Department of Vascular and Endovascular Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Eur J Cardiothorac Surg. 2021 Dec 1;60(6):1455-1463. doi: 10.1093/ejcts/ezab289.
The aim of this study was to evaluate technical/clinical outcomes of the Gore TAG Conformable Thoracic Stent Graft with Active Control System (CTAG with ACS) in thoracic aortic disease since its introduction in Europe in 2017.
Patients undergoing thoracic endovascular aortic repair (TEVAR) with the device between 2017 and 2020 were identified from a prospectively maintained single-centre database and retrospectively analysed. Predominant indications were aortic dissection (n = 46), thoracic/thoraco-abdominal aneurysm (n = 20/n = 7), penetrating ulcer (n = 14) and intramural haematoma (n = 12). Emergency procedures were performed in 47% (54/115). The primary outcome was technical success. Secondary outcomes were clinical success, serious adverse events and procedure-related reintervention. ACS was assessed regarding angulation, accuracy and apposition. The median follow-up was 8.46 months (interquartile range: 3.18-16.89 months).
A total of 115 consecutive patients (82 males, median age 63; interquartile range: 53-74 years) have been included. Technical success was achieved in 95.7% (110/115). Clinical success rate was 80.9% (93/115); mostly due to procedure-related death (n = 14). Overall mortality was 19.1% (22/115), with significant differences between elective/emergency procedures (log-rank: P < 0.001). Procedure-related serious adverse event rate was 44.3% (51/115). Procedure-related reintervention was performed in 20.9% (24/115). The cumulative incidence for reintervention differed significantly between elective/emergency cases (Gray's test: P = 0.0033). Angulation was used in 40.9% of patients (47/115), mostly in type II arches (52.7%). Deployment accuracy was 87.8% (101/115). Sufficient apposition was present in 93.0% (107/115).
This single-centre study shows encouraging performance of the CTAG with ACS in an array of aortic pathologies. Although longer-term data must be awaited, ACS leads to overall favourable device placement. Despite ongoing advances in device technology, TEVAR remains challenging and is associated with significant burden inherent to the underlying disease.
本研究旨在评估自 2017 年 Gore TAG 顺应性胸主动脉覆膜支架带主动控制系统（CTAG 带 ACS）在欧洲引入以来，其在胸主动脉疾病中的技术/临床结果。
从一个前瞻性维护的单中心数据库中确定了 2017 年至 2020 年间接受该器械进行胸主动脉腔内修复术（TEVAR）的患者，并进行回顾性分析。主要适应证为主动脉夹层（n=46）、胸/胸腹主动脉瘤（n=20/n=7）、穿透性溃疡（n=14）和壁内血肿（n=12）。47%（54/115）为急诊手术。主要结局为技术成功。次要结局为临床成功、严重不良事件和与手术相关的再次干预。评估 ACS 的角度、准确性和贴壁情况。中位随访时间为 8.46 个月（四分位间距：3.18-16.89 个月）。
共纳入 115 例连续患者（82 例男性，中位年龄 63 岁；四分位间距：53-74 岁）。技术成功率为 95.7%（110/115）。临床成功率为 80.9%（93/115）；主要是由于与手术相关的死亡（n=14）。总死亡率为 19.1%（22/115），择期/急诊手术之间有显著差异（对数秩检验：P<0.001）。与手术相关的严重不良事件发生率为 44.3%（51/115）。与手术相关的再次干预发生率为 20.9%（24/115）。择期/急诊病例的再干预累积发生率差异有统计学意义（Gray 检验：P=0.0033）。40.9%（47/115）的患者使用了角度（angulation），主要是在 II 型弓（52.7%）。部署准确性为 87.8%（101/115）。足够的贴壁率为 93.0%（107/115）。
这项单中心研究显示，在一系列主动脉病变中，CTAG 带 ACS 的表现令人鼓舞。尽管需要等待更长期的数据，但 ACS 导致了整体有利的器械放置。尽管器械技术不断进步，TEVAR 仍然具有挑战性，并且与潜在疾病固有的显著负担相关。
