Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, 22442Carolinas Medical Center, Charlotte, NC, USA.
171799The University of Tennessee at Chattanooga College of Arts and Sciences, Chattanooga, TN, USA.
Vascular. 2022 Oct;30(5):934-942. doi: 10.1177/17085381211037883. Epub 2021 Aug 29.
Vascular closure devices (VCDs) are widely used for arteriotomy closure after percutaneous catheter-based procedures. In comparison to manual compression, VCDs have been associated with shorter time to hemostasis, shorter time to ambulation, and also decreased length of stay. Complexity of deployment, lack of immediate hemostasis, and residual deformity of the arterial wall remain as limitations of current VCDs. The aim of this study was to investigate the AbsorbaSeal™ 5.6.7F vascular closure device, a novel, completely bioabsorbable, intuitive, and easy to use VCD which uses a compressive, "sandwich"-type design comprising a low profile intravascular distal seal and gasket and an extravascular floating foot and proximal seal, in an open infrarenal aortic swine model.
Eight fully heparinized swine at a good laboratory practices facility underwent AbsorbaSeal™ 5.6.7F VCD closure of three 6F arteriotomies each in the proximal, mid, and distal infrarenal aorta. Two swine underwent harvest at each of four time cohorts: 30, 60, 90, and 120 days. Acute and chronic procedural safety and efficacy, as well as target site vascular remodeling over time, were the primary outcomes evaluated. Secondary outcome measures included local and systemic inflammatory responses, end-organ tissue analysis, and device-related complications through the follow-up periods. Histopathological evaluation was performed by a blinded pathologist. Standard statistical methods were used.
In deployment of 24 AbsorbaSeal™ 5.6.7F VCDs, there were no device-related complications or mortalities. All deployments resulted in rapid arteriotomy seal (100% deployment success), with a mean time to hemostasis (cessation of arterial flow) of 21.5 s (median: 6.5 s) across a mean activated clotting time (ACT) of 356 s. Twenty of the 24 implant sites (83%) attained complete hemostasis within 20 s. Immediate post-implant and pre-termination angiographies at all time points were performed of all swine which demonstrated normal aortic appearance and tissue structure and normal downstream vascular beds. At 30 days, each implant's intravascular distal seal and gasket were removed from the circulation and completely covered with a smooth neointimal layer. Minimal inflammation and no intimal or luminal thrombus were observed at any site at every time point.
AbsorbaSeal™ 5.6.7F is a safe, effective, and secure VCD that demonstrates rapid hemostasis in a fully heparinized open aortic porcine model. Removal from circulation and complete coverage of the intravascular distal seal and gasket with neointima occurred within 30 days post-implant. Natural transmural vessel healing from the arteriotomy itself with minimal inflammation was noted for each implant at every time point.
血管闭合装置（VCD）广泛用于经皮导管介入手术后的动脉切开闭合。与手动压迫相比，VCD 具有更快的止血时间、更快的下床时间，并且住院时间也更短。目前的 VCD 仍然存在一些局限性，如操作复杂性、缺乏即时止血和动脉壁残余畸形。本研究旨在研究 AbsorbaSeal™ 5.6.7F 血管闭合装置，这是一种新型、完全可吸收、直观且易于使用的 VCD，它采用一种压缩的“三明治”式设计，包括一个低轮廓的血管内远端密封垫和垫圈，以及一个血管外浮动脚和近端密封垫。
在一家良好的实验室实践设施中，8 只完全肝素化的猪接受了 AbsorbaSeal™ 5.6.7F VCD 闭合术，每个猪的近、中、远肾下主动脉各进行 3 次 6F 动脉切开术。每个时间队列（30、60、90 和 120 天）进行两次猪的收获。急性和慢性程序安全性和有效性以及随着时间的推移目标部位血管重塑是主要评估的结果。次要结果包括局部和全身炎症反应、终末器官组织分析以及通过随访期间的设备相关并发症。由一位盲法病理学家进行组织病理学评估。使用标准统计方法。
在 24 个 AbsorbaSeal™ 5.6.7F VCD 的部署中，没有发生与设备相关的并发症或死亡。所有的部署都导致了动脉切开术的快速止血（100%的部署成功率），平均止血时间（动脉血流停止）为 21.5 秒（中位数：6.5 秒），平均激活凝血时间（ACT）为 356 秒。24 个植入部位中的 20 个（83%）在 20 秒内完全止血。所有猪都进行了即时植入后和终止前的血管造影，结果显示主动脉外观和组织结构正常，下游血管床正常。在 30 天时，每个植入物的血管内远端密封垫和垫圈从循环中取出，并完全被光滑的新生内膜覆盖。在每个时间点的所有部位均观察到最小的炎症，没有内膜或管腔血栓形成。
AbsorbaSeal™ 5.6.7F 是一种安全、有效且可靠的 VCD，在完全肝素化的开放猪主动脉模型中可快速止血。植入后 30 天内，血管内远端密封垫和垫圈从循环中取出并完全被新生内膜覆盖。每个植入物在每个时间点都表现出从动脉切开术本身引起的自然穿壁血管愈合，炎症最小。
