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可吸收下腔静脉滤器:体内猪模型试验。

Resorbable inferior vena cava filters: trial in an in-vivo porcine model.

机构信息

Department of Surgery, Good Samaritan Hospital, Cincinnati, Ohio, USA.

出版信息

J Vasc Interv Radiol. 2011 Mar;22(3):330-5. doi: 10.1016/j.jvir.2010.11.030.

Abstract

PURPOSE

To determine the feasibility, effects, and complications of a resorbable inferior vena cava (IVC) filter in a porcine model.

MATERIALS AND METHODS

Ten handmade, dual-filtration level, resorbable IVC filters were produced and gas sterilized. A dual-filtration cone was constructed using polyglycolic acid polymer strands oriented in a staggered cone formation with the apex of the cone in a cephalad orientation in relation to the IVC. IVC fixation was accomplished using a nitinol Z-stent, which was not resorbable. Operative insertion employing a paramedian incision, infrarenal vena caval dissection, venotomy, and device insertion using an 8-F rigid sheath was performed on 10 Yorkshire-type pigs (> 50 lb). Percutaneous delivery was not performed because of cost constraints. The IVC filters were operatively removed en bloc 6 weeks after implantation, and the pigs were euthanized. The IVC specimens were subsequently analyzed grossly and using light microscopy.

RESULTS

In 9 (90%) of the 10 retrieved devices, the filtration cones were completely dissolved. One device (10%) had a retained strand of filtration cone material completely incorporated into the caval wall, excluded from luminal flow. Significant inflammatory response was appreciated from the specimen histology, and significant collagen deposition was observed, especially on trichrome staining. The intima and media of 9 of 10 specimens were two to three times normal thickness. Significant reactive change was also appreciated in the pericaval lymph nodes that were taken in the specimen. One pig (10%) developed a postoperative wound infection requiring treatment.

CONCLUSIONS

Resorbable IVC filters are feasible and could be used for specific patient populations. This study outlines the need for further research of bioabsorbable polymers, absorption mechanics in the vascular system, absorption times, efficacy models, and practical application.

摘要

目的

在猪模型中确定可吸收下腔静脉(IVC)过滤器的可行性、效果和并发症。

材料和方法

制作了 10 个手工制作的、具有双重过滤水平的可吸收 IVC 过滤器,并进行了气体灭菌。使用聚乙二醇酸聚合物线构建了一个双重过滤锥体,这些线以交错的锥体形式定向,锥体的顶点朝向 IVC 的头侧。使用不可吸收的镍钛诺 Z 支架实现 IVC 固定。通过旁正中切口、肾下腔静脉解剖、静脉切开术和使用 8-F 刚性护套插入装置在 10 头约克夏型猪(>50 磅)上进行手术插入。由于成本限制,未进行经皮递送。在植入后 6 周,整块操作取出 IVC 过滤器,然后对猪进行安乐死。随后对 IVC 标本进行大体和光镜分析。

结果

在 10 个回收装置中,有 9 个(90%)的过滤锥体完全溶解。一个装置(10%)有一条保留的过滤锥体材料的线完全嵌入腔壁,排除在管腔血流之外。标本组织学显示明显的炎症反应,观察到明显的胶原沉积,尤其是在三色染色上。10 个标本中的 9 个标本的内膜和中膜厚度是正常的两到三倍。在标本中取出的腔周淋巴结也观察到明显的反应性变化。一只猪(10%)术后发生伤口感染,需要治疗。

结论

可吸收 IVC 过滤器是可行的,可以用于特定的患者群体。本研究概述了对生物可吸收聚合物、血管系统中的吸收机制、吸收时间、疗效模型和实际应用进行进一步研究的必要性。

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