Department of Vascular Surgery, Hellenic Air Force Hospital, Athens, Greece.
J Endovasc Ther. 2012 Dec;19(6):707-15. doi: 10.1583/JEVT-12-4008R.1.
To investigate the feasibility and early results of endoanchoring (endostapling) using a new commercially available device as an adjunctive procedure during endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with an unfavorable proximal neck.
Between June 2010 and May 2012, 13 consecutive patients (all men; median age 73 years, range 62-82) were prospectively enrolled in a 2-center registry to follow outcomes of adjunctive primary endoanchoring (Aptus HeliFX Aortic Securement System) of the proximal endograft to enhance proximal graft fixation and sealing during EVAR. Indications for proximal neck endoanchoring included at least one of the following: neck angulation 45° to 90°, length 8 to 15 mm, diameter 29 to 33 mm, conical neck configuration, or an irregularly shaped neck. The median AAA diameter was 56 mm (range 50-98). The Endurant stent-graft was implanted in 4 patients and the Zenith device in 9.
A median of 4 endoanchors were implanted per patient (range 3-10) in adjunctive procedures that required a median 12 minutes (range 7-20). Intraoperatively, 2 proximal type I endoleaks were present following endoanchor implantation (85% primary technical success); a cuff was deployed in 1 case, which successfully sealed the endoleak (92% assisted primary technical success). The second proximal type I endoleak was minute and sealed spontaneously within 30 days. No further major device-related complications occurred intraoperatively. In the 30-day perioperative period, the only procedure-related complications were 2 type II endoleaks, which required no intervention. Over a median follow-up of 7 months (range 2-17), no further complications occurred apart from an asymptomatic internal iliac artery occlusion and a non-lethal myocardial infarction at 9 months. The type II endoleaks spontaneously sealed. No endograft migration was noticed nor loss of endoanchor integrity. No deaths occurred throughout follow-up.
Primary endoanchoring using the HeliFX aortic securement system is feasible, and early results were promising in this series.
研究使用一种新型商业可获得设备进行血管内腹主动脉瘤修复（EVAR）中近端瘤颈不良的辅助性腔内锚固（endoanchoring，endostapling）的可行性和早期结果。
在 2010 年 6 月至 2012 年 5 月期间，连续 13 例患者（均为男性；中位年龄 73 岁，范围 62-82 岁）前瞻性入组 2 个中心的注册研究，以随访辅助性腔内近端锚定（Aptus HeliFX 主动脉固定系统）的结果，以增强 EVAR 中近端移植物的固定和密封。近端颈部腔内锚固的适应证包括以下至少一种：颈部成角 45°至 90°，长度 8 至 15mm，直径 29 至 33mm，锥形颈部形态或不规则形状的颈部。中位 AAA 直径为 56mm（范围 50-98mm）。4 例患者植入 Endurant 支架移植物，9 例患者植入 Zenith 装置。
中位每例患者植入 4 个腔内锚固器（范围 3-10 个），辅助手术需要中位 12 分钟（范围 7-20 分钟）。术中，2 例植入腔内锚固器后出现近端 I 型内漏（85%初始技术成功率）；1 例植入了袖带，成功封堵内漏（92%辅助初始技术成功率）。第二次近端 I 型内漏轻微，30 天内自行封闭。术中无其他主要器械相关并发症。30 天围手术期内，唯一与手术相关的并发症是 2 例 II 型内漏，无需干预。中位随访 7 个月（范围 2-17 个月）期间，除无症状性髂内动脉闭塞和 9 个月时非致死性心肌梗死外，无其他并发症。II 型内漏自行封闭。未发现移植物迁移或腔内锚固完整性丧失。随访期间无死亡。
使用 HeliFX 主动脉固定系统进行腔内锚固是可行的，本系列研究的早期结果令人鼓舞。
