Department of Vascular and Endovascular Surgery, Carolinas Medical Center, Charlotte, NC.
Department of Vascular and Endovascular Surgery, Carolinas Medical Center, Charlotte, NC.
J Vasc Surg. 2019 Sep;70(3):732-740. doi: 10.1016/j.jvs.2018.11.033. Epub 2019 Mar 6.
Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA.
In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months.
In this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months.
In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.
当肾下主动脉存在短或不存在健康段时,腹主动脉瘤(AAA)的血管内修复仍然是一个具有挑战性的临床情况。本研究旨在确定使用 Endurant II/IIs 覆膜支架(美敦力血管,加利福尼亚州圣罗莎)联合 Heli-FX EndoAnchor(美敦力血管)进行腔内缝合动脉瘤修复(ESAR)治疗短颈 AAA 的安全性和有效性。
在这项亚组分析中,根据核心实验室测量,从动脉瘤治疗中使用 Heli-FX EndoAnchor 系统全球注册(ANCHOR)中确定了 70 名存在肾下颈部长度<10mm 至 4mm 的患者。主要结局包括指数手术的技术成功率、1 个月和 12 个月时的 1A 型内漏率以及 12 个月时的二级手术率。
在这个短颈队列(n=70)中,平均颈部长度和直径分别为 6.9±1.6mm 和 25.7±4.0mm。研究者报告了 97.1%的总体手术成功率和 88.6%的技术成功率。植入程序、EndoAnchor 植入和总透视时间的持续时间分别为 148.0±80.0 分钟、17.1±11.5 分钟和 35.3±22.0 分钟,平均每个患者植入 5.5±2.1 个 EndoAnchor。在 30 天随访期间,4 名患者报告了 1A 型内漏,其中 3 名在 12 个月随访时自发缓解。通过 12 个月的随访,还出现了另外一个 1A 型内漏,但没有导致 AAA 增大或需要进行二次手术。Kaplan-Meier 估计在 365 天内免于二次血管内手术和全因死亡率分别为 95.4%和 92.7%。在 12 个月内,短颈队列中没有患者出现主体支架迁移、最大动脉瘤直径增加、动脉瘤破裂或需要转为开放手术修复。
在 ANCHOR 的这个短颈队列分析中,Endurant II/IIs 覆膜支架联合 Heli-FX EndoAnchor 植入物(ESAR)似乎是一种安全有效的治疗选择,具有较高的技术成功率和较低的 1A 型内漏率和二次干预率。尽管解剖结构复杂且具有敌意,但 ESAR 方法所需的手术和透视时间较短。这些短期结果表明,ESAR 可能是治疗具有敌意 AAA 解剖结构的现有治疗方法的补充,并且是短颈 AAA 患者可行的现成血管内治疗选择,尽管长期随访至关重要。