 2 的动脉瘤在直径（63 比 56mm，p<0.01）和长度（157 比 113mm，p<0.01）上均显著更大。支架移植物覆盖的胸主动脉百分比在组 2 中更大（80%比 50%，p<0.01）。组 2 的手术时间明显更长（124±48 比 100±39 分钟，p<0.01），术中估计失血量明显增加（248±359 比 169±139 毫升，p=0.05）。组 1 的 30 天手术成功率为 95%，组 2 为 85%（p=0.06）。组 1 中未观察到术后截瘫和截瘫，而组 2 中有 9 例（p=0.01）受影响。30 天、1 年和 2 年时，两组之间的治疗成功率、内漏、迁移、二次干预率以及全因和动脉瘤相关死亡率无显著差异。
使用 1 或 2 个 TX2 组件进行 TEVAR 在死亡率和中期治疗成功率方面具有相似的结果。使用 2 个组件治疗的患者围手术期发病率增加，包括截瘫，这可能与该患者组所需的移植物覆盖范围更大以及男性、以前的主动脉修复、手术时间延长和失血量增加有关。
