Zenith alpha覆膜支架移植物的初步临床经验。
Initial clinical experience with the Zenith alpha stent-graft.
作者信息
Torsello Giovanni F, Austermann Martin, Van Aken Hugo K, Torsello Giovanni B, Panuccio Giuseppe
机构信息
Westphalian Center for Radiology, Münster, Germany St. Franziskus Hospital and University Clinic of Münster, Germany Department of Anesthesiology, Intensive Care and Pain Therapy, University Clinic of Münster, Germany
St. Franziskus Hospital and University Clinic of Münster, Germany.
出版信息
J Endovasc Ther. 2015 Apr;22(2):153-9. doi: 10.1177/1526602815573239.
PURPOSE
To assess safety and short-term efficacy of endovascular repair of the thoracic aorta with the new Zenith Alpha stent-graft.
METHODS
Between August 2010 and May 2014, 33 patients (21 men; mean age 73.2±9.0 years) were treated Zenith Alpha stent-graft (group ZA). Outcomes of this group were compared with those of 34 patients (25 men; mean age 70.3±8.5 years) treated contemporaneously with the Zenith TX-2 for the same pathologies (group TX). The primary outcome measure was technical success. Data on iliac tortuosity, minimum access vessel diameter, and previous unsuccessful treatment with other endografts was also recorded.
RESULTS
Technical success was 93.9% in group ZA and 91.2% in group TX (p=0.67). There was no case of surgical death or conversion to open repair in either group. Two (6%) type I endoleaks occurred in group ZA and 3 (9%) in group TX (p=0.67). Three patients died within 30 days in group ZA vs. none in group TX (p=0.07). Mean minimum access vessel diameter was significantly smaller (5.07 vs. 6.65 mm, p=0.002) and iliac tortuosity indices significantly higher in group ZA (1.34 vs. 1.25, p=0.02). Access vessel complications occurred in 1 (3%) patient in group ZA and 4 (12%) patients in group TX (p=0.17). Significantly more patients in group ZA (6, 18%) were unsuccessfully treated previously with other endografts vs. none in group TX (p=0.01).
CONCLUSION
The new Zenith Alpha appears to be equally as safe and efficacious as the Zenith TX-2 while being used in patients with demanding access vessel morphology.
目的
评估使用新型Zenith Alpha覆膜支架进行胸主动脉腔内修复术的安全性和短期疗效。
方法
2010年8月至2014年5月期间，33例患者（21例男性；平均年龄73.2±9.0岁）接受了Zenith Alpha覆膜支架治疗（ZA组）。将该组患者的治疗结果与同期因相同病情接受Zenith TX-2治疗的34例患者（25例男性；平均年龄70.3±8.5岁）的结果进行比较（TX组）。主要观察指标为技术成功率。还记录了髂动脉迂曲情况、最小入路血管直径以及既往使用其他腔内移植物治疗失败的数据。
结果
ZA组的技术成功率为93.9%，TX组为91.2%（p = 0.67）。两组均无手术死亡或转为开放手术的病例。ZA组发生2例（6%）Ⅰ型内漏，TX组发生3例（9%）（p = 0.67）。ZA组有3例患者在30天内死亡，TX组无死亡病例（p = 0.07）。ZA组的平均最小入路血管直径明显更小（5.07 vs. 6.65 mm，p = 0.002），髂动脉迂曲指数明显更高（1.34 vs. 1.25，p = 0.02）。ZA组有1例（3%）患者发生入路血管并发症，TX组有4例（12%）患者发生（p = 0.17）。与TX组无患者（0%）相比，ZA组有更多患者（6例，18%）既往使用其他腔内移植物治疗失败（p = 0.01）。
结论
新型Zenith Alpha在用于入路血管形态要求较高的患者时，似乎与Zenith TX-2一样安全有效。
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