Department of Vascular and Endovascular Surgery, Ramón y Cajal's University Hospital, Madrid, Spain.
Bedfordshire - Milton Keynes Vascular Centre, Bedfordshire Hospitals Foundation Trust, Bedford, UK.
Vascular. 2022 Feb;30(1):27-37. doi: 10.1177/1708538121992596. Epub 2021 Feb 10.
We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR).
The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine (https://ClinicalTrials.gov). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. Follow-up imaging was scheduled according to each center's protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up.
Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12-48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation.
This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.
我们旨在描述多中心数据中关于辅助使用 Heli-FX EndoAnchor 在预防或修复腹主动脉瘤腔内修复术（EVAR）中失败的疗效的真实世界结果，即所谓的 EndoSutured-aneurysm-repair（ESAR）。
本研究在美国国立医学图书馆（https://ClinicalTrials.gov）获得了标识符（NCT04100499）。这是一项前瞻性收集数据的观察性回顾性研究，来自 2010 年 6 月至 2019 年 12 月的七个血管外科部门。 ANCHOR 登记册中的患者被排除在本分析之外。EndoAnchors 的使用是由治疗外科医生或多学科主动脉委员会根据每个中心的实践决定的。根据每个中心的方案安排随访影像学检查，这必然包括腹部超声或射线照相或计算机断层扫描成像。主要分析结果是技术成功、无 1a 型内漏（IaEL）、全因和动脉瘤相关死亡率，以及对至少有 6 个月影像学随访的患者进行的囊腔变化和趋势评估。
在研究期间，275 名患者在参与中心接受了 ESAR。排除后，最终纳入 221 名患者（男性 184 名，女性 37 名，平均年龄 75±8.3 岁）进行分析。队列的中位随访时间为 27（四分位距 12-48）个月。在 ESAR 中中位数使用了 6（四分位距 3）个 EndoAnchors，175 次（79%）为初次手术，46 次（21%）为翻修手术，其中 40 次与 1aEL 型相关。手术（初始）、30 天和总体技术成功率分别为 89%、95.5%和 96.8%；30 天的成功率较高，因为后续有自发性近端内漏封口。在两年时，整个系列中无 1aEL 的比例为 94%；原发性和翻修组分别为 96%和 86%；而全因死亡率、动脉瘤相关死亡率和再次干预的比例分别为 89%、98%和 87%。ESAR 前囊腔大小为 66±15.1，ESAR 后为 61±17.5（p<0.001），对于 180 名至少有 6 个月随访的患者，92.2%的患者处于稳定（51%）或退缩（41%）状态。
这项真实世界的研究表明，EVAR 中辅助使用 EndoAnchor 可实现较高的无 1aEL 率，包括在大量具有敌对颈部解剖结构的患者中，在囊腔大小演变方面呈积极趋势。进一步的长期随访数据可能有助于确立 EndoAnchor 作为 EVAR 的常规辅助手段，尤其是在敌对颈部。
