Hull York Medical School, University of York, York, UK.
Department of Vascular and Endovascular Surgery, Royal Blackburn Teaching Hospital, Blackburn, UK.
J Card Surg. 2022 Mar;37(3):561-562. doi: 10.1111/jocs.16181. Epub 2021 Dec 16.
The introduction of the single-step total arch replacement (TAR) with frozen elephant trunk (FET) has revolutionised the field of aortic surgery. TAR is indicated when the aortic arch is involved in aortic pathologies such as Type A aortic dissection and thoracic aortic aneurysms. Several FET devices are available commercially for global use, and example is the E-Vita Open NEO hybrid prosthesis (HP) developed by CryoLife-JOTEC. Unlike other FET devices available, this HP in particular features a design that puts it at a disadvantage as it does not incorporate gelatine or collagen in its structure, which makes it permeable to blood. Several studies have reported incidence of post-anastomotic blood oozing through the E-Vita Open NEO right after weaning from cardiopulmonary bypass.
This commentary aims to discuss the recent study by Tan et al. which investigated E-Vita NEO device oozing as well as the implications of using BioGlue to overcome this serious complications.
We carried out a literature search on multiple electronic databases including PUBMED and Scopus in order to collate research evidence on E-Vita NEO device oozing, BioGlue health risks, and other commercially available and globally used FET devices such as Thoraflex Hybrid.
It is proven fact that the E-Vita NEO excessively oozes blood, and while BioGlue is a safe and effective agent when used in small amounts, the amount needed to coat the E-Vita Open NEO and achieve haemostasis exceeds this by a wide margin which poses patients to great potential health risks. The Thoraflex Hybrid Prosthesis developed by Terumo Aortic is a commercially available and globally used FET device with long-standing favourable outcomes.
Tan et al. recently conducted an interesting study which proved that the E-Vita NEO HP does excessively ooze blood and tackled the issue of pre-emptive BioGlue use to tackle this complication as suggested by Ho et al. This leads on to the main question, is the use of BioGlue with E-Vita Open NEO to overcome oozing a long-term sustainable solution or is it merely a band aid?
In the face of fierce commercial competition, the choice of design and material of the E-Vita Open NEO HP would benefit from reconsideration.
采用冷冻象鼻技术（FET）的一步式全主动脉弓置换术（TAR）的出现彻底改变了主动脉外科领域。当主动脉弓受累于主动脉病变，如 A 型主动脉夹层和胸主动脉瘤时，需要进行 TAR。目前市场上有几种 FET 设备可供全球使用，例如由 CryoLife-Jotec 开发的 E-Vita Open NEO 杂交假体（HP）。与其他可用的 FET 设备不同，这种 HP 尤其具有设计上的劣势，因为它的结构中不包含明胶或胶原蛋白，这使其易于被血液渗透。有几项研究报告称，在从体外循环脱机后不久，E-Vita Open NEO 右侧吻合口会出现渗血。
本文旨在讨论 Tan 等人最近的研究，该研究调查了 E-Vita NEO 设备渗血的情况，以及使用 BioGlue 克服这一严重并发症的意义。
我们在多个电子数据库（包括 PUBMED 和 Scopus）上进行了文献检索，以整理关于 E-Vita NEO 设备渗血、BioGlue 健康风险以及其他市售和全球使用的 FET 设备（如 Thoraflex Hybrid）的研究证据。
事实证明，E-Vita NEO 会大量渗血，虽然 BioGlue 在小剂量使用时是一种安全有效的药物，但要涂覆 E-Vita Open NEO 并实现止血所需的量远远超过这个量，这会给患者带来巨大的潜在健康风险。由 Terumo Aortic 开发的 Thoraflex Hybrid 假体是一种市售和全球使用的 FET 设备，具有长期良好的效果。
Tan 等人最近进行了一项有趣的研究，证明 E-Vita NEO HP 确实会大量渗血，并解决了 Ho 等人提出的使用预防性 BioGlue 来解决这一并发症的问题。这就引出了一个主要问题，即使用 BioGlue 与 E-Vita Open NEO 来克服渗血是一个长期可持续的解决方案，还是仅仅是权宜之计？
在激烈的商业竞争面前，E-Vita Open NEO HP 的设计和材料选择需要重新考虑。
