Antonello Michele, Spertino Andrea, Gatta Emanuele, Piffaretti Gabriele, Isernia Giacomo, Mansour Wassim, Bertoglio Luca, Martelli Eugenio, Veraldi Gian Franco, Silingardi Roberto, Farneti Fabrizio, Corbetta Riccardo, D'Onofrio Augusto, Garofalo Alessandra Rinaldi, Squizzato Francesco, Piazza Michele
Vascular and Endovascular Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Vascular and Endovascular Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
J Vasc Surg. 2025 Oct;82(4):1137-1145. doi: 10.1016/j.jvs.2025.05.201. Epub 2025 Jun 13.
The aim of this study is to evaluate the safety, efficacy, and clinical outcomes of endovascular aortic arch repair using the Nexus and Nexus Duo endograft systems.
A multicenter, retrospective study with prospectively collected data was conducted as part of the Italian Nexus Aortic aRCH Endovascular Repair Registry (INARCHER) between 2019 and 2024. Nexus platforms include an off-the-shelf bimodular single branch endograft and a custom-made double-branch device. Patients who underwent endovascular aortic arch repair with the Nexus and Nexus Duo endograft systems at participating centers were included. The study addressed both aortic arch aneurysm and dissection. Data collection included baseline patient characteristics, procedural details, and follow-up results. The primary endpoints were early (30 days) major adverse events, major stroke, and mortality. Secondary endpoints included the need for device-related reintervention and the device-related endoleak.
We collected 31 cases from 11 centers. The mean age was 73.4 ± 7.32 years, and 77.4% were male. Thirteen patients had a degenerative aneurysm, three had a pseudoaneurysm after prior surgical repair, two had penetrating aortic ulcers, and 13 had an aortic dissection (subacute, n = 1; chronic, n = 12). Prior ascending aorta replacement was present in 15 cases (48.4%). Seven patients (22.6%) received urgent treatment. Twenty-five cases were treated with complete supra-aortic trunks debranching and Nexus, six cases with left subclavian artery-left common carotid artery debranching and Nexus Duo. The mean operative time was 230 ± 73 minutes. Technical success was achieved in 97% of procedures owing to one case of type IA endoleak. Perioperative mortality was 6.5%, related to a massive pulmonary embolism and a cardiac arrest. Major strokes occurred in 6.5%. The major adverse event rate was 22.6%. The mean follow-up period was 29.7 ± 24.9 months. Beyond 30 days, there was no aortic-related mortality, and freedom from related reintervention was 97% (95% confidence interval, 91%-100%).
The use of the Nexus and Nexus Duo endograft systems appears to be a safe option for the treatment of aortic arch dissection and aneurysm, with complication rates consistent with existing literature for such high-complexity cases. Endovascular aortic arch repair remains a challenging procedure with non-negligible neurologic complication, requiring ongoing improvements to enhance patient outcomes.
本研究旨在评估使用Nexus和Nexus Duo血管内移植物系统进行主动脉弓血管腔内修复术的安全性、有效性和临床结果。
作为意大利Nexus主动脉弓血管腔内修复注册研究（INARCHER）的一部分，于2019年至2024年进行了一项多中心回顾性研究，前瞻性收集数据。Nexus平台包括一款现成的双模块单分支血管内移植物和一款定制的双分支装置。纳入在参与中心接受Nexus和Nexus Duo血管内移植物系统进行主动脉弓血管腔内修复的患者。该研究涉及主动脉弓动脉瘤和夹层。数据收集包括患者基线特征、手术细节和随访结果。主要终点为早期（30天）主要不良事件、严重卒中及死亡率。次要终点包括与器械相关的再次干预需求及与器械相关的内漏。
我们从11个中心收集了31例病例。平均年龄为73.4±7 .32岁，77.4%为男性。13例患者患有退行性动脉瘤，3例在先前手术修复后出现假性动脉瘤，2例患有穿透性主动脉溃疡，13例患有主动脉夹层（亚急性，n = 1；慢性，n = 12）。15例（48.4%）患者曾行升主动脉置换术。7例患者（22.6%）接受了紧急治疗。25例采用完全主动脉弓上分支去分支术联合Nexus治疗，6例采用左锁骨下动脉 - 左颈总动脉去分支术联合Nexus Duo治疗。平均手术时间为230±73分钟。由于1例I A型内漏，97%的手术获得技术成功。围手术期死亡率为6.5%，与大面积肺栓塞和心脏骤停有关。严重卒中发生率为6.5%。主要不良事件发生率为22.6%。平均随访期为29.7±24.9个月。30天之后，无主动脉相关死亡，与器械相关的再次干预豁免率为97%（95%置信区间，91% - 100%）。
使用Nexus和Nexus Duo血管内移植物系统似乎是治疗主动脉弓夹层和动脉瘤的安全选择，并发症发生率与现有文献中此类高复杂性病例的发生率一致。主动脉弓血管腔内修复仍然是一项具有挑战性的手术，神经并发症不可忽视，需要不断改进以提高患者的治疗效果。
