Deutsches Herzzentrum Berlin, Germany.
J Endovasc Ther. 2011 Apr;18(2):131-43. doi: 10.1583/10-3233MR.1.
To evaluate the safety and performance of Relay stent-grafts in patients with acute or chronic aortic dissections.
Patients with types A or B aortic dissections suitable for treatment with Relay stent-grafts and followed for 2 years after thoracic endovascular aortic repair (TEVAR) were identified from a company-sponsored registry database established in January 2006. Ninety-one consecutive patients (69 men; mean age 65 years) underwent TEVAR with Relay stent-grafts for dissection. Most patients (76, 84%) had type B dissections; 61 of all patients were classified as chronic and 30 as acute.
The technical success rate was 95% (97% in acute, 95% in chronic, and 93% in type B dissections). The type I endoleak rate was 7% (7% in acute and 8% in chronic dissections); all occurred in patients with type B dissections. Paraplegia, paraparesis, and stroke occurred in 4, 1, and 2 patients, respectively; 2 cases of paraplegia occurred in patients with acute type B dissections. Thirty-day mortality was 8% (13% in acute and 5% in chronic dissections); all deaths occurred in patients with type B dissections. The 2-year survival rate was 82% in the overall population and 84% in patients with type B dissections.
The combination of Relay's features, such as stent conformability, radial force, atraumatic design, and controlled deployment and fixation, may contribute to the safety of the Relay stent-grafts for the treatment of thoracic aortic dissections, including acute and chronic type B dissections.
评估 Relay 支架移植物在急性或慢性主动脉夹层患者中的安全性和性能。
从 2006 年 1 月建立的公司赞助的注册数据库中确定了适合使用 Relay 支架移植物治疗的 A 型或 B 型主动脉夹层患者,并在胸主动脉腔内修复术(TEVAR)后随访 2 年。91 例连续患者(69 例男性;平均年龄 65 岁)接受 Relay 支架移植物治疗夹层。大多数患者(76 例,84%)为 B 型夹层;所有患者中有 61 例为慢性,30 例为急性。
技术成功率为 95%(急性为 97%,慢性为 95%,B 型夹层为 93%)。I 型内漏率为 7%(急性为 7%,慢性为 8%);所有发生在 B 型夹层患者中。截瘫、下肢轻瘫和中风分别发生在 4、1 和 2 例患者中,其中 2 例截瘫发生在急性 B 型夹层患者中。30 天死亡率为 8%(急性为 13%,慢性为 5%);所有死亡均发生在 B 型夹层患者中。总体人群的 2 年生存率为 82%,B 型夹层患者的 2 年生存率为 84%。
Relay 的特点,如支架顺应性、径向力、无创伤设计以及可控的展开和固定,结合起来可能有助于 Relay 支架移植物治疗胸主动脉夹层的安全性,包括急性和慢性 B 型夹层。