Division of Vascular Surgery, Vita-Salute University and IRCCS San Raffaele Scientific Institute, Milan, Italy.
Division of Vascular Surgery, Vita-Salute University and IRCCS San Raffaele Scientific Institute, Milan, Italy.
J Vasc Surg. 2021 May;73(5):1533-1540.e2. doi: 10.1016/j.jvs.2020.10.003. Epub 2020 Oct 14.
The analysis of endovascular treatment of thoracic aortic diseases using new low-profile stent grafts in large series is crucial to understanding the durability of these devices. The present study reports the midterm outcomes of a single-center experience using the Zenith Alpha thoracic endovascular stent graft.
The outcomes of 270 procedures performed on 262 patients (197 men; mean age, 70.5 ± 9.5 years) using the Zenith Alpha thoracic endovascular stent graft from November 2013 to December 2019 for different thoracic aortic diseases were analyzed. The primary endpoints were 30-day clinical success and midterm (5-year) clinical success. The secondary endpoints were the adverse event rate at 30 days and midterm and access- and device-related complications. The follow-up of surviving patients was performed using computed tomography angiography and office visits at 1, 6, and 12 months and annually thereafter. Kaplan-Meier analysis was performed for overall survival, and freedom from thoracic aortic endovascular repair-related mortality and related reinterventions.
The overall 30-day mortality was 5.2% (2.5% for elective and 30.8% for nonelective cases). Type I endoleaks were identified in six patients. The 30-day primary technical and clinical success rates were 97.8% and 92.6%, respectively. Femoral cutdown was used in 41.1% of cases and percutaneous access in 58.5%. The rate of femoral artery complications after the percutaneous approach was 5.1%, with the need for surgical conversion in 1.9%. The stroke rate was 4.1% (major stroke, 2.2%), and the spinal cord ischemia rate was 3.7% (permanent paraplegia, 0.7%). Of the 248 survivors, 239 complied with the follow-up protocol with adequate computed tomography angiograms available images. Overall follow-up survival was 94.0% at 1 year, 91.6% at 2 years, 88.9% at 3 years, and 88.5% at 5 years. The unplanned secondary endovascular procedure rate was 5.3%. No stent fractures or new-onset type I endoleaks due to stent graft migration were observed in the study cohort.
The midterm outcomes of this new generation of low-profile devices were satisfactory. The reported low incidence of secondary procedures and the absence of migrations are promising for the long-term durability of these devices.
分析使用新型微创支架移植物治疗胸主动脉疾病的血管内治疗结果，对于了解这些设备的耐用性至关重要。本研究报告了单中心使用 Zenith Alpha 胸主动脉血管内支架移植物的中期结果。
分析了 2013 年 11 月至 2019 年 12 月期间，使用 Zenith Alpha 胸主动脉血管内支架移植物治疗 262 例患者（197 例男性；平均年龄 70.5±9.5 岁）的 270 例不同胸主动脉疾病的手术结果。主要终点是 30 天临床成功率和中期（5 年）临床成功率。次要终点是 30 天和中期的不良事件发生率以及与入路和器械相关的并发症。对存活患者进行随访，使用计算机断层血管造影术和门诊就诊，随访时间分别为 1、6 和 12 个月，之后每年进行一次。对总体生存率和免于胸主动脉血管内修复相关死亡率和相关再介入的生存率进行 Kaplan-Meier 分析。
总的 30 天死亡率为 5.2%（择期手术为 2.5%，非择期手术为 30.8%）。6 例患者出现 I 型内漏。30 天主要技术和临床成功率分别为 97.8%和 92.6%。41.1%的病例采用股动脉切开术，58.5%采用经皮入路。经皮入路后股动脉并发症发生率为 5.1%，需要手术转换的比例为 1.9%。卒中发生率为 4.1%（大卒中，2.2%），脊髓缺血发生率为 3.7%（永久性截瘫，0.7%）。在 248 名存活患者中，239 名符合随访方案，有足够的计算机断层血管造影可供分析。1 年总体随访生存率为 94.0%，2 年为 91.6%，3 年为 88.9%，5 年为 88.5%。计划外再次血管内手术率为 5.3%。在研究队列中未观察到支架移植物迁移导致的支架断裂或新发 I 型内漏。
新一代微创设备的中期结果令人满意。报告的低二次手术发生率和无迁移发生率对这些设备的长期耐用性有希望。
