A new device as an open stent graft for extended aortic repair: a multicentre early experience in Japan
A new device as an open stent graft for extended aortic repair: a multicentre early experience in Japan
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DOI：
10.1093/ejcts/ezv310
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发表时间：
2016-04-01
影响因子：
3.4
通讯作者：
Kato, Masaaki
中科院分区：
文献类型：
--
作者：
Uchida, Naomichi;Katayama, Akira;Kato, Masaaki
用于扩大主动脉修复的开放式支架移植术已在世界各地广泛开展。我们报告了一种新装置作为开放式覆膜支架用于扩大主动脉修复的有效性。本研究中使用了一种新装置作为开放式覆膜支架。该装置的移植部分具有由镍钛诺丝（一种超弹性/形状记忆合金）制成的编织结构。本研究的对象是年龄在 20-84 岁之间，患有胸主动脉瘤（n = 38）或主动脉夹层（n = 22）的患者，包括远端主动脉弓和近端降主动脉。这项研究是一项多中心、非盲法研究。随访时间为36个月。3名受试者（5.0%）在住院期间因多器官功能衰竭死亡。 4 名受试者 (6.7%) 出现脊髓损伤 (SCI)：1 名受试者截瘫，3 名受试者截瘫。总体 3 年生存率为 76.7%：诊断为主动脉瘤的受试者（主动脉瘤组）为 68.4%，主动脉夹层患者（主动脉夹层组）为 90.9%。主动脉瘤组术后6个月有97%的患者观察到主动脉瘤内形成血栓，术后12个月为100%。同时，对于主动脉夹层组，主动脉夹层假腔术后6个月有94%的患者观察到血栓形成，术后12个月有94%的患者观察到血栓形成，术后24个月有100%的患者观察到血栓形成。 2 名受试者 (6.1%) 观察到主动脉瘤囊扩张。在这 2 名受试者中，1 名受试者观察到内漏，通过额外的胸主动脉腔内修复术改善了内漏。该研究装置的安全性和有效性在术后长达 36 个月的时间内得到了验证。未来还需要长期随访来进一步验证该装置的有效性。
Open stent grafting for extended aortic repair has been widely carried out around their world. We reported the effectiveness of a new device as an open stent graft for extended aortic repair.A new device was used as an open stent graft in this study. The graft part of the device has a woven structure made of Nitinol wire, a superelastic/shape-memory alloy. The subjects of this study were patients aged 20-84 with aneurysms (n = 38) or aortic dissection (n = 22) in the thoracic aorta, including the distal aortic arch and the proximal descending aorta. This study was a multicentre, non-blinded study. The follow-up period was 36 months.Three subjects (5.0%) died during hospitalization due to multiorgan failure. Spinal cord injury (SCI) was observed in 4 subjects (6.7%): paraplegia in 1 and paraparesis in 3 subjects. The 3-year survival rate was 76.7% overall: 68.4% for the subjects diagnosed as having aortic aneurysms (the aortic aneurysm group) and 90.9% for those having aortic dissection (the aortic dissection group). For the aortic aneurysm group, thrombus formation in the aortic aneurysm was observed in 97% of the patients 6 months after operation, and in 100% 12 months after operation. Meanwhile, for the aortic dissection group, with regard to the false lumen of aortic dissection, thrombus formation was observed in 94% of the patients 6 months after operation, in 94% 12 months after operation and in 100% 24 months after operation. Expansion of the aortic aneurysm sac was observed in 2 subjects (6.1%). Among these 2 subjects, endoleak was observed in 1 subject, which was improved by additional thoracic endovascular aortic repair.The safety and effectiveness of this investigational device was verified over a period up to 36 months after operation. A long-term follow-up would be necessary to further verify the effectiveness of the device in the future.