Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center, University Hospital Essen, Essen, Germany.
Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany.
Eur J Cardiothorac Surg. 2024 Jun 3;65(6). doi: 10.1093/ejcts/ezae206.
The aim of this multicentre study was to demonstrate the safety and clinical performance of E-vita OPEN NEO Stent Graft System (Artivion, Inc.) in the treatment of aneurysm or dissection, both acute and chronic, in the ascending aorta, aortic arch and descending thoracic aorta.
In this observational study of 12 centres performed in Europe and in Asia patients were enrolled between December 2020 and March 2022. All patients underwent frozen elephant trunk using E-vita OPEN NEO Stent Graft System. Primary end point was the rate of all-cause mortality at 30 days and secondary end points included further clinical and safety data are reported up to 3-6 months postoperatively.
A total of 100 patients (66.7% male; mean age, 57.7 years) were enrolled at 12 sites. A total of 99 patients underwent surgery using the E-vita OPEN NEO for acute or subacute type A aortic dissection (n = 37), chronic type A aortic dissection (n = 33) or thoracic aortic aneurysm (n = 29), while 1 patient did not undergo surgery. Device technical success at 24 h was achieved in 97.0%. At discharge, new disabling stroke occurred in 4.4%, while new paraplegia and new paraparesis was reported in 2.2% and 2.2%, respectively. Renal failure requiring permanent (>90 days) dialysis or hemofiltration at discharge was observed in 3.3% of patients. Between discharge and the 3-6 months visit, no patients experienced new disabling stroke, new paraplegia or new paraparesis. The 30-day mortality was 5.1% and the estimated 6-month survival rate was 91.6% (standard deviation: 2.9).
Total arch replacement with the E-vita OPEN NEO can be performed with excellent results in both the acute and chronic setting. This indicates that E-vita OPEN NEO can be used safely, including in the setting of acute type A aortic dissection.
本多中心研究旨在证明 E-vita OPEN NEO 支架移植物系统（Artivion，Inc.）在治疗升主动脉、主动脉弓和降胸主动脉的急性和慢性动脉瘤或夹层中的安全性和临床性能。
在这项在欧洲和亚洲的 12 个中心进行的观察性研究中，于 2020 年 12 月至 2022 年 3 月期间招募了患者。所有患者均接受了 E-vita OPEN NEO 冷冻象鼻手术。主要终点是 30 天全因死亡率，次要终点包括进一步的临床和安全性数据，直至术后 3-6 个月。
共有 100 名患者（66.7%为男性；平均年龄为 57.7 岁）在 12 个地点入组。共有 99 名患者接受了 E-vita OPEN NEO 手术，用于治疗急性或亚急性 A 型主动脉夹层（n=37）、慢性 A 型主动脉夹层（n=33）或胸主动脉瘤（n=29），而 1 名患者未接受手术。24 小时时器械技术成功率达到 97.0%。出院时，新发致残性卒中发生率为 4.4%，新发截瘫和新截瘫发生率分别为 2.2%和 2.2%。出院时需要永久性（>90 天）透析或血液滤过的肾衰竭发生率为 3.3%。在出院至 3-6 个月就诊期间，没有患者发生新的致残性卒中、新截瘫或新截瘫。30 天死亡率为 5.1%，估计 6 个月生存率为 91.6%（标准差：2.9）。
在急性和慢性情况下，使用 E-vita OPEN NEO 进行全主动脉弓置换可获得优异的结果。这表明 E-vita OPEN NEO 可以安全使用，包括在急性 A 型主动脉夹层的情况下。
