Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Vascular and Endovascular Surgery, Velindre University NHS Trust, Health & Education Improvement, Wales, UK.
J Card Surg. 2022 Mar;37(3):555-560. doi: 10.1111/jocs.16179. Epub 2021 Dec 14.
Since the introduction of the E-Vita Open NEO aortic prosthesis in 2020, several incidences of post-anastomotic oozing from the polyester portion of the graft have emerged. The use of BioGlue to prime E-Vita Open NEO to prevent this has been suggested as a way to mitigate this worrying complication. We investigate the extent of graft oozing in E-Vita Open NEO and evaluate the use of BioGlue in preventing oozing, both experimentally and in terms of potential clinical complications.
E-Vita Open NEO (in straight and branched configurations) was implanted in a perfused model. The distal stent graft and side branches were clamped, and the graft was pressurized with blood to 120 mmHg. The volume of blood (ml) oozing from the graft within 60 s was measured. Nonpressurized grafts were coated with BioGlue up to a thickness of 1, 2, and 3 mm, and the volume (mm ) of BioGlue required to do so was recorded.
Within 60 s, 250.0 ml of blood oozed from the grafts tested. 43.694, 87.389, and 174.778 mm of BioGlue were required to coat the device with 1, 2, and 3 mm of BioGlue.
Graft oozing from E-Vita Open NEO represents an omnipresent and worrying risk. The use of BioGlue herein is likely associated with several adverse consequences, which are an additional risk on top of that posed by graft oozing. These risks call into question the suitability of E-Vita Open NEO, especially when compared to alternative devices not affected by oozing.
自 2020 年引入 E-Vita Open NEO 主动脉假体以来,已出现几例来自移植物聚酯部分的吻合口渗血事件。建议使用 BioGlue 对 E-Vita Open NEO 进行预处理以防止这种情况,以减轻这种令人担忧的并发症。我们调查了 E-Vita Open NEO 中的移植物渗血程度,并评估了使用 BioGlue 预防渗血的效果,包括实验和潜在的临床并发症。
将 E-Vita Open NEO(直型和分支型)植入灌注模型中。夹闭远端支架移植物和侧支,并用血液将移植物加压至 120mmHg。测量 60 秒内从移植物中渗出的血液量(ml)。未加压的移植物用 BioGlue 涂层,厚度为 1、2 和 3mm,并记录所需的 BioGlue 体积(mm)。
在 60 秒内,从测试的移植物中渗出 250.0ml 的血液。用 1、2 和 3mm 的 BioGlue 涂层装置分别需要 43.694、87.389 和 174.778mm 的 BioGlue。
E-Vita Open NEO 的移植物渗血是一种普遍存在且令人担忧的风险。在此处使用 BioGlue 可能会带来一些不良后果,这是在移植物渗血之外的额外风险。这些风险使得 E-Vita Open NEO 的适用性受到质疑,尤其是与不受渗血影响的替代设备相比。