Department of Vascular Surgery, St Franziskus Hospital Münster, Germany.
Vascular Surgery, La Sapienza University of Rome, Italy.
J Endovasc Ther. 2021 Feb;28(1):56-62. doi: 10.1177/1526602820952416. Epub 2020 Sep 17.
To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy.
A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications.
The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears.
Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.
评估专为解决挑战性入路血管解剖问题而设计的 Zenith Alpha 胸主动脉覆膜支架的长期疗效。
对 2010 年 8 月至 2014 年 10 月在单中心接受治疗的 44 例连续患者(平均年龄 72.5±8.3 岁;25 例男性)进行回顾性分析,所有存活患者的随访时间均至少 5 年。使用 Zenith Alpha 胸主动脉覆膜支架治疗胸主动脉瘤(n=37)、胸腹主动脉瘤(n=5)或穿透性主动脉溃疡(n=2)。10 例(23%)患者美国麻醉医师协会(ASA)分级为 4 级,9 例(20%)为择期手术。入路血管解剖复杂(平均最小直径 5.4mm,迂曲指数 1.3)。5 年时的主要终点是临床持续成功(免于动脉瘤/手术相关死亡、二次干预、I 型或 III 型内漏、感染、血栓形成、动脉瘤扩张、破裂或转换)。次要终点是免于全因死亡率、移植物迁移、支架断裂、织物侵蚀、内漏、神经系统事件和入路血管并发症。
44 例患者中有 37 例(84%)持续临床成功,原因是 4 例动脉瘤相关死亡(9%)、3 例 I 型或 III 型内漏(1 例在死亡患者中)和 1 例动脉瘤扩张但无明显内漏。有 3 例入路血管并发症(7%),无术后神经系统事件。2 例(5%)出现移植物迁移。无支架断裂或织物撕裂。
尽管 Zenith Alpha 胸主动脉覆膜支架在设计和材料上进行了改动以减小支架的外径,但即使在患有多种合并症且髂动脉解剖复杂的患者中,该支架也取得了良好的长期疗效。