Department of Vascular and Endovascular Surgery, Ramón y Cajal´s University Hospital, Madrid, Spain.
Section of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Chicago Medicine, Chicago, Ill.
Vascular. 2023 Jun;31(3):455-462. doi: 10.1177/17085381221076320. Epub 2022 Feb 27.
To describe mid-term outcomes of the use of EndoAnchors as an adjunct for arch and thoracic endovascular aortic repair (TEVAR).
A retrospective multicentre series from nine centres using the Heli-FX EndoAnchor System (Medtronic Inc, Minneapolis, USA) at TEVAR over May 2014-May 2019 is presented. The study is registered at ClinicalTrials.gov with number NCT04100499. The primary outcome was freedom from Type I endoleak at EndoAnchors deployments; secondary outcomes included evaluation of aortic wall penetration (AWP) at first computed tomography scan, EndoAnchor-related issues and mortality.
54 high-risk patients (35 males/19 females, age 73 ± 11 years) with arch, thoracic and thoracoabdominal aneurysmal disease (3 chronic post-dissection and one patch pseudoaneurysm), with a mean neck length 19.7 ± 6.6 mm that were treated with multiple hybrid and endovascular techniques were included. A total of 329 EndoAnchors were used with a mean of 6.1 ± 2.5 per patient. Overall adequate AWP was 86%, whereas arch (Ishimaru's zones 0-2) deployments achieved 80.6% when compared to 87.3% in descending thoracic aorta (dTA); although there was no statistical significance. Freedom from type I endoleaks was 88% at 2 year follow-up, due to 4 type IA endoleaks, two of them successfully treated, one with conservative treatment due to complexity of repair and remaining patient died 1 year later due to endograft infection. There were reported five EndoAnchor-related issues; four losses and one renal stent-graft was crushed due to catheter deflection solved with balloon reinflation. None of the losses had clinical significance. Overall mortality is described for 7 (9.5%) patients, one of them aneurysm-related.
The adjunctive use of EndoAnchors in TEVAR and complex TEVAR procedures achieved acceptable outcomes at midterm in a high-risk series with hostile seal zones. Still, they should be still judiciously used as there is lack of data to suggest a more liberal use; therefore, the landing zone should not be compromised in favour of their use.
描述使用 EndoAnchors 作为主动脉弓和胸主动脉腔内修复术 (TEVAR) 辅助治疗的中期结果。
本研究回顾性纳入了 2014 年 5 月至 2019 年 5 月期间，9 家中心使用 Heli-FX EndoAnchor 系统 (Medtronic Inc，明尼苏达州，美国) 进行 TEVAR 的多中心系列研究。该研究已在 ClinicalTrials.gov 注册，编号为 NCT04100499。主要结果是评估 EndoAnchor 部署时的 I 型内漏发生率；次要结果包括首次 CT 扫描时的主动脉壁穿透 (AWP) 评估、EndoAnchor 相关问题和死亡率。
本研究纳入了 54 例高危患者（35 例男性/19 例女性，年龄 73 ± 11 岁），这些患者患有主动脉弓、胸和胸腹主动脉瘤性疾病（3 例慢性夹层后和 1 例修补假性动脉瘤），颈部长度平均为 19.7 ± 6.6mm，采用了多种杂交和血管内技术进行治疗。共使用了 329 个 EndoAnchors，平均每个患者使用 6.1 ± 2.5 个。总体而言，AWP 充分的比例为 86%，而在主动脉弓（Ishimaru 的 0-2 区）的植入中，80.6%的患者获得了充分的 AWP，而在降主动脉（dTA）中，这一比例为 87.3%；尽管无统计学意义。2 年随访时，I 型内漏发生率为 88%，主要是由于 4 例 I 型内漏，其中 2 例成功治疗，1 例因修复复杂而采用保守治疗，另 1 例患者 1 年后因移植物感染死亡。有 5 例报告了与 EndoAnchor 相关的问题；4 例脱落，1 例肾支架-移植物因导管偏转而受压，通过球囊再充气得以解决。这些脱落均无临床意义。总死亡率为 7 例（9.5%）患者，其中 1 例与动脉瘤相关。
在高危系列患者中，TEVAR 和复杂 TEVAR 手术中使用 EndoAnchors 作为辅助治疗，在中期取得了可接受的结果，这些患者的密封区具有挑战性。尽管如此，仍应谨慎使用，因为缺乏数据支持更自由地使用；因此，不应为了使用它们而损害着陆区。
